(142 days)
The Oxevision Sleep Device 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 subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data.
The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied.
The Oxevision Sleep Device is software assessing video from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments.
The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
Oxevision Sleep is a software-only medical device (SaMD) that provides noncontact sleep assessment in the inpatient setting based on the analysis of patient movement, activity and physiological sign data derived from video, without the need for contact devices to be attached to the patient or bed.
The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy bed spaces within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient movement, activity and physiological sign data and then to obtain information on bed occupancy and sleep state from the analysis of this data.
The device software automates recognition of sleep periods, generation of sleep reports, and their presentation in a graphical display for use by a healthcare professional.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Oxevision Sleep Device
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Oxevision Sleep Device Reported Performance | Meets Criteria? |
|---|---|---|
| Bed Occupancy Detection: Accuracy of periods of bed occupancy not inferior to 95% | 99% (95% CI: 99.0% - 99.7%) | Yes |
| Sleep/Wake Classification (Overall Agreement): Not inferior to 82% | 90% (95% CI: 89.0% - 91.8%) | Yes |
| Sleep/Wake Classification (Positive Agreement): Not inferior to 88% | 94% (95% CI: 92.3% - 95.6%) | Yes |
| Sleep/Wake Classification (Negative Agreement): Not inferior to 55% | 80% (95% CI: 74.3% - 83.5%) | Yes |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 60 individuals, resulting in a total of 772.65 hours of data.
- Data Provenance: The text does not explicitly state the country of origin. It mentions "a sample of 60 individuals" and "validation data collected from the 60 adults." The study appears to be prospective as it involved collecting "Reference measurements (physiological signals and video polysomnography data) ... concurrently from a standard off-the-shelf camera and hardware installed in two rooms."
3. Number of Experts and Qualifications for Ground Truth (Test Set)
- Polysomnography (PSG) Scoring:
- Number of Experts: Three trained sleep physiologists.
- Qualifications: "trained sleep physiologists, blinded to the video data collected by the standard off-the-shelf camera." They scored in accordance with the American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events version 2.6 of January 2020.
- Bed Occupancy Annotation:
- Number of Experts: Two reviewers.
- Qualifications: "blinded to the algorithm development details."
4. Adjudication Method for Test Set
- Sleep State (PSG): The ground truth for sleep state was established using "triple-scored PSG data" with an "epoch-by-epoch majority vote." Epochs where no majority label was available (e.g., due to artifact) were excluded from the analysis.
- Bed Occupancy (Video Annotation): The ground truth for bed occupancy was established by "two reviewers, blinded to the algorithm development details" who "reviewed and annotated" the video data. The specific adjudication method beyond "annotated" by two reviewers is not explicitly detailed (e.g., if discrepancies were resolved by a third reviewer).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document does not indicate that an MRMC comparative effectiveness study was done to evaluate the effect size of human readers improving with AI vs. without AI assistance. The study focuses on the standalone performance of the algorithm against reference standards.
6. Standalone Performance
- Yes, a standalone (algorithm only without human-in-the-loop performance) study was done. The entire clinical performance section describes the algorithm's performance against established reference standards for bed occupancy detection and sleep/wake classification.
7. Type of Ground Truth Used
- Bed Occupancy: Expert annotation of video data.
- Sleep/Wake Classification: Expert consensus from "triple-scored PSG data" by trained sleep physiologists, adhering to AASM guidelines. This can be categorized as a type of expert consensus based on a gold-standard diagnostic tool (PSG).
8. Sample Size for Training Set
- The document does not explicitly state the sample size for the training set. The "Clinical Performance" section specifically focuses on the "validation data collected from the 60 adults."
9. How Ground Truth for Training Set Was Established
- The document does not explicitly state how the ground truth for the training set (if distinct from the validation set) was established. It only describes the ground truth establishment for the clinical validation test set.
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April 3, 2024
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo consists of a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Oxehealth Limited Joao Jorge, PhD Sleep Analysis Lead Magdalen Centre North Oxford Science Park Oxford, OX4 4GA United Kingdom
Re: K233618
Trade/Device Name: Oxevision Sleep Device Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback device Regulatory Class: Class II Product Code: LEL Dated: March 4, 2024 Received: March 4, 2024
Dear Joao Jorge:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Patrick
Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional
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and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Oxevision Sleep Device
Indications for Use (Describe)
The Oxevision Sleep Device 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 subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data.
The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied.
The Oxevision Sleep Device is software assessing video from a fixed-installation device for use within single occupancy bed spaces within hospitals, general care and secured environments.
The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
Type of Use (Select one or both, as applicable)
( Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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oxehealth®
510(k) Summary
Oxevision Sleep Device K233618
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
General information
| Submitter's Name: | Dr. Joao Jorge |
|---|---|
| Address: | Oxehealth LimitedMagdalen Centre North,Oxford Science Park,Oxford, OX4 4GAUK |
| Phone: | +44 (0) 1865 900 599 |
| Contact Person: | Dr. Joao Jorge |
| Email: | joao.jorge@oxehealth.com |
| Date Prepared: | 4 March 2024 |
| Trade name: | Oxevision Sleep Device |
| Common Name: | Sleep Assessment System |
| Address of Sponsor: | Oxehealth LimitedMagdalen Centre North,Oxford Science Park,Oxford, OX4 4GAUK |
| Classification Name: | LEL, Biofeedback device, 21 CFR 882.5050 |
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Indication for Use: The Oxevision Sleep Device 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 subject activity, movement and physiological sign data associated with movement during sleep and to extract information about certain sleep parameters from these movements and physiological sign data.
The device provides a timeline of periods when a bed space is occupied, and periods when a subject is asleep when the bed space is occupied.
The Oxevision Sleep Device is software assessing video footage from a fixedinstallation device for use within single occupancy bed spaces within hospitals, general care and secured environments.
The Oxevision Sleep Device is indicated for use on subjects 18 years of age or older.
Device Description: Oxevision Sleep is a software-only medical device (SaMD) that provides noncontact sleep assessment in the inpatient setting based on the analysis of patient movement, activity and physiological sign data derived from video, without the need for contact devices to be attached to the patient or bed.
The device consists of custom-designed software assessing video footage collected using off-the-shelf cameras installed within single occupancy bed spaces within hospitals, general care and secured environments. Proprietary software-controlled algorithms are used to derive patient movement, activity and physiological sign data and then to obtain information on bed occupancy and sleep state from the analysis of this data.
The device software automates recognition of sleep periods, generation of sleep reports, and their presentation in a graphical display for use by a healthcare professional.
Technological Characteristics and Comparison:
The Oxevision Sleep Device is substantially equivalent to the SBV2™ System (K111514) from Fatigue Science Inc. based on the technological and performance characteristics as described in Table 1.
The subject device, Oxevision Sleep Device, and the predicate SBV2™ System are both intended for the assessment of sleep and are both used to measure, record, display, transmit and analyze physiological parameters during sleep and wake. Both are intended for documenting physical movements associated with applications in physiological monitoring in patients, and derive sleep measurements from these movements. Both can be used on adult patients. Both provide a timeline of periods when a subject is in bed, and of periods when a subject is asleep for a set time period (e.g. 7 days.) in
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reports that can be viewed and exported in electronic format. These similarities led to the conclusion that the Oxevision Sleep Device is substantially equivalent to the SBV2TM System.
Table 1: Comparison between the Oxevision Sleep Device and the previously cleared SBV2 System [K111514] (cleared by FDA under the LEL product code).
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| Subject Device | Predicate Device | Equivalence | |
|---|---|---|---|
| Trade Name | Oxevision Sleep Device | SBV2 | |
| Reference | K233618 | K111514 | |
| Sponsor | Oxehealth Limited | Fatigue Science Inc. | |
| Intended Use | Sleep Assessment Device | Sleep Assessment Device | |
| Product Code | LEL | LEL | Same as the predicatedevice. |
| Intended Use | The Oxevision Sleep Device is anactivity monitor designed andintended for documenting physicalmovements associated withapplications in physiologicalmonitoring. The device's intended useis to analyze subject activity,movement and physiological sign dataassociated with movement duringsleep and to extract informationabout certain sleep parameters fromthese movements and physiologicalsign data. | The SBV2 System is an activitymonitor designed and intended fordocumenting physical movementsassociated with applications inphysiological monitoring. Thedevice's intended use is to analyzelimb activity associated withmovement during sleep and toextract information about certainsleep parameters from thesemovements. SBV2 can also be usedto assess activity in any instancewhere quantifiable analysis ofphysical motion is desirable. | Substantially equivalentto the predicate device. |
| Intended UsePopulation | The Oxevision Sleep Device isindicated for use on subjects 18 yearsof age or older. | The use of SBV2 is indicated foradults 22 years of age and over. | Intended use populationis substantiallyequivalent to thepredicate device.Differences in agegroups have beenvalidated as part of aUS-census balancedstudy cohort. |
| Commercialdistribution | Prescription use. | Indicated for Over the Counter (OTC)Use. Patient receives data recordingunit from a dispensing agent such asa pharmacist. | Prescription userepresents a lower riskposture than OTC.Differences to predicatedo not introduce anyquestions of safety oreffectiveness. |
| Intended useenvironment | Single occupancy bed spaces withinhospitals, general care and securedenvironments. | Body-worn device providingactigraphy data to a PC processingapplication/software. For use in anysleeping location. | No change fromreference device. |
| DataCollection | Data collection is from an off-the shelfvideo camera, collecting continuously.The specification of the camera andqualification as suitable for use iscontrolled by Oxehealth | Data recording unit is attached topatient's limb or torso and worncontinuously | Differences to predicatedo not introduce anyquestions of safety oreffectiveness.Clinical performance hasbeen validated andfound to be as good orbetter than thepredicate. |
| Subject Device | Predicate Device | Equivalence | |
| UserInterface | Application developed by themanufacturer, installed on OTScomputer or mobile device. Installedby Oxehealth with no otherapplications in the operatingenvironment. | Application developed by themanufacturer, installed on OTScomputer. Installed by the user on aBYOD platform. | Differences to predicatedo not introduce anyquestions of safety oreffectiveness. |
| CompatibilitywithHardware | Standard, off the shelf computers andmobile devices, specified and installedby Oxehealth, and validated duringinstallation. | SleepAnalyzer application can beused in standard, off-the-shelfcomputers to retrieve collected datafrom the data recording unit andgenerate reports based on collecteddata. | Differences to predicatedo not introduce anyquestions of safety oreffectiveness. |
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Non-Clinical Performance :
Since the device is SaMD using off-the-shelf image acquisition and data processing equipment, no EMC or electrical safety testing has been performed.
Since the device has no patient contacting parts, no biocompatibility or mechanical safety testing has been performed.
Oxehealth have reviewed the FDA's database of recognised consensus standards and has consequently applied the following standards to the development of the device:
- ISO 14971:2019 + A11:2021 - Application of risk management to medical devices
- AAMI BS 34971:2022 Application of risk management to Artificial ● Intelligence and Machine Learning Devices
- IEC 62304:2006 + A1:2015 - Software life cycle processes
- IEC 82304-1:2016 - Health software
- IEC 80001-1:2021 - Application of risk management for IT-networks incorporating medical devices — Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
- IEC 81001-5-1:2021 - Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle
- IEC/TR 80002-1:2009 - Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
- IEC 62366-1:2015 +A1:2020 Application of risk management to ● medical devices
- ISO 15223-1:2021 - Medical devices — Symbols to be used with information to be supplied by the manufacturer
- ISO 20417:2021 Symbols to be used with information to be supplied by the manufacturer
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510(k) Summary
The firm has also performed penetration and vulnerability testing in line with FDA's guidance on cybersecurity.
Clinical Performance: The clinical performance (validation) testing of the Oxevision Sleep software device was designed to assess the performance of the Oxevision Sleep Device algorithm against reference standards on two tasks:
A. The accuracy of periods of bed occupancy detected using Oxevision Sleep Device algorithms measured against periods of human-labeled bed occupancy is not inferior to 95%;
B. The agreement between Oxevision Sleep Device algorithms in sleep/wake classification measured against polysomnographic reference standard during periods of bed occupancy detected using Oxevision Sleep Device algorithms is not inferior to Agreement = 82%, Positive agreement = 88%, and Negative Agreement = 55%.
These endpoints were selected as they are the stated performance specifications of the predicate device.
The clinical data used to determine the clinical performance of the device was obtained in a sample of 60 individuals (a total of 772.65 hours of data). The demographic characteristics of this sample are shown in Table 2.
Table 2: Summary of demographic characteristics for the validation data collected from the 60 adults in the validation sample.
| Variable | Value |
|---|---|
| Age (mean ± std) | 48.6 ± 14.5 years |
| Weight (mean ± std) | 76.2 ± 17.7 kg |
| Height (mean ± std) | 168.7 ± 9.7 cm |
| Body mass index (mean ± std) | 26.7 ± 5.6 kg/m² |
| SexMaleFemale | 30 volunteers30 volunteers |
| Fitzpatrick skin type | I : 3, Ⅱ : 12, Ⅲ : 21, IV : 6, V : 10, VI : 8 |
Reference measurements (physiological signals and video polysomnography data) were collected using an FDA-cleared polysomnography (PSG) device (SOMNOscreen™ plus device, Somnomedics, Germany). Video data was collected concurrently from a standard off-the-shelf camera and hardware installed in two rooms according to the Oxehealth Installation Instructions for use with the Oxevision Sleep Device software.
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Reference PSG measurements were assessed and scored (in accordance with the American Academy of Sleep Medicine Manual for the Scoring of Sleep and Associated Events version 2.6 of January 2020) by three trained sleep physiologists, blinded to the video data collected by the standard off-theshelf camera.
Oxevision video data was reviewed and annotated (to obtain a reference standard) for periods of bed occupancy by two reviewers, blinded to the algorithm development details.
Table 3: Confusion matrix of Oxevision Sleep Device outputs against the reference standards of expert-scored PSG and annotated bed occupancy for all epochs in the validation sample A.
| No. epochs | Reference standardfrom expert-scored PSG and annotated bed occupancy | |||||
|---|---|---|---|---|---|---|
| In Bed | ||||||
| Sleep | Wake | No sleepstatus1 | Out-of-bed1 | |||
| OxevisionSleep | InBed | Sleep | 33,951 | 2,872 | 78 | 0 |
| Wake | 2,072 | 11,203 | 2 | 136 | ||
| No sleep status | 1,273 | 1692 | 0 | 213 | ||
| Out-of-bed | 0 | 102 | 1 | 25,753 | ||
| State unavailable | 5 | 844 | 0 | 955 |
The analysis of pertinent data held by Oxehealth and used for the validation of the algorithm was performed under the following protocols.
The outputs of the Oxevision Sleep Device were evaluated against the reference standard for sleep states obtained from triple-scored PSG data to obtain sleep state statistics; and against the reviewer-annotated bed occupancy states to obtain bed state statistics.
1 The sleep state reference was constructed using epoch-by-epoch majority vote (see example in Appendix D - PSG reference standard for sleep state). Per protocol for data analysis in SLP.REG.241: Validation of the Oxevision Sleep device: Protocol for clinical data analysis, epochs for which no majority label was available, which occurred as sleep physiologists may label epochs as artefact under AASM guidelines, are excluded from the analysis. The number of epochs excluded for this reason will be reported.
2 This table entry has been amended due to a code print error in the previous version of this document. The previous version read 844 instances. Primary and secondary outcomes had been computed on the correct data, so no amendments were needed.
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Table 4: Performance of Oxevision Sleep device algorithms in the validation sample A data. An asterisk (*) denotes secondary outcome measures.
| Clinical-related evaluation of Oxevision Sleep Device outputs | |||||
|---|---|---|---|---|---|
| Bed State outputs | Sleep State outputs | ||||
| *Bed StateUnavailable | Accuracy | *SleepStateUnavailable | OverallAgreement | PositiveAgreement | NegativeAgreement |
| 2.3% | 99% | 2.8% | 90% | 94% | 80% |
Table 5 presents per epoch agreement statistics between the outputs of the Oxevision Sleep Device and the reference standards for bed occupancy state and sleep state.
Table 5: Performance of Oxevision Sleep Device algorithms in validation data collected from the 60 participants.
| Clinical-related evaluation of Oxevision Sleep Device outputs | |||
|---|---|---|---|
| Bed State outputs | Sleep State outputs | ||
| Accuracy | OverallAgreement | PositiveAgreement | NegativeAgreement |
| >95% | >82% | >88% | >55% |
The results show overall agreement (>82%), positive agreement (>88%) and negative agreement (>55%) between Oxevision Sleep Device outputs and the gold-standard PSG reference. A bed state accuracy of >95% against reviewer annotations was also reported.
Two-sided 95% confidence intervals for the mean of each performance statistic were obtained using a bootstrap resampling approach.
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Table 6: Two-sided 95% confidence intervals for the mean of each outcome measure over the 60 study sessions in the evaluation data (including validation samples A and B). Two-sided 95% confidence intervals were obtained based on the 2.5th and 97.5th percentiles of the bootstrap distribution of resamples (10,000 resamples).
| 95% Confidence intervals for primary outcome measures | |||
|---|---|---|---|
| Bed State outputs | Sleep State outputs | ||
| Accuracy | Overall Agreement | Positive Agreement | Negative Agreement |
| (99.0%; 99.7%) | (89.0%; 91.8%) | (92.3%; 95.6%) | (74.3%; 83.5%) |
This testing demonstrated device performance was superior to that produced for the predicate device [K111514] in their pre-market submission. All performance endpoints have therefore been met, which substantiate the claim of substantial equivalence to the predicate device.
Conclusions Based on the comparison to the predicate device and performance characteristics, the Oxevision Sleep Device is substantially equivalent to the currently U.S. legally marketed device Fatigue Science, SBV2™ System (K111514) and presents no new concerns about safety or effectiveness.
§ 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.