The IPC System with the TRITON Electric High-Torque Handpiece is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

Device Description

The purpose of this submission is to add a new handpiece and an accompanying software module as a line extension to the current Integrated Power Console IPC® System. The handpiece is powered by the previously cleared integrated Powered Console. In order to operate the TRITON Electric Handpiece, the IPC will be equipped with the appropriate software module to drive the handpiece. The handpiece is used for sawing, drilling, driving and placing screws, wires and pins when used in conjunction with various attachments previously cleared for use during spinal surgery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the TRITON Electric High Torque Handpiece and Software Module, a device used in various surgical procedures. The submission aims to demonstrate substantial equivalence to previously cleared predicate devices based on laboratory bench testing.

Here's an analysis of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Metric	Acceptance Criteria (from predicate device/general safety)	Reported Device Performance (TRITON Handpiece)
Maximum Applied Torque	7 Nm (Predicate Device)	With Attachment: 3.1 Nm
Range of Speed	0 - 250 rpm (Predicate Device)	With Attachment: 0 - 250 rpm Free Run: 0 to max free run speed of 1250 - 1800 rpm
Range of Safe Working Temperatures	48°C max (Predicate Device)	Max temperature through the entire operatingrange at any external surface location onhandpiece shall be less than 51 °C for less than1 minute and shall not exceed 48 °C for lessthan 10 minutes
Duty Cycle	Continuous Operation (Predicate Device)	Cycle Time: 20 seconds on maximum / 20seconds off minimumMaximum number of cycles before restinghandpiece: 6Maximum number of cycles before restingattachment: 3Minimum rest period: 25 minutes
Performance Characteristics	Substantially equivalent to predicate devices	Laboratory bench testing demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of clinical data or patient samples. The testing described is laboratory bench testing. Therefore, the concept of sample size for clinical test data or data provenance (country of origin, retrospective/prospective) is not applicable here as the study is not a clinical trial involving human subjects or patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. As the study is based on laboratory bench testing, there is no "ground truth" derived from expert consensus on clinical cases. The performance metrics are objectively measured physical properties of the device.

4. Adjudication Method for the Test Set

Not applicable. There is no expert adjudication for laboratory bench testing of device performance characteristics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document makes no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it discuss human readers or AI assistance. This submission pertains to a surgical handpiece, not an imaging or diagnostic device typically evaluated with MRMC studies.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This device is a physical surgical tool with an accompanying software module to control its operation. It is not an AI algorithm or a standalone diagnostic tool that would operate without human intervention. The "standalone" performance here refers to the device's functional characteristics as measured in a lab.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is based on objective physical measurements obtained during laboratory bench testing. These measurements are compared against the performance characteristics of predicate devices, which serve as the reference for establishing substantial equivalence.

8. Sample Size for the Training Set

Not applicable. The document describes a physical medical device (surgical handpiece) and its controlling software. There is no "training set" in the context of machine learning. The software module is designed to drive the handpiece and recognize its control parameters, not to learn from a data set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no machine learning "training set," there is no ground truth established for it. The software's functionality is pre-programmed based on engineering design and specifications.

Summary

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K12/264

5. 510(k) Summary

AUG 2 7 2012

This summary of safety and effectiveness is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Address of Manufacturer:	Medtronic Powered Surgical Solutions4620 North Beach StreetFort Worth, TX 76137(817) 788-6400 Phone
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(817) 788-6222 Facsimile

Establishment Registration Number: 1625507

Contact Person:

Date:

Trade or Proprietary Name:

Jeffrey Henderson VP, Quality, Clinical & RA

August 10, 2012

TRITON Electric High Torque Handpiece and Software Module

IPC System with the TRITON High Torque Handpiece

Common usual or Classification Name:

21 CFR 882.4360, Product Code HBC, Class II - Electric cranial drill motor

21 CFR 882.4310, Product Code HBE, Class II - Powered simple cranial drills, burrs, trephines, and their accessories

21 CFR 888.1100, Product Code HRX, Class II - Arthroscope

21CFR 878.4820, Product Code HWE, Class I - Surgical instrument motors and accessories/attachments

Description:

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The TRITON Electric High Torque Handpiece has the identical attachment connecting interfacing components as the handpiece cleared under K870157. As a result, the TRITON Electric High Torque Handpiece utilizes the same Attachments and Blades as those cleared under K870157.

Indications for Use:

The TRITON Electric High-Torque Handpiece is indicated for the incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone, and biomaterials in Neurosurgical (Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical procedures.

Predicate Device Identification:

The Medtronic TRITON Electric High Torque Handpiece and Software Module is substantially equivalent to the following predicate devices:

Device	Manufacturer	510(k) Number	Clearance Date
XPS 4000 System, Midas RexLegend EHS System, IntegratedPower Console (IPC)	Medtronic Xomed, Inc.	K081475	10/17/2008
XPS 4000 System, Midas RexLegend EHS System, IntegratedPower Console (IPC)	Medtronic Xomed, Inc.	K081277	09/05/2008
IPC® POWEREASETM System510(k) K111520	Medtronic Xomed, Inc.	K111520	10/26/2011

Table 1: Predicate Devices for the IPC System with TRITON High Torque Handpiece

Comparison to Predicate Device:

The TRITON Electric High Torque Handpiece and Software Module are similar in device design, function, intended use and fundamental scientific technology to the previously cleared devices listed above.

Table 2: Comparison of Subject Device to Predicate Device

Feature	Proposed IPC TM System w/ TRITONHigh Torque Handpiece	Predicate Devices
Intended Use	Integrated Powered Console System w/TRITON HandpieceThe IPC® system is indicated for theincision / cutting, removal, drilling, andsawing of soft and hard tissue andbone, and biomaterials inNeurosurgical (Cranial, Craniofacial)Orthopedic, Arthroscopic, Spinal,Sternotomy, and General surgicalprocedures. The IPC® provides powerto various drills and saws to drive	Integrated Powered Console - K081475The IPC® system is indicated for theincision / cutting, removal, drilling, andsawing of soft and hard tissue and bone,and biomaterials in Neurosurgical(Cranial, Craniofacial) Orthopedic,Arthroscopic, Spinal, Sternotomy, andGeneral surgical procedures. The IPC®provides power to various drills and sawsto drive attachments and tools duringsurgical procedures.
Feature	Proposed IPC™ System w/ TRITONHigh Torque Handpiece	Predicate Devices
	attachments and tools during surgicalprocedures.
Indication forUse	Integrated Powered Console w/TRITON HandpieceThe IPC® is indicated for the incision /cutting, removal, drilling, and sawing ofsoft and hard tissue and bone, andbiomaterials in Neurosurgical (Cranial,Craniofacial) Orthopedic, Arthroscopic,Spinal, Sternotomy, and Generalsurgical procedures	Integrated Powered Console - K081475The IPC® is indicated for the incision /cutting, removal, drilling, and sawing ofsoft and hard tissue and bone, andbiomaterials in Neurosurgical (Cranial,Craniofacial) Orthopedic, Arthroscopic,Spinal, Sternotomy, and General surgicalprocedures
OperatingPrinciple	Integrated Powered Console w/TRITON HandpieceThe IPC® System is an electricpowered instrument system consistingof multiple handpieces which arepowered by the IPC® console. Thehandpieces are intended to drivevarious types of interchangeableattachments and instruments used invarious surgical procedures. Whenactive, the motor of the handpiecerotates to drive the connectedattachment.	Integrated Powered Console - K081475The IPC® System is an electric poweredinstrument system consisting of multiplehandpieces which are powered by theIPC® console. The handpieces areintended to drive various types ofinterchangeable attachments andinstruments used in various surgicalprocedures. When active, the motor of thehandpiece rotates to drive the connectedattachment.
Software	Integrated Powered Console w/TRITON HandpieceThe IPC software is designed torecognize and control position, torqueand direction of the followinghandpieces, POWEREASE Driver,Stylus, Stylus Touch, EHS, Visao,Skeeter and Indigo drills, theOscillating, Reciprocating and Sagittalsaws, and Triton driver and the M4,SC1 microdebriders and the TRITONHigh Torque Handpiece.	Integrated Powered Console - K081475The IPC software is designed torecognize and control position, torque anddirection of the following handpieces,Stylus, Stylus Touch, EHS, Visao,Skeeter and Indigo drills, the Oscillating,Reciprocating and Sagittal saws, andTriton driver and the M4 and SC1microdebriders

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Handpiece Comparison

Metric	IPC® with TRITON Electric High TorqueHandpiece		Predicate Device
	Image: Free Run	Image: WithAttachment
MaximumApplied Torque	1.6 Nm	3.1 Nm(1)	7 Nm
Range ofSpeed	0 to max free run speed of1250 - 1800 rpm	0 - 250 rpm	0 - 250 rpm
Range of SafeWorkingTemperatures	Max temperature through the entire operatingrange at any external surface location onhandpiece shall be less than 51 °C for less than1 minute and shall not exceed 48 °C for lessthan 10 minutes		48°C max
Duty Cycle	Cycle Time: 20 seconds on maximum / 20seconds off minimumMaximum number of cycles before restinghandpiece: 6Maximum number of cycles before restingattachment: 3Minimum rest period: 25 minutes		Continuous Operation
Intended Use	The TRITON Electric High Torque Handpiece isintended to remove hard and soft tissue, drillpilot holes, drive screws, wires, and pinsduring, but not limited to, spinal, cranial, andsmall bone surgical procedures. The TRITONElectric High Torque Handpiece is intended tobe used in both open and minimally invasivesurgical procedures.		The IPC® POWEREASE™ Systemis indicated for drilling, tapping, anddriving screws and working endattachments during spinal surgery,including open and minimallyinvasive procedures. It is also usedin the placement of screws, orcutting of screws, posts, and rods.

ក្រុង

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Testing:

Laboratory bench testing conducted on the IPC System with the TRITON Electric High Torque Handpiece demonstrates substantially equivalent performance characteristics to the predicate devices currently on the market.

Conclusion/Summary:

Based upon the laboratory bench test summaries, intended use, and the successful completion of design control activities; the IPC System with the TRITON Electric High Torque Handpiece and software module is shown to be substantially equivalent to currently marketed predicate devices.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

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

AUG 27 2012

Medtronic Surgical Technologies c/o Mr. Jeffrey Henerson VP, Quality, Clinical & RA 4620 North Beach Street Fort Worth, TX 76137

Re: K121264

Trade/Device Name: TRITON Electric High Torque Handpiece and Software Module Regulation Number: 21 CFR 882.4360 Regulation Name: Electric Cranial Drill Motor Regulatory Class: Class II Product Code: HBC, HBE, HRX, HWE Dated: August 10, 2012 Received: August 13, 2012

Dear Mr. Henderson:

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.

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Page 2 - Mr. Jeffrey Henerson

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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

ர்ட

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

Sincerely vours.

Kesia Alexander

Malvina B. Evdelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

K121264 510(k) Number (if known):

Device Name: __ TRITON Electric High Torque Handpiece and Software Module

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ,

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121264

Prescription Use (Per 21 CFR 801.109)

Medtronic TRITON Electric High-Torque Handpiece

Regulation Number and Section

§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.

(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).