MUSCLESENSE II CLINICAL ELECTROMYOGRAPHY DEVICE

{0} 510(k) Summary K970051 Smith & Nephew, Inc. DonJoy Division 2777 Loker Ave. West Carlsbad, CA 92008 JUL 10 1997 Contact Person: Dan W. Miller Phone: (760) 438-9091 Date Prepared: April 11, 1997 # INTRODUCTION The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation training. We consider the Smith & Nephew MuscleSense™ II portable EMG to be substantially equivalent to the Autogenics Systems' AT Dual Channel EMG and the Promethius Group Pathway™ MR-25 EMG System. The MuscleSense™ II, AT, and Pathway MR-25 are all indicated for relaxation training and muscle re-education. All three devices are used in conjunction electrodes. The MuscleSense™ II threshold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity. There is no electrical current being delivered to the patient. The device is supplied with pre-gelled conductive electrodes which have been cleared for marketing by the Food and Drug Administration under K851522/A. The device is battery powered or by a UL544 approved wall mounted power supply. Smith & Nephew, Inc. DonJoy Division  Dan W. Miller Director, Regulatory Affairs & Quality Assurance {1} # SPECIFICATIONS Input Impedance: 10¹⁰ Ohms Sensitivity: 0.5 µV rms Bandwidth: 45-300 Hz CMRR: 115dB Notch Filter: 60 Hz, 24dB Input Noise: 0.28 µV Bias Current: 5 nA Range: x1 0-50µV rms x10 0-500µV rms x50 0-2500µV rms Modes: PEAK, COUNT, RATIO Power Source external: 7 Vdc wall mount supply (UL544 approved) battery pack: 6 Vdc rechargeable (optional) Niad battery pack battery life: 8 hours Dimensions width: 6" length: 6" height: 3.25" weight: 25 oz Storage Temperature: -20°C to +50°C (-4°F to +122°F) Operating Temperature: 0°C to +50°C (+32°F to +122°F) Note: Electrical specifications are typical. {2} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Dan W. Miller Director, Regulatory Affairs & Quality Assurance Smith & Nephew DonJoy, Inc. 2777 Loker Avenue West Carlsbad, California 92208-6601 JUL 10 1997 Re: K970051 Trade Name: MuscleSense II Dual Channel Electromyography Device Regulatory Class: II Product Code: 84HCC Dated: April 11, 1997 Received: April 15, 1997 Dear Mr. Miller: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. {3} Page 2 - Mr. Dan W. Miller This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for *in vitro* diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours,  Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4} 510(k) Number (if known): K970051 Device Name: MuscleSense II Dual Channel Electromyography Device Indications For Use: 1) Relaxation Training 2) Muscle Re-education (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)  Prescription Use ☑ (Per 21 CFR 801.109) Order The Counter Use ☑ (Optional Format 1-2-96)