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.

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. 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.

AI/ML Overview

The Philips Integris Allura Flat Detector release 1.0 is an angiographic x-ray system with a solid state x-ray imaging device. The provided text is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a detailed study is not available in the provided document.

Here's a breakdown of what can be extracted and what is missing:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the document. The 510(k) summary focuses on general safety and effectiveness and substantial equivalence to a predicate device. It does not list specific quantitative performance acceptance criteria or report on device performance against such criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

This information is not provided in the document. The 510(k) summary does not describe any specific test set, its sample size, or data provenance for performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not provided in the document. As no specific test set or ground truth establishment process is described, details about experts are absent.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not provided in the document. No adjudication method is mentioned as there's no description of a test set and ground truth establishment.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided in the document. The device is an x-ray system, not an AI-powered diagnostic tool, and there is no mention of an MRMC study or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not provided in the document. The device itself is an imaging system, and the document focuses on its substantial equivalence and general safety, not on standalone algorithm performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

This information is not provided in the document. There is no description of any ground truth being established for performance evaluation.

8. The sample size for the training set:

This information is not provided in the document. There is no mention of a "training set" as the device is an imaging system, not an AI model that undergoes training in this context.

9. How the ground truth for the training set was established:

This information is not provided in the document. No training set or its ground truth establishment is discussed.

Summary of available information:

The provided documents confirm the device's indications for use and its substantial equivalence to a predicate device (Philips Integris Allura 9 system with FD Option, K020055). The basis for clearance is that the device "does not introduce any new indications for use, nor does the use of the device result in any new potential hazard." The product is an angiographic x-ray system intended for cardiovascular x-ray imaging applications.

Summary

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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 Company22100 Bothell Everett HighwayP.O.Box 3003Bothell, 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 IZISolid 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:

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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:

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)

Over-The-Counter Use ......

David A. Heyman

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 172899 510(k) Number .

Regulation Number and Section

§ 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.