(34 days)
The N-550 Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The N-550 Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients during both no motion and motion conditions and for patients who are either well or poorly perfused, in hospitals, hospital-type facilities, intra-hospital transport, and home environments. This device is for prescription use only.
The N-550 Pulse Oximeter is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate by use of one of a range of compatible Nellcor Puritan Bennett OxiMAX oxygen transducers (sensors). The N-550 Pulse Oximeter displays digital values of SpO2 and Pulse Rate, and individual LED's are used for status indicators. Pulse Amplitude is displayed by means of a "blip bar" presentation.
The provided document is a 510(k) summary for the Nellcor OxiMAX N-550 Pulse Oximeter, asserting its substantial equivalence to a predicate device (Nellcor OxiMAX N-595 Pulse Oximeter). The document does not contain detailed information about specific acceptance criteria or the results of a study designed to prove the device meets those criteria. Instead, it states that clinical and non-clinical tests were performed and concluded that the device does not raise new questions of safety or effectiveness.
Therefore, the following information is not available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Results or even the conduct of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Results or even the conduct of a standalone (algorithm only) performance study.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
What is available:
1. Device Description and Intended Use:
- Device: Nellcor OxiMAX N-550 Pulse Oximeter.
- Function: Continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate.
- Intended Patient Population: Neonatal, pediatric, and adult patients.
- Conditions: Both no motion and motion conditions; well or poorly perfused patients.
- Environments: Hospitals, hospital-type facilities, intra-hospital transport, and home environments.
- Prescription Use Only: Yes.
2. Basis for Substantial Equivalence:
- Predicate Device: Nellcor Puritan Bennett, Inc., OxiMAX Pulse Oximetry System with N-595 Pulse Oximeter and OxiMAX Sensors (510(k) #K012891).
- Technological Characteristics: The N-550 Pulse Oximeter has the "same technological characteristics" as the N-595 Pulse Oximeter.
- Modifications (from predicate): Ergonomic change from LCD to LED display and a change in the oximeter module.
- Tests Performed: Clinical and non-clinical tests were performed.
- Clinical Study Regulations: Followed 21 CFR Part 812 (Investigational Device Exemptions), Part 50 (Protection of Human Subjects), and Part 56 (Institutional Review Boards).
- Conclusion: The technological characteristics and test results "do not raise new questions of safety or effectiveness when compared to the legally marketed (unmodified) device."
§ 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).