(210 days)
The Nonin® Model 9591Onyx® 3 Finger Pulse Oximeter is a small, lightweight, portable and reusable spot-check device indicated for use in measuring and displaying function of arterial hemoglobin (%SpO2) and pulse rate of patients who are well or poorly perfused. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute.
For %SpO2, and pulse rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, skilled nursing facilities, and home healthcare services. It is intended for adult and pediatric patients who are well or poorly perfused, with digits that are between 0.3 – 1.0 inch (0.8 –2.5 cm) thick, under non-motion conditions.
For Respiration rate, the 9591 is intended for use in hospitals, clinics, long-term care facilities, and home healthcare services. It is intended for adult who are well perfused, with digits that are between 0.3 – 1.0 inch (0.8 - 2.5 cm) thick, under non-motions. It is not intended for use in high-acuity environments, such as ICU or operating rooms where continuous monitoring is expected.
The Model 9591 Finger Pulse Oximeter is a small, lightweight, portable, reusable, digit pulse oximeter that displays numerical values for functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by measuring the absorption of red and infrared (IR) light passing through perfused tissue. The SpO2, pulse rate, and respiration rate are displayed on the LCD display contained within the device. A color LCD provides a visual indication of the pulse signal, while blinking at the corresponding pulse rate. The display will indicate of poor pulse quality that may affect the readings. The Respiration Rate parameter provides a non-invasive measurement of respiration rate, in breaths per minute. It is intended for spot-checking of adult and pediatric patients who are well or poorly perfused with digits that are between 0.3 - 1.0 inch (0.8 - 2.5 cm) thick.
This document describes the premarket notification (510(k)) for the Nonin Onyx 3, Model 9591 Finger Pulse Oximeter. The device measures functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate, and also provides a non-invasive measurement of respiration rate.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Nonin Onyx 3, Model 9591 are primarily based on demonstrating substantial equivalence to predicate devices and compliance with recognized standards such as ISO 80601-2-61:2011 for pulse oximeters. The performance values are compared against those of the predicate devices.
| Metric / Parameter | Acceptance Criteria (based on predicate/standards) | Reported Device Performance (Nonin Onyx 3, Model 9591) |
|---|---|---|
| SpO2 Accuracy (Adult/Pediatric) | ± 2 digits (± 1 ARMS) from predicate (K131021) | ± 2 digits (± 1 ARMS) |
| Low Perfusion SpO2 | ± 2 digits (± 1 ARMS) from predicate (K131021) | ± 2 digits (± 1 ARMS) |
| Pulse Rate Accuracy (Adult/Pediatric) | 20 to 250 BPM ± 3 digits from predicate (K131021) | 20 to 250 BPM ± 3 digits |
| Low Perfusion Pulse Rate | 40 to 240 BPM ± 3 digits (from predicate) | 40 to 240 BPM ± 3 digits |
| Respiration Rate Accuracy | Demonstrated through comparative study (against Capnography) | Accuracy was calculated using mean error and RMSE. Specific quantitative acceptance criteria or results are not explicitly stated in this document beyond "Pass" for "Performance" to ISO 80601-2-61. The comparison is made against the Nellcor reference device which has a range of 4 to 40 breaths/minute, and the proposed device has a range of 3 to 44 breaths/minute. |
| Electrical Safety | IEC 60601-1 | Pass |
| EMC (Immunity & Emissions) | IEC 60601-1-2 | Pass |
| Ingress Protection | ISO 80601-2-61 (IP32 for previous Nonin predicate) | IP32 (more protection than Nellcor IPX1) |
| Temperature and Humidity | IEC 60601-1 | Pass |
| Atmospheric Pressure (Altitude) | IEC 60601-1 | Pass |
| Mechanical Durability | IEC 60601-1, ISO 80601-2-61 | Pass |
| Biocompatibility | ISO 10993-1 | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance
- Respiration Rate Accuracy Verification Clinical (QATR10912):
- Sample Size: A total of 30 subjects were enrolled.
- Data Provenance: Single-center, randomized study. The country of origin is not specified, but given the FDA submission, it is likely the US. The study is described as "clinical," implying a prospective data collection approach for this specific test.
- SpO2 Accuracy Testing:
- Sample Size: Healthy, male and female, non-smoking, light to dark-skinned subjects that were 18 years of age and older. The exact number of subjects is not specified beyond "all subjects" when referring to ARMS calculation.
- Data Provenance: Conducted at an independent research laboratory. The country of origin is not specified, but likely the US. This also implies a prospective clinical study where arterial blood samples were taken.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test sets.
- Respiration Rate: Ground truth was established by Capnography based respiratory rate. This is an objective measurement, not directly relying on human expert interpretation for ground truth.
- SpO2 Accuracy: Ground truth was established by co-oximetry analysis of simultaneous arterial blood samples. This is a gold standard, objective measurement and does not involve human expert consensus for ground truth.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth for both Respiration Rate and SpO2 accuracy was established through objective, clinical gold standard measurements (Capnography and co-oximetry), rather than subjective expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The performance assessment focused on the device's accuracy against recognized clinical standards/predicate devices, not on how human readers' performance might improve with or without AI assistance from this device. This device is a direct measurement device (pulse oximeter), not an AI-assisted diagnostic tool for image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the studies described (Respiration Rate Accuracy, SpO2 Accuracy) evaluate the standalone performance of the device itself (the Model 9591 Pulse Oximeter) against established ground truth methods. It measures and displays the parameters, and its accuracy is assessed in isolation from human interpretation.
7. The Type of Ground Truth Used
- Respiration Rate: Capnography based respiratory rate. (Objective, physiological measurement)
- SpO2 Accuracy: Co-oximetry of simultaneous arterial blood samples. (Objective, laboratory gold standard)
8. The Sample Size for the Training Set
The document does not specify a separate "training set" or its sample size. For a device like a pulse oximeter that relies on physiological principles and signal processing, a distinct "training set" in the context of machine learning (where algorithms learn from large datasets) is typically not applicable in the same way as it would be for an AI-based image analysis tool. The device's algorithms are likely developed and validated through engineering design, signal processing, and testing against known physiological responses, rather than deep learning from a "training set" of patient data.
9. How the Ground Truth for the Training Set was Established
Not applicable, as a distinct "training set" in the context of machine learning is not mentioned or implied for this device's development as described. The performance validation relies on the clinical studies mentioned above, comparing the device's output to objective physiological measurements.
§ 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).