(291 days)
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 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
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.
§ 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).