INSIGHT MILLENNIUM by FASSTECH | FDA 510(k) Summary

I am unable to provide a description of the acceptance criteria and study that proves the device meets the acceptance criteria based on the provided text. The document is an FDA letter granting substantial equivalence for the "Insight Millennium" device (K990778).

Here's why the requested information cannot be extracted:

No Acceptance Criteria or Study Details: The letter approves the device for marketing and mentions its intended uses, but it does not contain any performance data, acceptance criteria, study design, or results. It's a regulatory approval document, not a scientific study report.
Focus on Substantial Equivalence: The core of this document is the FDA's determination that the Insight Millennium is "substantially equivalent" to predicate devices marketed before May 28, 1976. This process primarily involves comparing the device's technological characteristics and proposed indications for use to an already legally marketed device, not necessarily requiring a new, comprehensive clinical study with specific performance metrics to be detailed in the approval letter itself.
Missing Information: All aspects of your request (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth types, training set size, ground truth establishment for training set) are completely absent from the provided text. These details would typically be found in the 510(k) submission itself or in published studies about the device, which are not part of this document.

Summary

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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

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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
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Regulation Number and Section

§ 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.