ALLURA XPER FD20

K033737 · Philips Medical Systems North America, Inc. · OWB · Dec 9, 2003 · Radiology

Device Facts

• Record ID: K033737
• Device Name: ALLURA XPER FD20
• Applicant: Philips Medical Systems North America, Inc.
• Product Code: OWB · Radiology
• Decision Date: Dec 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Allura Xper FD20 is intended for: - Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis. - Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP). - Non-vascular interventions such as drainages, biopsies and vertebroplasties procedures.

Device Story

Allura Xper FD20 is a stationary fluoroscopic angiographic X-ray system. It captures X-ray images for visualization during vascular, neurovascular, cardiac, and non-vascular interventional procedures. Operated by clinicians in clinical settings (e.g., interventional suites), the system provides real-time imaging to guide procedures like stent placement, biopsies, and electrophysiology. Output is displayed for the physician to monitor anatomy and device placement, facilitating minimally invasive interventions and improving procedural accuracy.

Clinical Evidence

No clinical data provided; device relies on bench testing and compliance with established radiological and safety standards.

Technological Characteristics

Stationary fluoroscopic X-ray system. Complies with 21 CFR Subchapter J (radiological health) and UL 2601-1 (safety). Supports ACR/NEMA DICOM standards for digital imaging communication.

Indications for Use

Indicated for patients requiring diagnostic or interventional vascular, neurovascular, cardiac, or non-vascular imaging procedures, including angiography, stent placement, embolization, thrombolysis, atherectomy, pacemaker implantation, electrophysiology, drainage, biopsy, and vertebroplasty.

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

• Integris Allura (K002016)

Submission Summary (Full Text)

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DEC - 9 2003

Image /page/0/Picture/1 description: The image shows the Philips logo, which consists of the word "PHILIPS" at the top of a shield-shaped emblem. Below the text, there is a stylized globe with wavy lines representing water and curved lines representing land masses. The logo is in black and white.

Image /page/0/Picture/2 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The text appears to be a logo or brand name, likely for the electronics company Philips.

## Philips Medical Systems Nederland B.V.

# 510(k) Summary

Ko33737

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:<br>Telephone No.: | Lynn Harmer<br>[phone] |
| Date Prepared: | November 18, 2003 |
| Device (Trade) Name: | Allura Xper FD20 |
| Classification Names: | Stationary X-ray system,<br>21CFR892.1680, Class II (code 90KPR) |
| | Angiographic X-ray system,<br>21CFR892.1600, Class II (code 90IZI) |

#### Predicate Device:

The Allura Xper FD20 is substantially equivalent to the Integris Allura, both manufactured by Philips Medical Systems. The Philips Integris Allura received a 510(k) substantially equivalent determination in K002016 on September 6, 2000.

#### Device description:

The Allura Xper FD20 is a stationary fluoroscopic angiographic X-ray system for vascular, neurovascular and cardiovascular procedures, as well as non-vascular procedures.

#### Intended use:

The Allura Xper FD20 is intended for:

- Dedicated vascular and neurovascular imaging applications, including diagnostic and . interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis.
- Cardiac imaging applications including diagnostics, interventional procedures (such . as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP).
- Non-vascular interventions such as drainages, biopsies and vertebroplasties . procedures.

Document identification: XDB087-030820/RVI/vi

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Image /page/1/Picture/0 description: The image shows the Philips logo. The logo consists of a shield-like emblem on the left and the word "PHILIPS" in bold, uppercase letters on the right. The emblem features a stylized representation of stars and waves, enclosed within the shield shape.

### General Safety and Effectiveness Information:

The device and their labeling will comply with the applicable requirements of:

- 21CFR, Subchapter J Radiological Health, parts 1010, 1020.30, 1020.32 & . 1040.10.
- Underwriters Laboratories Standard for Safety UL 2601-1 and be classified by � Underwriters Laboratories.
- ACR/NEMA DICOM digital imaging communication standard. .

#### Conclusion:

The Allura Xper FD20 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 Allura Xper FD20 to be substantially equivalent with the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it. The symbol is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA". The text is arranged in a circular fashion around the caduceus symbol.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Philips Medical Systems North America Company c/o Mr. John C. So Senior Project Engineer Underwriters Laboratories, Inc. 6200 NW Lake Rd. Camas, WA 98607

JUL 1 9 2013

Re: K033737

Trade/Device Name: Allura Xper FD20 Regulation Number: 21 CFR 892.1650 Regulation Name: Intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB. JAA, 1ZI Dated: November 26, 2003 Received: November 28, 2003

Dear Mr. So:

This letter corrects our substantially equivalent letter of December 9, 2003.

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 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

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Page 2 - J. So

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Jaming M. Mense

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

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510(k) Number (if known): ___ バロタ:37 3 ア

Device name: Allura Xper FD20

Indications for use:

The Allura Xper FD20 is intended for:

- · Dedicated vascular and neurovascular imaging applications, including diagnostic and interventional procedures. This includes, " e.g., peripheral, cerebral, thoracic and abdominal angiography, as well as PTCAs, stent placements, embolisations and thrombolysis.
- · Cardiac imaging applications including diagnostics, interventional procedures (such as PTCA, stent placing, atherectomies), pacemaker implantations, and electrophysiology (EP),
- Non-vascular interventions such as drainages, biopsies and . vertebroplasties procedures.

Nancy C. Broughton

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K033737

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Per 21CFR801.109)

Use

OR

Over-The counter

Rel. nr. XDB087-030873/AVVrvi

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