BIOMOVE 5000 SYSTEM

{0}------------------------------------------------ K0860787 APR 1 7 2008 ## 510(K) SUMMARY ## Biomove 5000 System 510(k) Number K_ A. Applicant's Name: Curatronic Ltd. 4 Atsmon Street. Hashmonaim 73127, Israel Tel.: +972-8-9761441 Fax .: +972-8-9762020 e-mail: philipson@curatronic.com Ofer Hornick M.D. B. Contact Person: A. Stein - Regulatory Affairs Consulting 20 Ha'Ta'as St. Kfar Saba 44425 Israel Tel. + 972-9-7670002 Fax. +972-9-7668534 February 2008 C. Date Prepared: Biomove 5000 System D. Trade Name: Name: stimulator, muscle, powered E. Classification: Product Code: IPF Regulation No: 890.5850 Class': II Panel: Physical Medicine {1}------------------------------------------------ - F. Predicate Devices: The Biomove 5000 is substantially equivalent to the Biomove 3000 device manufactured by the same company and cleared under number K042650 in terms of intended use, indications for use, technological characteristics, performance and user interface. Both predicate devices are Class II medical devices. A discussion of substantial equivalence is provided in this submission. - G. Device Description: The Biomove 5000 is a powered EMG triggered neuromuscular electrical stimulator device used as a training system for rehabilitation of paralyzed muscles, mainly after stroke. The following accessories are supplied with the system: Patient Cable, re-usable electrodes (Biotrodes). H. Intended Use / Indication for Use: The Biomove 5000 is indicated for: - 1. Stroke Rehabilitation by Muscle Re-education - 2. Prevention of retardation of disuse atrophy - 3. Increasing local blood circulation - 4. Muscle re-education - 5. Maintaining or increasing range of motion - I. Performance Standards: The Biomove 5000 complies with U.S. Federal Performance Standard as set forth in 21 CFR 898 for electrode lead wires and Patient Cables. The device complies with the following recognized standards: {2}------------------------------------------------ - IEC 60601-1(1988), including amendments #1(1991), . #2(1995) - IEC 60601-2-10 (1987) � The device complies with the Guidance Document for Powered Muscle Stimulator 510(k)s; Final (1999). - J. Technological Characteristics: The technological characteristics, e.g., overall design, materials, mechanism of action, mode of operation, performance characteristics, etc., and the intended use of the Biomove 5000 device are substantially equivalent to the predicate device cited above. - K. Substantial Equivalence: The Biomove 5000 System is substantially equivalent to its predicate device as cited above and raises no new safety and/or effectiveness issues. 100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circle around the eagle. The eagle is black, and the text is also black. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 APR 1 7 2008 Curatronic, Limited % Ms. Ahava Stein Regulatory Affairs Consulting 20 Hata'as Street Kfar Saba 44425 Israel Re: K080787 > Trade/Device Name: Biomove 5000 system Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator. Regulatory Class: Class II Product Code: IPF Dated: March 16, 2008 Received: March 20, 2008 Dear Ms. Stein: 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 {4}------------------------------------------------ ## Page 2 - Ms. Ahava Stein forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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. 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 (240) 276-0120. 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 (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html Sincerely yours. Mark N Millman Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## INDICATIONS FOR USE STATEMENT 510(k) Number (if known): _ K 080787 Device Name: Biomove 5000 System. Indications for Use: The Biomove 5000 is indicated for: - 1. Stroke Rehabilitation by Muscle Re-education - 2. Prevention of retardation of disuse atrophy - 3. Increasing local blood circulation - 4. Muscle re-education - 5. Maintaining or increasing range of motion Prescription Use V AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) Over-The-Counter Use (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) > Concurrence of CDRH, Office of Device Evaluation (ODE) AP 111 (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** K090787 ¹³⁶