(86 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or any related technologies, and the described functions are standard physiological measurements.
No
The device measures and charts patient progress but does not actively treat or provide therapy itself. It is a diagnostic or monitoring tool.
Yes
The device is described as measuring physiological parameters like EMG, skin temperature, and range of motion, and charting patient progress, which are all activities associated with diagnosing or monitoring a medical condition.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only or includes hardware components. The intended uses suggest the need for sensors (EMG, temperature, motion), but it's unclear if these are part of the submitted device or rely on external hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The intended uses listed for this device involve measuring physical parameters directly from the patient's body (surface EMG, skin temperature, range of motion) along the spine.
- There is no mention of analyzing biological specimens.
Therefore, this device falls outside the scope of In Vitro Diagnostics. It appears to be a device for physiological measurement and monitoring.
N/A
Intended Use / Indications for Use
- To measure bilateral differences in surface EMG along the spine .
- To measure surface EMG along the spine during functional tasks .
- To measure bilateral differences in skin temperature along the spine .
- . To measure Range of Motion of the three spinal regions
- . To chart patient progress during the course of treatment
Product codes
HCC
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
spine
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Per 21 CFR 801.109)
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of three human profiles facing right, arranged in a stacked formation. The profiles are abstract and connected, creating a sense of unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 1999 JUN
Mr. Lee Brody Vice President Fasstech 155 Middlesex Turnpike Burlington, Massachusetts 01803
Re: K990778 Trade Name: Insight Millennium Regulatory Class: II Product Code: HCC Dated: March 8, 1999 Received: March 9,1999
Dear Mr Brody:
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 - Mr. Lee Brody
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 vour 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.
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
2
Page of of
510(k) Number (if known): Device Name: Indications for Use:
- To measure bilateral differences in surface EMG along the spine .
- To measure surface EMG along the spine during functional tasks .
- To measure bilateral differences in skin temperature along the spine .
- . To measure Range of Motion of the three spinal regions
- . To chart patient progress during the course of treatment
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
(Division Sign-Off)
Division of General Restorative Devices
| 510(k) Number | K990778 |
|---|---|
| --------------- | --------- |