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 (Craniofacial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Sternotomy, and General Surgical Procedures.

Device Description

The MR8 Drill System consists of electric and pneumatic drill handpieces, attachments, surgical dissecting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The surgical dissecting tools are provided sterile and are single use.

AI/ML Overview

The document provided is a 510(k) summary for the Medtronic MR8 Drill System. It describes the device, its intended use, and comparison to predicate devices, along with a summary of performance testing. However, it does not provide the detailed acceptance criteria and study information typically found in a clinical study report for an AI/ML medical device. The MR8 Drill System is a surgical drill, not an AI/ML device.

Therefore, many of the requested sections below, such as details on AI performance, sample sizes for training/test sets, expert ground truth establishment, adjudication methods, and MRMC studies, are not applicable to this submission. The information provided primarily focuses on the substantial equivalence of a physical surgical device.

1. Table of Acceptance Criteria and the Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the performance tests in the same way typical for AI/ML performance, but rather states the criteria implicitly by comparing to predicate devices or conformity to standards.

Test	Acceptance Criteria (Implicit from document)	Reported Device Performance
Motor Speed/Torque Analysis	Speed/torque profile similar to that of predicate Legend device	Speed/torque profile is similar to that of predicate Legend device
Drill System Cutting Performance	Cutting performance equivalent or better to that of predicate device in terms of tool chatter and hand vibration	Cutting performance was equivalent or better to that of predicate device
Electrical Safety	Conformance to IEC 60601-1:2005	Instruments conform to IEC 60601-1:2005 for electrical safety.
Electromagnetic Compatibility	Conformance to IEC 60601-1-2:2014	Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility.
Cadaveric Simulated Use (Usability)	Acceptable for its intended use in various surgical procedures by users	MR8 Drill System acceptable for its intended use in various surgical procedures (as evaluated by users on cadavers)

Regarding AI/ML Specific Information (Many are Not Applicable to this Device):

This device is a surgical drill system, a physical medical device, and not an AI/ML-driven diagnostic or therapeutic device. Therefore, the following sections are largely not applicable based on the provided FDA submission summary.

2. Sample size used for the test set and the data provenance: Not applicable. The "test set" for this device involved physical product testing and cadaveric use. Specific sample sizes for the cadaveric study are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable in the context of AI/ML ground truth. For the cadaveric study, professional users (surgeons/medics) would have evaluated the device, but specific numbers and qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device and study.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the cadaveric use, the "ground truth" would be the subjective and objective assessment of the device's performance and acceptability by the users during surgical simulation. For other tests, it's conformance to technical specifications and safety standards.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 28, 2017

Medtronic Powered Surgical Solutions % John Connor Senior Regulatory Affairs Specialist Medtronic Navigation 826 Coal Creek Circle Louisville, Colorado 80027

Re: K163565

Trade/Device Name: MR8 Drill System Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBB, HSZ, ERL, HBE Dated: December 16, 2016 Received: December 19, 2016

Dear Mr. Connor:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael J. Hoffmann -S

Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name MR8 Drill System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

|X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

December 19, 2016

I. Company: Medtronic Powered Surgical Solutions 4620 North Beach St. Fort Worth, TX 76137 Telephone Number: (817) 788-6400
- Contact: John Connor Senior Regulatory Affairs Specialist Telephone number: (720) 890-2311 Fax: (720) 890-3500 Email: john.m.connor@medtronic.com
II. Proprietary Trade Name: MR8 Drill System
III. Common Name: Powered Drill System
IV. Classification Name: Motor, Drill, Electric (21 CFR 882.4360) Motor, Drill, Pneumatic (21 CFR 882.4370) Drill, Surgical, ENT (21 CFR 874.4250) Drills, Burs, Trephines & Accessories (21 CFR 882.4310)
V. Classification: Class II
Product Code: HBC, HBB, HSZ, ERL, HBE VI.

VII. Product Description:

VIII. Indications for Use:

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.

IX. Identification of Legally Marketed Devices (Predicate Devices)

Midas Rex Legend EHS Electric Drill System (K081475)

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Midas Rex MR7 Pneumatic High Speed System (K090112) ●
Midas Rex Legend System (K020069)

X. Comparison of the Technological Characteristics:

The currently available Midas Rex Drill System consists of pneumatic and electric handpieces, attachments, surgical dissecting tools, and system accessories. The subject drill system remains similar to the predicate drill system in terms of operating principles, where air and/or electric energy is supplied to the handpiece to provide power to operate interchangeable Surgical Dissecting Tools supported by Attachments and intended for use in various surgical procedures to remove soft and hard tissue, bone, and biomaterials. The materials used in design and manufacturing of the drill system remain similar to those of the predicate drill system. Minor design changes were made to the electric/pneumatic handpieces and the attachments to both improve the performance/efficiency of the drill system. None of the changes to the system impact safety and effectiveness or its ability to perform to its intended use as a drill system.

XI. Discussion of the Performance Testing

Testing was completed to ensure the functionality of the new drill system. The following table summarizes the performance testing completed:

Test	Description	Results
Motor Speed/TorqueAnalysis	Analyzed motor speed/torque profile in comparison to predicate devices	Speed/torque profile is similar to that of predicate Legend device
Drill System CuttingPerformance	Cutting performance was compared to predicate drill system in terms of tool chatter and hand vibration	Cutting performance was equivalent or better to that of predicate device
Electrical Safety	Electric powered instruments evaluated for electrical safety	Instruments conform to IEC 60601-1:2005 for electrical safety.
ElectromagneticCompatibility	Electric powered instruments evaluated for electromagnetic compatibility	Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility.
Cadaveric SimulatedUse	Users evaluated the acceptability of the subject drill system to its intended use on a variety of procedures using cadavers	MR8 Drill System acceptable for its intended use in various surgical procedures

XII. Conclusions

The MR8 Drill System has been shown through comparison and testing to be substantially equivalent to the identified predicate devices.

Regulation Number and Section

§ 882.4360 Electric cranial drill motor.

(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).