(90 days)
The XYZ System is intended for biofeedback for relaxation and re-education of muscles.
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.
Here's an analysis of the provided text regarding the XYZ System's acceptance criteria and studies:
Analysis of the Provided Text (K983550 Summary):
The provided document is a 510(k) summary for the "XYZ System." A 510(k) submission is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, not necessarily on proving that a new device meets specific, pre-defined quantitative performance acceptance criteria through extensive clinical trials.
Based on the provided text, the application does not detail specific acceptance criteria in terms of quantitative metrics (e.g., sensitivity, specificity, accuracy) for device performance in biofeedback or relaxation. Instead, it focuses on demonstrating equivalence to the predicate device, emphasizing safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not present quantitative acceptance criteria in the typical sense (e.g., statistical thresholds for clinical performance). The "acceptance criteria" here are implicitly tied to demonstrating equivalence to the predicate device and meeting safety/performance standards.
| Acceptance Criteria (Implicit from Substantial Equivalence Claim) | Reported Device Performance (as stated in the K983550) |
|---|---|
| Intended Use Equivalence: Biofeedback for relaxation and re-education of muscles. | Meets: "The XYZ System is substantially equivalent in intended use... as the J&J Physicdata 1-330 System, K#945826. Both devices have the same intended use..." |
| Indication Statements Equivalence: Biofeedback, Relaxation Training, and Physiological Monitoring. | Meets: Identical to predicate. |
| Effectiveness Equivalence: Device is effective for its intended use. | Meets: States "Effective" (derived from predicate's effectiveness). |
| Personal Safety Equivalence: Device is safe. | Meets: States "Safe" (derived from predicate's safety). |
| Hardware Instrumentation: Use of J&J 1-330 Amplifier Modules (or equivalent performance). | Meets: "Uses same J&J 1-330 amplifier modules, as well as, CapScan EEG/EMG amplifier." |
| Software Program/Features: Similar auditory/visual representations of signals, data recording. | Meets: "Similar" software program and "None" for difference in software features. |
| Performance Standards Met: Electrical isolation (UL-544), software validation. | Meets: "Performance standards met include UL-544 (electrical isolation), software validation requirements and testing procedures for the multi-channel isolation board." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable. The document explicitly states "Not Applicable" for "Discussion of Clinical Tests Performed." The non-clinical tests performed relate to hardware and software validation, not a test set for clinical performance evaluation.
- Data Provenance: Not applicable for clinical test data. Non-clinical testing would have been conducted by the manufacturer (Ele-Monitoring International Corporation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No clinical tests or expert ground truth establishment for a clinical test set were reported.
4. Adjudication Method for the Test Set
- Not applicable. No clinical test set or adjudication was reported.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a "multi reader multi case (MRMC) comparative effectiveness study" was not done or reported in this 510(k) submission. The document clearly states "Not Applicable" for clinical tests.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone algorithm performance study was not explicitly reported in terms of specific performance metrics. The software validation mentioned is for functional correctness and safety, not for standalone clinical performance evaluation against a specific ground truth. The device is a biofeedback system, implying human-in-the-loop interaction rather than a standalone diagnostic or interpretative algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests (electrical isolation, software validation), the "ground truth" would be the applicable engineering standards (e.g., UL-544 requirements) and the pre-defined software specifications. This is not clinical ground truth (e.g., pathology, expert consensus).
8. The Sample Size for the Training Set
- Not applicable. This device is a biofeedback system, not an AI/ML algorithm that typically requires a 'training set' for model development in the sense of image analysis or diagnostic prediction. The "software" in this context refers to the operating system and processing of biofeedback signals, not a learned model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set for an AI/ML model for this device.
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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.
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Comparison to Predicate Devices: 6.
| Comparison Points | Physiodata 1-330 System5100(k) #K945326 | XYZ System System | Difference |
|---|---|---|---|
| Indication Statements | Biofeedback, RelaxationTraining, and Physio-logical Monitoring | Biofeedback, RelaxationTraining, and PhysiologicalMonitoring | None |
| Intended Use | 1) Provide electrical isolationbetween patient connectedsensors and AC line poweredequipment used to record anddisplay signals from thesensors2) Provide displays in softwareof the signals with visual andauditory displays3) Collect and record the datafrom the signals | 1) Provide electrical isolationbetween patient connectedsensors and AC line poweredequipment used to record anddisplay signals from thesensors2) Provide displays in softwareof the signals with visual andauditory displays3) Collect and record the datafrom the signals | None |
| Effectiveness | Effective | Effective | None |
| HardwareInstrumentationAmplifiers | J&J 1-330 Amplifier Modules | J&J 1-330 Amplifier Modulesand CapScan Amplifier | Uses same J&J1-330 amplifiermodules, aswell as,CapScanEEG/EMGamplifier |
| Software Program | Use System(Trade Name) | XYZ System Software | Similar |
| Software Features | Auditory and Visual Repre-sentations of the signals, datarecording | Auditory and VisualRepresentations of the signals,data recording | None |
| Performance Standards | Requirements Met | Requirements Met | Minimal |
| Personal Safety | Safe | Safe | None |
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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.
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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.
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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
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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
§ 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.