The Electric Drill System is a electrically operated surgical instrument system. The electric motor provides power to operate removable rotating surgical cutting tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as Ear Nose and Throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial and sternotomy surgeries.

Additionally, the Electric 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:

Lumbar Microdiscectomy
Lumbar Stenosis Decompression
Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Anterior Lumbar Interbody Fusion (ALIF)
Direct Lateral Interbody Fusion (DLIF)

Device Description

The Electric Drill System consists of an electric Integrated Power Console, Electric Foot Control unit with Y-Splitter, Connection Cables, Irrigation/Cooling Sets including a remote Irrigation Control Unit, and various Electric Handpieces and/or electric motors and Attachments to drive various Surgical Dissecting Tools. The Integrated Power Console device of the Electric Drill System can also function as an endoscope lens cleaning system.

AI/ML Overview

Thank you for providing the detailed documentation for the Medtronic Powered Surgical Solutions. However, after careful review, I must inform you that the provided information does not contain the specific details required to complete your request for acceptance criteria and a study proving a device meets those criteria.

The document is a 510(k) premarket notification for an Electric Drill System. While it discusses the device's indications for use and compares it to predicate devices, it primarily focuses on demonstrating substantial equivalence to previously cleared devices.

Here's why the requested information is not available in the provided text:

Acceptance Criteria for Device Performance: The document does not explicitly state quantitative or qualitative "acceptance criteria" for the device's performance that would typically be associated with a new or significantly modified device needing to demonstrate its capabilities against specific benchmarks. The focus is on demonstrating that the device performs similarly to previously cleared devices for its expanded indications.
Study Proving Device Meets Acceptance Criteria: Consequently, there is no detailed study described that proves the device meets such acceptance criteria. The performance testing sections (9.12) describe a "Clinical Literature Review" and "Cadaveric Testing."
- The Clinical Literature Review supports the use of the system for expanded indications, but doesn't quantify device performance against specific targets.
- The Cadaveric Testing states that "The Medtronic Electric Drill System is acceptable for its intended use in various surgical procedures," which is a qualitative conclusion rather than a demonstration against defined acceptance metrics. There are no details about what was measured, how it was measured, or what values would be considered acceptable.

Therefore, I cannot provide the requested table or detailed information regarding sample sizes, data provenance, ground truth establishment, or specific performance metrics from the provided document.

The document's purpose is to establish substantial equivalence based on comparable performance and indications for use, rather than to present a de novo study with explicit acceptance criteria for a new device's performance.

Summary

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Public Health Service

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

Medtronic Powered Surgical Solutions % Xiaojian Sun Sr. Regulatory Affairs Specialist Medtronic Neurosurgery 125 Cremona Dr. Goleta, California 93117

Re: K170312

Trade/Device Name: IPC Systems, Legend EHS Handpieces and Legend Stylus Touch Handpiece, Microsaw Handpieces, Triton Electric High Torque Handpiece, Attachments and Surgical Dissecting Tools Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBE, HRX, HWE, EOJ, ERL, KFK Dated: January 31, 2017 Received: February 1, 2017

May 15, 2017

Dear Xiaojian Sun:

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

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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 the quality systems (QS) 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.

Michael J. Hoffmann -S

for

Carlos L. Peña, PhD, MS 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) K170312

Device Name

IPC Systems, Legend EHS Handpieces and Legend Stylus Touch Handpieces, Triton Electric High Torque Handpiece, Attachments and Surgical Dissecting Tools

Indications for Use (Describe)

Lumbar Microdiscectomy
Lumbar Stenosis Decompression
Posterior Lumbar Interbody Fusion (PLIF)
Transforaminal Lumbar Interbody Fusion (TLIF)
Anterior Lumbar Interbody Fusion (ALIF)
Direct Lateral Interbody Fusion (DLIF)

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)

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SECTION 9: 510(k) SUMMARY

This summary is submitted in accordance with the requirements of 21CFR807.92.

9.1 DATE PREPARED

January 31, 2017

9.2 NAME AND ADDRESS OF MANUFACTURER

Table 4: Manufacturer information

Establishment Name	Establishment Registration Number
Medtronic Powered Surgical Solutions4620 North Beach StreetFort Worth, TX 76137 USA	1625507
Medtronic Xomed, Inc.6743 Southpoint Drive NorthJacksonville, FL 33216 USA	1045254

9.3 CONTACT PERSON

Xiaojian Sun Senior Regulatory Affairs Specialist 805.571.8758 Telephone: E-Mail: xiaojian.sun@medtronic.com

9.4 PROPRIETARY NAME OF THE PROPOSED DEVICES

IPC Systems, Legend EHS Handpieces and Legend Stylus Touch Handpiece, Microsaw Handpieces, Triton Electric High Torque Handpiece, Attachments and Surgical Dissecting Tools

9.5 COMMON/USUAL NAME

Surgical Drill Motors and Accessories

9.6 DEVICE CLASSIFICATION NAME

Table 5: FDA device classification information

Description	FDA Code	Regulation Number
Drills, burrs, trephines and accessories (simple, powered)	HBE	21CFR882.4310
Motor, drill, electric	HBC	21CFR882.4360
Arthroscope	HRX	21CFR888.1100
Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment	HWE	21CFR878.4820
Bur, ear, nose and throat	EQJ	21CFR874.4140
Drill, surgical, ent (electric or pneumatic) including handpiece	ERL	21CFR874.4250
Saw, pneumatically powered	KFK	21CFR878.4820

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9.7 PREDICATE DEVICE IDENTIFICATION

SUBJECT SYSTEM DESCRIPTION	PREDICATE
	SYSTEM DESCRIPTION	510(k) NUMBER
Medtronic Electric Drill System	Electric Drill System [XPS 4000 System, MidasRex Legend EHS System, IPC)	K081475
- IPC (Integrated Power Console)	- IPC (Integrated Power Console)	K081475
- Legend EHS Handpieces	- Legend EHS Handpieces	K081475, K012457
- Legend Stylus Touch Handpiece	- Legend Stylus Touch Handpiece	K081475, K012457
- Microsaw Handpieces and Blades	- Microsaw Handpieces and Blades	K081475
- Surgical Dissecting Tools	Surgical Dissecting Tools	K020069
- Surgical Dissecting Tools (Curved Bur)	- Surgical Dissecting Tools (Curved Bur)	K072315
- Legend Attachments	- Legend Attachments	K020069
- Electric Foot Pedal and Y-Splitter	- Electric Foot Pedal and Y-Splitter	K081475
- Irrigation Tubing Sets	- Irrigation Tubing Sets	K081475
- System Accessories	- System Accessories	K081475
Triton Electric High Torque Handpiece	Triton Electric High Torque Handpiece	K121264
- Triton Electric High Torque Handpiece	- Triton Electric High Torque Handpiece	K121264
- Surgical Dissecting Tools	Surgical Dissecting Tools	K121264, K870157
- Attachments	- Attachments	K121264, K870157
- System Accessories	- System Accessories	K121264, K870157
Legend Electric High Speed Drill System	Legend Electric High Speed Drill System	K012457
- Electric Handpiece	Electric Handpiece	K081475, K012457
- Surgical Dissecting Tools	Surgical Dissecting Tools	K020069
- Surgical Dissecting Tools (Curved Bur)	- Surgical Dissecting Tools (Curved Bur)	K072315
- Legend Attachments	- Legend Attachments	K020069

Table 6: Subject Devices that are in the scope of this Submission

9.8 DEVICE DESCRIPTION

The device design, function, the intended use and the general operating principles, and conditions of use of the overall Medtronic Electric Drill System remain similar to those cleared under K012457, K081475, and K121264.

The surgical dissecting tools and attachments remain similar to those covered under K870157, K020069, and K072315.

9.9 INDICATIONS FOR USE

Additionally, the Electric 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

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procedures, which may incorporate application of various surgical techniques during the following lumbar spinal procedures:

Lumbar Microdiscectomy O
Lumbar Stenosis Decompression o
Posterior Lumbar Interbody Fusion (PLIF) o
Transforaminal Lumbar Interbody Fusion (TLIF) o
Anterior Lumbar Interbody Fusion (ALIF) O
Direct Lateral Interbody Fusion (DLIF) O

9.10 COMPARISON OF INTENDED USE

The expanded indication of the subject device did not alter the intended use of the device, which is to remove soft and hard tissue, bone, and biomaterials during surgical procedures. The cadaveric study demonstrated that the addition of the proposed indications do not present any new issues of safety or effectiveness, and the systems perform as intended during surgical use, similar to the use during other various surgical procedures on currently cleared indications. Therefore it is concluded that the subject device has the same intended use as the predicate device.

9.11 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Electrically powered drill system, designed to remove soft and hard tissue, and bone, and biomaterials is the technological principle for both the subject and predicate systems.

The subject and predicate systems are based on the following same technological elements:

A Electric Drill System Application: Designed to remove soft and hard tissue, bone, and biomaterials during various surgical applications.
Operating Principle: The 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.

In terms of the materials used in manufacturing of the patient contacting components of the subject Electric Drill System, the subject Attachments, Surgical Dissecting Tools, and irrigation tubing sets are similar to the predicates.

DISCUSSION OF THE PERFORMANCE TESTING 9.12

TEST	DESCRIPTION	RESULTS
ClinicalLiteratureReview	A comprehensive clinical literaturesearch was conducted and reviewedregarding the safe and effective useof the Electric Drill System for theexpanded indications for use, whichis the subject of this submission.	The review of supporting literaturesupports the use of the MedtronicElectric Drill System in LM, PLIF,TLIF, LSD, ALIF, and DLIF spinalsurgical procedures, as well as anyvariations of these procedures.

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CadavericTesting	Users evaluated the acceptability ofthe subject electric drill system to itsintended use on a variety ofprocedures using cadavers.	The Medtronic Electric Drill Systemis acceptable for its intended use invarious surgical procedures.
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CONCLUSION 9.13

The subject Medtronic Electric Drill Systems when compared to the predicate Drill Systems have same intended use, where the subject and the predicate drill systems are intended for use in various surgical procedures to remove soft and hard tissue, and biomaterials. Results of cadaveric testing have demonstrated that the addition of the proposed indications do not present any new issues of safety or effectiveness, and the systems perform as intended during surgical use, similar to the use during various other surgical procedures on currently cleared indications.

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).