NEWPORT C250 AIR COMPRESSOR MODEL C250

K041406 · Newport Medical Instruments · BTI · Dec 15, 2004 · Anesthesiology

Device Facts

• Record ID: K041406
• Device Name: NEWPORT C250 AIR COMPRESSOR MODEL C250
• Applicant: Newport Medical Instruments
• Product Code: BTI · Anesthesiology
• Decision Date: Dec 15, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.6250
• Device Class: Class 2

Intended Use

The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, E150, E200, and e500 Newport Ventilators.

Device Story

Newport C250 Air Compressor is an electric device that draws air from the environment to provide a continuous supply of clean, oil-free pressurized air at 42 psig. It serves as a pneumatic power source for specific Newport ventilators (E100M, E150, E200, e500). The device is intended for clinical use to support ventilator operation, ensuring the delivery of pressurized gas to the patient circuit. It functions as a standalone compressor unit. By providing a reliable, dedicated air source, it enables the operation of ventilators in clinical settings where centralized medical air may be unavailable or as a primary/backup supply, directly supporting respiratory therapy.

Clinical Evidence

Bench testing only. Testing performed per IEC 60601-1-2:1993, CSA 22.2 No 601-1-M90, UL 2601-1, and EN 55011:1998 &A1:1999 to verify performance specifications and safety.

Technological Characteristics

Electric air compressor; provides 42 psig output; oil-free design. Standards: IEC 60601-1-2:1993, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011:1998 &A1:1999.

Indications for Use

Indicated for use as a source of clean, oil-free pressurized air at 42 psig for patients requiring mechanical ventilation using Newport E100M, E150, E200, or e500 ventilators.

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

• Bird 6500 Air Compressor (K864547)
• Newport C100 Air Compressor
• Newport C200D Air Compressor

Submission Summary (Full Text)

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K041406

DEC 1 5 2004

## 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### Name, Address, Phone and Fax Number of the Applicant A.

Newport Medical Instruments, Inc. 760 West 16th Street, Building N Costa Mesa, California 92627 Telephone: [phone] Fax: [phone]

#### B. Contact Person

Richard Waters

Vice President, Regulatory Affairs / Quality Assurance

760 West 16th Street, Building N

Costa Mesa, California 92627

Telephone: [phone]

Fax: [phone]

#### Date Prepared ்.

September 24th, 2004

#### D. Device Name

Newport C250 Air Compressor

#### Device Description ய்

The Newport C250 Air Compressor is electric and produces air from the normal environment to supply compressed air for Newport ventilators.

#### F. Device Intended Use

The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, E150, E200, and e500 Newport Ventilators.

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#### Substantial Equivalence Summary G.

The Newport C250 Air Compressor is substantially equivalent in intended use, physical characteristics, performance, and safety characteristics to the Bird 6500 Air Compressor, cleared under #K864547; the Newport C100 Air Compressor and the Newport C200D Air Compressor. Both the Newport C100 and C200D Air Compressors are preamendment devices that were on the US market prior to May 28, 1976.

#### Device Testing H.

Comprehensive testing has been conducted on The Newport C250 Air Compressor in accordance with various industry recognized standards, including: IEC 60601-1-2:1993, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011:1998 &A1:1999. The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three curved shapes that resemble a person embracing or supporting another, representing the department's mission of protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 5 2004

Mr. Richard Waters Vice President, Regulatory Affairs/ Quality Assurance Newport Medical Instrument, Incorporated 760 West 16" Street, Building N Costa, Mesa, California 92627

Re: K041406

Trade/Device Name: Newport C250 Air Compressor Model 250 Regulation Number: 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: November 16, 2004 Received: November 17, 4004

Dear Mr. Waters:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Waters

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Ling, Ph.D.

Chiu Lin, Ph.D. 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 (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _Newport C250 Air Compressor Model 250

Indications for Use:

The Newport C250 Air Compressor is designed and manufactured to supply a source of clean, oil-free pressurized air at 42 psig for use with the E100M, E150, E200, and e500 Newport Ventilators.

Prescription Use __ X (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)

Aum
(Division Sign Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number:

Page 1 of 1

(Posted November 13, 2003)

CONFIDENTIAL