(66 days)
Not Found
No
The summary describes a standard angiographic x-ray system and its components, with no mention of AI or ML capabilities in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is an imaging system used for diagnostic and interventional procedures, which are forms of treatment, but the device itself does not directly treat a disease or condition. It is used to visualize and guide procedures.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is intended for "cardiac x-ray imaging applications, including diagnostic, interventional procedures". The "Device Description" also mentions its use for "cardiovascular diagnostic and interventional procedures", and that it "supports generating and recording x-ray diagnostic images".
No
The device description clearly states it is an "angiographic x-ray system with a solid state x-ray imaging device" and mentions hardware components like a "G-arm frontal stand" and an "amorphous silicon with a cesium iodide scintillator" x-ray detector. This indicates it is a hardware-based medical device, not software-only.
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 "cardiac x-ray imaging applications, including diagnostic, interventional procedures...". This describes a medical imaging system used on a patient to visualize internal structures.
- Device Description: The description details an "angiographic x-ray system" that "supports generating and recording x-ray diagnostic images". This further confirms it's an imaging device.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The provided information does not mention any analysis of biological samples.
Therefore, the Philips Integris Allura 9 system with FD Option is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies) pacemaker implantations, and electrophysiology.
Product codes (comma separated list FDA assigned to the subject device)
JAA, IZI
Device Description
The Philips Integris Allura 9 system with FD Option is an angiographic x-ray system with a solid state x-ray imaging device for cardiovascular diagnostic and interventional procedures. The monoplane system can be configured as either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are detected with a flat dynamic x-ray detector (FD) and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on film (video or laser hardcopy) or on digital storage media.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
cardiac
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
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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Image /page/0/Picture/0 description: The image shows the Philips logo, which is a shield shape with the word "PHILIPS" at the top. Inside the shield, there is a globe-like symbol with a wavy line across the middle and a star-like shape in the upper left and lower right quadrants. The logo is black and white.
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are black and the background is white. The letters are slightly distressed, with some small imperfections and variations in the thickness of the lines.
MAR 1 5 2002
Philips Medical Systems
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 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Registration No .: | 1217116 |
| Contact Person:
Telephone No .: | Lynn Harmer
(425) 487-7312 |
| Date Prepared: | January 7, 2002 |
| Device (Trade) Name: | PHILIPS Integris Allura 9 system with FD Option |
| Classification Name: | Angiographic x-ray system, Class II, 90 IZI
Solid x-ray Imager, Class II, 90 MBQ |
Predicate Devices:
The Philips Integris Allura 9 System with FD Option is substantially equivalent to the Philips Integris H5000 system manufactured by Philips Medical Systems. The Integris H5000 received a 510(k) substantially equivalent determination in K984545 on February 25, 1999.
The FD option is also substantially equivalent to GE Medical Systems' solid state digital detector cleared by FDA on February 14, 2000, under 510(k) K993037.
Device Description:
The Philips Integris Allura 9 system with FD Option is an angiographic x-ray system with a solid state x-ray imaging device for cardiovascular diagnostic and interventional procedures. The monoplane system can be configured as either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques. X-ray images are
22100 Bothell Everett Highway
Bothell, Washington 98021-8431
(425) 487 7000
1
detected with a flat dynamic x-ray detector (FD) and are recorded on digital storage medium. The system offers the functionality to review and analyze the images. Digital images with corresponding patient and examination data may be archived on film (video or laser hardcopy) or on digital storage media.
Indications for Use:
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies) pacemaker implantations, and electrophysiology.
General Safety and Effectiveness:
The devices and their labeling will comply with the applicable requirements of 21 CFR, Subchapter J - Radiological Health, parts 1020.30, .31, and .32.
The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety, X-ray Equipment (UL 187 and UL 2601) and be classified by Underwriters Laboratories. The Integris Allura 9 system with FD Option will also comply with the ACR/NEMA DICOM digital imaging communication standard.
Conclusion:
The Phillips Integris Allura 9 system with FD Option does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems considers the Integris Allura 9 system with FD Option to be substantially equivalent with the predicate devices.
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in blue and is centered in the image. The font is sans-serif and the text is in all caps. There is a logo to the left of the text.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lynn Harmer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Hwy. BOTHELL WA 98041-3003
AUG 20 2043
Re: K020055
Trade/Device Name: Philips Integris Allura 9 System with FD Option Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and IZI Dated: January 7, 2002 Received: January 8. 2002
Dear Ms. Harmer:
This letter corrects our substantially equivalent letter of March 15, 2002.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Philips Integris Allura 9 system with FD Option Device Name:
Indications for Use:
The Philips Integris Allura 9 system with FD Option is intended for use in cardiac imaging applications including diagnostic, interventional procedures (such as PTCA, maging approaded mores,) pacemaker implantations, and electrophysiology (EP.)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Toriel A. Skynner
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K020055
510(k) Number
L Prescription Use_ (Per 21 CFR 801.109)
OR
Over-The-Counter Use_