(203 days)
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.
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.
The provided text describes the NEURIM SOMNITOR 32K ACTIVITY MONITOR DEVICE, but it does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results for performance validation against specific acceptance criteria.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's what can be inferred or stated as missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document primarily focuses on substantial equivalence to a predicate device, not on specific performance metrics or acceptance thresholds for a new study. | Not provided in the document. The document states that the device uses "validated algorithm[s]" but does not present the results of such validation or specific performance metrics. |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Not specified.
- Qualifications of experts: Not specified.
4. Adjudication method for the test set:
- Adjudication method: Not specified.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Was it done?: Not specified. The document does not describe any human reader studies, with or without AI assistance.
- Effect size: Not applicable as no MRMC study is described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Was it done?: Not explicitly stated with performance metrics. The document mentions "validated algorithm[s]" but provides no details of a standalone performance study.
7. The type of ground truth used:
- Type of ground truth: Not specified.
8. The sample size for the training set:
- Sample size: Not specified.
9. How the ground truth for the training set was established:
- How established: Not specified.
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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.
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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.
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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
§ 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.