(92 days)
No
The summary does not mention AI or ML, and the description focuses on standard X-ray imaging technology and comparison to a predicate device without these capabilities.
No
Explanation: This device is an X-ray imaging system used for visualization and diagnosis, not treatment, therapy, or rehabilitation.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device provides 2D medical imaging for "diagnostic interventional and surgical procedures."
No
The device description explicitly states that the device consists of two physical elements: a "C-Arm" (Mobile Stand) and a Monitor Cart. These are hardware components, making it a hardware and software system, not software-only.
Based on the provided information, the Ziehm Vision RFD 3D system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Ziehm Vision RFD 3D Function: The Ziehm Vision RFD 3D system is an X-ray imaging device that directly visualizes anatomical structures within the patient's body using fluoroscopy. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly describes providing medical imaging for diagnostic, interventional, and surgical procedures by visualizing internal anatomy. This is a form of in vivo (within the living body) imaging, not in vitro (in glass/outside the body) testing.
Therefore, the Ziehm Vision RFD 3D system falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where 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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.
The device is also intended to provide 3D medical imaging of patients during orthopedical, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists the clinician in the clinical outcome.
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 in any MRI environments.
Product codes
OWB
Device Description
The device Ziehm Vision RFD 3D is a medical Fluoroscopic X-ray imaging device used to assist trained physicians in the X-ray visualization of anatomical regions of a patient. The system is a non-contact device and is not intended to be in contact with patient to perform its intended use. The system provides X-ray image data by means of X-ray technique while the physician performs medical procedures and stores the image data temporarily.
The Ziehm Vision RFD 3D is intended for use to provide 2D- and 3D-image data specifically but not limited in the field of orthopedics, traumatology and oral and maxillofacial surgery. Furthermore it is intended for use specifically but not limited to the imaging of soft tissues.
The modified subject device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" of Mobile Stand (MS) because of its wheeled base and C-profile shaped image gantry; the second is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.
The modified Ziehm Vision RFD 3D employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD 3D (K231701). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD 3D.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, bones, joints, maxillofacial, pelvis, acetabulum
Indicated Patient Age Range
adult and pediatric populations
Intended User / Care Setting
trained physicians, diagnostic interventional and surgical procedures, critical care, emergency room procedures
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
The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison with the predicate system. Anthropomorphic phantoms so-called "sectional phantoms" were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software and cybersecurity testing was performed as required by "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison with the predicate system. Anthropomorphic phantoms so-called "sectional phantoms" were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue. The image comparison between the system settings of the predicate device and the optimized system settings (including 'Adult HQ 'body size and 2k imaging chain) of the modified device shows that the image quality acquired with the test device is better or at least equal. Almost all images generated by the test device show more details, improved detectability and are sharper than the corresponding reference images. From a radiological point of view the presented images that were acquired fulfil the requirements as stated by the intended use.
After review of the modified device Ziehm Vision RFD 3D risk control assessments, the verification activities which successfully confirmed device requirements have been fulfilled, system functionality is consistent with the uses and performs as designed and raises no new questions rearding either safety or effectiveness. Ziehm Imaging GmbH therefore, believes the modified device Ziehm Vision RFD 3D to be as safe and effective and performs as well as the predicate devices Ziehm Vision RFD 3D (K231701).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 21, 2025
Ziehm Imaging GmbH % Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, 90471 GERMANY
Re: K243303
Trade/Device Name: Ziehm Vision RFD 3D Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB Dated: November 22, 2024 Received: November 22, 2024
Dear Tsvetelina Milanova:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
2
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243303
Device Name Ziehm Vision RFD 3D
Indications for Use (Describe)
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where 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 angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for Computer-Assisted Surgery procedures.
The device is also intended to provide 3D medical imaging of patients during orthopedical, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists the clinician in the clinical outcome.
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 in any MRI environments
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| 510(k) #: | K243303 |
|---|---|
| 510(k) Summary | |
| Prepared on: 2025-01-20 |
Contact Details
| 21 CFR 807.92(a)(1) | |
|---|---|
| Applicant Name | Ziehm Imaging GmbH |
| Applicant Address | Lina-Ammon-Strasse 10 Nuremberg 90471 Germany |
| Applicant Contact Telephone | +4991166067581 |
| Applicant Contact | Tsvetelina Milanova |
| Applicant Contact Email | Zie-Regulatory@ziehm.com |
Device Name
| 21 CFR 807.92(a)(2) | |
|---|---|
| Device Trade Name | Ziehm Vision RFD 3D |
| Common Name | Image-intensified fluoroscopic x-ray system |
| Classification Name | Image-intensified fluoroscopic x-ray system |
| Regulation Number | 892.1650 |
| Product Code(s) | OWB |
Legally Marketed Predicate Devices
| 21 CFR 807.92(a)(3) | ||
|---|---|---|
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K231701 | Ziehm Vision RFD 3D | OWB |
Device Description Summary
| 21 CFR 807.92(a)(4) | |
|---|---|
| -- | --------------------- |
The device Ziehm Vision RFD 3D is a medical Fluoroscopic X-ray imaging device used to assist trained physicians in the X-ray visualization of anatomical regions of a patient. The system is a non-contact device and is not intended to be in contact with patient to perform its intended use. The system provides X-ray image data by means of X-ray technique while the physician performs medical procedures and stores the image data temporarily.
The Ziehm Vision RFD 3D is intended for use to provide 2D- and 3D-image data specifically but not limited in the field of orthopedics, traumatology and oral and maxillofacial surgery. Futhermore it is intended for use specifically but not limited to the imaging of soft tissues.
The modified subject device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" of Mobile Stand (MS) because of its wheeled base and C-profile shaped image gantry; the second is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.
The modified Ziehm Vision RFD 3D employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD 3D (K231701). Software architecture design is substantially equivalent to that of the predicate Ziehm Vision RFD 3D.
21 CFR 807 92(a)(5)
Intended Use/Indications for Use
The Ziehm Vision RFD 3D system is intended for use in providing both 2D and 3D pulsed and continuous fluoroscopic medical imaging for adult and pediatric populations.
The device provides 2D medical imaging for fluoroscopy, digital subtraction, and acquisition of cine loops during diagnostic interventional and surgical procedures where 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 carliology, heart surgery, hybrid procedures, interventional angiography, electropysiology, pediatics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurosurgery, critical care, emergency room procedures, and those
5
The device is also intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists the clinician in the clinical outcome.
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 in any MRI environments.
Indications for Use Comparison
The indications for use of the predicate and modified devices are equivalent.
Technological Comparison
The key modification refers to an software update to software version 7.10.0, which incorporates the 2k imaging chain "QuantumStream", along with the corresponding new "Image Insights" overlay, the optional EndoNaut Aorto liac (Al) Workflow Integration by Therenva (K222070), the PCCplus (Position Control Center plus), optional OR table controls, the new 'Adult HQ' body size for the '3D' operating mode as well as further 3D visualization improvements.
The predicate Ziehm Vision RFD 3D (K231701) and modified Ziehm Vision RFD 3D share substantially equivalent design, technology, functionality and have identical Indications for Use (IFU).
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The design of the modified Ziehm Vision RFD 3D was completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls, 21 CFR 820 and applicable standards. Verification and Validation testing were successfully conducted on the device in compliance with FDA requirements as stated in the following documentation.
New tests regarding electromagnetic compatibility according to IEC 60601-1-2 were performed and the modified device including option Position Control Center plus is compliant with this standard.
The modified Ziehm Vision RFD 3D complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant safety standards such as IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54.
Software and cybersecurity testing was performed as required by "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison with the predicate system. Anthropomorphic phantoms so-called "sectional phantoms" were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue. The image comparison between the system settings of the predicate device and the optimized system settings (including 'Adult HQ 'body size and 2k imaging chain) of the modified device shows that the image quality acquired with the test device is better or at least equal. Almost all images generated by the test device show more details, improved detectability and are sharper than the corresponding reference images. From a radiological point of view the presented images that were acquired fulfil the requirements as stated by the intended use.
After review of the modified device Ziehm Vision RFD 3D risk control assessments, the verification activities which successfully confirmed device requirements have been fulfilled, system functionality is consistent with the uses and performs as designed and raises no new questions rearding either safety or effectiveness. Ziehm Imaging GmbH therefore, believes the modified device Ziehm Vision RFD 3D to be as safe and effective and performs as well as the predicate devices Ziehm Vision RFD 3D (K231701).
21 CFR 807.92(a)(6)
21 CFR 807.92(a)(5)