(111 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study details for the TipTraQ (TTQ001) device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document presents the performance results directly without explicitly stating the "acceptance criteria" as a separate, quantified threshold. However, for the SpO2 validation, it states "met the predefined acceptance criteria <3.5". For the sleep validation study, it mentions "met all the predetermined acceptance criteria (set by prior studies and reference literatures)," implying these are the results shown in the table.
| Measure | Metric | Acceptance Criteria (Implied / Stated) | Reported Device Performance |
|---|---|---|---|
| SpO2 Accuracy | Arms (Artificial Root Mean Square) | < 3.5% (stated) | 1.41% (Overall) |
| SpO2 Range 70-100% | N/A (implied by meeting overall Arms) | 1.41 | |
| SpO2 Range 60-70% | N/A | 1.55 | |
| SpO2 Range 70-80% | N/A | 1.7 | |
| SpO2 Range 80-90% | N/A | 1.35 | |
| SpO2 Range 90-100% | N/A | 1.11 | |
| Pulse Rate (PR) Accuracy | Arms (Artificial Root Mean Square) | N/A | 1.64 |
| PR Range | N/A | 56-118 bpm | |
| Total Sleep Time | Pearson Correlation Coefficient (PCC) | N/A | 0.786 |
| Epoch-wise Sleep Stage (Wake) | Sensitivity | N/A | 0.655 |
| Specificity | N/A | 0.901 | |
| Accuracy | N/A | 0.837 | |
| Epoch-wise Sleep Stage (REM) | Sensitivity | N/A | 0.713 |
| Specificity | N/A | 0.930 | |
| Accuracy | N/A | 0.905 | |
| Epoch-wise Sleep Stage (NREM) | Sensitivity | N/A | 0.824 |
| Specificity | N/A | 0.738 | |
| AHI based on 1a rule | Overall Accuracy | N/A | 0.791 |
| AHI cutoff 5 sensitivity | N/A | 0.868 | |
| AHI cutoff 5 specificity | N/A | 0.741 | |
| AHI cutoff 15 sensitivity | N/A | 0.876 | |
| AHI cutoff 15 specificity | N/A | 0.755 | |
| AHI cutoff 30 sensitivity | N/A | 0.806 | |
| AHI cutoff 30 specificity | N/A | 0.905 | |
| AHI based on 1b rule | AHI cutoff 5 sensitivity | N/A | 0.924 |
| AHI cutoff 5 specificity | N/A | 0.801 | |
| AHI cutoff 15 sensitivity | N/A | 0.909 | |
| AHI cutoff 15 specificity | N/A | 0.908 | |
| AHI cutoff 30 sensitivity | N/A | 1.000 | |
| AHI cutoff 30 specificity | N/A | 0.933 |
2. Sample Size and Data Provenance for the Test Set
- SpO2 Validation Study:
- Sample Size: 12 subjects
- Data Provenance: University of California San Francisco (UCSF) - implies prospective study data from the US.
- Sleep Validation Study:
- Sample Size: 147 qualified samples
- Data Provenance: Duke University Hospital - implies prospective study data from the US.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or specific qualifications of experts used to establish the ground truth for either the SpO2 validation study or the sleep validation study.
- SpO2 Validation: The ground truth was established by "reference arterial blood gas sampling," which is a clinical standard, not an expert panel.
- Sleep Validation: The ground truth was established by "the gold standard in-lab polysomnography (PSG)." PSG scoring typically involves trained sleep technologists and often review by a board-certified sleep physician, but the number and qualifications of these individuals are not specified in the document.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1) for either the SpO2 validation study or the sleep validation study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with AI assistance is present in the document. The studies described are standalone performance validations against a gold standard.
6. Standalone Performance Study (Algorithm Only)
Yes, standalone performance studies were done. Both the SpO2 validation study and the sleep validation study describe the TipTraQ device's performance (which includes its algorithm, "TipTraQ Algorithm System") compared to a "gold standard" or reference method, without human-in-the-loop assessment as part of the primary performance metrics. The stated "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," clearly indicates an algorithm-only evaluation for these parameters.
7. Type of Ground Truth Used
- SpO2 Validation Study: "Reference arterial blood gas sampling." (Clinical standard measurement)
- Sleep Validation Study: "Gold standard in-lab polysomnography (PSG)." (Clinical standard physiological monitoring and expert scoring)
8. Sample Size for the Training Set
The document does not provide any information regarding the sample size for the training set used for the TipTraQ Algorithm System.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information regarding how the ground truth for the training set was established. It only describes the validation studies.
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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. 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 text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side.
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.
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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
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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
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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.
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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.
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| Characteristic | TipTraQ, K243268(Subject Device) | NightOwl, K220028(Primary Predicate) | Belun Sleep System BLS-100, K222579(Reference Device 1) | EnsoSleep PPG (formerlyAurora), K231355(Reference Device 2) |
|---|---|---|---|---|
| Intended Use/Indications for Use | The TipTraQ is awearable device intendedfor aiding in sleep apneaevaluation/diagnosis foradult patients suspectedof sleep apnea in bothhome-based and clinical-use environments. | The NightOwl is awearable deviceintended for use inthe recording, analysis,displaying, exporting,and storage ofbiophysical parametersto aid in the evaluationof sleep-relatedbreathing disorders ofadult patientssuspected of sleepapnea. The device isintended for theclinical and homesetting use underthe direction of aHealthcareProfessional (HCP). | The Belun Sleep SystemBLS-100 is a wearabledevice intended to record,analyze, display, export,and store biophysicalparameters to aid inevaluating moderateto severe sleep-relatedbreathing disorders ofadult patients suspected ofsleep apnea. The device isintended for use in clinicaland home settings underthe direction of aHealthcare Professional(HCP). | Aurora is a Software as aMedical Device (SaMD)that establishes sleepquality. Auroraautomatically analyzes,displays, and summarizesPhotoplethysmogram(PPG) data collectedduring sleep. Aurora isintended for use by andby order of a healthcareprofessional to aid in thediagnosis of sleepdisorders including sleepapnea in adults. TheAurora output, includingautomatically detectedrespiratory events andparameters, may bedisplayed and edited by aqualified healthcareprofessional. The Auroraoutput is not intended tobe interpreted or clinicalaction taken without |
| Characteristic | TipTraQ, K243268(Subject Device) | NightOwl, K220028(Primary Predicate) | Belun Sleep System BLS-100, K222579(Reference Device 1) | EnsoSleep PPG (formerlyAurora), K231355(Reference Device 2) |
| consultation of aqualified healthcareprofessional.Aurora is not intended foruse withpolysomnographydevices. | ||||
| IntendedEnvironment | Recording in the homeenvironment or clinicalenvironment with thereportinterpretation performedin the clinical setting. | Recording in the homeenvironment with thereportinterpretationperformed in theclinical setting. | Recording in the homeenvironment with thereport interpretationperformed in theclinical 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 rate3. Oximetry4. Actigraphy | 1. PAT2. Pulse rate3. Oximetry4. Actigraphy | 1. Photoplethysmography(PPG)2. Pulse rate3. Oximetry4. 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 (formerlyAurora), K231355(Reference Device 2) |
| Sensors | Optical plethysmographysensor (Red, InfraredRed, Green),accelerometer | Opticalplethysmographysensor (Red, InfraredRed), accelerometer | Optical plethysmographysensor (Red, InfraredRed), accelerometer | N/A (Software) |
| Wearable sensorlocation | Thephotoplethysmography(PPG) sensor andaccelerometercomponents are worn onthe fingertip. | Thephotoplethysmography(PPG) sensor andaccelerometercomponents are wornon the fingertip. | Thephotoplethysmography(PPG) sensor andaccelerometer componentsare worn on the proximalphalanx of index finger. | N/A (Software) |
| Sensor Software | Firmware is limited tocontrol the recording andcommunicationsprocesses. Presentation oftest results to the patientonly after confirmed byHCP. Data analyzed andpresented in a separatesoftware suite. | Firmware is limited tocontrol the recordingand communicationsprocesses. Nopresentation of testresults to the patient.Data analyzed andpresented in a separatesoftware suite. | Firmware is limited tocontrol the recordingand communicationsprocesses. Nopresentation of test resultsto the patient.Data analyzed andpresented in a separatesoftware suite. | N/A (Software) |
| Analysis Software- location | Analysis performed offthe recording device,exclusivelycloud-based by theTipTraQ software. | Analysis performedoff the recordingdevice, exclusivelycloud-based by theNightOwl software. | Analysis performed offthe recording device,exclusively stand-alone bythe Belun software. | Analysis performed offthe recording device,exclusivelycloud-based by theEnsoSleep software. |
| Characteristic | TipTraQ, K243268(Subject Device) | NightOwl, K220028(Primary Predicate) | Belun Sleep System BLS-100, K222579(Reference Device 1) | EnsoSleep PPG (formerlyAurora), K231355(Reference Device 2) |
| Analysis Software- algorithm- AHI | TQ-AHI calculationtuned to the AASM's '1ARule' for thescoring of hypopneaAND TQ-AHIcalculation tuned to theAASM's '1B Rule' forthe scoring of hypopnea | pAHI calculationtuned to the AASM's'1A Rule' for thescoring of hypopneaAND pAHIcalculation tuned tothe AASM's '1BRule' for thescoring of hypopnea | bAHI calculation tuned tothe AASM's '1BRule' for the scoring ofhypopnea | N/A |
| Analysis Software- algorithm - SleepTime | Total Sleep Time (TQ-TST)calculation,and,Total REM Time (TQ-TREMT)calculation | Total Sleep Time(TST)calculation,and,Total REM Timecalculation | bTST calculation (timesummation of REM andNREM stages) | N/A |
| Analysis Software- algorithm - SleepStage | 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 (formerlyAurora), K231355(Reference Device 2) |
| Data transfer | Data transfer through asmartphone by wirelessconnection. | Data transfer through asmartphone bywireless connection. | Data transfer by physicalor wireless connection. | N/A (Software) |
| Power Sourcerecorder | Internal rechargeable li-ion battery | Battery powered bycoin cell | 3.7V Lithium Battery | N/A (Software) |
| Patient Isolation | Device has no galvanicconnections to mains as itis a battery-operateddevice. | Device has nogalvanic connectionsto mains as it is abattery-operateddevice. | N/A | N/A (Software) |
| Sterilization | Non-sterile | Non-sterile | N/A | N/A (Software) |
| Material(s) inprimary contact | 1. PC2. Silicone rubber3. Nylon-based fabric | 1. Biocompatiblepolyethylene foam andpolyester filmwith acrylic adhesivelayer | 1. TPE2. PC | N/A (Software) |
| Characteristic | TipTraQ, K243268(Subject Device) | NightOwl, K220028(Primary Predicate) | Belun Sleep System BLS-100, K222579(Reference Device 1) | EnsoSleep PPG (formerlyAurora), K231355(Reference Device 2) |
| Contact duration(biocompatibility) | Prolonged duration (>24hours to 30 days),cumulatively | Limited duration (Upto 24 hours) | Prolonged duration (>24hours to 30 days),cumulatively | N/A (Software) |
| Bio-compatibility | Assessed to ISO 10993-1:2018 | Assessed to ISO10993-1:2009requirements forsensitization, irritation,and cytotoxicity | Tested in accordance toISO 10993-1:2018 forsensitization, 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) |
| EnvironmentalTesting | 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 (formerlyAurora), K231355(Reference Device 2) |
| Output parameters | 1. TQ-AHI2. Total Sleep Time3. Total REM Time4. Sleep Stages (Wake,REM, NREM)5. Sleep Efficiency6. Sleep Latency7. Wake After SleepOnset8. SpO2 (min, max)9. ODI 3%, ODI 4%10. T9011. Pulse Rate (PR)(mean, PR > 100 bpm,PR < 40 bpm) | 1. pAHI2. Total Sleep Time3. Total REM Time4. SpO2 (min, max)5. ODI 3%, ODI 4%6. T90, T887. Pulse Rate (PR)(mean, PR > 100 bpm,PR < 40 bpm, Min,Max) | 1. bAHI2. Total Sleep Time3. Sleep Stages (Wake,REM, NREM)4. SpO25. Pulse Rate6. Low Perfusion | 1. eAHI2. Total Sleep Time3. Sleep Stages4. Sleep Efficiency5. Sleep latency6. Wake After SleepOnset7. ODI |
| AHI Performance Using AASM 1a Rule | ||||
| AHI 1a cutoff = 5 | Sensitivity: 0.868Specificity: 0.741 | Sensitivity: 0.936Specificity: 0.727 | N/A | Sensitivity: 0.926Specificity: 0.716 |
| AHI la cutoff = 15 | Sensitivity: 0.876Specificity: 0.755 | Sensitivity: 0.978Specificity: 0.704 | N/A | N/A |
| Characteristic | TipTraQ, K243268(Subject Device) | NightOwl, K220028(Primary Predicate) | Belun Sleep System BLS-100, K222579(Reference Device 1) | EnsoSleep PPG (formerlyAurora), K231355(Reference Device 2) |
| AHI 1a cutoff = 30 | Sensitivity: 0.806Specificity: 0.905 | Sensitivity: 0.964Specificity: 0.844 | N/A | N/A |
| AHI Performance Using AASM 1b Rule | ||||
| AHI 1b cutoff = 5 | Sensitivity: 0.924Specificity: 0.801 | Sensitivity: 1.000Specificity 0.823 | N/A | Sensitivity: 0.894Specificity: 0.768 |
| AHI 1b cutoff = 15 | Sensitivity: 0.909Specificity: 0.908 | Sensitivity: 0.973Specificity: 0.886 | Sensitivity: 0.898Specificity: 0.860 | N/A |
| AHI 1b cutoff = 30 | Sensitivity: 1.000Specificity: 0.933 | Sensitivity: 0.840Specificity: 0.979 | Sensitivity: 0.840Specificity: 0.951 | N/A |
| Oximetry Performance | ||||
| SpO2 Accuracy(Overall Arms) | 1.41 | 2.69 | 2.7 | N/A (Software) |
| PR Range | 40-200 bpm | 50-118 bpm | 30-250 bpm | N/A (Software) |
| PR Accuracy(Arms) | 1.04 | 2.26 | ± 2.5 bpm or 2%whichever larger | N/A (Software) |
COMPARISON OF INDICATIONS & TECHNOLOGICAL CHARACTERISTICS VI.
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VII. NON-CLINICAL PERFORMANCE TESTS
The following performance tests were conducted in support the substantial equivalence determination:
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 TipTraO has been conducted per ISO 10993-1:2018 and FDA Guidance on the Use of International Standard ISO 10993-1.
VII. CLINICAL PERFORMANCE TESTS
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
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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 <3.5. Pulse rate validation was also conducted over a range of 56-118 bpm and Arms of 1.64 was obtained. Please see the following table for a brief performance summary of the TipTraQ device.
SpO2 Accuracy
| SaO2 range: | 70-100%(Overall) | 60-70% | 70-80% | 80-90% | 90-100% |
|---|---|---|---|---|---|
| TipTraQ Arms | 1.41 | 1.55 | 1.7 | 1.35 | 1.11 |
Sleep validation study
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). Please see the table below for a brief performance summary of the TipTraQ device.
| Measure | Metric | Result |
|---|---|---|
| Total Sleep Time | PCC | 0.786 |
| Epoch-wise Sleep Stage | Wake (0) sensitivity | 0.655 |
| specificity | 0.901 | |
| accuracy | 0.837 | |
| REM (1) sensitivity | 0.713 | |
| specificity | 0.930 | |
| accuracy | 0.905 | |
| NREM (2) sensitivity | 0.824 | |
| specificity | 0.738 |
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| Measure | Metric | Result |
|---|---|---|
| AHI based on 1arule | accuracy | 0.791 |
| AHI cutoff 5sensitivity | 0.868 | |
| specificity | 0.741 | |
| AHI cutoff 15sensitivity | 0.876 | |
| specificity | 0.755 | |
| AHI cutoff 30sensitivity | 0.806 | |
| specificity | 0.905 | |
| AHI based on 1brule | AHI cutoff 5sensitivity | 0.924 |
| specificity | 0.801 | |
| AHI cutoff 15sensitivity | 0.909 | |
| specificity | 0.908 | |
| AHI cutoff 30sensitivity | 1.000 | |
| specificity | 0.933 |
VIII. CONCLUSIONS
In conclusion, there are minor differences in the indications for use statements and technological characteristics. These differences do not alter the intended use of the device as an aid in the evaluation of sleep apnea, nor do they raise different questions of safety or effectiveness compared to the predicate device. The non-clinical and clinical performance testing referenced in the 510(k) submission support the conclusion that the device is substantially equivalent to the predicate device.
§ 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).