(110 days)
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Not Found
No
The provided text does not mention AI, ML, or any related terms, nor does it describe features or processes typically associated with these technologies in medical devices.
No
The device is used for diagnosis and measurement, not for treatment.
Yes
The "Intended Use / Indications for Use" states that "The MM-1 can be useful in the diagnosis of certain movement disorders, such as essential tremor and tremor in Parkinson's disease."
Unknown
The provided summary lacks sufficient detail about the device's components and how it acquires the movement data. It describes the intended use and measurements but doesn't explicitly state if it's purely software or relies on a specific hardware sensor or device for data acquisition.
Based on the provided information, the MM-1 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- MM-1 Function: The description states the MM-1 provides "quantitative measurements of several neurologically relevant movement phenomena: tremor, dexterity and reaction/movement time." This involves measuring physical movements of the patient, not analyzing biological samples.
- Lack of IVD Indicators: The provided text does not mention any analysis of biological samples, chemical reactions, or laboratory procedures, which are characteristic of IVDs.
Therefore, the MM-1 is a device that measures physical movement characteristics, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes
84GYD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1950 Tremor transducer.
(a)
Identification. A tremor transducer is a device used to measure the degree of tremor caused by certain diseases.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's focus on health, human services, and the future. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
JUL 28 1997
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Andrew L. Blatz, Ph.D. Requlatory Affairs Manager Axon Instruments, Inc. 1101 Chess Drive Foster City, California 04404
K971318 Re : Trade Name: Movement Monitor (MM-1) Requlatory 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, Druq, 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 reqistration, 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) requlation (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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
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Page__1_of__1__
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