(30 days)
Not Found
No
The document describes a standard C-arm X-ray system with image processing capabilities, but there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No
The device is described as being used for "radiological guidance and visualization during diagnostic, interventional, and surgical procedures," and its applications are listed as "Orthopedic, Neuro, Abdominal, Vascular, Thoracic, Cardiac." This indicates it is an imaging and guidance device, not a device that directly treats a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures." The mention of "diagnostic" directly indicates its use in diagnosing conditions.
No
The device description explicitly states it is a "counterbalanced C-arm with a thin flat detector x-ray system" and lists hardware components like the C-arm stand, X-ray generator, X-ray tube, Flat Detector, and mobile viewing station. While it includes software components (image processor, user interfaces), it is fundamentally a hardware system with integrated software.
Based on the provided information, the Veradius Unity device is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for "radiological guidance and visualization during diagnostic, interventional, and surgical procedures." This involves imaging the inside of the body using X-rays.
- Device Description: The description details a "counterbalanced C-arm with a thin flat detector x-ray system." This is a medical imaging device, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for this purpose.
Therefore, the Veradius Unity is a medical imaging device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Applications
- Orthopedic
- Neuro
- Abdominal
- Vascular
- Thoracic
- Cardiac
Product codes (comma separated list FDA assigned to the subject device)
OWB, OXO, JAA
Device Description
The proposed Veradius Unity is a counterbalanced C-arm with a thin flat detector x-ray system. The system consists of two main component 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, user interface for image/patient handling and optionally an integrated workstation)
Mentions image processing
Yes
Mentions AI, DNN, or ML
No
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
all patients except neonates (birth to one month)
Intended User / Care Setting
adequately trained, qualified, and authorized health care professionals such as physicians, surgeons, cardiologists, and radiographers
healthcare facilities both inside and outside the operating room, in sterile as well as nonsterile environments
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing has been performed on the proposed Veradius Unity and demonstrates compliance with International and FDA-recognized consensus standards and FDA guidance document.
IEC 60601-2-43 (2010)
IEC 60601-2-28 (2010)
IEC 62366(2007)
ISO 14971 (2007)
ISO 62304 (2006)
FDA Guidance document entitled, "Guidance for the Premarket Submissions for Software Contained in Medical Devices" issued May 11, 2005.
FDA Guidance "Radio Frequency Wireless Technology in Medical Devices" issued August 14, 2013
Additionally, the following verification and validation tests have been performed to address intended use, the technical claims, requirement specifications, usability and the risk management results for the significant changes:
New C-arm stand user interface:
- Prepare for acquisition
- Stand User Interface functions including the new concept SW controls
- Image reviewing and supporting functions
- Stand User Interface panel controls
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 Veradius Unity: Meets the acceptance criteria and is adequate for its intended use; Complies with the aforementioned international and FDA-recognized consensus.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
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.(b)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, resembling a symbol or emblem.
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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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FOR FDA USE ONLY
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. | |
| Veenpluis 4-6 | ||
| 5684 PC Best | ||
| The Netherlands | ||
| Establishment Registration Number: 3003768277 | ||
| Contact Person: | Jeanette Becker | |
| Regulatory Affairs Manager | ||
| Phone: +31611386380 | ||
| Fax: +31 40 2769100 | ||
| E-mail: jeanette.becker@philips.com | ||
| 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 | |
| detector x-ray system. The system consists of two main component 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, user interface for image/patient handling and optionally an | ||
| 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
(up/down/left/right) in the image with physical markers (3/6/9/12) on
the detector.
Wireless footswitch (Optional):
●
The predicate Veradius System is equipped with a footswitch that is
connected by wire to the system. The proposed Veradius Unity
system offers the possibility to optionally use a wireless footswitch in
addition to the wired footswitch
Electronic Blanking:
●
For the predicate Veradius System at higher voltage, the shutters on
the x-ray image may look gray instead of black. On the proposed
Veradius Unity system these lead shutters are overlaid by a black
area (blanking) on the shown x-ray image. This blanked (black) area
will not be shown as long as the physical shutters are still moving.
Only when the physical shutter has reached its requested end-position
after movement, the blanking will appear. | |
|-----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Based on the information provided in this premarket notification, the Veradius
Unity is considered substantially equivalent to the currently marketed and
predicate devices in terms of:
Indications for use;
●
Fundamental scientific technology;
●
Design and functionality;
●
Performance specifications and testing.
● | |
| Non-clinical
Performance Data: | Non-clinical performance testing has been performed on the proposed Veradius
Unity and demonstrates compliance with International and FDA-recognized
consensus standards and FDA guidance document.
IEC 60601-2-43 (2010)
●
IEC 60601-2-28 (2010)
●
IEC 62366(2007)
●
ISO 14971 (2007
●
ISO 62304 (2006)
●
FDA Guidance document entitled, "Guidance for the Premarket
●
Submissions for Software Contained in Medical Devices" issued
May 11, 2005.
FDA Guidance "Radio Frequency Wireless Technology in
●
Medical Devices" issued August 14, 2013
Additionally, the following verification and validation tests have been performed
to address intended use, the technical claims, requirement specifications,
usability and the risk management results for the significant changes:
New C-arm stand user interface:
●
Prepare for acquisition
O
Stand User Interface functions including the new concept
O | |
| | SW controls
Image reviewing and supporting functions
O
Stand User Interface panel controls
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 Veradius Unity : Meets the acceptance criteria and is adequate for its intended use; Complies with the aforementioned international and FDA-recognized consensus. | |
| | Therefore, the proposed Veradius Unity is substantially equivalent to the currently marketed and predicate device (K133819, July 10, 2014) in terms of safety and effectiveness. | |
| Clinical
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 Veradius Unity 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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