(198 days)
Not Found
Unknown
The summary describes algorithmic analysis of movement data but does not explicitly mention AI or ML, nor does it provide details about the algorithm's architecture or training that would confirm the use of these technologies.
No.
The device is an activity monitor designed to document physical movements and extract information about sleep parameters; it does not claim to treat or diagnose a disease.
Yes
The device's intended use is to analyze limb activity during sleep to extract information about certain sleep parameters, and its performance studies compare its sleep/wake classification to polysomnographic assessment. This indicates it is used to identify or monitor a physiological state (sleep parameters/sleep-wake cycles) which falls under the definition of a diagnostic device.
No
The device description explicitly states "The SBV2 System is a device that monitors activity. It relies on the measurement and analysis of wrist movements...". This indicates the system includes a hardware component (the device that monitors activity and measures wrist movements), not just software. The description of the intended user/care setting also mentions a "data recording unit" which is a hardware component.
Based on the provided information, this 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.
- SBV2 System Function: The SBV2 System is an activity monitor that measures physical movements (specifically wrist movements) to analyze sleep patterns. It does not analyze biological samples from the body.
- Intended Use: The intended use is to document physical movements for physiological monitoring and extract information about sleep parameters from these movements. This is a non-invasive measurement of physical activity.
Therefore, the SBV2 System falls under the category of a medical device that monitors physiological parameters through external measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SBV2 System is an activity monitor designed and intended for documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep and to extract information about certain sleep parameters from these movements. SBV2 can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable. The use of the SBV2 is indicated for adults 22 years of age and over.
Product codes
LEL
Device Description
The SBV2 System is a device that monitors activity. It relies on the measurement and analysis of wrist movements to detect and characterize sleep/wake periods. The device allows some aspects of sleep derived from the analysis of activity to be reported. The SBV2 System components include: SBV2 (Data Recording Unit); wristwatch-like device used to capture and store accelerometer data from user. ANT Dongle; A PC peripheral that uses a proprietary wireless protocol to transfer stored accelerometer data to SleepAnalyzer software application. PC Computer; standard PC used to host the SleepAnalyzer application. MultiCharger; coin cell battery charger used to fully charge the Data Recording Unit battery prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
wrist (implied by "wearable wristwatch-like device") and limb.
Indicated Patient Age Range
adults 22 years of age and over
Intended User / Care Setting
Over-The-Counter Use. Patient receives data recording unit from dispensing agent such as pharmacist. Dispensing agent retrieves collected data from data recording unit and generates report based on collected data. Further interpretations of sleep from the report should only be performed by a qualified health care professional such as a physician with training in the normal and abnormal physiology of sleep.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Phase 1:
Sample size: 180 participants
Data source: De-identified actigraph data
Annotation protocol: Agreement between algorithmic versus human classification of actigraphy into the following states: 1) Awake and moving about, 2) In bed-Awake or Asleep, or 3) Actigraph off wrist.
Phase 2:
Sample size: 50 patients
Data source: Actigraphy data collected simultaneously with polysomnographic assessment at the Kettering Sleep Disorders Center.
Annotation protocol: Comparison between in-bed polysomnography and in-bed actigraphy to determine specificity and sensitivity of actigraphic sleep/wake assessments. Polysomnography is considered to be the accepted medical standard for conducting sleep evaluations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance data produced by a two-phase investigation demonstrates substantial equivalence between polysomnographic sleep/wake classification and SBV2 actigraphic sleep/wake classification.
Study Type: Substantial Equivalence Evaluations, Classification Accuracy Study, Validation Study
Sample Size: Phase 1: 180 participants; Phase 2: 50 patients.
Key results:
Phase 1: Results indicated that the SBV2 algorithm accurately differentiated among the 3 states of interest between 87% and 95% of the time. (AWAKE, up and about: 95%; IN BED, awake or asleep: 95%; OFF WRIST: 87%)
Phase 2: SBV2 sleep/wake classification corresponded to night-time polysomnographic findings with a sensitivity of 88% and a specificity of 55%.
Final Result: An overall SBV2 vs polysomnography agreement level of 93% (calculated by averaging the "in-bed state detection" of 95% with the "in-bed-asleep detection" of 88%).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Identification accuracy of "up & about" vs "in bed" vs "off wrist":
AWAKE, up and about: 95%
IN BED, awake or asleep: 95%
OFF WRIST: 87%
Classification accuracy of SBV2 vs polysomnography sleep/wake:
Sensitivity: 88%
Specificity: 55%
Overall SBV2 vs polysomnography agreement level of 93%.
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
Russel, C.A, Caldwell, J.A., et al. (2011), "Validation of the Fatigue Science SBV2." Fatigue Science White Paper.
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Carskadon, M.A. (1994). Guidelines for the Multiple Sleep Latency Test (MSLT): A Standard Measure of Sleepiness, in Kryger et al. (eds.), "Principles and practice of Sleep Medicine," pp 962-966. Philadelphia: WB Saunders Co.
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Berger et al., (2005). Sleep/wake disturbances in people with cancer and their caregivers: State of the Science, "Oncology Nursing Forum," 32(6):E98-E126
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Bonnet and Arand (2007), EEG arousal norms by age, "Journal of Clinical Sleep Medicine," 3(3):271-274
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Image /page/6/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 stripes forming its body and wing. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Sleep Performance D.B.A. Fatigue Science c/o Mr. Mark Goodmand, Senior Associate Noblit & Rueland 5405 Alton Parkway, Suite A530 Irvine, CA 92604
Re: K111514
Trade/Device Name: SVB2 System Regulation Number: Unclassified Regulation Name: Sleep Assessment Device Regulatory Class: Unclassified Product Code: LEL Dated: November 21, 2011 Received: November 23, 2011
DEC 1 6 2011
Dear Dr. Downs:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA), 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
7
Page 2 - J. Hunter Downs III, Ph.D.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely vours.
Malvina B. Eydelman, M.D.
Director
Division of Ophthalmic, Neurological,
and Ear, Nose and Throat Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510 (k) Number (if known) K111514
Device Name SBV2 System
Indications The SBV2 System is an activity monitor designed and intended for for Use documenting physical movements associated with applications in physiological monitoring. The device's intended use is to analyze limb activity associated with movement during sleep and to extract information about certain sleep parameters from these movements. SBV2 can also be used to assess activity in any instance where quantifiable analysis of physical motion is desirable. The use of SBV2 is indicated for adults 22 years of age and over.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use X (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
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Kii514
510(k) Number