(111 days)
Yes
The device description explicitly mentions "cloud-based AI analysis" as part of the system.
No
The device is intended for aiding in sleep apnea evaluation/diagnosis, not for treating the condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for aiding in sleep apnea evaluation/diagnosis."
No
The device description explicitly states it comprises a "fingertip wearable device" which includes hardware components like PPG sensors, IMU, and a rechargeable battery. It also includes a "TipTraQ Charging Case" which is also a hardware component.
Based on the provided information, the TipTraQ device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. This typically involves blood, urine, tissue, or other bodily fluids.
- The TipTraQ device is a wearable sensor that collects physiological data from the body. It measures PPG and accelerometer data directly from the fingertip. It does not analyze a sample taken from the patient.
- The analysis performed by the TipTraQ system is based on the interpretation of these physiological signals. While it uses AI to process this data and provide diagnostic aid, the input is not a biological sample.
Therefore, the TipTraQ falls under the category of a medical device that collects and analyzes physiological signals in vivo (within the living body), rather than an in vitro diagnostic device.
No
The provided text explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found". This means there is no mention of the FDA reviewing, approving, or clearing a PCCP for this device.
Intended Use / Indications for Use
The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.
Product codes
MNR
Device Description
TipTraQ is a prescription-only medical device aiding in sleep apnea evaluation/diagnosis comprising a fingertip wearable device, a companion mobile app, a cloud-based AI analysis and an information display system. It collects essential physiological waveform information, including Photoplethysmogram (PPG) and accelerometer data. The TipTraQ Algorithm System determines Total Sleep Time (TST), Total REM Time (TREMT), Oxygen Desaturation Index (ODI), and Apnea-Hypopnea Index (AHI) from the recorded waveform signals.
TipTraQ Sensor includes a PPG sensor, which uses light sources (green, red, and infrared) and two photodetectors to measure the blood volume changes in the microvascular bed of tissue. Additionally, the TipTraQ Sensor utilizes an Inertial Measurement Unit (IMU) with three-axis accelerometers (device-function) and three-axis gyroscopes (non-device function), monitoring movement and actigraphy to assess sleep stages. The TipTraQ Expert Panel can display recorded physiological waveforms, while the TipTraQ API System generates output for essential physiological parameters analyzed by the TipTraQ Algorithm System.
The TipTraQ Sensor is rechargeable and designed to provide at least 12 hours of usage after fully charged. The TipTraQ Charging Case, which is also rechargeable, provides a battery capacity of eight full charges of the TipTraQ Sensor for user convenience. The TipTraQ Charging Case can be powered and charged using an external USB-C.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
...a cloud-based AI analysis and an information display system.
Input Imaging Modality
Not Found
Anatomical Site
Fingertip
Indicated Patient Age Range
22 years old and older
Intended User / Care Setting
Home-based and clinical-use environments.
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
A clinical validation study was conducted at Duke University Hospital, which compared the performance of the TipTraQ device to the gold standard in-lab polysomnography (PSG). The study eventually included 147 qualified samples with representative demographics and met all the predetermined acceptance criteria (set by prior studies and reference literatures).
Summary of Performance Studies
Bench testing: Testing was conducted to provide verification of pulse rate between 40 to 200 BPM using a multifunctional testing unit in accordance with ISO 80601-2-61:2019.
Software verification & validation (V&V): Software V&V was conducted in accordance with FDA guidance, Content of Premarket Submission for Device Software Functions, Guidance for Industry and Food and Drug Administration Staff.
Electrical, Mechanical, Thermal, and electromagnetic compatibility (EMC): Testing was conducted in accordance with the following FDA recognized consensus standards to support the electrical, mechanical, thermal safety, and electromagnetic compatibility (EMC) of the device: IEC 60601-1:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance- with US national differences; IEC 60601-1-2:2014 +AMD1:2021 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests; IEC 60601-1-11:2020 Medical electrical eauipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment; IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells and for batteries made from them for use in portable applications - Part 2: Lithium systems.
Biocompatibility evaluation: A biocompatibility assessment of TipTraQ has been conducted per ISO 10993-1:2018 and FDA Guidance on the Use of International Standard ISO 10993-1.
SpO2 validation study: An SpO2 validation study at University of California San Francisco (UCSF) was conducted in accordance with the FDA guidance, Pulse Oximeters- Premarket Notification Submissions [510(k)s], Guidance for Industry and Food and Drug Administration Staff and Annex EE.2 of ISO 80601-2-61:2019. The study included 12 subjects with a range of skin pigmentation, and compared the TipTraQ sensor performance to reference arterial blood gas sampling over the range of 70 to 100%. The resulting Average Root Mean Square (Arms) error was 1.41, which met the predefined acceptance criteria
§ 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).
0
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February 3, 2025
PranaO Pte. Ltd. % Amv Herder Founder & Principal Consultant MedIgnite Consulting, LLC 1709 Saracen Rd Austin, Texas 78733
Re: K243268
Trade/Device Name: TipTraO (TTO001) Regulation Number: 21 CFR 868.2375 Regulation Name: Breathing Frequency Monitor Regulatory Class: Class II Product Code: MNR Dated: October 15, 2024 Received: January 3, 2025
Dear Amy Herder:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Rachana Visaria -S
Rachana Visaria, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
TipTraQ (TTQ001)
Indications for Use (Describe)
The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.
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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Image /page/4/Picture/0 description: The image shows the logo for PranaQ. The word "prana" is written in a dark gray sans-serif font. To the right of the word "prana" is a large letter "Q" in a teal color. The letter "Q" is stylized with a small curved line extending from the bottom right of the circle.
510(k) Summary
[Prepared in accordance with 21 CFR 807.92]
Date: February 3, 2025
CONTACT DETAILS I.
Submitter: PranaQ Pte. Ltd. 331 NORTH BRIDGE ROAD, #12 - 03 ODEON TOWERS, SINGAPORE 188720
| +65 3158 4380 | ||
|---|---|---|
| Contact Name: | Jerry Chen | |
| jerry.chen@pranaq.com |
II. DEVICE NAME
| Device Name: | TipTraQ (TTQ001) |
|---|---|
| Common Name: | Breathing frequency monitor |
| Classification: | Ventilatory Effort Recorder |
| Regulation: | 21 CFR 868.2375 |
| Product Code: | MNR |
III. PREDICATE
Predicate Device(s): K220028, NightOwl (Primary) K222579, Belun Sleep System BLS-100 (Reference Device) K231355, EnsoSleep PPG (formerly Aurora) (Reference Device)
IV. DEVICE DESCRIPTION SUMMARY
TipTraQ is a prescription-only medical device aiding in sleep apnea evaluation/diagnosis comprising a fingertip wearable device, a companion mobile app, a cloud-based AI analysis and an information display system. It collects essential physiological waveform information, including Photoplethysmogram (PPG) and accelerometer data. The TipTraQ Algorithm System determines Total Sleep Time (TST), Total REM Time (TREMT), Oxygen Desaturation Index (ODI), and Apnea-Hypopnea Index (AHI) from the recorded waveform signals.
5
TipTraQ Sensor includes a PPG sensor, which uses light sources (green, red, and infrared) and two photodetectors to measure the blood volume changes in the microvascular bed of tissue. Additionally, the TipTraQ Sensor utilizes an Inertial Measurement Unit (IMU) with three-axis accelerometers (device-function) and three-axis gyroscopes (non-device function), monitoring movement and actigraphy to assess sleep stages. The TipTraQ Expert Panel can display recorded physiological waveforms, while the TipTraQ API System generates output for essential physiological parameters analyzed by the TipTraQ Algorithm System.
The TipTraQ Sensor is rechargeable and designed to provide at least 12 hours of usage after fully charged. The TipTraQ Charging Case, which is also rechargeable, provides a battery capacity of eight full charges of the TipTraQ Sensor for user convenience. The TipTraQ Charging Case can be powered and charged using an external USB-C.
INTENDED USE / INDICATIONS FOR USE V.
The TipTraQ is a wearable device intended for aiding in sleep apnea evaluation/diagnosis for adult patients suspected of sleep apnea in both home-based and clinical-use environments.
6
| Characteristic | TipTraQ, K243268
(Subject Device) | NightOwl, K220028
(Primary Predicate) | Belun Sleep System BLS-
100, K222579
(Reference Device 1) | EnsoSleep PPG (formerly
Aurora), K231355
(Reference Device 2) |
|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/
Indications for Use | The TipTraQ is a
wearable device intended
for aiding in sleep apnea
evaluation/diagnosis for
adult patients suspected
of sleep apnea in both
home-based and clinical-
use environments. | 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). | The Belun Sleep System
BLS-100 is a wearable
device intended to record,
analyze, display, export,
and store biophysical
parameters to aid in
evaluating moderate
to severe sleep-related
breathing disorders of
adult patients suspected of
sleep apnea. The device is
intended for use in clinical
and home settings under
the direction of a
Healthcare Professional
(HCP). | Aurora is a Software as a
Medical Device (SaMD)
that establishes sleep
quality. Aurora
automatically analyzes,
displays, and summarizes
Photoplethysmogram
(PPG) data collected
during sleep. Aurora is
intended for use by and
by order of a healthcare
professional to aid in the
diagnosis of sleep
disorders including sleep
apnea in adults. The
Aurora output, including
automatically detected
respiratory events and
parameters, may be
displayed and edited by a
qualified healthcare
professional. The Aurora
output is not intended to
be interpreted or clinical
action taken without |
| Characteristic | TipTraQ, K243268
(Subject Device) | NightOwl, K220028
(Primary Predicate) | Belun Sleep System BLS-
100, K222579
(Reference Device 1) | EnsoSleep PPG (formerly
Aurora), K231355
(Reference Device 2) |
| | | | | consultation of a
qualified healthcare
professional.
Aurora is not intended for
use with
polysomnography
devices. |
| Intended
Environment | Recording in the home
environment or clinical
environment with the
report
interpretation performed
in the clinical setting. | Recording in the home
environment with the
report
interpretation
performed in the
clinical setting. | Recording in the home
environment with the
report interpretation
performed in the
clinical setting. | N/A (Software) |
| Prescription | Prescription only | Prescription only | Prescription only | Prescription only |
| Target Population | 22 years old and older | 22 years old and older | 22 years old and older | Adults |
| Channels | 1. Photoplethysmography
(PPG)
2. Pulse rate
3. Oximetry
4. Actigraphy | 1. PAT
2. Pulse rate
3. Oximetry
4. Actigraphy | 1. Photoplethysmography
(PPG)
2. Pulse rate
3. Oximetry
4. Actigraphy | 1. Photoplethysmography
(PPG)
2. Oximetry |
| Characteristic | TipTraQ, K243268
(Subject Device) | NightOwl, K220028
(Primary Predicate) | Belun Sleep System BLS-
100, K222579
(Reference Device 1) | EnsoSleep PPG (formerly
Aurora), K231355
(Reference Device 2) |
| Sensors | Optical plethysmography
sensor (Red, Infrared
Red, Green),
accelerometer | Optical
plethysmography
sensor (Red, Infrared
Red), accelerometer | Optical plethysmography
sensor (Red, Infrared
Red), accelerometer | N/A (Software) |
| Wearable sensor
location | The
photoplethysmography
(PPG) sensor and
accelerometer
components are worn on
the fingertip. | The
photoplethysmography
(PPG) sensor and
accelerometer
components are worn
on the fingertip. | The
photoplethysmography
(PPG) sensor and
accelerometer components
are worn on the proximal
phalanx of index finger. | N/A (Software) |
| Sensor Software | Firmware is limited to
control the recording and
communications
processes. Presentation of
test results to the patient
only after confirmed by
HCP. 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. | 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. | N/A (Software) |
| Analysis Software
- location | Analysis performed off
the recording device,
exclusively
cloud-based by the
TipTraQ software. | Analysis performed
off the recording
device, exclusively
cloud-based by the
NightOwl software. | Analysis performed off
the recording device,
exclusively stand-alone by
the Belun software. | Analysis performed off
the recording device,
exclusively
cloud-based by the
EnsoSleep software. |
| Characteristic | TipTraQ, K243268
(Subject Device) | NightOwl, K220028
(Primary Predicate) | Belun Sleep System BLS-
100, K222579
(Reference Device 1) | EnsoSleep PPG (formerly
Aurora), K231355
(Reference Device 2) |
| Analysis Software - algorithm- AHI | TQ-AHI calculation
tuned to the AASM's '1A
Rule' for the
scoring of hypopnea
AND TQ-AHI
calculation tuned to the
AASM's '1B Rule' for
the scoring of hypopnea | pAHI calculation
tuned to the AASM's
'1A Rule' for the
scoring of hypopnea
AND pAHI
calculation tuned to
the AASM's '1B
Rule' for the
scoring of hypopnea | bAHI calculation tuned to
the AASM's '1B
Rule' for the scoring of
hypopnea | N/A |
| Analysis Software - algorithm - Sleep
Time | Total Sleep Time (TQ-
TST)
calculation,
and,
Total REM Time (TQ-
TREMT)
calculation | Total Sleep Time
(TST)
calculation,
and,
Total REM Time
calculation | bTST calculation (time
summation of REM and
NREM stages) | N/A |
| Analysis Software - algorithm - Sleep
Stage | Sleep Stages (Wake,
REM, NREM) | N/A | bSTAGES: WAKE,
NREM and REM | N/A |
| Characteristic | TipTraQ, K243268
(Subject Device) | NightOwl, K220028
(Primary Predicate) | Belun Sleep System BLS-
100, K222579
(Reference Device 1) | EnsoSleep PPG (formerly
Aurora), K231355
(Reference Device 2) |
| Data transfer | Data transfer through a
smartphone by wireless
connection. | Data transfer through a
smartphone by
wireless connection. | Data transfer by physical
or wireless connection. | N/A (Software) |
| Power Source
recorder | Internal rechargeable li-
ion battery | Battery powered by
coin cell | 3.7V Lithium Battery | N/A (Software) |
| Patient Isolation | Device has no galvanic
connections to mains as it
is a battery-operated
device. | Device has no
galvanic connections
to mains as it is a
battery-operated
device. | N/A | N/A (Software) |
| Sterilization | Non-sterile | Non-sterile | N/A | N/A (Software) |
| Material(s) in
primary contact | 1. PC
- Silicone rubber
- Nylon-based fabric | 1. Biocompatible
polyethylene foam and
polyester film
with acrylic adhesive
layer | 1. TPE - PC | N/A (Software) |
| Characteristic | TipTraQ, K243268
(Subject Device) | NightOwl, K220028
(Primary Predicate) | Belun Sleep System BLS-
100, K222579
(Reference Device 1) | EnsoSleep PPG (formerly
Aurora), K231355
(Reference Device 2) |
| Contact duration
(biocompatibility) | Prolonged duration (>24
hours to 30 days),
cumulatively | Limited duration (Up
to 24 hours) | Prolonged duration (>24
hours to 30 days),
cumulatively | N/A (Software) |
| Bio-compatibility | Assessed to ISO 10993-
1:2018 | Assessed to ISO
10993-1:2009
requirements for
sensitization, irritation,
and cytotoxicity | Tested in accordance to
ISO 10993-1:2018 for
sensitization, irritation,
and cytotoxicity | N/A (Software) |
| EMC | IEC 60601-1-2:2014
+AMD1:2020 | IEC 60601-1-2:2014 | IEC 60601-1-2:2014 | N/A (Software) |
| Electrical Safety | IEC 60601-1:2005
+A1:2012+A2:2020 | IEC 60601-1:2005
+AMD1:2012 | IEC 60601-1:2005
+A1:2012 | N/A (Software) |
| Environmental
Testing | IEC 60601-1-11:2015 +
A1:2020 | IEC 60601-1-11:2010 | IEC 60601-1-11:2015 | N/A (Software) |
| Characteristic | TipTraQ, K243268
(Subject Device) | NightOwl, K220028
(Primary Predicate) | Belun Sleep System BLS-
100, K222579
(Reference Device 1) | EnsoSleep PPG (formerly
Aurora), K231355
(Reference Device 2) |
| Output parameters | 1. TQ-AHI - Total Sleep Time
- Total REM Time
- Sleep Stages (Wake,
REM, NREM) - Sleep Efficiency
- Sleep Latency
- Wake After Sleep
Onset - SpO2 (min, max)
- ODI 3%, ODI 4%
- T90
- Pulse Rate (PR)
(mean, PR > 100 bpm,
PR 100 bpm,
PR