This K982789 submission is for a Medical Air Compressor "Model 98", not an AI/ML device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert adjudication, MRMC studies, and standalone performance, are not applicable.

The submission focuses on establishing substantial equivalence to a legally marketed predicate device, the Dräger Medical Air Compressor (K951126), through a comparison of specifications and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the "Medical Air Compressor Model 98" were based on demonstrating substantial equivalence to its predicate device, the "Medical Air Compressor (K 951126)". The reported performance for the new device matches the criteria set by the predicate.

Specification	Acceptance Criteria (from Predicate Device K951126)	Reported Device Performance (Medical Air Compressor Model 98)
Intended Use	Air compressor supplying compressed air for medical respirators	Air compressor supplying compressed air for medical respirators
Safety:
High temperature alarm?	Yes	Yes
Audible alarm?	Yes	Yes
Visible alarm?	Yes	Yes
Main Fuses?	Yes	Yes
Performance Characteristics:
Dew point depression: below room temperature?	Yes	Yes
Air quality: Dust and oil free?	Yes	Yes
Installed filter?	Yes	Yes
Standby-Mode?	Yes	Yes
Operating Characteristics	Substantially equivalent to predicate	All operating characteristics of both devices are substantially equivalent

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a conventional medical device without AI/ML components. The evaluation method relies on direct comparison of specifications and functionality rather than data-driven performance metrics on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a conventional medical device. Ground truth as typically defined for AI/ML devices is not relevant here. The evaluation is based on engineering specifications and adherence to existing medical device standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

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 conventional medical device.

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

Not applicable. This is a conventional medical device.

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

For this conventional device, the "ground truth" for demonstrating substantial equivalence is the established specifications, performance characteristics, and safety features of the predicate device (Dräger Medical Air Compressor K951126), as well as relevant medical device standards. The "Model 98" is deemed acceptable if it meets or matches these established benchmarks.

8. The sample size for the training set

Not applicable. This is a conventional medical device.

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

Not applicable. This is a conventional medical device.

Summary

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K982789
Dräger

OCT 2 9 1998

file: 510kstate.RTF Date: Feb. 1998 Author: Frank Clanzett

510(k) SUMMARY Summary of Safety and Effectiveness

APPLICANTS NAME AND ADDRESS: Drager Inc. . . . . . Critical Care Systems

3136 Quarry Road Telford , PA 18969

APPLICANTS TELEPHONE NUMBER: (215)-721-6917

APPLICANTS FACSIMILE NUMBER: (215)-721-6915

APPLICANTS CONTACT PERSON: Harald Kneuer Regulatory Affairs Manager

DATE THE SUMMARY WAS PREPARED: MArch, 1998

DEVICE NAME:

Trade Name: Common Name: Classification Name: Product Code:

Medical Air Compressor "Model 98" Medical Air Compressor Compressor, Air, Protable (per 21CFR868.6250) 73 BTI

LEGALLY MARKETED DEVICE TO WHICH DRÄGER IS CLAIMING SUBSTANTIAL EQUIVALENCE:

Dräger Medical Air Compressor- Manufactured by Dräger Medizintechnik GmbH, Lübeck, Germany and sold in the United States by Dräger, Inc.

Page 1 of 3

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DESCRIPTION OF THE DEVICE

The device is electric and produces compressed air from the normal environment to supply compressed air for medical ventilators.

.. . . .

INTENDED USE OF THE DEVICE

The device is an air compressor supplying compressed air for medical ventilators.

Specification	Medical Air Compressor(K 951126)	Medical AirCompressor Modell 98
Intended use	Air compressor supplyingcompressed air for medicalrespirators	Air compressor supplyingcompressed air for medicalrespirators
Safety:
High temperature alarm?	Yes	Yes
Audible alarm?	Yes	Yes
Visible alarm?	Yes	Yes
Main Fuses?	Yes	Yes
Performancecharacteristics
Dew point depression:below room temperature?	Yes	Yes
Air quality:Dust and oil free?	Yes	Yes
Installed filter?	Yes	Yes
Standby-Mode?	Yes	Yes
Operating Characteristics	All operating characteristics of both devices are substantialequivalent

COMPARISON OF THE DEVICES

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SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE DEVICE COMPARED TO THE PREDICATE DEVICES:

The compressor functions of the Dräger Medical Air Compressor " Model 90" is substantial equivalent to the predicate device Dräger Medical Air Compressor.

The "Model 98" integrates the same functions and performances that are presently performed by the predicate Dräger Medical Air Compressor.

The "Model 98" fulfils the same standards as the Dräger Medical Air Compressor.

Therefore the device under review is substantial equivalent to the predicate devices concerning safety, efficiency and the intended use.

Fllly

Frank Clanzett Regulatory Affairs Dräger Medizintechnik

PASSES OF ACTION OF THE COLLECTION OF CONSULTION OF

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines forming its body and head. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1998

Mr. Harald Kneuer Drager, Inc. Critical Care Systems 3136 Quarry Road Telford, PA 18969

Re: K982789 Medical Air Compressor, Model #8413419 Regulatory Class: II (two) Product Code: 73 BTI Dated: August 7, 1998 Received: August 10, 1998

Dear Mr. Kneuer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP requlation may result in assumptions. regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Harald Kneuer

This letter will allow you to beqin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,
Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Intended Use Statement of the Dräger Medical Air Compressor Model 98

Air compressor supplying compressed air for medical ventilators.

R. Degenhart.

Rainer Degenhart

Rainer Deg nhart (project manager)

May 1998

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kramer

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices K98278 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

・

(Optional Format 1-2-96)

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.