(70 days)
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.
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 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.
The provided document describes the 510(k) premarket notification for the Arthroscopy Pump A107. However, it does not contain information regarding acceptance criteria, device performance results from a study, sample sizes, expert qualifications, ground truth establishment, or details about comparative effectiveness studies for AI.
This document is a regulatory submission for a medical device (an arthroscopy pump), not a study report for an AI/CADe device. The "Performance Data" section merely states compliance with general electrical safety and electromagnetic compatibility standards, and that the device bears the CE mark. It does not present specific performance metrics or a study designed to evaluate how well it meets certain criteria in a clinical context.
Therefore, I cannot fulfill your request for the specific points related to acceptance criteria and study details based on the provided text. The document is solely focused on demonstrating substantial equivalence to predicate devices rather than proving performance against specific clinical efficacy metrics.
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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 andAccessory |
| 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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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_________________________________________________________________________________________________________________________________________________________________
§ 888.1100 Arthroscope.
(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.