(161 days)
The Nellcor OxiMax N-600x Pulse Oximeter is indicated for the continuous non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The Nellcor OxiMax N-600x Pulse Oximeter is intended for use with neonatal, pediatric, and adult patients, and for patients who are well or poorly perfused, in bospitals, hospital-type facilities, intra-hospital transport, and home environments. For prescription use only
The OxiMax N-600x Pulse Oximeter is a modification OxiMax Pulse Oximetry System with N-595 Pulse Oximeter and OxiMax Sensors and Cables. The N-600x is designed for continuous, non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate using OxiMax pulse oximetry sensors and the DOC-10 cable. The N-600x Pulse Oximeter displays digital values of SpO2 and Pulse Rate. Pulse Amplitude is displayed by means of a "blip bar" presentation or plethysmographic waveform. The N-600x can be powered by an internal power supply operating on AC from a standard electrical utility receptacle (manually switchable from 115V to 230V) or alternatively by an internal 6V rechargeable sealed lead-acid battery. The OxiMax N-600x Pulse Oximeter is intended for prescription use with adult, pediatric and neonatal patients in hospitals, hospital-type facilities, intra-hospital transport, and home environments.
The provided text is a 510(k) Summary for the Nellcor OxiMax N-600x Pulse Oximeter and primarily describes the device, its intended use, and its technological characteristics. It mentions that clinical and non-clinical tests were performed but does not provide specific details about acceptance criteria, the results of those tests, or the study design.
Therefore, many of the requested details cannot be extracted from this document, specifically:
- Acceptance Criteria and Reported Performance Table: Not provided.
- Sample size for the test set and data provenance: Not provided. The document states "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards," which implies prospective human subject research, but no details on size or origin.
- Number of experts and qualifications for ground truth: Not provided.
- Adjudication method: Not provided.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone algorithm performance: Not explicitly stated or detailed, although the device itself is a standalone algorithm within the oximeter.
- Type of ground truth used: Not provided.
- Sample size for the training set: Not provided, as the document doesn't explicitly discuss an "AI" or machine learning training phase in the modern sense. The "algorithm" mentioned is for processing signals from the sensor.
- How ground truth for the training set was established: Not provided.
Summary of available information:
The document broadly states that:
- "Clinical and non-clinical tests were performed to support the determination of substantial equivalence."
- "Clinical studies were conducted following regulations under Title 21 of the Code of Federal Regulations (21 CFR), Part 812 - Investigational Device Exemptions, Part 50 - Protection of Human Subjects and Part 56 - Institutional Review Boards."
- "The technological characteristics of the OxiMax N-600x Pulse Oximetry System and the results of non-clinical and clinical tests do not raise new questions of safety or effectiveness when compared to the legally marketed predicate devices."
This indicates that studies were conducted to show substantial equivalence to a predicate device, rather than to meet specific performance acceptance criteria for a novel technology in the way AI/ML devices might. The FDA's letter (K060576) confirms that the device was deemed substantially equivalent based on the submitted information.
§ 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).