Medtronic Powered Surgical Solutions May 22, 2019 Jenna … · 2019-06-10 · Jenna Groves...
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U.S. Food & Drug Administration 10903 New Hampshire Avenue Doc ID# 04017.04.03 Silver Spring, MD 20993 www.fda.gov Medtronic Powered Surgical Solutions May 22, 2019 Jenna Groves Regulatory Affairs Manager 4620 North Beach Street Fort Worth, Texas 76137 Re: K183644 Trade/Device Name: Stealth-Midas MR8 System Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic instrument Regulatory Class: Class II Product Code: OLO, HAW Dated: December 21, 2018 Received: December 26, 2018 Dear Jenna Groves: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
Transcript of Medtronic Powered Surgical Solutions May 22, 2019 Jenna … · 2019-06-10 · Jenna Groves...
U.S. Food & Drug Administration
10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 4 . 0 3
Silver Spring, MD 20993
www.fda.gov
Medtronic Powered Surgical Solutions May 22, 2019
Jenna Groves
Regulatory Affairs Manager
4620 North Beach Street
Fort Worth, Texas 76137
Re: K183644
Trade/Device Name: Stealth-Midas MR8 System
Regulation Number: 21 CFR 882.4560
Regulation Name: Stereotaxic instrument
Regulatory Class: Class II
Product Code: OLO, HAW
Dated: December 21, 2018
Received: December 26, 2018
Dear Jenna Groves:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
K183644 - Jenna Groves Page
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801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good
manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820)
for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if
applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-
1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn
(http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and
Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website
(http://www.fda.gov/DICE) for more information or contact DICE by email ([email protected]) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
For;
CAPT Raquel Peat, PhD, MPH, USPHS
Director
Office of Health Technology 6
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below.
510(k) Number (if known)K183644
Device NameStealth-Midas MR8 System
Indications for Use (Describe)The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(k) Summary
December 17, 2018
I. Company: Medtronic Powered Surgical Solutions4620 North Beach Street Fort Worth, TX 76137 Telephone Number: (817) 788-6400
Contact: Jenna Groves Regulatory Affairs Manager Telephone Number: (817) 788-6686 Fax: (817) 788-6222 Email: [email protected]
II. Proprietary Trade Name: Stealth-Midas MR8 System
III. Common Name: Orthopedic, Neurologic Stereotaxic Instrument
IV. Classification Name: Stereotaxic Instrument (21 CFR 882.4560)
V. Classification: Class II
VI. Product Code(s): OLO, HAW
VII. Product Description:
The Stealth-Midas MR8 consists of electric and pneumatic drill handpieces that feature anoptical navigation tracker, enabling navigation in conjunction with the StealthStation S8System and the Integrated Power Console (IPC). The system allows the navigation of aselection of currently available surgical dissecting tools. The navigated handpieces areprovided non-sterile and are reusable. The associated attachments are provided non-sterile andare reusable. The associated surgical dissecting tools and MR8 ClearView burs are providedsterile and are single-use.
VIII. Indications for Use:
The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
IX. Identification of Legally Marketed Devices (Predicate Devices):
• Stealth-Midas System (K160713)
K183644
Page 1 of 9.
• MR8 Drill System (K183515)
X. Comparison of the Technological Characteristic:The only significant difference between the subject navigated handpieces and the currentlycleared navigated handpieces are minor changes to the optical tracker geometry.
The passive optical tracking technology is identical to that employed in the use of thepredicate navigated instrument. Navigational accuracy testing confirms that the subjectnavigated drill system is as accurate as the predicate system.
The currently cleared MR8 Drill System consists of pneumatic and electric handpieces,attachments, and surgical dissecting tools that are indicated for various cranial and spinalprocedures. There are no changes to any of the attachments or surgical dissecting tools. Theonly significant difference between the subject handpiece and the currently available MR8handpiece is the addition of a passive optical tracker to the hind to enable navigation of aselection of dissecting tool. As a drill, the Stealth-Midas MR8 is identical to the MR8 drillsystem, with the exception, as stated, an optical tracker has been attached to the hind of thehandpiece to allow navigation. The addition of the tracker does not impact the ability of thedrill system to perform to their intended use as a drill system. See below table for acomparison of qualitative characteristics.
K183644, Page 2 of 9.
Feature Stealth-Midas System MR8 (subject devices)
Stealth Midas System (primary predicate) K160713
MR8 Drill System and MR8 ClearView (secondary predicate) K183515
Equivalence Discussion
Regulation 21 CFR 882.4560 (Stereotaxic Instrument)
21 CFR 882.4560 (Stereotaxic Instrument)
21 CFR 882.4360 (Motor, Drill, Electric) 21CFR 882.4370 (Motor, Drill, Pneumatic) 21 CFR 882.4310 (Drills, Burs, Trephines & Accessories
Same As a navigated drill, the Stealth-Midas MR8 falls into the same regulation number as the primary predicate Stealth-Midas and has the same intended use. Similar The Stealth-Midas MR8 operates and performs the same as the predicate MR8 drill and falls into a similar regulation.
Product Code OLO, HAW OLO HBC, HBB, HBE, ERL, HSZ Equivalent
The Stealth-Midas MR8 System is indicated for use in navigated cranial and spinal procedures. As such, it carries the same OLO product code (orthopedic stereotaxic instrument) as predicate Stealth-Midas spine instruments and also includes product code HAW (neurological stereotaxic). HAW falls within the same regulation number 21 CFR 882.4560 and has the same intended use as OLO.
Intended Use Incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials.
Incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials.
Incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials.
Equivalent
The Navigated Electric and Pneumatic Stealth-Midas MR8 motors, with the tracker on the hind of the motor, allow for optical tracking of the -tip at the surgical site. The subject Stealth-Midas MR8 and the predicate devices have the same intended use.
As a drill system the subject system intended use is identical to that of the predicate drill system. The only difference between the subject and the predicate MR8
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Handpieces is that the proposed Stealth-Midas MR8 Handpieces are supplied with a Tracker on the hind of the Handpieces.
Indications for Use
The Stealth-Midas MR8 System is indicated for the drilling, burring and removal of hard tissue and bone in spinal and cranial surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
The Stealth-Midas System is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in spinal surgical procedures. Computer-assisted surgery and its associated applications are intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as a long bone, or vertebra, can be identified relative to a CT- or MR-based model, fluoroscopic images, or digitized landmarks of the anatomy.
The Medtronic MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials in Neurosurgical (Cranial and Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures. Additionally, the MR8 Drill System is indicated for the incision/cutting, removal, drilling, and sawing of soft and hard tissue, bone, and biomaterials during open and minimally invasive spine procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures: • LumbarMicrodiscectomy• Lumbar StenosisDecompression• Posterior LumbarInterbody Fusion (PLIF)
Equivalent
The Navigated Electric and Pneumatic Stealth-Midas MR8 motors, with the tracker on the hind of the motor, allow for optical tracking of the tool-tip at the surgical site. The subject Stealth-Midas MR8 and the predicate devices have the same intended use, but the subject device is indicated for both cranial and spinal applications and the predicate Stealth-Midas is indicated for spinal applications.
As a drill system the subject system intended use is identical to that of the predicate MR8 drill system. The only difference between the subject motor and the predicate motor is the Stealth-Midas MR8 motors are supplied with a tracker on the hind of the handpieces/motor. The subject motor and the predicate motor are both indicated for spinal and cranial applications.
K183644, Page 4 of 9.
• Transforaminal LumbarInterbody Fusion (TLIF)• Anterior LumbarInterbody Fusion (ALIF)• Direct LateralInterbody Fusion (DLIF)The Midas Rex MR8ClearView Tools areused only in conjunctionwith the MR8 DrillSystem to perform asintended. Please refer to the MidasRex MR8Drill System andassociated User’s Guidesfor the Indications ofUse.
StealthStation Operating Principle (Tracking Method)
Optical (infra-red) Optical (infra-red) N/A Identical The Operating Principle of the subject Stealth-Midas MR8 device is identical to the predicate Stealth-Midas
StealthStation System Accuracy Requirements
3D Accuracy Testing: <2.00 mm 2D Accuracy Testing: <3.00 mm
3D Accuracy Testing: ≤2.27 mm 2D Accuracy Testing: ≤2.98 mm
N/A Equivalent The StealthStation S8 System accuracy requirements are equivalent to the StealthStation S7 System accuracy requirements. Accuracy validation testing conducted on the subject device confirms the Stealth-Midas MR8 when used with StealthStation S8 is equivalent in accuracy as the predicate Stealth-Midas when used with StealthStation S7.
System Components
• Electric Handpiece w/Passive Optical Tracker
• Pneumatic Handpiece w/Passive Optical Tracker
• Attachments• Surgical Dissecting
Tools
• Electric Handpiece w/Passive Optical Tracker
• Pneumatic Handpiece w/Passive Optical Tracker
• Attachments• Surgical Dissecting Tools
• Electric Handpiece• Pneumatic Handpiece• Attachments• Surgical Dissecting Tools
Equivalent
As a drill system the components are identical to those of the predicate MR8 drill system. The only difference is an improvement to the secondary lock mechanism that requires a ¼ turn instead of multiple rotations. Additional markings
K183644, Page 5 of 9.
were added to the subject handpiece to provide a visual aid when locking.
Navigation compatibility is enabled by use of a passive optical tracker, which is nearly identical to the tracker of the predicate navigated drills. The only difference is the tracker on the subject device has a slightly different geometry to allow differentiation from the predicate Stealth-Midas device.
The Stealth-Midas MR8 offers a single downward orientation for angled attachments versus the Stealth-Midas predicate device that offered a right or left downward orientation angled attachment. The single downward orientation versus a right/left orientation has no impact on functionality, performance or accuracy of the Stealth-Midas MR8 device
. Surgical Dissecting Tools – Overall Length
3-42 cm 3-42 cm 3-42 cm Similar
As a drill system there are no changes to currently marketed components. Select surgical dissecting tools, identified in the device description, will be compatible with spinal and/or cranial navigation.
Surgical Dissecting Tools – Head Diameter
0.5 – 25 mm 0.5 – 25 mm
0.5 – 25 mm Similar
As a drill system there are no changes to currently marketed components. Select surgical dissecting tools and MR8 ClearView burs, as identified in the device description, will be compatible with spinal and/or cranial navigation.
Attachment Length 2 – 40 cm
2 – 40 cm 2 – 40 cm Similar
K183644, Page 6 of 9.
As a drill system there are no changes to currently marketed components. Select combinations of surgical dissecting tools, MR8 ClearView burs and attachments, as identified in the device description, will be compatible with spinal or cranial navigation.
Drill System Operating Principle
• Electric (Powered byIPC)
• Pneumatic (Powered byPneumatic Pressure)
• Electric (Powered by IPC)• Pneumatic (Powered by
Pneumatic Pressure)
• Electric (Powered by IPC)• Pneumatic (Powered by
Pneumatic Pressure)
Identical The operating principle of the subject handpiece and the predicate handpieces are identical.
System Interface • IPC• StealthStation System
• IPC• StealthStation
System
• Electric (Powered by IPC)• Pneumatic (N/A)
Equivalent Both the subject Stealth-Midas MR8 and the predicate Stealth-Midas interface with the StealthStation. The predicate device interfaces with the StealthStation S7 System and the subject device interfaces with the StealthStation S8 System.
Sterilization & Cleaning
• Non-sterile (Handpieces,Attachments)
• Sterile (SurgicalDissecting Tools andMR8 ClearView burs)
• Non-sterile (Handpieces,Attachments)
• Sterile (Surgical DissectingTools and ClearView burs)
• Non-sterile (Handpieces,Attachments)
• Sterile (Surgical DissectingTools and MR8 ClearViewinstrument)
Similar
The subject system will be used with currently cleared Attachments as well as Surgical Dissecting Tools and MR8 ClearView burs available with the MR8 Drill System. The sterilization and cleaning parameters for the handpieces are similar to those of the predicate handpieces.
Materials Attachments: Stainless Steel, Aluminum, Ceramic, Phenolic, Epoxy, Chrome Coated Brass, Torlon 4301
Surgical Dissecting Tools: Stainless Steel, Tool Steel, Alloy Steel, Carbide, TDC Coating, Diamond Coating
Attachments: Stainless Steel, Aluminum, Ceramic, Phenolic, Epoxy, Chrome Coated Brass, Torlon 4301
Surgical Dissecting Tools: Stainless Steel, Tool Steel, Alloy Steel, Carbide, TDC Coating, Diamond Coating in
Attachments: Stainless Steel, Aluminum, Ceramic, Phenolic, Epoxy, Chrome Coated Brass, Torlon 4301
Surgical Dissecting Tools: Stainless Steel, Tool S teel, Alloy Steel, Carbide, TDC
Identical
The subject device uses identical materials to the primary and secondary predicate.
K183644, Page 7 of 9.
in Nickel Substrate, Titanium Nitride
Tracker: Aluminum
Nickel Substrate, Titanium Nitride
Tracker: Aluminum
Coating, Diamond Coating in Nickel Substrate, Titanium Nitride
Tracker: N/A
K183644, Page 8 of 9.
XI. Discussion of the Performance Testing
Testing was completed to ensure the functionality and compatibility with the identifiedMedtronic products. The following table summarizes the performance testing completed:
Test Description Navigation Accuracy Analysis Confirmed navigated instrument accuracy CAD Model Evaluation Verified that CAD models are accurately
reflected in the application software Formative Usability Confirmed users can follow the navigated
workflow and assemble the device Summative Testing Confirmed users can safely and effectively
use the Stealth-Midas MR8 navigated drill handpiece with the StealthStation S8 software.
XII. Conclusions
The Stealth-Midas MR8 System has been shown through comparison and testing to besubstantially equivalent to the identified predicate devices.
K183644, Page 9 of 9.
