(251 days)
For Software: The Covidien Nellcor™ Respiration Rate Software, when used in conjunction with a Nellcor pulse oximeter and a Nellcor Respiration Rate Sensor, is intended to be used for the continuous, non-invasive monitoring of respiration rate in adults in hospitals and hospital-type facilities.
For Sensor: The Nellcor™ Adult Respiratory Sensor, when used in conjunction with a Nellcor pulse oximeter and the Nellcor Respiration Rate Software Application, is indicated for single patient use when continuous noninvasive arterial oxygen saturation, pulse rate and respiration rate monitoring are required for adult patients weighing more than 30 kg.
The Covidien Nellcor™ Respiration Rate Software allows for the continuous noninvasive monitoring of arterial oxygen saturation (SpO2), pulse rate and respiration rate using a single sensor. The previously cleared Nellcor N-600x pulse oximeter collects the photoplethysmography signal from the patient via the Covidien Nellcor™ Adult Respiratory sensor attached to the patient. This signal is processed by the pulse oximeter to determine SpO2 and pulse rate. Data is then transmitted from the pulse oximeter to a medical grade PC via a data port.
The Respiration Rate Software (RRS) is installed on a medical-grade PC and utilizes data from the pulse oximeter to calculate respiration rate. The RRS also provides an interactive user interface to display respiration rate, trending, system status and alarm information to the user. The RRS also allows for the collection and storage of data on the medical grade PC for subsequent export.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Respiration Rate Monitoring Range (Adults) | 4-40 breaths/minute |
| Respiration Rate Accuracy | ±1 breath per minute |
| Non-invasive Monitoring | Achieved (uses photoplethysmography via a single sensor) |
| Continuous Monitoring | Achieved |
| Intended Population | Adults (≥30 kg, in hospitals and hospital-type facilities) |
| Substantial Equivalence to Predicate Device | Demonstrated with respect to safety, effectiveness, and performance. |
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text mentions "Clinical validation studies on healthy adult volunteers and on subjects from the hospital general care floor."
- Data Provenance:
- Country of Origin: Not explicitly stated.
- Retrospective or Prospective: Prospective, as it refers to "clinical validation studies... were conducted."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications: Not specified. The gold standard is mentioned, but not how experts interacted with it to establish ground truth for the device's assessment.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC study comparing human readers with and without AI assistance was not done. The study focused on the device's standalone accuracy compared to a gold standard and a predicate device.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:
- Standalone Performance: Yes. The "Respiration Rate Software algorithm" was evaluated for its accuracy. The text states, "The studies demonstrated the accuracy of the Respiration Rate Software algorithm was as good at the predicate, transthoracic impendence measurements, when both were compared a gold standard."
7. The Type of Ground Truth Used:
- Ground Truth: "Gold standard." While the specific nature of this gold standard is not detailed, in the context of respiration rate monitoring, it typically refers to direct observation, capnography, or a highly accurate clinical measurement method.
8. The Sample Size for the Training Set:
- Sample Size: Not provided. The document focuses on performance testing rather than algorithm development/training data.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth Establishment: Not provided. As with the training set size, the document does not detail the specifics of the algorithm's development or the ground truth used for its training.
§ 868.2375 Breathing frequency monitor.
(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).