ARTHROSCOPY PUMP, MODEL A107

K030402 · W.O.M. World of Medicine AG · HRX · Apr 17, 2003 · Orthopedic

Device Facts

• Record ID: K030402
• Device Name: ARTHROSCOPY PUMP, MODEL A107
• Applicant: W.O.M. World of Medicine AG
• Product Code: HRX · Orthopedic
• Decision Date: Apr 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthroscopy Pump A107 is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

Device Story

Arthroscopy Pump A107 is a microprocessor-controlled dual pump system for fluid management during arthroscopic surgery. System utilizes peristaltic pump heads for irrigation and suction; inputs include fluid flow requirements; outputs include pressurized fluid for joint distension and irrigation. Device operated by surgical staff in clinical settings; includes remote control, housing, power supply, roller wheels, and pinch valve. Redundant pressure measurement sensors monitor joint cavity pressure against pre-set nominal values to ensure conformity. System provides controlled fluid environment to facilitate visualization and surgical access in joint cavities.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), and UL 2601-1 standards.

Technological Characteristics

Microprocessor-controlled dual peristaltic pump system. Components: housing, power supply, two roller wheels, two pump heads, pinch valve, remote control. Redundant pressure measurement system for pressure regulation. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2; UL 2601-1 compliant.

Indications for Use

Indicated for fluid distension, irrigation, and suction of knee, shoulder, hip, elbow, ankle, and wrist joint cavities during diagnostic and operative arthroscopic procedures.

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

• Arthro-Surgimat-2000 ECU (K990443)
• FMS DUO (K954465)

Submission Summary (Full Text)

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K030402

APR 1 7 2003

# 510(K) SUMMARY Arthroscopy Pump A107

#### I. Submitter:

W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany

#### II. Device Names:

| 1. | Classification Name: | Arthroscope and Accessories |
|----|-----------------------|-------------------------------------------------|
| 2. | Common or Usual Name: | Arthroscopic Pump, Tubing Sets and<br>Accessory |
| 3. | Proprietary Name: | Arthroscopy Pump A107 |

#### III. Classification:

Class II. This device is described in 21 C.F.R. § 888.1100. The product code for the device is HRX.

#### IV. Predicate Devices:

- Arthro-Surgimat-2000 ECU (K990443) manufactured by W.O.M. ● WORLD OF MEDICINE AG
- . FMS DUO (K954465) manufactured by FUTURE MEDICAL SYSTEM, Inc.

#### V. Intended Use:

The Arthroscopy Pump A107 is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

#### VI. Device Description:

The Arthroscopy Pump A107 is a microprocessor controlled dual pump system designed to provide liquid distention and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. Both the irrigation and suction pump of the device function according to the peristaltic principle. The Arthroscopy Pump A107 consists of the following main components: a housing, power supply, two roller wheels, two pump heads, a pinch valve, various setting keys and display

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elements. The device is to be used with special designed irrigation and suction tubings and a remote control. A constant performed redundant pressure measurement controls the conformity of the actual pressure in the joint cavity with the pre-set nominal pressure.

#### VII. Substantial Equivalence:

The device described in this notification is similar in intended use, design and technological characteristics to the Arthro-Surgimat-2000 ECU (K990443) manufactured by W.O.M. WORLD OF MEDICINE AG and the FMS DU() (K954465) manufactured by FUTURE MEDICAL SYSTEM, Inc.

Both the Arthroscopy Pump A107 and the predicate devices are intended to provide fluid distension and irrigation of knee, shoulder, elbow, hip, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures. Furthermore, the Arthroscopy Pump A107 and the predicate device FMS DUO (K954465) are both intended to provide fluid suction during arthroscopic procedures.

In addition, the device described in this notification is similar in design and technical characteristics to the predicate devices. The differences between the Arthroscopy Pump A107 and the predicate devices are minor and raise no new questions of safety and effectiveness.

Accordingly, W.O.M. WORLD OF MEDICINE AG believes that the Arthroscopy Pump A107 is substantially equivalent to the predicate devices currently on the market.

#### VIII. Performance Data:

The device complies with the International Standard IEC 60601-1 (Electrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility). In addition, the device meets the requirements of the Underwriter Laboratories Standard UL 2601-1 and bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 1 7 2003

W.O.M. World of Medicine AG c/o Ms. Susanne Raab 91 Trowbridge Street Cambridge, Massachusetts 02138

Re: K030402

Trade/Device Name: Arthroscopy Pump A107 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: February 1, 2003 Received: February 6, 2003

Dear Ms. Raab:

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. 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. Susanne Raab

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]. 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Muriam C. Provost

for 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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## STATEMENT OF INDICATIONS FOR USE

W.O.M. WORLD OF MEDICINE AG APPLICANT: KO3C402 ----------------------------------------------------------------------------------------------------------------------------------------------------------------------510(K) NUMBER (if known): Arthroscopy Pump A107 DEVICE NAME:

### INDICATIONS FOR USE:

The Arthroscopy Pump A107 is a dual arthroscopic pump system intended to provide fluid distension and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.

### (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Muriam C. Provost

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

510(k) Number_________________________________________________________________________________________________________________________________________________________________