(164 days)
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, 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, 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. 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 near MRI systems.
The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (FPD) and 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 (FPD). The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor. 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, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.
The document provided describes the Ziehm Vision RFD, an image-intensified fluoroscopic X-ray system. The submission (K231692) is for a modified version of a previously cleared device (K203428). The key modification is the addition of a new 12-inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD) to the existing a-Si and CMOS FPD options.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission declares "substantial equivalence" to the predicate device (K203428). This implies that the new device is intended to meet or exceed the performance of the predicate device, especially regarding image quality, safety, and effectiveness. The acceptance criteria are primarily based on established regulatory standards and guidance, with comparative performance against the predicate.
For the new IGZO detector, the performance is reported as an improvement in resolution compared to aSi detectors.
| Feature / Standard | Acceptance Criteria (Implied) | Reported Device Performance (New IGZO FPD) |
|---|---|---|
| Image Quality | Comparable or improved to predicate device (K203428) | IGZO detector has a higher number of pixels and smaller pixel pitch compared to aSi detectors; therefore, the IGZO detector has better resolution compared to aSi detectors. Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality. Radiologist conclusion: image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device. |
| Dose Functionality | Ability to reduce dose for certain applications | Assessment regarding the low dose functionality shows the ability to reduce dose for certain applications. Non-clinical dose lab testing was employed. |
| Electrical Safety (ANSI/AAMI ES60601-1) | Compliance with the standard | Test results show compliance. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliance with the standard | Test results show compliance. |
| Radiation Protection (IEC 60601-1-3) | Compliance with the standard | Performed and complies. |
| X-ray Fluoroscopic Equipment Standards (21 CFR 1020.30-32) | Compliance with the federal performance standards | Performance testing confirmed compliance. |
| Solid State X-ray Imaging Devices (Guidance for 510(k) Submissions) | Compliance with the guidance | Documentation demonstrates compliance. |
| Safety and Effectiveness | Substantial equivalence to predicate device (K203428) | The modified device's image quality, safety, and effectiveness supports a determination of substantial equivalence. |
| Digital Radiography (Snapshot) / Operating Values | Identical to predicate device | Identical. |
| Collimator System | Same as already introduced CMOS FPD (for IGZO) | The collimator system of the IGZO is the same as the already introduced CMOS FPD. |
| Anti-scatter Grid | Slightly different values acceptable for IGZO while maintaining safety | The grid of the new IGZO has slightly different values compared to the anti-scatter grids for the other two FPD's (aSi, CMOS) but does not impact safety/effectiveness significantly. |
2. Sample Sizes used for the test set and data provenance
The document states: "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality." and "Anatomical simulation phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations."
- Sample Size for Test Set: Not explicitly stated regarding the number of images or cases. It mentions "sets of images" and "anatomical simulation phantoms."
- Data Provenance: "Non-clinical image and dose Lab testing." The country of origin for the data is not specified. It appears to be prospective data generated specifically for this submission through lab testing on phantoms.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document states: "A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device Ziehm Vision RFD (K203428) and fulfils the requirements as stated by the intended use."
- Number of Experts: "A Radiologist" (singular).
- Qualifications of Experts: Assumed to be a qualified radiologist, but specific years of experience or specialization are not detailed.
4. Adjudication method for the test set
The document mentions "A Radiologist performed an assessment" and provided a "conclusion." It does not specify any formal adjudication method like 2+1 or 3+1. It appears to be a single-reader assessment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI or human reader improvement with AI assistance. The device is an X-ray system, and the study focuses on the image quality and performance compared to a predicate device, not on diagnostic aids or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to an X-ray imaging system, not an algorithm. The assessment described in the document is about the physical device's performance (image quality, dose, safety) as a standalone imaging system.
7. The type of ground truth used
The "ground truth" for image quality assessment was established through:
- Expert Consensus / Assessment: A radiologist's assessment of image sets.
- Performance Metrics: Objective measurements such as DQE, MTF, pixel size, and system resolution (Nyquist) for the detectors.
- Phantom Studies: Use of anatomical simulation phantoms.
- Compliance with Standards: Meeting criteria defined by various IEC, ANSI, and 21 CFR standards.
8. The sample size for the training set
The document does not mention a "training set" as this device is an X-ray system and not an AI/ML algorithm that requires training data in the typical sense. The development and verification processes involve extensive testing and compliance with standards, but not a distinct "training set" for an algorithm.
9. How the ground truth for the training set was established
As there is no mention of a "training set" in the context of an AI/ML device, this question is not applicable based on the provided text. The device is a hardware X-ray system with integrated software for image acquisition and processing.
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November 20, 2023
Image /page/0/Picture/1 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below.
Ziehm Imaging GmbH % Stefan Fiedler Director Quality Management & Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY
Re: K231692
Trade/Device Name: Ziehm Vision RFD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: JAA, OWB, OXO Dated: October 23, 2023 Received: October 23, 2023
Dear 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 (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.
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).
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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.
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 mediation-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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Ziehm Vision RFD
Indications for Use (Describe)
The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, 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, 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. 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 near MRI systems.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The text is in a teal color, with the "imaging" portion being a darker shade of teal.
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
November 20, 2023
In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:
| Submitter Address: | Ziehm Imaging GmbHLina-Ammon-Strasse 1090471 NurembergGermanyPhone: +49 911 66067 0Fax: +49 911 66067 390 |
|---|---|
| Primary Contact PersonAgent: | Kevin BridgmanVP Quality Assurance & Requlatory AffairsZiehm-Orthoscan, Inc.14555 N 82nd StScottsdale AZ, 85260 |
| Secondary ContactPerson: | Stefan FiedlerDirector QM/RAZiehm Imaging GmbHPhone: +49 911 66067 219Fax: +49 172 8651712 |
| Device (Trade Name): | Ziehm Vision RFD |
| Common /UsualNames: | Mobile Fluoroscopic C-Arm |
| Regulation: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Product Code: | JAA; OWB; OXO |
| Classification: | II |
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Image /page/4/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic features a stylized human figure inside a globe-like structure. The text is in a teal color and appears to be a sans-serif font.
| Predicate Device: | K203428 - Ziehm Vision RFD |
|---|---|
| Decision Date: | 03/17/2021 |
| Regulation: | 21CFR 892.1650 |
| Regulation DescriptionName: | Image-intensified fluoroscopic x-ray system |
| Product Code: | JAA; OWB; OXO |
| Summary ofTechnologicalCharacteristics | 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, guided 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 both real-time image capture and post capture visualization and of in vivo surgical procedures and post-surgical outcomes. The Ziehm Vision RFD mobile fluoroscopy system is a flat panel detector (EPD) and fluoroscopic X-ray imaging system consisting of two mobile units. |
at panel detector (FPD) and 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 (FPD).
The mobile stand supports the optional wireless footswitch for optimum positioning for the surgeon by removing the cable on the floor.
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, wireless video display, wireless video server, injector connection and image storage devices (USB, DVD) and DICOM fixed wired and wireless network interfaces.
The proposed modified device Ziehm Vision RFD C-arm employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Vision RFD C-arm (K203428).
The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are the same as the predicate device Ziehm Vision RFD C-arm (K203428).
Software architecture design is substantially equivalent to that of the predicate device Ziehm Vision RFD C-arm (K203428).
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Image /page/5/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, accompanied by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font, with the letters gradually becoming darker from left to right.
The primary modification of the C-Arm includes a 12 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD) which have substantially equivalent technology characteristics as our predicate device Ziehm Vision RFD C-arm (K203428). The new 12 inch IGZO FPD is an addition to already introduced a-Si and CMOS FPD's. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8inch and 12 inch aSi, 8 inch and 12 inch CMOS and the only difference to the predicate Ziehm Vision RFD is the new 12 inch IGZO panel.
The comparison of the predicate device and the modified devices shows that the scientific and technical characteristics of the Ziehm Vision RFD are substantially equivalent as those of the Ziehm Vision RFD predicate device (K203428).
- Intended Use The Ziehm Vision RFD is a mobile C-arm providing image data by means of a non-invasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Vision RFD is intended for use in all medical indications requiring fluoroscopy. The Ziehm Vision RFD is intended for use to provide image data specifically but not limited in the field of interventional radiology and cardiology as well as in cardiac surgery and in hybrid applications. The system is intended for use with human beings of any age. It is the physician's responsibility to decide whether to use the system with infants, children and adipose patients. The system is intended for use with human bodies covering such structures but not limited to the following, e.q. organs, tissue, bones, implants depending on the medical indication. These devices are not intended for use in performing mammographic exposures. The systems are not intended for use near MRI systems.
- Indications for Use: The Ziehm Vision RFD is intended for use in providing medical imaging for adult and pediatric populations, 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. 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 all MRI environments.
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Device Comparison Table
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Model | ModifiedZiehm Vision RFD | PredicateZiehm Vision RFD(K203428) | Comparable PropertiesSubstantialEquivalence Discussion |
|---|---|---|---|
| 510(k) Number | K231692 | K203428 | - |
| Classification | Class II | Class II | Identical |
| Product Code | JAA (system, x-ray,fluoroscopic, image-intensified) | JAA (system, x-ray,fluoroscopic, image-intensified) | Identical |
| Application / Indications for Use | |||
| Indications forUse | The Ziehm Vision RFD isintended for use inproviding medicalimaging for adult andpediatric populations,using pulsed andcontinuous fluoroscopicdigital imaging, as wellas digital subtractionand cine image captureduring diagnosticinterventional andsurgical procedureswhere intra-operativeimaging andvisualization of complexanatomical structures ofboth lower and highercontrast density arerequired. Suchprocedures may includebut are not limited tothose of interventionalcardiology, heartsurgery, hybridprocedures,interventional radiology,interventional | The Ziehm Vision RFD isintended for use inproviding medical imagingforadult and pediatricpopulations, using pulsedand continuousfluoroscopicdigital imaging, as well asdigital subtraction and cineimage capture duringdiagnostic interventionaland surgical procedureswhere intra-operativeimaging and visualizationof complex anatomicalstructures of both lowerandhigher contrast density arerequired. Such proceduresmay include but arenot limited to those ofinterventional cardiology,heart surgery, hybridprocedures, interventionalradiology, interventionalangiography,electrophysiology,pediatrics, endoscopic | Identical |
| Model | ModifiedZiehm Vision RFD | PredicateZiehm Vision RFD(K203428) | Comparable PropertiesSubstantialEquivalence Discussion |
| angiography,electrophysiology,pediatrics, endoscopic,urological,gastroenterology,orthopedic, maxillofacialsurgery, neurology,neurosurgery, criticalcare, emergency roomprocedures, and thoseprocedures visualizingstructures of thecervical, thoracic, andlumber regions of thespine, and jointfractures of the upperand lower extremities,and where digital imagedata is required forcomputer aided surgeryprocedures andwhenever the clinicianbenefits from the highdegree of geometricimaging accuracy, andwhere such fluoroscopic,cine and DSA imaging isrequired. Thevisualization of suchanatomical structuresassists the clinician inthe clinical outcome.This device does notsupport directradiographic filmexposures and is notintended for use inperformingmammography. Thesystem is not intendedfor use in all MRIenvironments. | urological,gastroenterology,orthopedic, maxillofacialsurgery, neurology,neurosurgery, critical care,emergency roomprocedures, and thoseprocedures visualizingstructures ofthe cervical, thoracic, andlumber regions of thespine, and joint fracturesofthe upper and lowerextremities, and wheredigital image data isrequired forcomputer aided surgeryprocedures and wheneverthe clinician benefits fromthe high degree ofgeometric imagingaccuracy, and where suchfluoroscopic,cine and DSA imaging isrequired. The visualizationof such anatomicalstructures assists theclinician in the clinicaloutcome.This device does notsupport direct radiographicfilm exposures and is notintended for use inperformingmammography. Thesystem is not intendedfor use near MRI systems. | ||
| Model | ModifiedZiehm Vision RFD | PredicateZiehm Vision RFD(K203428) | Comparable PropertiesSubstantialEquivalence Discussion |
| DigitalRadiography(Snapshot) /Operating Values | • Variant 20kWkV range: 40 - 120 kVmA range: up to 200mA• Variant 25kWkV range: 40 - 120 kVmA range: up to 250mA• Variant 30 kWkV range: 40 - 120 kVmA range: up to 300mA | • Variant 20kWkV range: 40 - 120 kVmA range: up to 200mA• Variant 25kWkV range: 40 - 120 kVmA range: up to 250mA• Variant 30 kWkV range: 40 - 120 kVmA range: up to 300 mA | Identical |
| Beam Limiter/ Collimator | |||
| CollimatorSystem | Asymmetrical Collimator:• Devices with 12inchand 8inch cm Flat PanelDetectors:• Dedicated pre-collimator for FPD• Collimator Rotation:+/- 90°• Iris and AsymmetricSlotCollimator:- 50 - 307 mmdiameter (12 inch FPDCMOS & IGZO)-50 - 298 mmdiameter (12 inch FPDaSi)- 50-205 mm diameter(8inch FPD CMOS)• Virtual Collimationwithout radiation | Asymmetrical Collimator:• Devices with 12inch and8inch cm Flat PanelDetectors:• Dedicated pre-collimator for FPD• Collimator Rotation:+/- 90°• Iris and AsymmetricSlotCollimator:- 50 - 307 mmdiameter (12 inch FPDCMOS)-50 - 289 mm diameter(12 inch FPD aSi)- 50-205 mm diameter(8inch FPD CMOS)- 50-198 mm diameter(8inch FPD aSi)• Virtual Collimationwithout radiation | The collimator system ofthe IGZO is the same asthe already introducedCMOS FPD. |
| Image Detector | |||
| DetectorTechnology | Variant aSi FPD:• Type:AmorphousSiliconFlat PanelDetector (aSi)• Scintillator:Cesium-Iodide (CsI)Variant CMOS FPD: | Variant aSi FPD:• Type: Amorphous SiliconFlat Panel Detector (aSi)• Scintillator:Cesium-Iodide (CsI)Variant CMOS FPD:• Type: CMOS Flat Panel | The new 12 inch IGZO(FPD) is an additional flatpanel type beside thealready established FPDsbased on aSi (amorphousSilicon) and CMOS(Complementary MetalSemi-conductor) |
| Model | ModifiedZiehm Vision RFD | PredicateZiehm Vision RFD(K203428) | Comparable PropertiesSubstantialEquivalence Discussion |
| • Type: CMOS Flat PanelDetector• Scintillator: Cesium-Iodide (CsI)Variant IGZO FPD:• Type: IGZO Flat PanelDetector• Scintillator: Cesium-Iodide (CsI) | • Scintillator: Cesium_ | technology. IGZO FPDsare using the aSi/IGZOsensor technology | |
| Detector Sizes | 30cm x 30cm (12inch) aSi(amorphous silicon TFTtechnology)• Size: 29.8 cm x 29.8cm• Detector matrix:1,536 x 1,536 pixels• Magnifier 1:1,024 x 1,024 pixels• Magnifier 2:768 x 768 pixels• Scintillator cesiumiodide• Dynamic Range: 94 dB• DQE: 77%• MTF>50%@1lp/mm• Pixel size 194µm• Garyscale 65,536 grayscale values (16bit)• System resolution(Nyquist):2.6 lp/mm | 30cm x 30cm (12inch) aSi(amorphous silicon TFTtechnology)• Size: 29.8 cm x 29.8cm• Detector matrix:1,536 x 1,536 pixels• Magnifier 1:1,024 x 1,024 pixels• Magnifier 2:768 x 768 pixels• Scintillator cesiumiodide• Dynamic Range: 94 dB• DQE: 77%• MTF>50%@1lp/mm• Pixel size 194µm• Garyscale 65,536 grayscale values (16bit)• System resolution(Nyquist):2.6 lp/mm | The active pixel area ofthe detector types are notidentical but are verysimilar in image area ofapprox. 12 inch x 12 inch.IGZO detector has highernumber of pixel andsmaller pixel pitchaccordingly; therefor theIGZO detector has betterresolution compared toaSi detectors. This showsthe technical advantageover the established aSisystems.The slight differences indetector and pixel sizedoes not have influence onsafety and effectiveness ofthe C-arm. |
| Variant 31 cm x 31 cm(12inch) CMOSTechnology:• Size: 30.7 cm x 30.7cm• Detector matrix:3,072 x 3,072 pixels• Magnifier 1:2,048x 2,048 pixels• Magnifier 2:1,536 x 1,536 pixels• Dynamic Range:- 1x1 binning:84 dB- 2x2 binning: 95 dB | Variant 31 cm x 31 cm(12inch) CMOSTechnology:• Size: 30.7 cm x 30.7cm• Detector matrix:3,072 x 3,072 pixels• Magnifier 1:2,048x 2,048 pixels• Magnifier 2:1,536 x 1,536 pixels• Dynamic Range:- 1x1 binning:84 dB- 2x2 binning: 95 dB | ||
| Model | ModifiedZiehm Vision RFD | PredicateZiehm Vision RFD(K203428) | Comparable PropertiesSubstantialEquivalence Discussion |
| • Scintillator: cesiumiodide• DQE: 75%• MTF:- 1 lp/mm: 55 %- 2 lp/mm: 23 %- 3 lp/mm: 10 %- 4 lp/mm: 5 %• Pixel size 100 µm• Garyscale 65,536 grayscale values (16bit)System resolution(Nyquist):5 lp/mm | • Scintillator: cesiumiodide• DQE: 75%• MTF:- 1 lp/mm: 55 %- 2 lp/mm: 23 %- 3 lp/mm: 10 %- 4 lp/mm: 5 %• Pixel size 100 µm• Garyscale 65,536 grayscale values (16bit)System resolution(Nyquist):5 lp/mm | ||
| 20 cm x 20 cm (8inch) aSi(amorphous silicon TFTtechnology)• Size: 19.9 cm x 19.9cm• Detector matrix:1,024 x 1,024 pixels• Magnifier 1:768 x 768 pixels• Magnifier 2:512 x 512 pixels• Scintillator cesiumiodide• Dynamic Range: 94 dB• DQE: 77%• MTF>50%@1lp/mm• Pixel size 194µm• Garyscale 65,536 grayscale values (16bit)• System resolution(Nyquist):2.6 lp/mm | 20 cm x 20 cm (8inch) aSi(amorphous silicon TFTtechnology)• Size: 19.9 cm x 19.9cm• Detector matrix:1,024 x 1,024 pixels• Magnifier 1:768 x 768 pixels• Magnifier 2:512 x 512 pixels• Scintillator cesiumiodide• Dynamic Range: 94 dB• DQE: 77%• MTF>50%@1lp/mm• Pixel size 194µm• Garyscale 65,536 grayscale values (16bit)• System resolution(Nyquist):2.6 lp/mm | ||
| Variant 21 cm x 21 cm(8inch) CMOSTechnology:• Size: 20.5 cm x 20.5cm• Detector matrix:2,053x 2,053 pixels• Magnifier 1:1,536 x 1,536 pixels | Variant 20.5 cm x 20.5 cm(8inch) CMOS Technology:• Size: 20.5 cm x 20.5cm• Detector matrix:2,048x 2,048 pixels• Magnifier 1:1,536 x 1,536 pixels• Magnifier 2: | ||
| Model | ModifiedZiehm Vision RFD | PredicateZiehm Vision RFD(K203428) | Comparable PropertiesSubstantialEquivalence Discussion |
| Magnifier 2:1,024 x 1,024 pixels Dynamic Range:- 1x1 binning:84 dB- 2x2 binning: 95 dB Scintillator: cesium iodide DQE: 75% MTF:- 1 lp/mm: 55 %- 2 lp/mm: 23 %- 3 lp/mm: 10 %- 4 lp/mm: 5 % Pixel size 100 μm Garyscale 65,536 gray scale values (16bit) System resolution (Nyquist):5 lp/mm 31 cm x 31 cm (12inch)IGZO (IGZO technology) Size: 30.7 cm x 30.7 cm Detector matrix:2,048 x 2,048 pixels Magnifier 1:1,536 x 1,536 pixels Magnifier 2:1,024 x 1,024 pixels Scintillator cesium iodide DQE:- 80% @ 0 lp/mm- 67% @ 0.5 lp/mm- 59% @ 1 lp/mm- 46% @ 2 lp/mm MTF- 0.5 lp/mm: 82%- 1 lp/mm: 60%- 2 lp/mm: 30% Pixel size 150μm Garyscale 65,536 gray scale values (16bit) | Dynamic Range:- 1x1 binning:84 dB- 2x2 binning: 95 dB Scintillator: cesium iodide DQE: 75% MTF:- 1 lp/mm: 55 %- 2 lp/mm: 23 %- 3 lp/mm: 10 %- 4 lp/mm: 5 % Pixel size 100 μm Garyscale 65,536 gray scale values (16bit) System resolution (Nyquist):5 lp/mm | ||
| Model | ModifiedZiehm Vision RFD | PredicateZiehm Vision RFD(K203428) | Comparable PropertiesSubstantialEquivalence Discussion |
| • System resolution(Nyquist):3.3 lp/mm | |||
| Anti-Scatter Grid | |||
| Anti-scatter grid | fixed anti-scatter grid:a-Si (8inch & 12inch)• Pb 8/70CMOS (8inch & 12inch)• Pb 8/70IGZO (12inch)Pb 6/80 | fixed anti-scatter grid:a-Si (8inch & 12inch)• Pb 8/70CMOS (8inch & 12inch)• Pb 8/70 | The grids for the a-Si andCMOS FPD are identicalfor the predicate ZiehmVision RFD (K203428) andmodified Ziehm VisionRFD. The grid of the newIGZO has slightly differentvalues compared to theanti-scatter grids for theother two FPD's. |
| Digital Image Processing | |||
| Application-OrientedAnatomicalPrograms(AOAP) | • Bone: Extremities,Trunk• Heart, Abdomen, Soft• Cardio (option):Heart Coro , Heart EP• Vascular (option):Extremities, Trunk,Bolus, DSA, MSA, RSA• Urology (option)• Endo (option) | • Bone: Extremities,Trunk• Heart, Abdomen, Soft• Vascular (option):Extremities, Trunk,Bolus, DSA, MSA, RSA• Urology (option)• Endo (option) | Cardio application wasreorder of anatomicalprogram and anoptimization of alreadyexisting heart APR. |
| AnatomicalMarking Tool -AMT (Option) | • Mark anatomicalstructures• Indicate side of body• 2D measurementfunctionEnhanced VesselVisualization(EVV) | • Mark anatomicalstructures• Indicate side of body• 2D measurementfunction | Identical, EVV wasalready part of K203428. |
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- Conclusion of Table The changes of the proposed modified device Ziehm Vision RFD C-arm above: described in the table do not change the fundamental control mechanism, operating principle, energy type, or intended use found on predicate device and supports substantially equivalents to the predicate device Ziehm Vision RFD (K203428) in accordance with its labeling.
- Safety and Performance: The proposed Ziehm Vision RFD C-arm's potential radiation, mechanical, and electrical hazards are identified and analyzed as part of risk management, and controlled by meeting the applicable CDRH 21CFR subchapter J performance
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requirements, recognized and general consensus standards, designing and manufacturing under Ziehm Imaging GmbH Quality System, and system verification and validation testing ensure the device performs to the product specifications and its intended use. The adherence to these applicable requlations and certification to Recognized Consensus Standards that apply to this product provides the assurance of device safety and effectiveness.
Summary of Non-Ziehm Vision RFD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision RFD (K203428).
The design of the modified Ziehm Vision RFD 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.
Testing regarding electrical safety according to ANSI/AAMI ES60601-1 and reqarding electromagnetic compatibility according to IEC 60601-1-2 was performed. The test results show compliance with both standards.
Testing according to Guidance's "Radio Frequency Wireless Technology in Medical Devices" and "Design Considerations and Premarket Submissions Recommendations for Interoperable Medical Devices" show, neither the wireless features nor the interoperable interfaces of the device affect the safety and effectiveness.
Performance testing confirmed that the modified Ziehm Vision RFD 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.
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
With reqard to the flat panel detector (SSXI), documentation provided in this submission demonstrates compliance of the modified device Ziehm Vision RFD (K203428) to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
Furthermore, an assessment regarding the low dose functionality of the modified Ziehm Vision RFD shows the ability to reduce dose for certain applications.
Software testing was performed as required by "Content of Premarket Submissions for Device Software Functions". Cybersecurity remains exactly the same as in the predicate device.
Determination of
Substantial Equivalence:
Determination of The verification/validation activities successfully confirmed device requirements Substantial Equivalence: have been fulfilled, system functionality is consistent with the user needs, intended uses, and performs as designed, and raises no new questions regarding either safety or effectiveness.
Therefore, Ziehm Imaging GmbH believes the modified device Ziehm Vision RFD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision RFD (K203428).
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Compliance to FDA Guidance and Standards
21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems.
General Standards / Regulations
| MDSAP | Medical Device Single Audit Program (MDSAP) |
|---|---|
| MDD 93/42/EEC | Annex II of the Medical Devices Directive (MDD) 93/42/EEC |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements for regulatory purposesDate: 2016 |
Recognized Consensuses Standards
- ANSI/AAMI ES60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, mod) Date: 2012 Conformance Standard #19-4
- IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General Requirements for Safety, Electromagnetic Compatibility Edition 4.0, Date: 2014-02 Conformance Standard #19-8
- IEC 60601-1-3: Medical Electrical Equipment, Part 1-3: Radiation Protection in Diagnostic X-ray Equipment Edition 2.1, Date: 2013-04 Conformance Standard #12-269
- IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: Usability Edition 3.2, Date: 2020-07 Conformance Standard #5-132
- IEC 60601-2-43: Medical electrical equipment, Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures Edition 2.2, Date: 2019-10 Conformance Standard #12-239
- IEC 60601-2-54: Medical electrical equipment, Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Edition 1.2, Date: 2018-06 Conformance Standard #12-317
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- IEC 61304: Medical device software Software life cycle processes Edition 1.1, Date 2015-06 Conformance Standard #13-79
- IEC 60825-1: Safety of laser products, Equipment Safety, requirements, and user guide Edition 2.0, Date: 2007-03 Conformance Standard #12-273
- ISO 14971: Medical devices Application of risk management to medical devices Edition 3.0, Date: 2019-12 Conformance Standard #5-40
Substantial Equivalence:
Determination of Summary Bench Testing
Verification and Validation including hazard mitigations executed resulted in demonstrated system met Design Input and user needs.
The device was tested by the notified test laboratory resulting in device being certified compliant with ANSI/AAMI ES6060-1-1 series, including IEC 60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.
The modified Ziehm Vision RFD development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to,
- . Risk Analysis
- Required reviews ●
- Design reviews ●
- Component testing .
- Integration testing .
- . Performance testing
- . Safety testing
- . Product use testing
Performance bench testing included:
Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality. Further in line with UCM089742 - Premarket Assessment of Pediatric Medical Devices May 24, 2014 and UCM 302938- Pediatric Information for X-ray Imaging Device Premarket Notifications Nov 28, 2017. Non-clinical image and dose Lab testing, were employed. Anatomical simulation phantoms were employed, imaqe comparison sets taken were representative of both the adult and pediatric populations. A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm Vision RFD results in a comparable patient care to the Predicate device Ziehm Vision RFD (K203428) and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision RFD C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision RFD (K203428).
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Conclusion Ziehm Imaging GmbH considers the Ziehm Vision RFD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision RFD (K203428) in accordance with its labeling.
§ 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.