(203 days)
Not Found
No
The document describes a standard air compressor for ventilators and contains no mention of AI or ML technology.
No.
The device's description and intended use clearly state it is an air compressor designed to supply pressurized air to Newport Ventilators, not to directly treat a medical condition itself.
No
Explanation: The device is an air compressor intended to supply air to ventilators, not to diagnose a condition or disease.
No
The device description clearly states it is an "electric" air compressor that "produces air from the normal environment," indicating it is a physical hardware device.
Based on the provided information, the Newport C250 Air Compressor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to supply compressed air to ventilators, which are medical devices used for respiratory support. This is a direct interaction with the patient's respiratory system, not the analysis of biological samples in vitro (outside the body).
- Device Description: The description focuses on producing compressed air from the environment for use with ventilators. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Newport C250 Air Compressor is a medical device, but it falls under a different category than IVD devices.
N/A
Intended Use / 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.
Product codes
BTI
Device Description
The Newport C250 Air Compressor is electric and produces air from the normal environment to supply compressed air for Newport ventilators.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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: (949) 642-3910 Fax: (949) 645-5026
B. Contact Person
Richard Waters
Vice President, Regulatory Affairs / Quality Assurance
760 West 16th Street, Building N
Costa Mesa, California 92627
Telephone: (949) 642-3910
Fax: (949) 645-5026
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.
1
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.
2
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.
3
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 (240) 276-0120. 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 (800) 638-2041 or (301) 443-6597 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
4
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