(80 days)
Not Found
No
The document describes a standard angiographic x-ray system and does not mention any AI or ML capabilities in the intended use, device description, or other sections.
No.
The device is an angiographic x-ray system intended for imaging and diagnostic purposes in cardiovascular procedures, not for therapeutic intervention. While it supports interventional procedures, its role is for imaging during those procedures, not for treatment itself.
Yes
The "Intended Use" section explicitly states it is for "cardiovascular x-ray imaging applications, including diagnostic, interventional procedures." The "Device Description" also mentions it is for "cardiovascular diagnostic and interventional procedures."
No
The device description explicitly states it is an "angiographic x-ray system with a solid state x-ray imaging device" and describes hardware components like a "flat dynamic x-ray detector" and a "G-arm frontal stand." This indicates it is a hardware system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. They are used outside of the body (in vitro).
- Device description: The Philips Integris Allura Flat Detector system is an angiographic x-ray system. It uses x-rays to create images of the cardiovascular system within the body.
- Intended Use: The intended use clearly states it's for "cardiovascular x-ray imaging applications," including diagnostic and interventional procedures performed on the patient.
This device is an in vivo imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Philips Integris Allura Flat Detector release 1.0 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectornies), pacemaker implantations, and electrophysiology.
Product codes (comma separated list FDA assigned to the subject device)
JAA, IZI
Device Description
The Philips Integris Allura Flat Detector release 1.0 system 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 a either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cessium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
Cardiovascular
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" written at the top. Below the word is a globe with a wavy line going through the middle. The logo is in black and white.
Philips Medical Systems
KO 22899
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: | August 26, 2002 |
| Device (Trade) Name: | Philips Integris Allura Flat Detector release 1.0 |
| Classification Name: | Angiographic x-ray system, Class II, 90 IZI
Solid x-ray Imager, Class II, 90 MBO |
Predicate Device:
The Philips Integris Allura Flat Detector release 1.0 system is substantially equivalent to the Philips Integris Allura 9 system with FD Option manufactured by Philips Medical Systems. The Philips Integris Allura 9 system with FD Option received a 510(k) substantially equivalent determination in K020055 on March 15, 2002.
The solid state x-ray imaging device is the same product in both systems.
Device description:
The Philips Integris Allura Flat Detector release 1.0 system 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 a either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cessium iodide scintillator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques.
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Image /page/1/Picture/0 description: The image shows a logo for Philips. The logo is in a shield shape with the word "PHILIPS" at the top. Below the word is a globe with a horizontal line through the middle. At the bottom of the image is the number -2/2-.
Image /page/1/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. Below the word "PHILIPS" is the number "02008003", also in a bold font. The text is black against a white background.
510(k) Summary Philips Integris Allura Flat Detector system Page 2 of 2
X-ray images are detected with a flat dynamic x-ray detector 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 digital storage media, video or laser hardcopy.
Indications for Use:
The Philips Integris Allura Flat Detector release 1.0 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology.
General Safety and Effectiveness:
The device and their labeling will comply with the applicable requirements of 21 CFR, Subchapter J - radiological Health, parts 1020.30, 32 and 1040.10 The device will comply with applicable requirements of the Underwriters Laboratories Standard for Safety UL 2601 and be classified by Underwriters Laboratories. The Philips Integris Allura Flat Detector release 1.0 system will also comply with the ACR/NEMA DICOM digital imaging communication standard.
Conclusion:
The Philips Integris Allura Flat Detector release 1.0 system 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 Flat Detector release 1.0 system to be substantially equivalent with the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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AUG 20 2013
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Lynn Hammer Manager, Regulatory Submissions Philips Medical Systems 22100 Bothell Everett Hwy. BOTHELL WA 98041-3003
Re: K022899
Trade/Device Name: Philips Integris Allura Flat Detector release 1.0 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and IZI Dated: August 30, 2002 Received: September 3, 2002
Dear Ms. Hammer:
This letter corrects our substantially equivalent letter of November 22, 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 of
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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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Philips Medical Systems
Indications for Use statement
510(k) Number (if known):
Device Name: Philips Integris Allura Flat Detector release 1.0
Indications for Use:
The Philips Integris Allura Flat Detector release 1.0 system is intended for use in cardiovascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectornies), pacemaker implantations, and electrophysiology.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ... (Per 21 CFR 801.109)
OR
Over-The-Counter Use ......
David A. Heyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 172899 510(k) Number .