The Philips OmniDiagnost Eleva is a multifunctional, universal, overtable X-ray system offering radiographic, fluoroscopic, angiographic, and interventional techniques in a wide variety of applications. The Philips OmniDiagnost Eleva consisting of a floor mounted stand with an integrated tilting patient support table is supported at only one end, allowing patient access from both sides.

As a fully integrated system, the Philips OmniDiagnost Eleva stand can be configured with X-ray generators from the Philips generator family and Philips digital spot film device. The system comes with a 38 cm multimode Image Intensifier, XTV imaging system, collimator for patient positioning without X-rays, Philips glass or metal X-ray tubes, and TV monitors.

AI/ML Overview

This document is a 510(k) premarket notification for the Philips OmniDiagnost Eleva X-ray system. It establishes substantial equivalence to a predicate device and declares compliance with various safety and regulatory standards. However, it does not contain any information about acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML or diagnostic performance evaluation.

The document focuses on:

Identifying the device and its manufacturer.
Declaring the device's intended use (radiographic, fluoroscopic, angiographic, and interventional applications).
Stating its substantial equivalence to a predicate device (Philips OmniDiagnost).
Outlining the general safety and effectiveness requirements the device and its labeling will comply with (e.g., 21 CFR, UL Standard, DICOM).
The FDA's letter of clearance, granting permission to market the device based on substantial equivalence.

Therefore, for the information requested in your prompt regarding acceptance criteria and performance studies, the provided text does not contain any of that information.

Specifically, I cannot extract:

A table of acceptance criteria and the reported device performance: Not present. The document focuses on regulatory compliance and substantial equivalence, not specific performance metrics against pre-defined acceptance criteria.
Sample size used for the test set and the data provenance: Not present. No performance study data is included.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No ground truth establishment is described.
Adjudication method: Not present.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not present. The device is an X-ray machine, not an AI/ML algorithm requiring such comparison for its own performance. The document does not discuss AI assistance.
If a standalone performance (algorithm only) was done: Not applicable and not present, as this is an X-ray system, not an AI algorithm.
The type of ground truth used: Not present.
The sample size for the training set: Not applicable and not present.
How the ground truth for the training set was established: Not applicable and not present.

This document serves as a regulatory submission for a medical device, not a scientific publication detailing performance evaluation against specific clinical metrics.

Summary

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JUL 17 2003

Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-shaped emblem. The emblem contains a stylized representation of radio waves or sound waves, with a circular shape and two horizontal wavy lines inside. There are also four stars or asterisks placed at the corners of the circular shape, adding a decorative element to the logo.

Philips Medical Systems Nederland B.V.

The following information is be bmitted in accordance with the requirements of 21 CFR 807.92.

Company Name:Address:	Philips Medical Systems North America Company22100 Bothell Everett HighwayP.O.Box 3003Bothell, WA 98041-3003, USA
Registration No .:	1217116
Contact Person:Telephone No .:	Lynn Harmer(425) 487-7312
Date Prepared:	June 12, 2003
Device (Trade) Name:	Philips OmniDiagnost Eleva
Classification Names:	Stationary X-ray system,21CFR892.1680, Class II (code 90KPR)
	Image-intensified fluoroscopic X-ray system,21CFR892.1650, Class II (code 90JAA)
	Angiographic X-ray system,21CFR892.1600, Class II (code 90IZI)

Predicate Device:

The OmniDiagnost Eleva is substantially equivalent to the Philips OmniDiagnost manufactured by Philips Medical Systems. The OmniDiagnost system received a 510(k) substantially equivalent determination in K982993 on August 26, 1998.

Device description:

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510(k) Summary Philips OmniDiagnost Eleva Page 2 of 2

Image /page/1/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" in bold, sans-serif font above a shield-like emblem. The emblem features a stylized representation of radio waves or sound waves emanating from a central point, with additional star-like symbols placed above and below the waves. The logo is presented in black and white.

Image /page/1/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The word is the primary focus of the image, taking up most of the space.

Intended use:

K∅3 2∅4L

The Philips OmniDiagnost Eleva is a diagnostic-imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

General Safety and Effectiveness:

The device and their labeling will comply with the applicable requirements of:

21 CFR, Subchapter J Radiological Health, parts 1020.30, 31, 32 .
Underwriters Laboratories Standard for Safety UL 2601-1 and be classified by . Underwriters Laboratories.
ACR/NEMA DICOM digital imaging communication standard. ●

Conclusion:

The Philips OmniDiagnost Eleva does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the OmniDiagnost Eleva to be substantially equivalent with the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's name around the perimeter. In the center is a stylized depiction of an eagle with its wings spread, symbolizing the department's mission to protect and promote the health and well-being of the nation.

Public Health Service

JUL 17 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems North America Company % Mr. Marc Mouser Project Engineer/Program Manager Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607

Re: K032046

Trade/Device Name: Philips OmniDiagnost Eleva Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: 90 IZI, JAA, and KPR Dated: June 30, 2003 Received: July 2, 2003

Dear Mr. Mouser:

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 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.

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.

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Page 2

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 one of the following numbers, based on the regulation number at the top of the letter:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number if Known):______________________________________________________________________________________________________________________________________________________

Device Name: Philips OmniDiagnost Eleva

Indications for Use:

The Philips OmniDiagnost Eleva is a diagnostic imaging device intended for radiographic, fluoroscopic, angiographic, and interventional applications.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The Counter Use _________________________________________________________________________________________________________________________________________________________

David R. Seymon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K032046

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.