EnsoSleep

K210034 · Ensodata, Inc. · OLZ · Jun 16, 2021 · Neurology

Device Facts

• Record ID: K210034
• Device Name: EnsoSleep
• Applicant: Ensodata, Inc.
• Product Code: OLZ · Neurology
• Decision Date: Jun 16, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: AI/ML, Software as a Medical Device, Pediatric

Intended Use

EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric as follows: - Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic - Adult patients with PSGs obtained in a Hospital or Sleep Clinic - Adult patients with Home Sleep Tests EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of arousals, leg movements, and sleep disordered breathing events including obstructive apneas (OSA), central sleep apneas (CSA), and hypopneas. All automatically scored events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician. Central sleep apneas (CSA) should be manually reviewed and modified as appropriate by a clinician. All events can be manually marked or edited within records during review. Photoplethysmography (PPG) total sleep time is not intended for use when electroencephalograph (EEG) data is recorded. PPG total sleep time is 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.

Device Story

Software-only device for automated analysis of pre-recorded physiological signals from sleep studies (PSG/HST). Inputs: EEG, ECG, EOG, EMG, actigraphy, airflow, oximetry, SpO2, RIP, PVDF, PPG, pulse rate, snoring microphone, esophageal manometry. Operation: Cloud-based processing platform analyzes raw signals to detect respiratory events (OSA, CSA, MSA, hypopnea, Cheyne-Stokes, periodic breathing), sleep stages (Wake, N1-N3, REM), arousals, leg movements, cardiac events (bradycardia/tachycardia), and derived indices (AHI, sleep efficiency, etc.). Used in clinics/hospitals by physicians, technicians, and administrators. Output: Visualized events and summaries on a web-based dashboard for clinician review/editing. Does not diagnose; assists physician decision-making by automating scoring tasks. Benefits: Standardized, efficient sleep study scoring and reporting.

Clinical Evidence

Cross-sectional study using retrospective clinical PSG data (N=100 adults, N=47 pediatric, N=100 for respiratory rate). Compared EnsoSleep automated scoring against a 2/3 majority consensus reference of 9 independent RPSGTs. Endpoints: sleep staging, sleep apnea diagnostic agreement, event detection (SDB, OSA, CSA, hypopnea, arousal, leg movement), and physiologic analysis (RR, TST). Results: EnsoSleep met or exceeded pre-specified performance benchmarks (PA, NA, OA) compared to predicate. No statistically significant performance differences between pediatric and adult samples. Bench testing only for software verification.

Technological Characteristics

Software-only device; operates on Windows 7+ workstations. Connectivity: Cloud-based storage/processing via API. Inputs: Standard PSG/HST physiological signals. Algorithms: Automated signal processing and event detection. Cybersecurity: Authentication, authorization, cryptographic, access, and database controls. No hardware components; no biocompatibility/electrical safety testing required.

Indications for Use

Indicated for diagnostic evaluation of sleep quality and sleep/respiratory disorders in pediatric patients (13+ years) via in-clinic/hospital PSG, and adult patients via in-clinic/hospital PSG or Home Sleep Tests (HST).

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

• EnsoSleep (K162627)

Reference Devices

• MICHELE Sleep Scoring (K112102)

Submission Summary (Full Text)

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EnsoData, Inc. Sigrid Schoepel Director of Regulatory Affairs 111 S. Hamilton St. Suite 30 Madison, Wisconsin 53703

Re: K210034

Trade/Device Name: EnsoSleep Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OLZ Dated: May 11, 2021 Received: May 12, 2021

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 (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 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

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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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K210034

Device Name EnsoSleep

Indications for Use (Describe)

EnsoSleep is intended for use in the diagnostic evaluation by a physician to assess sleep quality and as an aid for physicians in the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric as follows:

- · Pediatric patients 13 years and older with polysomnography (PSG) tests obtained in a Hospital or Sleep Clinic
- · Adult patients with PSGs obtained in a Hospital or Sleep Clinic
- · Adult patients with Home Sleep Tests

EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of arousals, leg movements, and sleep disordered breathing events including obstructive apneas (OSA), central sleep apneas (CSA), and hypopneas.

All automatically scored events and physiological signals which are retrieved, analyzed, displayed, and summarized are subject to verification by a qualified clinician. Central sleep apneas (CSA) should be manually reviewed and modified as appropriate by a clinician.

All events can be manually marked or edited within records during review.

Photoplethysmography (PPG) total sleep time is not intended for use when electroencephalograph (EEG) data is recorded. PPG total sleep time is 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.

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

| <div> <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# K210034 EnsoSleep Traditional 510(k) Summary Prepared in accordance with the content and format outlined in 21 CFR 807.92

#### T SUBMITTER INFORMATION

| Name: | EnsoData, Inc. |
|-----------------|----------------------------------|
| Address: | 111 S. Hamilton Street, Suite 30 |
| | Madison, WI 53703 USA |
| Phone: | [phone] |
| Contact Person: | Sigrid Schoepel |
| Email: | [e-mail] |
| Date: | June 8, 2021 |

II. SUBJECT DEVICE INFORMATION

| Trade Name: | EnsoSleep |
|----------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Automatic Event Detection Software for Polysomnography with Electroencephalograph (EEG) |
| Classification Name: | Electroencephalograph 21 CFR 882.1400 |
| Regulatory Class: | II |
| Product Code: | OLZ |
| Intended Use: | EnsoSleep is intended for use for the diagnostic evaluation by a physician to assess slee |

leep quality and as an aid for the diagnosis of sleep disorders and respiratory related sleep disorders in pediatric patients ages 13 years and older. EnsoSleep is a software-only medical device to be used under the supervision of a clinician to analyze physiological signals and automatically score sleep study results, including the staging of sleep, detection of arousals, leg movements, and sleep disordered breathing events including obstructive apneas, central apneas, and hypopneas. All automatically scored events and physiological signals analyzed are retrieved, displayed, and summarized, and are subject to verification by a qualified clinician. All events can be manually marked or edited within records during review.

Target Patient Population: Adult and Pediatric

III. PREDICATE DEVICE K162627 Trade Name: EnsoSleep Target Patient Population: Adults only

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#### SUBJECT DEVICE DESCRIPTION IV.

EnsoSleep is a software-only medical device that analyzes previously recorded physiological signals obtained during sleep. Users of EnsoSleep are consistent with the roles required to run a sleep clinic: sleep physicians, sleep technicians, clinic operations managers, and IT administrators. EnsoSleep can analyze at-home and in-lab sleep studies for both adult and pediatric patients who are at least 13 years old. Automated algorithms are applied to the raw signals in order to derive additional signals and interpret the raw and derived signal information. The software automates recognition of the following: respiratory events, sleep staging events, arousal events, movement events, cardiac events, derived signals, and calculated indices. EnsoSleep does not interpret the results, nor does it suggest a diagnosis. The device only marks events of interest for review by a physician who is responsible for diagnoses. The device does not analyze data that are different from those analyzed by human scorers.

The signals and automated analyses can be visually inspected and edited prior to the results being integrated into a sleep study report.

The software consists of 4 major components:

- The Application Platform runs on local clinic workstations and manages the detection, ● upload, and download of study records and scoring to and from the Storage Platform
- The Processing Platform accepts raw physiological signals as inputs in order to recognize events, derive signals, and calculate indices
- . The Storage Platform facilitates file and database storage in the EnsoSleep cloud through an API
- The Dashboard is a web-based user interface to support configuration, clinic management, and sleep study scoring

Input signals used to derive outputs include:

- Electroencephalogram (EEG) ●
- Electrocardiogram (ECG) ●
- Electro-oculogram (EOG) ●
- Electromyogram (EMG) ●
- Actigraphy
- Airflow
- Oximetry
- Saturation of Peripheral Oxygen (SpO2)
- Respiratory Inductance Plethysmogram (RIP)
- Polyvinylidene Flouride (PVDF)
- Photoplethysmogram (PPG)
- Pulse Rate
- Snoring Microphone ●
- . Esophogeal Manometry

# Outputs that are displaved to users include:

- Respiratory Events
- o Obstructive Sleep Apneas (OSA)

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- Central Sleep Apneas (CSA) o
- Mixed Sleep Apneas (MSA) O
- Hypopneas O
- Cheyne-Stokes Respiration O
- Periodic Breathing O
- Sleep Staging Events ●
- Stage Wake O
- Stage N1 O
- Stage N2 O
- Stage N3 O
- O Stage REM (rapid eye movement)
- Arousal Events ●
- O Arousals
- Movement Events ●
- o Leg Movements (LM)
- o Periodic Leg Movement Series (PLMS)
- Cardiac Events* ●
- o Bradycardia
- o Tachycardia
- Respiratory Rate Events
- o Respiratory Rate
- Sleep-Wake Events ●
- o Wake
- o Sleep
- Apnea-Hypopnea Index (AHI) ●
- Sleep Architecture ●
- Sleep Efficiency (SE) ●
- Arousal Index (ArI) ●
- Sleep Latency (SL) .
- REM Latency (RL)
- Total Sleep Time (TST)
- Periodic Leg Movements (PLMS) Index ●

Capnogram data are not displayed to users.

The primary differences between the predicate device and subject device include:

-Target patient population: pediatric patients are included

-Automated scoring of Cheyne-Stokes and Periodic Breathing respiration events and Total Sleep Time

-Browser-based scoring interface to view and edit sleep studies

-Home-sleep studies are supported

* The tachycardia and bradycardia outputs are not for use for cardiovascular monitoring or diagnosis, nor does the device detect arrhythmias.

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#### V. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The table below compares the predicate device EnsoSleep with the subject device EnsoSleep.

| Element | Predicate Device<br>EnsoData, Inc.<br>K162627<br>EnsoSleep | Submitted Device<br>EnsoData, Inc.<br>K210034<br>EnsoSleep | Discussion |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | EnsoSleep is intended for use<br>for the diagnostic evaluation<br>by a physician to assess sleep<br>quality and as an aid for the<br>diagnosis of sleep and<br>respiratory related sleep<br>disorders in adults only.<br>EnsoSleep is a software-only<br>medical device to be used<br>under the supervision of a<br>clinician to analyze<br>physiological signals and<br>automatically score sleep<br>study results, including the<br>staging of sleep, detection of<br>arousals, leg movements, and<br>sleep disordered breathing<br>events including obstructive<br>apneas. All automatically<br>scored events are subject to<br>verification by a qualified<br>clinician. Central apneas,<br>mixed apneas, and hypopneas<br>must be manually marked<br>within records. | EnsoSleep is intended for<br>use in the diagnostic<br>evaluation by a physician<br>to assess sleep quality and<br>as an aid for physicians in<br>the diagnosis of sleep<br>disorders and respiratory<br>related sleep disorders in<br>pediatric and adult patients<br>as follows:<br>• Pediatric patients ages 13<br>years and older with<br>polysomnography (PSG)<br>tests obtained in a Hospital<br>or Sleep Clinic<br>• Adult patients with PSGs<br>obtained in a Hospital or<br>Sleep Clinic<br>• Adult patients with<br>Home Sleep Tests<br>EnsoSleep is a software-<br>only medical device to be<br>used under the supervision<br>of a clinician to analyze<br>physiological signals and<br>automatically score sleep<br>study results, including the<br>staging of sleep, detection<br>of arousals, leg<br>movements, and sleep<br>disordered breathing<br>events including<br>obstructive apneas (OSA),<br>central sleep apneas<br>(CSA), and hypopneas.<br>Central sleep apneas<br>(CSA) should be manually<br>reviewed and modified as<br>appropriate by a clinician. | Different The subject<br>device includes expansion<br>of the indications for use to<br>the pediatric population.<br>Clinical testing using the<br>scoring methodology for<br>the predicate device were<br>applied and validation to<br>demonstrate scoring for<br>expanded uses to pediatric<br>population and new<br>automated outputs. |
| Element | Predicate Device<br>EnsoData, Inc.<br>K162627<br>EnsoSleep | Submitted Device<br>EnsoData, Inc.<br>K210034<br>EnsoSleep | Discussion |
| | | All events can be<br>manually marked or edited<br>within records during<br>review. | |
| | | Photoplethysmography<br>(PPG) total sleep time is<br>not intended for use when<br>electroencephalograph<br>(EEG) data is recorded.<br>PPG total sleep time is not<br>intended to be used as the<br>sole or primary basis for<br>diagnosing any sleep<br>related breathing disorder,<br>prescribing treatment, or<br>determining whether<br>additional diagnostic<br>assessment is warranted. | |
| Intended Use | Analyze pre-recorded<br>physiological data acquired<br>during sleep. | Same as predicate. | Same |
| Patient<br>population | Adults only. | Adults and pediatric<br>patients 13 years old and<br>above. | Different |
| Environment of<br>use | Physician office (data analysis<br>and reporting). No limitation<br>on where data are acquired. | Same as predicate. | Different; the subject<br>device includes analysis of<br>home sleep testing (HST)<br>of adult patients. |
| Signals analyzed | EEG, ECG, EOG, EMG<br>waveforms; SpO2; respiratory<br>effort; airflow; heart/pulse<br>rate; snoring loudness; head<br>movement and position. | EEG, ECG, EOG, EMG<br>waveforms; SpO2;<br>respiratory effort; airflow;<br>heart/pulse rate; snoring<br>loudness; head movement<br>and position. | Similar |
| Sleep measures | Sleep, REM and N3 onset;<br>total sleep and recording<br>times; sleep efficiency % time<br>by sleep stage; awakenings<br>per hour; wake after sleep<br>onset. | Same as predicate. | Same |
| Automatically<br>score sleep stages | Yes; automatically detects<br>stage Wake (W), REM (R), | Same as predicate. | Same |
| Element | Predicate Device<br>EnsoData, Inc.<br>K162627<br>EnsoSleep | Submitted Device<br>EnsoData, Inc.<br>K210034<br>EnsoSleep | Discussion |
| | NREM 1 (N1), NREM 2 (N2)<br>and slow wave sleep (N3). | | |
| Automatically<br>score sleep<br>disordered<br>breathing events | No; OSA, CSA and mixed<br>hypopneas must be manually<br>scored | Yes; automatic detection<br>of the following events:<br>Obstructive apneas<br>(OSA), Central<br>apneas (CSA), Hypopneas, Cheyne-Stokes<br>respiration (CSR), and Periodic breathing<br>(PBE). Additional apnea and<br>sleep disordered<br>breathing event types<br>may be manually<br>marked within the<br>records. CSA events<br>should also be<br>manually scored | Similar<br>Sleep disordered breathing<br>events are detected, and the<br>additional events are<br>identified using the existing<br>airflow inputs as in the<br>predicate device. |
| Automatically<br>score arousal<br>events | Yes; automatically detects<br>arousal events. | Yes; automatically detects<br>arousal events;<br>respiratory-effort related<br>arousals, limb movement<br>related arousals, and<br>spontaneous cortical<br>arousal. | Different<br>The general arousal events<br>detected by the subject<br>device are now identified<br>more specifically as to the<br>type of arousal events<br>(same events as detected by<br>the predicate). |
| Automatically<br>score movement<br>events | Yes; automatically detects leg<br>movement events. | Same as predicate. | Same |
| Automatically<br>score cardiac<br>events | No. | Yes; brachycardia and<br>tachycardia. | Different<br>The ECG signals used to<br>determine these events<br>were used in the predicate<br>device to determine<br>breathing, arousal, and<br>movement events are also<br>used to detect cardiac<br>events. The tachycardia and<br>bradycardia feature is not<br>intended for use for<br>cardiovascular monitoring<br>or diagnosis, nor does the |
| Element | Predicate Device<br>EnsoData, Inc.<br>K162627<br>EnsoSleep | Submitted Device<br>EnsoData, Inc.<br>K210034<br>EnsoSleep | Discussion |
| Automatically<br>determine<br>derived values | No. | Yes; effort belt respiratory<br>rate and PPG respiratory<br>rate. | subject device detect<br>arrhythmias.<br><br>Different<br>The RIP and PVDF signals<br>used to determine these<br>values are used in the<br>predicate device to<br>determine breathing,<br>arousal, and movement<br>events. |
| Automated study<br>uploadand<br>download | Yes. | Same as predicate. | Same |
| Automatically<br>initiates study<br>scoring | Yes. | Same as predicate. | Same |
| Heart rate<br>accuracy | No. | Same as predicate. | Same |
| Headposition | No. | Same as predicate. | Same |
| Snoring level | No. | Same as predicate. | Same |
| Allows editing in<br>sleep study<br>viewers | Yes. Sleep studies can be<br>opened and edited in sleep<br>study scoring devices that<br>support EDF formatted files. | Yes, and within EnsoSleep<br>using EDF formatted files. | Different<br>The subject device allows<br>that signals be edited within<br>the existing patient view of<br>the web dashboard. |
| Sleep study<br>reporting | Yes. | Same as predicate. | Same |
| Two-night<br>reports | No. | Same as predicate. | Same |
| Disease<br>management<br>comments | No. | Same as predicate. | Same |
| Data format | EDF | Same as predicate. | Same…