STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR

K981717 · Stryker Instruments · FTD · Jun 30, 1998 · General, Plastic Surgery

Device Facts

• Record ID: K981717
• Device Name: STRYKER KNIFELIGHT, STRYKER ILLUMINATED RETRACTOR
• Applicant: Stryker Instruments
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Jun 30, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Illuminated Retractor is a manual surgical instrument with an integrated light source that will be sold separately as a single use only device. This can be used with the Knifelight to facilitate ligament or tissue division, or it can be used by itself to retract soft tissue.

Device Story

Manual surgical instrument; integrated light source; single-use. Used in surgical settings by clinicians. Functions as a retractor for soft tissue or in conjunction with the Knifelight for ligament/tissue division. Provides illumination to the surgical site to assist visualization during procedures. Benefits include improved visibility and tissue management during surgery.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual surgical instrument; integrated light source; single-use design. No electronic or software components.

Indications for Use

Indicated for use as a manual surgical instrument for soft tissue retraction or to facilitate ligament or tissue division when used with the Knifelight.

Regulatory Classification

Identification

A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.

Special Controls

*Classification.* Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

Predicate Devices

• Stryker Knifelight (K981717 modification)
• Ruggles illuminated retractors

Submission Summary (Full Text)

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JUN 3 0 1998

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11525 11131 11341 131151

1100 East Milham A mazoo. MI 490 323-7700 [phone]

K981717

## Premarket Notification 510(k) Summary StrykerIlluminated Retractor, a modification of the Stryker Knifelight Submission Summary Prepared: 6/9/98

## Device Name:

Classification Name:

Surgical Instrument Illuminated Retractor Surgical Instrument Light

Illuminated Retractor

Common/Usual Namc;

Proprietary Name:

Stryker Illuminated Retractor

Device Sponsor:

Stryker Corporation Instruments Division 4100 East Milham Avenue Kalamazoo, MI 49001 Registration No: 1811755

Regulatory Class:

Class II

## Summary of Safety and Effectiveness:

The Stryker Illuminated Retractor is a manual surgical instrument with an integrated light source that will be sold scharately as a single use only device. This can be used with the Knifelight to facilitate ligament or tissue division, or it can be used by itself to retract soft tissue.

The Stryker Illuminated Retractor is equivalent to existing marketed products by companies such as Ruggles and Stryker. Intended use, function, and safety risks are all substantially equivalent.

and the change

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The Stryker Illuminated Retractor does not raise any new safety and efficacy concerns when compared to similar legally marketed devices. Thereforc, the Stryker Illuminated Retractor is substantially equivalent to these existing devices.

More Petty

Nicole Petty Regulatory Affairs Representative Stryker Instruments

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping profiles, suggesting a focus on people and services. The overall design is simple and professional, reflecting the department's role in public health and welfare.

JUN 3 0 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nicole Petty ·Stryker Instruments 4100 East Milham Avenue Kalamazoo, Michigan 49001

Re: K981717 Trade Name: Stryker Illuminated Retractor Regulatory Class: II Product Code: FTD Dated: May 12,1998 Received: May 15, 1998

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 mayor 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 (OS) 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.

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.

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Page 2 - Ms. Petty

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,

Celia M. Witten, Ph.D., M.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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K981717 510(k) Number (if known):__

Stryker Illuminated Retraccor Dovice Name:

Indications For Use:

The Illuminated Retractor is a manual surgical instrument with an
the interest of the cold on cold opparetely as a single Incegrated light source that will be sold separatedy as a single use only device. This can be used with the Knthelly to facilitate use only device. This can be used with the icrossing.
Ifgament or tissue division, or it can be used by itself to recract soft tissue.

(PLEASE DO NOT WRITE B ILOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K981717

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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