(180 days)
No
The summary describes data collection, transmission, storage, and review by a healthcare professional using a scoring manual. There is no mention of AI/ML being used for data analysis, interpretation, or diagnosis. The performance studies focus on comparison to PSG and SpO2 accuracy, not on the performance of an AI/ML algorithm.
No
The device is described as a "wearable sensor system intended for use in the collection, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders" and "a wireless physiological recorder for use as an aid in the diagnosis of sleep-related breathing disorders". Its purpose is to collect data for diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended for use in the collection, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders...". The "Device Description" also explicitly states it is "for use as an aid in the diagnosis of sleep-related breathing disorders".
No
The device description explicitly states it is a "wearable sensor system" featuring "two skin-mounted, biointegrated sensors" that measure physiological parameters. This indicates the device includes hardware components beyond just software.
Based on the provided information, the ANNE Sleep device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically includes blood, urine, tissue, etc.
- ANNE Sleep is a wearable sensor system. It collects physiological parameters from the body surface (chest and finger) through non-invasive sensors. It does not analyze samples taken from the body.
- The device measures physiological parameters directly. It measures things like PAT, oximetry, pulse rate, snoring, movement, etc., which are physical signals from the body.
Therefore, ANNE Sleep falls under the category of a medical device that collects physiological data, rather than an IVD that analyzes biological samples.
N/A
Intended Use / Indications for Use
ANNE Sleep is a wearable sensor system intended for use in the collection, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP).
Product codes (comma separated list FDA assigned to the subject device)
MNR
Device Description
ANNE Sleep is a wireless physiological recorder for use as an aid in the diagnosis of sleep-related breathing disorders by healthcare professionals. The system features two skin-mounted, biointegrated sensors that pair with an associated proprietary software application for the transmission and storage of data. The sensors, which are placed on the chest and finger, measure peripheral arterial tonometry (PAT), oximetry (SpO2), pulse rate, snoring, chest movement, body position, total sleep time, and heart rate. These data are uploaded to a cloud backend that can communicate with a compatible third-party software viewer, where they are reviewed by a qualified healthcare professional to identify sleep-disordered breathing events according to a scoring manual. The number of sleep-disordered breathing events per hour of sleep is the Sibel-AHI, a parameter that functions as an aid to diagnosis of sleep apnea by physicians. A sleep report is generated from this score and uploaded to a web portal, the ANNE Sleep Hub, where it can be stored and further reviewed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
chest and finger
Indicated Patient Age Range
22 years of age and older
Intended User / Care Setting
Healthcare Professional (HCP), clinical and home setting
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
SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (ARMS) was 2.31%, meeting the requirements of the above-mentioned standard.
Comparison to PSG: The performance of the ANNE Sleep system as a diagnostic aid for moderate to severe obstructive sleep apnea (OSA) in adults was evaluated compared to the gold standard, polysomnography (PSG), in a single-arm, open-label, multi-center clinical study with n=225 subjects that was conducted in the United States. Subjects were representative of the intended target population, individuals 22 years of age or older who are suspected of having OSA. Subjects were 44% male and 56% female. Subjects were 73% white, 12% Black or African American. 9% Asian. 0.4% American Indian or Alaska Native, and 4% multi-racial.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varying from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (ARMS) was 2.31%, meeting the requirements of the above-mentioned standard.
Comparison to PSG: The performance of the ANNE Sleep system as a diagnostic aid for moderate to severe obstructive sleep apnea (OSA) in adults was evaluated compared to the gold standard, polysomnography (PSG), in a single-arm, open-label, multi-center clinical study with n=225 subjects that was conducted in the United States. Subjects were representative of the intended target population, individuals 22 years of age or older who are suspected of having OSA. Subjects were 44% male and 56% female. Subjects were 73% white, 12% Black or African American. 9% Asian. 0.4% American Indian or Alaska Native, and 4% multi-racial. The results of the study indicate that ANNE Sleep is sufficiently accurate as an aid to the diagnosis of moderate to severe OSA, with a sensitivity and specificity of 90% and 98%, respectively. Additionally, skin tolerance was assessed following removal of the chest sensor for n=184 patients. No evidence of increased breakdown or skin dryness was reported, and only a small average increase in temporary redness was observed in 32% of subjects. No adverse events were reported during the study.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Aid to Diagnosis of Moderate to Severe OSA (AHI>=15): Sensitivity 90%, Specificity 98%
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).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 11, 2022
Sibel Inc. Peter Xu Chief Operating Officer 6650 W. Touhy Ave. Niles, Illinois 60714
Re: K220095
Trade/Device Name: ANNE Sleep Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: June 7, 2022 Received: June 8, 2022
Dear Peter Xu:
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, 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
Indications for Use
510(k) Number (if known) K220095
Device Name ANNE Sleep
Indications for Use (Describe)
ANNE Sleep is a wearable sensor system intended for use in the collection, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP).
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary
-Submitter:
Sibel Inc. 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859
Official Correspondent: Sarah Coughlin, Regulatory Affairs and Quality Assurance Engineer 6650 W. Touhy Avenue, Niles, IL 60714 Tel: (224) 251-8859
Date Prepared: 7/10/2022
II. Device Information
Name of Device: ANNE Sleep 510(k) Number: K220095 Classification Name: Breathing Frequency Monitor Regulation: 21 CFR §868.2375 Regulatory Class: Class II Product Classification Code: MNR
lll. Predicate Device
Trade Name: WatchPAT One 510(k): K183559 Device Manufacturer: Itamar Medical, Ltd.
IV. Reference Device
Trade Name: ANNE One 510(k): K211305 Device Manufacturer: Sibel Inc.
V. Device Description
ANNE Sleep is a wireless physiological recorder for use as an aid in the diagnosis of sleep-related breathing disorders by healthcare professionals. The system features two skin-mounted, biointegrated sensors that pair with an associated proprietary software application for the transmission and storage of data. The sensors, which are placed on the chest and finger, measure peripheral arterial tonometry (PAT), oximetry (SpQ2), pulse rate, snoring, chest movement, body position, total sleep time, and heart rate. These data are uploaded to a cloud backend that can communicate with a compatible third-party software viewer, where they are reviewed by a
4
qualified healthcare professional to identify sleep-disordered breathing events according to a scoring manual. The number of sleep-disordered breathing events per hour of sleep is the Sibel-AHI, a parameter that functions as an aid to diagnosis of sleep apnea by physicians. A sleep report is generated from this score and uploaded to a web portal, the ANNE Sleep Hub, where it can be stored and further reviewed.
VI. Indications for Use
ANNE Sleep is a wearable sensor system intended for use in the collection, analysis, display, and storage of physiological parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for use in the clinical and home setting under the direction and interpretation by a Healthcare Professional (HCP).
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| | Subject device
ANNE Sleep | Primary predicate device
Itamar Medical, Ltd. | Reference device
Sibel Inc. | Variances / Equivalence |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | ANNE Sleep | WatchPat One | ANNE One | |
| 510(k) Number | K220095 | K183559 | K211305 | N/A |
| Class | II | II | II | Equivalent |
| Product Code | MNR | MNR | DRG, MWI, FLL | Equivalent
ANNE Sleep's product code is
equivalent to WatchPat One. |
| Regulation
Number and
Regulation Name | 868.2375
Breathing Frequency Monitor | 868.2375
Breathing Frequency Monitor | 870.2910
Transmitters and Receivers,
Physiological Signal,
Radiofrequency | Equivalent
ANNE Sleep's regulation number
and name is equivalent to
WatchPat One. |
| Indications for
Use | ANNE Sleep is a wearable
sensor system intended for use
in the collection, analysis,
display, and storage of
physiological parameters to aid in
the evaluation of sleep-related
breathing disorders of adult
patients suspected of sleep
apnea. The device is intended for
use in the clinical and home
setting under the direction and
interpretation by a Healthcare
Professional (HCP). | The WatchPAT One (WP1)
device is a non-invasive home
care device for use with patients
suspected to have sleep related
breathing disorders. The WP1 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 WP1 generates a
peripheral arterial tonometry
( | | |
| | | | | |
| Target Population | 22 years of age and older | PAHIc is indicated for use in
patients 17 years and older. All
other parameters are indicated
for 12 years and older. | Adults, 18 years of age and older | Substantially Equivalent
The ANNE Sleep target
population is more restrictive
than WatchPAT One. |
| Use Environment | Recording in the home
environment with the report and
interpretation performed in the
clinical setting. | Recording in the home
environment with the report and
interpretation performed in the
clinical setting. | Hospital Setting | Equivalent
The intended use environment
for ANNE Sleep is equivalent to
WatchPAT One. |
| Sensor
Placement | Finger and Chest | Finger, Chest, and Wrist | Finger and Chest | Substantially Equivalent
ANNE Sleep does not have a
sensor located on the wrist |
| Components | Limb Sensor
Chest Sensor
Accelerometer
ECG Module
PPG Module
ANNE Sleep Application
Software | uPAT Finger Probe
Actigraph
Controller
Microphone
Accelerometer
ZzzPAT Software
Chest Sensor | Limb Sensor
Chest Sensor
Accelerometer
ECG Module
ANNE View Application Software | Substantially Equivalent
ANNE Sleep does not include a
microphone or controller.
Performance testing
demonstrates that this difference
does not influence overall safety
and effectiveness. |
| | | from an external integrated
snoring and body position
sensor. The WP1's PSTAGES
and snoring level and body
position provide supplemental
information to its
PRDI/PAHI/PAHIc. The WP1's
PSTAGES and snoring level and
body position are not 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. | heart rate on ambulatory
patients. | |
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7
| ANNE Hub Software | ||||
|---|---|---|---|---|
| Channels | PAT | |||
| Pulse Rate | ||||
| Oximetry | ||||
| Snoring | ||||
| Body Position | ||||
| Chest Movement | ||||
| Heart Rate | PAT | |||
| Pulse Rate | ||||
| Oximetry | ||||
| Actigraphy | ||||
| Snoring | ||||
| Body Position | ||||
| Chest Movement | Heart Rate | |||
| Respiratory Rate | ||||
| Body Position | ||||
| Temperature | Substantially Equivalent | |||
| ANNE Sleep collects the same | ||||
| channels as WatchPAT One, as | ||||
| well as heart rate, which is | ||||
| supported by the reference | ||||
| device | ||||
| Analysis Outputs | Sibel-AHI (based on manual | |||
| scoring of data by HCP) | ||||
| Body Position Discrete States | ||||
| Heart Rate | ||||
| Total Sleep Time | ||||
| SpO2 | pRDI | |||
| pAHI | ||||
| pAHIc | ||||
| Sleep Stages | ||||
| Snoring Level | ||||
| Body Position Discrete States | Heart Rate | |||
| Respiratory Rate | ||||
| Step Count | ||||
| Fall Count | ||||
| Temperature | Substantially Equivalent | |||
| Sibel-AHI is a device specific | ||||
| approximation of AHI that is | ||||
| manually scored by an HCP and | ||||
| is similar to the pAHI value that is | ||||
| automatically calculated by | ||||
| WatchPAT. ANNE Sleep is not | ||||
| intended for sleep staging or the | ||||
| discrimination between central | ||||
| and obstructive sleep apneic | ||||
| events. Snoring level and pRDI | ||||
| are supplemental parameters | ||||
| that are not directly utilized in the | ||||
| diagnosis of sleep disordered | ||||
| breathing. Performance testing of | ||||
| SpO2 and heart rate | ||||
| measurements with ANNE Sleep | ||||
| demonstrate that output of these | ||||
| parameters do not influence the | ||||
| overall safety and effectiveness | ||||
| of the device. | ||||
| Performance | Pulse Rate: 30-300 bpm ± 3 bpm | |||
| Heart Rate: 30-300 bpm ± the | ||||
| greater of ± 10% or ± 5 bpm | ||||
| SpO2: ARMS ≤ 3% (range 70- | ||||
| 100%) | Pulse Rate: 30-150 bpm ± 1 bpm | |||
| SpO2: ARMS ≤ 3% (range 70- | ||||
| 100%) | Heart Rate: 30-270 bpm ± the | |||
| greater of ± 10% or ± 5 bpm | ||||
| Temperature: 73.4°F - 109.4°F ± | ||||
| 0.54°F | Substantially Equivalent | |||
| Aid to Diagnosis of Moderate to | ||||
| Severe OSA (AHI≥15): Sensitivity | ||||
| 90%, Specificity 98% | ||||
| Data Collection | ||||
| and Transfer | Patient data is wirelessly | |||
| transferred via Bluetooth from the | ||||
| sensors to a mobile phone. Data | ||||
| is then wirelessly transferred | ||||
| from the phone to the cloud when | ||||
| connected to the internet. | Patient data is wirelessly | |||
| transferred via Bluetooth from the | ||||
| sensors to a mobile phone. Data | ||||
| is then wirelessly transferred | ||||
| from the phone to the cloud when | ||||
| connected to the internet. | Data transmitted wirelessly via | |||
| Bluetooth from sensors to mobile | ||||
| device | Equivalent | |||
| Data collection and transfer with | ||||
| ANNE Sleep is equivalent to | ||||
| WatchPAT One. | ||||
| Recording | ||||
| Capacity | 36 hours of continuous use | Approx. 10 hours | 36 hours of continuous use | Equivalent |
| ANNE Sleep is equivalent in | ||||
| recording capacity to ANNE One. | ||||
| Differences between WatchPAT | ||||
| One and ANNE Sleep do not | ||||
| influence safety or effectiveness | ||||
| as both can operate over a full | ||||
| night of sleep. | ||||
| Energy Source | Rechargeable Lithium Polymer | |||
| Battery | One OTS 1.5V Alkaline AAA | |||
| Battery | Rechargeable Lithium Polymer | |||
| Battery | Equivalent | |||
| Analysis Software | Analysis performed off the | |||
| recording device, on a | ||||
| compatible cloud-based software | ||||
| platform. | Analysis performed off the | |||
| recording device, on the PC or | ||||
| cloud-based by the zzzPAT | ||||
| software. | None | Substantially Equivalent |
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VII. Clinical Studies
SpO2 Accuracy: Sibel validated the accuracy of SpO2 measurements compared to blood gas analysis in n=12 healthy subjects over the range of 70-100% oxygen saturation according to Section 201.12.1 of ISO 80601-2-61 and Pulse Oximeters - Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug Administration Staff, Issued March 2013. Enrolled subjects had skin tones varving from Fitzpatrick 2-5, with two subjects having darker skin pigmentation (Fitzpatrick 5). The average root mean square error (Asws) was 2.31%, meeting the requirements of the above-mentioned standard.
Comparison to PSG: The performance of the ANNE Sleep system as a diagnostic aid for moderate to severe obstructive sleep apnea (OSA) in adults was evaluated compared to the gold standard, polysomnography (PSG), in a single-arm, open-label, multi-center clinical study with n=225 subjects that was conducted in the United States. Subjects were representative of the intended target population, individuals 22 years of age or older who are suspected of having OSA. Subjects were 44% male and 56% female. Subjects were 73% white, 12% Black or African American. 9% Asian. 0.4% American Indian or Alaska Native, and 4% multi-racial. The results of the study indicate that ANNE Sleep is sufficiently accurate as an aid to the diagnosis of moderate to severe OSA, with a sensitivity and specificity of 90% and 98%, respectively. Additionally, skin tolerance was assessed following removal of the chest sensor for n=184 patients. No evidence of increased breakdown or skin dryness was reported, and only a small average increase in temporary redness was observed in 32% of subjects. No adverse events were reported during the study.
VIII. Performance Data
The following consensus standards and bench testing were used to evaluate the safety and effectiveness of ANNE Sleep:
- Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI ● ES60601-1:2005/(R)2012 and IEC 60601-1-2:2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
- Safety and Performance testing of pulse oximeter per ISO 80601-2-61:2017. ●
- . Biocompatibility testing according to ISO 10993-1:2018, ISO 10993-5:2009, and ISO 10993-10:2010 for new patient contacting materials.
- Wireless coexistence testing according to ANSI IEEE C63.27-2017.
- Software verification and validation testing according to IEC 62304:2015 and the FDA guidance document, Content of Premarket Submissions for Software Contained in Medical Devices.
- Shelf life testing of the adhesive to demonstrate safe and effective performance over the intended device life cycle.
- Bench testing to demonstrate the mechanical durability of the sensors.
- Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices
- Performance testing of heart rate, body position, PAT, pulse rate, perfusion index, snore, . total sleep time, and chest movement parameters.
- . Performance testing to demonstrate the precision and repeatability of the system over multiple nights of sleep.
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- Cybersecurity evaluation according to the requirements of the FDA draft guidance . document, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Assessment of Software of Unknown Provenance per the FDA quidance document. Off-● The-Shelf Software Use in Medical Devices
IX. Summarv
ANNE Sleep is substantially equivalent to its predicate, the WatchPAT One, in regards to both intended use and technology characteristics. Both devices function as aids to the diagnosis of sleep-related breathing disorders. The WatchPAT One is composed of skin-mounted sensors located on the finger, wrist, and chest. The WatchPAT chest sensor measures snoring, body position, and chest movements. The ANNE Chest Sensor collects similar data as the WatchPAT chest sensor, with the addition of ECG-derived heart rate. Both the ANNE Limb Sensor and WatchPAT finger sensor collect a PPG signal for PAT and SpO2 measurements. Performance of both devices were validated in clinical studies against PSG and in testing according to the same recognized consensus standards.
X. Conclusion
The results of the substantial equivalence assessment, taken together with the clinical and performance testing data, demonstrate that ANNE Sleep's performance characteristics are substantially equivalent to the predicate devices in both technology and intended use.