(291 days)
Not Found
No
The summary describes a standard pulse oximeter with a sensor, base station, and mobile app. There is no mention of AI, ML, or any advanced algorithms beyond basic signal processing for SpO2 and pulse rate measurement. The performance studies focus on accuracy against a gold standard and skin irritation, not on the performance of any AI/ML component.
No.
The device is indicated for measuring and displaying SpO2 and pulse rate for monitoring purposes, and alarms if readings are outside prescribed limits. It does not exert any therapeutic effect on the patient.
Yes
The device measures and displays functional oxygen saturation (SpO2) and pulse rate, which are physiological parameters used to assess a patient's health status. While it doesn't provide a diagnosis itself, the monitoring of these vital signs to initiate an alarm when readings are outside prescribed limits and to provide data for review (SpO2 and Pulse rate) serves a diagnostic purpose in identifying potential health issues.
No
The device description explicitly lists hardware components (Sock, Sensor, Base Station) in addition to the Mobile App.
Based on the provided information, the BabySat 3 pulse oximeter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- BabySat 3 Function: The BabySat 3 measures physiological parameters (SpO2 and Pulse Rate) directly from the patient's body using a sensor placed on the foot. It does not analyze samples taken from the body.
- Intended Use: The intended use is for monitoring vital signs in infants, not for analyzing biological samples for diagnostic purposes.
Therefore, the BabySat 3 falls under the category of a medical device that performs in vivo measurements, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
DQA
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
- 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
- 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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Foot
Indicated Patient Age Range
greater than one month old up to 18 months old
Intended User / Care Setting
Home environment
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
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.
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.
Key Metrics
Desaturation study SpO2 Accuracy: Non-motion and motion 70-100% ±3.0% Arms
Pulse Rate Accuracy: Non-motion ± 3 bpm Arms, Motion ± 5 bpm Arms
Predicate Device(s)
K182882 - Taiwan Aulisa Medical Devices Technologies, Inc. - Guardian Angel Rx GA 1001 Digital Vital Sign Monitoring System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
Indications for Use
510(k) Number (if known)
K22597
Device Name
BabySat 3
Indications for Use (Describe)
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
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 PP
3
| Date Prepared: | 08-Jun-2023 |
|---|---|
| Owlet Baby Care Inc. | |
| 3300 Ashton Blvd. | |
| Suite 300 | |
| Lehi, UT 84043 | |
| Tel - 801-901-4303 | |
| Official Contact: | Tammy Lavery |
| Sr. Director, Quality Engineering & Regulatory Affairs | |
| Submission Correspondent: | Paul Dryden |
| ProMedic, LLC | |
| 131 Bay Point Dr NE | |
| St. Petersburg, FL 33704 | |
| Proprietary or Trade Name: | |
| Common/Usual Name: | |
| Classification: | BabySat 3 |
| Oximeter | |
| 21 CFR 870.2700 | |
| DQA - Oximeter | |
| Predicate Devices: | K182882 - Taiwan Aulisa Medical Devices |
| Technologies, Inc. - Guardian Angel Rx GA 1001 | |
| Digital Vital Sign Monitoring System | |
| Common/Usual Name: | |
| Classification: | Oximeter |
| 21 CFR 870.2700 | |
| DQA - Oximeter |
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
- 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
4
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:
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.
5
510(k) Summary
Page 3 of 11
Table 1 - Comparison - Subject vs. Predicate
| Subject Device | Predicate | Comparison | Does the difference raise
different questions of safety
and effectiveness? | |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model: | BabySat 3 | GA 1001 | | |
| Manufacturer: | Owlet, Inc. | Taiwan Aulisa Medical Devices
Technologies | | |
| K# | K222597 | K182822 | | |
| ProCode | DQA - Oximeter
CFR 870.2700 | DQA - Oximeter
CFR 870.2700 | Same | No |
| General Specifications | | | | |
| Use Environment | Home setting | hospitals, medical facilities, home
care, and subacute environments | Similar, with the subject
restricted to home use
only | No, Subject device has a more
limited use environment than
predicate. |
| Patient population | Infant at least 1 month old and up to
18 months old and 6-30 lbs. | Infants and pediatrics | Similar | No, Subject device has a more
limited patient population. |
| Indications for use: | 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 | The Guardian Angel Rx GA1001
Digital Vital Sign Monitoring
System 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 pediatrics and
infants during non-motion and
under well-perfused conditions.
The intended environments of use
are hospitals, medical facilities,
home care, and subacute
environments. This system is a
reusable device. | Similar | No, Equivalent with exception
of the more limited patient
population for the subject
device. Also, the subject device
is not limited to non-motion
conditions. |
| | Subject Device | Predicate | Comparison | Does the difference raise
different questions of safety
and effectiveness? |
| Contraindications: | - Not for patients under 1
month old or weighing less than 6
pounds
- Not for patients older than 18
months or weighing more than 30
pounds - Not a substitute for a caregiver
- Not for use as an apnea monitor | -Do not use any part of this
system in an MRI environment.
-Explosion Hazard: Do not use
this system in an explosive
atmosphere or in the presence of
flammable anesthetics or gasses.
-This device is not a replacement
for a caregiver. | Similar | No
Subject device is for home use
only. MRI environments do not
need to be contraindicated
because they are not found in
home environments.
Explosive environments are
uncommon in the home
environment. |
| Application sight: | Foot | Foot | Same | No |
| Accessory | Sock with sensor | Sock with sensor | Similar | No |
| Materials in patient
contact | ISO 10993 tested | Unknown | Similar | No
Same patient contact |
| Operating
Temperature
Range: | 5 to 40°C | 5 to 40°C | Same | No
Equivalent. Specified by
60601-1-11:2015, 4.2.3.1 |
| Storage/Transport
Temperature
Range: | -25 to 60°C | -25 to 60°C | Similar | No
Equivalent. Specified by
60601-1-11:2015, 4.2.3.1 |
| Storage/Transport
Atmospheric
Pressure: | 500 to 1060 hPa | Not specified | Similar | No
Based on 60601-1 subclause
7.9.3.1 rationale |
| Operating Altitude: | ≤ 3000 m | ≤ 3000 m | Same | No |
| Operating
Atmospheric
Pressure: | 700 hPa to 1013 hPa | 700 hPa to 1013 hPa | Same | No, Equivalent. Specified by
60601-1-11:2015, 4.2.3.1 |
| Operating
Humidity: | 15 to 90% RH non-condensing | 15 to 90% RH non-condensing | Same | No, Equivalent. Specified by
60601-1-11:2015, 4.2.3.1 |
| | Subject Device | Predicate | Comparison | Does the difference raise
different questions of
safety and effectiveness? |
| Storage/Transport
Humidity: | 0% to 90 %, non-condensing.
Water vapor pressure not to
exceed 50hPa. | 10% to 93% RH non-condensing | Similar | No
Subject device meets
requirements specified by
60601-1-11:2015, subclause
4.2.2 |
| Ingress rating: | Sensor: IP35
Base: IP22 | IP22 | Similar | No
Sensor meets more stringent
ingress 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 BPM
Range: 75 to 275 | Default: 200 BPM
Range: 75 to 275 | Same | No |
| Pulse Lower Limit: | Default: 75 bpm
Range: 30 to 110 | Default: 75 bpm
Range: 30 to 110 | Similar | No
Min range of 30 bpm is
adequate for the patient
population of the subject device. |
| Alarm Silence
Duration: | 2 min | 2 min | Same | No |
| Alarm Sound
Pressure: | 55-60 dBA at 1m | 60 db | Similar | No |
| Permanent Alarm
Silence: | No permanent alarm silence | Alarm can be permanently
silenced | 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 raise
different questions of
safety and effectiveness? |
| Wireless Communication | | | | |
| Transmitter
Bluetooth
compliance: | BLE 4.0 | BLE 4.0 | Same | No |
| Transmitter
Operating Range: | 30 feet | 10 meters | Similar | No |
| Accuracy and Range | | | | |
| Oxygen Saturation
Range: | 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 motion
70-100% ±3.0% Arms | Non-motion
70-100% ± 3 digits | Same | No
Adding motion data |
| Pulse Rate Accuracy: | Non-motion
± 3 bpm Arms
Motion
± 5 bpm Arms | ± 3 digits | Same | No
Predicate not suitable for motion |
| Sensor Specifications | | | | |
| Measurement
Wavelength/Power
(Red): | 653 nm, 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
13
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.