TECA. MILLENNIUM

K965065 · Medelec , Ltd. · GWF · Jun 20, 1997 · Neurology

Device Facts

• Record ID: K965065
• Device Name: TECA. MILLENNIUM
• Applicant: Medelec , Ltd.
• Product Code: GWF · Neurology
• Decision Date: Jun 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Millennium is a 2 or 5 channel electromyograph which provides facilities for RMG and Evoked Potentials testing for a range of clinical applications. Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment. Caution: Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner.

Device Story

Millennium is a 2 or 5 channel electromyograph (EMG) system; records, displays, and documents electrophysiological signals from human nervous and muscular systems. Used in clinical environments by physicians or licensed practitioners for EMG and evoked potentials testing. Device transforms raw electrical signals into visual waveforms for clinician review; aids in diagnostic assessment of neuromuscular function. Benefits include reliable data acquisition for clinical decision-making.

Technological Characteristics

2 or 5 channel electromyograph; supports EMG and evoked potentials testing; clinical environment use.

Indications for Use

Indicated for clinical electrophysiological recording, display, and documentation of the human nervous and muscular system via electromyography (EMG) and evoked potentials testing. Intended for use by physicians or licensed practitioners.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN 20 1997

Mr. Jeff Hall
Quality Assurance Manager
Medelec Limited
Manor Way
Old Woking
Surrey GU22 9JU
UNITED KINGDOM

Re: K965065
Trade Name: Millenium
Regulatory Class: II
Product Code: 84GWF, 84GWE, 84GWJ, 84JXE, and 89IKN
Dated: March 26, 1997
Received: March 31, 1997

Dear Mr. Hall:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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

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Page 2 - Mr. Jeff Hall

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.

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,

Thomas J. Callahan, Ph.D.
Director
Division of Cardiovascular, Respiratory, and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page of

510(k) Number (if known): K965065

Device Name: MILLENNIUM

Indications For Use:

The indications for use statements shown below are now to be included in the Millennium User Manual, see Introduction Section under the headings of System Overview and Cautions and Warnings respectively.

The Millennium is a 2 or 5 channel electromyograph which provides facilities for RMG and Evoked Potentials testing for a range of clinical applications.

Millennium is designed to enable reliable recording, display and documentation of electrophysiological information from the human nervous and muscular system in a clinical environment.

Caution: Federal law restricts this device to sale by or on the order of a physician, or other licensed practitioner.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number

Prescription Use ☑ (Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐ (Optional Format 1-2-96)

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AIO TNIOM SHXOIA

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