SMITH & NEPHEW 25 FLUID MANAGEMENT SYSTEM

{0}------------------------------------------------ # JUN 1 5 2005 We are K051326 Page 1 of 2 # SECTION IV 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by the Safe Medical Devices Act of 1990 and codified in 21 CFR 807.92 upon which the substantial equivalence is based. #### Smith & Nephew 25 Fluid Management System Date Prepared: May 18, 2005 ## A. Submitter's Name: Smith & Nephew, Inc., Endoscopy Division 150 Minuteman Road Andover MA, 01810 ## B. Company Contact Janice Haselton Sr. Regulatory Affairs Specialist Phone: (978) 749-1494 FAX: (978) 749-1443) #### C. Device Name | Trade Name: | Smith & Nephew 25 Fluid Management System | |---------------------------------|-------------------------------------------| | Common Name: | Arthroscopic Fluid Management System | | Classification Name:Arthroscope | | # D. Predicate Devices The Smith & Nephew 25 Fluid Management System is substantially equivalent in Intended Use and Fundamental Scientific Technology to the following legally marketed device in commercial distribution: The Smith & Nephew InteliJET™ HERMES-Ready (K031605) and Smith & Nephew InteliJET™ Fluid Management Systems (K050580). {1}------------------------------------------------ K05/326 Page 2 of 2 # E. Description of Device The Smith & Nephew 25 Fluid Management System is a microprocessor controlled arthroscopic fluid management system that is designed for controlled delivery of irrigation fluids during intra-articular surgery. The system controls joint pressure independently of aspiration rate over a wide range of flow rates. The system will maintain control of intra-articular pressure regardless of varying outflow rates and may be used with any arthroscopic inflow cannula. #### F. Intended Use The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site. #### G. Comparison of Technological Characteristics The Smith & Nephew 25 Fluid Management System is substantially equivalent in design, materials, function and intended use to the Smith & Nephew InteliJET™ HERMES-Ready, cleared in K031605 and the Smith & Nephew InteliJET™ Fluid Management System cleared in K050580. The proposed and the prodicate devices both have the same intended use and the same fundamental scientific technology. # H. Summary Performance Data The performance testing and the software verification and validation conducted on the Smith & Nephew 25 Fluid Management System demonstrates substantial equivalence to the Smith & Nephew InteliJET™ HERMES-Ready, cleared in K031605 and the Smith & Nephew InteliJET™ Fluid Management System cleared in K050580. The testing also demonstrates that the differences in the new device and the predicate device do not raise any new issues of safety and efficacy. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring three curved lines that resemble a human figure. JUN 1 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Ms. Janice Haselton Sr. Regulatory Affairs Specialist Endoscopy Division Smith & Nephew Incorporated 150 Minuteman Road Andover, Massachusetts 01810 Re: K051326 Trade/Device Name: Smith & Nephew 25 Fluid Management System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: June 8, 2005 Received: June 8, 2005 Dear Ms. Haselton: We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(t) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule) to regally the enactment date of the Medical Device Amendments, or to commence prior to May 20, 1976, the enated with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). and Cosmetic Act (Fee) that do not require act the general controls provisions of the Act. The Y ou may, therefore, market the device, public requirements for annual registration, listing of general Controls provisions of the fiest 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 and It may be subject to such additional Regulations, Title 21, Parts 800 to 898. In addition, FDA can be found in the Oode of Features concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean Ficase be advised that I Dri 3 issuanted or our device complies with other requirements of the Act that IDA has made a decommanding administered by other Federal agencies. You must of any I ederal statutes and regarations and limited to: registration and listing (21 Comply with an the Net 8 requirements, and manufacturing practice requirements as set CITY art 607), adomig (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. {3}------------------------------------------------ Page 2- Ms. Janice Haselton This letter will allow you to begin marketing your device as described in your Section 510(k) rms reket 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 (240) 276-0115 . 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Emm A. Th Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ Ko5-1326 #### Indications for Use 510(k) Number (if known): Device Name: Smith & Nephew 25 Fluid Management System Indications For Use: The Smith & Nephew 25 Fluid Management System is indicated for use during arthroscopic joint surgery to regulate flow of irrigation fluids in the knee, shoulder, hip and small joints to maintain intra-articular pressure for uniform distension and clear visualization of the surgical site. Prescription Use (Per 21 CFR 801 Subpart D) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ AND/OR (21 CFR 807 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 k051326 Smith & Nephew 25 Page 15 of 510