(28 days)
Not Found
No
The description focuses on traditional image processing techniques and cardiac modeling, with no mention of AI or ML terms, training data, or performance metrics typically associated with AI/ML devices.
No
The device is used for analysis by creating 3D views from 2D X-ray images, assisting physicians in diagnosis, not for direct treatment of a disease or condition.
No.
The device assists physicians in analyzing X-ray images by creating 3D views from 2D images, which is an image processing function rather than a diagnostic one.
No
The device description explicitly states it contains an "image processing computer" and is linked to an X-ray system, indicating it includes hardware components beyond just software.
Based on the provided information, the Allura 3D-CA release 1 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality.
- Allura 3D-CA Function: The Allura 3D-CA release 1 processes X-ray images taken directly from the patient's body (in vivo) to create 3D views. It does not examine specimens derived from the human body (like blood, urine, tissue samples, etc.).
- Intended Use: The intended use is to assist physicians in analyzing 2D X-ray images by creating 3D views, which is a form of medical imaging processing and visualization, not in vitro testing.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ, IZI
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Coronary arteries / heart
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians / Angiographic suite control room
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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 Company
22100 Bothell Everett Highway
P.O.Box 3003
Bothell, 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:
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.
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.
1
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.
2
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.
3
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.
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)