SBV2, MULTICHARGER MODEL MC10V2
Device Facts
| Record ID | K111514 |
|---|---|
| Device Name | SBV2, MULTICHARGER MODEL MC10V2 |
| Applicant | Sleep Performance D.B.A. Fatigue Science |
| Product Code | LEL · Neurology |
| Decision Date | Dec 16, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.5050 |
| Device Class | Class 2 |
| Attributes | Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K111514 · Dec 16, 2011 | SBV2, MULTICHARGER MODEL MC10V2 | Sleep Performance D.B.A. Fatigue Science | De-identified actigraph data from 180 participants | Retrospective analysis of existing actigraph data was used to validate the device's algorithm for differentiating between 'awake and moving about', 'in-bed', and 'off-wrist' states. | Retrospective analysis; Actigraphy; Algorithm validation |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| Phase 1 Scoring Validation; Retrospective analysis of de-identified actigraph data | 180 participants; Sample Size: 180 | Not applicable for this study | Agreement between algorithmic versus human classification of actigraphy into three states (awake/moving, in-bed, off-wrist) |
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.
Device Story
SBV2 System is a wrist-worn activity monitor; captures accelerometer data to characterize sleep/wake periods and physical activity. Device consists of a data recording unit, MultiCharger, ANT Dongle, and PC running SleepAnalyzer software. User wears unit on limb/torso; data transferred wirelessly via ANT protocol (2.4 GHz) to PC. Software processes raw accelerometer data to differentiate 'up-and-about' vs 'in-bed' states and classify sleep/wake episodes. Output is a sleep report providing metrics like sleep duration, latency, and efficiency. Intended for OTC use; dispensing agent retrieves data and generates report. Healthcare providers use report to assess sleep patterns; aids in monitoring physiological activity. Benefits include objective, quantifiable sleep/activity data for adult users.
Clinical Evidence
Two-phase validation study. Phase 1: 180 participants; compared algorithmic vs. human classification of 'up-and-about' vs 'in-bed' vs 'off-wrist' states; accuracy 87-95%. Phase 2: 50 patients; compared SBV2 actigraphy vs. in-bed polysomnography (gold standard). Results: 88% sensitivity, 55% specificity for sleep/wake classification. Overall agreement level of 93% when weighting sleep identification.
Technological Characteristics
Wrist-worn accelerometer; 16 Hz sampling interval; 2.4 milliGs sensitivity. Enclosure: Polycarbonate; Wrist band: Santoprene. Battery: 3.7V rechargeable Lithium Coin Cell. Connectivity: Wireless ANT protocol (2.4 GHz ISM band). Operating temperature: 0°C to +40°C. Water resistant.
Indications for Use
Indicated for adults 22 years of age and over for documenting physical movements, analyzing limb activity during sleep to extract sleep parameters, and assessing activity where quantifiable motion analysis is desired.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- ActiGraph (K040554)
Submission Summary (Full Text)
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# < 111514
DEC 1 6 2011
# 1. 510(k) Summary - Basic Information
- 1.1 Sponsor
Submitter: Address:
Company:
Voice:
FAX:
Cell:
Email:
Fatigue Science 700 Bishop Street, Suite 2000 Honolulu, Hawaii, 96813
### Contact:
Marc Goodman (on behalf of Fatigue Science) Noblitt & Rueland 5405 Alton Parkway, Suite A530 Irvine, CA 92604 (949) 398-5222 (949) 398-5223 (949) 872-1011 marcgood@ca.rr.com
Date Prepared:
November 21, 2011
# 1.2 Device Name
SBV2TM System Proprietary Name: Common Name: Activity Recording Device Classification Name: GWQ, Electroencephalograph, 882.1400, Class II
# 1.3 Identification of Legally Marketed Device
SBV2 is substantially equivalent to the ActiGraph device (K040554).
# 1.4 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 is graphically depicted in Figure 1.
# Figure 1: SBV2 System Graphic Depiction
Image /page/0/Figure/17 description: The image shows a diagram of a data recording system. The system includes an SBV2 data recording unit, a MultiCharger, an ANT Dongle, and a PC Computer. The SBV2 unit is connected to the ANT Dongle, which is connected to the PC Computer.
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#### 1.4.1 Components
The following SBV2 System components (depicted in Figure 1) are briefly described as follows:
- 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.
# 1.5 Intended 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.
# 1.6 Comparison to Cleared Device
SBV2 is substantially equivalent to the ActiGraph (K040554). Table 1 compares the features of SBV2 with those of ActiGraph.
| Characteristic | SBV2 | ActiGraph |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Usage Characteristics | |
| Intended Use | The SBV2 System is an activity monitor<br>designed and intended for documenting physical<br>movements associated with applications in<br>physiological monitoring. The device's intended<br>use is to analyze limb activity associated with<br>movement during sleep and to extract<br>information about certain sleep parameters from<br>these movements. SBV2 can also be used to<br>assess activity in any instance where<br>quantifiable analysis of physical motion is<br>desirable. The use of the SBV2 is restricted to<br>adults 22 years of age and over. | The ActiGraph is a small limb worn activity<br>monitor designed for documenting physical<br>movements associated with applications in<br>physiological monitoring. The device's intended<br>use is to analyze limb activity associated with<br>movement during sleep. The unit can also be<br>used to assess activity in any instance where<br>quantifiable analysis of physical motion is<br>desirable. |
| Principle of<br>Operation | Accelerometer used to collect actigraphy data to<br>determine a person's activity level during the<br>course of a day. | same |
| Components | Data recording unit (SBV2 activity monitor)<br>worn by patient<br>PC software application prepares data<br>recording unit, retrieves collected data, and<br>generates report. | same |
| Data Collection<br>Method | Data recording unit is attached to patient's limb<br>or torso and worn continuously during data<br>collection period. | same |
| Sampling Interval | 16 Hz | 1 Hz and up (web site indicates 30 Hz) |
| Recording Time | 1 to 30 days. Typically 7 days. | 2 hours to 180 days (end of battery life) |
# Table 1: Comparison of SBV2 to ActiGraph (K040554)
510(k) Summary (per 21 CFR 807.92)
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| Characteristic | SBV2 | ActiGraph |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Data Recording Unit<br>to PC Interface | Wireless communications using ANT protocol in<br>2.4 GHz ISM Band. | RS232 or USB |
| Commercial<br>Distribution | Indicated for Over the Counter Use. Patient<br>receives data recording unit from dispensing<br>agent such as pharmacist. | Prescription Use |
| Reporting | Dispensing agent retrieves collected data from<br>data recording unit and generates report based<br>on collected data. | Same |
| Physical Characteristics | | |
| Size | 1.5"x1.35"x.4" | 2" x 2" x 0.5" (does not include wrist band) |
| Weight | 1 oz. | 1.5 oz, with battery 2.5 oz |
| Battery | rechargeable 3.7V Lithium Coin Cell | same |
| Recharging Method | MultiCharger | connection to USB port |
| Accelerometer<br>Sensitivity | 2.4 milliGs | 16 milliGs |
| Enclosure | Polycarbonate | same |
| Wrist Band | Santoprene | Nylon w Velcro |
| Moisture<br>susceptibility | Water resistant | same |
| Storage<br>Temperature | -40°C to +60°C | -10°C to +50°C |
| Operating<br>Temperature | 0°C to +40°C | 0°C to +45°C |
### Differences between SBV2 and ActiGraph 1.6.1
The meaningful differences between SBV2 and the ActiGraph predicate device are their means of commercial distribution and their methods for communicating between data recording unit and PC software application.
- SBV2 is intended for Over-The-Counter commercial distribution. ActiGraph is ● indicated for Prescription Use.
- . SBV2 uses wireless communications between its data recording unit and its PC software. ActiGraph uses hardwired serial communications.
# 2. Performance Information
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Performance data produced by a two-phase investigation demonstrates substantial equivalence between polysomnographic sleep/wake classification and SBV2 actigraphic sleep/wake classification.
### 2.1 Substantial Equivalence Evaluations
The Fatigue Science SBV2 was validated against expert human actigraphy scoring and against polysomnography as a device for accurately measuring sleep/wake periods. Polysomnography is considered to be the accepted medical standard for conducting sleep evaluations. There were two phases of the evaluation. A detailed account may be found in the Fatigue Science White Paper entitled Validation of the Fatigue Science SBV2 authored by Russell, Caldwell, Arand, Myers, Wubbels, and Downs (2010).
#### 2.1.1 Overview
The first phase of the scoring validation effort was conducted by research personnel at Archinoetics, LLC. These personnel possessed substantial expertise in the visual
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examination and classification of raw actigraphy data into various states such as "awake and moving about" versus "lying quietly in bed or elsewhere". The second phase of the classification yalidation effort was conducted by Dr. Donna Arand, Board Certified Sleep Specialist, Kettering Hospital; Dr. John Caldwell, Experimental Psychologist, Fatigue Science; and Dr. Chris Russell, Senior Scientist, Archinoetics, LLC; in conjunction with the Wallace Kettering Health Networks Sleep Disorders Center in Kettering Ohio.
#### 2.1.2 Phase 1 Summary
Since the SBV2 is designed to be worn 24-hours per day for several days at a time, it was first necessary to ensure that the "up-and-about periods" could be correctly differentiated from the "lying-in-bed periods." Using de-identified actigraph data from 180 participants, we determined the 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. Results indicated that the SBV2 algorithm accurately differentiated among the 3 states of interest between 87% and 95% of the time (see Table 1).
| | Table 1. Identification accuracy of "up & about" vs "in bed" vs "off wrist" | | | | | | |
|--|-----------------------------------------------------------------------------|--|--|--|--|--|--|
|--|-----------------------------------------------------------------------------|--|--|--|--|--|--|
| AWAKE, up and about | IN BED, awake or asleep | OFF WRIST |
|---------------------|-------------------------|-----------|
| 95% | 95% | 87% |
### 2.1.3 Phase 2 Summary
Since once the "in-bed" state was determined to have occurred it was of utmost importance to show correct actigraphy-based classification of sleep and wake episodes, a second study focused on the comparison between in-bed polysomnography and in-bed actigraphy. Via the collection of actigraphy data simultaneously from 50 patients undergoing polysomnographic assessment at the Kettering Sleep Disorders Center, the specificity and sensitivity of actigraphic sleep/wake assessments were determined. Results indicated that SBV2 sleep/wake classification corresponded to night-time polysomnographic findings with a sensitivity of 88% and a specificity of 55% (see Table 2).
| | THE SE STAULTIONAL AND POST LA LE POLL CARTER STERES MICA | |
|----------------|-----------------------------------------------------------------|-------|
| Total accuracy | ensitivity | |
| 040 | 000 | 5 201 |
| Table 2: Classification accuracy of SBV2 vs polysomnography sleep/wake<br>and the contract of the contract and the comments of the comments of the contribution of the comments of the contribution of the comments of the contribution of the contribut | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
#### 2.1.4 Final Result
Considering that for most people the majority of in-bed time would be spent sleeping, the in-bed sensitivity (correct identification of sleep) was weighted slightly more heavily than the in-bed specificity (correct identification of wake) by averaging the "in-bed state detection" of 95% with the "in-bed-asleep detection" of 88%. This yielded an overall SBV2 vs polysomnography agreement level of 93%.
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### 2.2 Sleep Report Summary
The device allows some aspects of sleep derived from the analysis of activity to be described in a sleep report. The sleep report uses a set of parameters that describe the normal ranges for an average adult user. Any 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. These normal ranges are supported by the following data.
### 2.2.1 Sleep Duration
The normal range of sleep duration for adults is set to 7-9 hours according to supporting data from Table 1 in 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. In addition, both the National Sleep Foundation and the Mayo Clinic state that 7-9 is the normal range for adults. The following table appears at http://www.sleepfoundation.org/article/howsleep-works/how-much-sleep-do-we-really-need:
| How Much Sleep Do You Really Need? | |
|------------------------------------|----------------|
| Age | Sleep Needs |
| Newborns (0-2 months) | 12-18 hours |
| Infants (3 to 11 months) | 14 to 15 hours |
| Toddlers (1-3 years) | 12 to 14 hours |
| Preschoolers (3-5 years) | 11 to 13 hours |
| School-age children (5-10 years) | 10 to 11 hours |
| Teens (10-17) | 8.5-9.25 hours |
| Adults | 7-9 hours |
### 2.2.2 Sleep Latency
The normal range of sleep latency is set to 10-20 minutes according to supporting data found in a published chapter by Kryger et al. in "Principles and practice of Sleep Medicine, 2nd edition, page 965."
Source: National Steep Foundation
#### Sleep Efficiency Range 2.2.3
The normal sleep efficiency range is stated as 95-80% according to supporting data found in Table 1 in 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; as well as in Table 2 in Bonnet and Arand (2007). EEG arousal norms by age, Journal of Clinical Sleep Medicine, 3(3):271-274.
### Bedtime Deviation 2.2.4
There are no established norms for this measure, however it is widely considered a general good-sleep-hygeine practice to minimize the deviation in bedtimes from night to night in order to promote quality restorative sleep.
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Therefore, this metric (without displaying the norm) is shown in the sleep report to present users with an assessment of how well they are following this recommended practice (of adhering to a consistent bedtime).
### 2.3 Obtaining References
All referenced materials will be provided to dispensers in the form of hard copies in a binder. Below is a list of included references:
- => Russel, C.A, Caldwell, J.A., et al. (2011), "Validation of the Fatigue Science SBV2." Fatigue Science White Paper.
- > 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.
- > 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
- > 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.
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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
