(28 days)
Not Found
No
The summary does not mention AI or ML, and the device description focuses on standard X-ray imaging technology.
No
The device is an imaging system designed to provide 2D and 3D medical images for visualization during diagnostic, interventional, and surgical procedures. It does not provide therapy.
Yes
The device is intended for "diagnostic interventional and surgical procedures" and provides imaging to assist in the "visualization of complex anatomical structures." This indicates its use in aiding diagnosis.
No
The device description explicitly states that the device consists of two physical elements: a "C-Arm" (Mobile Stand) and a Monitor Cart. This indicates the presence of hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Ziehm Vision RFD 3D system is an imaging device that uses X-rays to visualize anatomical structures within the patient's body. It does not process or analyze samples taken from the patient.
- Intended Use: The intended use clearly describes providing 2D and 3D medical imaging during various procedures to assist physicians in visualizing internal structures. This is a form of in vivo (within the living body) imaging, not in vitro.
Therefore, the Ziehm Vision RFD 3D system falls under the category of medical imaging devices, not In Vitro Diagnostics.
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 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 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 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 Carm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists 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 near MRI systems.
Product codes (comma separated list FDA assigned to the subject device)
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 device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" or Mobile Stand (MS) because of its wheeled base and C-profile shaped is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
Complex anatomical structures of both lower and higher contrast density, interventional cardiology, heart, hybrid, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial, neurology, neurosurgery, critical care, emergency room, cervical, thoracic, and lumbar regions of the spine, joint fractures of the upper and lower extremities, 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.
Indicated Patient Age Range
adult and pediatric populations
Intended User / Care Setting
trained physicians in a medical setting.
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)
Ziehm Vision RFD 3D is based on the direct modifications to cleared predicate devices Ziehm Vision RFD 3D (K202360); The 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 on the Ziehm Vision RFD 3D. Further compliance testing for the modified device to all FDA requirements as stated in "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as applicable including software risk hazards was done. Tests performed on the Ziehm Vision RFD 3D, demonstrated that the device is safe and effective, performs comparably to the predicate devices, and substantially equivalent to the predicate devices.
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
July 10, 2023
Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Ziehm Imaging GmbH % Mr. Stefan Fiedler Director Quality Management & Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY
Re: K231701
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: June 12, 2023 Received: June 12, 2023
Dear Mr. Stefan Fiedler:
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. 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 located 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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-regulatoryassistance/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
2
Indications for Use
Submission Number (if known)
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 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 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 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 Carm positioning data is required for Computer-Assisted Surgery procedures.
The visualization of such anatomical structures assists 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 near MRI systems.
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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3
| 510(k) #: | 510(k) Summary | Prepared on: 2023-06-12 |
|---|---|---|
| ----------- | ---------------- | ------------------------- |
| Contact Details | 21 CFR 807.92(a)(1) |
|---|---|
| ----------------- | --------------------- |
| Applicant Name | Ziehm Imaging GmbH |
|---|---|
| Applicant Address | Lina-Ammon-Strasse 10 Nuremberg Bavaria 90471 Germany |
| Applicant Contact Telephone | 0911-66067-219 |
| Applicant Contact | Mr. Stefan Fiedler |
| 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 | Interventional Fluoroscopic X-Ray System |
| Regulation Number | 892.1650 |
| Product Code | OWB |
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) |
|---|---|
| ------------------------------------ | --------------------- |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K202360 | 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 device Ziehm Vision RFD 3D consists of two physical elements. The first referred to as the "C-Arm" or Mobile Stand (MS) because of its wheeled base and C-profile shaped is referred to as the Monitor Cart (MC) because it provides real-time monitor displays for visualization and records of patient anatomy.
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, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumbar regions of the spine 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 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
21 CFR 807.92(a)(5)
4
rractures 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 clinical outcome. This device does not support direct radiographic film exposures and is not in performing mammography. The system is not intended for use near MRI systems.
Indications for Use Comparison
The indications for use are identical for predicate and proposed device.
Technological Comparison
21 CFR 807.92(a)(6)
The predicate and proposed devices have the similar technological characteristic. The key modification pertains to an updated release of the software, which incorporates an operating system upgrade from Ubuntu 16.04 to Ubuntu 20.04.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Ziehm Vision RFD 3D is based on the direct modifications to cleared predicate devices Ziehm Vision RFD 3D (K202360); The 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 on the Ziehm Vision RFD 3D. Further compliance testing for the modified device to all FDA requirements as stated in "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as applicable including software risk hazards was done. Tests performed on the Ziehm Vision RFD 3D, demonstrated that the device is safe and effective, performs comparably to the predicate devices, and substantially equivalent to the predicate devices.
21 CFR 807 92(a)(5)