(65 days)
Not Found
Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered devices.
No
The device is described as acquiring "diagnostic quality images," which indicates it is used for diagnosis, not therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "intended for use in acquiring diagnostic quality images."
No
The device description explicitly states that the systems are "fully integrated, single and biplane, cath labs," which are hardware systems used for acquiring images.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications." This describes an imaging system used on a patient to visualize internal structures, not a device used to test samples outside the body (in vitro).
- Device Description: The description refers to "cath labs" and "single and biplane" systems, which are typical components of medical imaging equipment used in a clinical setting for procedures on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are designed to perform tests on samples taken from the human body to provide information about a person's health status. This device is an imaging system used for direct visualization of the body.
N/A
Intended Use / Indications for Use
The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI
Device Description
The Philips Integris Series Release 2 systems include the Integris H5000, BH5000, V5000, BV5000, and HM2000. These systems are fully integrated, single and biplane, cath labs.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Cardiac, angiographic, vascular, neurovascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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.
Philips Integris V5000 and H5000
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
§ 892.1600 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
0/25/99
Image /page/0/Picture/1 description: The image shows the Philips logo. The logo consists of the word "PHILIPS" in bold, uppercase letters above a circular emblem. The emblem contains two wavy lines representing water and four stars. The stars are positioned above and below the wavy lines.
Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in large, bold, black letters. Above the word "PHILIPS" is a handwritten number that appears to be "K984545". The font of the word "PHILIPS" is sans-serif and the letters are closely spaced. The image is black and white.
Philips Medical Systems
510(k) Summary
| 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: | December 21, 1998 |
| Device name: | Philips Integris Series Release 2 systems |
| Classification name: | Angiographic X-ray system, 21 CFR 892.1600 |
| Class II (90 IZI) | |
| Common/Usual name: | Angiographic x-ray system |
| Predicate Device(s): | Philips Integris V5000 and H5000 |
Intended use:
The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.
System description:
The Philips Integris Series Release 2 systems include the Integris H5000, BH5000, V5000, BV5000, and HM2000. These systems are fully integrated, single and biplane, cath labs.
Safety / Software Information
An overview of the software description, the design, the summary of hazard analysis results and technical and safety information was included. The systems are designed in compliance with the applicable sections of Title 21 CFR part 1020, UL 187 and 2601, and comply with the ACR/NEMA DICOM digital imaging communication standard.
AK-5
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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 1999
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Re:
K984545 Philips Integris Series Release 2 Systems Dated: December 21, 1998 Received: December 22, 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 have headly we have reviewed your seculor of the indications for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce procles with the provisions of the mailkeled predicale devices marketed in merced in accordance with the provisions of the the pages lease Medical Device Antendheins, or to devices that hure between market the device, subject to the general controls, controls Federal Food, Drug, and Cosment controls provisions of the Act include requirements for annual registration, listing of
provisions of the Act. The general controls provision provisions of the Act. The general controls promotio of the netinst misbranding and adulteration.
If your device is classified (see above) into either class III (Special Controls) or class III (Premarket Approval), it may it your device is classified (see above) into elited in (e.g.) (2) in the can be found in the Code of be subject to such additional controls. Existing major rogalization assumes comes compliance with Federal Regulations, Thue 21, Parts ooo oo oour rrents, as set forth in the Quality System Regulation (QS) for the Food Manufacturing Prados requirements) and that, through periodic QS inspections, the Food and Medical Devices. "General regulations. Failure to comply with the GMP regulation may result in Drug Administration (1 DA) will volly dail assumediation of the announcements concerning your device in the Federal register. In addition, I DA may pablion remarket notification submission does not affect any obligation your Register. Prease fore: this response to your promation in 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 for for I fills letter will anow you to begin marked to a legally marketed in your case 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 Pat 801 and additionally 809.10 for in il you desire specific advice in your don'tee 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. Allso, the promotion and advertising of your donoor po by reference to premarket notification"(21 CFR 807.97). Other please note tre regulation entitled internation to prohained 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
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Philips Integris Systems, Release 2 Device Name :
Indications For Use :
The Philips Integris Series Release 2 systems are intended for use in acquiring diagnostic quality images during cardiac, angiographic, vascular, neurovascular, and interventional applications.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Syverson
(Division Sign Off)
Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number
Prescription Use
(Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)