FLOSIMPLE ARTHROSCOPY PUMP A120

K062380 · W.O.M. World of Medicine AG · HRX · Dec 14, 2006 · Orthopedic

Device Facts

• Record ID: K062380
• Device Name: FLOSIMPLE ARTHROSCOPY PUMP A120
• Applicant: W.O.M. World of Medicine AG
• Product Code: HRX · Orthopedic
• Decision Date: Dec 14, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Indications for Use

The FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

Device Story

FLOSIMPLE Arthroscopy Pump A120 is a microprocessor-controlled single-roller peristaltic pump. It provides fluid distension and irrigation for arthroscopic procedures in knee, shoulder, hip, elbow, ankle, and wrist joints. The device uses a cartridge tube set and a single ceramic pressure sensor to monitor joint cavity pressure. It features a touch screen display for user control and preselectable pressure/flow levels for different joint types. The system performs continuous pressure measurement; if actual pressure exceeds the preset nominal value, a software-controlled active pressure reduction mechanism engages. Alarms notify the operator of overpressure conditions. The device is mounted on a roller-wheel stand and may be used with an optional remote control. It is intended for use by clinicians in surgical settings to maintain joint distension, facilitating visualization and operative access during arthroscopy.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Microprocessor-controlled single-roller peristaltic pump. Features: touch screen display, rechargeable battery pack, single ceramic pressure sensor. Connectivity: optional remote control. Mounting: roller-wheel stand. Software: microprocessor-based control for pressure monitoring and active pressure reduction. Materials: cartridge tube set (specific materials not listed).

Indications for Use

Indicated for fluid distension and irrigation of knee, shoulder, hip, elbow, ankle, and wrist joint cavities during diagnostic and operative arthroscopic procedures in patients requiring such interventions.

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

• Arthroscopy Pump A107 (K030402)
• Arthro-Surgimat-A103 (K000153)
• Arthro-Surgimat-1500 (K983910)
• Lap-Wave 3000 (K990732)

Submission Summary (Full Text)

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## 510(k) SUMMARY

| | | DEC 14 2006 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter: | W.O.M. WORLD OF MEDICNE AG<br>Alte Poststraße 11<br>96337 Ludwigsstadt<br>Germany<br>Phone: [phone]<br>Fax: [phone] | |
| | | |
| Official<br>Correspondent: | Susanne Raab<br>Regulatory Affairs Consultant<br>1480 Cambridge Street<br>Cambridge, MA 02139<br>Phone: [phone]<br>Fax: [phone]<br>e-mail: [e-mail] | |
| Trade Name: | FLOSIMPLE Arthroscopy Pump A120 | |
| Common Name: | Arthroscopic Pump, Tubing Sets and Accessory | |
| Classification<br>Name: | Arthroscope, 21 C.F.R. 888.1100 | |
| Regulatory Class: | II | |
| Product Code: | HRX | |
| | | |
| Predicate Devices: | 1. Arthroscopy Pump A107 (K030402)<br>2. Arthro-Surgimat-A103 (K000153)<br>3. Arthro-Surgimat-1500 (K983910)<br>4. Lap-Wave 3000 (K990732) | |
| Device Description: | The FLOSIMPLE Arthroscopy Pump A120 (the “A120”) is<br>a microprocessor controlled single roller pump, which<br>functions according to the peristaltic system. The device<br>incorporates the following major components and features: a<br>casing, a world power supply, a rechargeable battery pack, a | |

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The A120 performs a continuous pressure measurement to ensure that the actual pressure in the joint cavity complies with the pre-set nominal pressure. In addition, a software controlled active pressure reduction mechanism is activated if the actual pressure measured in the joint cavity exceeds the preset nominal pressure value. The device is also designed with several alarms to inform the operator in case of an overpressure. For user convenience, the device is equipped with a touch screen display. The A120 is to be mounted on a roller-wheel stand and is to be used with a specially designed cartridge tube set and with an optional remote control.

- The FLOSIMPLE Arthroscopy Pump A120 is intended to Intended Use / provide fluid distension and irrigation of knee, shoulder, hip, Indication for Use: elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.
The A120 is substantially equivalent to the Arthroscopy Substantial Pump A107 (K030402) (the "A107") manufactured by Equivalence: W.O.M. WORLD OF MEDICINE AG. Both the A120 and the A107 have the same intended use, function according to the peristaltic system and have a maximum flow performance of 3 1/min. The technological differences between the A120 and the A107 are minor and primarily related to the modification of the casing to allow for mounting of the A120 on a roller-wheel stand, the development of a new cartridge tube set, the offering of preselectable pressure and flow levels (knee, shoulder, small joints), the incorporation of a rechargeable power pack and of a touch screen. Unlike the A107, the A120 is a single roller pump that does not allow for the aspiration of liquids out of joint cavities. Finally, the A120 incorporates only one pressure sensor in place of the redundant pressure measurement of the A107.

> Furthermore, the A120 is substantially equivalent to the Arthro-Surgimat-A103 (K000153) (the "A103"), the Arthro-Surgimat-1500 (K983910) (the "Arthro-Surgimat") and the Lap-Wave 3000 (K990732) (the "Lap-Wave"), all three manufactured by W.O.M. WORLD OF MEDICINE AG. Specifically, the A120 and the predicate devices A103 and Arthro-Surgimat have the same intended use, are designed as a single roller pump and function according to the peristaltic system. In addition, like the A103, the A120 incorporates a single ceramic sensor to perform actual pressure measurements.

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Furthermore, both the A120 and the Arthro-Surgimat are designed with preselectable pressure levels (knee, shoulder, small joint) that can be programmed by the user. Finally, the A120 is substantial equivalent to the laparoscopic pump Lap-Wave with regards to the casing. Both devices are designed with a smaller casing that is to be mounted on a roller wheel stand. In sum, the technological differences between the A120 and the predicate devices are minor and raise no new questions of safety and effectiveness.

August 10, 2006 Date Prepared:

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 4 2006

World of Medicine AG % Ms. Susanne Raab Regulatory Affairs Consultant 1480 Cambridge Street Cambridge, Massachusetts 02139

Re: K062380

Trade/Device Name: FLOSIMPLE Arthroscopy Pump A120 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: November 29, 2006 Received: December 5, 2006

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, 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 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) I mis lotter will anon your to be one finding of substantial equivalence of your device to a legally promaties motive 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 it you t 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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## Indication for Use

510(k) Number (if known): K062380

Device Name: FLOSIMPLE Arthroscopy Pump A120

Indications for Use:

The FLOSIMPLE Arthroscopy Pump A120 is intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

P

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

510(k) Number_