The BabySat 3 pulse oximeter is indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and Pulse rate. It is indicated for spot-checking and/or continuous monitoring of well-perfused patients greater than one month old up to 18 months old and weighing between 6 and 30 lbs., in the home environment

Device Description

The Owlet BabySat 3 is a Pulse Oximeter for use in the home while the baby is resting or sleeping. The Sock secures the Sensor to the baby's foot. The Sensor measures the baby's readings (SpO2 and Pulse Rate) and transmits the baby's readings to the Base Station directly via Bluetooth. The Base Station monitors the baby's readings and will alarm if the readings are outside prescribed limits. The Base Station also relays the data to the App and to the Owlet servers. The Owlet BabySat 3 mobile device application displays the baby's readings.

The device is stand-alone and not part of a multiparameter module. The device is non-sterile, single patient use reusable and cleanable. The device is not reprocessed.

The BabySat 3 Pulse Oximeter is comprised of several components:

Sock
Sensor
Base Station
Mobile App

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: BabySat 3 (K222597)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (BabySat 3)	Comments
SpO2 Accuracy	Non-motion and motion: 70-100% ±3.0% Arms	This includes performance under motion, which the predicate device did not specify.
Pulse Rate Accuracy	Non-motion: ±3 bpm Arms; Motion: ±5 bpm Arms	This includes performance under motion.
Cleaning/Durability	Components met intended service-life and pre-defined acceptance criteria after testing	Performed on reusable sock and sensor.
Electrical Safety, EMC, RFID, Wireless Co-existence	Met performance requirements for intended use and environment, tested against AAMI ANSI ES 60601-1:2005 + A1: 2012, IEC 60601-1-2: 2014, IEC 60601-1-11: 2015 +AMD1: 2020, IEC 60601-1-8 2020, AIM Standard 7351731, and Wireless coexistence standards.
Software	Met all requirements after verification and validation testing
Biocompatibility	Materials met applicable requirements for biocompatibility safety for surface contact, intact skin, permanent use (>30 days). Tested per ISO 10993-5, ISO 10993-10, ISO 10993-11.	Additional ISO 10993-1 testing was performed per Agency feedback.
Desaturation Study (SpO2 Accuracy)	Met requirements and was similar to the predicate. Included subjects across the full Fitzpatrick Scale score.	Performed in accordance with FDA guidance and ISO 80601-2-61.
Signal Quality (Non-Clinical)	Studied on bench and from clinical data. Results were reportable, but no pass/fail criteria specified.	Additional testing beyond what the predicate performed.
Skin Irritation (Observational Study)	No clinically significant skin irritation events were reported when instructions for use were followed.	Collected signal quality data across various use conditions and Fitzpatrick skin tones.
Human Factors/Usability	Successful implementation of all critical tasks by intended users (lay people).	Human Factors study was performed with lay users, which was not done for the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the exact sample sizes for each clinical study (desaturation, signal quality/at-home, observational, human factors). However, it mentions:

Desaturation Study: Included subjects across the "full Fitzpatrick Scale score."
Signal Quality and At-Home Study: Covered a "full spectrum of evidence supporting the form factor of the Owlet device under review, accuracy related to the gold standard of arterial blood gas measurements, and accuracy in a real world, intended use population against a transfer standard." This implies a sufficiently diverse and representative sample.
Observational Study: Conducted "in the intended population" for skin irritation.
Provenance: The studies are clinical studies, implying prospective data collection for the specific device in question. No specific country of origin for the clinical data is mentioned, but the implication is data collected for the FDA submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide details on the number of experts or their specific qualifications for establishing ground truth in any of the studies mentioned.

4. Adjudication Method for the Test Set

The document does not specify any adjudication methods (e.g., 2+1, 3+1) used for establishing ground truth in the clinical studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being done, nor any effect size regarding human reader improvement with AI assistance. This device is a standalone pulse oximeter, not an AI-assisted diagnostic tool for interpretation by human readers.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, the studies performed (desaturation, signal quality, accuracy measurements) represent the standalone performance of the device (algorithm and hardware) in automatically measuring and displaying SpO2 and pulse rate. The human factors study involved lay users, but the performance criteria like SpO2 and Pulse Rate accuracy are intrinsic to the device's measurement capabilities.

7. Type of Ground Truth Used

SpO2 Accuracy: The ground truth for SpO2 accuracy in the desaturation study is implicitly stated to be the "gold standard of arterial blood gas measurements."
Skin Irritation: Ground truth for skin irritation was established through observation for "clinically important skin reactions."
Human Factors: Ground truth for human factors involved the "successful implementation of all critical tasks" by lay users.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for a training set. This device is a traditional pulse oximeter and not described as using a machine learning algorithm that requires a distinct "training set" in the sense of AI/ML development. Its performance is validated through traditional clinical and non-clinical testing.

9. How the Ground Truth for the Training Set was Established

As noted above, the document does not indicate the use of a "training set" for an AI/ML algorithm. Therefore, "how the ground truth for the training set was established" is not applicable based on the provided information.

Summary

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June 16, 2023

Owlet Baby Care, Inc. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K222597

Trade/Device Name: BabySat 3 Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: Class II Product Code: DQA Dated: May 25, 2023 Received: May 25, 2023

Dear Paul Dryden:

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.

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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 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.

James J. Lee -S

James J. Lee, PhD 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)

K22597

Device Name

BabySat 3

Indications for Use (Describe)

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

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (6/20)

Page 1 of 1

PSC Publishing Services (301) 443-6740 PP

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Date Prepared:	08-Jun-2023
Owlet Baby Care Inc.3300 Ashton Blvd.Suite 300Lehi, UT 84043Tel - 801-901-4303
Official Contact:	Tammy LaverySr. Director, Quality Engineering & Regulatory Affairs
Submission Correspondent:	Paul DrydenProMedic, LLC131 Bay Point Dr NESt. Petersburg, FL 33704
Proprietary or Trade Name:Common/Usual Name:Classification:	BabySat 3Oximeter21 CFR 870.2700DQA - Oximeter
Predicate Devices:	K182882 - Taiwan Aulisa Medical DevicesTechnologies, Inc. - Guardian Angel Rx GA 1001Digital Vital Sign Monitoring System
Common/Usual Name:Classification:	Oximeter21 CFR 870.2700DQA - Oximeter

Device Description:

The device is stand-alone and not part of a multiparameter module. The device is non-sterile, single patient use reusable and cleanable. The device is not reprocessed.

The BabySat 3 Pulse Oximeter is comprised of several components:

. Sock
- This holds the sensor in the appropriate place O
- There are 2 size of socks available O
- It is cleanable O
Sensor
- This is a battery-operated sensor with LED and collects data that is transmitted to O the Base Station
. Base Station
- This is a local unit that has audible and visual alarms which follow the prescribed O and pre-set alarm limits for Pulse rate and SpO2

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510(k) Summary Page 2 of 11

It can transmit data to the Cloud or a mobile device with the downloaded app o
Mobile App
- o This connects with the Base Station via a Wi-Fi local network and allows the individual to monitor and receive messages and alarms remotely

Principle of Operation:

The BabySat 3 sock contains a sensor which uses red and infrared light which is transmitted through oxyhemoglobin and are sensed in the photoelectric cell. The red and infrared light is absorbed in different amounts depending on the oxygenation of the blood. This data is then used to calculate SpO2. This is the standard principle of almost all pulse oximeters.

The BabySat 3 Pulse Oximeter measures functional Oxygen Saturation of arterial Hemoglobin (SpO2) and Pulse Rate. Pulse oximetry measurements are based on two physiological principles: The differences in optical absorbance properties between oxyhemoglobin (HbO2, oxygenated blood) and deoxyhemoglobin (Hb, non-oxygenated blood). The volume (and therefore light absorption) of arterial blood changes due to heart pulsation as it is distributed in tissue throughout the body.

A Pulse Oximeter determines the saturation of arterially Perfused tissue by sequential illumination with the red (653nm) and infrared (931nm) wavelengths of light via light emitting diodes (LED's). The time-varying signal passing through the tissue is measured from a photodiode detector many times per second, and the differences between the maximum and minimum absorbance due to pulsation are used to determine the saturation, and the pulsation time period is used to calculate the Pulse Rate.

Indications for Use:

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510(k) Summary

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Table 1 - Comparison - Subject vs. Predicate

Subject Device	Predicate	Comparison	Does the difference raisedifferent questions of safetyand effectiveness?
Model:	BabySat 3	GA 1001
Manufacturer:	Owlet, Inc.	Taiwan Aulisa Medical DevicesTechnologies
K#	K222597	K182822
ProCode	DQA - OximeterCFR 870.2700	DQA - OximeterCFR 870.2700	Same	No
General Specifications
Use Environment	Home setting	hospitals, medical facilities, homecare, and subacute environments	Similar, with the subjectrestricted to home useonly	No, Subject device has a morelimited use environment thanpredicate.
Patient population	Infant at least 1 month old and up to18 months old and 6-30 lbs.	Infants and pediatrics	Similar	No, Subject device has a morelimited patient population.
Indications for use:	The BabySat 3 pulse oximeter isindicated for use in measuring anddisplaying functional oxygensaturation of arterial hemoglobin(SpO2) and Pulse rate. It isindicated for spot-checking and/orcontinuous monitoring of well-perfused patients greater than onemonth old up to 18 months old andweighing between 6 and 30 lbs., inthe home environment	The Guardian Angel Rx GA1001Digital Vital Sign MonitoringSystem is indicated for use inmeasuring and displayingfunctional oxygen saturation ofarterial hemoglobin (SpO2) andpulse rate. It is indicated for spot-checking and/or continuousmonitoring of pediatrics andinfants during non-motion andunder well-perfused conditions.The intended environments of useare hospitals, medical facilities,home care, and subacuteenvironments. This system is areusable device.	Similar	No, Equivalent with exceptionof the more limited patientpopulation for the subjectdevice. Also, the subject deviceis not limited to non-motionconditions.
	Subject Device	Predicate	Comparison	Does the difference raisedifferent questions of safetyand effectiveness?
Contraindications:	- Not for patients under 1month old or weighing less than 6pounds- Not for patients older than 18months or weighing more than 30pounds- Not a substitute for a caregiver- Not for use as an apnea monitor	-Do not use any part of thissystem in an MRI environment.-Explosion Hazard: Do not usethis system in an explosiveatmosphere or in the presence offlammable anesthetics or gasses.-This device is not a replacementfor a caregiver.	Similar	NoSubject device is for home useonly. MRI environments do notneed to be contraindicatedbecause they are not found inhome environments.Explosive environments areuncommon in the homeenvironment.
Application sight:	Foot	Foot	Same	No
Accessory	Sock with sensor	Sock with sensor	Similar	No
Materials in patientcontact	ISO 10993 tested	Unknown	Similar	NoSame patient contact
OperatingTemperatureRange:	5 to 40°C	5 to 40°C	Same	NoEquivalent. Specified by60601-1-11:2015, 4.2.3.1
Storage/TransportTemperatureRange:	-25 to 60°C	-25 to 60°C	Similar	NoEquivalent. Specified by60601-1-11:2015, 4.2.3.1
Storage/TransportAtmosphericPressure:	500 to 1060 hPa	Not specified	Similar	NoBased on 60601-1 subclause7.9.3.1 rationale
Operating Altitude:	≤ 3000 m	≤ 3000 m	Same	No
OperatingAtmosphericPressure:	700 hPa to 1013 hPa	700 hPa to 1013 hPa	Same	No, Equivalent. Specified by60601-1-11:2015, 4.2.3.1
OperatingHumidity:	15 to 90% RH non-condensing	15 to 90% RH non-condensing	Same	No, Equivalent. Specified by60601-1-11:2015, 4.2.3.1
	Subject Device	Predicate	Comparison	Does the difference raisedifferent questions ofsafety and effectiveness?
Storage/TransportHumidity:	0% to 90 %, non-condensing.Water vapor pressure not toexceed 50hPa.	10% to 93% RH non-condensing	Similar	NoSubject device meetsrequirements specified by60601-1-11:2015, subclause4.2.2
Ingress rating:	Sensor: IP35Base: IP22	IP22	Similar	NoSensor meets more stringentingress standard.
Alarms
SpO2 Upper Limit	Default: Off, Range: 85 to 100	Default: Off, Range: 85 to 100	Same	No
SpO2 Lower Limit:	Default: 85%, Range: 50 to 95	Default: 85%, Range: 50 to 95	Same	No
Pulse Upper Limit:	Default: 200 BPMRange: 75 to 275	Default: 200 BPMRange: 75 to 275	Same	No
Pulse Lower Limit:	Default: 75 bpmRange: 30 to 110	Default: 75 bpmRange: 30 to 110	Similar	NoMin range of 30 bpm isadequate for the patientpopulation of the subject device.
Alarm SilenceDuration:	2 min	2 min	Same	No
Alarm SoundPressure:	55-60 dBA at 1m	60 db	Similar	No
Permanent AlarmSilence:	No permanent alarm silence	Alarm can be permanentlysilenced	Similar	No
Classification (IEC 60601-1)
Type of Protection:	Class II	Class II	Same	No
Degree of Protection:	Type BF-Applied Part	Type BF-Applied Part	Same	No
Mode of Operation:	Continuous	Continuous	Same	No
	Subject Device	Predicate	Comparison	Does the difference raisedifferent questions ofsafety and effectiveness?
Wireless Communication
TransmitterBluetoothcompliance:	BLE 4.0	BLE 4.0	Same	No
TransmitterOperating Range:	30 feet	10 meters	Similar	No
Accuracy and Range
Oxygen SaturationRange:	1% to 100%	1% to 100%	Same	No
Pulse Rate Range:	30 to 300 bpm	30 to 300 bpm	Same	No
SpO2 Accuracy:	Non-motion and motion70-100% ±3.0% Arms	Non-motion70-100% ± 3 digits	Same	NoAdding motion data
Pulse Rate Accuracy:	Non-motion± 3 bpm ArmsMotion± 5 bpm Arms	± 3 digits	Same	NoPredicate not suitable for motion
Sensor Specifications
MeasurementWavelength/Power(Red):	653 nm, <10 mW max.	660 nm @ 9.8mW	Similar	NoValidated by clinical study
MeasurementWavelength/Power(Infrared):	931 nm, <10 mW max	880 nm @ 6.5mW	Similar	NoValidated by clinical study
Sensor InternalBattery:	3.8 V	3.7 V	Similar	No
	Subject Device	Predicate	Comparison	Does the difference raisedifferent questions ofsafety and effectiveness?
Sensor Battery Life:	16 hrs	22 hrs	Similar	No risks associated with 12 hoursensor battery life. Base stationprovides a low priority alarmwhen sensor battery is gettinglow. Base station gives amedium priority alarm if thesensor runs out of battery andpowers off.
Sensor Weight:	14 grams (with Large sock)	17.5 grams	Similar	No
Sensor Dimensions:	2.2" L x 1.4" W x 0.5" H	5.6" D x 1.2" W x 0.6" H	Similar	No

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510(k) Summary

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Base Specifications

Numeric display:	Mobile device app	10.1" TFT Touch Panel	Similar	NoSubject device provides greaterability for view of data throughuse of app than the Predicatedevice.
Mains power:	100-240 V AC 50-60 Hz	100-240 V AC 50-60 Hz	Same	No
DC adapter:	5 V	5 V	Same	No
Internal Battery:	3.7V	3.7V	Same	No
Base station batterycapacity:	10 min continuous	2 hrs continuous	Similar	NoSubject device is not intended tobe used deliberately on internalbattery power. Base Stationbattery is for alarm backup only.BabySat 3 alarms continuouslywhen unplugged from power.Alarm continues for 10 minutes,then the BabySat 3 powers itselfoff.
	Subject Device	Predicate	Comparison	Does the difference raisedifferent questions ofsafety and effectiveness?
Base stationDimensions:	2.4" H x 2.4" L x 0.7" H	7.1" H x 10.8" W x 0.5" D	Similar	No
Base station Weight:	40 grams	750 grams	Similar	No
Biocompatibility	Surface contactSkinPermanent duration of useISO 10993-5ISO 10993-10ISO 10993-11	Surface contactSkinPermanent duration of use	Similar	NoAdditional ISO 10993-1 testingwas performed per Agencyfeedback
Standards	AAMI ANSI ES 60601-1:2005+ A1: 2012IEC 60601-1-2: 2014IEC 60601-1-11: 2015+AMD1: 2020IEC 60601-1-8 2020ISO 80601-2-61: 2017Wireless coexistence	IEC 60601-1:IEC 60601-1-2IEC 60601-1-11IEC 60601-1-8ISO 80601-2-61	Similar	No
SpO2 Accuracy	Desaturation studyNon-motionMotion	Desaturation studyNon-motion	Similar	NoSubject device was also testingfor motion
Signal Quality /Intensity	Studied on bench and fromClinical data	Not available	Similar	Subject device includedadditional testing
ISO 80601-2-61	Pulse Rate AccuracyPulse AmplitudeSpO2 Full Range PerformanceEnvironmental TemperatureMax Temperature of AppliedPartsSignal Quality Scoring	Details not specified	Similar	No
	Subject Device	Predicate	Comparison	Does the difference raisedifferent questions ofsafety and effectiveness?
Human Factors	Testing performed	Not performed	Similar	NoSubject device performed HFtesting with lay users
Clinical study	Observational study for skinirritation	Not performed	- -	Subject device performed anobservational study for skinirritation

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510(k) Summary Page 9 of 11

Discussion of Differences and Substantial Equivalence Conclusion

Table 1 above compares the key features of the proposed Owlet BabySat 3 with the identified predicate – K18282 - Taiwan Aulisa Medical Devices Technologies, Inc. - Guarcian Angel Rx GA 1001 Digital Vital Sign Monitoring System. It demonstrates that the proposed devices can be found to be substantially equivalent.

Indications for Use -

The indications for use are substantively identical for the proposed to the predicate – K182882 - Taiwan Aulisa Medical Devices Technologies, Inc. - Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System.

Discussion – Each device is indicated for use measuring and Pulse Rate. The subject device is more suitable for the infant population with its ability to handle motion.

Technology and construction -

The design, fabrication, shape, size, etc. are equivalent to the predicate - K182882 - Taiwan Aulisa Medical Devices Technologies, Inc. - Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System.

Discussion – The design utilizes transmission of data and a separate display device, sensor placement on the foot. There are no differences which raise different risk or safety concerns.

Environment of Use -

of use is more restricted as compared to the predicate - K182882 - Taiwan Aulisa Medical Devices Technologies, Inc. -The environment Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System.

Discussion – There are no differences which raise different risk or safety concerns as the subject device has a more limited environment of use.

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510(k) Summary Page 10 of 11

Patient Population -

The patient population of the subject device is limited to patients greater than 1 month and 6 to 30 lbs. whereas the predicate has been cleared for a larger population. Discussion - The identified patient population is within the predicate population.

Non-Clinical Testing Summary -

Cleaning / durability -

Cleaning durability testing was performed on the reusable sock and sensor. Tested demonstrated that the components meet there intended service-life and pre-defined acceptance criteria after testing.

Electrical Safety, EMC, RFID and Wireless Co-existence -

The device underwent testing following the following standards:

AAMI ANSI ES 60601-1:2005 + A1: 2012 ●
IEC 60601-1-2: 2014
IEC 60601-1-11: 2015 +AMD1: 2020
IEC 60601-1-8 2020 ●
AIM Standard 7351731 .
Wireless coexistence ●

The device met the performance requirements for the intended use and environment.

Software -

Software verification and validation testing was performed and the device met all of its requirements.

Bench testing -

We performed testing in accordance with the applicable standards for safety, EMC. Cleaning, ISO 80601-2-61.

Discussion - The results met the standards. There are no differences which would raise different concerns of risk than the predicate.

Biocompatibility -

Both devices are considered surface contact, intact skin, permanent duration of use (> 30 days). Discussion – The subject materials were found to meet the applicable requirements for biocompatibility safety for the intended population.

Clinical Testing Summary -

Desaturation testing -

We performed a desaturation study in accordance with FDA guidance and ISO 80601-2-61 and the subject device met the requirement and was similar to the predicate. Testing included subjects across the full Fitzpatrick Scale score.

Signal Quality Study and At Home Study

Signal quality across the intended use population, anatomic size, and location would be acquired and analyzed. The study included comparison to a reference pulse oximeter. The aggregate of data provided covered a full spectrum of evidence supporting the form factor of the Owlet device under review, accuracy related to the gold standard of arterial blood gas measurements, and accuracy in a real world, intended use population against a transfer standard. The evidence

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510(k) Summary Page 11 of 11

presented demonstrates versatility of the device under review within the intended weight range, age range, and across Fitzpatrick skin tone.

Observational Study

We conducted an Observational study in the intended population for skin irritation and to collect signal quality data.

The primary objective of the study was to estimate the incidence of clinically important skin reactions when instructions for use were followed. Secondary objectives included: an estimation of time for recovery from skin reaction, an estimation of skin reactions that required medical intervention, and an estimation of incidence of any skin reactions, overall and by severity. The results were that there were no skin irritation events which were considered clinically significant. In addition, we collected signal quality data to support SpO2 accuracy under various use conditions and with a range of patient with Fitzpatrick skin scale. The testing included subjects across the complete Fitzpatrick scale.

Human Factors / Usability

We conducted a Human Factors study following the FDA Guidance with the intended users, lay people, which confirmed successful implementation of all critical tasks.

Discussion of Differences –

The subject device was tested under motion conditions while the predicate was not. We have disclosed the motion performance results and included in labeling what happens to performance under motion conditions.

We provided Signal Quality and Intensity testing which the predicate did not perform. The results were only reportable with no pass / fail criteria.

The observational study was specific to skin irritation, the predicate did not perform such a study. The results supported safe use of the subject device in the intended population and environment.

The differences noted above do not raise different questions of safety.

Substantial Equivalence Conclusion

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to be substantially equivalent.

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).