BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient's physiological signals during sleep and scores apneas and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.

Device Description

BresoDX1 is a lightweight data acquisition system intended for use by Health Care Professional (HCP) as an aid in the diagnosis of moderate to severe sleep apnea for adults. It is suitable for independent use in unattended settings, like in the home, or with minimal assistance in clinic settings.

BresoDX1 is to be worn while sleeping and consists of: (1) a BresoSensor which is placed on the patient's suprasternal notch with a disposable BresoSensor Frame (2) a BresoHub, which is located at the bedside; (3) a Nonin WristOx2® pulse oximeter, which is worn on the patient's wrist, where the oximeter sensor is to be placed on the patient's finger; and (4) BresoDX1 software.

The BresoSensor and the Nonin WristOx2® pulse oximeter sensor will record patient's tracheal breathing sounds, neck/body position and movement, tracheo-sternal movement, arterial oxyhemoglobin saturation and heart rate overnight during sleep. Recorded data on the BresoSensor and oximeter will be sent to the BresoHub wirelessly via Wi-Fi and Bluetooth for pre-processing and storing. When the patient returns the BresoDX1 system to the health care professional, stored data that had been uploaded will be processed for analysis and sleep study report generation. The generated report will show the following channels: heart rate, SpO2, airflow, respiratory effort, and body position. The health care professional will be able to use the software to review data, edit automated scoring, and re-generate a sleep study report based on the edited scoring for further interpretation. The health care professional will reprocess the device after each use.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the BresoDX1 device meets them, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance

The core acceptance criteria for the BresoDX1 device revolve around its diagnostic accuracy for moderate to severe sleep apnea when compared to Polysomnography (PSG), which serves as the gold standard.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the clinical study results, particularly for sensitivity, specificity, positive predictive value, negative predictive value, and correlation with PSG metrics. The document explicitly states "All tests confirmed that the subject device meets the pre-determined acceptance criteria and the requirements of the relevant standards" but does not enumerate the numerical acceptance values beforehand. Therefore, the reported performance is the demonstration of meeting acceptance.

Metric (Diagnostic Criteria: AHI cut-off 15)	Acceptance Criteria (Implied by Study Success)	Reported Device Performance (REIb-based diagnosis)
Sensitivity	High (to correctly identify true positives)	88.5% (79.2%, 94.6%)
Specificity	High (to correctly identify true negatives)	84.9% (75.5%, 91.7%)
Positive Predictive Value	High (likelihood of having condition if test is positive)	84.1% (74.4%, 91.3%)
Negative Predictive Value	High (likelihood of not having condition if test is negative)	89.0% (80.2%, 94.9%)
Correlation between REIb and AHI(PSG)	Strong positive correlation (e.g., >0.9)	0.93
Correlation between ODI(BresoDX1) and ODI(PSG)	Strong positive correlation (e.g., >0.9)	0.95

Note on REIb: REIb is the total number of respiratory events scored by BresoDX1 x 60 divided by monitoring time (in minutes).

Beyond clinical performance, other acceptance criteria implicitly include:

Electrical Safety: Compliance with IEC 60601-1:2005+A1:2012, CAN/CSA-C22.2 No. 60601-1:2014, ANSI/AAMI ES60601-1:2005/A1:2012. (Achieved)
Home Healthcare Environment: Compliance with IEC 60601-1-11:2015. (Achieved)
Usability: Compliance with IEC60601-1-6:2010+A1:2013 and IEC 62366-1:2015/COR1:2016. (Achieved)
EMC Testing: Compliance with IEC 60601-1-2:2014, FCC part 15. (Achieved)
Biocompatibility: Compliance with ISO10993-1, ISO 10993-5 (2009), ISO 10993-10 (2010). (Achieved)
Device Precision & Repeatability: Demonstrated via bench performance tests. (Achieved)
Oximetry Integration Accuracy: Validated against ISO 80601-2-61:2017 Sub-clauses 201.12.1.103 & 201.12.1.104. SpO2 accuracy of ±2% (non-motion, low perfusion) / ±3% (motion) and pulse rate accuracy of ±3% (motion, non-motion, low perfusion). (Achieved)

Study Proving Device Meets Acceptance Criteria

2. Sample Size and Data Provenance

Test Set Sample Size: 164 subjects.
Data Provenance: Prospective, single-arm, multiple-site, blinded study. The document does not explicitly state the country of origin, but generally, FDA submissions involve studies conducted in the US or Canada, as Bresotec Inc. is based in Canada.

3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, it mentions "in-laboratory polysomnography (PSG)" and "AHI(PSG)" and "ODI(PSG)", which strongly implies that board-certified sleep physicians or registered polysomnography technologists, typically under the supervision of a sleep physician, established the ground truth according to standard clinical practice.

4. Adjudication Method for the Test Set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1). The nature of PSG scoring usually involves a single trained technologist scoring and a sleep physician reviewing and finalizing the report. If discrepancies arose between multiple scorers (though not explicitly mentioned as being present for ground truth establishment), standard practice would involve a consensus process, but this is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This study focuses on the device's performance against PSG, not on how human readers' performance with or without AI assistance changes. The BresoDX1 is presented as an "aid in the diagnosis," and its software processes data to generate reports for a Health Care Professional (HCP) to review and interpret. The study appears to validate the automated scoring capabilities of the device as accurate for diagnosis.

6. Standalone (Algorithm Only) Performance
Yes, a standalone performance study was done. The clinical study directly compares the BresoDX1 device's automated scoring (REIb) and other metrics (ODI) against the concurrently recorded and independently scored "gold standard" in-laboratory PSG. The results presented for sensitivity, specificity, PPV, NPV, and correlations are measures of this standalone algorithm's performance.

7. Type of Ground Truth Used
The type of ground truth used was expert consensus / clinical standard, specifically in-laboratory Polysomnography (PSG). PSG is widely considered the gold standard for diagnosing sleep apnea.

8. Sample Size for the Training Set
The document does not specify the sample size for the training set. The clinical study described (164 subjects) is presented as the validation or test set for performance evaluation.

9. How the Ground Truth for the Training Set Was Established
The document does not provide details on how the ground truth for the training set (if a separate training set was used for the algorithm's development) was established. It only describes the methodology for the reported pivotal clinical validation study's ground truth (PSG). It's common practice for algorithm development to use retrospective datasets, where PSG would also be the ground truth.

Summary

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December 21, 2022

Bresotec Inc Mehrnaz Tabibi Regulatory and Quality Director 55 York Street Unit 200 Toronto, Ontario M5J 1R7 Canada

Re: K220012

Trade/Device Name: BresoDX1 Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: November 21, 2022 Received: November 21, 2022

Dear Mehrnaz Tabibi:

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

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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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K220012

Device Name

BresoDX1

Indications for Use (Describe)

BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient's physiological signals during sleep and sores and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.

Type of Use (Select one or both, as applicable)

Z Prescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

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K220012 - 510(k) SUMMARY

Submitter

Bresotec, Inc. 55 York Street Suite 200 Toronto, Ontario, M5J 1R7 Canada

Phone: +1 (647)930-1777 Facsimile: +1 (437)800-1139 Contact Person: Mehrnaz Tabibi Date Submitted: January 4, 2022

Name of Device: BresoDX1

Common or Usual Name: Ventilatory Effort Recorder

Classification Name: 21 C.F.R. 868.2375, Breathing Frequency Monitor

Regulatory Class: II

Product Code: MNR

Predicate Device: ACCUSOM manufactured by NovaSom, Inc. (K110486)

Referenced Devices: WatchPat200U, manufactured by Itamar Medical, Ltd. (K203839), and AcuPebble SA100 manufactured by Acurable Limited (K210480)

Device Description

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Intended Use / Indications for Use

BresoDX I is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients. BresoDX1 records a patient's physiological signals during sleep and scores apneas and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.

Comparison of Technological Characteristics

Comparison of technological characteristics with predicate and reference devices
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	Bresotec'sBresoDX1	NovaSom'sACCUSOM(Predicate)	Itamar' sWatchPat200U(Reference Device)	AcuPebble SA100(Reference Device)	Comparison
RegulatoryClass,ProductCode	Class II, MNR	Class II, MNR	Class II, MNR	Class II, MNR
510k #	K220012	K110486	K203839	K210480
IntendedUse /Indicationsfor Use	The BresoDX1 isindicated for use asan aid in thediagnosisof moderate to severesleep apnea in adultpatients. TheBresoDX1 records apatient'sphysiological signalsduring sleep andscores apneas andhypopneas. TheBresoDX1 isintended to be used inthe home and clinicsettings.	The ACCUSOM deviceis indicated for use in thediagnostic evaluation ofadults with possiblesleep apnea. TheACCUSOM can scoreobstructive apneas,which includes mixedapneas.The ACCUSOM deviceis intended for use in thehome and clinic setting.	The Watch-PAT200U(WP200U) device is anon-invasive home caredevice for use withpatients suspected to havesleep related breathingdisorders. The WP200U isa diagnosticaid for the detection ofsleep related breathingdisorders, sleep staging(Rapid EyeMovement (REM) Sleep,Light Sleep, Deep Sleepand Wake), snoring leveland bodyposition. The WP200Ugenerates a peripheralarterial tonometry("PAT") RespiratoryDisturbance index("PRDI"), Apnea-Hypopnea index("PAHI"), CentralApnea-Hypopnea index("PAHIc"), PAT sleepstaging identification(PSTAGES) and optionalsnoring level and bodyposition discrete statesfrom an externalintegrated snoring andbody position sensor. TheWP200U's PSTAGES andsnoring level and bodypositionprovide supplementalinformation to itsPRDI/PAHI/PAHIc. TheWP200U's PSTAGESand snoring level andbody position are not	AcuPebble SA100 isindicated to sense, record,and interpret a patient'sphysiological signals(including respiratorypattern) during sleep for thepurpose of pre-screeningpatients for obstructivesleep apnea (OSA)syndrome. The device isdesigned for use in home-screening of adults withsuspected possible sleepbreathing disorders(although it can also beused in clinic). Results areused to assist the healthcareprofessional in the patient'sevaluation.The system is not intendedas a substitute for fullpolysomnography whenadditional parameters suchas sleep stages, limbmovements or EEG activityare required.	Substantially equivalent topredicate device.BresoDX1 does notdifferentiate betweenobstructive and mixedapneas. This differencedoes not impact the abilityof BresoDX1 to provideinformation to the user asan aid in the diagnosis ofmoderate to severe sleepapnea.
			intended to be used as thesole or primarybasis for diagnosing anysleep related breathingdisorder, prescribingtreatment, ordetermining whetheradditional diagnosticassessment is warranted.PAHiC is indicated for usein patients 17 years andolder. All otherparameters are indicatedfor 12 years and older.
UserPopulation	Home and clinicsetting	Home and clinic setting	A non-invasive home caredevice	For use in home-screening(although it can be used inclinic)	Substantially equivalent topredicate device.
Sensors	-Microphone inBresoSensor placedon the suprasternalnotch-Oximeter sensorplaced on finger -Three-dimensionalaccelerometer inBresoSensor placedon suprasternal notch	-Breath Sensor (sensingmicrophone and ambientnoise microphone)placed under the nose-Oximeter finger sensorplaced on the finger- Chest Sensor locatedon the chest.	-uPAT fingerprobe placed on thefinger-Actigraphy on the wrist- (optional) ExternalSBP/RESBP chest sensor(microphone, three-dimensionalaccelerometer) placed onthe chest right under thesternal notch	-Microphone placed on theneck above the suprasternalnotch	Substantially Equivalent topredicate device.In addition, BresoDX1 andreference device uses three-dimensional accelerometer.
Channels	Airflow, respiratoryeffort, tracheal breathsounds tracheo-sternal movement,pulse rate, SpO2,body position	Airflow, respiratorysounds, pulse rate, SpO2,snoring level	PAT, pulse rate, oximetry,actigraphy, snoring, bodyposition, chest movement	Sounds (Cardiac features,respiratory features,movement features)	Substantially Equivalent topredicate device.BresoDX1 does not providethe output of snoring levels.Snoring is optional forHSAT and is not essentialfor the diagnosis of sleepapnea.The difference of systemoutput between BresoDX1with its predicates does notraise any uncertainty ofsafety, effectiveness, andefficacy.
Portability	Yes (wearable)	Yes (wearable)	Yes (wearable)	Yes (wearable)	Identical to predicatedevice.
DataDownload	Transfer throughwireless connection	Transfer throughwireless connection	Transfer through USBconnection	Transfer through wirelessconnection	Substantially equivalent topredicate device.
Size andWeight ofsensor	BresoSensor:17.4×38.7×35.5 mm17g	Patient Module :100.3×71.9×29.5 mm116.2 g	Chest sensor:1.3inch (32mm) diameter12g	29.5mm diameter × 16mmheight7g	Different but difference insize and weight do not raisesafety or effectivenessquestion.
PowerSource	BresoHub: wallmount power adaptorBresoSensor:Lithium-ionrechargeable batteryOximeter: 2 × 1.5VAlkaline AAAbattery	Patient Module:Rechargeable batteryoperated	One OTS 1.5V AlkalineAAA battery OROne rechargeable AAA1.2V Nickel-metalhydride batteryrechargeable (NiMH)battery	Rechargeable lithiumpolymer battery	Different but difference inpower source do not raisesafety or effectivenessquestion.
Indicators	Visual indicatorsLEDs onBresoSensor andBresoHub.Indicators onBresoHub WebInterface	Audio and visualindicators	Visual indicator – errormessages	N/A	Different. BresoDX1 doesnot have audio indicators,but it has visual indicators.This difference does notraise safety or effectivenessquestion.
Sterilization	Nonsterile	Nonsterile	Nonsterile	Nonsterile	Identical.

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BresoDX1 and its predicate device, ACCUSOM, utilize the same technology to monitor key signals. Both devices use a microphone to detect a patient's breathing pattern, and a pulse oximeter to determine a patient's arterial oxyhemoglobin saturation and pulse rate. BresoDX1 processes recorded sound data and accelerometer data using a proprietary software algorithm to estimate a subject's airflow changes and respiratory effort and to generate the corresponding waveforms.

Software

BresoDX I Software collects and stores the data during a test. Data will be uploaded to the cloud. BresoDX1 Software will process and analyze the data to generate a test report. The test report and the data will be reviewed and interpreted by a Health Care Professional.

Some functionalities require connectivity with the cloud system. Those functionalities are as follows:

i. Data upload
ii. Data Storage
iii. Data Analysis
User and Study Management iv.
V. Study Editor
vi. Study Report Generator

The BresoDX1 software is developed according to Medical Device Software/ Software lifecycle processes: IEC 62304:2006/A12016. Also, BresoDX1 software is developed according to Information security, cybersecurity and privacy protection, Information security controls: ISO/ IEC 27002: 2022.

Performance Data

A series of safety and functional testing was performed to confirm that BresoDX1 meets the requirements of the relevant standards. These tests include electrical safety testing according to IEC 60601-1:2005+A1:2012, CAN/CSA-C22.2 No. 60601-1:2014, ANSI/AAMI ES60601-1:2005/A1:2012, home healthcare environment testing according to IEC 60601-1-11:2015, usability according to IEC60601-1-6:2010+A1:2013, application of usability engineering to medical devices according to IEC 62366-1:2015 and IEC 62366-1:2015/COR1:2016, EMC testing according to IEC 60601-1-2:2014, FCC part 15 tests.

Biocompatibility of the patient contacting components (BresoDX1 plastic housing, tape on the BresoSensor Frame) in direct contact with patient's healthy closed skin for up to 8 hours were tested in accordance with ISO10993-1 and FDA's corresponding guidance document, Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Biocompatibility tests for these patient contacting components of the subject device complaint with the following standards:

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· Cytotoxicity per ISO 10993-5 (2009)
· Irritation per ISO 10993-10 (2010)
· Skin sensitization per ISO 10993-10 (2010)

Bench performance tests were performed to demonstrate that the system meets its performance requirements by verifying the device precision and evaluating the inter-device and intra-device repeatability and reproducibility in detecting sleep apnea events and evaluating the impact of environmental noises on the device performance. Oximetry input integration validation test was performed to evaluate the accuracy of the integration of Nonin WristOx2® Model 3150 BLE pulse oximeter with the BresoDX1 system.

All tests confirmed that the subject device meets the pre-determined acceptance criteria and the requirements of the relevant standards.

Clinical performance testing was performed in compliance with the recognized consensus standard ISO 14155:2020 (Clinical investigation of medical devices for human subjects-Good clinical practice to evaluate the capability of BresoDX1. A prospective, single-arm, multiple-site, blinded study was performed to validate the BresoDX1 in comparison with in-laboratory polysomnography (PSG). The study involved overnight recording of the BresoDX1 and clinical PSG in the sleep laboratory, simultaneously. One hundred and sixty-four (164) subjects were evaluated. Based on the clinical performance as documented in the pivotal clinical study, the BresoDX1 has a safety and effectiveness profile that is similar to the predicate device.

The BresoDX1 diagnosis accuracy from the clinical study is summarized as follows:

	REIb based diagnosis*n/Total, (95% Confidence Interval)
Sensitivity	69/78, 88.5% (79.2%, 94.6%)
Specificity	73/86, 84.9% (75.5%, 91.7%)
Positive Predictive Value	69/82, 84.1% (74.4%, 91.3%)
Negative Predictive Value	73/82, 89.0% (80.2%, 94.9%)

REIb is the total number of respiratory events scored × 60 divided by monitoring time (in minutes). The diagnostic criteria were based on the established threshold, AHI cut-off 15.

The REIn accuracy from the clinical study is summarized as follows:

Correlation between REIb and AHI(PSG) is 0.93 AHI(PSG) = $1.033 × REI_b - 0.0705$

REIb is Respiratory Event Index calculated by BresoDX1 software and AHI(PSG) is Apnea and Hypopnea Index calculated by clinical PSG.

The Oxygen Desaturation Index (ODI) accuracy from the clinical study is summarized as follows:

Correlation between ODI(BresoDX1) and ODI(PSG) is 0.95 ODI(PSG) = $1.334 × ODI_{(BresoDX1)} + 5.317$

ODI(BresoDX1) is Oxygen Desaturation Index calculated by BresoDX1 and ODI(PSG) is Oxygen Desaturation Index calculated by clinical PSG.

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SpO2 and Pulse Rate Measurement Accuracy

The accuracy of the Nonin 3150BLE SpO2 and pulse rate values in comparison to the co-oximeter samples measured over the SpO2 range of 70% - 100% are validated in accordance with Medical Electrical Equipment- ISO 80601-2-61:2017 Sub-clauses 201.12.1.103 & 201.12.1.104 Pulse Rate and SpO2 accuracy. Accuracy data is calculated using the root-mean-square ($A_{rms}$ value) for all data points using the following RMS figure of merit calculation:

$$A_{rms} = \frac{\sqrt{\Sigma_{i=1}^n (X_i - X_{Ri})^2}}{n}$$

$X_i$ is the oximeter 4 beat average reading and $X_{Ri}$ is the Oxitest setting at the corresponding sample time.

The accuracy of SpO2 ($A_{rms}$ value) is ±2% (non-motion, low perfusion) ±3% (motion) within the SpO2 range of 70% - 100%. The accuracy of pulse rate ($A_{rms}$ value) is ±3% (motion, non-motion, low perfusion) within the pulse rate range of 18-300 BPM (beats per minutes).

Conclusions

BresoDX1 has the same intended use and similar indications for use, technological characteristics, and principles of operation as its predicate device (K110486). Performance data demonstrated substantially equivalent performance as the ACCUSOM. Thus, BresoDX1 is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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).