(203 days)
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Unknown
The description mentions a "new Neurim algorithm" but provides no details about its nature. While "Neurim" could potentially relate to neural networks (a type of AI/ML), the summary lacks any explicit mention of AI, ML, deep learning, or related concepts. Without further information about the "Neurim algorithm," it's impossible to definitively confirm or deny the presence of AI/ML.
No
The device is described as an activity monitor used to determine periods of sleep and wakefulness, not to treat a condition. While it monitors a health-related activity, monitoring alone does not qualify it as a therapeutic device. Its predicate device, the Mini-Motion Logger Actigraph, also indicates a monitoring purpose rather than therapeutic intervention.
No
The device monitors physical activity and determines periods of sleep and wakefulness, which is a measurement function, not a diagnostic one. While it uses algorithms to analyze data, it doesn't state that it identifies or diagnoses any specific medical condition or disease.
No
The device description explicitly states it is a "wrist worn device consisting of an activity (movement) detector and a data logger with internal data storage," indicating it includes hardware components beyond just software.
Based on the provided information, the Somnitor 32K Activity Monitor 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.
- Somnitor 32K Function: The Somnitor 32K Activity Monitor is a wearable device that monitors physical activity (movement) and uses algorithms to determine sleep and wake periods. It does not analyze biological samples from the body.
The device falls under the category of a medical device used for monitoring physiological parameters, but it does not meet the definition of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Somnitor 32K Activity Monitor is intended to monitor physical activity with an ambulatory monitoring and data logging device and after downloading the data to a personal computer, determine the periods when the patient was awake or sleeping using a validated algorithm.
Product codes
84 LEL
Device Description
The Somnitor 32K Activity Monitor is a wrist worn device consisting of an activity (movement) detector and a data logger with internal data storage. The device is used with a personal computer running software which can download data from the data logger and analyze it according to a validated algorithm to determine periods of sleep and wakefulness. Four algorithms for assessing sleep activity data may be used for analysis, including the Bounded Trigger algorithm, the Cole algorithm, the Sadeh algorithm, and a new Neurim algorithm.
Mentions image processing
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
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.(b)
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.
0
510(k) Summary
NEURIM SOMNITOR 32K ACTIVITY MONITOR DEVICE
Unclassified Common/Classification Name:
Sponsor:
JUL 1 0 1997
Neurim Pharmaceuticals, Ltd. 8 Hanechoshet St. Tel-Aviv 69710 ISRAEL + 972-3-6499340 + 972-3-6494568
Contact:
Ran Frenkel
Prepared:
December 10, 1996
LEGALLY MARKETED PREDICATE DEVICES A.
The Somnitor 32K Sleep Activity Monitor is similar in design, intended use, and performance to the Mini-Motion Logger Actigraph by Ambulatory Monitoring which was cleared by FDA as K854030. This 510(k) Summary will summarize the basis for a decision that the Somnitor 32K is substantially equivalent to the predicate device.
DEVICE DESCRIPTION B.
The Somnitor 32K Activity Monitor is a wrist worn device consisting of an activity (movement) detector and a data logger with internal data storage. The device is used with a personal computer running software which can download data from the data logger and analyze it according to a validated algorithm to determine periods of sleep and wakefulness. Four algorithms for assessing sleep activity data may be used for analysis, including the Bounded Trigger algorithm, the Cole algorithm, the Sadeh algorithm, and a new Neurim algorithm.
C. INTENDED USE
The Somnitor 32K Activity Monitor is intended to monitor physical activity with an ambulatory monitoring and data logging device and after downloading the data to a personal computer, determine the periods when the patient was awake or sleeping using a validated algorithm.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three human profiles incorporated into its body. The text "SERVICES • USA" is arranged above the eagle, and the text "DEPARTMENT OF HEALTH & HUMAN" is arranged around the left side of the eagle.
100000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
T. Whit Athey, Ph.D. Neurim Pharmaceuticals, Ltd. c/o C.L. McIntosh Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852
JUL 1 0 1997
Re: K965079 Somnitor 32K Sleep Activity Monitor Requlatory Class: Unclassified Product Code: 84 LEL Dated: April 11, 1997 Received: April 11, 1997
Dear Dr. Athey:
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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.
2
Paqe 2 - T. Whit Athey, 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 (301) 594-4639. 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 Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE
510(k) Number (if known): K965079
Device Name: Somnitor 32K Activity Monitor
Indications For Use:
The Somnitor 32K Activity Monitor is intended to monitor physical activity with rne oblinker one iter downloading the data to a personal computer, determine the periods when the patient was awake or sleeping using a validated algorithm.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Costello
(Division Sign-Off)
Division of Cardiovascular, espiratory, and Neurological Devi 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
0000006