(90 days)
K#945826
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware components and standard software.
Yes
The device is intended for "biofeedback for relaxation and re-education of muscles," which describes a therapeutic purpose.
No
The device is intended for "biofeedback for relaxation and re-education of muscles," which describes a therapeutic or training purpose, not a diagnostic one. No diagnostic claims or performance metrics are mentioned.
No
The device description explicitly lists multiple hardware components (Amplifier Modules, Analog to Digital Housing, IBM-PC compatible computer) in addition to the software.
Based on the provided information, the XYZ System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "biofeedback for relaxation and re-education of muscles." This describes a device that interacts with the body to provide feedback on physiological signals, which is a therapeutic or monitoring function, not an in vitro diagnostic function.
- Device Description: The description details components like amplifier modules, analog-to-digital converters, and a computer system. These are consistent with a biofeedback device that measures and processes physiological signals from the body. There is no mention of reagents, samples (like blood, urine, etc.), or analysis of biological specimens outside of the body, which are hallmarks of IVDs.
- Lack of IVD Indicators: There is no mention of analyzing biological samples, detecting specific analytes, or providing diagnostic information based on laboratory tests.
Therefore, the XYZ System, as described, falls under the category of a biofeedback device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The XYZ System is intended for biofeedback for relaxation and re-education of muscles.
Product codes (comma separated list FDA assigned to the subject device)
HCC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K#945826
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
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
5100(k) #K945326 | XYZ System System | Difference |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| Indication Statements | Biofeedback, Relaxation
Training, and Physio-
logical Monitoring | Biofeedback, Relaxation
Training, and Physiological
Monitoring | None |
| Intended Use | 1) Provide electrical isolation
between patient connected
sensors and AC line powered
equipment used to record and
display signals from the
sensors
2) Provide displays in software
of the signals with visual and
auditory displays
3) Collect and record the data
from the signals | 1) Provide electrical isolation
between patient connected
sensors and AC line powered
equipment used to record and
display signals from the
sensors
2) Provide displays in software
of the signals with visual and
auditory displays
3) Collect and record the data
from the signals | None |
| Effectiveness | Effective | Effective | None |
| Hardware
Instrumentation
Amplifiers | J&J 1-330 Amplifier Modules | J&J 1-330 Amplifier Modules
and CapScan Amplifier | Uses same J&J
1-330 amplifier
modules, as
well as,
CapScan
EEG/EMG
amplifier |
| Software Program | Use System
(Trade Name) | XYZ System Software | Similar |
| Software Features | Auditory and Visual Repre-
sentations of the signals, data
recording | Auditory and Visual
Representations of the signals,
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