VERADIUS UNITY

K142708 · Philips Medical Systems Nethrlands BV · OWB · Oct 22, 2014 · Radiology

Device Facts

• Record ID: K142708
• Device Name: VERADIUS UNITY
• Applicant: Philips Medical Systems Nethrlands BV
• Product Code: OWB · Radiology
• Decision Date: Oct 22, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Veradius Unity 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 neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, in sterile environments, in a variety of procedures.

Device Story

Veradius Unity is a mobile, counterbalanced C-arm X-ray system for intraoperative imaging. It captures X-ray images via a flat detector and X-ray tube, processing them for display on a mobile viewing station. Operated by trained clinicians (surgeons, cardiologists, radiographers) in ORs or clinical settings. New features include a touchscreen stand interface, optional position tracking sensors, digital 'Outline tool' for anatomical marking, 'ClearGuide' for directional communication between surgeon and operator, optional wireless footswitch, and electronic blanking to mask shutter movement. These tools assist clinicians in real-time guidance, improving procedural accuracy and communication. The device provides visual feedback to support clinical decision-making during minimally invasive interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, verification, and validation of system modifications, confirming performance equivalent to the predicate.

Technological Characteristics

Counterbalanced C-arm with flat detector. Components: X-ray generator, X-ray tube housing, beam limiting device. Connectivity: Wired/wireless footswitch, touchscreen interface. Standards: IEC 60601-2-43, IEC 60601-2-28, IEC 62366, ISO 14971, ISO 62304. Software: GUI-based control, digital position tracking, electronic blanking, and annotation tools.

Indications for Use

Indicated for radiological guidance and visualization during diagnostic, interventional, and surgical procedures (orthopedic, neuro, abdominal, vascular, thoracic, cardiac) in patients excluding neonates (birth to one month).

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

• Veradius (K133819)

Submission Summary (Full Text)

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

October 22, 2014

Philips Medical Systems Netherlands BV % Ms. Jeanette Becker Regulatory Affairs Manager Veenpluis 4-6 BEST 5684 PC THE NETHERLANDS

Re: K142708

Trade/Device Name: Veradius Unity Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, JAA Dated: September 16, 2014 Received: September 22, 2014

Dear Ms. Becker:

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 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Smh

for

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

Enclosure

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# Indications for Use

510(k) Number (if known)

K142708

Device Name Veradius Unity

#### Indications for Use (Describe)

The Veradius Unity 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 neonates (birth to one month), within the limits of the device is to be used in health care facilities both inside and outside the operating room, in sterile environments, in a variety of procedures.

Applications

- · Orthopedic
- Neuro
- Abdominal
- Vascular
- · Thoracic
- Cardiac

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# 510(k) Summary

This 510(k) summary is prepared in accordance with 21 CFR 807.92.

| Date Prepared: | September 16, 2014 | |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Manufacturer: | Philips Medical Systems Nederland B.V.<br>Veenpluis 4-6<br>5684 PC Best<br>The Netherlands<br>Establishment Registration Number: 3003768277 | |
| Contact Person: | Jeanette Becker<br>Regulatory Affairs Manager<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Device Name: | Veradius Unity | |
| Classification: | Classification Name: | Interventional Fluoroscopic X-Ray System |
| | Classification Regulation: | 21 CFR892.1650 |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Primary product code: | OWB |
| | Secondary product code | OXO; JAA |
| Predicate Device | Trade Name: | Veradius |
| | Manufacturer: | Philips Medical Systems Nederland B.V. |
| | 510(k) Clearance: | K133819 (July 10, 2014) |
| | Classification Regulation: | 21 CFR, Part 892.1650 |
| | Classification Name: | Interventional Fluoroscopic X-Ray System |
| | Classification Panel: | Radiology |
| | Device Class: | Class II |
| | Product Code: | OWB; OXO; JAA |
| Device description: | The proposed Veradius Unity is a counterbalanced C-arm with a thin flat<br>detector x-ray system. The system consists of two main component parts: the C-<br>arm stand (comprising X-ray generator and X-ray tube, Flat Detector and the X-<br>ray control user interface) and the mobile viewing station (comprising the image<br>processor, monitors, user interface for image/patient handling and optionally an<br>integrated workstation) | |

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Indications for Use: The proposed Veradius Unity device is intended to be used and operated by: adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, 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 neonates (birth to one month), within the limits of the device. The device is to be used in healthcare facilities both inside and outside the operating room, in sterile as well as nonsterile environments, in a variety of procedures.

### Applications

- Orthopedic
- Neuro
- Abdominal
- Vascular
- Thoracic
- Cardiac

The proposed Philips Veradius Unity has identical indications to the currently marketed and predicate Veradius Mobile C-arm X-ray system (Veradius R1.2).

- The technology used in the development of the major components of the Technology: proposed Veradius Unity which includes X-ray generator, X-ray tube housing assembly, Image detection system and beam limiting device is identical to the currently marketed and predicate Veradius R1.2. The significant changes being proposed in this submission for the proposed Veradius Unity, when compared to the currently marketed and predicate Veradius R1.2, are as follows:
- . New C-arm stand user interface:

The stand user interface in the predicate Veradius system is based on hard buttons and a small monochrome display. This user interface has been replaced in the proposed Veradius Unity by a touch screen based user interface. The touch screen enables the end user to change and make any settings or pre-sets, but also displays the X-ray image which has just been taken by the physician.

- . Position tracking(optional):
The predicate Veradius system as well as the proposed Veradius Unity system has printed scales on the C-arc as reference for the geometrical position of the C-arc. The proposed Veradius Unity system can optionally be equipped with sensors on four C-arc axes to digitally read-out the geometrical position of these axes. The user can also store up to three positions for reference (Position Memory) which will indicate how to get back to these positions.

. Outline tool (Optional): On the proposed Veradius Unity system a digital equivalent of a marker pen has been implemented to draw vessel outlines and other anatomical references on the imaging monitor.

- . ClearGuide:
The ClearGuide function provided on the proposed Veradius Unity system is to improve the communication in the Operation Room

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| | between Surgeon and Operator by correlating directions<br>(up/down/left/right) in the image with physical markers (3/6/9/12) on<br>the detector.<br>Wireless footswitch (Optional):<br>●<br>The predicate Veradius System is equipped with a footswitch that is<br>connected by wire to the system. The proposed Veradius Unity<br>system offers the possibility to optionally use a wireless footswitch in<br>addition to the wired footswitch<br>Electronic Blanking:<br>●<br>For the predicate Veradius System at higher voltage, the shutters on<br>the x-ray image may look gray instead of black. On the proposed<br>Veradius Unity system these lead shutters are overlaid by a black<br>area (blanking) on the shown x-ray image. This blanked (black) area<br>will not be shown as long as the physical shutters are still moving.<br>Only when the physical shutter has reached its requested end-position<br>after movement, the blanking will appear. | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Based on the information provided in this premarket notification, the Veradius<br>Unity is considered substantially equivalent to the currently marketed and<br>predicate devices in terms of:<br>Indications for use;<br>●<br>Fundamental scientific technology;<br>●<br>Design and functionality;<br>●<br>Performance specifications and testing.<br>● | |
| Non-clinical<br>Performance Data: | Non-clinical performance testing has been performed on the proposed Veradius<br>Unity and demonstrates compliance with International and FDA-recognized<br>consensus standards and FDA guidance document.<br>IEC 60601-2-43 (2010)<br>●<br>IEC 60601-2-28 (2010)<br>●<br>IEC 62366(2007)<br>●<br>ISO 14971 (2007<br>●<br>ISO 62304 (2006)<br>●<br>FDA Guidance document entitled, "Guidance for the Premarket<br>●<br>Submissions for Software Contained in Medical Devices" issued<br>May 11, 2005.<br>FDA Guidance "Radio Frequency Wireless Technology in<br>●<br>Medical Devices" issued August 14, 2013<br>Additionally, the following verification and validation tests have been performed<br>to address intended use, the technical claims, requirement specifications,<br>usability and the risk management results for the significant changes:<br>New C-arm stand user interface:<br>●<br>Prepare for acquisition<br>O<br>Stand User Interface functions including the new concept<br>O | |
| | SW controls<br>Image reviewing and supporting functions<br>O<br>Stand User Interface panel controls<br>O | |
| | GUI behavior and state transitions Position tracking(optional) Accuracy Serviceability Calibration Outline tool (Optional) Free format drawing on live fluoro images Full editing functions including delete, undo, disable, enable ClearGuide The function is activated from the Stand User Interface Indicators are displayed on the examination monitor, stored to USB, printed with the internal printer. Actual indicators are placed on the detector Wireless footswitch (Optional) Startup/shutdown Functional test on X-Ray modes Coexistence with other wireless devices Electronic Blanking Image Quality | |
| | The results from the verification and validation tests as mentioned above demonstrate that the proposed <b>Veradius Unity</b> : Meets the acceptance criteria and is adequate for its intended use; Complies with the aforementioned international and FDA-recognized consensus. | |
| | Therefore, the proposed <b>Veradius Unity</b> is substantially equivalent to the currently marketed and predicate device (K133819, July 10, 2014) in terms of safety and effectiveness. | |
| Clinical<br>Performance Data: | The subject of this premarket submission Veradius Unity did not require clinical studies to support substantial equivalence because the Veradius Unity utilizes identical components throughout the imaging chain and the system's equivalent performance in light of the modifications could be supported through verification and validation testing alone." | |
| Conclusion: | The modifications of the device are verified and validated to ensure that the modifications are properly introduced; conformance to IEC standards and guidance documents. All of these tests were used to support substantial equivalence of the subject device. The proposed <b>Veradius Unity</b> is substantially equivalent to the currently marketed and predicate Veradius R1.2 system with regards to : Indications for use; Fundamental scientific technology; Design and functionality; Performance specifications and testing. | |

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