(335 days)
The Pulse Oximeter CMS50EW is a non-invasive device intended for spot-check or continuous monitoring of non-invasive oxygen saturation of arterial hemoglobin (SpO2) and the pulse rate through the finger of adult patients in home and hospital environments (including clinical use internist/surgery, anesthesia, and intensive care settings). The device is reusable and not intended for out-of-hospital transport use.
The proposed device, Pulse Oximeter CMS50EW is a battery powered fingertip device, which can display % SpO2, pulse rate value and pulse strength. It is based on digital blood oxygen technology.
The proposed device is composed of power module, signal acquisition module, control and signal processing module. The power source of it is a built-in rechargeable lithium battery. And it has alarm function, to raise the user's attention for exceeding of physiological limit and device error via visual and audio alarming indicator. And the pulse oximeter can communicate with computer by USB data wire and Bluetooth.
The proposed device, Pulse Oximeter CMS50EW, is a modification to the predicate device, CMS50E, cleared under K090671; the modification is to add the blue tooth functionality, however, the oximetry technology including the sensor was unchanged.
The provided text focuses on the 510(k) summary for the Contec Medical Systems Co., Ltd.'s Pulse Oximeter CMS50EW, which is seeking substantial equivalence to its predicate device, the Pulse Oximeter CMS50E (K090671). The key modification is the addition of Bluetooth functionality, while the oximetry technology and sensor remain unchanged.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria provided are primarily in the context of performance specifications for SpO2 and Pulse Rate (PR) measurement, which are identical to the predicate device. The "reported device performance" is implicitly that the device meets these existing specifications due to the unchanged oximetry technology.
| Metric | Acceptance Criteria (Predicate) | Reported Device Performance (Proposed) |
|---|---|---|
| SpO2 Accuracy | 70% | 70% |
| SpO2 Range | 0%-100% (Same for predicate) | 0%-100% (Identical to predicate) |
| PR Measurement Range | 30bpm~250bpm (Same for predicate) | 30bpm~250bpm (Identical to predicate) |
| PR Accuracy | ±2bpm or ±2% (select the larger) (Same for predicate) | ±2bpm or ±2% (select the larger) (Identical to predicate) |
| Electrical Safety | Comply with IEC 60601-1 (Same for predicate) | Complies with IEC 60601-1 |
| EMC | Comply with IEC 60601-1-2 (Same for predicate) | Complies with IEC 60601-1-2 |
| Wireless Function | Complies with FDA guidance for Radio Frequency Wireless Technology | Wireless transmission performance, data integrity, wireless coexistence, and security of wireless data complied with acceptance criteria. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "Clinical testing was not necessary in this submission to support the device modification because the oximetry technology including the sensor is unchanged from the predicate device."
Therefore, there is no information provided regarding a specific clinical test set, sample size, or data provenance (country of origin, retrospective/prospective) for this device modification. The equivalence is based on the predicate device's established performance and non-clinical testing for the new Bluetooth functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
As no clinical testing was deemed necessary for the oximetry performance, there is no mention of experts establishing ground truth for a test set related to SpO2 or PR accuracy for the CMS50EW. Any such data would pertain to the original clearance of the predicate device (K090671) and is not detailed here.
4. Adjudication method for the test set
Not applicable, as no clinical test set for oximetry performance was performed for this submission.
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
Not applicable. This device is a pulse oximeter, not an AI-assisted diagnostic tool that would involve human readers or MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device's core functionality (SpO2 and PR measurement). The device's performance is standalone in the sense that it provides direct measurements. The non-clinical tests conducted (IEC standards, wireless transmission tests) assess this standalone performance. No detailed "algorithm only" performance separate from the device's integrated operation is described in a way that suggests a disaggregated study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the SpO2 and PR measurements, the ground truth would typically be established by established measurement techniques (e.g., co-oximetry for SpO2, ECG for heart rate) during the original clinical validation of the predicate device. However, this specific submission does not detail the ground truth methodology for this device because it relies on the predicate's established oximetry technology. For the new wireless functionality, the "ground truth" would be the expected technical specifications and performance indicators for wireless transmission.
8. The sample size for the training set
Not applicable, as this is not an AI/machine learning device requiring a training set in the conventional sense. The device's oximetry technology is formula-based, using the Lambert-Beer Law.
9. How the ground truth for the training set was established
Not applicable for the same reason as point 8. The device's operation is based on established biophysical principles and calibrated with known values, not trained on a dataset.
§ 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).