X-TREME ARTHROSCOPIC PUMP AND SHAVER SYSTEM

{0}------------------------------------------------ #### 510(k) SUMMARY for NeXtra™ arthroscopic pump and shaver system. # JAN - 7 2005 Date of submission: July 4th 2004 510k #: K041824 1/2 #### I. Submitter: | Owner / Operator: | Future Medical Systems, SA. | |-------------------|---------------------------------------------------| | Address: | 265 Route de la Baronne, ST. Jeannet 06640 France | | Phone: | 011-33-4-92-12-32-56 | | Fax: | 011-33-4-92-12-04-75 | | Contact: | Patrick Janin | Official correspondent: | Company: | Future Medical Systems, Inc. | |----------|--------------------------------------------| | Address: | 504 McCormick Drive, Glen Burnie, MD 21061 | | Phone: | 410 761 9411 ext. 11 | | Fax: | 410 760 9422 | | Contact: | Mr. Steve Janin | #### II. Device Names: | Classification name: | Arthroscope and Accessories | |----------------------|--------------------------------------------------------------------| | Common name: | Arthroscopic pump and shaver (debridement) system and accessories. | | Proprietary name: | NeXtraTM arthroscopic pump and shaver system. | #### III. Classification: Class II. Product code is HRX. This device is described in 21 C.F.R § 888.1100 #### IV. Predicate devices: K954465: FMS DUO (pump and shaver), Future Medical Systems K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) K932699: ARTHREX AR-8200 SHAVER SYSTEM (Arthrex) K940075: SHAVER BLADE SET (Arthrex) #### V. Intended use: The NeXtra™ arthroscopic pump and shaver system is intended to provide controlled fluid distension and suction, controlled cutting, burring, shaving and abrading of bone and tissue during orthopedic procedures of the knee, shoulder, elbow, wrist, ankle, hip, small joints and temporal mandibular joint (TMJ). #### VI. Device Description: The NeXtra™ arthroscopic pump and shaver system is a dual pump system that provides inflow and outflow to and from the joint cavities during arthroscopy. It combines a built in shaver that allows the removal of bone and soft tissue during orthopedic procedures. The NeXtra™ console consists of the following components: {1}------------------------------------------------ ### K64 1824 2/2 510(k) SUMMARY for NeXtra™ arthroscopic pump and shaver system. A power supply, housing, a motherboard, two peristaltic roller heads, three tube rs power supply, nousing, and a touch screen LCD. The system has a user-friendly cassette load system with an intuitive LCD touch screen. Several asor friendry casbette four pedal and a remote control are available as optional features. The NeXtra™ is to be used exclusively with specific FMS tube sets. ## VII. Substantial Equivalence: The device and its accessories described in this notification are similar in intended use, design and technological characteristics as the K954465: FMS DUO (pump and shaver), Future Medical Systems, the K913028: Arthro-Flow Irrigation system (pump), Davol (BARD) and the K932699: Arthrex AR-8200 Shaver System and K940075: Shaver blade set, Arthrex. The predicate devices and the NeXtra™ are both intended to provide inflow and outflow during arthroscopic surgery. The shaver systems are both intended to remove bone and soft tissue during arthroscopic surgery. We believe the NeXtra™ is substantially equivalent to these predicate devices since the basic features; specifications, design and intended uses are similar. The minor differences do not raise any new issues of safety and effectiveness. ### VIII. Performance Data: The device complies with IEC 60601-1 (electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), CE mark in accordance with the Medical Device Directive 93/42/EEC, manufactured in an ISO 9001 Version 2000 and ISO 13485 facility. {2}------------------------------------------------ Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 7 2005 Mr. Patrick Janin Manager Future Medical Systems 265, Route de la Baronne 06640 Saint-Jeannet France Re: K041824 K041824 Trade/Device Name: NeXtra™ arthroscopic pump and shaver system Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: II Product Code: HRX Dated: November 29, 2004 Received: December 1, 2004 Dear Mr. Janin: We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) premaited is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate referenced above and have delemined the devices marketed predicate devices marketed in interstate for use stated in the enclosure) to regally manced promoted provice Amendments, or to commerce prior to May 28, 1976, the enactment date of the Enderel Food. Drug commerce prior to May 26, 1970, the encentials with the provisions of the Federal Food, Drug, devices that have been reciassified in accordance what a premarket approval application (PMA). and Cosmetic Act (Act) that do not require approval of a previsions of the Act and Cosmetic Act (Act) that do not require approvate controls provisions of the Act. The Act. The You may, merelore, market the device, basjoct to the ... general controls provisions of the Act include requirements michreading and general controls provisions of the receined requirement 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 If your device is classified (see above) mis chaires and many of the strecting your device can may be subject to such additional controls. Existing major regulations all pro may be subject to such adultional controller. Extrang major of to 898. In addition, FDA may be found in the Code of Federal Regulations, Title 21, Parts of Research be found in the Code of Poderal Regarmers 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 Please be advised that FDA s issualice of a subscribe with other requirements of the Act that FDA has made a determination that your device of a complies. You must that FDA has made a determination that your as roo over Federal agencies. You must or any Federal statures and regulations administered of registration and listing (2) comply with all the Act's requirements, including, but not limited to: ret comply with an the Act 3 requirements, mo; good manufacturing practice requirements as set CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electron CFR Part 807); labeling (21 CFR Pat 001); good and frapplicable, the electronic forth in the quality systems (QS) regulation (21 CFR Patt 820); and if applicable, 11 CFR 1000 forth in the quality systems (Q5) regulation (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000 {3}------------------------------------------------ Page 2 - Mr. Patrick Janin This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to begin makeming your antial equivalence of your device to a legally premarket notification. The PDA midning of backannel of 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 If you desire specific advice for Joan as (240) 276-0115. Also, please note the regulation entitled, Collier the Office of Computine at (210) 216-215 Part 807.97). You may obtain "Misoralluling by relefence to promance as promance the Act from the Division of Small on and information on your responsibilities under the Act from the Division of Small other general information on your respenses is its toll-free number (800) 638-2041 or Manufacturers, International and Ochss.http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Miriam C. Provost 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 {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K041824 Device Name: NeXtra™ arthroscopic pump and shaver system. Indications For Use: The NeXtra™ arthroscopic pump and shaver system is intended to provide controlled The Nextra ™ arthroscopic pump and sharer Jording, shaving and abrading of bone fluid distension and suction, controlled cutting, blank, wrist, ankle, wrist, ankle, bi fluid disension and Suction, continued outfilly, burning and one of the survive, ankle, hip, and tissue during orthopedic procedures of the Kree, shoulder, elbow, wrist, ankl and tissue danny enporal mandibular joint (TMJ). Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (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) | Miriam C Provost | | |------------------------------------------------------------|-------------| | (Division Sign-Off) | | | Division of General, Restorative, and Neurological Devices | Page 1 of 1 | | 510(k) Number | K041824 |