SOPRO 670 ARTHROSCOPIC PUMP

K080122 · Sopro · HRX · Jul 11, 2008 · Orthopedic

Device Facts

• Record ID: K080122
• Device Name: SOPRO 670 ARTHROSCOPIC PUMP
• Applicant: Sopro
• Product Code: HRX · Orthopedic
• Decision Date: Jul 11, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1100
• Device Class: Class 2

Intended Use

The SOPRO 670 irrigation pump is an 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 that may only be used by qualified physicians.

Device Story

SOPRO 670 is a microprocessor-controlled peristaltic pump system for arthroscopic procedures. It provides fluid distension, irrigation, and aspiration of joint cavities. The system includes a housing, power supply, roller wheel, pump head, servo-motor, setting keys, and display elements. It operates with specific irrigation/suction tubing sets and a foot-remote control. A redundant pressure measurement system continuously monitors joint cavity pressure, comparing it against a pre-set nominal pressure to ensure conformity. Used in clinical settings by qualified physicians, the device maintains joint distension to facilitate visualization and surgical access during diagnostic and operative arthroscopy. The automated pressure control helps maintain stable joint conditions, potentially improving surgical outcomes and patient safety by preventing over-pressurization.

Clinical Evidence

Bench testing only. The device complies with IEC 601-1 (Electrical Safety) and UL 60601-1 standards. No clinical data provided.

Technological Characteristics

Peristaltic pump system; microprocessor-controlled; servo-motor driven. Components include roller wheel, pump head, display, and foot-remote. Connectivity includes specialized irrigation/suction tubing. Complies with IEC 601-1 and UL 60601-1. Sterilization method not specified.

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 in patients requiring such intervention. For use by qualified physicians only.

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

• Future Medical Systems FMS DUO (K954465)

Submission Summary (Full Text)

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# 10. Summary of Safety and Effectiveness - "510 (k) Summary"

A. Submitter Information SOPRO JUL 1 1 2008 ZAC Athélia IV Avenue des Genévriers 13705 La Ciotat Cedex FRANCE Telephone: [phone] Fax: [phone] Contact Person: Steve Salesky SOPRO c/o ACTEON, Inc. 124 Gaither Drive, Suite 140 Mt. Laurel. NJ 08054 Tel: [phone] Fax: [phone] E-mail: [e-mail] Date Prepared: January 11, 2008 B. Device Identification Classification Name: Arthroscope and Accessories Common Usual Name: Arthroscopic Pump

Common Sample Name: Form Sample Strip

Proprietary Name: SOPRO 670 Arthroscopic Pump

C. Identification of Predicate Device

| Device | Applicant | 510(k) No. | Date Cleared |
|-----------------------------------|---------------------------|------------|--------------|
| Future Medical<br>Systems FMS DUO | Future Medical<br>Systems | K954465 | Nov. 9, 1995 |

The SOPRO 670 Arthroscopic Pump is substantially equivalent to the arthroscopic pump functions of the predicate device by Future Medical Systems, arthroscopic pump and shaver model FMS DUO (K954465) previously cleared by the FDA and currently marketed.

## D. Device Description

The SOPR0 670 irrigation pump is a peristaltic pump system designed to automatically provide and control distension and irrigation of the operative site during arthroscopic procedures and fluid irrigation of the operative site during laparoscopic procedures using sterile fluids. The pump is used in conjunction with specific tubing sets designed for arthroscopic procedures.

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- 1080122
The Arthroscopy Pump SOPRO 670 is a microprocessor controlled pump system designed to provide liquid distension and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. The Arthroscopy SOPRO 670 consists of the following main components: housing, power supply, roller wheel, pump head, a servo-motor, various setting keys and display elements. The device is to be used with special designed irrigation and suction tubings and a foot-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.

### E. Intended Use

The SOPRO 670 irrigation pump is an 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 that may only be used by qualified physicians.

#### F. Substantial Equivalence

The SOPRO 670 is substantially equivalent to the Arthroscopic pump functions of the predicate device by Future Medical Systems, Arthroscopy Pump and Shaver Model FMS DUO (K954465) previously cleared by the FDA and currently marketed. Both the Arthroscopy Pump SOPRO 670 and the predicate device 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 SOPRO 670 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 Arthroscopic pump of the predicate device.

Differences that exist between the devices relating to technical specifications, performances and intended use are minor and do not affect the safety and effectiveness of the SOPRO 670 Arthroscopic Pump.

#### G. Performance Data

The device complies with the International Standard IEC 601-1 (Electrical Safety) .In addition, the device meets the requirements of the Underwriter Laboratories Standard UL60601-1 and bears the CE mark in accordance with the Medical Device Directive 93/42/EEC.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SOPRO % ACTEON, Inc. Mr. Steve Salesky 124 Gaither Drive, Suite 140 Mt. Laurel, New Jersey 08054

JUL 11 2008

Re: K080122

Trade/Device Name: SOPRP 670 Arthroscopic Pump Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: June 6, 2008 Received: June 9, 2008

Dear Mr. Salesky:

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 - Mr. Steve Salesky

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 M. Wilkinson

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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# Indications for Use

510(k) Number:

SOPRO 670 Arthroscopic Pump Device Name:

Indications for Use:

The SOPRO 670 irrigation pump is a 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 that may only be used by qualified physicians

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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number korap