(25 days)
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
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 X-ray 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 is a 510(k) Summary for the Ziehm Vision FD, a mobile fluoroscopic C-arm system. It focuses on demonstrating substantial equivalence to a predicate device (Ziehm Vision FD K061534) rather than presenting a standalone study with specific acceptance criteria and detailed performance metrics of a novel AI device. Therefore, much of the requested information, particularly regarding AI-specific performance, sample sizes for test and training sets, number and qualifications of experts for ground truth, adjudication methods, and MRMC studies, is not available in this document as it pertains to a traditional medical device modification and not an AI/ML-based diagnostic system.
However, I can extract the relevant information regarding the non-clinical testing and the comparison to the predicate device to address the core of your request as much as possible from the provided text.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence of a modified conventional X-ray device, the "acceptance criteria" are not explicit performance metrics in the way one might expect for an AI/ML device. Instead, the acceptance criteria are largely implied by demonstrating compliance with various regulatory standards and showing equivalent performance to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance (Summary from Non-Clinical Tests) |
|---|---|
| Safety and Effectiveness: No new safety or effectiveness concerns compared to the predicate device. | The design 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, ensuring the device performs to product specifications and intended use. |
| Electrical Safety: Compliance with IEC 60601-1 standards. | Testing regarding electrical safety according to ANSI/AAMI ES60601-1 was performed, and test results show compliance. |
| Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2 standards. | Testing regarding electromagnetic compatibility according to IEC 60601-1-2 was performed, and test results show compliance. |
| Wireless & Interoperability Safety: No adverse effect on safety/effectiveness from wireless features and interoperable interfaces. | Testing according to Guidance's "Radio Frequency Wireless Technology in Medical Devices" and "Design Considerations and Premarket Submissions Recommendations for Interoperable Medical Devices" shows neither the wireless features nor the interoperable interfaces of the device affect safety and effectiveness. |
| X-Ray System Performance: Compliance with FDA requirements for diagnostic X-ray systems (e.g., leakage radiation, kV, mA, exposure rates, beam-limiting alignment) and 21 CFR 1020.30-32. Also, relevant safety standards like IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54. | Documentation demonstrated compliance of the modified device to FDA requirements stated in "A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components." This includes, but is not limited to, leakage radiation, peak tube potential (kV), tube current (mA), fluoroscopic entrance exposure rates, and beam-limiting alignment. Performance testing confirmed compliance with 21 CFR 1020.30-32 and relevant safety standards (IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54). |
| Image Quality: Equivalence regarding image quality to the predicate device, while potentially providing reduced dose. | Non-clinical image comparison with sets of images from the modified device and the predicate shows equivalence regarding image quality. Assessment of the low dose functionality shows the ability to reduce dose for certain applications. An image comparison study using anthropomorphic phantoms concluded that the image quality combined with reduced patient dosage will result in comparable patient care to the predicate. A Radiologist assessed individual image sets from anthropomorphic phantoms, concluding comparable image quality and fulfilling intended use requirements. |
| Software Safety: Compliance with guidance for software in medical devices and cybersecurity. | Software testing was performed as required by "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." |
| Risk Management: Potential radiation, mechanical, and electrical hazards identified, analyzed, and controlled. | Hazards were identified and analyzed as part of risk management and controlled by meeting 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. Adherence to regulations and certifications provides assurance of safety and effectiveness. This included Risk Analysis, Required reviews, Design reviews, Component testing, Integration testing, Performance testing, Safety testing, and Product use testing. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not specified. The document mentions "sets of images" and "anthropomorphic phantoms" but does not give a number of images or cases.
- Data Provenance: The images were generated using "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." This indicates that the data is synthetic/phantom-based rather than from human patients. Therefore, information on country of origin, retrospective, or prospective is not applicable in the traditional sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of Experts: "A board-certified Radiologist." Implies one expert.
- Qualifications: "board-certified Radiologist." No specific years of experience are mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication Method: "Evaluation of the individual images arranged in image sets was conducted by a board-certified Radiologist." This indicates a single reader assessment rather than an adjudication process involving multiple readers. Therefore, methods like 2+1 or 3+1 are not applicable.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitely states: "The modified Ziehm Vision FD mobile fluoroscopic C-arm system did not require live human clinical studies to support substantial equivalence." The evaluation was a comparison of image quality between the modified device and the predicate device, performed by a single radiologist using phantom images.
- Effect Size with AI: Not applicable, as this is a traditional medical imaging device modification, not an AI-based system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not an AI/ML algorithm; it is a fluoroscopic X-ray system. Therefore, the concept of "standalone algorithm performance" is not applicable. The device itself is the "standalone" system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: For the image quality comparison, the "ground truth" was implicitly the assessment and conclusion of a single "board-certified Radiologist" based on images derived from "anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms." This isn't pathology or outcomes data, but rather an expert's qualitative judgment of image quality and its suitability for patient care.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not an AI/ML device that requires a training set in that sense. The device's modifications are based on engineering design and validation processes, not machine learning model training.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no AI/ML training set mentioned in the document.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 20, 2019
Ziehm Imaging GmbH % Steve Seeman Director of Regulatory Affairs and Ouality Assurance Ziehm Imaging, Inc. 6280 Hazeltine National Drive ORLANDO, FL 32822
Re: K193230
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 8, 2019 Received: November 25, 2019
Dear Mr. Seeman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
For
Thalia Mills, Ph.D. Division Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K193230
Device Name Ziehm Vision FD
Indications for Use (Describe)
The Ziehm Vision FD is intended for use in providing medical imaging for general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and as vascular, cardiac, angiographic, cholangiography, endoscopic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 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 text is in a sans-serif font and is a gradient of teal, with the left side being a lighter shade and the right side being a darker shade.
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
Volume 005 510 (k) Summary
November 08, 2019
In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:
| Submitter Address: | Ziehm Imaging GmbH |
|---|---|
| Donaustrasse 31 | |
| 90451 Nuremberg | |
| Germany | |
| Phone: + 49.911.2172-0 | |
| Fax: +49.911.2172-390 | |
| Primary Contact Person /Agent: | Steve Seeman |
| Director of Regulatory Affairs and Quality Assurance | |
| Ziehm Imaging, Inc. | |
| Phone: (480) 503 8010 ext 7011 | |
| Fax: (480) 503-8011 | |
| E-Mail: Steve.Seeman@Ziehm.com |
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Image /page/4/Picture/1 description: The image contains a logo and the word "ziehmimaging". The logo is a circular design with a stylized figure inside, possibly representing a person with arms outstretched. The text "ziehmimaging" is written in a sans-serif font, with a gradient effect that transitions from a darker teal to a lighter teal color.
| Device (Trade Name): | Ziehm Vision FD |
|---|---|
| 510(k) Number: | unknown |
| Common /Usual Names: | Mobile Fluoroscopic C-Arm |
| Regulation number: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, JAA |
| Predicate Device: | Ziehm Vision FD (K061534) |
| Regulation number: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, JAA |
| General Description: | The Ziehm Vision FD mobile fluoroscopy system is comprised of a mobilestand with a C-Profile shaped support with both a mono-block highvoltage generator assembly and Flat Panel image receptor. These attachto either end of a C-Profile providing a fixed SID. The device performs 2Dmedical imaging using 4 axes of manual movement and one vertical axesof motorized movement. A user touch screen provides for concise userselectable anatomical programs and X-ray technique control. Integratedhigh-resolution flat panel display monitors directly mounted on themonitor cart providing the clinician with a precise angle for visualizationof live fluoroscopic images of the patient's anatomy. This visualizationhelps to localize regions of pathology for surgical procedures. The mobilestand supports both a cable bound and optional wireless fluoroscopicfootswitch. The Wireless footswitch operation allows for optimumpositioning for the surgeon by removing the cable on the floor. Theoptional interface panel of the Ziehm Vision FD provides connection ofperipheral devices such as external monitors, thermal video printers, andimage storage devices (USB, DVD) and DICOM fixed wire and wirelessnetwork interfaces. |
| Intended Use | The Ziehm Vision FD is a mobile C-arm providing image data by means ofa non-contact noninvasive x-ray technique during medical procedures andstores themtemporarily.The system can be used for all medical indications where fluoroscopy isrequired.The system is intended for use with human beings of any age. It is thephysician's responsibility to decide whether to use the system withinfants, children and adipose patients. |
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Image /page/5/Picture/1 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic on the left and the word "ziehmimaging" on the right. The circular graphic contains a stylized image of a person inside of a circle. The text is in a teal color and appears to be a sans-serif font.
The system is intended for use with human bodies covering structures such as 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 general populations. The device provides pulsed and continuous fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. It is intended for use in visualizing complex anatomical structures and procedures such as vascular, cardiac, angiographic, cholangiography, endoscopic, urologic, orthopedic, neurologic, critical care, emergency room procedures, and where higher accuracy in Image geometry is required. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
Technology: The proposed modified device Ziehm Vision FD C-arm employs the same fundamental control, and scientific technology as that of our predicate device Ziehm Vision FD C-arm (K061534).
The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are very similar to the predicate device Ziehm Vision FD C-arm (K061534).
Software architecture design is nearly identical to that of the predicate device Ziehm Vision FD C-arm (K061534).
modification of the software to support, lower dose with functionality, processing applications related to the optional low dose range, image, Variable beam limiting device, and device specific features.
The primary modifications of the C-Arm include a larger but virtually the same medical grade Image receptor, and a new CMOS image receptor as that of the predicate device Ziehm Vision FD Carm (K061534). virtual beam limiting device for precise collimating to anatomical structures, new pre-filter for lower skin entrance dose imaging, incorporation of mechanical design improvements in the C-Arm and mobile workstation balancinq, locks, and maneuverability improving operator workflow during extended procedures while keeping the essential profile of our predicate device Ziehm Vision FD C-arm (K061534).
Summary of Technological The comparisons of the predicate device and the modified Ziehm Vision Characteristics: FD show, the scientific and technology characteristics of the Ziehm Vision FD are substantial equivalence to the predicate device Ziehm Vision FD (K061534)
Substantial Equivalence Table
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Image /page/6/Picture/1 description: The image contains the logo for ziehmimaging. The logo consists of a circular emblem on the left and the word "ziehmimaging" on the right. The emblem 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.
| Model | ModifiedZiehm Vision FD | PredicateZiehm Vision FD(K061534) | Comparable PropertiesSubstantialEquivalence Discussion |
|---|---|---|---|
| 510(k) Number | Unknown at this time | K061534 | TBD |
| Product Codes | 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 |
| Device Image/GeneralOverview | Image: Ziehm Vision FD 8"x 8"Image: Ziehm Vision FD 12"x 12" | Image: Ziehm Vision FD | The modified Ziehm VisionFD and the predicateZiehm Vision FD(K061534) share thesame general design. Thepredicate and new devicevariant share asubstantial equivalencewith regard to but notlimited to the intendeduse, indications for use,operational functionalityof imaging, use of thesame mono blockgenerator designs, X-raytube types, thermalmanagement control andradiation control, generalsystem software, userinterface controls,imaging acquisition,dimensional features,scientific technologies,risk assessment, riskanalysis, safety andeffectiveness.The variants between thepredicate and the newdevice do not raise newsafety or effectivenessconcerns. |
| X-ray GeneratorMaximumParameter | • Variant A0:max. 2.0 kW,max. 110 kV,max. 20 mA• Variant A1:max. 2.4 kW, | Variant A0:max. 2.0 kW,max. 110 kV,max. 20 mA | Predicate Ziehm Vision FD(K061534) and modifiedZiehm Vision FD share thesame generator variantA0. |
| PulsedFluoroscopy:Operating values | max. 120 kV,max. 24 mA• Variant A0:kV range: 40 - 110 kVmA range: 0.2 - 16 mA• Variant A1:kV range: 40 - 120 kVmA range: 0.2 - 20 mA(8" FPD)mA range: 0.2 - 24 mA (12" FPD) | Variant A0:kV range: 40 - 110 kVmA range: 0.2 - 20 mA | The new generator(variant A1) has a highermaximum power output,functions of 120 kV @ 24mA.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device.Predicate Ziehm Vision FD(K061534) and modifiedZiehm Vision FD share thesame generator variantAO.The new generator(variant A1) has a highermaximum power output. |
| PulsedFluoroscopy:Pulse andDuration | • 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, 25pulse/s1, 2, 5, 10, 15, 30pulse/s | • pulse width:10 - 30 ms• pulse rate:50 Hz: 1, 2, 4, 8, 12.5,25 pulse/s60 Hz: 1, 2, 5, 10, 15, 30pulse/s | Although not identical thepredicate Ziehm Vision FD(K061534) and modifiedZiehm Vision FD both usethe identical basicgenerator with PulsedFluoroscopy. They bothincorporate features andoperational parameters,such as but not limited topulse fluoroscopytechnology, pulse durationand pulse width controldelivered power, X-raytube anode loading, andheat dissipation. Pulsewidth is up to 40 ms asmaximum and pulse rateof 25 p/s or 30 p/s arepossible for modifiedZiehm Vision FD,depending on the deviceconfiguration.These changes do not |
| DigitalRadiography(Snapshot) /Operating Values | • Variant A0:kV range: 40 - 110 kVmA range: up to 20 mA• Variant A1:kV range: 40 - 120 kV | • kV range: 40-110 kV• mA range: up to 20 mA | raise new safety oreffectiveness concernswith regard to thepredicate device.Although the modifieddevice is not identical tothe predicate K061534.The general systemexposure control |
| mA range: up to 20mA (8" FPD Varex aSi)mA range: up to 24mA (8" FPD VarexCMOS, 12" FPD VarexaSi, 12" FPD FujifilmaSi) | technology andoperational functionalityare identical in theseregards for all availablevariants. Only the systemprogrammable settingswhich define the limits ofusable mA and kV aredifferent.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. | ||
| ThermalManagement | Active cooling | Active cooling | Identical |
| X-ray Tube | |||
| Tube Type | stationary anode | stationary anode | Identical |
| Beam Limiter/ Collimator | |||
| CollimatorSystem | Devices with 8" x 8" FlatPanel Detector:• Dedicated pre-collimator for FPD• Collimator Rotation:+/- 90°• Iris Collimator:50 – 198 mm diameter• Asymmetric SlotCollimator:50 – 198 mm diameter• Virtual Collimationwithout radiationDevices with 12" x 12"Flat Panel Detector:• Dedicated pre-collimator for FPD• Collimator Rotation:+/- 90°• Iris Collimator:50 – 307 mmdiameter• Asymmetric SlotCollimator:50 – 307 mmdiameter• Virtual Collimationwithout radiation | Devices with 8" x 8" FlatPanel Detector:• Dedicated pre-collimator• Collimator Rotation:+/- 90°• Iris Collimator:50 – 198 mm diameter• Asymmetric SlotCollimator:50 – 198 mm diameter• Virtual Collimationwithout radiationDevices with 12" x 12" FlatPanel Detector:• N/A | The collimator system forthe predicate and themodified Ziehm Vision FDwith 8" x 8" Flat PanelDetector is identical.Since there is also a 12" x12" Flat Panel Detector forthe modified Ziehm VisionFD, a larger collimator isused. Even though thesize is different thegeneral design of bothcollimator systems is thesame.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
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Image /page/7/Picture/0 description: The image features the logo of Ziehm Imaging, a company specializing in medical imaging solutions. The logo consists of two distinct elements: a stylized globe-like icon on the left and the company name "ziehmimaging" on the right. The globe icon is rendered in a light teal color, while the company name is presented in a gradient of teal shades, transitioning from lighter to darker hues from left to right.
Ziehm Vision FD - Special 510(k) Submission
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Image /page/8/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 graphic features a stylized human figure inside a globe-like structure. The text is in a teal color, with the color gradient changing from light to dark from left to right.
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Image /page/9/Picture/1 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The graphic features a stylized human figure inside a circle with orbital lines, suggesting a focus on medical imaging and technology.
I mage Detector
Image /page/9/Figure/3 description: This image shows two flat panel detectors, both labeled as image detectors. The detector on the left has two variants: aSi FPD and CMOS FPD, with details on their type and scintillator. The detector on the right lists its type as Amorphous Silicon Flat Panel Detector (aSi) and its scintillator as Cesium-Iodide (CsI). The detector sizes are also listed, with the left detector having a variant of 20cm x 20cm (8"x 8") aSi and the right detector having a size of 19.9 cm x 19.9 cm.
Although not identical in the cosmetic design of the housing, both devices use similar safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD).
These changes do not raise safety new or effectiveness concerns with regard the to predicate device.
Even though the detector materials of the Flat Panel Detector (FPD)/(SSXI) are not identical, both devices use solid state X-rav imagers (FPDs) having similar advantageous of higher image stability, higher DQE, image contrast range and higher qeometric sharpness with regard to magnetic earth field effects which can distort image an as compared to an image intensifiers (II).
changes These do not raise new safety or effectiveness concerns with regard to the predicate device.
The modified device and the predicate both use Solid State X-ray Imagers (FPD). The dimensions of the detectors are not identical but are very similar in image area for 8″ x 8″.
The modified Ziehm Vision FD introduces Flat Panel Detectors with 12" x 12" , which did not exist in the predicate.
The detector matrices differ due to different pixel pitches. For the resulting
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Image /page/10/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon on the left and the text "ziehmimaging" on the right. The icon 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.
Variant 20.5cm x 20.5cm (8″x 8″) 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/mm
Variant 30cm x 30cm (12″x 12″) 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/mm
Variant 30.7cm x
- 30.7cm (12″x 12″) 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/mm
Anti-Scatter Grids
image on the monitor there is no significant difference because the image processing steps are equivalent.
These changes do not new safety raise or effectiveness concerns reqard the with to predicate device.
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Image /page/11/Picture/1 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 graphic features a stylized human figure inside a globe-like structure. The text is in a teal color, with a gradient effect that transitions from lighter to darker shades.
Fixed antiscatter grid
optional
removable anti-
scatter grid
fixed anti-scatter grid: Pb 8/70
Removable Grid: Pb
fixed anti-scatter grid: Pb 8/40
Removable Grid: N/A, fixed anti-scatter grid only
The grids are equivalent for the predicate and modified Ziehm Vision FD.
The predicate Ziehm Vision FD (K061534) is equipped with a fixed antiscatter grid only, not a anti-scatter removable grid. However, the grid material and type of antiscatter grid is comparable to the modified Ziehm Vision FD.
These changes do not new safety raise or effectiveness concerns with regard to the predicate device.
Laser Positioning Device
8/70
Laser Positioning Device on Generator (optional)
Image /page/11/Picture/11 description: This image shows a close-up of a white device with warning labels on top. The text "Class 2M (IEC 60825-1), 635 nm" indicates that the device is a Class 2M laser product with a wavelength of 635 nanometers. The warning labels on the device include a laser hazard symbol and other safety information.
Class 2M (IEC 60825-1), 635 nm
Laser Positioning Device on Image Detector (optional)
Image /page/11/Picture/14 description: The image shows a close-up of a black and white electronic device. The device has a square screen in the center, surrounded by a black frame. There are two small buttons on the top corners of the device. The device appears to be a type of medical or scientific instrument.
Class 2M (IEC 60825-1), 635 nm
Image /page/11/Picture/16 description: The image shows a close-up of a white, rectangular device with a cylindrical component on top. The device has warning symbols, including a radiation symbol and a laser warning symbol. Two arrows point to small, circular indentations on the cylindrical component. The device appears to be a piece of medical or industrial equipment.
Class 2M (IEC 60825-1), 635 nm
Image /page/11/Picture/18 description: The image shows a close-up of a piece of equipment with a black, textured surface. A white square and circle are drawn on the surface. Two arrows point to screws on the top corners of the equipment. The equipment appears to be part of a larger structure, possibly a machine or a device.
Nearly Identical and equivalent laser positioning device
Although not identical in location they are nearly identical laser positioning and functionality for both predicate and modified device.
These changes do not safety raise new or effectiveness concerns with regard to the predicate device.
Electrical Requirements
Electrical Requirements
- · Power supply: 100-240 VAC (± 10%), 50/60 Hz
- Current consumption: 100-120 V: 10 A continuous, 22 A shorttime 200-240 V: 8 A
- · Power supply: 100-240 VAC (± 10%), 50/60 Hz
- Current consumption: 100-120 V: 10 A continuous, 22 A short time 200-240 V: 8 A
Equivalent electrical specifications for predicate and modified Ziehm Vision FD.
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Image /page/12/Picture/1 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, surrounded by orbital lines. To the right of the graphic is the company name, "ziehmimaging", written in a gradient teal color.
continuous, 16 A shorttime
- Max. impedance: 100-200 V: ≤ 0.3 Ω 220-240 V: ≤ 0.6 Ω • Class I equipment,
Type B
continuous, 16 A shorttime
- Max. impedance:
- < 0.6 Ω
- Class I equipment, Type B
| Mechanics | |||
|---|---|---|---|
| Source-ImageReceptorDistance (SID) | 109 cm | 111 cm | Source to Image ReceptorDistance for the predicateand the modified deviceZiehm Vision FD are notidentical, but very similar.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| Vertical FreeSpace | 87 cm | 89.5 cm | Vertical free space for thepredicate and the modifieddevice Ziehm Vision FDare not identical, but verysimilar.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| C-arm Depth | 68 cm | 68 cm | Identical |
| Width | 80 cm | 80 cm | Identical |
| Length of MobileStand | • 160 / 182 cm* (20/20135° orbital)• optional: 180 / 202cm* (20/20 165° orbitallowered C, 20/20 165°orbital with liftingcolumn expansion)• optional: 176 / 198cm* (31/31 165°orbital)* depending onconfiguration | 160 / 182 cm | The length of the predicateand the modified device issimilar but not identical.The dimensions vary forthe modified Ziehm VisionFD depending on theconfiguration of imagereceptor size.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| Height of MobileStand | • 155 / 200 cm* (20/20135° orbital)• optional: 155 / 197cm* (20/20 165°orbital lowered C,31/31 165° orbital)• optional: 158 / 220cm* (20/20 165° | 158 / 201 cm | Although not identical thedifference between thepredicate and modifieddevice is a result ofdifferent configurations ofthe device.The dimensions vary for themodified Ziehm Vision FD |
| orbital with liftingcolumn expansion)* depending onconfiguration | depending on theconfiguration of imagereceptor size.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. | ||
| ManuallyOperatedA-Axis(angulation) | +/- 225° (450°) | +/- 225° (450°) | Identical |
| ManuallyOperatedB-Axis(swiveling) | +/- 10° (20°) | +/- 10° (20°) | Identical |
| ManuallyOperatedC-Axis (orbital) | -120° / +45° (165°) | -90° / +45° (135°) | Although the modifiedZiehm Vision FD is notidentical the additional30° of rotationalmovement in the C-Axis ascompared to the predicateprovides an improved userrange of motion whenperforming obliqueimaging and in no waydiminishes or changes thedevices effectiveness,therefore, the operation ofthe C-Axis is substantiallyequivalent to thepredicates.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| ManuallyOperatedY-Axis(horizontal) | 22 cm | 22 cm | Identical |
| Motor DrivenZ-Axis (vertical) | 42 cmoptional: 63 cm | 43 cm | Although not identical, thebasic configuration ofpredicate and modifieddevice is equivalent. Themodified device alsoprovides an optionalextended lift column whichresults in differentdimensions. The |
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Image /page/13/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular emblem on the left and the company name "ziehmimaging" on the right. The emblem features a stylized human figure within interconnected circles, and the text is in a teal color.
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Image /page/14/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The text is in a teal color and appears to be in a sans-serif font.
dimensions vary for the modified Ziehm Vision FD depending on the configuration image of receptor size. These changes do not raise safety new or effectiveness concerns the with regard to predicate device.
Although identical, not modified Ziehm Vision FD incorporates additional features (e.g. Remote Vision Center, articulating monitor arm) which result in a slightly higher weight. These changes do not safety raise new or effectiveness concerns with regard to the predicate device.
Weight
Mobile Stand: max. 337 kg Monitor Cart: max. 233 kg
Mobile Stand: max. 245 kq Monitor Cart: max. 160 kg
Monitors
Display Monitor
The device can be equipped with monitors of different sizes
- dual 19″ flat screen monitors
- · 26″ color flat screen monitor
- · 27″ flat screen monitor
- · 32″ flat screen monitor
Monitor on Monitor Cart
The device can be equipped with monitors of different sizes • dual 18″ flat screen
- monitors • dual 20″ flat screen
- monitors
Monitor on Monitor Cart
Image /page/14/Picture/16 description: The image shows a GE OEC 9800 Plus C-Arm, a mobile X-ray imaging system commonly used in surgical and interventional procedures. The system consists of a C-shaped arm that houses the X-ray source and detector, allowing for real-time imaging during medical procedures. The image also shows a workstation with monitors for displaying the X-ray images and controlling the system's functions. The system is white with light blue accents.
The modified Ziehm Vision FD can be equipped with up-to-date monitors in different sizes.
These changes do not safety raise new or effectiveness concerns with regard to the predicate device.
The monitors of both devices are located at the Monitor Cart.
The modified Ziehm Vision FD can also be ordered with external video port connections to extend to an additional video external monitor.
changes do not These raise new safety or effectiveness concerns with regard the to predicate device.
Location of Display Monitor
Image /page/14/Picture/23 description: The image shows two medical imaging systems. The system on the left has a monitor displaying two X-ray images, and the system on the right has a C-arm design with a monitor attached. Both systems are white with teal accents and are on wheels for mobility. The C-arm system has a curved arm that allows for imaging around a patient.
optional video port connections used to extend video to additional monitor
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Image /page/15/Picture/1 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 is a stylized representation of a globe with a human figure inside. The text is in a sans-serif font and is a teal color.
Image /page/15/Picture/2 description: The image shows a medical display screen with two X-ray images of a shoulder joint. The X-rays appear to be of the same shoulder, taken from slightly different angles. The images are in grayscale, highlighting the bone structure and soft tissues of the shoulder area. The display screen is mounted on a medical imaging device, commonly used in hospitals or clinics for diagnostic purposes.
mounted on external support arm
Monitor Cart with fix or articulating monitor arm (option)
Image /page/15/Picture/5 description: The image shows a medical device with a monitor attached to an adjustable arm. The monitor is rectangular and appears to be displaying a blank screen. The arm is articulated in multiple places, allowing for flexible positioning of the monitor. The base of the device is white and has a small display screen and some buttons.
Monitor Cart with fix monitor arm
Image /page/15/Picture/7 description: The image shows a medical device on wheels. The device has a white body with teal accents. There are two screens at the top of the device, and a control panel in the middle. The device also has handles on the side for easy maneuvering.
The modified device also provides an optional articulating monitor arm mounted on the monitor cart. This allows the user to move the monitor in several directions to provide the most ergonomic viewing angle for the clinician in diverse OR set-ups.
These changes do not raise new safety or effectiveness concerns with regard the to predicate device.
Identical operation. A 26" monitor replaces the dual 18″ monitors. This allows the Monitor Cart to display color images that are routed by a video switch directly from an external endoscopic video source.
The C-ram only displays the video out from external endoscopic device for visualization of endoscopic procedures.
These changes do not raise new safety or effectiveness concerns regard with to the predicate device.
Monitor Arm
Image /page/15/Picture/14 description: The image shows a medical imaging device, likely an X-ray machine, on a mobile cart. The device has a monitor displaying X-ray images, a control panel, and a printer slot. The cart is white with teal accents and has wheels for easy movement. The background is plain white, focusing attention on the medical equipment.
26″ color flat screen monitor
Endoscopy Display Option
Image /page/15/Picture/17 description: The image shows a medical device on wheels with a screen on top. The device is white with teal accents. The screen displays two images, one of which appears to be an X-ray. There are also three smaller images to the left of the device.
dual 18″ flat screen monitors
Image /page/15/Picture/19 description: The image shows a medical device on wheels. The device has a white body with teal accents. There are two screens at the top of the device, one showing a blue circle and the other showing a medical image. The device also has a control panel and a drawer.
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Image /page/16/Picture/1 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 graphic features a stylized human figure inside a globe-like structure, and the text is in a teal color.
User Interface
Vision Center (User touch panel and X-ray Control) on mobile stand (MS) and monitor cart (MC) monitor cart (MC) and Control Elements Touch Panel Remote Vision Center 1 Radiation Button 2 Emergency Stop Button 3 X-Ray indication lamp
Vision Center (User touch panel and X-ray Control) on mobile stand (MS) and
Image /page/16/Picture/5 description: The image shows a computer monitor with a keyboard displayed on the screen. The monitor has a white frame and a green logo at the bottom. The keyboard on the screen is a standard QWERTY layout. The screen also displays some text, but it is difficult to read due to the image quality.
Although the Vision Center on the predicate Ziehm Vision FD (K061534) is not identical in design of the housing and implementation the of radiation button, emergency and stop, radiation indicator, the interface user for exposure control, work flow of procedures and selection of features and functions is essentially identical as can be seen in the pictures to the left.
The modified Ziehm Vision can optionally FD be equipped with a Remote Vision Center.
These changes do not safety raise new or effectiveness concerns with regard to the predicate device.
Radiation Switches
X-Ray hand switch
X-Ray foot
switch
- cable bound hand switch on Mobile Stand
- Cable bound footswitch
- · optional: Wireless footswitch with emergency cord if battery is low
- optional: protective bracket for footswitch
- · cable bound hand switch on Mobile Stand
· Cable bound footswitch
- Identical
Although not identical, the modified device provides up-to-date variants for the footswitch.
These changes do not raise new safety or effectiveness concerns with regard to the predicate device.
Although the Vision Center on the predicate Ziehm Vision FD (K061534) is not identical in design of the housing and implementation of the radiation button, stop, emergency and indicator; radiation the Vision Center used on the predicate still the radiation indicator as a
| Further |
|---|
| X-ray switches |
Radiation button at "Vision Center" Radiation button at "Remote Vision Center"
N/A
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Image /page/17/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular emblem on the left and the company name "ziehmimaging" on the right. The emblem features a stylized human figure surrounded by orbital lines, all in a teal color scheme. The text is also in teal, creating a cohesive and professional brand identity.
| lighted radiation symbolon the touch panel display(GUI).These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. | |||
|---|---|---|---|
| Digital Image Processing | |||
| Real-Timeprocessingfunctions | • Recursive filter: 4 levels• Stack filter ('LastImage Hold'): 5 levels• Edge enhancementfilter: 5 levels• Windowing and stepwindowing• Digital image rotationand reversal withoutradiation• Grayscale inversion• Virtual collimators• Ziehm AdaptiveImage Processing(ZAIP) | • Recursive filter: 4 levels• Stack filter ('Last ImageHold'): 5 levels• Edge enhancementfilter: 5 levels• Windowing and stepwindowing• Digital image rotationand reversal withoutradiation• Grayscale inversion• Virtual collimators | Modified Ziehm Vision FDcontains "Ziehm AdaptiveImage Processing" (ZAIP).ZAIP enhances the imagequality of Ziehm C-armswith flat-panel detector.ZAIP uses hardware-based filters and the latestalgorithms for noisefiltering, edgeenhancement and doseoptimization to achievethe best results inintraoperative imaging.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| Application-OrientedAnatomicalPrograms(AOAP) | • Bone: Extremities/cervical spine/ head,Trunk• Heart, Abdomen, Soft• Vascular (option):Extremities, Trunk,Bolus• Urology (option)• Endo (option) | • Bone• Heart, Abdomen, Endo,Uro• Soft | Although not identical thepredicate and the modifieddevice have similaranatomical programswhich the user can select,except for the vascularAOAP.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| AdditionalFunctions | • Metal• Reposition• High Quality• Low Dose• Obese Patient• Motion | • Metal• High Quality• Large Patient• Motion | The predicate sharesnearly identical functionswith exception for themodified device provides aLow Dose setting andReposition function.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| ImageAcquisition | • Auto save• Cine loop with auto-playback (option)- sequential imagestorage and display:1-8 or 1-12.5 or 1-25 frames persecond- start, stop andreplay ratecontrols | • Auto save• Cine loop with auto-playback (option)- sequential imagestorage and display:50 Hz: 1-8 or 1-12.5or 1-25 frames/s60 Hz: 1-10 or 1-15or 1-30 frames persecond- start, stop and replayrate controls | Nearly identical operationand control, the onlyexception is the framerates.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| Post-ProcessingFunctions | • Edge enhancement: 5levels• Zoom: 3 levels• Image rotation• Windowing and stepwindowing• Grayscale inversion• Image cropping (digitalcollimators)• Digital measurementfunctions:distance/angle (option) | • Edge enhancement: 5levels• Zoom: 7 levels• Image rotation• Windowing and stepwindowing• Grayscale inversion• Image cropping (digitalcollimators)• Digital measurementfunctions:distance/angle (option) | The modified deviceshares nearly identicalpost-processing functionswith the predicate exceptfor zoom levels. The Zoomlevels do not raise newsafety or effectivenessconcerns with regard tothe predicate device. |
| DSA Functions(option) | • DSA real-timesubtraction with re-masking capability• MSA max. opacificationsequence• Single frame,Multiframe RSA(road-mapping)• Pixel shift /landmarking | • DSA real-timesubtraction with re-masking capability• MSA max. opacificationsequence• RSA road-mapping• Pixel shift / landmarking | The basic DSAfunctionality of themodified device isidentical to the predicate.However, the modifieddevice has someadditional functions.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| CO2 Package(option) | Automatic imageoptimization when usingnegative contrast mediumin vascular modes | Automatic imageoptimization when usingnegative contrast mediumin subtraction modes | Identical |
| AnatomicalMarking Tool -AMT (Option) | • Mark anatomicalstructures• Indicate side of body | N/A | The predicate does notprovide an anatomicalmarking tool.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| Digital Memory | • Storage capacity: up to100,000 images | • Storage capacity: up to55,000 images | Even though not identical,modified Ziehm Vision FD |
| • Memory matrix: 1,024 x 1,024 pixels | • Memory matrix: 1,024 x 1,024 pixels | Vision FD (K061534) are very similar in digital memory.These changes do not raise new safety or effectiveness concerns with regard to the predicate device. | |
| DataOrganization | • Patient-based data management with 16-image mosaic display• Pre-registration via DICOM Worklist (option)• Manual input or emergency registration• HIPAA security package• Radiation Dose Structured Report (RDSR) | • Patient-based data management with 16-image mosaic display• Pre-registration via DICOM Worklist (option)• Manual input or emergency registration• HIPAA security package | The predicate and modified Ziehm Vision FD have the same data Organization. However the modified device provides additional functionality required by new standards for dose reporting.These changes do not raise new safety or effectiveness concerns with regard to the predicate device. |
| HIPAA | Option for HIPAA Security | Option for HIPAA Security | Identical |
| Dose AreaProduct meter | • calculated Air Kerma• optional: calculated Dose Area Product (DAP)• optional: measured Dose Area Product (DAP)• DAP/air kerma value tagged to stored image | • calculated Air Kerma• optional: calculated Dose Area Product (DAP)• optional: measured Dose Area Product (DAP)• DAP/air kerma value tagged to stored image | Identical |
| ArchivingExternal Media(optional) | • Video printer (option)• USB port:- storage capacity depends on storage medium- formats: DICOM, TIFF, Multimedia (AVI)- downsized formats: DICOM, JPG• DVD-RW drive (option) :– 4.7 GB storage capacity- formats: DICOM, TIFF, Multimedia (AVI)- downsized formats:DICOM, JPG | • Video printer• USB port:- storage capacity depends on storage medium- formats: DICOM, TIFF, Multimedia (AVI)– downsized formats:DICOM, JPG• 3.5″ floppy disk drive:- storage capacity: 1 image• DVD-RW drive:- 4.7 GB storage capacity- formats: DICOM, TIFF, Multimedia (AVI) | The predicate was also equipped with an optional 3.5″ floppy disk. However the 3.5″ floppy is no longer the standard for external image storage in medical facilities. Facilities now require USB options.These changes do not raise new safety or effectiveness concerns with regard to the predicate device. |
| Archiving /Networking(optional) | • Ziehm NetPort: DICOM3.0 interface (RJ45 orWLAN connection) fordigital networkintegration• Primary Capture 'mode• WLAN interface forwireless data transfer | • Ziehm NetPort: DICOM3.0 interface (RJ45 orFO connection) fordigital networkintegration• 'Primary Capture 'mode• WLAN interface forwireless data transfer | The basic archiving /networking functionality ofthe modified device isidentical to the predicate.However, the modifieddevice provides up-to-date functionality.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. |
| Available DICOMClasses | • multiframe capabilityand StorageCommitment• Print Class• Media Class• Worklist Class incl.Modality PerformedProcedure Step (MPPS)• Query Class• Retrieve Class• Verification Class | • multiframe capabilityand StorageCommitment• Print Class• Media Class• Worklist Class incl.Modality PerformedProcedure Step (MPPS)• Query Class• Retrieve Class• Verification Class | Identical |
| Application / Indications for Use | |||
| Indications forUse | The Ziehm Vision FD isintended for use inproviding medical imagingfor general populations.The device provides pulsedand 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 devicedoes not support directradiographic filmexposures and is | The Ziehm Vision FD isintended to provide pulsedand 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. At thediscretion of a physicianthe device may be usedfor other imagingapplications. | The Indications for Use forthe modified Ziehm VisionFD are almost identical tothe predicate,representing identicalindications for use andtype of interventional andfluoroscopic procedures.However, the IFU for themodified device ZiehmVision FD excludes thefollowing items from thepredicate.• "At thediscretion of aphysician thedevice may beused for otherimagingapplications".• "device does notsupport directradiographicfilm exposures |
Ziehm Vision FD - Special 510(k) Submission
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Image /page/18/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular emblem on the left and the company name "ziehmimaging" on the right. The emblem features a stylized human figure within interconnected circles, and the text is in a teal color.
and the predicate Ziehm
{19}------------------------------------------------
Image /page/19/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular icon on the left and the text "ziehmimaging" on the right. The icon features a stylized human figure inside a circle with intersecting lines, and the text is in a teal color gradient.
Organizat
HIPAA
{20}------------------------------------------------
Image /page/20/Picture/0 description: The image shows the alphanumeric string "K193230" in a simple, sans-serif font. The text is horizontally oriented and appears to be a code or identifier. The characters are uniformly sized and spaced, with a clear distinction between the letter 'K' and the numerical digits that follow.
Image /page/20/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the word "ziehmimaging" on the right. The circular graphic contains a stylized image of a person inside of a circle with other circular shapes around it. The text is in a teal color.
– downsized formats: DICOM, JPG
- film exposures and is not
Ziehm Vision FD - Special 510(k) Submission
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Image /page/21/Picture/1 description: The image contains the logo for ziehmimaging. The logo consists of a circular icon on the left and the text "ziehmimaging" on the right. The icon features a stylized human figure inside a globe. The text is in a teal color.
not intended for use in performing mammography.
The exposure of humans
to ionizing radiation must
final decision lies with the
The system may only be used in heights up to
6561.7 ft (2000 m) above
sea level and must be
used within the limits
defined by the technical
specification. The use of
the system is only allowed
in rooms used for medical purposes in accordance
with EMC class A as well as
protective
may only be used in an
oxygen saturation <25%.
attending physician
attending surgeon.
intended for use performing in mammography"
Further the new device indication for use includes the statement that the modified device is intended for "general populations" in response to FDA Guidance UCM 356190-Pediatric Information for X-Ray imaging device permarket notifications.
These changes do not new safety raise or effectiveness concerns reqard to the with predicate device.
Identical
Even though the application environment for the predicate was not defined in such detail as for the modified device, the general application environment is equivalent.
These changes do not new safety raise or effectiveness concerns with regard to the predicate device.
always be medically justified. Especially when used on pregnant women, adolescents, children, and Contraindication pediatric patients, s to the use of procedures using ionizing radiation should be used with caution or be avoided altogether. However, the
with
conductor.
environment
Application Environment
X-rays
Ziehm Vision FD - Special 510(k) Submission
The exposure of humans to
be
justified. Especially when
used on pregnant women,
adolescents, children, and
procedures using ionizing
radiation should be used
with caution or be avoided
altogether. However, the
final decision lies with the
Proper and safe operation
of the system requires
adequate transportation,
maintenance. The limiting
values indicated in this
user manual must not be
exceeded; this applies also
when putting the system
assembly
use
as well as
attending physician
attending surgeon.
storage,
installation
appropriate
into service.
must
all
or
and
and
medically
ionizing radiation
pediatric patients,
always
all
or
earth
an
The system
with
{22}------------------------------------------------
Image /page/22/Picture/1 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 graphic features a stylized human figure inside a globe-like structure, and the text is in a sans-serif font with a teal color scheme.
| Human Factors | Device labeling definesthat only trained andinstructed qualifiedpersonnel are allowed tooperate the system. | Device labeling definesthat only trained andinstructed qualifiedpersonnel are allowed tooperate the system. | Identical | |
|---|---|---|---|---|
| Material / Compatibility | ||||
| Materials /Biocompatibility | N/A. The device is a non-contact medical devicethat performsFluoroscopic imaging andtherefore, is not requiredto be in contact withpatient to perform itsintended use as a mobilex-ray System. | N/A. The device is a non-contact medical devicethat performs Fluoroscopicimaging and therefore, isnot required to be incontact with patient toperform its intended useas a mobile x-ray System. | Identical | |
| Inter-operability(options) | • Ziehm NaviPort 2D• Ziehm NetPort (DICOM3.0 interface)• Generic interface toinjector• Z-Conference (videoserver)• Video transmission(video connector orwireless video)• Interface for externalseparate X-rayindication lamp | • Ziehm NaviPort 2D• Ziehm NetPort DICOM 3Networking• Generic interface toinjector• Video transmission(video connector)• Interface for externalseparate X-rayindication lamp | Although not identical tothe predicate, modifiedZiehm Vision FD providesmore up-to-date networkoptions.These changes do notraise new safety oreffectiveness concernswith regard to thepredicate device. | |
| Sterility | ||||
| Sterility | N/A. The device is not asterile product. | N/A. The device is not asterile product. | Identical | |
| Conclusion of Tableabove: | The changes and similarities of the proposed Ziehm Vision FD C-armdescribed in the table do not change the control mechanism, operatingprinciple, energy type, or intended use found on predicate device andsupports substantially equivalents to the predicate device Ziehm VisionFD (K061534) in accordance with its labeling. | |||
| Adverse Effects onHealth: | The proposed Ziehm Vision FD C-arm's potential radiation, mechanical,and electrical hazards are identified and analyzed as part of riskmanagement, and controlled by meeting the applicable CDRH 21CFRsubchapter J performance requirements, recognized and generalconsensus standards, designing and manufacturing under Ziehm ImagingGmbH Quality System, and system verification and validation testingensure the device performs to the product specifications and its intendeduse. The adherence to these applicable regulations and certification toRecognized Consensus Standards that apply to this product provides theassurance of device safety and effectiveness. |
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Image /page/23/Picture/1 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, accompanied by the text "ziehmimaging" in a teal-colored, sans-serif font. The text is positioned to the right of the circular graphic.
Summary of Non-Clinical Test Data:
Ziehm Vision FD is based on direct modifications to cleared predicate device Ziehm Vision FD (K061534).
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.
Documentation provided demonstrates compliance of the modified device Ziehm Vision FD to FDA requirements stated in "A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components" as applicable. This includes but is not limited to leakage radiation of diagnostic source assembly, peak tube potential (kV), tube current mA, fluoroscopic entrance exposure rates, and beamlimiting alignment to device image receptor. Further, this 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 regard to the flat panel detector (SSXI), test 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 "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices".
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Determination of The verification/validation activities successfully confirmed device requirements have been fulfilled, system functionality is consistent with Substantial Equivalence: 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 FD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Vision FD (K061534).
Compliance Standards:
Compliance to FDA Guidance and Standards
| FDA/CDRHFrom 3626 (8/17) | "A Guide for the Submission of Initial Reports on Diagnostic X-RaySystems and Their Major Components" |
|---|---|
| 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 European Medical Devices Directive (MDD)93/42/EEC. |
| EN ISO 13485 | Medical devices - Quality management systems - Requirementsfor regulatory purposesDate: 2016 |
Recognized Consensuses Standards
| ANSI/AAMI ES60601-1: | Medical Electrical Equipment, Part 1: General Requirements forBasic Safety 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 forSafety, Electromagnetic CompatibilityEdition 4.0, Date: 2014-02Conformance Standard #19-8 |
| IEC 60601-1-3: | Medical Electrical Equipment, Part 1-3: Radiation Protection inDiagnostic X-ray EquipmentEdition 2.1, Date: 2013-04Conformance Standard #12-269 |
| IEC 60601-1-6: | Medical Electrical Equipment, Part 1-6: UsabilityEdition 3.1, Date: 2013-10Conformance Standard #5-89 |
| IEC 60601-2-43: | Medical electrical equipment, Part 2-43: Particular requirementsfor basic safety and essential performance of X-ray equipment forinterventional proceduresEdition 2.0, Date: 2010-03Conformance Standard #12-202 |
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| IEC 60601-2-54: | Medical electrical equipment, Part 2-54: Particular requirementsfor the basic safety and essential performance of X-ray equipmentfor radiography and radioscopyEdition 1.1, Date: 2015Conformance Standard #12-296 |
|---|---|
| IEC 60825-1: | Safety of laser products, Equipment Safety, requirements, anduser guideEdition 2.0, Date: 2007Conformance Standard #12-273 |
| ISO 14971: | Medical devices - Application of risk management to medicaldevicesEdition 2.0, Date: 2007Conformance Standard #5-40 |
| Summary ofClinical Test Data: | The modified Ziehm Vision FD mobile fluoroscopic C-arm systemdid not require live human clinical studies to support substantialequivalence in accordance with the FDA guidance Documents,UCM089742- Premarket Assessment of Pediatric Medical DevicesMay 24, 2014 and UCM 302938- Pediatric Information for X-rayImaging Device Premarket Notifications Nov 28, 2017. |
| Therefore, Ziehm Imaging GmbH conducted an image comparisonstudy employing the use of anthropomorphic phantoms inestablishing substantial equivalence based on the modifications tothe proposed device and the bench data taken. Evaluation of theindividual images arranged in image sets was conducted by aboard-certified Radiologist. His conclusion was the image qualitycombined with a reduced patient dosage will result in acomparable patient care to the Predicate device Ziehm Vision FD(K061534).). His comparison of the dose and images provided further evidencein addition to the laboratory performance data that the completesystem works as intended and is substantially equivalent to thepredicate device | |
| Determination of SubstantialEquivalence: | Summary Bench Testing |
| Verification and Validation including hazard mitigations executedresulted in demonstrated system met Design Input and userneeds. | |
| The device was tested by the notified test laboratory resulting indevice being certified compliant with ANSI/AAMI ES6060-1-1series, including IEC 60601-2-54. Further device met all applicablesections of 21 CFR Subchapter J performance standards. | |
| The modified Ziehm Vision FD development occurred under ourdesign control processes, software development processes, andoverall quality management system. They included but are notlimited to, | |
| Risk AnalysisRequired reviews |
- Design reviews •
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- . 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. Anthropomorphic (PMMA material) phantoms and anatomical simulation 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 Predicate device Ziehm Vision FD (K061534). and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Vision FD Carm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Vision FD (K061534).
- Ziehm Imaging GmbH considers the modified Ziehm Vision FD to Conclusion: be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision FD (K061534) in accordance with its labeling.
End of 510(k) Summary
§ 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.