VERADIUS, MODEL 718-130

K090590 · Philips Medical Systems North America Co. · OWB · Mar 16, 2009 · Radiology

Device Facts

• Record ID: K090590
• Device Name: VERADIUS, MODEL 718-130
• Applicant: Philips Medical Systems North America Co.
• Product Code: OWB · Radiology
• Decision Date: Mar 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologist, radiologists and radiographers who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies, within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures. Applications: Orthopedic Neuro Abdominal Vascular Thoracic Cardiac

Device Story

Mobile C-arm X-ray system for intraoperative and diagnostic imaging. Input: X-ray radiation captured by flat panel detector. Transformation: X-ray signals converted to digital images via image detection subsystem; processed by mobile viewing station for display and archiving. Output: Real-time fluoroscopic images for clinical visualization. Used in ORs and clinical settings by surgeons, cardiologists, and radiographers. Output assists in surgical guidance and diagnostic decision-making; provides real-time anatomical visualization to improve procedural accuracy.

Clinical Evidence

Bench testing only. Comparison of image pairs taken during non-clinical performance tests between Veradius and the predicate device demonstrated equal or better image quality.

Technological Characteristics

Mobile C-arm X-ray system. Components: iXion HF Generator, X-ray tube (RO-0306), BV300 collimator, flat dynamic X-ray detector, and mobile viewing station. Connectivity: digital image processing and archiving. Software: Moderate level of concern. Sterilization: N/A (device is for radiological imaging).

Indications for Use

Indicated for radiological guidance and visualization during diagnostic, interventional, and surgical procedures (orthopedic, neuro, abdominal, vascular, thoracic, cardiac). Patient population: all patients except babies. Intended for use by trained healthcare professionals (physicians, surgeons, cardiologists, radiographers) in clinical facilities.

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

• Pulsera 3D-RX Option for BV Pulsera, Release 2.2 (K061685)

Submission Summary (Full Text)

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K09.05-590

510(k) Premarket Notification, Veradius Philips Medical Systems Nederland B.V.

### Page 1 of 3 November 10, 2008

# 510(k) Summary of Veradius device

MAR 1 6 2009

## In accordance with the requirements of 21 CFR 807.92

### 1) Submitted by

Philips Medical Systems North America Company 22100 Bothell Everett Highway Bothell, WA 98021 Establishment Registration No. 1217116

Contact: Phone: Fax: Email: Date prepared: Lynn Harmer [phone] [phone] [e-mail] November 10, 2008

#### 2) Manufacturer

Philips Medical Systems Nederland B.V. Veenpluis 4-6 5684 PC Best The Netherlands Establishment Registration No. 3003768277

#### 3) Device name and classification

Trade name: VERADIUS Classification name: System, x-ray, mobile and Solid State X-Ray Imager (Flat Panel/Digital Imager) Classification panel: Radiology devices Regulatory status: Class II 21CFR 892.1720 Class II (IZL) and 21 CFR Device classification reg.nr: 892.1650 Class II (MQB)

### 4) Predicate device

Device name: K-Number: Trade name: Manufacturer:

Pulsera K061685 3D-RX Option for BV Pulsera, Release 2.2 Philips Medical Systems Nederland B.V.

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510(k) Premarket Notification. Veradius Philips Medical Systems Nederland B.V.

Page 2 of 3 November 10, 2008

#### 5) Device description (summarized)

The Veradius device is a Mobile C-arm X-ray System designed for medical applications during diagnostic, interventional and surgical procedures.

The device consists mainly of two parts: the C-arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-ray control user interface) and the mobile viewing station (comprising the image processor, monitors, mains control unit, an user interface for image/patient handling and optionally an integrated workstation).

All movements of the C-arm stand are manual except the height movement. The Mobile viewing station can be used standalone for reviewing and archiving purposes,

#### 6) Indications for Use

The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologists and radiographers who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies, within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Applications:

- Orthopedic Neuro Abdominal Vascular Thoracic Cardiac
#### 7) Technological characteristics and substantial equivalence

The Veradius does not introduce any new indications for use, nor does the use of the device result in any new potential hazard. Philips Medical Systems Nederland BV considers the Veradius to be substantially equivalent with the predicate device.

The Veradius is a mobile X-ray system consisting of components mention in Table 1 Device Comparison.

All units are the same as in the predicate device and known to FDA, except 4 and 5.

#### Image Detection Subsystem

The Image Detection Subsystem (IDS) is new. For the Veradius the IDS based on an Image Intensifier is replaced by an IDS with a Flat Detector. The IDS detect X-rays and convert them to digital images, and apply calibration to obtain the required data.

The function (intended use) of the Image Detection Subsystem is not different from its predicate device. Only the technologic characteristics are different.

The new IDS consist out of an anti scatter grid, a flat dynamic X-ray detector and a detector controller. The new technologic characteristic does not affect safety or introduce any new type of hazards.

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510(k) Premarket Notification, Veradius Philips Medical Systems Nederland B.V.

## Table 1 Device Comparison

-

| | | Pulsera | | Veradius | |
|---|-----------------------------------|--------------|----------------------------------------------------------------------------------------------------------------------|--------------|----------------------------------------------------------------------------------|
| | | Manufacturer | Model | Manufacturer | Type |
| 1 | X-ray generator | Gilardoni | iXion HF Generator | Gilardoni | iXion HF Generator |
| 2 | X-ray tube<br>housing<br>assembly | Gilardoni | iXion Monoblock with<br>X-ray tube from Philips<br>RO-0306 | Gilardoni | iXion Monoblock with<br>X-ray tube from Philips<br>RO-0306 |
| 3 | Beam Limiting<br>Device | PMS Ned. BV | X-ray beam collimator<br>BV300 | PMS Ned. BV | X-ray beam collimator<br>BV300 |
| 4 | Image Detection<br>Subsystem | PMS Ned. BV | IDS-7<br>Circular grid.<br>Detector is a 9" or 12"<br>II with digital camera.<br>Controller integrated in<br>camera. | PMS Ned. BV | FDS S FL1.1<br>Rectangular grid.<br>Flat detector.<br>Separate FD<br>controller. |
| 5 | Detector laser<br>aiming device | LAB Laser | Mounted with belt<br>around II | PMS Ned. BV | Integrated in FD<br>covers. |
| 6 | Laser Alignment<br>Tool | PMS Ned. BV | Laser Alignment Tool<br>BV300 | PMS Ned. BV | Laser Alignment Tool<br>BV300 |
| 7 | Mobile C-arm<br>Stand | PMS Ned. BV | C-arm Stand BV<br>Family R2 | PMS Ned. BV | C-arm Stand BV<br>Family R2 |
| 8 | Mobile Viewing<br>Station | PMS Ned. BV | MVS BV Family R2 | PMS Ned. BV | MVS BV Family R2 |
| 9 | Indications for<br>Use | PMS Ned. BV | Refer to 510(k)<br>K061685 | PMS Ned. BV | Indications for Use are<br>equal to Pulsera. Refer<br>to chapter 6. |

## 8) Non-Clinical and Clinical performance tests

Non-Clinical and clinical tests have been performed to verify and validate the system functionality for the intended use. Results of the conducted tests conclude that the Veradius is substantial equivalent to its predicate device.

Based on comparison between tmages pairs laken during non-clinical performance tests with the Veradius and its predicate device, it can be concluded that the Image Quality is equal or even better.

## 9) Safety information

The Level of Software concern is MODERATE as determined according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" dated May/11/2005.

A product risk management is executed and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.

Philips Medical Systems North America Company feels that sufficient information and data are contained in this submission to enable CDRH to reach a determination of substantial equivalence.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUL 30 2012

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

Philips Medical Systems, North America Company % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K090590 Trade/Device Name: Veradius Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: March 3. 2009 Received: March 4, 2009

Dear Mr. Job:

This letter corrects our substantially equivalent letter of March 16, 2009.

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 (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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510(k) Premarket Notification, Veradius Philips Medical Systems Nederland B.V.

Page 1 of 1 November 10, 2008

## Indications for Use

510(k) Number (if known):

Device Name: Veradius

Indications For Use:

The Veradius device is intended to be used and operated by: adequately trained, qualified and authorized health care professionals such as physicians, surgeons, cardiologist, radiologists and radiographers who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device.

The device is used for radiological guidance and visualization during diagnostic, interventional and surgical procedures on all patients, except babies, within the limits of the device. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile environment in a variety of procedures.

Applications:

Orthopedic Neuro Abdominal Vascular

Thoracic

Cardiac

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Section A6