STRYKER KNIFELIGHT

K100884 · Howmedica Osteonics Corp. · FTD · Jun 25, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100884
• Device Name: STRYKER KNIFELIGHT
• Applicant: Howmedica Osteonics Corp.
• Product Code: FTD · General, Plastic Surgery
• Decision Date: Jun 25, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4580
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.

Device Story

Stryker Knifelight is a sterile, single-use, disposable surgical instrument for carpal tunnel ligament release. Device integrates a cutting blade with an internal light source to improve visualization of the carpal ligament, median nerve, and surrounding tendons/tissues during minimally open surgery. Integral protective retractors shield surrounding tissue during the procedure. Operated by surgeons in a clinical/surgical setting. Device provides direct illumination of the surgical site, enabling the surgeon to perform the release through a small incision with minimal tissue disturbance. Benefits include improved visualization and tissue protection.

Clinical Evidence

No clinical data. The submission is a labeling change and manufacturer location update for a previously cleared device.

Technological Characteristics

Sterile, single-use, disposable manual surgical instrument. Features integrated light source and protective retractors. No electronic or software components described.

Indications for Use

Indicated for the release of the carpal tunnel ligament in patients undergoing minimally open surgical release.

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 (K961122)

Submission Summary (Full Text)

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K100824

# 510(k) Summary of Safety and Effectiveness: Labeling Change Being Effected: Stryker Knifelight

| Proprietary Name: | Stryker Knifelight | JUN 2 5 20 |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Common Name: | Lighted Knife | |
| Classification Name and Reference: | 21 CFR 878.4800<br>Manual Surgical Instrument for General Use | |
| | 21 CFR 878.4580<br>Surgical Lamp | |
| Proposed Regulatory Class: | Class I (Surgical Instrument) & Class II (Surgical<br>Lamp) | |
| Product Codes: | 79 EMF (Surgical Instrument), 79 FSQ (Surgical<br>Lamp) | |
| For Information contact: | Avital Merl-Margulies<br>Regulatory Affairs Specialist<br>Howmedica Osteonics Corp.<br>325 Corporate Drive<br>Mahwah, NJ 07430<br>Phone: [phone] Fax: [phone] | |
| Date Prepared: | June 23, 2010 | |

#### Description:

The Stryker Knifelight is a sterile, single use, completely disposable ligament and tissue release knife with an integrated light source. The device is intended to provide improved visualization of tissues and ligaments inside areas with restricted view due to small incisions. During minimally open carpal ligament surgical release, this device will improve visualization of the carpal ligament, median nerve and functional ligaments and tendons. Additionally, the device has integral protective retractors which provide for additional protection of the surrounding tissue during surgery.

The Knifelight consists of two integrated components: a handpiece that acts as a power source that is connected to a blade assembly. They are sold as one device.

#### Indications for Use:

The Stryker Knifelight is a manual surgical instrument used for the release of the carpal tunnel ligament. It features an integrated light source to illuminate the surgical site which allows for a minimally open technique with minimal disturbance of surrounding tissue.

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### Proposed Modification:

The purpose of this premarket notification is to document the legal manufacturer location change and add disposal information, additional warnings & new contraindications to the package insert for the Stryker Knifelight device.

## Predicate Device:

The subject Stryker Knifelight device is substantially equivalent to the predicate Stryker Knifelight device cleared under K961122.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Howmedica Osteonics Corporation % Ms. Avital Merl-Margulies Regulatory Affairs Specialist 325 Corporate Drive Mahwah, New Jersey 07430

# JUN 2 5 2010

Re: K100884

Trade/Device Name: The Stryker Knifelight Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: March 24, 2010 Received: March 30, 2010

Dear Ms. Merl-Margulies:

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 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

. .

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Page 2 - Ms. Avital Merl-Margulies

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 (OS) 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/CDRH0ffices/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/ReportalProblem/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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely your

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Stryker Knifelight

Change Being Effected 510(k)

. Indications for Use

510(k) Number (if known): _K/00 884

The Stryker Knifelight is a manual surgical instrument used for the release of the samal The Stryker Knitenght is a manual surgicul minute to illuminate the surgical site which
tunnel ligament. It features an integrated light source of surrounding tissue tunnel itgament. It reatures an integrated itgitt bears in the minimal disturbance of surrounding tissue.

Over-The-Counter Use X Prescription Use AND/OR (21 CFR 807 Subpart C) (Part 21 CFR 801 Subpart D) (Patt 21 CFR 801 Subpar 27)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Neil R.P. Ogden for nxm

Division Sign-Off) (Division Sign-Off)
Division of Surgical, Orthopedic, Division of Surges and Restorative Devices

510(k) Number. K100884

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