XYZ SYSTEM

{0}------------------------------------------------ 6983550 # JAN - 7 1999 # 510(K) SUMMARY This summary of 50(x) safety and effectiveness information is being submitted in ternation in the same comparact of SMDA ISSO and 21 CFR §807.92 This summary of 5.0(k) safety and enectivenised intones accordance with the requirements of SMDA ISSO and 21 CFR 5807.92. The assigned 510(k) number is:K#983550. # Submitter's Identification: 1. Ele-Monitoring International Corporation P.O. Bcx 52514 Sirevepor. LA 71135 Shreveport. LA 71155 Contact Person: Mr. Samuel J. Caldwell, President Date Summary Prepared: October 28, 1998 ### Name of the Device: 2. XYZ System ### Predicate Device Information: 3. J&J Physicdata 1-330 System, K#945826 #### Device Description: 4. The XYZ System contains 5 major parts: The Amplifier Modules, The Amplifier Proved to System Ann Analifican and Icelched Rower, the Analog to Digital The XYZ System contains 5 major parts. The Analog to Digital Housing with Isolation Ampitifiers and Isolated Power, the Analog to Digital Housing with Issac De Amplifiers an Housing with Isolathon Ampilliers and Toulater Converter, the IBM-PC compatible computer and XYZ Software. #### Intended Use: 5. The XYZ System is intended for biofeedback for relaxation and re-education of muscles. {1}------------------------------------------------ # Comparison to Predicate Devices: 6. | Comparison Points | Physiodata 1-330 System<br>5100(k) #K945326 | XYZ System System | Difference | |-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------| | Indication Statements | Biofeedback, Relaxation<br>Training, and Physio-<br>logical Monitoring | Biofeedback, Relaxation<br>Training, and Physiological<br>Monitoring | None | | Intended Use | 1) Provide electrical isolation<br>between patient connected<br>sensors and AC line powered<br>equipment used to record and<br>display signals from the<br>sensors<br>2) Provide displays in software<br>of the signals with visual and<br>auditory displays<br>3) Collect and record the data<br>from the signals | 1) Provide electrical isolation<br>between patient connected<br>sensors and AC line powered<br>equipment used to record and<br>display signals from the<br>sensors<br>2) Provide displays in software<br>of the signals with visual and<br>auditory displays<br>3) Collect and record the data<br>from the signals | None | | Effectiveness | Effective | Effective | None | | Hardware<br>Instrumentation<br>Amplifiers | J&J 1-330 Amplifier Modules | J&J 1-330 Amplifier Modules<br>and CapScan Amplifier | Uses same J&J<br>1-330 amplifier<br>modules, as<br>well as,<br>CapScan<br>EEG/EMG<br>amplifier | | Software Program | Use System<br>(Trade Name) | XYZ System Software | Similar | | Software Features | Auditory and Visual Repre-<br>sentations of the signals, data<br>recording | Auditory and Visual<br>Representations of the signals,<br>data recording | None | | Performance Standards | Requirements Met | Requirements Met | Minimal | | Personal Safety | Safe | Safe | None | {2}------------------------------------------------ # 7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows: Performance standards met include UL-544 (electrical isolation), software validation requirements and testing procedures for the multi-channel isolation beard. #### 8. Discussion of Clinical Tests Performed: Not Apolicable #### ರು. Conclusions: The XYZ System is substantially equivalent in intended use, design, material and technology as the J&J Physicdata 1-330 System, K#945826. Both devices have the same intended use, similar software program, minimal differences in performance parameters and meet electrical safety requirements. Regarding software, the XYZ System uses the same Physiodata I-330 amplifier modules as well as the CapScan EEG/EMG amplifier. The XYZ System does not incorporate any changes in intended use, method of operation, material or design that could affect safety or effectiveness. {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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN - 7 1999 Anand Akerkar, Ph.D. Official Correspondent Bio-Monitoring International Corporation Post Office Box 52614 Shreveport, Lousiana 71135 Re: K983550 Trade Name: XYZ System Regulatory Class: II Product Code: HCC Dated: October 2, 1998 Received: October 9, 1998 Dear Dr. Akerkar: 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. {4}------------------------------------------------ Page 2 - Dr. Anand Akerkar 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) 594-4595. 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, Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ P.06 K# 983550 EXHIBIT #3 SIO(K) NUMBER (IF KNOWN): Bio-Monitoring International Corporation XYZ System DEVICE NAME : .... --------- INDICATIONS FOR USE: The XYZ System is intended for biofeedback for relaxation and re-education of muscles. (FILESE DO MOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF IS NEEDED.) Concurrent of CDRE, Office of Device Evaluation (ODE) Prescription Use ( 22 2 2 2 C 2 2 2 2 2 2 2 2 2 2 0 2 1 0 3 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 ೧೯ Cver-The-Counter-Use er-The-Councer Format 1-2-53 Neil RPOgden (Division Sign-Off) Division of General Restorative Devices 510(k) Number 983550