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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.

Device Description

The Oricare C4500 Medical Air Compressor operates from an AC Voltage source and produces air from the normal environment supply compressed air for medical

AI/ML Overview

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) <600VA	Oricare device consumes slightly less power, meaning it is slightly more efficient.
10	Air filtration	5 micron	5 micron	No Difference
11	Pressure dew point	@ 40 Lpm 20°C - 5°C below ambient temperature	@ 40 Lpm 3°C below ambient temperature	No real discernible difference.
12	Outlet connection	DISS	1- DISS	No Difference
13	Sound level	< 51 dB(A)	< 52 dB(A)	No real discernible difference. An increase in the dB(A) provides an advantage to the user for alarm annunciation.
14	Mode of operation	Continuous - SI	Continuous - SI	No Difference
15	Separation of condensed water	Automatic	Automatic	No Difference
16	Operating pressure of safety valve	116 psig	65 psig	Device regulates pressure at 40 psig. The lower safety valve pressure is still well above the operating pressure.
17	Adjustment of pressure	Pressure regulator	Pressure regulator	No Difference
18	Alarm for cooling failure / high temp	Acoustic and optical if increase in internal temp > 80°C	Acoustic and optical if increase in internal temp > 80°C	No Difference
19	Automatic turn-on pressure	When central distribution pressure < 40.6 psig	When central distribution pressure < 40.6 psig	No Difference
20	Output pressure	Pressure gauge	Pressure gauge	No Difference
21	Alarm - loss of power	No, but instructions require connection to equipment with this alarm	Yes	Advantage for Oricare product safety.
22	Additional Visual Indicators	Not included	"AC Power" light, "Ready" light, "Air Source - Wall" light	Safety Advantage for determining AC Mains Power is connected.
23	Indication of drying	Pressure gauge	None	Design includes chiller and external water trap to remove excess moisture, thus an explicit drying indication is not deemed necessary.
24	Alarm for low pressure	None, instructions require connection to equipment with this alarm	Yes, triggers when output pressure <25.4 psig	Oricare device does not rely on 3rd party device to be connected, providing an advantage.
25	Material in gas pathway	Aluminum, brass, nickel plated brass, polyurethane and silicon tubing, copper tubing, Plastic (PA, PET, POM, PBT, PC, Acetyl, Polyester), polyurethane foam, NBR rubber, Stainless steel, die cast zinc	Aluminum, brass, nickel plated brass, polyurethane and silicon tubing, copper tubing, Plastic (PA, PET, POM, PBT, PC, Acetyl, Polyester), polyurethane foam, NBR rubber, Stainless steel, die cast zinc	No Difference
26	Air tank capacity	5L	2L	Excess capacity not needed to supply sufficient peak flow. Predicate device is larger because extra capacity requires additional weight and physical size, making the Oricare's smaller capacity an advantage.
27	Compressor Type	Oil free piston and ring- positive	Oil free wobble type rocker piston- positive	No Difference
28	Type of lubrication	Oil-less	Oil-less	No Difference
29	Ambient Environment	41 to 104 degrees F; up to 95% RH	50 to 104 degrees F; 15 – 90% RH	Oricare device range is typical of many ventilators. The narrower humidity range is not considered an adverse difference.
30	Dimensions	19(L)x20(W)x33(H) in	16.22 (L)x17.4(W)x15.75(H) in	Oricare device is smaller. This is an advantage.
31	Weight	101 lbs	66 lbs	Oricare device is lighter. This is an advantage.
32	Electrical Safety	EN 60601-1	IEC 60601-1:1988, +A1:1991, +A2:1995	No difference, both comply (IEC 60601-1 is the international standard from which EN 60601-1 is derived).
33	Mechanical Safety	EN 60601-1	IEC 60601-1:1988, +A1:1991, +A2:1995	No difference, both comply.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes a "Substantial Equivalence Summary" based on a comparison to a predicate device and compliance with recognized standards. This is not a study in the typical sense of testing a specific sample size of the device to collect performance data from the field. Instead, it's a design and engineering comparison.

Test Set Sample Size: The document does not specify a "test set" in the context of a clinical trial or a large-scale performance study with a numerical sample size. The testing appears to be functional and safety testing as part of design verification, likely performed on a limited number of engineering or production units.
Data Provenance: The data primarily comes from device testing described as having been done "in accordance with various recognized standards, including ISO 10993-1:1999, AAMI BI79:1995 and IEC 60601-2-2:2007." Additionally, Air Purity Testing was conducted. This indicates the testing was likely done in a prospective manner during the device development and verification phase by Oricare, Inc. or its designated testing facilities, presumably in the USA (where Oricare, Inc. is based and the 510(k) was submitted). The "comparison to predicate device" serves as the primary "data" for substantial equivalence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This type of submission (510(k) for a medical air compressor) typically does not involve a "ground truth" derived from expert consensus in the same way a diagnostic AI algorithm would. The "ground truth" for a device like this would be established through engineering specifications, regulatory standards, and objective physical measurements.

Number of Experts: Not applicable in the context of expert human review for ground truth
Qualifications of Experts: N/A for this type of device submission

4. Adjudication Method for the Test Set

Again, this is not applicable for a device of this nature where objective engineering and performance specifications are the "truth." There is no mention of "adjudication" in the context of resolving differing expert opinions.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI) where human readers (e.g., radiologists) interpret cases with and without algorithmic assistance. The Oricare C4500 is an air compressor, not a diagnostic device, and does not involve human interpretation or AI assistance in a diagnostic capacity.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The device is an air compressor, not an algorithm, and therefore doesn't have "standalone" algorithm performance to be assessed. Its performance is measured directly by its physical output and adherence to specifications.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

Objective Engineering Specifications: The technical requirements and design parameters of the device (e.g., flow rate, pressure, power consumption, filtration).
Compliance with Recognized Standards: Verification that the device meets relevant national and international medical device performance and safety standards (e.g., ISO 10993-1, AAMI BI79, IEC 60601-1).
Bench Testing and Performance Data: Direct measurements of the device's output and characteristics (e.g., air purity through air testing, sound level, temperature performance).
Predicate Device Specifications: The established performance and safety characteristics of the legally marketed EKOM DK50 D Medical Compressor, which serves as the benchmark for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. This device is an air compressor and does not involve AI or machine learning that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable. Since there is no training set, there is no ground truth established for one.

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