(49 days)
Not Found
No
The description focuses on 3D reconstruction from 2D images using image processing software, with no mention of AI, ML, or related concepts.
No.
The device creates 3D views from 2D images for analysis and does not directly treat a disease or condition.
Yes
The device is described as assisting physicians in analyzing X-ray images by creating 3D views from 2D images, which is a function directly related to diagnosis.
No
The device description explicitly states it is comprised of an "image processing computer loaded with 3D-RA software," indicating it includes hardware (the computer) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Integris 3D RA Option processes X-ray images taken from the body, not samples from the body. It assists physicians in analyzing these images by creating 3D views.
- Intended Use: The intended use is to assist physicians in analyzing existing images, not to perform a diagnostic test on a biological sample.
Therefore, the device falls under the category of medical imaging software or a medical image processing system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Integris 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by creating three dimensional views from sets of two dimensional images created during Rotational angiographic runs.
Product codes
90 IZI
Device Description
The Integris 3D-RA option is comprised of an image processing computer loaded with 3D-RA software. It is linked through a DICOM port to the Integris system and is intended to be placed in the control room of the Angiography suite. The set of 2-Dimensional images from the rotational angiographic examination are transferred via DICOM Connection to the 3D RA Workstation. A 3-Dimensional image is reconstructed from the delivered image information resulting in an object which can be viewed from almnost any angle.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
DSA X-ray images
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
control room of the Angiography suite
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)
Advantx LCN+ and LCLP+ (K974367).
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
DEC 2 1 1998
Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in a bold, sans-serif font above a circular emblem. The emblem contains four stars and three wavy lines, all rendered in a simple, line-art style.
510(k) Summary Philips Medical Systems
| Company name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport Avenue, Shelton, CT 06484 |
| Contact person: | P. Altman |
| Telephone number: | 203-926-7031 |
| Prepared: | October 30, 1998 |
| Device name: | Philips Integris 3D RA Option |
| Classification name: | Angiographic X-ray system, 21 CFR 892.1600 |
| Class II (90 IZI) | |
| Common/Usual name: | Angiographic x-ray system |
| Predicate Device(s): | Advantx LCN+ and LCLP+ (K974367). |
Intended use:
The Integris 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by creating three dimensional views from sets of two dimensional images created during Rotational angiographic runs.
System description:
The Integris 3D-RA option is comprised of an image processing computer loaded with 3D-RA software. It is linked through a DICOM port to the Integris system and is intended to be placed in the control room of the Angiography suite. The set of 2-Dimensional images from the rotational angiographic examination are transferred via DICOM Connection to the 3D RA Workstation. A 3-Dimensional image is reconstructed from the delivered image information resulting in an object which can be viewed from almnost any angle.
Substantial equivalence Information
The Integris 3D RA Option is substantially equivalent to the 3D image reconstruction and image intensifier distortion capabilities of the GE Medical Sytems' Advantx LCN+ and LCLP+ (K974367). Differences between the new and predicate device are identified in a Comparison matrix.
Conclusion:
It is the opinion of Philips Medical Systems that Integris 3D-RA is safe and potential hazards are controlled by a risk management plan including hazard analysis, system software quality assessment plan, software validation statement, test activities and external evaluations by hospitals. The use of Integris 3D-RA option does not change the intended use of the angiographic systems with which it is used.
Philips Medical Systems
North America Company
710 Bridgeport Avenue
P.O. Box 860
Shelton, Connecticut 06484-0917
Tel: (203) 926-7674
Fax: (203) 929-6099
1
Image /page/1/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract design that resembles an eagle or bird in flight. The design is composed of three curved lines that form the body and wings of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 1 1998
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917
Re: K983877
Philips/Integris 3D RA Option for Angiographic X-Ray System Dated: October 30, 1998 Received: November 2, 1998 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
Dear Mr. Altman:
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). 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 regulations affecting your device can be found in the Code of Federal Requlations. Title 21. Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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.
This letter will allow you to begin 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation 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,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
n98381 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ -Unknown
Device Name : Philips Integris 3D RA Option
Indications For Use :
The 3D RA Option is intended to assist physicians when analyzing two dimensional, DSA X-ray images by creating three dimensional views from sets of two dimensional images created during Rotational angiographic runs.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Seym
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 1983877 510(k) Number _
Prescription Use ( Per 21 CFR 801.109 OR
Over-The-Counter Use
(Optional Format 1-2-96)