NightOwl

K213463 · Ectosense NV · MNR · Dec 16, 2021 · Anesthesiology

Device Facts

• Record ID: K213463
• Device Name: NightOwl
• Applicant: Ectosense NV
• Product Code: MNR · Anesthesiology
• Decision Date: Dec 16, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 868.2375
• Device Class: Class 2

Intended Use

The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).

Device Story

NightOwl is a wearable home sleep apnea test (HSAT) device. It consists of a fingertip sensor and cloud-based analysis software. The sensor uses red/infrared LEDs for photoplethysmography (PPG) and an accelerometer for movement detection. Data is recorded overnight, stored on-board or streamed via Bluetooth to a smartphone app, then uploaded to a cloud-based signal processing suite. The software analyzes the PPG and actigraphy signals to calculate sleep-related breathing parameters, including pAHI (pediatric/peripheral apnea-hypopnea index) using either AASM 1A or 1B scoring rules. Results are presented in a dashboard for review by a prescribing healthcare professional to assist in diagnosing sleep-related breathing disorders. The device is intended for use in home or clinical settings under HCP direction.

Clinical Evidence

Clinical validation compared the modified device (1B rule) against gold-standard polysomnography (PSG). Performance metrics at AHI cutoffs of 5, 15, and 30 were reported. At AHI cutoff 5: sensitivity 1.000, specificity 0.823. At AHI cutoff 15: sensitivity 0.973, specificity 0.886. At AHI cutoff 30: sensitivity 0.840, specificity 0.979. The pAHI correlation was 0.946.

Technological Characteristics

Wearable fingertip sensor with red/IR LEDs and accelerometer. Biocompatible enclosure and adhesive. Battery-powered (coin cell). Connectivity via Bluetooth to smartphone or offline storage. Cloud-based signal processing. Complies with IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-1-11 (environmental), and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for adult patients (22+ years) suspected of sleep apnea to aid in the evaluation of sleep-related breathing disorders.

Regulatory Classification

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.

Predicate Devices

• NightOwl (K191031)

Submission Summary (Full Text)

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December 16, 2021

Ectosense nv Bart Van Pee Product Manager Bosbessenlaan 19 A Rotselaar, Vlaams Brabant 3110 Belgium

Re: K213463

Trade/Device Name: NightOwl Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing frequency monitor Regulatory Class: Class II Product Code: MNR Dated: October 26, 2021 Received: October 27, 2021

Dear Bart Van Pee:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K213463

Device Name NightOwl

Indications for Use (Describe)

The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea.

The device is intended for the clinical and home setting use under the direction of 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

#### NightOwl

#### 1. SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED

Ectosense nv Bosbessenlaan 19A Rotselaar Vlaams-Brabant 3110 Belgium Phone: [phone]

Contact Person: Bart Van Pee

Date Prepared: 15th of December 2021

#### 2. DEVICE

#### Name of Device

NightOwl

#### Trade Name

NightOwl

#### Common or Usual Name

Ventilatory Effort Recorder

#### Classification Name/Product Code/CFR Reference

Class II, Ventilatory Effort Recorder, Product Code: MNR; 21 CFR 068.2375

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#### 3. PREDICATE DEVICE

Predicate: Ectosense's NightOwl (K191031)

#### 4. DEVICE DESCRIPTION

The NightOwl is prescribed by a Health Care Professional for the patient to use in the home as a 'home sleep apnea test' (HSAT).

The NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") over-night whilst the subject is sleeping and cloud-based analysis software (the "NightOwl Software").

The NightOwl Sensor has a small biocompatible enclosure. The sensor has 2 LEDs, one in the red spectrum and the other in the infrared spectrum, and an accelerometer. The sensor is attached to the fingertip by single-use biocompatible adhesive tape, with the sensor window applied against the fingerprint area of the fingertip. The sensor measures the reflected red/infrared signals to record the photoplethysmograph (PPG) signal. The accelerometer is used to detect movement.

The data recorded by the NightOwl Sensor can either be stored in on-board memory ("Offline" mode) or streamed via a Bluetooth link to an Ectosense app on a smartphone ("Streaming" mode)

- if the data is stored on the device, the data is retrieved when the NightOwl sensor . is returned to the prescribing HCP and passed up to a cloud-based signal processing suite, the NightOwl Software.
- If the device is used in Streaming mode, the data is stored by the Ectosense app . on the smartphone during the recording. At the end of the recording, it is then passed directly up to the cloud-based signal processing suite.
- The NightOwl Software signal processing algorithms produce a number of sleep . and sleep-disordered breathing related traces and parameters. The trace and parameter information are passed to a company-managed database for storage and access by the prescribing Health Care Professional in the Ectosense Dashboard.

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#### 5. INTENDED USE / INDICATIONS FOR USE

The NightOwl is a wearable device intended for use in the recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adult patients suspected of sleep apnea. The device is intended for the clinical and home setting use under the direction of a Healthcare Professional (HCP).

# 6. DEVICE MODIFICATIONS AND COMPARISON OF TECHNOLOGICAL

#### CHARACTERSITICS WITH THE PREDICATE DEVICE

We have now incorporated an alternative tuning of the NightOwl algorithm to include hypopnea as scored using the 1B rule. The HCP can now choose to display either the 1A-tuned or the 1B-tuned pAHI (or both) on the NightOwl Examination report. As per the American Academy of Sleep medicine (AASM):

1A rule: a hypopnea is scored when:

- 1. There is an airflow reduction of 30% for at least 10 seconds
- 2. There is an oxygen desaturation of at least 3 percent or an arousal.

1B rule: a hypopnea is scored when:

- 1. There is an airflow reduction of 30% for at least 10 seconds
- 2. There is an oxygen desaturation of at least 4 percent

| Characteristic | NightOwl (K191031) | NightOwl (K213463) | Comparison |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|------------|
| Intended Use/<br>Indications for<br>Use | The NightOwl is a wearable device intended for use in<br>the recording, analysis, displaying, exporting, and<br>storage of biophysical parameters to aid in the<br>evaluation of sleep-related breathing disorders of adult<br>patients suspected of sleep apnea. The device is<br>intended for the clinical and home setting use under the<br>direction of a Healthcare Professional (HCP). | | Equivalent |
| Intended<br>Environment | Recording in the home environment with the report<br>interpretation performed in the clinical setting. | | Equivalent |
| Prescription | Prescription only | | Equivalent |

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| Target<br>Population | 22 years old and older | | Equivalent |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Channels | 1. PAT<br>2. Pulse rate<br>3. Oximetry<br>4. Actigraphy | | Equivalent |
| Sensors | Optical plethysmography sensor, accelerometer | | Equivalent |
| Wearable sensor<br>location | The photoplethysmography (PPG) sensor and accelerometer<br>components are worn on the fingertip. | | Equivalent |
| Sensor Software | Firmware is limited to control the recording and<br>communications processes. No presentation of test results<br>to the patient. Data analyzed and presented in a separate<br>software suite. | | Equivalent |
| Analysis Software<br>- location | Analysis performed off the recording device, exclusively<br>cloud-based by the NightOwl software. | | Equivalent |
| Analysis Software<br>- algorithm | pAHI calculation tuned to<br>the AASM's '1A Rule' for<br>the scoring of hypopnea | pAHI calculation tuned to<br>the AASM's '1A Rule' for<br>the scoring of hypopnea<br>AND<br>pAHI calculation tuned to<br>the AASM's '1B Rule' for<br>the scoring of hypopnea | Substantially equivalent<br>Addition of pAHI<br>calculation tuned to the<br>AASM's '1B Rule' for the<br>scoring of hypopnea<br>The addition of the pAHI<br>calculation tuned to the<br>AASM's '1B Rule' for the<br>scoring of hypopnea<br>does not alter the<br>device's intended use<br>and does not introduce<br>any change to the safety<br>and effectiveness of the<br>originally cleared device<br>(predicate device). As<br>such, the algorithm of<br>the altered device<br>remains substantially<br>equivalent to that of the<br>originally cleared device<br>(predicate device). |
| Data transfer | Data transfer through a smartphone by wireless connection. | | Equivalent |
| Power Source<br>recorder | Battery powered by coin cell | | Equivalent |
| Patient<br>isolation | Device has no galvanic connections to mains as it is a<br>battery-operated device. | | Equivalent |
| Sterilization | Non-sterile | | Equivalent |
| Bio-<br>compatibility | Assessed to ISO1099-1:2009 requirements for<br>sensitization, irritation, and cytotoxicity | | Equivalent |
| EMC | IEC 60601-1-2:2014 | | Equivalent |
| Electrical<br>Safety | IEC 60601-1:2005 +AMD1:2012 | Equivalent | |
| Environmental<br>Testing | IEC 60601-1-11:2010 | Equivalent | |

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# 7. PERFORMANCE DATA

Software validation: In support of the substantial equivalence determination of the modification made to the device, software validation was performed.

Clinical Study: The clinical validation of the NightOwl performance using 1B rule was compared to the gold standard polysomnography (PSG) in the US population. The following table compares the performance of the subject and predicate devices.

| Endpoint Parameters | 1A rule performance of<br>originally cleared device<br>(Predicate K191031) | 1B rule performance of<br>modified device<br>(Subject) |
|------------------------------|----------------------------------------------------------------------------|--------------------------------------------------------|
| Sensitivity at AHI cutoff 5 | 0.936 | 1.000 |
| Specificity at AHI cutoff 5 | 0.727 | 0.823 |
| Sensitivity at AHI cutoff 15 | 0.978 | 0.973 |
| Specificity at AHI cutoff 15 | 0.704 | 0.886 |
| Sensitivity at AHI cutoff 30 | 0.964 | 0.840 |
| Specificity at AHI cutoff 30 | 0.844 | 0.979 |
| pAHI correlation | 0.909 | 0.946 |

## 8. CONCLUSIONS

Based on (i) the results of the clinical validation testing, (ii) the results of the software validation testing, and (iii) the unchanged product risk analysis, the NightOwl has been demonstrated to be substantially equivalent to the predicate device.