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 Description

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

AI/ML Overview

This document appears to be a 510(k) summary for a medical device, the Newport C250 Air Compressor. It details the device's intended use, its substantial equivalence to predicate devices, and the testing performed. However, it does not contain a study that proves the device meets specific acceptance criteria in the format requested.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that comprehensive testing was conducted "in accordance with various industry recognized standards" and that "The combined testing and analysis of results provides assurance that the device meets its specifications and is safe and effective for its intended use." However, it does not explicitly state quantitative acceptance criteria or corresponding reported device performance values in a table.

The standards mentioned are:

IEC 60601-1-2:1993
CSA 22.2 No 601-1-M90
UL 2601-1
EN 55011:1998 &A1:1999

These are general safety and electromagnetic compatibility (EMC) standards for medical electrical equipment. They would have specific test limits and pass/fail criteria, but these are not enumerated in the 510(k) summary. The summary only states that the device meets its specifications and is safe/effective, implying it passed the tests against these standards.

2. Sample size used for the test set and the data provenance:

This type of information is not applicable to this 510(k) submission. The Newport C250 Air Compressor is an electromechanical device, not an AI/software device that processes data in the way typically associated with "test sets" or data provenance (e.g., country of origin for clinical images). Testing would involve a fixed number of physical units of the compressor, often a single unit or a small batch, subjected to rigorous environmental, electrical, and performance tests. The data provenance would be from laboratory testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable to the Newport C250 Air Compressor. "Ground truth" established by experts is relevant for diagnostic or image analysis AI/software, not for a physical air compressor whose performance is measured by objective physical parameters (e.g., pressure, flow, purity, noise, electrical safety).

4. Adjudication method for the test set:

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human experts in labeling or assessing data, which is not relevant for the testing of this physical device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device (an air compressor), not an AI-assisted diagnostic or image analysis system. Therefore, MRMC studies and "human readers improving with AI" are not relevant to its premarket submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The "ground truth" for a device like an air compressor would be its physical specifications and objective measurements of its performance (e.g., pressure output, air purity, noise levels, power consumption) against established engineering and safety standards.

8. The sample size for the training set:

Not applicable. Training sets are used for machine learning models, not for physical electromechanical devices like an air compressor.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary of what the document does provide regarding acceptance and testing:

Acceptance Criteria (Implied): The device's specifications (e.g., "supply a source of clean, oil-free pressurized air at 42 psig") and compliance with the listed industry standards (IEC 60601-1-2, CSA 22.2 No 601-1-M90, UL 2601-1, EN 55011). While not numerically stated here, these standards contain specific, measurable acceptance criteria.
Study/Testing Information: "Comprehensive testing has been conducted... in accordance with various industry recognized standards." The results of this testing "provides assurance that the device meets its specifications and is safe and effective for its intended use." The 510(k) pathway relies on demonstrating substantial equivalence to a legally marketed predicate, often through a combination of design, performance testing, and comparison of technical characteristics to the predicate. The FDA's clearance implies they were satisfied with the demonstration of compliance with the standards and the device's specifications.

This 510(k) summary is typical for a Class II electromechanical device that does not involve AI or complex data analysis, hence the absence of the detailed information about test sets, experts, or training data that you requested.

Summary

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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: (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.

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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 (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

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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

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.