STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM

K991696 · Stryker Instruments · DZI · Oct 25, 1999 · Dental

Device Facts

• Record ID: K991696
• Device Name: STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
• Applicant: Stryker Instruments
• Product Code: DZI · Dental
• Decision Date: Oct 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4120
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include use of the SES Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

Device Story

Surgical power system for bone/tissue manipulation; includes motors, attachments, and accessories. Integrates with HERMES voice control system for hands-free operation. Used in OR by surgeons for orthopedic, dental, ENT, and neurological procedures. Inputs include surgeon voice commands (via HERMES) and manual control; outputs are mechanical rotation/oscillation for cutting, drilling, or reaming. Facilitates precise tissue resection and fixation device placement. Benefits include improved surgical efficiency and reduced manual handling through voice-activated control of power settings and instrument functions.

Clinical Evidence

Bench testing only. Device performance verified against voluntary safety standards including IEC 601-1, IEC 601-1-1, IEC 601-1-2, IEC 601-1-4, UL 2601-1, and CAN/CSA-C22.2 NO. 601.1-M90.

Technological Characteristics

Surgical motor system with voice-control interface. Complies with IEC 601-1 (General Safety), IEC 601-1-1 (Electrical Systems), IEC 601-1-2 (EMC), IEC 601-1-4 (Programmable Electronic Systems), UL 2601-1, and CAN/CSA-C22.2 NO. 601.1-M90. System includes motor handpieces, attachments, and accessories for bone/tissue cutting and fixation. Connectivity includes integration with HERMES voice control platform.

Indications for Use

Indicated for patients requiring bone or bone-related tissue cutting, drilling, reaming, decorticating, or smoothing in orthopedic, dental, oral, maxillofacial, plastic, ENT, or neurological surgery. Also indicated for placement of fixation devices (screws, wires, pins) and metal cutting. Endoscopic use indicated for joint tissue morselization, debridement of synovitis, cartilage flaps, or ligaments, and management of osseous lesions (eburnated surfaces, osteophytes).

Regulatory Classification

Identification

A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.

Predicate Devices

• Stryker SE5 Arthroscopy System with Hermes Voice Control (K974771)
• HERMES™ (K973700)
• HERMES™ (K980787)
• Stryker Total Performance System (K942956)
• Stryker Total Performance System (K943540)
• Stryker Total Performance System (K943589)
• Stryker Total Performance System (K943563/S2)
• Stryker Total Performance System (K943541)

Submission Summary (Full Text)

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OCT 25 1999

#### Premarket Notification 510(k) Safety and Effectiveness Summary 9

# Stryker HERMES-Ready™ Total Performance System 510(k)

Stryker Instruments is submitting the following safety and effectiveness summary.

1) Submitter Information:

Stryker Instruments 4100 E. Milham Ave. Kalamazoo, MI 49001 [phone] Contact: Nicole Petty Prepared: March 12, 1999

2) Name of Device:

Proprietary Name: Stryker HERMES-Ready™ Total Performance System Common Name is Stryker HERMES-Ready™ Total Performance System Classification Name: Surgical instrument motors and accessories/attachments

- 3) Substantially equivalent to Stryker SE5 Arthroscopy System with Hermes Voice Control 510(k) 974771, HERMESTM 510/k)'s K973700 and K980787. and Stryker Total Performance System K942956. K943540, K943589, K943563/S2, K943541.
The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, 4) reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often used in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal. The endoscopic applications with TPS include use of the SE5 Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

5) The Stryker HERMES-Ready™ Total Performance System will be designed and tested to the following voluntary standards.

- IEC 601-1 Medical Electrical Equipment General Requirements for Safety ●
- IEC 601-1-1 Medical Electrical Equipment Collateral Standard: Safety Requirements for Electrical ● Systems
- Medical Electrical Equipment Collateral Standard: Electromagnetic Compatibility ● IEC 601-1-2 Requirements and Tests
- . IEC 601-1-4 Medical Electrical Equipment - Collateral Standard: Requirements for Programmable Electronic Systems
- UL 2601-1 -- UL Standard for Safety for Medical Electrical Equipment -- General Requirements for Safety . (US Deviations for IEC 601-1)
- . CAN/CSA-C22.2 NO. 601.1-M90 - Medical Electrical Equipment General Requirements for Safety: A National Standard of Canada (Canadian Deviation for IEC 601-1)

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# 10 Stryker HERMES-Ready™ Total Performance System Additional Appendix to User Manual

All other sections of the current User's Manual will remain unchanged.

Please refer to Tab A for the proposed appendix and current user instructions.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human profiles or a bird in flight, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 1999

Ms. Nicole Petty Regulatory Affairs Analyst Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K991696

> Trade Name: Stryker HERMES-Ready™ Total Performance System Regulatory Class: II Product Code: DZI, EIA, ERL, HBC, HBC, HBE, HWE Dated: September 16, 1999 Received: September 17, 1999

Dear Ms. Petty:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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### Page 2 - Ms. Nicole Petty

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

fo callista

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page __ 1_ of __ 1____________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Stryker HERMES-Ready™ Total Performance System

## Indications For Use:

The Stryker HERMES-Ready™ Total Performance System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures. Procedures for use on bone are often in orthopedics, dental, oral surgery, maxilliofacial, plastics, ENT, and neurological. It is also used in the placement of screws, wires, pins, and other fixation devices. It can also be used to cut metal.

The endoscopic applications with TPS include use of the SES Small Joint Shaver in the wrist are any need for morselization of tissue within the joint. Cutters will be used to debride synovitis, articular cartilage flaps, or torn ligaments when surgeons deem resection appropriate. Burs are indicated for management of osseous lesions such as eburnated articular surfaces or osteophytes.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of General Restorative Devices | |
| 510(k) Number | K991696 |

| Prescription Use<br>(Per 21 CFR 801.109) | |
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OR

| Over-The-Counter Use | |
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