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510(k) Data Aggregation
(113 days)
Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd.
The Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
The Pulse Oximeter is intended for measuring the functional oxygen saturation and pulse rate (PR) through a patient's finger. It is applicable for spot-checking SpO2 and pulse rate (PR) of adult and pediatric patients in homes and clinics.
The Pulse Oximeter is as a stand-alone device, which is powered by an internal battery. The device is for multi-use. The device is not for life supporting or life sustaining, not for implant. The device is not sterile, the device is not a reprocessed single-use device, and the device does not contain drug or biological products.
The provided text describes the 510(k) submission for a Pulse Oximeter, asserting its substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided information:
Key Takeaway: This submission focuses on demonstrating substantial equivalence of a new Pulse Oximeter to an existing one, primarily through non-clinical testing and a clinical study to validate SpO2 accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are largely defined by regulatory standards (ISO 80601-2-61 for SpO2 accuracy) and comparison to a predicate device. The performance is reported in relation to these standards and the predicate.
| Acceptance Criteria / Performance Metric | Specific Criterion / Reported Performance |
|---|---|
| Functional Oxygen Saturation (SpO2) Accuracy (Primary Clinical Metric) | Criterion: Root-mean-square (Arms) value of the Pulse Oximeter is less than ±2% SpO2 over the declared range of 70% to 100% (per ISO 80601-2-61). |
| Reported Performance: The root-mean-square (Arms) value of the Pulse Oximeter is less than ±2% SpO2 over the declared range of 70% to 100%. Agreement between Methods of Measurement with Multiple Observations per each subject was analyzed with the Bland and Altman statistics, demonstrating the vast majority of data is within ±95% limit of agreement. | |
| Pulse Rate (PR) Display Range | Criterion (Predicate): 25bpm~250bpm |
| Reported Performance (Subject Device): 30bpm~240bpm (Different from predicate, but complies with claimed display range according to bench test report). | |
| Pulse Rate (PR) Measurement Accuracy | Criterion (Predicate): ±2bpm |
| Reported Performance (Subject Device): ±1bpm (Different from predicate, but complies with claimed measurement accuracy according to bench test report). This indicates improved accuracy compared to the predicate, which is a positive difference. | |
| Operating Environment | Criterion (Predicate): Temperature: 5°C ~ 40°C, Humidity: 15% ~ 85% |
| Reported Performance (Subject Device): Temperature: 5°C ~ 40°C, Humidity: 30% ~ 80% (non-condensing), Atmospheric pressure: 70kPa ~ 106kPa (Differences verified conforming to IEC 60601-1, IEC 60601-1-11, ISO 80601-2-61). | |
| Storage & Transport Environment | Criterion (Predicate): Temperature: -20°C ~ +55°C, Humidity: 10% ~ 95% |
| Reported Performance (Subject Device): Temperature: -20°C ~ +55°C, Humidity: 10% ~ 93% (non-condensing), Atmospheric pressure: 70kPa ~ 106kPa (Differences verified conforming to IEC 60601-1, IEC 60601-1-11, ISO 80601-2-61). | |
| Electrical Safety | Criterion: Compliance with ANSI AAMI ES60601-1:2005/(R)2012 |
| Reported Performance: Pass | |
| Electromagnetic Compatibility (EMC) | Criterion: Compliance with IEC 60601-1-2 Edition 4.0 2014-02 |
| Reported Performance: Pass | |
| Home Healthcare Environment Requirements | Criterion: Compliance with IEC 60601-1-11 Edition 2.0 2015-01 |
| Reported Performance: Pass | |
| Biocompatibility | Criterion: Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Reported Performance: Pass for all (ISO 10993-1, ISO 10993-5: Tests for in vitro cytotoxicity, ISO 10993-10: Tests for irritation and skin sensitization). | |
| Risk Management | Criterion: Compliance with ISO 14971 Second edition 2007-03-01 |
| Reported Performance: Pass | |
| Software Level of Concern | Criterion: FDA Guidance document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff" |
| Reported Performance: MODERATE level of concern; software validation documentation summarizes required information. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Testing for SpO2 Accuracy): 12 healthy adult volunteers (5 men and 7 women).
- Data Points: 278 data points were sampled for analysis.
- Data Provenance:
- Country of Origin: Not explicitly stated, but the submission is from Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd. in China, so it is likely from China.
- Retrospective or Prospective: The description "The clinical testing was completed..." suggests a prospective study, as it was conducted specifically to validate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable in the context of this Pulse Oximeter clinical study. The ground truth (SaO2 values) was established by a laboratory CO-oximeter measurement of arterial blood samples.
- Qualifications of Experts: Not applicable, as expert consensus was not the method for ground truth.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The ground truth was established by direct measurement using a CO-oximeter, not by expert review requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This device is a Pulse Oximeter, which provides objective measurements (SpO2, PR). Its performance is evaluated against reference methods (CO-oximeter reading of blood samples) and relevant standards, not by comparing human reader performance with and without AI assistance. Therefore, an MRMC study is not relevant for this type of device.
- Effect Size of Human Readers Improvement: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was a standalone study done? Yes. The clinical study for SpO2 accuracy (comparing the device's SpO2 readings to CO-oximeter SaO2 readings) is an example of standalone performance testing. The device operates independently to provide these measurements.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for SpO2 accuracy was established by outcomes data, specifically:
- Measurement of arterial hemoglobin oxygen (SaO2) values from blood samples using a CO-oximeter. This is considered the gold standard for measuring blood oxygen saturation.
8. The Sample Size for the Training Set
- Sample Size: Not applicable. Pulse Oximeters generally rely on optical principles and algorithms based on physiological models (Lambert-Beer Law) rather than machine learning models requiring extensive training data. The "algorithm" here refers to the embedded logic for calculation of SpO2 and PR, derived from established principles, not a typical AI/ML training process.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable, as there isn't a "training set" in the sense of an AI/ML model needing to learn from labeled data. The device's underlying principles are based on known physics and physiology, and its accuracy is validated against a gold standard in clinical testing.
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