(420 days)
The Pulse Oximeter is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare. The device is not intended to be used under motion and low perfusion. It is designed for finger thickness between 0.8cm and 2.2cm (0.3 inches to 0.9 inches).
The proposed device, Pulse Oximeter, is a battery powered device, which can mainly detect and display the measured oxyhemoglobin saturation (SpO2) and pulse rate (PR) value. It available two models, MD300CN130 and MD300CN356. The model MD300CN130 is adopted LED screen to display SpO2 and Pulse Rate (PR) value, low power indication and pulse bar, the device has 2 display modes. The model MD300CN356 using LCD screen with 7 display modes, it can display SpO2, Pulse Rate (PR), Perfusion Index (PI), waveform, battery indicator, signal indicator and pulse bar, the brightness level can be adjusted 1-10 level.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
The enclosure of the proposed device is made of ABS and the fingertip cushion is made of Silicone Gel.
The proposed device is not for life-supporting or life-sustaining, not for implant.
The device is not sterile, and the transducers are reusable and do not need sterilization.
The device is for prescription.
The device does not contain drug or biological products.
Here's an analysis of the acceptance criteria and study detailed in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance document indicates that the device's performance was compared to its predicate device and to standards. For SpO2 and PR accuracy, the acceptance criteria are generally established by standards like ISO 80601-2-61.
| Feature / Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance (from studies) |
|---|---|---|
| SpO2 Display Range | 0%~100% | 0%~100% |
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| SpO2 Accuracy (70%~100%) | ± 2% | 70%~100%, ± 2% (implied by meeting standards) |
| SpO2 Accuracy (0~69%) | No definition | 0~69% no definition |
| SpO2 Resolution | 1% | 1% |
| PR Display Range | 30 bpm~250 bpm | 30 bpm~250 bpm |
| PR Measurement Range | 30 bpm~250 bpm | 30 bpm~250 bpm |
| PR Accuracy (30 bpm~99 bpm) | ± 2 bpm | 30 bpm~99 bpm, ± 2 bpm (implied by meeting standards) |
| PR Accuracy (100 bpm~250 bpm) | ± 2% | 100 bpm~250 bpm, ± 2% (implied by meeting standards) |
| PR Resolution | 1 bpm | 1 bpm |
| Biocompatibility | Meet ISO 10993-1, -5, -10 | Tests confirm meeting requirements (Section 5, Analysis 9) |
| Electrical Safety | Conformed to IEC60601-1, IEC 60601-1-11 | Conformed (Section 7, Non-Clinical Test Conclusion) |
| EMC | Conformed to IEC60601-1-2 | Conformed (Section 7, Non-Clinical Test Conclusion) |
| Software Validation | Compliance with FDA Guidance for Software in Medical Devices | Compliance (Section 7, Non-Clinical Test Conclusion) |
| Operational Temp (MD300CN130) | 0℃~40℃ | 0℃~40℃ (implied by meeting standard ISO 80601-2-61) |
| Operational Temp (MD300CN356 & Predicate) | 5°C~40°C | 5°C~40°C (implied by meeting standard ISO 80601-2-61) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 11 healthy adult volunteer subjects.
- Data Provenance: The study was a prospective clinical study conducted to validate SpO2 accuracy. The country of origin is not explicitly stated, but the manufacturer is based in Beijing, China, suggesting the study likely occurred in China or an affiliated location. The subjects had "light to dark pigmentation, include male and female."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not explicitly state the number of experts used to establish ground truth or their qualifications. However, the ground truth was established by "arterial blood co-oximeter," which is a laboratory instrument. This implies expert handling and interpretation of the co-oximeter results, but no specific human expert qualifications are provided for the ground truth establishment itself. Clinical personnel would have been involved in drawing blood samples and operating the co-oximeter.
4. Adjudication Method for the Test Set
Not applicable. This was a quantitative measurement comparison study against a reference standard (co-oximeter), not a qualitative assessment requiring adjudication of interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the pulse oximeter against a clinical reference standard. It did not involve human readers interpreting results with or without AI assistance.
6. If a Standalone Study Was Done
Yes, a standalone study was done. The clinical study described in Section 7 (Clinical Test) was conducted to evaluate the SpO2 accuracy performance of the proposed pulse oximeter itself, without human-in-the-loop interaction for interpretation, other than operating the device.
7. The Type of Ground Truth Used
The ground truth used was outcomes data / reference standard measurement from an "arterial blood co-oximeter." This is considered a gold standard for measuring arterial oxygen saturation (SaO2).
8. The Sample Size for the Training Set
The document does not provide information regarding a training set or its size. As this is a traditional medical device (pulse oximeter) and not explicitly a machine learning/AI device in the context of image analysis or complex pattern recognition requiring a training set, such information would typically not be present in its 510(k) submission. Pulse oximeters operate based on established physiological principles and algorithms, rather than training on large datasets in the way modern AI models do.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set information is provided or implied for this type of 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).