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.

Summary

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10(K) Summar

David Jamison, Executive Vice Presider
Oricare, Inc.
Thone: 215-538-2470 KOM DK50D Medical Compresso 500 Medical Air Compress Oricare, Inc.
1900 AM Drive, Suite 10
Quakertown, PA. 18951 mpressor, Air, Portab edical Air Compress ectober 19, 201 1CFR868.6256 060781 вті ame: Common / Usua evice Trade Name assification Nam egulation Numbe edicate 510(k) { Predicate Device ontact Persor Date Prepared Product Code Submitter

Substantial Equivalence Summary

stantial Equivalence Summary
C4500 Medical Compressor is substantially equivalent in intended use, physical characteristics, performance, and
acteristics to the EKOM DK50K, c

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Intended Use

Intended Use:
This air compressor can be used as a gas supply for a critical care ventilat

cations for Use:
Oricare C4500 Medical Air Compressor is indicated to supply dry filtered and compressed air to a Medical Ventilator
France within the C4500 Compresses monufa perates within the C4500 Compressor manufacturer specification

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 nedical

Device Testing

eners Four easing has been on case in accordance with vality ratous inh valier recognized
tandard, include tester 1999, 42:1995 and EC 6001-2-2.2007, Additionally, Air Esti

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#	Item of comparison	EKOM DK50 D Medical Compressor(K060781)	Oricare C4500 Air Compressor	Discussion of thedifferences
1.	Intended use of thedevice	The DK50 D Medical Compressor isindicated for supplying compressedair for medical ventilators.	This air compressor can be used as a gassupply for a critical care ventilator.	No differences
2	Indications for use	The EKOM DK50 D, DK50 DM isindicated for use as medical aircompressor to supply a source ofclean, oil-free pressurized air for usewith medical ventilators.	The Oricare C4500 Medical AirCompressor is indicated to supply dryfiltered and compressed air to a MedicalVentilator that operates within the C4500Compressor manufacturer specifications.	No differences
3	Environment of Use	Medical Care Facilities	Medical Care Facilities	No Differences
4	Principle ofoperation	Compression, cooling, drying andfiltering of oil-free air	Compression, cooling, drying and filteringof 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 pm for 2 sec	Peak Flow 180 Lpm for 0.6 sec	No Differences
7	Power	120V/60 Hz	Power 115V/60 Hz	AC Mains line voltagevaries from 103VAC to127VAC. Both systemsare within the range.
8	Power consumption	5.6 A	Nominal current (amps) <600VA	Oricare device consumesslightly less powermeaning it is slightlymore efficient.
#	Item of comparison	EKOM DK50 D Medical Compressor(K060781)	Oricare C4500 Air Compressor	Discussion of thedifferences
10	Air filtration	5 micron	5 micron	No Difference
11	Pressure dew point	@ 40 Lpm 20°C - 5°C below ambienttemperature	@ 40 Lpm 3°C below ambient temperature	No real discernibledifference.
12	Outlet connection	DISS	1- DISS	No Difference
13	Sound level	< 51 dB(A)	< 52 dB(A)	No real discernibledifference. The audible toneis for alarm annunciationpurposes. An increase in thedB(A) would provide anadvantage to user.
14	Mode of operation	Continuous - SI	Continuous - SI	No Difference
15	Separation ofcondensed water	Automatic	Automatic	No Difference
16	Operating pressure ofsafety valve	116 psig	65 psig	Device regulates pressure at40 psig.
17	Adjustment of pressure	Pressure regulator	Pressure regulator	No Difference
18	Alarm for coolingfailure / high	Acoustic and optical if increase ininternal temperature > 80°C	Acoustic and optical if increase in internaltemperature > 80°C	No Difference
19	Automatic turn-onpressure	When central distribution pressure <40.6 psig	When central distribution pressure < 40.6psig	No Difference
20	Output pressure	Pressure gauge	Pressure gauge	No Difference
21	Alarm - loss of power	No, but instructions require connectionto equipment with this alarm	Yes	Advantage for Oricareproduct Safety
#	Item of comparison	EKOM DK50 D Medical Compressor(K060781)	Oricare C4500 Air Compressor	Discussion of thedifferences
22	Additional VisualIndicators	Not included	"AC Power" light"Ready" light - outlet pressure ready"Air Source - Wall" light	Safety Advantage fordetermining AC MainsPower is connected
23	Indication of drying	Pressure gauge	None	design includes chiller andexternal water trap toremove excess moisture.
24	Alarm for low pressure	None instructions require connectionto equipment with this alarm	Yes, triggers when output pressure <25.4 psig	Oricare device does not relyon 3rd party device to beconnected.
25	Material in gas pathway	Aluminum, brass, nickel plated brass,polyurethane and silicon tubing, coppertubing, Plastic (PA, PET, POM, PBT, PC,Acetyl, Polyester), polyurethane foam,NBR rubber, Stainless steel, die castzinc	Aluminum, brass, nickel plated brass,polyurethane and silicon tubing, coppertubing, Plastic (PA, PET, POM, PBT, PC,Acetyl, Polyester), polyurethane foam, NBRrubber, Stainless steel, die cast zinc	No Difference
26	Air tank capacity	5L	2L	Excess capacity not neededto supply sufficient peakflow. Predicate device islarger because extracapacity requires additionalweight and physical size.
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
#	Item of comparison	EKOM DK50 D Medical Compressor(K060781)	Oricare C4500 Air Compressor	Discussion of thedifferences
29	Ambient Environment	41 to 104 degrees F; up to 95% RH	50 to 104 degrees F; 15 – 90% RH	Oricare device range istypical of many ventilators.
30	Dimensions	19(L)x20(W)x33(H) in	16.22 (L)x17.4(W)x15.75(H) in	Oricare device is smaller
31	Weight	101 lbs	66 lbs	Oricare device is lighter
32	Electrical Safety	EN 60601-1	IEC 60601-1:1988, +A1:1991, +A2:1995	No difference, both comply
33	Mechanical Safety	EN 60601-1	IEC 60601-1:1988, +A1:1991, +A2:1995	No difference, both comply

omparison to Predicate Device

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Image /page/6/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

-AUG-1-0-2012-

ORICARE, Incorporated Mr. Fred Cowdery Manager Regulatory Affairs and Quality Assurance 1900 AM Drive, Suite 100 Ouakertown. Pennsylvania 18951

Re: K113338

Trade/Device Name: C4500 Medical Air Compressor Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: July 31, 2012 Received: August 02, 2012

Dear Mr. Cowdery:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2- Mr. Cowdery

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies-You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Cintan Om

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: -- K113338 US -------------------------------------------------------------------------------------------------------------------------------------------------

Device Name: C4500 Medical Air Compressor

Indications for Use:

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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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for l. Schultheis

(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

510(k) Number: K113328

Regulation Number and Section

§ 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.