(136 days)
The Reusable SpO2 Sensors are indicated for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.
The proposed device, Reusable SpO2 Sensors are accessories to patient monitors, which are intended for continuous non-invasive monitoring of functional arterial oxygen saturation and pulse rate. The compatible patient monitor is EDAN iM50 with Nellcor SpO2 module (K113623).
The sensor shall be connected with its corresponding monitor. 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 pulse rate conditions.
Each sensor has two LEDs, emitting both red and infrared light, and a photodiode. The light is emitted through human finger and received by a photodiode. Then the received signal is forwarded to the corresponding oximeter that amplifies the signal and an algorithm that calculates the ratio. The saturation value is determined by the percentage ratio of the oxygenated hemoglobin (HbO2) to the total amount of hemoglobin (Hb).
Here's a breakdown of the acceptance criteria and study details for the Reusable SpO2 Sensor, based on the provided FDA 510(k) summary:
This device is a Reusable SpO2 Sensor, an accessory to patient monitors used for continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult (> 40 kg) and pediatric (10-50 kg) patients.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document specifically details performance criteria and claims for SpO2 and PR accuracy compared to a legally marketed predicate device.
| Criteria | Acceptance Criteria (Predicate Device K142832) | Reported Device Performance (Reusable SpO2 Sensor) | Meets Criteria? |
|---|---|---|---|
| SpO2 Range | 70% - 100% | 70% - 100% | Yes |
| SpO2 Accuracy | ±3% | ±3% | Yes |
| PR Range | 30 bpm - 250 bpm | 30 bpm - 250 bpm | Yes |
| PR Accuracy | ±3 | ±3 | Yes |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Yes |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Yes |
| Performance (general) | Complied with ISO 80601-2-61 | Complied with ISO 80601-2-61 | Yes |
| Biocompatibility - Cytotoxicity | Complied with ISO 10993-5 | Complied with ISO 10993-5 | Yes |
| Biocompatibility - Skin Irritation | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Yes |
| Biocompatibility - Sensitization | Complied with ISO 10993-10 | Complied with ISO 10993-10 | Yes |
Note: The document emphasizes substantial equivalence to the predicate device, meaning the new device's performance is demonstrated to be equivalent to a device already cleared by the FDA. The performance data presented are in direct comparison to the predicate's stated specifications.
Study Details Proving Device Meets Acceptance Criteria:
The information provided is typical for a 510(k) submission, focusing on demonstrating substantial equivalence rather than a detailed standalone clinical study report.
2. Sample Sizes Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document states that "Clinical hypoxia test results were obtained in human adult volunteers." However, the specific number of adult volunteers (sample size) used for the clinical accuracy testing is not provided in this summary.
- Data Provenance: The data appears to be prospective clinical data gathered specifically for this submission, as indicated by "Clinical testing has been performed under an approved protocol with subject informed consent." The country of origin for the data is not explicitly stated, but the submitting company and correspondent are based in Shenzhen, China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- This information is not provided in the document. For pulse oximetry clinical studies, ground truth is typically established by arterial blood gas analysis (co-oximetry), not by expert consensus on visual assessment or interpretation.
4. Adjudication Method for the Test Set:
- Adjudication methods (like 2+1, 3+1) are typically relevant for studies involving human interpretation of medical images or data where subjective decisions are made. For a pulse oximetry study where ground truth is established by a quantitative measurement (co-oximetry), traditional adjudication methods as described are not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. MRMC studies are designed to compare the performance of human readers, often with and without AI assistance, especially in diagnostic imaging. This device is a sensor, and its accuracy is assessed quantitatively against a gold standard (co-oximetry), not through human reader interpretation. Therefore, questions about an effect size of human readers improving with AI assistance are not applicable to this type of device and study.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done:
- Yes, in essence. The clinical accuracy study ("Clinical hypoxia test results were obtained in human adult volunteers to validate the accuracy of Changke Reusable SpO2 Sensors versus arterial oxygen saturation (SaO2) as determined by co-oximetry") assesses the performance of the device (including its internal algorithm for calculating SpO2 and PR) against a gold standard. While the device outputs data for human use, the accuracy assessment itself is effectively a standalone performance evaluation of the sensor and its processing capabilities.
7. The Type of Ground Truth Used:
- The ground truth used for the clinical accuracy testing was arterial oxygen saturation (SaO2) as determined by co-oximetry. Co-oximetry is considered the gold standard for measuring arterial oxygen saturation.
8. The Sample Size for the Training Set:
- This information is not provided in the 510(k) summary. For medical devices, particularly sensors, "training set" is often interpreted as the data used during the development and calibration of the device's algorithms. The summary focuses on the validation data (clinical studies) rather than internal R&D or algorithm training data.
9. How the Ground Truth for the Training Set Was Established:
- As the sample size and specific details of a "training set" (in an AI/ML context) are not explicitly mentioned for this device's development, the method for establishing ground truth for any such internal data is not provided. However, it is inferred that similar, highly accurate methods (like co-oximetry) would have been used during the sensor's design and calibration phases to ensure its foundational accuracy.
§ 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).