MEDICAL AIR COMPRESSOR

K113338 · Oricare, Inc. · BTI · Aug 10, 2012 · Anesthesiology

Device Facts

• Record ID: K113338
• Device Name: MEDICAL AIR COMPRESSOR
• Applicant: Oricare, Inc.
• Product Code: BTI · Anesthesiology
• Decision Date: Aug 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2

Intended 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.

Device Story

The Oricare C4500 is a portable medical air compressor designed for use in medical care facilities. It operates from an AC voltage source to provide a continuous supply of clean, oil-free, pressurized air to medical ventilators. The device utilizes an oil-free wobble-type rocker piston to compress ambient air, which is then cooled, dried, and filtered (5-micron) before delivery. It features automatic condensed water separation and pressure regulation. The system includes acoustic and optical alarms for high internal temperature (>80°C), power loss, and low output pressure (<25.4 psig). Visual indicators confirm AC power, ready status, and air source. By providing a reliable, independent gas supply, the device ensures the continuous operation of connected ventilators, supporting patient respiratory therapy.

Clinical Evidence

Bench testing only. Performance was verified through comparison of output flow, pressure, filtration, and electrical/mechanical safety standards (IEC 60601-1:1988, +A1:1991, +A2:1995) against the predicate device.

Technological Characteristics

Materials: Aluminum, brass, nickel-plated brass, polyurethane/silicon tubing, copper tubing, various plastics (PA, PET, POM, PBT, PC, Acetyl, Polyester), polyurethane foam, NBR rubber, stainless steel, die-cast zinc. Principle: Oil-free wobble-type rocker piston compression. Output: 40 L/min at 50 psig. Filtration: 5 micron. Connectivity: Standalone. Power: 115V/60Hz. Safety: Acoustic/optical alarms for temperature, power, and pressure.

Indications for Use

Indicated for supplying dry, filtered, compressed air to medical ventilators operating within manufacturer specifications in medical care facilities.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• EKOM DK50 D Medical Compressor (K060781)

Submission Summary (Full Text)

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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<br>(K060781) | Oricare C4500 Air Compressor | Discussion of the<br>differences |
|----|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1. | Intended use of the<br>device | The DK50 D Medical Compressor is<br>indicated for supplying compressed<br>air for medical ventilators. | This air compressor can be used as a gas<br>supply for a critical care ventilator. | No differences |
| 2 | Indications for use | The EKOM DK50 D, DK50 DM is<br>indicated for use as medical air<br>compressor to supply a source of<br>clean, oil-free pressurized air for use<br>with medical ventilators. | The Oricare C4500 Medical Air<br>Compressor is indicated to supply dry<br>filtered and compressed air to a Medical<br>Ventilator that operates within the C4500<br>Compressor manufacturer specifications. | No differences |
| 3 | Environment of Use | Medical Care Facilities | Medical Care Facilities | No Differences |
| 4 | Principle of<br>operation | Compression, cooling, drying and<br>filtering of oil-free air | Compression, cooling, drying and filtering<br>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 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 voltage<br>varies from 103VAC to<br>127VAC. Both systems<br>are within the range. |
| 8 | Power consumption | 5.6 A | Nominal current (amps) <600VA | Oricare device consumes<br>slightly less power<br>meaning it is slightly<br>more efficient. |
| # | Item of comparison | EKOM DK50 D Medical Compressor<br>(K060781) | Oricare C4500 Air Compressor | Discussion of the<br>differences |
| 10 | Air filtration | 5 micron | 5 micron | No Difference |
| 11 | Pressure dew point | @ 40 Lpm 20°C - 5°C below ambient<br>temperature | @ 40 Lpm 3°C below ambient temperature | No real discernible<br>difference. |
| 12 | Outlet connection | DISS | 1- DISS | No Difference |
| 13 | Sound level | < 51 dB(A) | < 52 dB(A) | No real discernible<br>difference. The audible tone<br>is for alarm annunciation<br>purposes. An increase in the<br>dB(A) would provide an<br>advantage to user. |
| 14 | Mode of operation | Continuous - SI | Continuous - SI | No Difference |
| 15 | Separation of<br>condensed water | Automatic | Automatic | No Difference |
| 16 | Operating pressure of<br>safety valve | 116 psig | 65 psig | Device regulates pressure at<br>40 psig. |
| 17 | Adjustment of pressure | Pressure regulator | Pressure regulator | No Difference |
| 18 | Alarm for cooling<br>failure / high | Acoustic and optical if increase in<br>internal temperature > 80°C | Acoustic and optical if increase in internal<br>temperature > 80°C | No Difference |
| 19 | Automatic turn-on<br>pressure | When central distribution pressure <<br>40.6 psig | When central distribution pressure < 40.6<br>psig | No Difference |
| 20 | Output pressure | Pressure gauge | Pressure gauge | No Difference |
| 21 | Alarm - loss of power | No, but instructions require connection<br>to equipment with this alarm | Yes | Advantage for Oricare<br>product Safety |
| # | Item of comparison | EKOM DK50 D Medical Compressor<br>(K060781) | Oricare C4500 Air Compressor | Discussion of the<br>differences |
| 22 | Additional Visual<br>Indicators | Not included | "AC Power" light<br>"Ready" light - outlet pressure ready<br>"Air Source - Wall" light | Safety Advantage for<br>determining AC Mains<br>Power is connected |
| 23 | Indication of drying | Pressure gauge | None | design includes chiller and<br>external water trap to<br>remove excess moisture. |
| 24 | Alarm for low pressure | None instructions require connection<br>to equipment with this alarm | Yes, triggers when output pressure <25.4 psig | Oricare device does not rely<br>on 3rd party device to be<br>connected. |
| 25 | Material in gas pathway | Aluminum, brass, nickel plated brass,<br>polyurethane and silicon tubing, copper<br>tubing, Plastic (PA, PET, POM, PBT, PC,<br>Acetyl, Polyester), polyurethane foam,<br>NBR rubber, Stainless steel, die cast<br>zinc | Aluminum, brass, nickel plated brass,<br>polyurethane and silicon tubing, copper<br>tubing, Plastic (PA, PET, POM, PBT, PC,<br>Acetyl, Polyester), polyurethane foam, NBR<br>rubber, Stainless steel, die cast zinc | No Difference |
| 26 | Air tank capacity | 5L | 2L | Excess capacity not needed<br>to supply sufficient peak<br>flow. Predicate device is<br>larger because extra<br>capacity requires additional<br>weight 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<br>(K060781) | Oricare C4500 Air Compressor | Discussion of the<br>differences |
| 29 | Ambient Environment | 41 to 104 degrees F; up to 95% RH | 50 to 104 degrees F; 15 – 90% RH | Oricare device range is<br>typical 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 |

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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 [phone] or [phone] 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