PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0

K022899 · Philips Medical Systems North America Co. · JAA · Nov 22, 2002 · Radiology

Device Facts

• Record ID: K022899
• Device Name: PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0
• Applicant: Philips Medical Systems North America Co.
• Product Code: JAA · Radiology
• Decision Date: Nov 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended 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.

Device Story

Angiographic x-ray system for cardiovascular diagnostic and interventional procedures; utilizes monoplane floor or ceiling-suspended G-arm stand. Inputs: x-ray radiation detected by amorphous silicon flat dynamic detector with cesium iodide scintillator. System transforms x-ray signals into digital images; records images on digital storage media. Used in clinical settings by physicians; supports image review, analysis, and archiving. Output: digital diagnostic images for clinical decision-making during procedures like stent placement or electrophysiology. Benefits: enables real-time visualization for minimally invasive cardiovascular interventions.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and compliance with established radiological and safety standards.

Technological Characteristics

Amorphous silicon flat dynamic x-ray detector with cesium iodide scintillator. Monoplane G-arm configuration (floor or ceiling). Complies with 21 CFR 1020.30, 1020.32, 1040.10, and UL 2601. Supports ACR/NEMA DICOM digital imaging communication standard.

Indications for Use

Indicated for patients undergoing cardiovascular x-ray imaging, including diagnostic and interventional procedures (e.g., PTCA, stent placement, atherectomy), pacemaker implantation, and electrophysiology.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Philips Integris Allura 9 system with FD Option (K020055)

Submission Summary (Full Text)

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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:<br>Address: | Philips Medical Systems North America Company<br>22100 Bothell Everett Highway<br>P.O.Box 3003<br>Bothell, WA 98041-3003, USA |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Registration No.: | 1217116 |
| Contact Person:<br>Telephone No.: | Lynn Harmer<br>[phone] |
| 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<br>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/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 [phone]. 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 [phone] or [phone] 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 .