(23 days)
The Mark 5 Nuvo OCSI (M5C5) Oxygen Concentrator is intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.
The proposed device is an AC powered device that provides a high level of inspired oxygen by separating oxygen from ambient air utilizing pressure swing adsorbers (PSA). Air is drawn into the device with a piston-type compressor and exposed to molecular sieve adsorbent that selectively retains nitrogen and other components until they are released when the pressure is vented to the atmosphere. This cycle is controlled by a motorized rotary 4-way valve and protected from over pressurization by the compressor's pressure relief valve. The device provides a nominal oxygen enriched gas concentration of 90% ±3% at a flow rate of 5 l/min ±10%. The oxygen concentration status indicator (OCSI) board controls the device status indicators including an operator alert when the oxygen concentration in the product gas is below the set point. It is not a life-supporting, life-sustaining or sterile device.
The proposed device is a durable, reusable, semi-portable unit weighing approximately 50 pounds [23 kg]. The device is available in both 115V and 230V models that have been designed and validated according to applicable requirements of EN 60601-1-2:2001, IEC 60601-1-2:2001, UL 60601-1:2003, CAN/CSA-C22.2 No 601.1-M90 with A1 & A2:1999, ISO 8359 and FDA Reviewer Guidance document "Excerpts Related to EMI from November 1993" as appropriate to the area of usage.
The proposed device may be used with one of the many legally marketed humidifiers, connecting tubing and nasal cannula as prescribed. One of these devices may optionally be included with the device.
The provided text is a 510(k) summary for the Nidek Medical Products, Inc. Mark 5 Nuvo OCSI (M5C5) Oxygen Concentrator. This document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
This 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Mark 5 Nuvo Concentrator K032509) by detailing the device description, technological characteristics, and nonclinical performance (compliance with various electrical and safety standards).
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Information on sample size, data provenance, number or qualifications of experts, or adjudication methods for a test set.
- Details about a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
- The type of ground truth used, sample size for the training set, or how ground truth was established for the training set.
The core of this 510(k) is that the proposed device is "exactly the same as the predicate device except the board configuration was modified to incorporate an oxygen concentration status indicator (OCSI)." The performance claims revolve around the device providing a "nominal oxygen enriched gas concentration of 90% ±3% at a flow rate of 5 l/min ±10%" and the OCSI board controlling a "operator alert when the oxygen concentration in the product gas is below the set point." However, it does not present a specific study with defined acceptance criteria to quantitatively prove these performance metrics in the way your request describes. It primarily relies on compliance with existing safety and electrical standards and the substantial equivalence to the predicate device.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).