(103 days)
Fingertip Pulse Oximeter (Model:C101A2,C101B1,C101A3) is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in hospitals.
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained. The pulse oximeter, model C101A2, C101B1, C101A3 is designed for spot checking of the pulse oxygen saturation and pulse rate for adults in a clinic environment. This medical device can be reused. Not for continuously monitoring.
The device is not for life-supporting or life-sustaining, not for implant.
The device is not provided sterile and is NOT a reprocessed single-use device.
The device is a spot-check pulse oximeter and does not include alarms.
The device does not support the measurement in the condition of low perfusion.
The device is not intended for life-supporting or life-sustaining.
The device is reusable and does not need sterilization.
Acceptance Criteria and Device Performance Study for Pulse Oximeter (Model C101A2, C101B1, C101A3)
The provided document, a 510(k) Summary for the Pulse Oximeter (Model C101A2, C101B1, C101A3), indicates that the device is substantially equivalent to a previously cleared predicate device (Pulse Oximeter, Model C101H1). This means that the acceptance criteria and performance data for the subject device are considered equivalent to those established for the predicate device.
Crucially, the document states: "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the predicate device, additional testing was not considered necessary to support the substantial equivalence."
Therefore, the information below refers to the performance that the predicate device (K173123) demonstrated, which the subject device (K221979) is claimed to meet by virtue of substantial equivalence. The summary does not include new testing data specifically for the subject device's performance against these criteria, except for biocompatibility due to a color change in patient-contacting materials.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied by the specifications of the predicate device, which the subject device is deemed to meet.
| Item | Acceptance Criteria (from Predicate Device K173123) | Reported Device Performance (for Subject Device K221979) |
|---|---|---|
| SpO2 Measuring Range | 0%-100% | 0%-100% |
| SpO2 Resolution | 1% | 1% |
| SpO2 Accuracy | 70-100%, ±3% | 70-100%, ±3% |
| PR Measuring Range | 30-240 BPM | 30-240 BPM |
| PR Resolution | 1 bpm | 1 bpm |
| PR Accuracy | ±1 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater |
| Electrical Safety | Comply with IEC 60601-1, IEC 60601-1-11 | Comply with IEC 60601-1, IEC 60601-1-11 |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 |
| Performance Standard | ISO 80601-2-61 | ISO 80601-2-61 |
| Biocompatibility | Comply with ISO 10993-1, FDA Guidance (for previous device) | Cytotoxicity per ISO 10993-5, Irritation per ISO 10993-10, Sensitization per ISO 10993-10 (for new device due to color change) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states that "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." and "As the subject device utilizes the same monitoring technology as the predicate device, additional testing was not considered necessary to support the substantial equivalence."
Therefore, no new performance test data for SpO2 or PR accuracy is included for the subject device (K221979) in this submission. The assumption is that the previously cleared predicate device (K173123) met these criteria, and since the technology is the same, no new testing was deemed necessary for these aspects. Details regarding the sample size and data provenance for the predicate device's original performance testing are not provided in this summary.
For Biocompatibility testing (which was performed for the subject device due to a color change in patient-contacting materials):
- Sample Size: Not specified for each test (Cytotoxicity, Irritation, Sensitization), but standard procedures would involve multiple samples of the actual patient-contacting materials.
- Data Provenance: Not specified; assumed to be conducted in a laboratory setting as per international standards (ISO 10993).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the 510(k) summary, as no new clinical or performance studies for SpO2/PR accuracy were conducted for the subject device. For the original predicate device, pulse oximeter accuracy studies typically involve comparing the device's readings to arterial blood gas analysis (co-oximetry) measurements, which serve as the ground truth. This process usually involves clinical personnel (e.g., nurses, physicians, respiratory therapists) performing the measurements and often statistical experts involved in data analysis, but not necessarily "experts establishing ground truth" in the sense of image interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided as no new clinical or performance studies involving adjudication were conducted for the subject device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is a Pulse Oximeter, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a standalone pulse oximeter that provides direct measurements of SpO2 and PR. Its performance evaluation would inherently be "standalone" in the sense that it directly measures physiological parameters without human interpretation in the loop (beyond reading the display). The performance criteria listed (SpO2/PR accuracy) are indicative of standalone performance against a clinical reference standard. The document states "As there were no hardware, software or performance changes made to the subject device when compared to the primary predicate device, no additional non-clinical testing was considered necessary to support the substantial equivalence." This implies that the standalone performance requirements previously established for the predicate device were considered met.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For pulse oximetry, the ground truth for SpO2 accuracy is typically arterial blood gas analysis (co-oximetry), which provides a highly accurate measure of arterial oxygen saturation. For Pulse Rate (PR), the ground truth is often established by electrocardiography (ECG) or a manually measured pulse using a stopwatch. This information is not explicitly stated in this 510(k) summary for the predicate device's original testing, but these are the standard methods for validating pulse oximeter performance.
8. The sample size for the training set
This is not applicable/not provided. The device is a traditional medical device (pulse oximeter) that relies on physical principles (spectrophotometry and photoplethysmography) rather than machine learning or AI models that require training data.
9. How the ground truth for the training set was established
This is not applicable/not provided for the same reason as above; there is no "training set" in the context of this traditional device.
§ 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).