MM-1 MOVEMENT MONITOR

K971318 · Axon Instruments, Inc. · GYD · Jul 28, 1997 · Neurology

Device Facts

• Record ID: K971318
• Device Name: MM-1 MOVEMENT MONITOR
• Applicant: Axon Instruments, Inc.
• Product Code: GYD · Neurology
• Decision Date: Jul 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1950
• Device Class: Class 2

Intended Use

The MM-1 provides useful, quantitative measurements of several neurologically relevant movement phenomena: tremor, dexterity and reaction/movement time. The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease.

Device Story

MM-1 Movement Monitor measures neurologically relevant movement phenomena; inputs include patient tremor, dexterity, and reaction/movement time data. Device transforms physical movement inputs into quantitative measurements; assists clinicians in diagnosing movement disorders like essential tremor and Parkinson's disease. Used in clinical settings; operated by healthcare professionals. Output provides objective data to support clinical decision-making; aids in patient assessment and diagnostic process.

Clinical Evidence

No clinical data provided.

Indications for Use

Indicated for patients requiring quantitative measurement of tremor, dexterity, and reaction/movement time to assist in the diagnosis of movement disorders, including essential tremor and Parkinson's disease.

Regulatory Classification

Identification

A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.

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

Andrew L. Blatz, Ph.D.
Regulatory Affairs Manager
Axon Instruments, Inc.
1101 Chess Drive
Foster City, California 94404

Re: K971318
Trade Name: Movement Monitor (MM-1)
Regulatory Class: II
Product Code: 84GYD
Dated: July 15, 1997
Received: July 17, 1997

Dear Dr. Blatz:

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 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 - Andrew L. Blatz, Ph.D.

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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510(k) Number: K971318

Device Name: Movement Monitor (MM-1)

Indications For Use:

The MM-1 provides useful, quantitative measurements of several neurologically relevant movement phenomena: tremor, dexterity and reaction/movement time. The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

Thomas J. Callahan
(Division Sign-Off)
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number K971318