(80 days)
Not Found
No
The summary describes motorized movement and distance control based on object detection, but does not mention any AI or ML algorithms for image analysis, diagnosis, or other functions. The image processing mentioned is likely standard digital image processing techniques.
No.
This device is an imaging system (fluoroscopic X-ray) used to visualize anatomical structures during medical procedures, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use in providing medical imaging... during diagnostic interventional and surgical procedures."
No
The device description clearly outlines hardware components like a Mobile Stand (C-Arm) with an X-ray generator and Flat Panel Detector, and a Monitor Cart with displays and image processing hardware. While it mentions software for control and image processing, it is an integral part of a larger hardware system.
Based on the provided text, the ZIEHM VISION RFD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for providing medical imaging using X-rays during diagnostic, interventional, and surgical procedures. This involves visualizing anatomical structures within the patient's body.
- Device Description: The description details a mobile fluoroscopy system with an X-ray generator, flat panel detector, and image processing capabilities. This is consistent with an in-vivo imaging device.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body. IVD devices are specifically designed for testing these types of samples.
Therefore, the ZIEHM VISION RFD is an in-vivo medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures, and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, OXO
Device Description
The ZIEHM VISION RFD employs X-rays as its imaging technology for visualizing human anatomy. The X-ray tube in the generator produces X-rays that are directed toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides real-time visualization and image capture of in vivo surgical procedures and post-surgical outcomes.
The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FD) fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator and the image receptor Flat Panel Detector (FD).
The proposed device will add motorized movement to three additional axes of the predicate device vertical motorized movement. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C-Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.
The motorization of the three axes provides the user an alternative for visualizing anatomical structures using a selectable iso-centric location. With the freely selectable iso-center and distance control, any given anatomical structure can be safely visualized from different angles without having to re-adjust the C-arm. The iso-center is not restricted to orbital movements, but is held during angulations and vertical travel using the now available 4 motorized axes. The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.
The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, injectors and image storage devices (USB, DVD) and DICOM Network interfaces.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, fluoroscopic, digital imaging, digital subtraction, cine image capture
Anatomical Site
complex anatomical structures of both lower and higher contrast density, interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician, clinician
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 Test Data: Performance testing confirmed, that the Ziehm Vision RFD complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards listed in the table below. Together, the verification/validation activities successfully confirmed device requirements are fulfilled, system functionality is consistent with the user needs, intended uses, and the Ziehm Vision RFD device correctly performs as designed, and raises no new questions regarding either safety or effectiveness. Therefore, when compared to the predicate device the Ziehm Vision RFD supports a determination of substantial equivalence to the predicate device.
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.
K083545 Ziehm Vision RFD
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
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Ziehm Imaging GmbH | Donaustrasse 31 | 90451 Nuremberg | Germany
U.S. Food and Drug Administration Center for Devices and Radiological Health Document Mail Center - W066-G609 10903 New Hampshire Avenue Silver Spring, MD 20993-0002
DEC 0 5 2013
Volume 002 – 510 (k) Summary
Oct 31, 2013
In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:
| Submitter Address: | Ziehm Imaging GmbH
Donaustrasse 31 `
90451 Nuremberg
Germany
Phone: + 49.911.2172-219
Fax: +49.911.2172-390 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person /
Agent: | Richard L. Westrich
Director of Regulatory Affairs and Quality Assurance
Ziehm Imaging, Inc.
Phone: (407) 615-8560 Ext 140
Fax: (470) 615-8561 |
| Secondary Contact Person: | Stefan Fiedler
Director QM/RA
Ziehm Imaging GmbH
Phone: + 49.911. 2172-219
Fax: +49.911.2172-390 |
| Device (Trade Name): | Ziehm Vision RFD |
Common /Usual Names: Mobile Fluoroscopic C-Arm
Ziehm Vision RFD - Special 510(k) Submission
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| Classification Product Code: | 21CFR 892.1650 |
|---|---|
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB |
| Subsequent Classification(s) | 21CFR 892.1650 |
| Product Code: | |
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device: | System, x-ray, fluoroscopic, image-intensified |
| Product Code: | JAA |
| Subsequent Classification(s) | 21CFR 892.1650 |
| Product Code: | |
| Classification Names: | image-intensified fluoroscopic x-ray system, mobile |
| Device: | Image-intensified fluoroscopic x-ray system. |
| Product Code: | OXO |
| Predicate Device: | K083545 Ziehm Vision RFD |
The ZIEHM VISION RFD employs X-rays as its imaging General Description: technology for visualizing human anatomy. The X-ray tube in the generator produces X-rays that are directed toward the patient under control of the user at the direction of a physician who determines the specific clinical procedure. The images from the system assist the physicians in visualizing the patient's anatomy. This visualization helps to localize regions of pathology and for surgical procedures. The device provides real-time visualization and image capture of in vivo surgical procedures and post-surgical outcomes.
The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FD) fluoroscopic X-ray imaging system consisting of two mobile units: a Mobile Stand (C-Arm) and a Monitor Cart/Workstation. The Mobile Stand is comprised of a mono-block high voltage generator, X-ray control, and a C-Profile which is "C" shaped and supports the X-ray generator and the image receptor Flat Panel Detector (FD).
2
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The proposed device will add motorized movement to three additional axes of the predicate device vertical motorized movement. This provides the user/operator the option to use manual or motorized linear and rotational movements of the C- Profile for positioning of the imaging components at various angles and distances with respect to the patient using a control interface, Vision Center, Remote Vision Center or remote Position Control Center.
The motorization of the three axes provides the user an alternative for visualizing anatomical structures using a selectable iso-centric location. With the freely selectable iso-center and distance control, any given anatomical structure can be safely visualized from different angles without having to re-adjust the C-arm. The iso-center is not restricted to orbital movements, but is held during angulations and vertical travel using the now available 4 motorized axes. The Distance Control surface detection integrated around the lower edge of the flat panel detects objects, such as patients. When the flat panel approaches an object, the device reduces speed, slowing the motorized movement. The movement stops immediately before entering a defined safety zone.
The Monitor Cart is a mobile platform that connects to the Mobile Stand by a cable, and which integrates the LCD flat panel display monitors, image processing user controls and image recording devices. Interfaces provided for optional peripheral devices such as external monitors, thermal video printers, injectors and image storage devices (USB, DVD) and DICOM Network interfaces.
- Indications for Use: The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intraoperative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography. electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room
3
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procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures, and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.
Summary of Technological Characteristics:
The comparisons of the predicate device show the scientific and technology characteristics of the Ziehm Vision RFD are substantial equivalence to that of the predicate device.
Summary of Non-Clinical Test Data:
Ziehm Vision RFD is based on modifications to a cleared predicate device Ziehm Vision RFD (K083545); The Ziehm Vision RFD design changes were completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls and Engineering, standards compliance, and Verification and Validation testing were successfully conducted. Tests were performed on the Ziehm Vision RFD which demonstrated that the device is safe and effective, performs comparably to the predicate device, and is substantially equivalent to the predicate device. Tests included verification/validation testing to internal: functional specifications (including software) and nonclinical image comparisons involving flat panel display images taken with the new device and the predicate device. Documentation provided demonstrates compliance of the modified device Ziehm Vision RFD to all FDA requirements stated in Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests to software requirements and software risk hazards.
Performance testing confirmed, that the Ziehm Vision RFD complies with 21 CFR 1020.30-32 Federal Performance
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Standards for X-Ray Fluoroscopic equipment and with relevant voluntary safety standards for Electrical Safety and Electromagnetic Compatibility testing, specifically IEC standards listed in the table below. Together, the verification/validation activities successfully confirmed device requirements are fulfilled, system functionality is consistent with the user needs, intended uses, and the Ziehm Vision RFD device correctly performs as designed, and raises no new questions regarding either safety or effectiveness. Therefore, when compared to the predicate device the Ziehm Vision RFD supports a determination of substantial equivalence to the predicate device.
Compliance Standards:
| FDA/CDRH From 3626 (5/11) A Guide for the Submission of Initial Reports on
| Diagnostic X-Ray Systems and Their Major Components. |
|---|
| 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray |
- Systems. MDD 93/42/EEC Annex II of the Medical Devices Directive (MDD)
- 93/42/EEC
- IEC 60601-1:2005 Medical Electrical Equipment, General Requirements for Safety. Edition 3.0, Date: 2005-12-15, Conformance Standard #5-4
- IEC 60601-1-2: 2007 Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility. Edition 3.0, Date: 2007-03-30, Conformance Standard #5-53
- IEC 60601-1-3: 2008 Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment. Edition 2.0, Date: 2008-01-22, Conformance Standard #12-210
- IEC 60601-2-43: 2010 Medical electrical equipment, Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures. Edition 2.0, Date: 2010-03-25, Conformance Standard #12-202
- IEC 60601-2-54: 2009 Medical electrical equipment, Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy. Edition 1.0, Date: 2009-06-29, Conformance Standard #12-201
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- IEC 60825-1: 2007 Safety of laser products, Equipment Safety, requirements, and user guide Edition 2.0, Date: 2007-03-30 Conformance Standard #12-220
- ISO 14971: 2007 Application of risk management to medical devices. Edition 2.0, Date: 2007-03-01, Conformance Standard # 5-40
- Conclusion Ziehm Imaging GmbH considers the modified Ziehm Vision RFD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision RFD (K083545) and in accordance with its labeling.
- ISO 14971: 2007 Application of risk management to medical devices. Edition 2.0, Date: 2007-03-01, Conformance Standard # 5-40
End of 510(k) Summary
Richard L. Westrich
Official Agent and Correspondent for Ziehm Imaging GmbH. Ziehm Imaging Inc, 6280 Hazeltine National Drive Orlando, Fl. 32822
୧/୧
6
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Cemer - WO66-Citios Silver Spring, MI) 20993-0002
December 5. 2013
Zichm Imaging OmbH % Mr. Richard L. Westrich Director of Regulatory Affairs and Quality Assurance Zichm Imaging, Inc. 6280 Hazeltine National Drive ORLANDO FL 32822
Re: K132904 Trade/Device Name: Zichm vision rfd Regulation Number: 21 CFR 892.1650. Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. OXO, JAA Dated: November 4, 2013 Received: November 8, 2013
Dear Mr. Westrich:
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. Ilisting 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 cither 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.
7
Page 2 - Mr. Richard Westrich
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 (800) 638-2041 or (301) 796-7100 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" (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/MedicalDcvices/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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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): K132904
Device Name:
ZIEHM VISION RFD
Indications for Use:
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imaging, as well as digital subtraction and cine image capture during diagnostic interventional and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required. Such procedures may include but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures, and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinician in the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.
Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
・・・・・・・・・・・・・・・・・・・・・・・・・・ ここではやまりはやっていますときにはきたい Concurrence of Center for Devices and Radiological Health (CDRH) .
AND/OR
Division Sign-Off Office of In Vitro Diagnostics and Radiological Health
510(k) K132904
Ziehm Vision RFD - Special 510(k) Submission