INSIGHT MILLENNIUM

K990778 · Fasstech · HCC · Jun 3, 1999 · Neurology

Device Facts

• Record ID: K990778
• Device Name: INSIGHT MILLENNIUM
• Applicant: Fasstech
• Product Code: HCC · Neurology
• Decision Date: Jun 3, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2

Intended 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

Device Story

Insight Millennium measures spinal physiological parameters; inputs include surface EMG signals, skin temperature, and range of motion data. Device operates in clinical settings; used by healthcare professionals to assess spinal function. Outputs consist of quantitative measurements of bilateral EMG/temperature differences and spinal range of motion. Data used to chart patient progress during treatment courses. Benefits include objective monitoring of spinal health and treatment efficacy.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on 510(k) regulatory review.

Technological Characteristics

Device measures surface EMG, skin temperature, and range of motion. System is designed for spinal assessment. Technical specifications and materials not detailed in provided documentation.

Indications for Use

Indicated for patients requiring spinal assessment, including measurement of bilateral surface EMG differences, surface EMG during functional tasks, bilateral skin temperature differences, and range of motion across three spinal regions to monitor treatment progress.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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 |
|---------------|---------|
|---------------|---------|