(270 days)
The Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator that operates within the C4500 Compressor manufacturer specifications.
The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for medical
The Oricare C4500 Medical Air Compressor is a medical device designed to supply dry, filtered, and compressed air to medical ventilators. The submission provides a "Substantial Equivalence Summary" rather than a detailed study report with acceptance criteria and direct performance metrics. However, it implicitly demonstrates that the device meets acceptance criteria by establishing substantial equivalence to a legally marketed predicate device, the EKOM DK50 D Medical Compressor (K060781). This is achieved by comparing various operational and physical characteristics of the Oricare C4500 against those of the predicate device.
Here's an analysis based on the provided text, outlining the acceptance criteria (inferred from predicate device characteristics) and the reported performance of the Oricare C4500:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are inferred from the specifications of the predicate device, the EKOM DK50 D Medical Compressor (K060781). The reported device performance is that of the Oricare C4500 Air Compressor, demonstrating that it either matches or has minor, non-adverse differences compared to the predicate.
| # | Item of Comparison | Acceptance Criteria (Predicate: EKOM DK50 D) | Reported Device Performance (Oricare C4500) | Discussion of Differences |
|---|---|---|---|---|
| 1 | Intended use | Supplying compressed air for medical ventilators. | Supply gas for critical care ventilator. | No differences |
| 2 | Indications for use | Clean, oil-free pressurized air for medical ventilators. | Dry filtered and compressed air to a Medical Ventilator. | No differences |
| 3 | Environment of Use | Medical Care Facilities | Medical Care Facilities | No Differences |
| 4 | Principle of operation | Compression, cooling, drying, filtering of oil-free air. | Compression, cooling, drying, filtering of oil-free air. | No Differences |
| 5 | Output flow/pressure | 40 l/min at 51 psig | 40 l/min at 50 psig | No Differences |
| 6 | Peak Flow | 200 lpm for 2 sec | 180 Lpm for 0.6 sec | No Differences (The slight difference in peak flow duration is considered non-significant for substantial equivalence). |
| 7 | Power | 120V/60 Hz | 115V/60 Hz | AC Mains line voltage varies from 103VAC to 127VAC. Both systems are within the range. |
| 8 | Power consumption | 5.6 A | Nominal current (amps) 80°C | Acoustic and optical if increase in internal temp > 80°C |
| 19 | Automatic turn-on pressure | When central distribution pressure |
§ 868.6250 Portable air compressor.
(a)
Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.