The Allura 3D-CA release 1 is intended to assist physicians when analyzing 2-Dimensional X-ray images by creating 3-Dimensional views from a pair of 2-Dimensional images created during rotational angiographic runs.

Device Description

The Allura 3D-CA release 1 device contains an image processing computer loaded with 3D-CA application software. It is linked through a DICOM port to a Philips Cardio-Vascular X-ray system and is intended to be placed in the control room of the Angiographic suite. 3D Coronary Angiography refers to 3D scanning of the coronary arteries, employing a C-arm based X-ray system. 2D projections are generated during a rotational scan, in which the patient's heart is scanned over an angular range of ca. 100-120 degrees. The complexity of making a 3D image of the coronary arteries is mainly caused by motion of the heart. 3D-CA uses a cardiac modeling technique to obtain a still 3D model of the heart. Cardiac modeling allows the construction of a 3D surface model of a coronary segment, or multiple segments, from two 2D projection images.

AI/ML Overview

The provided text from the 510(k) submission for the "Allura 3D-CA, release 1" device does not contain information about specific acceptance criteria or an explicit study proving the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to a predicate device (Integris 3D-RA release 4.2) and confirming compliance with general safety and effectiveness regulations, such as DICOM standards and UL safety standards.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

This submission is a premarket notification (510(k)) which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with specific performance metrics and acceptance criteria.

Summary

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SEP 2 7 2004

510(k) SUMMARY

The following information is being submitted 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:	11 August 2004
Device (Trade) Name:	Allura 3D-CA, release 1
Regulation Name:	Picture archiving and communications system
Regulation Number:	21 CFR 892.2050
Regulatory Class:	II
Product Code:	90 LLZ

Predicate Device:

The Allura 3D-CA release 1 device is substantially equivalent to the Integris 3D-RA release 4.2. (FDA ref. K040254)

Device Description:

Indications for Use:

The Allura 3D-CA release 1 device is intended to assist physicians when analyzing 2-Dimensional X-ray images by creating 3-Dimensional views from a pair of 2-Dimensional images created during rotational angiographic runs.

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General Safety and Effectiveness:

General Salety and Enconvolv with the applicable requirements of the federal The Gevice and tis laboling will Semply all Regulations, Title 21, subchapter J -- Radiological periormance standards (Ood of Packarlogally, the Allura 3D-CA release 1 complies with the ACR/NEMA DICOM digital imaging communication standard.

The device will comply with applicable requirements of the Underwriters Laboratories Standard for The device will be million with applicable in a reports have been or will be supplied to the Salely - OL oversight agency to establish compliance with the applicable requirements.

Conclusion:

Conclusion.
The Allura 3D-CA release 1 does not introduce new indications for use, nor does the use of the The Allura JD-OA release i Good nechikit addical Systems considers the Philips Allura 3D-CA release 1 substantially equivalent with the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem of an eagle with its wings spread. The eagle is facing to the left and has three lines extending from its head.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems North America Company

% Mr. Marc Mouser ` Senior Project Engineer/Program Reviewer Underwriters Laboratories, Inc. 2600 N.W. Lake Road CAMAS WA 98607-8542

Re: K042334

SEP 2 7 2004

Trade/Device Name: Allura 3D-CA Release 1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulatory Class: II Product Code: 90 LLZ and IZI Dated: September 16, 2004 Received: September 17, 2004

· 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 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.

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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ough marked of substantial equivalence of your device to a legally prematication. The PDF mining 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 If you desire specific acrise to your 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 Additionally, for questions on the please note the regulation entitled, "Misbranding Other of Othphanes as ( . ) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . by received to promaritor to promation the Act may be obtained from the Division of Small miorination on your responsibility of the Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

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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Page 1 of 1

510(k) Number (if known) :

Device Name :

Allura 3D-CA release 1

Indications For Use :

The Allura 3D-CA release 1 is intended to assist physicians when analyzing 2-The Allura SD-OA Cloud 110 mensional views from a pair of 2-Dimensional A ray mages created during rotational angiographic runs.

K642334

Prescription Use: X (Per 21 CFR 801.109) OR

Over-The-Counter Use . . . . .

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David R. Syprom

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042334

(Optional Format 1-2-96)

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).