COLORADO MICRODISSECTION NEEDLE

K033232 · Stryker Corp. · GEI · Feb 25, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K033232
• Device Name: COLORADO MICRODISSECTION NEEDLE
• Applicant: Stryker Corp.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Feb 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectorny and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.

Device Story

Monopolar electrosurgical instrument for precision soft tissue dissection; used for cutting, dissecting, and cauterizing soft tissue. Single-use device; operated by clinicians in surgical settings. Device functions by delivering electrical energy to tissue via a needle tip to achieve desired surgical effect. Benefits include precision in soft tissue procedures like tonsillectomy and blepharoplasty.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use similarity to predicate devices.

Technological Characteristics

Monopolar electrosurgical needle; single-use; intended for soft tissue cutting and coagulation. No specific materials or software algorithms described.

Indications for Use

Indicated for precision soft tissue dissection, including tonsillectomy and blepharoplasty. Contraindicated for use in the central nervous system or central circulatory system.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Stryker Leibinger Colorado MicroDissection Needle (K000348)
• Colorado Biomedical, Inc. Colorado MicroDissection Needle (K881763)

Submission Summary (Full Text)

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FEB 2 5 2004

| 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: | |
|----------------------------------------------------|------------------------------------------------------------------------------------------|
| Stryker Leibinger Colorado MicroDissection Needle® | |
| General Information | |
| Proprietary Name: | Stryker Leibinger Colorado MicroDissection Needle® |
| Common Name: | Electrode, Electrosurgical |
| Proposed Regulatory Class: | Class II |
| Device Classification: | GEI<br>878.4400, Electrosurgical Electrode |
| Submitter: | Stryker Leibinger<br>4100 East Milham Avenue<br>Kalamazoo, MI 49001<br>269-323-4226 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 9616696 |
| Contact Person: | Wade T. Rutkoskie<br>Associate Manager RA QA<br>Phone: [phone]<br>Fax: [phone] |

## Intended Use

The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectorny and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.

## Substantial Equivalence

EQUIVALENT PRODUCTS:

The Stryker Colorado MicroDissection Needle is equivalent to the previous version of the product cleared under K000348, and the product manufactured by Colorado Biomedical, Inc. and cleared with K881763. Equivalent product information is found in Appendix 3.

Wade T. Kuttorffie

Wade T. Rutkoskie Associate Manager RA QA Stryker Instruments Leibinger Division

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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 is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles an abstract bird in flight, composed of three curved lines above a wavy base. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2004

Mr. Wade T. Rutkoskie Associate Manager RA, QA Stryker Leibinger 4100 East Milham Avenuc Kalamazoo, Michigan 49001

Re: K033232

Trade/Device Name: Strykcr Leibinger Colorado MicroDisscction Needle® Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 9, 2003 Received: December 10, 2003

Dear Mr. Rutkoskic:

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 Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the l'ederal 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can mar be bained 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 or mr) vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Or R ratt 80 7) at regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Wade T. Rutkoskie

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

L. Mark A. Melkersson

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

Enclosure

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Pagc 1 of 1

510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Colorado MicroDissection Needle®

Intended Use:

The Colorado MicroDissection Needle® is a monopolar electrosurgical instrument used for precision soft tissue dissection. Including but not limited to tonsillectorny and blepharoplasty. It is a single-use device intended for cutting, dissecting and cauterizing soft tissue. The Colorado MicroDissection Needle is not intended for use in the central nervous system or in the central circulatory system.

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| Concurrence of CDRH, Office of Device Evaluation (ODE) | <div>(Division Sign-Off)</div> |
|------------------------------------------------------------|--------------------------------|
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | K033232 |

| Prescription Use (per 21 CFR 801.109) | |
|---------------------------------------|----------------------|
| or | Over-The-Counter Use |

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