BIOREHAB SYSTEM

{0}------------------------------------------------ SEP - 6 2001 Image /page/0/Picture/1 description: The image shows the logo for "Nicolet Biomedical". The word "Nicolet" is in a large, bold, sans-serif font, with a thick black line underneath it. Below the line, the word "BIOMEDICAL" is printed in a smaller, sans-serif font, with the letters spaced out. K011823 ## Summary of Safety and Effectiveness | Company Name: | Nicolet Biomedical Incorporated<br>5225 Verona Road<br>Madison, WI 53711 | |----------------------------|-------------------------------------------------------------------------------------| | Contact:<br>Phone:<br>Fax: | Glen Hermanson, Manager of Standards and Compliance<br>608 441-2065<br>608 441-2007 | | Summary Date: | June 6, 2001 | | Trade Name: | BioRehab System | | Common Name: | Biofeedback Device | | Classification Name: | 21 CFR 882.5050; Product Code: HCC | | Predicate Device(s): | | K960508 510(k) Number: The Prometheus Group Manufacture: Pathway II Perineometer, MR Series of Amplifiers Trade Name: K935853 Product Code: HCC 510(k) Number: UniTech Research Inc. Manufacture: EMG Trainer Trade Name: K854277 Product Code: HCC 510(k) Number: Therapeutic Alliance Inc. Manufacture: Trade Name: NeuroEducator #### Description of Device 1.0 The BioRehab System consists of an EMG amplifier, computer and software. Under the care and guidance of a physician or therapist, the BioRehab System supports relaxation and muscle reeducation by the application of electromyography (EMG) biofeedback. The BioRehab System supports patient game playing under EMG control. The patient consciously controls the EMG signal level from the therapist's selected muscle groups. #### Nicolet Biomedical Inc Image /page/0/Picture/11 description: The image shows the ISO 9001 logo. The logo is black and white and features the letters "ISO" stacked on top of the number "9001". There are some other words on the left and right side of the logo, but they are too blurry to read. The logo is a symbol of quality management system certification. 5225 Verona Road Bldg. 2 Madison, Wisconsin USA 53711-4495 Tel: 608/273-5000 Fax: 608/273-5067 Toll free: 1-800/356-0007 Summary of Safety and Effectiveness Page 1 of 2 122 A Teermo Electron Company {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in large, bold, sans-serif font. Below "Nicolet" is a thick black line. Under the line, the word "BIOMEDICAL" is in a smaller, sans-serif font, with a space between each letter. #### 2.0 Intended Use The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations. #### 3.0 Technological The BioRehab System applies EMG signal detection and amplification to support relaxation and muscle reeducation therapy. The significant components of the BioRehab System are a battery powered patient interface amplifier, computer software. Commercially available surface EMG electrodes connect to the amplifier. The EMG signal output of the BioRehab system is qualitative not quantitative. Under control of the therapist, an EMG signal threshold is set for the patient to support control of the computer cursor. The control of the computer cursor supports patient game playing on the computer. #### 4.0 Conclusions The characteristics of the BioRehab System are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised. 123 {2}------------------------------------------------ Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, which are meant to represent the human services provided by the department. The seal is black and white. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 6 2001 Nicolet Biomedical, Inc. c/o Mr. Gary Syring Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589 Re: K011823 Trade/Device Name: BioRehab System Regulation Number: 882.5050 Regulation Name: Biofeedback Device Regulatory Class: II Product Code: HCC Dated: June 6, 2001 Received: June 11, 2001 Dear Mr. Syring: We have reviewed your Section 510(k) notification of intent to market the device referenced we have hove have determined the device is substantially equivalent (for the indications for use above and 10 hors assort as a 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 press to rid) = 3, if = 1, = 1, = 1, = 1, = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Costions of the Act. The general controls provisions of the Act include requirements for annual provisions of all Production 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 ( frenting 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 requirements, 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. Gary Syring 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) 594-4659. 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsma/dsmamain.html". Sincerely yours, Susan Wall, us \$ 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}------------------------------------------------ # 510(k) Number (if known): KO11823 Device Name: BioRehab System Indications For Use: The BioRehab System is used for electromyography (EMG) biofeedback support of relaxation and muscle reeducation. The BioRehab System may be used by licensed medical practitioners to support their methods of muscle relaxation and reeducation/rehabilitation. The BioRehab System can be used in hospital, physician office, clinics, long-term patient care facilities, home and other therapy locations. (PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98) Signature of Officer (Division Sign-Off) Division of General, Restorative and Neurological Devices 510(k) Number_KO 1/8 2