(147 days)
The pulse oximeter is indicated for the noninvasive spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) for adult and pediatic (≥10Kg) patients during both no motion and for patients who are well or poorly perfused.
Pulse Oximeter is intended for hospitals, hospital-type facilities, home environments.
The Pulse Oximeter is a small, lightweight, portable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR) and perfusion index (PI) by measuring the absorption of red and infrared light passing through perfused tissue. It indicated for adult and pediatric (≥10Kg) patients during both no motion and motion conditions, and for patients who are well or poorly perfused.
The device consists of probe, electronic circuits, OLED/LED display (differentiated by models) and plastic housing which powered by two alkaline AAA batteries.
The provided text describes the Unimed Medical Supplies Pulse Oximeter (UC-200, UC-201, UC-202, UC-203, UC-204, UC-100, UC-101, UC-102, UC-103, UC-104) and its acceptance criteria as well as the study that proves it meets those criteria.
Acceptance Criteria and Device Performance
The device's performance is compared against the ISO 80601-2-61 standard for pulse oximeters. The acceptance criteria and reported device performance are presented in the table below:
Table 1: Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (per ISO 80601-2-61) | Reported Device Performance (All Models unless specified) |
|---|---|---|
| Measurement Accuracy (SpO2) | ||
| SpO2, No Motion | 70 – 100%, 2% ARMS, adults/pediatrics | 70 – 100%, 2% ARMS, adults/pediatrics |
| SpO2, Motion | 70 – 100%, 3% ARMS, adults/pediatrics | 70 – 100%, 3% ARMS, adults/pediatrics |
| SpO2, Low Perfusion | 70 – 100%, 2% ARMS, adults/pediatrics | 70 – 100%, 2% ARMS, adults/pediatrics (for UC-200/UC-100) |
| Measurement Accuracy (Pulse Rate) | ||
| Pulse Rate, No Motion | 25 – 250 BPM, 2 BPM ARMS, adults/pediatrics | 25 – 250 BPM, 2 BPM ARMS, adults/pediatrics |
| Pulse Rate, Motion | 25 – 250 BPM, 4 BPM ARMS, adults/pediatrics | 25 – 250 BPM, 4 BPM ARMS, adults/pediatrics |
| Pulse Rate, Low Perfusion | 25 – 250 BPM, 2 BPM ARMS, adults/pediatrics | 25 – 250 BPM, 2 BPM ARMS, adults/pediatrics (for UC-200/UC-100) |
| Display Range | ||
| Oxygen Saturation (SpO2) | 0-100% | 0-100% |
| Pulse Rate (PR) | 25-250 beats per minute (BPM) | 25-250 beats per minute (BPM) |
| Perfusion Index (PI) | 0.02-20% | 0.02-20% |
| Display Resolution | ||
| SpO2 | 1% | 1% |
| PR | 1 BPM | 1 BPM |
| Other Compliance Standards | ||
| Biocompatibility | ISO 10993-1, ISO 10993-5, ISO 10993-10 | ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Electrical Safety | IEC 60601-1, IEC 60601-1-11 | IEC 60601-1, IEC 60601-1-11 |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 |
| Photobiological Safety | IEC 62471 | IEC 62471 |
| Usability | IEC 60601-1-6, IEC 62366-1 | IEC 60601-1-6, IEC 62366-1 |
| Symbols | EN ISO 15223-1 | EN ISO 15223-1 |
Study Proving Acceptance Criteria is Met
The document states that the subject devices (Unimed Pulse Oximeters) are identical to the predicate device (Nariq Bio-Medical Pulse Oximeter, K211632). Therefore, the studies conducted for the predicate device are used to demonstrate the substantial equivalence and compliance of the subject device.
Here's the breakdown of the study details based on the provided text:
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1. Sample sized used for the test set and the data provenance:
- The document does not explicitly state the sample size for the test set of the predicate device.
- The data provenance is not explicitly mentioned as retrospective or prospective, nor is the country of origin specified in detail for the clinical data. It generally refers to clinical testing that aligns with ISO 80601-2-61:2017.
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2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The general reference is to compliance with ISO standards, which implies the ground truth methodology as defined in those standards for pulse oximetry accuracy.
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3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document. The text indicates that the predicate devices have undergone clinical testing that meets relevant consensus standards (ISO 80601-2-61:2017), which would dictate the clinical study design and ground truth establishment methods for SpO2 accuracy.
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4. 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:
- This is not applicable to this device. The device is a pulse oximeter for measuring SpO2 and pulse rate, not an AI-assisted diagnostic tool for human readers.
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5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance metrics provided (SpO2 and PR accuracy) are inherent to the device's measurement algorithms and sensors. Therefore, the bench and clinical testing of the predicate device assesses the standalone performance of the oximetry technology. No human-in-the-loop component is mentioned for these accuracy measurements.
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6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For SpO2 accuracy claims, the ground truth would typically be established through controlled desaturation studies against a co-oximeter (which provides gold standard arterial blood gas measurements). This is implied by the adherence to ISO 80601-2-61, which outlines these requirements.
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7. The sample size for the training set:
- This information is not applicable as the device is not described as an AI/ML product developed with a training set in the conventional sense. Its performance is based on established optical measurement principles.
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8. How the ground truth for the training set was established:
- This information is not applicable for the same reason as above.
§ 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).