(100 days)
For Covidien Nellcor Bedside Respiratory Patient Monitoring System with Respiration Rate Software:
The Nellcor™ Bedside Respiratory Patient Monitoring System is a portable pulse oximeter intended for prescription use only as a continuous non-invasive monitor of arterial oxygen saturation (SpO₂) and pulse rate of adult, pediatric, and neonatal patients and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport. The OxiMax SPD™ Alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.
The Respiration Rate parameter, when used in conjunction with the Nellcor Bedside Respiratory Patient Monitoring System and Nellcor Respiratory Sensor, is intended to be used for the continuous non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.
The Covidien Nellcor Bedside Respiratory Patient Monitoring System is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of a range of compatible Nellcor OxiMax oxygen transducers (sensors). The Bedside Respiratory Patient Monitoring System displays digital values of SpO2 and pulse and respiratory rate. Pulse amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (from 80VAC to 264VAC) or alternatively by an integral sealed 7.2V, 83W/hr rechargeable lithium-ion battery. The Nellcor OxiMax Bedside Respiratory Patient Monitoring System is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, and intra-hospital transport.
The provided 510(k) summary for the Covidien Nellcor Bedside Respiratory Patient Monitoring System primarily establishes substantial equivalence to predicate devices and focuses on the integration of existing respiration rate software. It does not present a new study with specific acceptance criteria and detailed performance data for this device.
Instead, the summary states:
- "The Bedside Respiratory Patient Monitoring System features the same performance characteristics as the predicate K083325, N-600x Pulse Oximeter with Oximax SPD Alert."
- "performance data to demonstrate saturation and pulse rate accuracy, and SPD are unchanged and the associated information provided in K060576 and K083325 are applicable to the device subject of this submission."
- "Integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate based upon oximetry ohotoplethysmography data, therefore performance data to respiration rate are unchanged and the associated information provided in K111933 are applicable to the device subject of this submission."
Therefore, the detailed acceptance criteria and study information you requested would reside within the referenced predicate device submissions (K060576, K083325, and K111933), not in this document. This submission relies on the previously established performance of its components.
However, I can extract the information provided about the overall performance testing and what was confirmed by this submission:
1. Table of Acceptance Criteria and Reported Device Performance
As this submission does not present new, specific acceptance criteria for a novel study, but rather refers to predicate devices, the table below reflects the general scope of verification mentioned. Specific quantitative acceptance criteria and reported numerical performance values for parameters like SpO2 accuracy, pulse rate accuracy, and respiration rate accuracy are not provided in this document but would be found in the predicate 510(k)s.
| Acceptance Criterion (Type of Test) | Reported Device Performance (as stated in this submission) |
|---|---|
| Saturation (SpO2) Accuracy | Unchanged from K060576 and K083325 predicate devices. |
| Pulse Rate Accuracy | Unchanged from K060576 and K083325 predicate devices. |
| SPD (OxiMax SPD Alert) Performance | Unchanged from K083325 predicate device. Validated for detection of patterns indicative of repetitive reductions in airflow. |
| Respiration Rate Accuracy | Unchanged from K111933 predicate device. |
| Mechanical System Features Verification | Met specified requirements. |
| Software System Features Verification | Met specified requirements. |
| Operating Range Verification | Met specified requirements. |
| 20-point COPs Accuracy (Bench Test) | All verification and validation activities met product requirements. |
| Low Perfusion Pulse Rate and Saturation Accuracy (Bench Test) | All verification and validation activities met product requirements. |
| Usability / Human Factors | Formative and Summative studies demonstrated adequate assurance of safety and performance for patient and operator. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes "Bench Testing" and "Usability / Human Factors" studies.
- Bench Testing: No sample sizes are specified for 20-point COPs or Low Perfusion tests in this document. The data provenance is implied to be laboratory/bench testing.
- Usability / Human Factors: No sample size is specified. The study was "simulated operating environments."
- Clinical Performance (SpO2, Pulse Rate, Respiration Rate): No new test set sample sizes or data provenance are stated for these parameters, as the submission relies on the data from predicate devices K060576, K083325, and K111933.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the current document, as it refers to predicate device data for clinical performance. For the usability studies, the "users" involved are noted, but their qualifications are not specified nor is there mention of experts establishing a ground truth in the context of human factors.
4. Adjudication Method
This information is not provided in the current document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not provided, and given the nature of the device (a monitoring system for physiological parameters), an MRMC study comparing human readers with and without AI assistance is unlikely to be relevant in the traditional sense. The AI (algorithm) here is for parameter calculation, not diagnostic image interpretation.
6. Standalone Performance Study
The submission states that "integration of Covidien Respiration Rate Software has not resulted in any change to the software algorithm which calculates patient respiration rate." This implies that the performance data for the algorithm (standalone) for respiration rate was established in the K111933 submission and is referenced here as unchanged. Similarly, SpO2 and pulse rate algorithms would have standalone performance established in K060576 and K083325.
This document describes "Bench Testing" which included "20-point COPs and Low Perfusion Pulse Rate and Saturation Accuracy tests," which are forms of standalone performance evaluation against a known standard.
7. Type of Ground Truth Used
- For SpO2 and Pulse Rate: Historically, pulse oximeter accuracy studies (like those in K060576, K083325) use arterial blood gas (ABG) analysis as the gold standard for oxygen saturation (SaO2), along with ECG-derived heart rate for pulse rate.
- For Respiration Rate: The K111933 submission would have detailed the ground truth for respiration rate, which typically involves manual counting by experts from capnography, impedance pneumography, or direct observation/audio recording.
- For Bench Testing: Controlled laboratory standards and reference measurements are used as ground truth (e.g., precise oxygen mixtures for CO-oximetry, simulated pulse signals).
8. Sample Size for the Training Set
This information is not provided in the current document, as the core algorithms and their training (if any neural networks were involved, which is not explicitly stated but implied by "software algorithm") were developed prior to this submission and are referenced via predicate devices.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the current document, for the same reasons as point 8.
§ 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).