PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2

K031333 · Philips Medical Systems North America, Inc. · IZI · May 13, 2003 · Radiology

Device Facts

• Record ID: K031333
• Device Name: PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.2
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: IZI · Radiology
• Decision Date: May 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular 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/vascular diagnostic and interventional procedures. System utilizes floor or ceiling-suspended G-arm stand; amorphous silicon flat-panel detector with cesium iodide scintillator captures x-ray signals. Transforms x-ray inputs into digital images via fluoroscopic/fluorographic techniques. Used in clinical settings (e.g., OR, cath lab) by physicians/technicians. System records, reviews, and analyzes images; supports archiving to digital media, video, or hardcopy. Output assists clinicians in real-time visualization for procedures like stent placement or pacemaker implantation, facilitating minimally invasive interventions.

Clinical Evidence

No clinical data provided; substantial equivalence established through technological comparison and bench testing.

Technological Characteristics

Monoplane G-arm x-ray system. Detector: amorphous silicon with cesium iodide scintillator. Connectivity: DICOM compliant. Safety standards: 21 CFR Subchapter J, UL 2601-1. Imaging: fluoroscopic and fluorographic.

Indications for Use

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

Regulatory Classification

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.

Predicate Devices

• Philips Integris Allura Flat Detector release 1.0 system (K022899)
• GE Innova 4100 system

Submission Summary (Full Text)

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MAY 1 3 2003

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16031333

## Philips Medical Systems

### 510(k) SUMMARY

The following information is being submitted in accordance with the requirements of 21 CFR 807.92.

| Company Name: | Philips Medical Systems North America Company |
|----------------------|-------------------------------------------------------------------------------------|
| Address: | 22100 Bothell Everett Highway<br>P.O. Box 3003<br>Bothell, WA 98041-3003, USA |
| Registration No.: | 1217116 |
| Contact Person: | Lynn Harmer |
| Telephone No.: | [phone] |
| Date Prepared: | April 16, 2003 |
| Device (Trade) Name: | Philips Integris Allura Flat Detector release 1.2 system |
| Classification Name: | Angiographic x-ray system, Class II, 90 IZI<br>Solid x-ray Imager, Class II, 90 MBQ |

#### Predicate Device:

The Philips Integris Allura Flat Detector release 1.2 system is substantially equivalent to the Philips Integris Allura Flat Detector release 1.0 system manufactured by Philips Medical Systems and GE Innova 4100 system. The Philips Integris Allura Flat Detector release 1.0 system received a 510(k) substantially equivalent determination in K022899 on November 22, 2002. The solid state x-ray Imaging device is the same product in both of the Integris Allura systems.

#### Device description:

The Philips Integris Allura Flat Detector release 1.2 system is an angjographic x-ray system with a solid state x-ray imaging device for cardiovascular and vascular diagnostic and interventional procedures. The monoplane system can be configured either a floor or ceiling suspended G-arm frontal stand. The x-ray detector is comprised of amorphous silicon with a cesium iodide scintilator. The system supports generating and recording x-ray diagnostic images using fluoroscopic and fluorographic techniques.

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K031 333

510(k) Summary Philips Integris Allura Flat Detector System, release 1.2 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 1.2 system is intended for use in cardiovascular and vascular 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 the labeling will comply with the applicable requirements of 21CFR, 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 2601-1 and be classified by Underwriters Laboratories. The Philips Integris Allura Flat Detector release 1.2 system will also comply with the ACR/NEMA DICOM digital imaging communication standard.

#### Conclusion:

The Philips Integris Allura Flat Detector release 1.2 system is substantially equivalent in safety and effectiveness to the predicate devices identified.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle or bird with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 3 2003

Philips Medical Systems North America Company % Mr. Morten S. Christensen Senior Project Engineer Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050

Re: K031333

Trade/Device Name: Philips Integris Allura Flat Detector release 1.2 Regulation Number: 21 CFR 892.1600 Regulation Name: Angiographic x-ray system Regulation Class: II Product Code: 90 IZI Dated: April 23, 2003 Received: April 28, 2003

Dear Mr. Christensen:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 v 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# K0313333

#### Indications for Use statement

510(k) Number (if known):

Philips Integris Allura Flat Detector release 1.2 Device Name:

Indications for Use:

The Philips Integris Allura Flat Detector release 1.2 system is intended for use in cardiovascular and vascular x-ray imaging applications, including diagnostic, interventional procedures (such as PTCA, stent placing, atherectomies), 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)

Nancy C. Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031333

Prescription Use .\/
(Per 21 CFR 801.109)

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OR

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