(361 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 during both no motion and motion conditions, and for patients who are well or poorly perfused. The monitoring system is intended for use in hospitals, hospitaltype facilities, and during intra-hosport. 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 for the continuous, non-invasive monitoring of respiration rate in adult patients who are well perfused during no motion conditions, 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 monioning of functional onlygon 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 ber" presentation or plethysmographic waveform. The Bedside Respiratory Patient Monitoring System can be bur "proomation" on plannyamosphy 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.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Metric / Condition | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (70-100% SpO2 Range) | Root Mean Square (ARMS) within defined standards (implied by adherence to "Pulse Oximeters Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug . Administration Staff") | Meets ARMS acceptance criteria for both SpO2 and Pulse Rate in comparison to reference-standard measurements of blood SaO2 by a CO-Oximeter during motion and non-motion conditions. Also demonstrated accuracy in low saturation conditions. |
| Pulse Rate Accuracy | Root Mean Square (ARMS) within defined standards (implied by adherence to "Pulse Oximeters Premarket Notification Submissions [510(k)s]: Guidance for Industry and Food and Drug . Administration Staff") | Meets ARMS acceptance criteria for both SpO2 and Pulse Rate in comparison to reference-standard measurements of blood SaO2 by a CO-Oximeter during motion and non-motion conditions. Also demonstrated accuracy in low saturation conditions. |
| Respiration Rate Accuracy (Adults, well perfused, no motion, 4-40 BrPM) | ±1 breath per minute | Calculates respiration rate within a stated accuracy of ±1 breath per minute. |
2. Sample Size Used for the Test Set and Data Provenance
- SpO2 and Pulse Rate: "healthy, well perfused adults ranging in skin pigmentation from light to dark" were used for clinical testing. The specific number of subjects is not provided.
- Respiration Rate: "healthy adult volunteers" were used for clinical validation studies. The specific number of subjects is not provided.
- Data Provenance: Clinical studies were conducted following US regulations (21 CFR Part 812, 50, 56) and ICH Harmonized Tripartite Guideline for Good Clinical Practice (E6(R1)10). This indicates it was prospective clinical data, likely collected in the United States or in accordance with international standards that might imply multi-country data if a multi-site study, but no specific country is explicitly stated beyond the regulatory framework.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of "experts" in the context of establishing ground truth for the device's performance. Instead, it refers to reference-standard measurements of blood SaO2 by a CO-Oximeter for SpO2 and Pulse Rate, and the "Respiration Rate Software algorithm" itself for respiration rate.
4. Adjudication Method for the Test Set
No adjudication method is mentioned or implied for either the SpO2/Pulse Rate or Respiration Rate accuracy studies. The ground truth relies on objective reference measurements (CO-Oximeter readings).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This device is a measurement instrument (pulse oximeter) and the studies described are focused on comparing its readings to a gold standard, not on human readers' interpretation aided by AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the studies described are standalone performance evaluations of the device's algorithms. The device itself (the "Bedside Respiratory Patient Monitoring System") directly measures and displays SpO2, pulse rate, and respiration rate. The "Respiration Rate Software algorithm" is specifically mentioned as a standalone component whose accuracy was validated. There is no mention of a human-in-the-loop component for these quantitative measurements.
7. The Type of Ground Truth Used
- SpO2 and Pulse Rate: Reference-standard measurements of blood SaO2 by a CO-Oximeter. This is considered a gold standard objective measurement for blood oxygen saturation.
- Respiration Rate: The clinical validation studies "assessed the accuracy of the Respiration Rate Software residing on the oximeter." It also states, "The studies demonstrated the Respiration Rate Software algorithm calculates respiration rate within a stated accuracy of ±1 breath per minute, and is shown to be substantially equivalent to the predicate device with respect to Respiration Rate (for adults)." While not explicitly stated, it's generally understood that respiration rate accuracy for such devices is established against a clinical reference standard, most commonly manual counting by an expert or a calibrated spirometer/capnograph. The document does not explicitly state the specific reference method used for respiration rate, but it refers to "mimic clinical free breathing studies on healthy volunteer subjects."
8. The Sample Size for the Training Set
The document does not provide any information about a training set size. The context is a 510(k) submission for a device with an engineering design change (new PCBA) and expanded indications for use. The focus is on demonstrating clinical accuracy and equivalence, rather than developing a new algorithm from scratch using a separate training set. It's possible the algorithms were developed and "trained" internally by Covidien, but no details are publicly supplied here.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the provided text, there is no information on how its ground truth was established.
§ 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).