(186 days)
The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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.
The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. These attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and Xray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.
The provided document, a 510(k) Summary for the Ziehm Vision FD, describes a premarket notification for a modified fluoroscopic x-ray system. The study focuses on demonstrating substantial equivalence to a previously cleared predicate device (K193230), rather than establishing new acceptance criteria or proving clinical efficacy in a traditional sense. The changes primarily involve an additional 8-inch IGZO flat panel detector and updates to software and mechanical components.
Therefore, the acceptance criteria and study detailed below are framed within the context of a substantial equivalence submission, emphasizing performance comparison with a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the "acceptance criteria" are implied by the performance of the predicate device and the new device's ability to demonstrate comparable safety and effectiveness. The "reported device performance" refers to how the modified Ziehm Vision FD performs relative to the predicate.
| Acceptance Criteria (Implied by Predicate Performance & Safety Standards) | Reported Device Performance (Modified Ziehm Vision FD) |
|---|---|
| Image Quality: Comparable or improved image quality. | Non-clinical image comparison: Sets of images with the modified device and the predicate show equivalence regarding image quality. The modified device with IGZO has a higher resolution size compared to the predicate's 8-inch a-Si FPD, leading to better image quality. |
| Radiation Dose: Ability to reduce dose for certain applications. | Low-dose functionality assessment: Shows the ability to reduce dose for certain applications while maintaining image quality. Non-clinical image and dose lab testing with anatomical phantoms demonstrated the device's capability for reduced dose and maintained image quality. |
| Electrical Safety: Compliance with ANSI/AAMI ES60601-1. | Testing conducted: Test results show compliance with ANSI/AAMI ES60601-1. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2. | Testing conducted: Test results show compliance with IEC 60601-1-2. |
| X-Ray Performance: Compliance with 21 CFR 1020.30-32, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54. | Performance testing confirmed: Modified Ziehm Vision FD complies with 21 CFR 1020.30-32 and relevant safety standards (IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54). The device met all applicable sections of 21 CFR Subchapter J performance standards. |
| Software Safety & Effectiveness: No new safety or effectiveness concerns raised by software changes. | Software testing performed: As required by "Content of Premarket Submissions for Device Software Functions." Updates and optimizations of software features do not influence safety and effectiveness. Cybersecurity remains exactly the same as in the predicate device. |
| Mechanical & Other Changes: No influence on safety and effectiveness. | Mechanical changes: Length and height of mobile stand optimized; discontinued older FPD technology. These changes do not influence safety and effectiveness. Other changes: Updates to features like "Anatomical Marking Tool" and "Video output" are stated to have no influence on safety and effectiveness. Discontinued options do not impact core safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "non-clinical image comparison with sets of images" and "non-clinical image and dose Lab testing" using "anatomical phantoms."
- Test set sample size: Not explicitly stated as a number of images or cases. It refers to "sets of images" and "anatomical phantoms."
- Data provenance: Non-clinical (phantom-based) lab testing. The country of origin for the data is not specified but the manufacturer is based in Germany. The testing appears to be retrospective in comparison to the predicate, as it's a verification and validation activity for a modified device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of experts: "A Radiologist performed an assessment of individual image sets." This implies one radiologist.
- Qualifications of experts: The document only states "A Radiologist." No specific experience level (e.g., "10 years of experience") is provided.
4. Adjudication Method for the Test Set
The document mentions that "A Radiologist performed an assessment of individual image sets" and provided a "conclusion." This suggests a single expert review rather than a formal adjudication method (like 2+1 or 3+1 consensus).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The study described is a non-clinical, phantom-based image comparison assessed by a single radiologist for substantial equivalence (comparability) in image quality and safety, not for an improvement in human reader performance with or without AI assistance. The device is an imaging system, not an AI-powered diagnostic aid meant to directly improve human reader effectiveness.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a fluoroscopic x-ray system, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm doesn't directly apply here. The performance tests described (image quality, dose, safety standards compliance) characterize the device's inherent capabilities without human interpretation as part of the core performance metric.
7. The Type of Ground Truth Used
For the non-clinical image comparison and dose testing, the "ground truth" was established using:
- Anatomical phantoms: These provide a known, controlled imaging target.
- Radiologist assessment: A radiologist's qualitative assessment of image quality and how it compares between the modified and predicate devices.
8. The Sample Size for the Training Set
This submission is for a medical imaging device (hardware and associated software), not a machine learning algorithm that requires a separate "training set." Therefore, the concept of a training set for an AI model is not applicable here. The software updates mentioned are optimizations and version changes, not a new AI model being trained.
9. How the Ground Truth for the Training Set was Established
As explained in point 8, a training set is not applicable to this device submission.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
December 15, 2023
Ziehm Imaging GmbH c/o Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY
Re: K231700
Trade/Device Name: Ziehm Vision FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: November 23, 2023 Received: November 24, 2023
Dear Ms. 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 (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.
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 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 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 Radiological 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
510(k) Number (if known) K231700
Device Name Ziehm Vision FD
Indications for Use (Describe)
The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510k Summary K231700 -
November, 23 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 Person | Tsvetelina MilanovaSpecialist Regulatory AffairsZiehm Imaging GmbHPhone: +49 911 66067 219Fax: +49 172 8651712 |
| Secondary ContactPerson: | Stefan FiedlerDirector QM/RAZiehm Imaging GmbHPhone: +49 911 66067 219Fax: +49 172 8651712 |
| US Agent | Kevin BridgmanVP Quality Assurance & Regulatory AffairsZiehm-Orthoscan, Inc.14555 N 82nd StScottsdale AZ, 85260 |
| Device (Trade Name): | Ziehm Vision FD |
| Common /UsualNames: | Mobile Fluoroscopic C-Arm |
| Regulation: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
510(k) Summary
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| Product Code: | OWB , JAA |
|---|---|
| Product Class: | II |
| Predicate Device: | K193230 Ziehm Vision FD |
| Decision Date: | 20/12/2019 |
| Regulation: | 21CFR 892.1650 |
| Regulation DescriptionName: | Image-intensified fluoroscopic x-ray system |
| Product Code: | JAA; OWB |
| Device Class: | II |
Device Class
Summary of Technological Characteristics The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobile stand with a C-Profile shaped support with both a mono-block high voltage generator assembly and Flat Panel image receptor. These attach to either end of a C-Profile providing a fixed SID. The device performs 2D medical imaging using 4 axes of manual movement and one vertical axes of motorized movement. A user touch screen provides for concise user selectable anatomical programs and Xray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports both a cable bound and optional wireless fluoroscopic footswitch. The Wireless footswitch operation allows for optimum positioning for the surgeon by removing the cable on the floor. The optional interface panel of the Ziehm Vision FD provides connection of peripheral devices such as external monitors, thermal video printers, and image storage devices (USB, DVD) and DICOM fixed wire and wireless network interfaces.
modified device Ziehm Vision FD employs The proposed the same fundamental control, and substantially equivalent scientific technology as that of predicate device Ziehm Vision FD (K193230). Software architecture our design is substantially equivalent to that of the predicate Ziehm Vision FD.
The primary modification of the C-Arm includes an 8 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD). The new 8 inch IGZO FPD is an addition to already introduced CMOS and a-Si FPD. 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) 8 inch CMOS, 12 inch a-Si and the only difference to the predicate Ziehm Vision FD is the additional 8 inch IGZO panel.
The comparison of the predicate device and the modified devices shows that the scientific and technical characteristics of the Ziehm Vision FD are
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substantially equivalent as those of the Ziehm Vision FD predicate device (K193230).
The Ziehm Vision FD is a mobile C-arm providing image data by means of a Intended Use non-contact noninvasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Vision FD is intended for use in all medical indications requiring fluoroscopy.
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.g. organs, tissue, bones, implants depending on the medical indication.
- Indications for Use: The Ziehm Vision FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy 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 near MRI systems.
Device Comparison Table
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
|---|---|---|---|
| 510(k)Number | K231700 | K193230 | - |
| ProductCodes | OWB (interventionalfluoroscopic x-ray system)Subsequent:JAA (system, x-ray,fluoroscopic, image-intensified) | OWB (interventionalfluoroscopic x-ray system)Subsequent:JAA (system, x-ray,fluoroscopic, image-intensified) | Identical |
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| DeviceImage/GeneralOverview | Image: Ziehm Vision FD 8"x 8"Image: Ziehm Vision FD 12"x 12" | Image: Ziehm Vision FD 8"x 8"Image: Ziehm Vision FD 12"x 12" | The modified Ziehm Vision FDand the predicate Ziehm VisionFD (K193230) share the sameouter design.The flat panel detectors areidentical in the design of thehousing, both devices usesafety shielding for radiationsuppression and use solid statex-ray image receptors (SSXI /FPD) 12 inch aSi, 8 inch CMOSand the difference to thepredicate Ziehm Vision FD is thenew 8 inch IGZO FPD.The 8 inch and 12 inch a-SiVarex FPD's have beendiscontinued. |
| X-ray Generator | |||
| MaximumOutput | Variant A0: 2.0 kWVariant A1: 2.4 kW | Variant A0: 2.0 kWVariant A1: 2.4 kW | Identical. |
| PulsedFluoroscopy:Pulse andDuration | • pulse width:7 - 23 ms (12" FPD)10 - 40 ms (8" FPD)• pulse rate:1, 2, 4, 8, 12.5, 25pulse/s (8" and 12"FPD)1, 2, 5, 10, 15, 30pulse/s (8" FPD) | • pulse width:7 - 23 ms (12" FPDFujifilm aSi)10 - 40 ms (12" FPDVarex, 8" FPD VarexaSi/CMOS)• pulse rate:1, 2, 4, 8, 12.5, 25 pulse/s1, 2, 5, 10, 15, 30 pulse/s | Substantial equivalence.The 8 inch and 12 inch a-SiVarex FPD's have beendiscontinued.. |
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| DigitalRadiography(Snapshot) /OperatingValues | • Variant A0:kV range: 40 - 110 kVmA range: up to 20 mA• Variant A1:kV range: 40 - 120 kVmA range: up to 24 mA(8" and 12" FPD) | • Variant A0:kV range: 40 -110 kVmA range: up to 20 mA• Variant A1:kV range: 40 - 120 kVmA range: up to 20 mA (8"FPD Varex aSi)mA range: up to 24 mA (8"FPD VarexCMOS, 12" FPD Varex aSi,12" FPD Fujifilm aSi) | Substantial equivalence.The 8 inch and 12 inch a-SiVarex FPD's have beendiscontinued. |
| Image Detector | |||
| ImageDetector | Flat Panel DetectorImage: Flat panel detector | Flat Panel DetectorImage: Flat panel detector | Substantial equivalence.They are identical in the outerproduct design of the housing,both devices use safetyshielding for radiationsuppression and use solid statex-ray image receptor (SSXI /FPD) The modified Ziehm VisionFD has additionally new 8 inchIGZO (Indium gallium zincoxide) flat panel detector.The 8 inch and 12 inch a-SiVarex FPD's have beendiscontinued. |
| DetectorTechnology | Variant aSi FPD:• Type: Amorphous SiliconFlat Panel Detector (aSi)• Scintillator: Cesium-Iodide (CsI)Variant CMOS FPD:• Type: ComplementaryMetal Semi-conductor)• Scintillator: Cesium-Iodide (CsI)Variant IGZO FDP:• Type: Indium galliumzinc oxide• Scintillator: Cesium-Iodide (CsI) | Variant aSi FPD:• Type: Amorphous SiliconFlat Panel Detector (aSi)• Scintillator: Cesium-Iodide(CsI)Variant CMOS FPD:• Type: Complementary MetalSemi-conductor)• Scintillator: Cesium-Iodide(CsI) | Substantial equivalence.IGZO based detectors aremanufactured using processesthat are similar to aSidetectors. The slight differencesin used sensor glass technologydoes not have influence onsafety and effectiveness of theC-arm product. |
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| DetectorSizes | Variant 21cm x 21cm(8"x8") CMOS:• Size: 21 cm x 21 cm• Detector matrix:2,053 x 2,051 pixels• Magnifier 1:1,536 x 1,536 pixels• Magnifier 2:1,024 x 1,024 pixels• Dynamic Range:– 1 x 1 binning: 84 dB– 1 x 2 binning: 95 dB• System resolution(Nyquist):5 lp/mmVariant 31cm x 31cm(12"x12") aSi:• Size: 31 cm x 31 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• Dynamic Range: ≥86 dB• System resolution(Nyquist):3.3 lp/mmVariant 21cm x 21cm(8"x8") IGZO:• Size: 21 cm x 21 cm• Detector matrix:1,536 x 1,536 pixels• Magnifier 1:1,024 x 1,024 pixels• Magnifier 2:768 x 768 pixels• System resolution(Nyquist):3.7 lp/mm | Variant 20.5cm x 20.5cm(8"x8") CMOS:• Size: 20.5 cm x 20.5 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• Dynamic Range:– 1 x 1 binning: 84 dB– 1 x 2 binning: 95 dB• System resolution(Nyquist):5 lp/mmVariant 20cm x 20cm (8"x8")aSi:• Size: 19.9 cm x 19.9 cm• Detector matrix:1,024 x 1,024 pixels• Magnifier 1:768 x 768 pixels• Magnifier 2:512 x 512 pixels• Dynamic Range: 94 dB• System resolution:2.6 lp/mmVariant 30cm x 30cm(12"x12") aSi:• Size: 29.8 cm x 29.8 cm• Detector matrix:1,536 x 1,536 pixels• Magnifier 1:1,024 x 1,024 pixels• Magnifier 2:768 x 768 pixels• Dynamic Range: 94 dB• System resolution(Nyquist):2.6 lp/mmVariant 30,7 cm x 30.7 cm(12"x12") aSi:• Size: 31 cm x 31 cm• Detector matrix:2,048 x 2,048 pixels• Magnifier 1:1,536 x 1,536 pixels | Substantial equivalence.The active pixel area of thedetector types are not identicalbut are very similar in imagearea of approx. 8 inch x 8 inch.The modified device ZiehmVision FD with IGZO has ahigher resolution size incomparison to predicate devicewith 8 inch a-Si FPD, whichleads to better image quality.All other differences with regardto the used technology have noinfluence on safety andeffectiveness of the C arm.Variant 20cm x 20cm (8"x8")aSi and Variant 30cm x 30cm(12"x12") aSi werediscontinued. |
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| Anti-Scatter Grids | Magnifier 2:1,024 x 1,024 pixels System resolution(Nyquist):3.3 lp/mm | ||
| Fixed anti-scatter grid | fixed anti-scatter grid:CMOS (8inch) Pb 8:1/70 lines/cm IGZO (8inch) Pb 8:1/70 lines/cm | fixed anti-scatter grid:CMOS (8inch) Pb 8/70 | Substantial equivalence.The grids for the CMOS and theIGZO FPD are identical for thepredicate and the modifiedZiehm Vision FD. |
| optionalremovableanti-scattergrid | Removable Grid:CMOS (8inch) Pb 8:1/70 lines/cm a-Si (12inch) Pb 6:1 /80 lines/cm IGZO (8inch) Pb 8:1/70 lines/cm Image: [removable anti-scatter grid] | Removable Grid:CMOS (8inch) Pb 8:1/70 lines/cm a-Si (8inch) Pb 8:1/70 lines/cm a-Si (12inch) Pb 6:1 /80 lines/cm | Substantial equivalence.The grids for the CMOS and theIGZO FPD are identical for thepredicate and the modifiedZiehm Vision FD. The grid of thea-Si (12 inch) FPD has a slightlydifferent value compared to theanti-scatter grids for the othertwo FPD's. The 8 inch and 12inch a-Si Varex FPD's have beendiscontinued. |
| Mechanics | |||
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| Length ofMobile Stand | IGZO & CMOS (8"):174 cm/196 cm aSi (12"): 176 cm /198 cm | 160 / 182 cm (20/20 135° orbital) CMOS (8"): 180 / 202 cm(orbital with lifting column expansion) aSi (12"): 176 / 198 cm | Substantial equivalence.Ziehm Vision FD 8" a-Si , the length of 160 / 182 cm (20/20 135° orbital) for Ziehm Vision FD a-Si 8" and the optional orbital length with lifting column expansion were discontinued.The length of Mobile Stand for Ziehm Vision FD 8" CMOS has been optimized and does not have influence on the safety and effectiveness of the C-arm. |
| Height ofMobile Stand | IGZO, CMOS and a-Si:155 / 197 cm | a-Si (8"): 155 / 200 cm CMOS (8") and a-Si (12"):155 / 197 cm CMOS (8") (optional): 158 / 220 cm (20/20 165° orbital with lifting column expansion) | Substantial equivalence.a-Si (8"): 155 / 200 cm and the option for CMOS (8"): 158 / 220 cm (20/20 165° orbital with lifting column expansion) were discontinued. |
| Weight | Mobile Stand:max. 321 ± 5% kg (FD 8") max. 326 ± 3% kg (FD 12") Monitor Cart: 156 kg ± 10% | Mobile Stand: max. 321 ± 5% kg (FD 8") max. 326 ± 3% kg (FD 12") Monitor Cart: max 233 kg | Identical.The weight of the monitor cart of the predicate and the modified Ziehm Vision FD is identical. The value given before was a typing error. |
| Digital Image Processing | |||
| Real-Timeprocessingfunctions | Recursive filter: 4 levels 'Last Image Hold' Edge enhancement filter:5 levels Windowing and stepwindowing Digital image rotation and reversal without radiation Grayscale inversion Virtual collimators Ziehm Adaptive ImageProcessing (ZAIP) | Recursive filter: 4 levels Stack filter ('Last Image Hold'): 5 levels 'Last Image Hold' Edge enhancement filter: 5 levels Windowing and step windowing Digital image rotation and reversal without radiation Grayscale inversion Virtual collimators Ziehm Adaptive Image Processing (ZAIP) | Substantial equivalence.Stack filter ('Last Image Hold'): 5 levels has been discontinued. |
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| AnatomicalMarking Tool- AMT(Option) | • Mark anatomicalstructures• Indicate side of body• Line and connectedline | • Mark anatomical structures• Indicate side of body | Substantial equivalence.An optimization of the tool hasbeen made and has noinfluence on the safety andeffectiveness of the device. |
| DataOrganization | • Patient-based datamanagement with 16-image mosaic display• Pre-registration viaDICOM Worklist• Manual input oremergency registration• Calculated Dose AreaProduct (DAP)• Optional: measured DoseArea Product (DAP)• DAP value tagged tostored image• Air Kerma dose display• Air Kerma value taggedto stored image• HIPAA security package(option)• Video output- Full HD SDI(split display)- 1920 x 1080p- 60Hz• Radiation DoseStructured Report(RDSR) | • Patient-based datamanagement with 16-imagemosaic display• Pre-registration via DICOMWorklist• Manual input or emergencyregistration• Calculated Dose AreaProduct (DAP)• Optional: measured DoseArea Product (DAP)• DAP value tagged to storedimage• Air Kerma dose display• Air Kerma value tagged tostored image• HIPAA security package(option)• Radiation Dose StructuredReport (RDSR) | Substantial equivalent.As required by the IEC 60601-2-43 the modified device ZiehmVision FD displays dose areaproduct (DAP), air kerma rateand cumulative air kerma at thesame time.An optimization have beenmade through the Video output,which have no influence on thedevice safety and effectiveness. |
| Device Options List | |||
| Summary ofOptions | • Removable anti-scattergrid• Footswitch withcustomer-specific switchassignment: cable boundor wireless, with orwithout protectivebracket• Laser positioning deviceon the generator and/ordetector• Different sizes of displaymonitor | • Removable anti-scatter grid• Footswitch with customer-specific switch assignment:cable bound or wireless,with or without protectivebracket• Laser positioning device onthe generator and/ordetector• Different sizes of displaymonitor• Monitor Arm: articulatingmonitor arm | Substantial equivalence.The option Z-Conference forvideo streaming and film forprinting was discontinued.The option No 3.5" floppy diskdrive and vertical 63 cm hasbeen discontinued. |
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| • Monitor Arm: articulatingmonitor arm • Additional handrails on Cfor orbital rotationsupport • Vertical lift: 42 cm • Dose Area Product (DAP)and Air Kerma:measured or calculated • Key switch Power on/offor X-ray on/off • Emergency stop buttonon the Monitor Cart • Printer: paper • USB port • DVD drive • Ziehm NetPort (DICOM3.0 interface for digitalnetwork integration) • Ziehm NaviPort 2D(Interface for transfer of2D image information toa navigation system;only in combination withDICOM 3.0 interface) • WLAN (interface forwireless data transfer) • Wireless Video(transmission of wirelessvideo signal from thedevice to local displaymonitors) • Video connector(s):analog or digital signal • Application-OrientedAnatomical Programs • Measurement functions • Anatomical Marking Tool(AMT) • Vascular package • Cine loop: up to 25frames per second • CO2 package (providesthe option to use CO2 ascontrast media for | • Additional handrails on C fororbital rotation support • Vertical lift: 42 cm or 63 cm • Dose Area Product (DAP)and Air Kerma: measured orcalculated • Key switch Power on/off orX-ray on/off • Emergency stop button onthe Monitor Cart • Printer: paper or paper/film • USB port • DVD drive • No 3.5" floppy disk drive • Ziehm NetPort (DICOM 3.0interface for digital networkintegration) • Ziehm NaviPort 2D(Interface for transfer of 2Dimage information to anavigation system; only incombination with DICOM 3.0interface) • WLAN (interface for wirelessdata transfer) • Wireless Video(transmission of wirelessvideo signal from the deviceto local display monitors) • Z-Conference (Video-serverfor streaming the live imageof the left monitor withinthe hospital network) • Video connector(s): analogor digital signal • Application-OrientedAnatomical Programs • Measurement functions • Anatomical Marking Tool(AMT) • Subtraction modes DSA,MSA, RSA • Pixel shift and landmarking • Cine loop: up to 25 framesper second | ||
| displaying vessels)• Generic interface topower injector | • CO2 package (provides theoption to use CO2 ascontrast media fordisplaying vessels) | ||
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| • User administration(HIPAA)• Interface for externalseparate X-ray indicationlamp• DICOM viewer software• External display monitor• Interface for RemoteVision Center• Remote Vision Center• Mounting bracket forRemote Vision Center• Mobile Cart for RemoteVision Center | • Generic interface to powerinjector• User administration (HIPAA)• Interface for externalseparate X-ray indicationlamp• DICOM viewer software• External display monitor• Interface for Remote VisionCenter• Remote Vision Center• Mounting bracket forRemote Vision Center• Mobile Cart for RemoteVision Center | ||
| OptionalAccessories | • Sterile disposable covers• Skin protection | • Sterile disposable covers• Hand surgery table• Skin protection | Substantial equivalentThe optional Hand surgery tableis no longer available.Note: Ziehm Imaging GmbH isnot the manufacturer of theoptional accessories |
| Software | |||
| Level ofConcern | Enhanced | Moderate | IdenticalThe term of level of concern haschanged according to theGuidance "Content ofPremarket Submissions forDevice Software Functions", butthere have been no additionalchanges to the device that haveincreased the level of concern. |
| Software | • Version 7.06.11• Linux based OS Ubuntu | • Version 7.06 SP2• Linux based OS Ubuntu | Substantial equivalence.Updates and optimization ofsoftware features, which doesnot have influence on safetyand effectiveness of the device.For details please refer toDevice Description_ZiehmVision FD_revised. |
| Application / Indications for Use | |||
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| Indicationsfor Use | The Ziehm Vision FD isintended for use inproviding medical imagingfor general populations.The device providespulsed and continuousfluoroscopic imaging ofpatients during diagnostic,interventional and surgicalprocedures. It is intendedfor use in visualizingcomplex anatomicalstructures and proceduressuch as vascular, cardiac,angiographic,cholangiography,endoscopic, urologic,orthopedic, neurologic,critical care, emergencyroom procedures, andwhere higher accuracy inImage geometry isrequired. This device doesnot support directradiographic filmexposures and is notintended for use inperforming mammography.The system is not intendedfor use near MRIsystems. | The Ziehm Vision FD isintended for use in providingmedical imaging for generalpopulations. The deviceprovides pulsed and continuousfluoroscopic imaging of patientsduring diagnostic,interventional and surgicalprocedures. It is intended foruse in visualizing complexanatomical structures andprocedures such as vascular,cardiac, angiographic,cholangiography, endoscopic,urologic, orthopedic,neurologic, critical care,emergency room procedures,and where higher accuracy inImage geometry is required.This device does not supportdirect radiographic filmexposures and is not intendedfor use in performingmammography. | Substantial equivalentThe wording of the indicationsfor use were updated. Thesechanges do not raise new safetyor effectiveness concerns withregard to the predicate device. |
| HumanFactors | Only trained and instructedqualified personnel areallowed to operate thesystem. | Device labeling defines thatonly trained and instructedqualified personnel are allowedto operate the system. | Substantial equivalence.The wording has changed, butdoes not have influence on thesafety and effectiveness of theC-arm product. |
| Standards | |||
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD (K193230) | Comparable PropertiesSubstantial EquivalenceDiscussion |
| Standards | • IEC 60601-1:2006/AMD1:2013• IEC 60601-1-2:2014• IEC 60601-1-3:2008/AMD1:2013• IEC 60601-1-6:2010/AMD2:2021• IEC 60601-2-43:2010/AMD2:2020• IEC 60601-2-54:2009/AMD2:2019• IEC 60825-1:2007• ISO 14971:2019 | • ANSI/AAMI ES60601-1:2012• IEC 60601-1-2:2014• IEC 60601-1-3:2008 +A1:2013• IEC 60601-1-6:2013• IEC 60601-2-43:2010• IEC 60601-2-54:2009 +A1:2015• IEC 60825-1:2007• ISO 14971:2007 | Applicable standards for themodified Ziehm Vision FD andthe predicate Ziehm Vision FD(K193230) remain as before.Newer versions of thestandards have been applied. |
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Conclusion of Table The changes of the proposed modified device Ziehm Vision FD described in the above: table do not change the fundamental control mechanism, operating principle or intended use found on predicate device and supports substantially equivalents to the predicate device Ziehm Vision FD (K193230) in accordance with its labeling.
- Safety and Performance: The proposed Ziehm Vision FD 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 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 FD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Vision FD (K193230).
The design of the modified Ziehm Vision FD 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 regarding 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.
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The performance testing confirmed that the modified Ziehm Vision FD 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 FD 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 FD 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 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 Imaqing GmbH believes the modified device Ziehm Vision FD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision FD (K193230).
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) |
|---|---|
| Regulation (EU)2017/745 | Annex IX Chapter I, Section2 and 3 and Chapter III |
| EN ISO 13485 | Medical devices - Quality management systems - Requirements forregulatory purposesDate: 2016 |
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Recognized Consensuses Standards
| ANSI/AAMI ES60601-1: Medical Electrical Equipment, Part 1: General Requirements for BasicSafety and Essential Performance (IEC 60601-1:2005, mod)Date: 2012Conformance Standard #19-4 |
|---|
| IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General Requirements for Safety,Electromagnetic CompatibilityEdition 4.0, Date: 2014-02Conformance Standard #19-8 |
| IEC 60601-1-3: Medical Electrical Equipment, Part 1-3: Radiation Protection in DiagnosticX-ray EquipmentEdition 2.1, Date: 2013-04Conformance Standard #12-269 |
| IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: UsabilityEdition 3.2, Date: 2020-07Conformance Standard #5-132 |
| IEC 60601-2-43: Medical electrical equipment, Part 2-43: Particular requirements for basicsafety and essential performance of X-ray equipment for interventionalproceduresEdition 2.2, Date: 2019-10Conformance Standard #12-239 |
| IEC 60601-2-54: Medical electrical equipment, Part 2-54: Particular requirements for thebasic safety and essential performance of X-ray equipment for radiographyand radioscopyEdition 1.2, Date: 2018-06Conformance Standard #12-317 |
| IEC 61304: Medical device software - Software life cycle processesEdition 1.1, Date 2015-06Conformance 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
Determination of Summary Bench Testing Substantial Equivalence: 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
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60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.
The modified Ziehm Vision FD 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 emploved. Anatomical phantoms were employed, image 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 FD results in a comparable patient care to the reference device Ziehm Vision FD (K193230) and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision FD C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision FD (K193230).
- Conclusion Ziehm Imaging GmbH considers the Ziehm Vision FD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision FD (K193230) 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.