(275 days)
Yes
The device description explicitly states that the algorithm functions by "applying machine learning algorithms including multiple deep neural network machine learning models".
No
The device aids in the diagnosis and evaluation of sleep disorders, but it does not directly provide therapy or treatment.
Yes
The intended use explicitly states, "Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults." The device analyzes PPG data to provide outputs like eAHI and ODI, which are used to evaluate and inform the diagnosis of sleep disorders.
Yes
The device is explicitly described as "Software as a Medical Device (SaMD)" and a "software application" that runs on a general-purpose computing platform. It analyzes data from compatible, separate FDA-cleared medical purpose pulse oximeters, indicating it does not include its own hardware for data acquisition.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
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 detect diseases, conditions, or infections. The tests are performed outside of the body ("in vitro").
- Aurora's Function: Aurora analyzes Photoplethysmogram (PPG) data collected during sleep. PPG is a non-invasive method that measures changes in blood volume in the skin, typically using a pulse oximeter. This data is collected from the body, not from a sample taken from the body.
- Intended Use: The intended use is to aid in the diagnosis of sleep disorders by analyzing physiological data collected from the patient during sleep. This is not a diagnostic test performed on a biological sample.
Therefore, Aurora falls under the category of a Software as a Medical Device (SaMD) that analyzes physiological signals, not an In Vitro Diagnostic device.
No
The clearance letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults.
The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Aurora is not intended for use with polysomnography devices.
Product codes
MNR
Device Description
Aurora is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management. Aurora is a software application that is indicated for use on a general-purpose computing platform. It is a cloud-based software-as-a-medicaldevice (SaMD) with a user interface that runs in a web browser.
Aurora automatically analyzes and displays photoplethsmography (PPG) signal data including SPO2 and pulse/heart rate only from compatible FDA-cleared medical purpose pulse oximeters that meet Aurora's data acquisition requirements for sampling rate, digital resolution, measurement range, and accuracy range.
Following upload of a compatible PPG study to the cloud software, the algorithm functions by verifying minimum signal quality, study length, and technical adequacy requirements, preprocessing the data including normalization, digital filtration, and artifact detection/rejection procedures, applying machine learning algorithms including multiple deep neural network machine learning models, statistical signal processing analyses including time-domain and time-frequency domain analyses over multiple time and resolution scales, and other analyses output a detected set of events and derived signals for the PPG study that are post-processed and logically filtered according to algorithm rules based on the American Academy of Sleep Medicine (AASM) recommended scoring event, desaturation, and association rules. Aurora algorithm outputs, including scored respiratory events, sleep stages, Aurora Apnea-Hypopnea Index (eAHI), Total Sleep Time (TST), Sleep Efficiency (SE), Sleep Latency (SL), Wake After Sleep Onset (WASO), and Oxygen Desaturation Events Index (ODI) measures, are stored and made available for display, editing, and review in Aurora by qualified healthcare professionals.
Aurora reports results of the automated data analysis based on AASM guidelines, including the Aurora output Apnea-Hypopnea Index (eAHI) and total sleep time (TST). The algorithm outputs are graphical and numerical displays and reports of sleep latency, sleep quality, and sleep pathologies including sleep disordered breathing. The Aurora displays and reports are for the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders for adults.
The clinician can view raw data for interpretation, edit events, write clinical notes, and customize sleep reports for the patient.
Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
...applying machine learning algorithms including multiple deep neural network machine learning models...
Input Imaging Modality
Photoplethysmogram (PPG) data collected during sleep. Aurora analyzes PPG and oximetry data.
Anatomical Site
Not Found
Indicated Patient Age Range
Adults
Intended User / Care Setting
...by and by order of a healthcare professional...
...Used by or on the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders.
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
The performance testing validated Aurora's determination of the eAHI on single channel photoplethysmography (PPG) and oximetry signals for adult patients. Supportive performance testing validated Aurora's determination of Wake, Light non-rapid eye movement (NREM), Deep NREM, and REM Sleep, and performance metrics for TST; Sleep Efficiency (SE); Sleep Latency (SL); Wake After Sleep Onset (WASO); and Oxygen Desaturation Events Index (ODI).
Simultaneous polysomnography (PSG) and home sleep apnea test (HSAT) recordings were collected for adult patients (n=158) using Philips Respironics Sleepware G3 (K202142), Natus Sandman Elite (K153353), and Polysmith Sleep System (K161650) for PSG recordings, and Viatom Checkme O2 (K191088) for HSAT recordings. Each of the PSG recordings were manually scored by three registered polysomnographic technologists using guidelines following the 3% desaturation guidance. For an event to be officially scored or reported, a consensus of at least two-thirds among the scorers was required. Each PSG was reviewed by a board-certified sleep physician to provide clinical confirmation of scoring and technical adequacy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination. Since this is a software-only medical device that does not control other devices the performance data do not include biocompatibility, electrical safety, electromagnetic compatibility, mechanical, acoustic, or animal testing.
The primary metric for assessing performance of Aurora (subject device) is the Aurora Apnea Hypopnea Index (eAHI). The eAHI depends on the number of sleep disordered breathing events detected, normalized by a determination of total sleep time (TST), where the TST is the total amount of sleep time during the recording period.
The performance testing validated Aurora's determination of the eAHI on single channel photoplethysmography (PPG) and oximetry signals for adult patients. Supportive performance testing validated Aurora's determination of Wake, Light non-rapid eye movement (NREM), Deep NREM, and REM Sleep, and performance metrics for TST; Sleep Efficiency (SE); Sleep Latency (SL); Wake After Sleep Onset (WASO); and Oxygen Desaturation Events Index (ODI).
Simultaneous polysomnography (PSG) and home sleep apnea test (HSAT) recordings were collected for adult patients (n=158) using Philips Respironics Sleepware G3 (K202142), Natus Sandman Elite (K153353), and Polysmith Sleep System (K161650) for PSG recordings, and Viatom Checkme O2 (K191088) for HSAT recordings. Each of the PSG recordings were manually scored by three registered polysomnographic technologists using guidelines following the 3% desaturation guidance. For an event to be officially scored or reported, a consensus of at least two-thirds among the scorers was required. Each PSG was reviewed by a board-certified sleep physician to provide clinical confirmation of scoring and technical adequacy.
Performance in terms of sensitivity and specificity was assessed at an AHI cut-off of AHI >= 5.
Key Results:
eAHI (3% Desaturation) (n=158): Sensitivity 92.6%, Specificity 71.6%
eAHI (4% Desaturation) (n=158): Sensitivity 89.4%, Specificity 76.8%
Sleep Staging (n=52,622 Wake; n=69,438 Light Non-REM; n=10,195 Deep Non-REM; n=14,459 REM):
Wake: Sensitivity 86.7%, Specificity 93.5%
Light Non-REM: Sensitivity 80.9%, Specificity 85.5%
Deep Non-REM: Sensitivity 63.4%, Specificity 95.9%
REM: Sensitivity 83.6%, Specificity 97.5%
Sleep Profile and Oxygen Saturation (Bland-Altman analysis):
eAHI (3%): Mean Difference 1.000, Upper Limit 14.575, Lower Limit -12.574
eAHI (4%): Mean Difference -1.039, Upper Limit 9.307, Lower Limit -11.386
Total Sleep Time: Mean Difference -0.093, Upper Limit 1.145, Lower Limit -1.330
Sleep Efficiency: Mean Difference -0.011, Upper Limit 0.163, Lower Limit -0.185
Sleep Latency: Mean Difference -0.129, Upper Limit 0.884, Lower Limit -1.143
Wake After Sleep Onset: Mean Difference 0.167, Upper Limit 1.131, Lower Limit -0.797
Oxygen Desaturation Index: Mean Difference -1.046, Upper Limit 13.223, Lower Limit -15.315
The subject device met objective performance goals for eAHI, staging, sleep profile, and saturation analysis of the compatible pulse oximeter device in comparison to the manually scored simultaneously collected PSG sleep tests.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity, Specificity, Mean Difference, Upper Limit of Agreement, Lower Limit of Agreement.
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 8, 2024
EnsoData Sigrid Schoepel Vice President Regulatory Affairs 10 E Doty St., Suite 449 Madison, Wisconsin 53703
Re: K231355
Trade/Device Name: Aurora Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: January 10, 2024 Received: January 11, 2024
Dear Sigrid Schoepel:
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"
1
(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 QS 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 (OS) 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,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia,
2
Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K231355
Device Name Aurora
Indications for Use (Describe)
Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults
The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Aurora is not intended for use with polysomnography devices.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K231355 Aurora Traditional 510(k) Summary Prepared in accordance with the content and format outlined in 21 CFR 807.92
I. SUBMITTER
| Name: | EnsoData, Inc. |
|---|---|
| Address: | 10 E. Doty Street, Suite 449 |
| Madison, WI 53703 USA | |
| Phone: | (608)509-4704 |
| Contact Person: | Sigrid Schoepel |
| Email: | sigrid@ensodata.com |
| Date: | January 11, 2024 |
SUBJECT DEVICE INFORMATION II.
| Trade Name: | Aurora |
|---|---|
| Common Name: | Automatic Event Detection Software for Sleep Device Signals |
| Classification Name: | 21 CFR 868.2375 Breathing Frequency Monitor |
| Regulatory Class: | II |
| Product Code: | MNR |
Intended Use:
Aurora is a Software as a Medical Device (SaMD) that establishes sleep quality. Aurora automatically analyzes, displays, and summarizes Photoplethysmogram (PPG) data collected during sleep using compatible devices. Aurora is intended for use by and by order of a healthcare professional to aid in the diagnosis of sleep disorders including sleep apnea in adults.
The Aurora output, including automatically detected respiratory events and parameters, may be displayed and edited by a qualified healthcare professional. The Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
Aurora is not intended for use with polysomnography devices.
III. PREDICATE DEVICE
| Trade Name: | SleepImage System |
|---|---|
| Common Name: | Automatic Event Detection Software for Sleep Device Signals |
| Classification Name: | 21 CFR 868.2375 Breathing Frequency Monitor |
| Regulatory Class: | II |
| Product Code: | MNR |
ensodata.com connect@ensodata.com
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510(k): K182618
IV. SUBJECT DEVICE DESCRIPTION
Aurora is a Class II Software as a Medical Device (SaMD), intended to aid in the evaluation of sleep disorders, where it may inform or drive clinical management. Aurora is a software application that is indicated for use on a general-purpose computing platform. It is a cloud-based software-as-a-medicaldevice (SaMD) with a user interface that runs in a web browser.
Aurora automatically analyzes and displays photoplethsmography (PPG) signal data including SPO2 and pulse/heart rate only from compatible FDA-cleared medical purpose pulse oximeters that meet Aurora's data acquisition requirements for sampling rate, digital resolution, measurement range, and accuracy range.
Following upload of a compatible PPG study to the cloud software, the algorithm functions by verifying minimum signal quality, study length, and technical adequacy requirements, preprocessing the data including normalization, digital filtration, and artifact detection/rejection procedures, applying machine learning algorithms including multiple deep neural network machine learning models, statistical signal processing analyses including time-domain and time-frequency domain analyses over multiple time and resolution scales, and other analyses output a detected set of events and derived signals for the PPG study that are post-processed and logically filtered according to algorithm rules based on the American Academy of Sleep Medicine (AASM) recommended scoring event, desaturation, and association rules. Aurora algorithm outputs, including scored respiratory events, sleep stages, Aurora Apnea-Hypopnea Index (eAHI), Total Sleep Time (TST), Sleep Efficiency (SE), Sleep Latency (SL), Wake After Sleep Onset (WASO), and Oxygen Desaturation Events Index (ODI) measures, are stored and made available for display, editing, and review in Aurora by qualified healthcare professionals.
Aurora reports results of the automated data analysis based on AASM guidelines, including the Aurora output Apnea-Hypopnea Index (eAHI) and total sleep time (TST). The algorithm outputs are graphical and numerical displays and reports of sleep latency, sleep quality, and sleep pathologies including sleep disordered breathing. The Aurora displays and reports are for the order of physicians, trained technicians, or other healthcare professionals to evaluate sleep disorders where it may inform or drive clinical management taking into consideration other factors that normally are considered for clinical management of sleep disorders for adults.
The clinician can view raw data for interpretation, edit events, write clinical notes, and customize sleep reports for the patient.
Aurora output is not intended to be interpreted or clinical action taken without consultation of a qualified healthcare professional.
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COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE V. PREDICATE DEVICE
The table below compares the predicate device, "SleepImage System" with the subject device Aurora.
| Element | Predicate Device
MyCardio, LLC dba SleepImage
K182618
SleepImage System | Subject Device
EnsoData, Inc.
K231355
Aurora | Equivalency |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Indications for use | The SleepImage System is Software as a
Medical Device (SaMD) that establishes sleep
quality. The SleepImage System analyzes,
displays and summarizes Electrocardiogram
(ECG) or Plethysmogram (PLETH) data,
typically collected during sleep, that is intended
for use by or on the order of a Healthcare
Professional to aid in the evaluation of sleep
disorders, where it may inform or drive clinical
management for children, adolescents and
adults.
The SleepImage Apnea Hypopnea Index
(sAHI), presented when oximeter data is
available, is intended to aid healthcare
professionals in diagnosis and management of
sleep disordered breathing.
The SleepImage System output is not intended
to be interpreted or clinical action taken without
consultation of a qualified healthcare
professional. | Aurora is a Software as a Medical Device
(SaMD) that establishes sleep quality. Aurora
automatically analyzes, displays, and summarizes
Photoplethysmogram (PPG) data collected during
sleep. Aurora is intended for use by and by order
of a healthcare professional to aid in the diagnosis
of sleep disorders including sleep apnea in adults.
The Aurora output, including automatically
detected respiratory events and parameters, may
be displayed and edited by a qualified healthcare
professional. The Aurora output is not intended to
be interpreted or clinical action taken without
consultation of a qualified healthcare
professional.
Aurora is not intended for use with
polysomnography devices. | Similar |
| Intended Use | The SleepImage System is Software as a
Medical Device (SaMD) that establishes sleep
quality, intended for use by or on the order of a
Healthcare Professional to aid in the evaluation
of sleep disorders based on Electrocardiogram
(ECG) or Plethysmogram (PLETH) recordings,
typically collected during sleep. | Aurora is intended for use by and by order of a
healthcare professional to aid in the diagnosis and
evaluation of sleep disorders including sleep
apnea, where it may inform or drive clinical
management for adults. | Similar |
| Patient Population | Children, Adolescents and Adults | Adults | Similar
Aurora operates on
a subset of the
population of
SleepImage |
| Environment of Use | N/A (Software)
(Clinicians use the device within their clinic to
view and edit the automatically scored sleep
tests) | N/A (Software)
(Clinicians use the device within their clinic to
view and edit the automatically scored sleep tests) | Same |
| Method of Access | General-purpose computing platform with
internet connection | General-purpose computing platform with
internet connection | Same |
| Element | Predicate Device | Subject Device | Equivalency |
| | MyCardio, LLC dba SleepImage
K182618
SleepImage System | EnsoData, Inc.
K231355
Aurora | |
| Principle of
Operation | Cloud-based web application Software as a
Medical Device (SaMD) | Cloud-based web application Software as a
Medical Device (SaMD) | Same |
| Input Source | HSAT and PSG devices | EDF signal files from compatible FDA-cleared
medical purpose pulse oximeters PPG devices | Similar
Aurora uses a
subset of the input
sources |
| Signals Analyzed | ECG or PPG; with oximetry | PPG and oximetry | Similar |
| | Without referencing a particular, or a list of
particular, ECG [or PPG] signal sources or
recording devices. | Aurora analyzes PPG and oximetry data for the
purposes of sleep analysis and sleep disorder
detection with compatible FDA-cleared medical
purpose PPG and oximetry signal sources and
recording devices. | Aurora uses a
subset of the
predicate signals |
| | | PPG and oximetry are recorded by a third-party
PPG device, converted into EDF (European Data
Format), and the EDF files are analyzed by the
Aurora system. | |
| Interoperable Data
Format | EDF; ASCII | EDF | Similar |
| Output Parameters | Sleep duration (total sleep time), sleep latency,
sleep efficiency, wake after sleep onset, sleep
stages, sleep quality, fragmentation &
periodicity, oxygen desaturation | Sleep duration (total sleep time), sleep latency,
wake after sleep onset, sleep stages, sleep
efficiency, duration and percentage of sleep and
wake, oxygen saturation and desaturation | Similar |
| Analysis of Sleep-
Disordered
Breathing Events | The SleepImage Apnea Hypopnea Index
(sAHI), presented when oximeter data is
available, is intended to aid healthcare
professionals in diagnosis and management of
sleep disordered breathing. | Automatic detection of sleep-disordered breathing
events, for calculation of eAHI when both PPG
and oximetry data are present, is intended to aid
healthcare professionals in diagnosis and
management of sleep disordered breathing. | Similar |
| Diagnostic
Parameters | SQI, SAI, RDI, ODI, AHI (AHI, oAHI, cAHI),
WASO, TST | Apnea-Hypopnea Index (eAHI), Total Sleep Time
(TST), Sleep Efficiency (SE), Sleep Latency (SL),
Wake After Sleep Onset (WASO), and Oxygen
Desaturation Events Index (ODI) | Similar
Aurora offers a
subset of the
predicate
diagnostic
parameters |
| Display of Analysis
Results | Graphical and numerical presentations and
reports | Graphical and numerical presentations and reports | Same |
| Edits and
Corrections to
Automatic Analysis | The clinician can view raw data for
interpretation, adjust events, write clinical notes,
and customize sleep reports for the patient.
Clinicians may review and utilize the results to | The clinician can view raw data for interpretation,
adjust events, write clinical notes, and customize
sleep reports for the patient. | Same |
| Element | Predicate Device
MyCardio, LLC dba SleepImage
K182618
SleepImage System | Subject Device
EnsoData, Inc.
K231355
Aurora | Equivalency |
| | make recommendations for further testing,
referral, and/or therapy. | Clinicians may review and utilize the results to
make recommendations for further testing,
referral, and/or therapy. | |
| Intended Users | Used by or on the order of physicians, trained
technicians, or other healthcare professionals to
evaluate sleep disorders where it may inform or
drive clinical management taking into
consideration other factors that normally are
considered for clinical management of sleep
disorders. | Used by or on the order of physicians, trained
technicians, or other healthcare professionals to
evaluate sleep disorders where it may inform or
drive clinical management taking into
consideration other factors that normally are
considered for clinical management of sleep
disorders. | Same |
| Cybersecurity | Use of secure authentication protocols
Data is transferred between user's general-
purpose computing platform and cloud- based
server, utilizing secure authentication protocols
over the Internet | Authentication controls, authorization controls,
cryptographic controls, access controls, checksum
controls, software distribution controls, intrusion
detection system controls, network and systems
controls, and database controls. | Same |
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VI. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination. Since this is a software-only medical device that does not control other devices the performance data do not include biocompatibility, electrical safety, electromagnetic compatibility, mechanical, acoustic, or animal testing.
The device was designed and tested under the following standards and guidelines:
- . EN ISO 13485 Third Edition 2016/A11 Medical devices - Quality management systems -Requirements for regulatory purposes
- . EN ISO 14971 Third Edition 2019-12 Medical devices - Application of risk management to medical devices
- IEC 62304 Edition 1.1 2015-06 Medical device software - Software life cycle processes
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket ● Submissions - FDA guidance issued September 27, 2023
- . Content of Premarket Submissions for Device Software Functions - FDA guidance issued June 14, 2023
The primary metric for assessing performance of Aurora (subject device) is the Aurora Apnea Hypopnea Index (eAHI). The eAHI depends on the number of sleep disordered breathing events detected, normalized by a determination of total sleep time (TST), where the TST is the total amount of sleep time during the recording period.
The performance testing validated Aurora's determination of the eAHI on single channel photoplethysmography (PPG) and oximetry signals for adult patients. Supportive performance testing validated Aurora's determination of Wake, Light non-rapid eye movement (NREM), Deep NREM, and
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REM Sleep, and performance metrics for TST; Sleep Efficiency (SE); Sleep Latency (SL); Wake After Sleep Onset (WASO); and Oxygen Desaturation Events Index (ODI).
Simultaneous polysomnography (PSG) and home sleep apnea test (HSAT) recordings were collected for adult patients (n=158) using Philips Respironics Sleepware G3 (K202142), Natus Sandman Elite (K153353), and Polysmith Sleep System (K161650) for PSG recordings, and Viatom Checkme O2 (K191088) for HSAT recordings. Each of the PSG recordings were manually scored by three registered polysomnographic technologists using guidelines following the 3% desaturation guidance. For an event to be officially scored or reported, a consensus of at least two-thirds among the scorers was required. Each PSG was reviewed by a board-certified sleep physician to provide clinical confirmation of scoring and technical adequacy.
| Apnea Hypopnea Index (eAHI vs sAHI) | ||||
|---|---|---|---|---|
| Device | Desaturation | Sample Size | ||
| (n) | Sensitivity | Specificity | ||
| Aurora | ||||
| Subject | ||||
| K231355 | 3% | 158 | 92.6% | |
| (87.2%, 97.2%) | 71.6% | |||
| (59.2%, 83.7%) | ||||
| 4% | 158 | 89.4% | ||
| (81.6%, 96.1%) | 76.8% | |||
| (67.1%, 85.4%) | ||||
| SleepImage | ||||
| Predicate | ||||
| K182618 | Unspecified | 189 | 98.7% | |
| (97.0%, 100%) | 84.8% | |||
| (72.6%, 97.1%) |
Performance in terms of sensitivity and specificity was assessed at an AHI cut-off of AHI >= 5.
| Sleep Staging | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device | Category | Sample Size | |||||||
| (n) | Sensitivity | Specificity | |||||||
| Aurora | |||||||||
| Subject | |||||||||
| K231355 | Wake | 52,622 | 86.7% | ||||||
| (86.5%, 87.0%) | 93.5% | ||||||||
| (93.4%, 93.7%) | |||||||||
| Light | |||||||||
| Non-REM | 69,438 | 80.9% | |||||||
| (80.6%, 81.2%) | 85.5% | ||||||||
| (85.2%, 85.7%) | |||||||||
| Deep | |||||||||
| Non-REM | 10,195 | 63.4% | |||||||
| (62.4%, 64.3%) | 95.9% | ||||||||
| (95.7%, 96.0%) | |||||||||
| REM | 14,459 | 83.6% | |||||||
| (83.0%, 84.2%) | 97.5% | ||||||||
| (97.4%, 97.5%) |
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| Sleep Profile and Oxygen Saturation | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Device | Deming Regression | Bland-Altman | |||||||
| Category | Slope ẞ1 | Intercept ß0 | Mean | ||||||
| Difference | |||||||||
| (MD) | Upper Limit | ||||||||
| (ULOA) | Lower Limit | ||||||||
| (LLOA) | |||||||||
| Aurora | |||||||||
| Subject | |||||||||
| K231355 | eAHI (3%) | ||||||||
| [events/hour] | 0.936 | ||||||||
| (0.853, 1.033) | 0.023 | ||||||||
| (-1.185, 1.122) | 1.000 | ||||||||
| (0.630, 1.367) | 14.575 | ||||||||
| (13.779, 15.363) | -12.574 | ||||||||
| (-13.371,-11.786) | |||||||||
| eAHI (4%) | |||||||||
| [events/hour] | 0.982 | ||||||||
| (0.903, 1.130) | 1.219 | ||||||||
| (0.116, 1.985) | -1.039 | ||||||||
| (-1.326, -0.749) | 9.307 | ||||||||
| (8.692, 9.931) | -11.386 | ||||||||
| (-12.001,-10.763) | |||||||||
| Total Sleep Time | |||||||||
| [hours] | 1.159 | ||||||||
| (1.035, 1.318) | -0.695 | ||||||||
| (-1.576, -0.005) | -0.093 | ||||||||
| (-0.132, -0.059) | 1.145 | ||||||||
| (1.060, 1.216) | -1.330 | ||||||||
| (-1.414, -1.259) | |||||||||
| Sleep Efficiency | |||||||||
| [hours/hours] | 1.154 | ||||||||
| (1.031, 1.317) | -0.088 | ||||||||
| (-0.205, 0.003) | -0.011 | ||||||||
| (-0.017, -0.007) | 0.163 | ||||||||
| (0.151, 0.173) | -0.185 | ||||||||
| (-0.198, -0.176) | |||||||||
| Sleep Latency | |||||||||
| [hours] | 1.114 | ||||||||
| (0.997, 1.290) | -0.023 | ||||||||
| (-0.185, 0.090) | -0.129 | ||||||||
| (-0.154, -0.089) | 0.884 | ||||||||
| (0.831, 0.970) | -1.143 | ||||||||
| (-1.196, -1.057) | |||||||||
| Wake After | |||||||||
| Sleep Onset | |||||||||
| [hours] | 1.073 | ||||||||
| (0.938, 1.219) | -0.271 | ||||||||
| (-0.436, -0.121) | 0.167 | ||||||||
| (0.140, 0.196) | 1.131 | ||||||||
| (1.073, 1.193) | -0.797 | ||||||||
| (-0.855, -0.735) | |||||||||
| Oxygen | |||||||||
| Desaturation | |||||||||
| Index [events/ | |||||||||
| hours] | 0.962 | ||||||||
| (0.896, 1.056) | 1.667 | ||||||||
| (0.330, 2.847) | -1.046 | ||||||||
| (-1.417, -0.677) | 13.223 | ||||||||
| (12.426, 14.015) | -15.315 | ||||||||
| (-16.111,-14.522) |
CONCLUSION
The subject device met objective performance goals for eAHI, staging, sleep profile, and saturation analysis of the compatible pulse oximeter device in comparison to the manually scored simultaneously collected PSG sleep tests. The subject device agreement with single-channel PPG is considered substantially equivalent to the predicate device and the subject device does not raise new or additional questions of safety and effectiveness.
VII. CONCLUSIONS
The subject device is similar in intended use and functionality to the predicate device. The subject device has the same technological characteristics and features as the predicate device and does not raise new questions of safety or effectiveness as demonstrated through the system design and testing. Software verification and validation, cybersecurity, and performance testing were conducted to confirm the device design met user needs and specifications and was acceptable to qualified users.
The conclusions drawn from the clinical and nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as the legally marketed predicate device.