(303 days)
The Pulse Oximeter is intended for spot-checking oxygen saturation and pulse rate, and the device is a reusable device and intended to be used with the finger of adults in professional healthcare facility or home conditions when physician follow-up and operated by a physician. And it is not intended to be used under motion or low perfusion scenarios.
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subject device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.
Here's a breakdown of the acceptance criteria and study information for the Pulse Oximeter, models SO611, SO711, SO811, and SO911:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Set by Standard ISO 80601-2-61:2017) | Reported Device Performance (K212665) |
|---|---|
| SpO2 Accuracy: 70-100%: ±2% | 70-100%: ±2% |
| SpO2 Range: 0%-100%, effective measurement range 70%-100% | 0%-100%, effective measurement range 70%-100% |
| SpO2 Resolution: 1% | 1% |
| Pulse Rate Range: 25 bpm ~ 250 bpm (Predicate device's criteria, subject device is within a comparable range) | 30 bpm ~ 250 bpm |
| Pulse Rate Accuracy: ±3 bpm (Meets requirements defined in ISO 80601-2-61, Clause 201.12.1.104) | ±3 bpm |
| Pulse Rate Resolution: 1 bpm | 1 bpm |
| Biocompatibility: Complies with ISO 10993-1 (Cytotoxicity, Skin Sensitization, Skin Irritation) | Passed (Cytotoxicity, Skin Sensitization, Skin Irritation) |
| Electrical Safety: Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-11:2015 | Complies with IEC 60601-1:2005/A1:2012, IEC 60601-1-11:2015 |
| EMC: Complies with IEC 60601-1-2:2014 | Complies with IEC 60601-1-2:2014 |
| Software Verification & Validation: Complies with FDA Guidance for "moderate level of concern" software | Provided and passed |
| Cleaning Validation: No degradation after repeated cleaning/disinfection as per FDA guidance | No degradation observed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 13 healthy volunteers.
- Data Provenance: The document does not explicitly state the country of origin but implies a clinical study conducted by the manufacturer or a contracted clinical research organization. The study included "3 light skin subjects and 3 dark skin subjects" suggesting an attempt at diversity but does not specify nationality. The study is prospective as it's a clinical trial designed to evaluate the device's accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not mention the use of experts to establish ground truth for the clinical test set. Instead, it refers to a clinical study conducted "per Annex EE Guideline for evaluating and documenting SpO₂ACCURACY in human subjects of ISO 80601-2-61:2011". This typically implies comparison against a co-oximeter or another highly accurate, reference method for blood oxygen saturation measurement directly from blood samples as the ground truth.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth for SpO2 accuracy is typically established by high-precision medical reference devices (e.g., co-oximeters) which do not involve expert adjudication in the same way as imaging studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No MRMC comparative effectiveness study was mentioned. This type of study is more common for diagnostic imaging devices where human interpretation plays a significant role. For a pulse oximeter, the performance is typically assessed by objective accuracy measurements against a reference standard.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, the performance testing described is for the device in a standalone capacity. The clinical testing evaluates the device's ability to accurately measure SpO2 and pulse rate on its own, without human intervention affecting the measurement output. The device itself is "intended for spot-checking oxygen saturation and pulse rate" and is operated by a physician, but the performance validation is of the device's direct measurement capabilities.
7. Type of Ground Truth Used
The ground truth used for SpO2 accuracy in the clinical study is established "per Annex EE Guideline for evaluating and documenting SpO₂ACCURACY in human subjects of ISO 80601-2-61:2011". This standard typically refers to fractional oxygen saturation measured directly from arterial blood samples using a co-oximeter as the reference standard. The document implies a direct comparison of the device's readings against this gold standard.
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. For traditional medical devices like pulse oximeters, particularly those not heavily relying on complex machine learning algorithms for core functionality, dedicated "training sets" are often not explicitly defined in the same way as for AI/ML devices. The device's calibration and algorithm development might be based on extensive in-house data and engineering, but not typically disclosed as a distinct "training set" in regulatory submissions for these types of devices.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a distinct training set and its ground truth establishment are not described in the document for this 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).