(60 days)
The Disposable SpO2 Sensor is indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adults in hospital environment.
The proposed device, Disposable SpO2 Sensor is an accessory to the patient monitors, which are intended for continuous monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 cleared in K113623. The sensor shall be connected to its corresponding monitor through adapter cable model CK-03-452. Oxygenation of blood is measured by detecting the infrared and red-light absorption characteristics of deoxygenated hemoglobin and oxygenated hemoglobin, which consists of a probe attached to the patient's finger. The sensor is connected to a data acquisition system which is used to calculate and display oxygen saturation levels and heart rate conditions. Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. Red and infrared light are emitted through fingertips and received by a photodiode can be induced to change with pulse light intensity; the electrical signals in the form of change. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. By measuring the wave crest of the pulse wave and the absorbance of the trough, SpO2 is calculated to obtain the correct oxygen saturation value. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
The provided text is a 510(k) Summary for a Disposable SpO2 Sensor (K200069). It details the device's technical specifications, intended use, and comparison to a predicate device (K191279). The document also outlines the performance data submitted to support the substantial equivalence determination, including biocompatibility, non-clinical, and clinical studies.
Based on the provided text, here's the information requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Range | 70% - 100% | 70% - 100% |
| SpO2 Accuracy | +/- 3% | +/- 3% |
| PR Range | 30 bpm - 250 bpm | 30 bpm - 250 bpm |
| PR Accuracy | +/- 3 | +/- 3 |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
| Performance | Complied with ISO 80601-2-61 | Complied with ISO 80601-2-61 |
| Biocompatibility (Cytotoxicity) | Complied with ISO 10993-5 | Complied with ISO 10993-5 |
| Biocompatibility (Skin Irritation) | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
| Biocompatibility (Sensitization) | Complied with ISO 10993-10 | Complied with ISO 10993-10 |
Study Proving Acceptance Criteria:
The study that proves the device meets the acceptance criteria is a clinical hypoxia test conducted on human adult volunteers to validate the accuracy of the Disposable SpO2 Sensor against arterial oxygen saturation (SaO2) determined by co-oximetry. This clinical study was performed according to ISO 80601-2-61:2017 and FDA guidance for Pulse Oximeters - Premarket Notification Submissions.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document states "human adult volunteers" but does not specify the exact number of subjects used in the clinical hypoxia test.
- Data Provenance: The data is prospective clinical data obtained from human adult volunteers. The country of origin is not explicitly stated, but the applicant and correspondent are based in Shenzhen, China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information about the number or qualifications of experts used to establish the ground truth. It states that arterial oxygen saturation (SaO2) was "determined by co-oximetry," which is a laboratory method, not typically an expert consensus per se.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. The ground truth was established by co-oximetry.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted. This is a medical device, specifically a sensor, that provides a direct measurement, rather than an interpretation requiring multiple readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the clinical hypoxia test evaluated the standalone performance of the device's ability to measure SpO2. The device functions as a sensor with an algorithm to calculate SpO2 and PR, and the clinical study validated this algorithm's accuracy without a human explicitly "in the loop" for interpretation.
7. The Type of Ground Truth Used
The type of ground truth used was outcomes data / reference standard measurement, specifically arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is a highly accurate laboratory method for measuring various hemoglobin species, including SaO2.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. This device is a sensor and likely uses empirically derived algorithms and calibration, rather than a machine learning model that requires a distinct training set. The clinical study mentioned is for validation/testing.
9. How the Ground Truth for the Training Set Was Established
As no training set is explicitly mentioned or implied for a machine learning model, the method for establishing its ground truth is not applicable in this context. The core algorithm for pulse oximetry is based on known physical principles of light absorption by blood components.
§ 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).