THE BAGNOLI-8 EMG SYSTEM

K990356 · Delsys, Inc. · HCC · Apr 29, 1999 · Neurology

Device Facts

• Record ID: K990356
• Device Name: THE BAGNOLI-8 EMG SYSTEM
• Applicant: Delsys, Inc.
• Product Code: HCC · Neurology
• Decision Date: Apr 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5050
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is to be used for biofeedback applications.

Device Story

Bagnoli-8 EMG System is an electromyography (EMG) device used for biofeedback applications. It captures electrical signals from muscles; processes these signals to provide feedback to the user. Used in clinical settings by healthcare professionals to assist in muscle retraining or relaxation training. Output allows providers to monitor muscle activity levels, facilitating clinical decision-making regarding patient rehabilitation or stress management. Benefits include improved patient awareness and control over muscle function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

EMG system for biofeedback; electrical signal acquisition; 8-channel configuration. Technical specifications and materials not detailed in the provided document.

Indications for Use

Indicated for biofeedback applications. Patient population not specified.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 1999

Mr. Gianluca De Luca Research Engineer Delsys, Inc. P.O. Box 15734 Boston, Massachusetts 02215

Re: K990356 Trade Name: The Bagnoli-8 EMG System Regulatory Class: II Product Code: HCC and IRC Dated: January 27, 1999 Received: February 5, 1999

Dear Mr. De Luca:

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. Gianluca De Luca

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 [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. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Statement of Indications for Use

| 510(k) Number (if known) | K 990356 |
|--------------------------|----------------------|
| Device Name: | Bagnoli-8 EMG System |

Indications For Use:

This device is to be used for biofeedback applications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dcoee/s

(Division Sign-Off) Division of General Restorative Devices

510(k) Number

**Prescription Use**
Per 21 CFR 801.109 OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional format 1-2-96)