(12 days)
Not Found
No
The document describes a standard mobile C-arm X-ray system with image processing capabilities, but there is no mention of AI, ML, or related terms. The focus is on image quality and functional equivalence to a predicate device.
No
The device is used for radiological guidance and visualization during diagnostic, interventional, and surgical procedures, not for delivering therapy.
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."
No
The device description explicitly states it consists of a C-arm stand (including hardware like X-ray generator, tube, and detector) and a mobile viewing station (including hardware like image processor and monitors), indicating it is a hardware-based system with integrated software.
Based on the provided information, the Veradius device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health. The Veradius device, as described, is an X-ray system used for radiological guidance and visualization during procedures directly on the patient's body.
- The description focuses on imaging the internal structures of the patient using X-rays, not analyzing biological samples.
- The intended use and device description clearly indicate it's a medical imaging system for use during surgical and interventional procedures.
Therefore, the Veradius device falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
all patients, except babies
Intended User / Care Setting
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.
health care facilities both inside and outside the operating room, sterile as well as non-sterile environment.
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 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.
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.
0
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 (425) 487-7312 (425) 487-8666 lynn.harmer@philips.com 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.
2
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 | ||||
| housing | |||||
| assembly | Gilardoni | iXion Monoblock with | |||
| X-ray tube from Philips | |||||
| RO-0306 | Gilardoni | iXion Monoblock with | |||
| X-ray tube from Philips | |||||
| RO-0306 | |||||
| 3 | Beam Limiting | ||||
| Device | PMS Ned. BV | X-ray beam collimator | |||
| BV300 | PMS Ned. BV | X-ray beam collimator | |||
| BV300 | |||||
| 4 | Image Detection | ||||
| Subsystem | PMS Ned. BV | IDS-7 | |||
| Circular grid. | |||||
| Detector is a 9" or 12" | |||||
| II with digital camera. | |||||
| Controller integrated in | |||||
| camera. | PMS Ned. BV | FDS S FL1.1 | |||
| Rectangular grid. | |||||
| Flat detector. | |||||
| Separate FD | |||||
| controller. | |||||
| 5 | Detector laser | ||||
| aiming device | LAB Laser | Mounted with belt | |||
| around II | PMS Ned. BV | Integrated in FD | |||
| covers. | |||||
| 6 | Laser Alignment | ||||
| Tool | PMS Ned. BV | Laser Alignment Tool | |||
| BV300 | PMS Ned. BV | Laser Alignment Tool | |||
| BV300 | |||||
| 7 | Mobile C-arm | ||||
| Stand | PMS Ned. BV | C-arm Stand BV | |||
| Family R2 | PMS Ned. BV | C-arm Stand BV | |||
| Family R2 | |||||
| 8 | Mobile Viewing | ||||
| Station | PMS Ned. BV | MVS BV Family R2 | PMS Ned. BV | MVS BV Family R2 | |
| 9 | Indications for | ||||
| Use | PMS Ned. BV | Refer to 510(k) | |||
| K061685 | PMS Ned. BV | Indications for Use are | |||
| equal to Pulsera. Refer | |||||
| 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.
3
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
4
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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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
5
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