STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL

K974771 · Stryker Endoscopy · GCJ · May 29, 1998 · Gastroenterology, Urology

Device Facts

• Record ID: K974771
• Device Name: STRYKER SE5 ARTHROSCOPY SYSTEM WITH HERMES VOICE CONTROL
• Applicant: Stryker Endoscopy
• Product Code: GCJ · Gastroenterology, Urology
• Decision Date: May 29, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SE5 Arthroscopy System is intended to be used by surgeons in orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, hip and tempomandibular joint. It will be used to resect tissue and bur bone. Indications for 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.

Device Story

Electrically powered arthroscopy system for intra-articular debridement; includes SE5 Shaver handpiece and HERMES OR Control Center. System enables resection of tissue and bone burring via cutters and burs. HERMES component provides voice-activated control of surgical equipment. Used by orthopedic surgeons in OR setting. Voice activation functionality allows hands-free operation of system parameters. Device benefits patient by facilitating precise, minimally invasive joint tissue/bone management.

Clinical Evidence

Bench testing only. Device tested for compliance with IEC 601-1, IEC 601-2-18, UL 2601-1, EMC Directive 89/336/EEC, and CAN/CSA-C22.2 standards. Functional testing performed on HERMES voice control system.

Technological Characteristics

Electrically powered surgical motor system. Components include shaver handpiece and control console. Complies with IEC 601-1, IEC 601-2-18, UL 2601-1, and CAN/CSA-C22.2 standards. Features voice-activated control interface.

Indications for Use

Indicated for orthopedic surgeons performing intra-articular debridement in joints including knee, shoulder, ankle, elbow, wrist, hip, and TMJ. Used for resection of synovitis, articular cartilage flaps, torn ligaments, and management of osseous lesions like eburnated surfaces or osteophytes.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• SE 5 Shaver (K941333)
• AESOP (K931783)
• AESOP (K960652)

Submission Summary (Full Text)

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K974771

## 11. Premarket Notification 510(k) Safety and Effectiveness Summary

## Stryker SE5 Arthroscopy System with HERMES OR Control Center System 510(k) Summary

Stryker Endoscopy is submitting the following safety and effectiveness summary.

- l) Submitter Information
Stryker Endoscopy 2590 Walsh Avenue Santa Clara, CA 95051 [phone] Contact: Salmaan Hameed Prepared December 18, 1997

2) Name of Device:

Proprietary Name: SE5 Arthroscopy System with HERMES Voice Control™ Common Name is SE5 Arthroscopy System with HERMES Voice Control Classification Name: Surgical instrument motors and accessories/attachments

- 3) Substantially equivalent to SE 5 Shaver 510(k) 941333, AESOP 510(k)'s K931783 and K960652
- 4) The SE5 Arthroscopy and Small Joint Debrider Systems are electrically powered instrumentation specifically designed for intra-articular debridement. A common control console powers the SE5 Shaver Handpiece. The SE5 Arthroscopy System is intended to be used by surgeons in orthopedic joints, including the knee, shoulder, ankle, elbow, wrist, hip and tempomandibular joint. It will be used to resect tissue and bur bone. The voice activation system is substantially equal to AESOP voice activation system. With this upgrade there are no new issues of safety and effectiveness.

5) The Stryker SE5 Arthroscopy System with HERMES OR Control Center is designed and tested to the following Computer Motion and voluntary standards.

- IEC 601-1 Second Edition 1988 International Standard for Medical Electrical Equipment .
- IEC 601-1 Amendment 1 1991 International Standard for Medical Electrical Equipment .
- IEC 601-2-18 First Edition 1990 International Standard for Medical Electrical Equipment .
- . UL 2601-1
- EMC Directive European Union 89/336/EEC ●
- CAN/CSA-C22.2 NO. 601.1-M90 & NO. 601.2.18-92 ●
- HERMES Voice control System Functional Test Requirements .

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle faces right and appears above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 1998

Mr. Salmaan Hameed ·Project Engineer Stryker Endoscopy 2590 Walsh Avenue Santa Clara, California 95051

Re: K974771 Trade Name: Stryker SE5 Arthroscopy System With 'Hermes' Voice Control Regulatory Class: II Product Code: GCJ April 3, 1998 Dated: Received: April 7, 1998

Dear Mr. Hameed:

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 reqistration, 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. ਸੈਂ 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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Paqe 2 - Mr. Salmaan Hameed

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 requlation (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,

Cecelia M. Witton, Ph.D.

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 _______________________________________________________________________________________________________________________________________________________________________

K97477 510(k) Number (if known):

Device Name: Stryker SE5 Arthroscopy System with 'Hermes' voice control

## Indications For Use:

Indications for 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.

(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 General Restorative Devices | |
| 510(k) Number | K984771 |

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use