(351 days)
No
The summary describes data acquisition, pre-processing, storing, and processing for analysis and report generation. It mentions "automated scoring" but also explicitly states the health care professional can "review data, edit automated scoring, and re-generate a sleep study report based on the edited scoring." There is no mention of AI, ML, or related terms, nor is there a description of training or test sets for an AI/ML model. The focus is on signal processing and automated scoring that can be manually edited, which is not indicative of AI/ML.
No
The device is indicated as an "aid in the diagnosis," meaning it helps identify a condition rather than treating or curing it.
Yes
The "Intended Use / Indications for Use" states that "BresoDX1 is indicated for use as an aid in the diagnosis of moderate to severe sleep apnea in adult patients."
No
The device description explicitly states that the BresoDX1 system consists of hardware components (BresoSensor, BresoHub, Nonin WristOx2® pulse oximeter) in addition to the BresoDX1 software.
Based on the provided information, the BresoDX1 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. These tests are performed outside of the body (in vitro).
- BresoDX1 Function: The BresoDX1 records physiological signals directly from the patient's body during sleep (tracheal breathing sounds, neck/body position and movement, tracheo-sternal movement, arterial oxyhemoglobin saturation, and heart rate). It does not analyze samples taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of sleep apnea by recording and analyzing physiological signals, not by performing tests on biological samples.
Therefore, the BresoDX1 falls under the category of a medical device that monitors physiological parameters, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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 and hypopneas. BresoDX1 is intended to be used in the home and clinic settings.
Product codes (comma separated list FDA assigned to the subject device)
MNR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
suprasternal notch, finger, wrist
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Health Care Professional (HCP), home and clinic settings
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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*:
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
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
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.
The accuracy of SpO2 (Arms value) is ±2% (non-motion, low perfusion) ±3% (motion) within the SpO2 range of 70% - 100%. The accuracy of pulse rate (Arms value) is ±3% (motion, non-motion, low perfusion) within the pulse rate range of 18-300 BPM (beats per minutes).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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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
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 Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known)
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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3
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
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.
4
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 | ||
|---|---|---|
| ---------------------------------------------------------------------------------- | -- | -- |
| | Bresotec's
BresoDX1 | NovaSom's
ACCUSOM
(Predicate) | Itamar' s
WatchPat200U
(Reference Device) | AcuPebble SA100
(Reference Device) | Comparison |
|---------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
Class,
Product
Code | Class II, MNR | Class II, MNR | Class II, MNR | Class II, MNR | |
| 510k # | K220012 | K110486 | K203839 | K210480 | |
| Intended
Use /
Indications
for Use | The BresoDX1 is
indicated for use as
an aid in the
diagnosis
of moderate to severe
sleep apnea in adult
patients. The
BresoDX1 records a
patient's
physiological signals
during sleep and
scores apneas and
hypopneas. The
BresoDX1 is
intended to be used in
the home and clinic
settings. | The ACCUSOM device
is indicated for use in the
diagnostic evaluation of
adults with possible
sleep apnea. The
ACCUSOM can score
obstructive apneas,
which includes mixed
apneas.
The ACCUSOM device
is intended for use in the
home and clinic setting. | The Watch-PAT200U
(WP200U) device is a
non-invasive home care
device for use with
patients suspected to have
sleep related breathing
disorders. The WP200U is
a diagnostic
aid for the detection of
sleep related breathing
disorders, sleep staging
(Rapid Eye
Movement (REM) Sleep,
Light Sleep, Deep Sleep
and Wake), snoring level
and body
position. The WP200U
generates a peripheral
arterial tonometry
("PAT") Respiratory
Disturbance index
("PRDI"), Apnea-
Hypopnea index
("PAHI"), Central
Apnea-
Hypopnea index
("PAHIc"), PAT sleep
staging identification
(PSTAGES) and optional
snoring level and body
position discrete states
from an external
integrated snoring and
body position sensor. The
WP200U's PSTAGES and
snoring level and body
position
provide supplemental
information to its
PRDI/PAHI/PAHIc. The
WP200U's PSTAGES
and snoring level and
body position are not | AcuPebble SA100 is
indicated to sense, record,
and interpret a patient's
physiological signals
(including respiratory
pattern) during sleep for the
purpose of pre-screening
patients for obstructive
sleep apnea (OSA)
syndrome. The device is
designed for use in home-
screening of adults with
suspected possible sleep
breathing disorders
(although it can also be
used in clinic). Results are
used to assist the healthcare
professional in the patient's
evaluation.
The system is not intended
as a substitute for full
polysomnography when
additional parameters such
as sleep stages, limb
movements or EEG activity
are required. | Substantially equivalent to
predicate device.
BresoDX1 does not
differentiate between
obstructive and mixed
apneas. This difference
does not impact the ability
of BresoDX1 to provide
information to the user as
an aid in the diagnosis of
moderate to severe sleep
apnea. |
| | | | intended to be used as the
sole or primary
basis for diagnosing any
sleep related breathing
disorder, prescribing
treatment, or
determining whether
additional diagnostic
assessment is warranted.
PAHiC is indicated for use
in patients 17 years and
older. All other
parameters are indicated
for 12 years and older. | | |
| User
Population | Home and clinic
setting | Home and clinic setting | A non-invasive home care
device | For use in home-screening
(although it can be used in
clinic) | Substantially equivalent to
predicate device. |
| Sensors | -Microphone in
BresoSensor placed
on the suprasternal
notch
-Oximeter sensor
placed on finger -
Three-dimensional
accelerometer in
BresoSensor placed
on suprasternal notch | -Breath Sensor (sensing
microphone and ambient
noise microphone)
placed under the nose
-Oximeter finger sensor
placed on the finger
- Chest Sensor located
on the chest. | -uPAT finger
probe placed on the
finger
-Actigraphy on the wrist - (optional) External
SBP/RESBP chest sensor
(microphone, three-
dimensional
accelerometer) placed on
the chest right under the
sternal notch | -Microphone placed on the
neck above the suprasternal
notch | Substantially Equivalent to
predicate device.
In addition, BresoDX1 and
reference device uses three-
dimensional accelerometer. |
| Channels | Airflow, respiratory
effort, tracheal breath
sounds tracheo-
sternal movement,
pulse rate, SpO2,
body position | Airflow, respiratory
sounds, pulse rate, SpO2,
snoring level | PAT, pulse rate, oximetry,
actigraphy, snoring, body
position, chest movement | Sounds (Cardiac features,
respiratory features,
movement features) | Substantially Equivalent to
predicate device.
BresoDX1 does not provide
the output of snoring levels.
Snoring is optional for
HSAT and is not essential
for the diagnosis of sleep
apnea.
The difference of system
output between BresoDX1
with its predicates does not
raise any uncertainty of
safety, effectiveness, and
efficacy. |
| Portability | Yes (wearable) | Yes (wearable) | Yes (wearable) | Yes (wearable) | Identical to predicate
device. |
| Data
Download | Transfer through
wireless connection | Transfer through
wireless connection | Transfer through USB
connection | Transfer through wireless
connection | Substantially equivalent to
predicate device. |
| Size and
Weight of
sensor | BresoSensor:
17.4×38.7×35.5 mm
17g | Patient Module :
100.3×71.9×29.5 mm
116.2 g | Chest sensor:
1.3inch (32mm) diameter
12g | 29.5mm diameter × 16mm
height
7g | Different but difference in
size and weight do not raise
safety or effectiveness
question. |
| Power
Source | BresoHub: wall
mount power adaptor
BresoSensor:
Lithium-ion
rechargeable battery
Oximeter: 2 × 1.5V
Alkaline AAA
battery | Patient Module:
Rechargeable battery
operated | One OTS 1.5V Alkaline
AAA battery OR
One rechargeable AAA
1.2V Nickel-metal
hydride battery
rechargeable (NiMH)
battery | Rechargeable lithium
polymer battery | Different but difference in
power source do not raise
safety or effectiveness
question. |
| Indicators | Visual indicators
LEDs on
BresoSensor and
BresoHub.
Indicators on
BresoHub Web
Interface | Audio and visual
indicators | Visual indicator – error
messages | N/A | Different. BresoDX1 does
not have audio indicators,
but it has visual indicators.
This difference does not
raise safety or effectiveness
question. |
| Sterilization | Nonsterile | Nonsterile | Nonsterile | Nonsterile | Identical. |
5
6
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:
7
- · 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.
8
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.