(71 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related concepts, and the device description and performance study sections are not available to provide further clues. The predicate device also does not suggest AI/ML capabilities.
No.
The device is indicated for diagnostic imaging examinations, not for therapy.
Yes
The device is indicated for use in "Angiographic diagnostic imaging examinations," which directly states its diagnostic purpose.
No
The summary describes an "Option for Philips MultiDIAGNOST 4," which is a hardware imaging system. The "Rotational Angiography Option" is likely a feature or software component of this hardware system, not a standalone software-only device. The predicate device is also a hardware imaging system with a rotational angio function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Angiographic diagnostic imaging examinations." This describes an imaging procedure performed on a patient, not a test performed on a sample (like blood, urine, or tissue) outside the body.
- Device Description: While the description is "Not Found," the intended use strongly suggests an imaging system.
- Mentions image processing, AI, DNN, or ML: These are not mentioned, which is common for imaging systems but less so for complex IVDs that might involve automated analysis.
- Input Imaging Modality: "Angiographic" is an imaging modality, not a type of sample analysis.
- Predicate Device: The predicate device is an "Angio function," further confirming the device's nature as an imaging system.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's intended use and the nature of angiography clearly fall outside of this definition.
N/A
Intended Use / Indications for Use
The Rotational Angiography Option for Philips MultiDIAGNOST 4 is indicated for use in Angiographic diagnostic imaging examinations.
Product codes (comma separated list FDA assigned to the subject device)
90 IZI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
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
Image /page/0/Picture/0 description: The image shows a logo for Philips. The logo is in black and white and features the word "PHILIPS" at the top. Below the word is a circular emblem with two stars and two wavy lines inside of it. The logo is enclosed in a shield-like shape.
Philips Medical Systems
P.O. Box 10000, 5680 DA Best. The Nett
Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.
JUL - 3 1997
TOM XRD XDB 087-970165/RR/π
1997.03.17
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for
PHILIPS MULTI DIAGNOST 4 - ROTATIONAL ANGIOGRAPHY OPTION
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The undersigned certifies that the 510(k) Pre-Market notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence.
This information and data is summarized as follows:
-
- The MD 4 Rotational Angiography option is subject to Federal Performance Standards, defined in 21CFR - part 1000;
-
- The MD 4 Rotational Angiography option will be manufactured in accordance with voluntary safety standards, such as UL 187 ;
-
- The information for Users contains comprehensive information to insure safe and effective use;
-
- Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users. Refer to the Philips Integris V3000 Rotational Angio function, cleared under K923813
Ing. R.W.Rijntjes
Approbation manager
Quality Assurance dept. XCP / XCP
Quality Assurance dept. XSB / XCB Philips Medical Systems Nederland BV Best, The Netherlands.
522 104 2803
Stuis 6. Best The Nethe 3 40 27 91 11 +31 40 27 622 05 ercial Register Eindho
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue Shelton , CT 06484-0917
Re: K971489 Rotational Angiography Option for Philips MultiDIAGNOST 4 Dated: April 21, 1997 Received: April 23, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
JUL - 3 1997
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 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). 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 regulatory 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 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 question and advertising of your device. Dease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation 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/dsmamain.html"
Sincerely vours,
h.T. Hiau Yu.
Lillian Yin. Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Unknown K97148 510(k) Number (if known): ____
Rotational Angiography Option for Philips MultiDIAGNOST 4 Device Name :
Indications For Use :
The Rotational Angiography Option for Philips MultiDIAGNOST 4 is indicated for use in Angiographic diagnostic imaging examinations.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvin A. Beysson
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
OR
Prescription Use ( Per 21 CFR 801.109 Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)