LINVATEC 10K IRRIGATION SYSTEM

K033573 · Linvatec Corp. · HRX · Feb 11, 2004 · Orthopedic

Device Facts

• Record ID: K033573
• Device Name: LINVATEC 10K IRRIGATION SYSTEM
• Applicant: Linvatec Corp.
• Product Code: HRX · Orthopedic
• Decision Date: Feb 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

Device Story

Peristaltic, microprocessor-controlled pump system; provides liquid distention and irrigation during arthroscopic and laparoscopic procedures. Used with specific tubing sets. Operated by clinical staff in surgical settings. Microprocessor controls fluid flow to maintain operative site visibility and distension. Benefits patient by facilitating surgical access and maintaining clear operative field.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and technological characteristics.

Technological Characteristics

Peristaltic pump; microprocessor-controlled; intended for arthroscopic and laparoscopic use; utilizes specific tubing sets.

Indications for Use

Indicated for patients undergoing arthroscopic and laparoscopic procedures requiring controlled fluid distension and irrigation at the operative site.

Regulatory Classification

Identification

An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.

Predicate Devices

• Apex Universal Irrigation System (K961590)
• Hydro-Flex Li Laparoscopic Irrigation System (K961224)

Submission Summary (Full Text)

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033573 1/2

# FEB 1 1 2004

November 03, 2003

# SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the Linvatec 10k Irrigation System 510(k) Number _________________________________________________________________________________________________________________________________________________________

### A. Submitter

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908 Registration Number: 1017294

## Company Contact B.

Laura D. Krejci, RAC Manager, Regulatory Affairs [phone] Telephone [phone] FAX

## C. Device Name

| Trade Name: | Linvatec 10k Irrigation System |
|-----------------------------------------|--------------------------------------------------------------|
| Common Name: | Irrigation System |
| Classification Names: | Arthroscope, 888.1100<br>Endoscope and Accessories, 876.1500 |
| Proposed Class/Device:<br>Product Code: | Class II<br>HRX, GCJ |

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Summary of Safety and Effectiveness 10K Irrigation System 510(k) # _ November 03, 2003

### Predicate/Legally Marketed Devices D.

Apex Universal Irrigation System 510(K) # K961590 Linvatec Corporation

Hydro-Flex Li Laparoscopic Irrigation System: 510(K) # K961224 Davol Incorporated

## Device Description ய்

The Linvatec 10k Irrigation System is a peristaltic, microprocessor controlled pump system designed to provide liquid distention and irrigation during arthroscopic and laparoscopic procedures. The pump is used in conjunction with specific tubing sets designed for either arthroscopic or laparoscopic procedures.

### F. Intended Use

The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

### G. Substantial Equivalence

The Linvatec 10k Irrigation System is similar in intended use, design and technological characteristics as the Apex® Universal Irrigation System (Linvatec Corporation) and Hydro-Flex Li Laparoscopic Irrigation System (Davol Incorporated). Testing has been conducted to assure the differences in the new device and the predicate devices do not raise any new issues of safety and efficacy.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 1 2004

Ms. Laura D. Krejci, RAC Manager, Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K033573

Tradc/Device Name: Linvatec 10k Irrigation System Regulation Number: 21 CFR 888.1100, 21 CFR 876.1500 Regulation Name: Arthroscope, Endoscope and accessories Regulatory Class: II Product Code: HRX, GCJ Dated: November 3. 2003 Received: November 13, 2003

Dear Ms. Krejci:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enactment date of the enactment date of the Medical Device Amendments, or to econiner to 1125 2011-125 20:12:12 in accordance with the provisions of the Federal Food, Drug, de rioss that have tective approval of a premarket approval application (PMA). and coometry refore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) 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 – Ms. Laura D. Krejci, RAC

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 p arketed 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,

Miriam C. Provost

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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November 03, 2003

510(k) Number (if known): KOBBS 73

Device Name: Linvatec 10k Irrigation System

Indications for Use:

The Linvatec 10k Irrigation System provides controlled fluid distension and irrigation to the operative site during arthroscopic and laparoscopic procedures.

(Please DO NOT WRITE BELOW THIS LINE - Continue on ANOTHER PAGE If NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-the-Counter Use_ Prescription Use_ √ он (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Muriam C Provost

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K033573