(118 days)
The Nellcor™ Bedside SpO2 Patient Monitoring System is indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO₂) and pulse rate. The Nellcor™ Bedside SpO2 Patient Monitoring System is intended for prescription use only with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in hospitals, hospital-type facilities, and intra-hospital transport.
Note:
- · Hospital use typically covers such areas as general care floors (GCFs), operating rooms, special procedure areas, intensive and critical care areas within the hospital, and in hospitaltype facilities.
- · Hospital-type facilities include physician office-based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acute centers.
- · Intra-hospital transport includes transport of a patient within the hospital or hospital- type facility.
The Nelloor™ Bedside SpO2 Patient Monitoring System provides continuous, noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
Here's an analysis of the provided text regarding the Nellcor™ Bedside SpO2 Patient Monitoring System's acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance:
The provided document, a 510(k) Summary, acts as a submission for substantial equivalence. It does not explicitly state acceptance criteria in a quantitative format (e.g., specific accuracy thresholds for SpO2 or pulse rate) for the device under review. Instead, the primary "acceptance criterion" is qualitative: substantial equivalence to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (Covidien Oximeter, Model Nellcor OxiMax N-600x Pulse Oximeter with SPD - K083325) in terms of performance, technology, and intended use. | The Nellcor™ Bedside SpO2 Patient Monitoring System uses the same Oximax SpO2 technology and software algorithm as the predicate device (N-600X). It is intended to be used with the same Nellcor SpO2 sensors. The clinical performance is stated to be equivalent to the Nellcor Puritan Bennett, model OxiMax N-600X Pulse Oximeter with. The device operates with an extended pulse rate measurement range of 20 to 250 BPM, same as the predicate. |
| Compliance with general controls and relevant standards for medical devices. | The system has been tested in accordance with system V&V summary (#MDR-YW110610-01). Risk analysis has been developed and applied. Mediana's quality system conforms to 21CFR820, ISO 9001, ISO13485, and CMDCAS ISO 13485. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states: "Because there are no changes to the performance, technology, and intended use of the device, the clinical data submitted as part of the premarket notifications for the predicate device (N-600X) also applies to the Nellcor Bedside SpO2 Patient Monitoring System."
Therefore, there is no new clinical test set specifically for the Nellcor™ Bedside SpO2 Patient Monitoring System described in this 510(k) summary. The "test set" and its provenance would refer to the clinical studies submitted for the predicate device (K083325). The current document does not provide details about the sample size, country of origin, or retrospective/prospective nature of the data pertaining to the predicate device's studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
As explained above, no new clinical test set for this device is detailed. Therefore, this document does not provide information on the number or qualifications of experts used to establish ground truth for a test set. This information would need to be found in the 510(k) submission for the predicate device (K083325).
4. Adjudication Method for the Test Set:
Given that no new clinical test set specific to this device is presented, the document does not describe an adjudication method. This information would refer to the studies for the predicate device.
5. 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 device is an oximeter, which provides direct physiological measurements (SpO2 and pulse rate). It is not an AI-assisted diagnostic imaging device or a system that involves human "readers" interpreting images or complex data and making decisions that could be improved by AI assistance. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed or mentioned in this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The document describes the device as a "continuous, noninvasive monitoring system" that provides "functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate." This is inherently a "standalone" performance by the algorithm/device. The device's performance is reported in terms of its equivalence to the predicate, which itself is a standalone oximetry device.
The statement, "The clinical performance of the Nellcor™ Bedside SpO2 Patient Monitoring System when used with adult, pediatric and neonatal patients is equivalent to the Nelloor Puritan Bennett, model OxiMax N-600X Pulse Oximeter with," suggests a standalone comparison was essentially accepted by virtue of its identical technology to the predicate.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):
Again, referring to the predicate device's clinical data, the ground truth for pulse oximetry accuracy is typically established through arterial blood gas (ABG) analysis, where direct measurements of arterial oxygen saturation (SaO2) are obtained and then compared to the SpO2 readings from the pulse oximeter. This is a physiological gold standard. The document does not explicitly state the type of ground truth, but for pulse oximeters, ABG is the standard.
8. The Sample Size for the Training Set:
The device utilizes the "same Oximax SpO2 technology and software algorithm as the predicate device, N-600X." This implies that any "training" (e.g., algorithm development and optimization) for this specific technology would have occurred during the development of the predicate device. The current submission does not provide details on the sample size used for training for the underlying Oximax SpO2 algorithm.
9. How the Ground Truth for the Training Set Was Established:
Similar to the above, any ground truth establishment for the training of the Oximax SpO2 algorithm would refer to the development phase of the predicate device. This document does not describe how ground truth was established for the training set.
§ 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).