ARTHOSCOPY PUMP A115

K033927 · W.O.M. World of Medicine AG · HRX · Jan 15, 2004 · Orthopedic

Device Facts

• Record ID: K033927
• Device Name: ARTHOSCOPY PUMP A115
• Applicant: W.O.M. World of Medicine AG
• Product Code: HRX · Orthopedic
• Decision Date: Jan 15, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 888.1100
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

Device Story

Arthroscopy Pump A115 is a microprocessor-controlled single-roller pump; provides fluid distention and irrigation of joint cavities during diagnostic and operative arthroscopic procedures. System components include housing, roller wheel, pump head, setting keys, display, power supply, irrigation tubing, and foot pedal. Device performs constant redundant pressure monitoring to ensure conformity between actual joint cavity pressure and pre-set nominal pressure. Used in clinical settings by surgeons; assists in maintaining joint visibility and stability during arthroscopy. Benefits include controlled fluid management for improved surgical access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Microprocessor-controlled single-roller pump. Components: housing, roller wheel, pump head, display, foot pedal. Complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for fluid distention and irrigation 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

• Arthroscopy Pump A107 (K030402)
• Arthro-Surgimat- 2000 ECU (K990443)
• Arthro-Surgimat-1500 (K983910)

Submission Summary (Full Text)

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Ko 33927 1/2

'JAN 1 5 2004

### 510(K) SUMMARY Arthroscopic Pump A115

### Submitter's Name, Address, Telephone Number, Contact Person, I. Sublishment Registration Number and Date Summary was Prepared:

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

| Phone number: | 001 49 30 399 81 610 |
|---------------|----------------------|
| FAX number: | 001 49 30 399 81 592 |

Establishment registration number: 8043980

| Contact Person: | Susanne Raab |
|-----------------|----------------------------|
| | 368 North St. Asaph Street |
| | Alexandria, VA 22314 |
| Phone number : | 703 299 0523 |
| Fax number: | 703 299 0523 |
| Date Prepared : | Dezember 9, 2003 |

#### II. Device Names:

- Arthroscope and Accessories Classification Name: 1.
- Arthroscopic Pump, Tubing Sets and Common or Usual Name: 2.
- Accessory Arthroscopic Pump A115 Proprietary Name: 3.

#### Product Classification: III.

| Product Code: | HRX |
|-----------------|----------------------|
| C.F.R. Section: | 21 C.F.R. § 888.1100 |
| Device Class: | II |

#### Predicate Devices: IV.

- Arthroscopy Pump A107 (K030402) manufactured by W.O.M. WORLD . OF MEDICINE AG
- Arthro-Surgimat- 2000 ECU (K990443) manufactured by W.O.M. WORLD . OF MEDICINE AG
- Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. WORLD OF . MEDICINE AG

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### 510(K) SUMMARY Page -2- / -2-

#### Intended Use: V.

The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation The Arthroscopy I amp Arre ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

#### Device Description: VI.

The Arthroscopy Pump A115 is a microprocessor controlled single roller pump I no Arch obbopy of the micronand irrigation of joint cavities during designed to provide throscopy. The pump functions according to the thaghostic and operative anaists of the following main components: a housing, a portsuitio principler wheel, a pump head, various setting keys and display power supply, a roner whose used with special designed irrigation tubings, a clemonts. The and foot pedal. A constant performed redundant pressure remove control and 1000 peonformity of the actual pressure in the joint cavity with the pre-set nominal pressure.

#### Substantial Equivalence: VII.

The Arthroscopy Pump A115 described in this notification is similar in design and technological characteristics to the Arthroscopy Pump A107 (K030402), to the Arthro-Surgimat-2000 ECU (K990443) and Arthro-Surgimat-1500 (K983910) manufactured by W.O.M. WORLD OF MEDICINE AG. In addition, both the manufactured by Pump A115 and the predicate devices are intended to provide fluid distention and irrigation of knec, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

The differences between the Arthroscopy Pump A 1 15 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 A 115 is substantially equivalent to the predicate devices currently on the market.

## VIII. Performance/Clinical Data:

No performace or clinical data is provided.

#### IX. Voluntary Standards:

The device complies with the International Standard IEC 60601-1 (Flectrical Safety) and IEC 60601-1-2 (Electromagnetic Compatibility) and bears the CE mark in accordance with the Medical Device Directive 93/42/FEC.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS) in the USA. The seal features a stylized eagle with outstretched wings, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2004

W.O.M. World of Medicine AG c/o Ms. Susanne Raab 368 North Saint Asaph Street Alexandria, Virginia 22314

Re: K033927

Trade/Device Name: Arthroscopy Pump A115 Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope and accessories Regulatory Class: II Product Code: HRX Dated: December 16, 2003 Received: December 18, 2003

Dear Ms. Raab:

We have reviewed your Scction 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 (o 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 cither 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 docs 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]. 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

fed 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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# INDICATION FOR USE STATEMENT

510(k) Number (if known): KO53927

Device Name: Arthroscopy Pump A115

Indications for Use:

The Arthroscopy Pump A115 is intended to provide fluid distention and irrigation of knee, shoulder, hip, elbow, ankle and wrist joint cavities during diagnostic and operative arthroscopic procedures.

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

Sivision Sign-Oil) Division of General, Restorative and Neurological Devices

KO 33927 l (h) Nameru . .

Prescription Use
Use
(Per 21 C.F.R. 801.109)

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Over-The-Counter

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