(182 days)
Yes
The device description and performance study summary explicitly mention "deep-learning algorithms" and "Belun Sleep AI Software" used for calculating the apnea-hypopnea index and sleep staging.
No.
The device is intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating sleep-related breathing disorders, which is a diagnostic function, not a therapeutic one.
Yes
The intended use explicitly states the device is "intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders suspected of sleep apnea." This purpose of evaluating a disorder signifies a diagnostic function.
No
The device description explicitly states that the system comprises a "Belun Ring" which is a wearable sensor with hardware components (LEDs, accelerometer, on-board memory) that collects data. While there is standalone analysis software, the system includes a physical hardware component essential for its function.
Based on the provided information, the Belun Sleep System BLS-100 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Belun Sleep System Function: The Belun Sleep System BLS-100 is a wearable device that records biophysical parameters (PPG signal and movement) directly from the patient's finger. It analyzes this data to aid in evaluating sleep-related breathing disorders. It does not analyze samples taken from the body.
Therefore, the Belun Sleep System BLS-100 falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).
Product codes
MNR
Device Description
The Belun Sleep System BLS-100 is prescribed by a Health Care Professional (HCP) for the patient to use in the home as a 'home sleep apnea test' (HSAT).
The Belun Sleep System BLS-100 comprises a sensor that is worn on the proximal phalanx of index finger (Belun Ring) over-night whilst the subject is sleeping and a stand-alone analysis software (Belun Sleep AI).
The Belun Ring has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is placed on the proximal phalanx of the index finger, with the sensor window applied against the palmar side of the proximal phalanx of the index finger.
The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement.
The data recorded by the Belun Ring is stored in device on-board memory. The data is exported when the Belun Ring is returned to the prescribing HCP via USB or Bluetooth and passed to the Belun Sleep AI Software, which is standalone PC software. The Belun Sleep Al loads and processes the signal from the exported data and generates the apnea-hypopnea index (bAHI) and sleep staging identification (bSTAGES).
Signals from the Belun Ring device include the following:
- . Oxygen saturation
- Beat-to-beat pulse period
- Photoplethysmography
- . Actigraphy
Mentions image processing
Not Found
Mentions AI, DNN, or ML
The Belun Sleep Al loads and processes the signal from the exported data and generates the apnea-hypopnea index (bAHI) and sleep staging identification (bSTAGES).
The clinical evaluation has confirmed that the Belun Sleep System deep-learning algorithms calculating the Belun Apnea Hypopnea Index (bAHI) and Belun Sleep Stage (bSTAGES) generate comparable output to human manual scoring of an Apnea Hypopnea Index (AHI) from Polysomnography (PSG) studies, using American Academy of Sleep Medicine (AASM) scoring guidelines for adult patients, with accuracy, sensitivity and specificity similar to the predicate and reference devices.
The proposed system and the predicate use the similar sensors: optical plethysmography sensor and accelerometer. The differences between predicate are that the proposed device feeds PPG whose envelop is similar to the information provided by PAT to its AI algorithms.
Input Imaging Modality
Optical plethysmography sensor
Anatomical Site
proximal phalanx of index finger
Indicated Patient Age Range
22 years old and older
Intended User / Care Setting
Prescribed by a Health Care Professional (HCP) for the patient to use in the home. Intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).
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
Clinical Study: Comparison to PSG sleep lab results: The purpose of this study is to evaluate the accuracy, sensitivity and specificity of the Apnea-Hypopnea Index (AHI) and sleep staging (wake, Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM)) of the Belun Sleep System BLS-100 compared with overnight polysomnography (PSG) study according to the American Academy of Sleep Medicine (AASM) guidelines in a sleep laboratory with 106 patients suspected of obstructive sleep apnea (OSA). All sleep studies were manually scored based on the AASM scoring manual (version 2.4) by a senior sleep tech scorer and reviewed by a board-certified sleep physician. All investigators, sleep lab team, and scorers were blinded to the results until statistical analysis was performed.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Study:
The Clinical Test consists of 2 parts:
(1) SpO2 accuracy: This testing was performed in K211407 and leveraged for this submission.
(2) Comparison to PSG sleep lab results: The purpose of this study is to evaluate the accuracy, sensitivity and specificity of the Apnea-Hypopnea Index (AHI) and sleep staging (wake, Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM)) of the Belun Sleep System BLS-100 compared with overnight polysomnography (PSG) study according to the American Academy of Sleep Medicine (AASM) guidelines in a sleep laboratory with 106 patients suspected of obstructive sleep apnea (OSA). All sleep studies were manually scored based on the AASM scoring manual (version 2.4) by a senior sleep tech scorer and reviewed by a board-certified sleep physician. All investigators, sleep lab team, and scorers were blinded to the results until statistical analysis was performed.
The accuracy, sensitivity and specificity at AHI cutoff 15 and 30 are summarized in the table below.
AHI Cutoff 15: Accuracy 0.877, Sensitivity 0.898, Specificity 0.860
AHI Cutoff 30: Accuracy 0.925, Sensitivity 0.840, Specificity 0.951
The accuracy, sensitivity, and specificity of 3-categorization sleep stages [wake, Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM)] are summarized in the table below.
Wake: Number of Epochs 85471, Accuracy 0.885, Sensitivity 0.604, Specificity 0.961
REM: Accuracy 0.908, Sensitivity 0.712, Specificity 0.944
NREM: Accuracy 0.827, Sensitivity 0.904, Specificity 0.695
The total sleep time (bTST) of the Belun Sleep System BLS-100 is the time summation of REM and NREM stages. The mean difference between bTST and PSG-TST was 21.8 minutes with a standard deviation of 41.6 minutes. The mean absolute difference between bTST and PSG-TST was 30.8 minutes.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
AHI Cutoff 15: Accuracy 0.877, Sensitivity 0.898, Specificity 0.860
AHI Cutoff 30: Accuracy 0.925, Sensitivity 0.840, Specificity 0.951
Wake: Accuracy 0.885, Sensitivity 0.604, Specificity 0.961
REM: Accuracy 0.908, Sensitivity 0.712, Specificity 0.944
NREM: Accuracy 0.827, Sensitivity 0.904, Specificity 0.695
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
February 23, 2023
Belun Technology Company Limited Leung Lap Wai Lydia CEO Unit 218, 2/F, Core Building 2, No. 1 Science Park West Avenue, Hong Kong Science Park Sha Tin, Hong Kong China
Re: K222579
Trade/Device Name: Belun Sleep System BLS-100 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: January 10, 2023 Received: January 13, 2023
Dear Leung Lap Wai Lydia:
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. 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 located 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.
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
1
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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Opthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222579
Device Name Belun Sleep System BLS-100
Indications for Use (Describe)
The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92 on 23-Feb-2023.
l. SUBMITTER
Belun Technology Company Limited Address: Unit 218, 2 Floor, Core Building 2, 1 Science Park West Avenue, Hong Kong Science Park, Shatin, Hong Kong Contact Person: Leung Lap Wai Lydia Phone: +852 706 5640
II. PROPOSED DEVICE
Trade/Device Name: Belun Sleep System BLS-100 Model: BLS-100 Classification Name: Ventilatory Effort Recorder Regulation Number: 21 CFR 868.2375 Regulatory Class: II Product Code: MNR
PREDICATE DEVICE III.
Device Name: NightOwl (K220028) Classification Name: Ventilatory Effect Recorder Regulation Number: 21 CFR 868.2375 Regulatory Class: II Product Code: MNR
IV. DEVICE DESCRIPTION
The Belun Sleep System BLS-100 is prescribed by a Health Care Professional (HCP) for the patient to use in the home as a 'home sleep apnea test' (HSAT).
The Belun Sleep System BLS-100 comprises a sensor that is worn on the proximal phalanx of index finger (Belun Ring) over-night whilst the subject is sleeping and a stand-alone analysis software (Belun Sleep AI).
The Belun Ring has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is placed on the proximal phalanx of the index finger, with the sensor window applied against the palmar side of the proximal phalanx of the index finger.
4
The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement.
The data recorded by the Belun Ring is stored in device on-board memory. The data is exported when the Belun Ring is returned to the prescribing HCP via USB or Bluetooth and passed to the Belun Sleep AI Software, which is standalone PC software. The Belun Sleep Al loads and processes the signal from the exported data and generates the apnea-hypopnea index (bAHI) and sleep staging identification (bSTAGES).
Signals from the Belun Ring device include the following:
- . Oxygen saturation
- Beat-to-beat pulse period
- Photoplethysmography
- . Actigraphy
V. INDICATIONS FOR USE
The Belun Sleep System BLS-100 is a wearable device intended to record, analyze, display, export, and store biophysical parameters to aid in evaluating moderate to severe sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in clinical and home settings under the direction of a Healthcare Professional (HCP).
5
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE AND THE REFERENCE DEVICE VI.
| Table 1 Performance Specification Comparison Table between the Belun Sleep System BLS-100 and Predicate Device | |||
|---|---|---|---|
| Characteristic | Proposed Device | ||
| Belun Sleep System BLS-100 | Predicate Device | ||
| NightOwl (K220028) | Comparison | ||
| Regulation No. | 21 C.F.R. 868.2375 | 21 C.F.R. 868.2375 | Identical to predicate device |
| Classification | ll | ll | Identical to predicate device |
| Classification Name | Breathing frequency monitor | Breathing frequency monitor | Identical to predicate device |
| Product Code | MNR | MNR | Identical to predicate device |
| Intended Use | The Belun Sleep System BLS-100 is a | ||
| wearable device intended to record, | |||
| analyze, display, export, and store | |||
| biophysical parameters to aid in | |||
| evaluating moderate to severe sleep- | |||
| related breathing disorders of adult | |||
| patients suspected of sleep apnea. | |||
| The device is intended for use in | |||
| clinical and home settings under the | |||
| direction of a Healthcare Professional | |||
| (НСР). | The NightOwl is a wearable device | ||
| intended for use in the recording, | |||
| analysis, displaying, exporting, and | |||
| storage of biophysical parameters to | |||
| aid in the evaluation of sleep-related | |||
| breathing disorders of adult patients | |||
| suspected of sleep apnea. The device | |||
| is intended for the clinical and home | |||
| setting use under the direction of a | |||
| Healthcare Professional (HCP). | Substantially equivalent to | ||
| predicate | |||
| The proposed system and the | |||
| predicate have the similar | |||
| intended use. | |||
| Table 1 Performance Specification Comparison Table between the Belun Sleep System BLS-100 and Predicate Device | |||
| Characteristic | Proposed Device | ||
| Belun Sleep System BLS-100 | Predicate Device | ||
| NightOwl (K220028) | Comparison | ||
| Use Environment | Recording in the home environment with the | ||
| report interpretation performed in the | |||
| clinical setting. | Recording in the home environment with the | ||
| report interpretation performed in the | |||
| clinical setting. | Identical to predicate device | ||
| Target population | 22 years old and older | 22 years old and older | Identical to predicate device |
| Sensor software | Firmware is limited to control the recording | ||
| and communications processes. No | |||
| presentation of test results to the patient. | |||
| Data analyzed and presented in a separate | |||
| software suite. | Firmware is limited to control the recording | ||
| and communications processes. No | |||
| presentation of test results to the patient. | |||
| Data analyzed and presented in a separate | |||
| software suite. | Identical to predicate device | ||
| Analysis software | |||
| location | Analysis performed off the recording device, | ||
| exclusively stand-alone by the Belun software | Analysis performed off the recording device, | ||
| exclusively cloud-based by the NightOwl | |||
| software | Substantially equivalent to | ||
| predicate | |||
| The software is verified and validated. | |||
| The difference of the analysis software | |||
| location does not raise different questions of | |||
| safety and effectiveness. | |||
| Table 1 Performance Specification Comparison Table between the Belun Sleep System BLS-100 and Predicate Device | |||
| Characteristic | Proposed Device | ||
| Belun Sleep System BLS-100 | Predicate Device | ||
| NightOwl (K220028) | Comparison | ||
| Analysis software | |||
| algorithm - AHI | bAHI calculation tuned to the AASM's '1B Rule' for the scoring of hypopnea | pAHI calculation tuned to the AASM's '1A Rule' for the scoring of hypopnea AND | |
| pAHI calculation tuned to the AASM's | |||
| '1B Rule' for the scoring of hypopnea | Substantially equivalent to | ||
| predicate | |||
| The clinical evaluation has confirmed that | |||
| the Belun Sleep System deep-learning | |||
| algorithms calculating the Belun Apnea | |||
| Hypopnea Index (bAHI) and Belun Sleep | |||
| Analysis software | |||
| algorithm - Sleep | |||
| stages | bSTAGES: WAKE, NREM and REM | ||
| bTST calculation (time summation of REM and | |||
| NREM stages) | Total Sleep Time (TST) calculation | ||
| Total REM Time calculation | Stage (bSTAGES) generate comparable | ||
| output to human manual scoring of an | |||
| Apnea Hypopnea Index (AHI) from | |||
| Polysomnography (PSG) studies, using | |||
| American Academy of Sleep Medicine | |||
| (AASM) scoring guidelines for adult | |||
| patients, with accuracy, sensitivity and | |||
| specificity similar to the predicate and | |||
| reference devices. | |||
| Sensors | Optical plethysmography sensor, | ||
| accelerometer | Optical plethysmography sensor, | ||
| accelerometer | Identical to predicate device | ||
| Battery | 3.7V Lithium Battery | Battery powered by coin cell | Substantially equivalent to |
| predicate | |||
| The battery safety is verified and | |||
| validated. The difference in battery type | |||
| does not raise different questions of safety | |||
| and effectiveness | |||
| Characteristic | Proposed Device | ||
| Belun Sleep System BLS-100 | Predicate Device | ||
| NightOwl (K220028) | Comparison | ||
| Channels | Photoplethysmography (PPG), Pulse rate, Oximetry, Actigraphy | PAT, Pulse rate, Oximetry, Actigraphy | Substantially equivalent to predicate |
| The proposed system and the predicate | |||
| Wearable sensor | |||
| location | The photoplethysmography (PPG) sensor and accelerometer components are worn on the proximal phalanx of index finger. | The photoplethysmography (PPG) sensor and accelerometer components are worn on the fingertip. | use the similar sensors: optical plethysmography sensor and accelerometer. The differences between predicate are that the proposed device feeds PPG whose envelop is similar to the information provided by PAT to its AI algorithms. Also, the PPG sensor and accelerometer components are worn on the proximal phalanx of index finger instead of fingertip. The clinical evaluation has confirmed that the Belun Sleep System deep-learning algorithms calculating the Belun Apnea Hypopnea Index (bAHI) and Belun Sleep Stage (bSTAGES) generate comparable output to human manual scoring of an Apnea Hypopnea Index (AHI) from Polysomnography (PSG) studies. As such, the proposed system does not introduce any change to the safety and effectiveness of the predicate device. |
| Similar to Somnapatch (K183625) which uses PPG instead of PAT to aid in evaluating OSA. |
6
7
8
9
VII. PERFORMANCE DATA
Non-clinical Test
The proposed device Belun Ring is tested in accordance with the following standards and FDA guidance documents (leveraged from K211407), including:
- . IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- . IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- . IEC 60601-1:2005 + a1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- . IEC 62133:2012 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- . ISO 80601-2-61:2017 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
- ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
- . ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- . ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- . ISO 10993-10:2010 Biological evaluation of medical devices -- Part 11: Tests for systemic toxicity
- . IEC 62366-1:2015 Medical devices — Part 1: Application of usability engineering to medical devices
- . BQB Bluetooth qualification
- FCC Part 15B & FCC Part 18 certification .
- . FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- . FDA Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- . FDA Guidance for Applying Human Factors and Usability Engineering to Medical Devices: 2016
10
The Belun Ring BLR-100X has been validated for low perfusion saturation and pulse rate in K211407. There are no changes in those features or algorithms for clearance of this device to be used as a home sleep apnea test (HSAT).
Clinical Study
The Clinical Test consists of 2 parts:
- (1) SpO2 accuracy: This testing was performed in K211407 and leveraged for this submission.
- (2) Comparison to PSG sleep lab results: The purpose of this study is to evaluate the accuracy, sensitivity and specificity of the Apnea-Hypopnea Index (AHI) and sleep staging (wake, Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM)) of the Belun Sleep System BLS-100 compared with overnight polysomnography (PSG) study according to the American Academy of Sleep Medicine (AASM) guidelines in a sleep laboratory with 106 patients suspected of obstructive sleep apnea (OSA). All sleep studies were manually scored based on the AASM scoring manual (version 2.4) by a senior sleep tech scorer and reviewed by a board-certified sleep physician. All investigators, sleep lab team, and scorers were blinded to the results until statistical analysis was performed. The accuracy, sensitivity and specificity at AHI cutoff 15 and 30 are summarized in the table below.
| Cutoff | Accuracy | Sensitivity | Specificity |
|---|---|---|---|
| 15 | 0.877 | 0.898 | 0.860 |
| 30 | 0.925 | 0.840 | 0.951 |
The accuracy, sensitivity, and specificity of 3-categorization sleep stages [wake, Rapid Eye Movement (REM) and Non-Rapid Eye Movement (NREM)] are summarized in the table below.
| Class | Number of
Epochs | Accuracy | Sensitivity | Specificity |
|-------|---------------------|----------|-------------|-------------|
| Wake | 85471 | 0.885 | 0.604 | 0.961 |
| REM | | 0.908 | 0.712 | 0.944 |
| NREM | | 0.827 | 0.904 | 0.695 |
The total sleep time (bTST) of the Belun Sleep System BLS-100 is the time summation of REM and NREM stages. The mean difference between bTST and PSG-TST was 21.8 minutes with a standard deviation of 41.6 minutes. The mean absolute difference between bTST and PSG-TST was 30.8 minutes.
VIII. CONCLUSIONS
In conclusion, the proposed device of Belun Sleep System BLS-100 has the same classification information, similar intended use, similar product design and specification as
11
the predicated device. According to the results of non-clinical test and clinical study, the proposed device is Substantially Equivalent (SE) to the predicate device.