(323 days)
Not Found
Unknown
The summary mentions "signal processing algorithms" but does not explicitly state whether these algorithms utilize AI or ML. The lack of mention of AI/ML in the "Mentions AI, DNN, or ML" section and the absence of details about training/test sets further support this uncertainty.
No
The device is intended for recording, analysis, displaying, exporting, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders, which makes it a diagnostic device, not a therapeutic one.
Yes
The device is intended "to aid in the evaluation of sleep-related breathing disorders" and uses biophysical parameters to analyze and provide "sleep and sleep-disordered breathing related traces and parameters," which are characteristics of a diagnostic device.
No
The device description clearly states that the NightOwl comprises both a sensor (hardware) and cloud-based analysis software. The sensor is a physical component worn on the fingertip that measures biophysical parameters.
Based on the provided information, the NightOwl 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.
- The NightOwl is a wearable device that measures biophysical parameters on the human body. It uses a sensor on the fingertip to record PPG signals and accelerometer data. It does not analyze samples taken from the patient.
- The intended use is to aid in the evaluation of sleep-related breathing disorders. This is a diagnostic process, but the device itself is measuring physiological signals directly from the patient, not analyzing a biological sample.
Therefore, the NightOwl falls under the category of a medical device that measures physiological parameters in vivo (within the living body), rather than an in vitro diagnostic device.
N/A
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).
Product codes
MNR
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 Ectosense NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") and cloud-based analysis software (the "NightOwl Software").
The NightOwl Sensor is a small biocompatible enclosure with a sensor window made from PMMA (bottom part) and ABS (top part). 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Photoplethysmograph (PPG) signal
Anatomical Site
Fingertip
Indicated Patient Age Range
adult patients
22 years old 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
Not Found
Summary of Performance Studies
SpO2 measurement accuracy validation: The NightOwl's pulse oximeter function was within the pass/fail criteria as described in ISO80601-2-61:2019 Clause 201.12.1.101.1. The pulse rate root mean square (RMS) value was found to be 2.26 bpm for a claimed range of 50 to 118 bpm.
Comparison to PSG Sleep Lab Results (Belgium): The NightOwl sensitivity and specificity at an AHI cutoff 5 were 0.943 and 0.813, respectively.
Comparison to United States PSG Sleep Lab Results: The NightOwl sensitivity and specificity at an AHI cutoff 5 were 0.936 and 0.727, respectively.
Summary of AHI accuracy results (pooled analysis US and Belgium): Regression line with AHI (Expert PSG) = 0.9981 x pAHI (NightOwl) + 2.235
Key Metrics
Pulse rate root mean square (RMS) value: 2.26 bpm (range 50 to 118 bpm)
Sensitivity (AHI cutoff 5): 0.943 (Belgium), 0.936 (US)
Specificity (AHI cutoff 5): 0.813 (Belgium), 0.727 (US)
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 the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 6, 2020
Ectosense nv Bart Van Pee COO Bosbessenlaan 19A Rotselaar, 3110 BE
Re: K191031
Trade/Device Name: NightOwl Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: February 3, 2020 Received: February 3, 2020
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 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 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.
for Michael Ryan Division Director DHT1C: Division of ENT, 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) K191031
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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l. 510(K) SUMMARY
510(k) SUMMARY
Ectosense nv's NightOwl
1. SUBMITTER'S NAME, ADDRESS, TELEPHONE NUMBER, CONTACT PERSON AND DATE PREPARED
Ectosense nv Bosbessenlaan 19A Rotselaar Vlaams-Brabant 3110 Belgium
Phone: +32 2 588 9044
Contact Person: Bart Van Pee
Date Prepared: 06 March 2020
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
Itamar Medical Ltd's WatchPAT 200U (K161579) Predicate:
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 Ectosense NightOwl comprises a sensor that is worn on the fingertip (the "NightOwl Sensor") and cloud-based analysis software (the "NightOwl Software").
The NightOwl Sensor is a small biocompatible enclosure with a sensor window made from PMMA (bottom part) and ABS (top part). 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. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Both the NightOwl and the predicate WatchPAT 200U are built around fingertip mounted optical plethysmography (PPG) measurements and incorporate an accelerometer for detection of limb movement. The accelerometer is used to estimate when the wearer is asleep by actigraphy methods. The PPG sensor produces a signal that is further analyzed to produce an SpO2 measurement and pulse rate. The variations in the PPG amplitude, SpO2, and pulse rate are then used to determine apnea and hypopnea events and thus indicate the patient's AHI for that night.
The variations in PPG amplitude reflect pulsatile volume changes in the peripheral tissue that reflect changes in Peripheral Arterial Tone ("PAT"). As both devices analyze such changes in peripheral arterial tone from the fingertip, the AHI value is characterized as "peripheral AHI" or "pAHI". The sleep reports presented to the prescribing HCP also contain derived sleep-related parameters such as estimated Total Sleep Time (TST) and maxima and minima of parameters to provide general sleep information to the HCP.
The NightOwl and its predicate are based upon the similar technological elements:
- Fingertip optical plethysmography sensor
- Accelerometer on the limb ●
- External signal processing
- . Key output is pAHI
The below table compares NightOwl and WatchPAT devices.
| Characteristic | Predicate Device
WatchPAT 200U | NightOwl | Comparison |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for
Use | The WatchPAT 200U
(WP200U) device is a non-
invasive home care device | The NightOwl is a
wearable device intended
for use in the recording, | Substantially equivalent. |
| Characteristic | Predicate Device
WatchPAT 200U | NightOwl | Comparison |
| | for use with patients
suspected to have sleep
related breathing disorders.
The WP200U is a diagnostic
aid for the detection of sleep
related breathing disorders,
sleep staging (Rapid Eye
Movement (REM) Sleep,
Light Sleep, Deep Sleep and
Wake), snoring level and
body position.
The WP200U generates a
peripheral arterial tonometry
("PAT") Respiratory
Disturbance Index ("PRDI"),
Apnea-Hypopnea index
("PAHI"), Central Apnea-
Hypopnea index ("PAHIc"),
PAT sleep staging
identification (PSTAGES)
and optional snoring level
and body position discrete
states from an external
integrated snoring and body
position sensor.
The WP200U's PSTAGES
and snoring level and body
position provide
supplemental information to
its PRDI/PAHI/PAHIc. The
WP200U's PSTAGES and
snoring level and body
position are not 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. | 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). | The NightOwl's Intended
Use and Indications for
Use does not include
sleep staging, snoring
level, body position, or the
discrimination between
central and obstructive
sleep apneic events.
The NightOwl is only
intended for use in an
adult patient population. |
| Intended
Environment | Recording in the home environment with the report
interpretation performed in the clinical setting. | | Equivalent. |
| Characteristic | Predicate Device
WatchPAT 200U | NightOwl | Comparison |
| Prescription | Prescription only | | Equivalent |
| Target
Population | 12 years old and older (for
the main indications) | 22 years old and older | Substantially equivalent.
NightOwl target patient
population is more
restrictive. |
| Channels | 1. PAT
2. Pulse rate
3. Oximetry
4. Actigraphy
5.Snoring and Body
Position (SBP) integrated
external sensor | 1. PAT
2. Pulse rate
3. Oximetry
4. Actigraphy | Substantially equivalent in
non-optional channels.
The Predicate is provided
with an optional external
snoring and body position
sensor which NightOwl
does not provide. |
| Sensors
(non-optional) | Optical plethysmography sensor, accelerometer | Optical plethysmography sensor, accelerometer | Substantially Equivalent |
| Wearable
sensor location | Finger probe for PAT and
SpO2 sensing components
are worn on the finger.
Embedded actigraphy that is
located in a wrist-mounted
enclosure. | The photoplethysmography
(PPG) sensor and
accelerometer components
are worn on the fingertip. | Substantially equivalent
The difference in location
of the actigraphy
components does not
affect performance in
sensing movement. |
| Device size | Wrist-mounted enclosure:
3.2" long x 2" wide x 0.8"
deep (80x50x20 mm) | 0.75" high x 1.1" wide x
0.4" thick (19x28x11mm) | Substantially equivalent. |
| Device weight | 4 $^{19}/{32}$ oz (130g) for wrist-
mounted enclosure,
$^{23}/{32}$ oz (20g) for finger probe | $^{7}/_{32}$ oz (6g) | Substantially equivalent. |
| Sensor
Software | Firmware is limited to control the recording and
communications processes. No presentation of test results
to the patient. Data analyzed and presented in a separate
software suite. | Firmware is limited to control the recording and
communications processes. No presentation of test results
to the patient. Data analyzed and presented in a separate
software suite. | Substantially equivalent |
| Analysis
Software -
location | Analysis performed off the
recording device, on the PC
or cloud-based by the
zzzPAT software. | Analysis performed off the
recording device,
exclusively cloud-based by
the NightOwl software. | Substantially equivalent.
The Predicate allows for
local analysis on a PC,
where NightOwl only
allows for cloud-based
processing. |
| Characteristic | Predicate Device
WatchPAT 200U | NightOwl | Comparison |
| Data transfer | Data transfer through a PC
by means of USB cable. | Data transfer through a
smartphone by wireless
connection. | Substantially equivalent.
The Predicate uses the
PC while the NightOwl
uses the smartphone as a
data forwarder. |
| Memory | Embedded flash memory, 64 MB | | Equivalent. |
| Power Source
recorder | Internal rechargeable li-ion battery | | Equivalent |
| Patient
isolation | Device has no galvanic connections to mains as it is a
battery-operated device. | | Equivalent |
| Sterilization | Non-sterile | | Equivalent |
| Bio-
compatibility | Assessed to ISO1099-1:2009 requirements for
sensitization, irritation and cytotoxicity | | Equivalent. |
| EMC | IEC 60601-1-2:2014 | | Equivalent. |
| Electrical
Safety | IEC 60601-1:2005 +AMD1:2012 | | Equivalent. |
| Environmental
Testing | IEC 60601-1-11:2015 | IEC 60601-1-11:2010 | Substantially equivalent. |
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7. PERFORMANCE DATA
The following performance data has been provided in support of the substantial equivalence determination.
Biocompatibility Testing
The biocompatibility evaluation for the NightOwl device was conducted in accordance with the FDA guidance document: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1 : Evaluation and testing within a risk management process", as recognized by FDA, with passing results. The tests conducted were:
- Cytotoxicity ●
- Sensitization ●
- Irritation ●
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Electrical Safety and Electromagnetic Compatibility (EMC)
The Ectosense NightOwl has been tested to the relevant parts of the following recognized performance standards:
- IEC60601-1:2012 Medical electrical equipment Part 1: General requirements . for basic safety and essential performance.
- IEC60601-1-2:2014 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
The NightOwl complied with all of the requirements of the performance standards for use in the home environment.
The following additional testing was carried out:
- . RF immunity in the presence of Home RF emitters: A cell phone, when it is closer than 10 feet away, may emit RF fields in excess of those tested by IEC60601-1-2. A bench test was carried out to demonstrate that the NightOwl was unaffected by common household RF emitters that were within 3 feet of it.
Software Verification and Validation Testing
Software verification and validation testing was conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern.
Clinical Studies
The three clinical studies of the NightOwl consisted of:
SpO2 measurement accuracy: To validate the accuracy of the NightOwl derived SpO2 values and the pulse rate (PR) trace in accordance with ISO 80601-2-61:2019 201.12.1.101.2 and Annex EE.2 as recommended by the FDA Guidance for Industry and FDA Staff Pulse Oximeters - Premarket Notification Submissions [510(k)s]. The NightOwl's pulse oximeter function was within the pass/fail criteria as described in ISO80601-2-61:2019 Clause 201.12.1.101.1. The pulse rate root mean square (RMS) value was found to be 2.26 beats per minute (bpm) for a claimed range of 50 to 118 bpm.
Comparison to PSG Sleep Lab Results: The clinical validation of the NightOwl accuracy in the calculation of pAHI when compared to the gold standard analysis of the polysomnography (PSG). This trial was conducted in Belgium. It was evidenced that the NightOwl sensitivity and specificity at an AHI cutoff 5 were 0.943 and 0.813, respectively.
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Comparison to United States PSG Sleep Lab Results: A repeat study of the PSG comparison trial conduced in the United States to confirm that the NightOwl's pAHI accuracy is similar when the device is used in a US population. It was evidenced that the NightOwl sensitivity and specificity at an AHI cutoff 5 were 0.936 and 0.727, respectively.
Summary of AHI accuracy results: The AHI accuracy results of the pooled analysis containing the patients from the clinical trials in the United States and Belgium can be summarized as follows:
- . Regression line with AHI (Expert PSG) = 0.9981 x pAHI (NightOwi) + 2.235
8. CONCLUSIONS
Based on the performance data and testing in conformance to consensus standards, the NightOwl has been demonstrated to be substantially equivalent to the predicate device.