The DK50 D and DK50 DM Medical Compressors are electric and produces air from the normal environment to supply compressed air for medical ventilators.

AI/ML Overview

The provided text describes a 510(k) premarket notification for two medical compressors, DK50 D and DK50 DM. It details their intended use, describes them as substantially equivalent to a predicate device, and lists the standards they were tested against. However, the document does NOT contain information about acceptance criteria or a study proving device performance against such criteria in the way typically expected for an AI/ML device.

This document is for a traditional medical device (compressors), not an AI/ML device, and therefore the concepts of "acceptance criteria" and "device performance" are addressed differently. The "study" mentioned is a general statement about adherence to industry standards, not a specific clinical or performance evaluation with statistical metrics.

Given the information provided, here's how the questions can be addressed:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics in the document. The general acceptance criterion is that the device "meets its specifications and is safe and effective for its intended use" and is "substantially equivalent" to the predicate device.
- Reported Device Performance: The document states that "Comprehensive testing has been conducted on The DK50 D and DK50 DM Medical Compressors in accordance with various industry recognized standards, including: IEC 60601-1-2:2001, EN 55011:1998 &A1:1999." The outcome of this testing is that the device "meets its specifications." Specific performance metrics (e.g., flow rate, pressure, noise levels, durability) are not detailed in this summary.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with IEC 60601-1-2:2001, EN 55011:1998 & A1:1999	Testing conducted; device meets specifications
Safety and Effectiveness for intended use (supplying compressed air for medical ventilators)	Deemed safe and effective; substantially equivalent to predicate

Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable / Not provided. The testing mentioned refers to engineering and quality assurance testing against standards, not a clinical study with a "test set" of patients or data in the context of AI/ML.
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 / Not provided. Ground truth is not established in this context. The "truth" is whether the device adheres to engineering specifications and safety standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are relevant for interpreting complex data, often in clinical imaging or diagnostic studies, where human consensus is needed for ground truth. This is not
  pertinent to the testing of an air compressor.
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 / Not done. MRMC studies are for evaluating human performance, often with or without AI assistance, usually in diagnostic tasks. This device is an air compressor, not a diagnostic tool, and has no human-in-the-loop AI component.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not done. This refers to AI algorithm performance. The device is a mechanical compressor.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. In the context of this device, "ground truth" would be the engineering specifications and performance parameters as defined by internal design documents and relevant industry standards. The summary does not provide specific details on how conformity to these was verified beyond stating "comprehensive testing."
The sample size for the training set
- Not applicable / Not provided. This concept is for AI/ML models.
How the ground truth for the training set was established
- Not applicable / Not provided. This concept is for AI/ML models.

Summary

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K060781

OCT - 3 2006

DK50 D and DK50 DM Medical Compressors Traditional 510(k)

Section 3. 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.

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

EKOM s.r.o

ЕКОМ

Priemyselna 5031/18 921 01 Piestany Slovak Republic Tel: +421 33 7967255 Fax: +421 33 7967223

B. Contact Person

Julius Ivan
EKOM s.r.o
Priemyselna 5031/18
921 01 Piestany
Slovak Republic### C. Date Prepared

March 3, 2006

D. Device Name

Medical Compressors DK50 D and DK50 DM

E. Device Description

The DK50 D and DK50 DM Medical Compressors are electric and produces air from the normal environment to supply compressed air for medical ventilators.

F. Device Intended Use

The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators.

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G. Substantial Equivalence Summary

The DK50 D and DK50 DM Medical Compressors are substantially equivalent in intended use, physical characteristics, performance, and safety characteristics to the Newport C250 Air Compressor, cleared under #K041406.

H. Device Testing

Comprehensive testing has been conducted on The DK50 D and DK50 DM Medical Compressors in accordance with various industry recognized standards, including: IEC 60601-1-2:2001, 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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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "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-like figure.

OCT - 3 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ekom S.R.O. C/O Ms. Esther Saltz Esther Saltz Regulatory Consulting 32884 Danapoplar Dana Point, California 92629

Re: K060781

Trade/Device Name: Medical Compressor, Models DK50 D and DK50 DM Regulation Number: 21 CFR 868.6250 Regulation Name: Portable Air Compressor Regulatory Class: II Product Code: BTI Dated: September 11, 2006 Received: September 13, 2006

Dear Ms. Saltz:

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 - Ms. Saltz

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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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Appendix A. Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: The Medical Compressor Models DK50 D and DK50 DM

Indications for Use:

The DK50 D and DK50 DM Medical Compressors are indicated for supplying compressed air for medical ventilators.

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Page 1 of 1

(Posted November 13, 2003)

Guy Salmon

Ji) Sign-Cit) on of Anesthesiology, General Hospital. Jon Control, Dental Devices

Number K060781

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.