(187 days)
The Ziehm Solo 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.
The Ziehm Solo FD uses X-ray imaging technology to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the control of the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The device enables real-time image acquisition as well as visualization of in vivo surgical procedures and post-operative results.
The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the positioning of the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system.
The mechanical C-Profile supports the generator, the flat panel detector and an integrated laser positioning device.
The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand.
The proposed modified device Ziehm Solo FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Solo FD (K161976). Software architecture design is substantially equivalent to that of the predicate Ziehm Solo 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 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 and the only difference to the predicate Ziehm Solo FD is the additional 8 inch IGZO panel.
The provided text describes the 510(k) premarket notification for the Ziehm Solo FD, a mobile fluoroscopic C-Arm. The submission asserts substantial equivalence to a predicate device (Ziehm Solo FD K161976) and references a comparative reference device (Ziehm Vision FD K193230) for specific comparisons related to flat panel detector technology (IGZO vs. a-Si).
However, the document does not contain the detailed information necessary to fully answer all aspects of your request regarding specific acceptance criteria for AI/algorithm performance and a comparative effectiveness study (MRMC) demonstrating human reader improvement with AI assistance. This is likely because the device described is an X-ray system, not an AI-powered diagnostic algorithm. The testing described focuses on the device's fundamental imaging capabilities, electrical safety, electromagnetic compatibility, and compliance with X-ray performance standards, rather than the diagnostic performance of an AI algorithm.
The closest relevant information relates to image quality assessment and dose reduction.
Here's a breakdown of the available and missing information based on your request:
Acceptance Criteria and Device Performance (Based on available information)
The document does not explicitly state "acceptance criteria" in the format of specific quantitative metrics for a diagnostic AI algorithm. Instead, it details that the device's safety and performance are confirmed by:
- Compliance with applicable CDRH 21 CFR subchapter J performance requirements.
- Adherence to recognized and general consensus standards.
- Designing and manufacturing under Ziehm Imaging GmbH Quality System (21 CFR 820).
- System verification and validation testing to ensure the device performs to product specifications and its intended use.
- Bench testing, including non-clinical imaging and dose testing, demonstrating the device's ability to provide reduced dose while maintaining image quality.
The performance is reported qualitatively through statements of compliance and equivalence.
| Acceptance Criteria (Implied by Compliance) | Reported Device Performance |
|---|---|
| Electrical Safety (ANSI/AAMI ES60601-1) | "Testing regarding electrical safety according to ANSI/AAMI ES60601-1... was performed. The test results show compliance with both standards." |
| Electromagnetic Compatibility (IEC 60601-1-2) | "Testing regarding electromagnetic compatibility according to IEC 60601-1-2 was performed. The test results show compliance with both standards." |
| X-ray Performance Standards (e.g., 21 CFR 1020.30-32, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54) | "Documentation provided demonstrates compliance... 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 beam-limiting alignment to device image receptor. Further, this performance testing confirmed that the modified Ziehm Solo FD complies with 21 CFR 1020.30-32... and with relevant safety standards..." |
| Image Quality Equivalence to Predicate/Reference Device | "Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality." "Radiologist conclusion, the image quality of the Ziehm Solo 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." |
| Low Dose Functionality | "Furthermore, an assessment regarding the low dose functionality of the modified Ziehm Solo FD shows the ability to reduce dose for certain applications." |
Study Details (Based on available information)
-
Sample Size used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a numerical count of images or patients. The document mentions "sets of images" and "anatomical phantoms" representing "both the adult and pediatric populations."
- Data Provenance: The study used "non-clinical imaging and dose testing methods," implying the use of phantoms rather than real patient data. There is no mention of country of origin or whether it was retrospective/prospective clinical data, as it was a phantom-based bench study.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of experts: Singular. "A Radiologist performed an assessment of individual image sets."
- Qualifications of experts: "A Radiologist." No further details on years of experience or specialization are provided.
-
Adjudication method for the test set:
- No explicit adjudication method (like 2+1, 3+1) is mentioned. The assessment was performed by "A Radiologist."
-
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:
- No, an MRMC comparative effectiveness study was not done. The document describes a technical performance validation of an X-ray imaging system, not a study assessing an AI algorithm's impact on human diagnostic performance. The statement "Radiologist conclusion, the image quality of the Ziehm Solo FD results in a comparable patient care to the reference device Ziehm Vision FD (K193230)" indicates an expert's qualitative judgment on image quality itself, not a measure of improved human reader performance with AI assistance.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is not applicable in the context of the provided document, as the device is an X-ray system, and there's no mention of a standalone AI algorithm for diagnostic inference. The "software" updates mentioned are for system control and image processing, not for AI-driven diagnostic tasks.
-
The type of ground truth used:
- Expert Consensus/Assessment based on Phantoms: For image quality assessment, the "ground truth" was established through the "Radiologist's conclusion" on "anatomical phantoms" and "image comparison sets." This is a form of expert assessment of image quality, not clinical ground truth derived from pathology or patient outcomes.
-
The sample size for the training set:
- Not applicable/Not provided. This document does not describe the development or training of an AI algorithm in the sense of machine learning, so there is no "training set." The software mentioned is traditional device control and image processing software.
-
How the ground truth for the training set was established:
- Not applicable/Not provided. As there is no AI algorithm training set discussed, this information is not relevant to the content of the provided document.
Summary of what's provided vs. what's missing for an AI-focused request:
The document details the substantial equivalence of an X-ray imaging system based on hardware modifications and compliance with electrical, mechanical, and X-ray performance standards. It provides limited information regarding formal clinical study design, especially concerning human reader performance or the training/validation of an AI-driven diagnostic algorithm. The "software" sections refer to system operating software, not typically advanced AI for image interpretation that would require MRMC or standalone AI performance metrics.
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December 12, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Ziehm Imaging GmbH % Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY
Re: K231669
Trade/Device Name: Ziehm Solo FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: November 13, 2023 Received: November 14, 2023
Dear Tsvetelina Milanova:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
Submission Number (if known)
Device Name
Ziehm Solo FD
Indications for Use (Describe)
The Ziehm Solo 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.
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/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The graphic is a stylized representation of a globe with a human figure inside. The text is in a teal color and a serif font.
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
December, 7 2023
In accordance with 21 CFR §807.92 the following 510(k) K231669 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 & Requlatory AffairsZiehm-Orthoscan, Inc.14555 N 82nd StScottsdale AZ, 85260 |
| Device (Trade Name): | Ziehm Solo FD |
| Common /UsualNames: | Mobile Fluoroscopic C-Arm |
| Requlation: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
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Image /page/4/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a stylized globe-like icon on the left, followed by the company name "ziehmimaging" in a teal-colored sans-serif font. The globe icon features a human figure within intersecting circles, giving it a modern and technological appearance.
| Product Code: | OWB; JAA, OXO |
|---|---|
| Classification: | II |
| Predicate Device: | K161976 Ziehm Solo FD |
| Reference Device | K193230 Ziehm Vision FD |
| Decision Date: | 10/06/2016 |
| Regulation: | 21CFR 892.1650 |
| Regulation Description Name: | Image-intensified fluoroscopic x-ray system |
| Product Code: | OWB; JAA, OXO |
| Summary of Technological Characteristics | The Ziehm Solo FD uses X-ray imaging technology to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the control of the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The device enables real-time image acquisition as well as visualization of in vivo surgical procedures and post-operative results.The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the positioning of the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system.The mechanical C-Profile supports the generator, the flat panel detector and an integrated laser positioning device.The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand.The proposed modified device Ziehm Solo FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Solo FD (K161976). Software architecture design is substantially equivalent to that of the predicate Ziehm Solo FDThe 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 FPD. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding |
510(k) Summary
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for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8 inch CMOS and the only difference to the predicate Ziehm Solo 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 Solo FD are substantially equivalent as those of the Ziehm Solo FD predicate device (K161976).
- Intended Use The Ziehm Solo FD is a mobile C-arm providing image data by means of a noninvasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Solo 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 svstem is intended for use with human bodies covering such structures but not limited to the following, e.q., organs, tissue, bones, implants depending on the medical indication.
Indications for Use: The Ziehm Solo 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, cholanqiography, 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 Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
|---|---|---|---|
| 510(k)Number | K231669 | K161976 | --- |
| ProductCodes | OWB (interventional fluoroscopic x-raysystem)Subsequent:JAA (system, x-ray, fluoroscopic) | OWB (interventional fluoroscopic x-ray system)Subsequent:JAA (system, x-ray, fluoroscopic) | Identical |
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Image /page/6/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized human figure inside of a circle with curved lines. The company name is written in a teal sans-serif font.
| Model | ModifiedZiehm Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
|---|---|---|---|
| DeviceImage/GeneralOverview | image-intensified),OXO (image-intensified fluoroscopic x-ray system, mobile)Image: Modified Ziehm Solo FD | image-intensified),OXO (image-intensified fluoroscopicx-ray system, mobile)Image: Predicate Ziehm Solo FD (K161976) | The flat paneldetectors areidentical in thedesign of thehousing, bothdevices usesafety shieldingfor radiationsuppression anduse solid state x-ray imagereceptor (SSXI /FPD) 8 inch CMOSand the onlydifference to thepredicate ZiehmSolo FD is thenew 8 inch IGZOFPD. |
| Model | ModifiedZiehm Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| X-ray Generator | |||
| PulsedFluoroscopy:Operatingvalues | kV range:variant B0: 40 - 110 kVvariant B1+B2: 40 - 120 kV mA range:variant B0: 0.2 - 16 mAvariant B1: 0.2 - 16 mAvariant B2: 0.2 - 20 mA | kV range:variant B0: 40 - 110 kVvariant B1+B2: 40 - 120 kV mA range:variant B0: 0.2 - 16 mAvariant B1: 0.2 - 16 mAvariant B2: 0.2 - 16 mA | Substantialequivalent.The characteristicline was changedto 20mA, whichhas no effect onthe safety as it isbelow themaximum dose. |
| X-ray Tube | |||
| Tube Type | stationary anode | stationary anode | Identical. |
| X-RayTubes | for variants B0, B1, and B2 Avg. Power: 0.6 kW Peak Power: 2,4kW Max. Voltage: 125kV for variants B0+B1 Avg. Power:0.6 kW Peak Power: 2.02 kW Max. Voltage: 120 kV | for variants B0, B1, and B2 Avg. Power: 0.6 kW Peak Power: 2,4kW Max. Voltage: 120kV for variants B0+B1 Avg. Power:0.6 kW Peak Power: 2.02 kW Max. Voltage: 120 kV | SubstantialequivalentThe maximalvoltage of the X-Ray tube forvariants B0, B1,and B2 have themax. Voltage upto 125kV, but asthe generator isup to 120kV thevalue was givenas 120kV. |
| Monitors | |||
| DisplayMonitor | The device can be equipped withmonitors of different sizes 19" Duo flat-screen monitor(optionally with Quick Release) 27" flat screen monitor | The device can be equipped withmonitors of different sizes 19" DUO flat-screen monitor 24" flat screen monitor | Substantialequivalent.The 24" flatscreen monitorhas beendiscontinued bythe manufacturerand have beenreplaced by 27"monitor. |
| Radiation Switches | |||
| X-Rayfootswitch | Cable bound footswitch (with orwithout protective bracket) optional: Wireless footswitch withan emergency cord the if battery is | Cable bound footswitch optional: Wireless footswitchwith an emergency cord the ifbattery is low | SubstantialequivalentAll footswitchesare available with |
| Model | ModifiedZiehm Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| low (with or without protectivebracket) | protectivebracket. | ||
| Digital Imaging Processing | |||
| Real-Timeprocessingfunctions | • Recursive filter: 4 levels• Last Image Hold• Edge enhancement filter: 5 levels• Windowing and step windowing• Digital image rotation and reversalwithout radiation• Grayscale inversion• Digital collimators• Ziehm Adaptive Image Processing(ZAIP) | • Recursive filter: 4 levels• Stack filter 'Last Image Hold': 5levels• Last Image Hold• Edge enhancement filter:5 levels• Windowing and step windowing• Digital image rotation andreversal without radiation• Grayscale inversion• Digital collimators• Ziehm Adaptive ImageProcessing (ZAIP) | Substantialequivalent.Stack filter 'LastImage Hold' wasdiscontinued. |
| Appli-cation-OrientedAnato-micalPrograms(AOAP) | • Bone: Extremities, Trunk• Heart, Abdomen, Soft, Uro (option)• Vascular: Extremities, Trunk, Bolus | • Bone: Extremities, Trunk• Abdomen, Soft, Uro (option),Long Procedure Spine• Vascular: Extremities, Trunk,Bolus | Substantialequivalent.Long procedurespine wasdiscontinued. |
| Model | ModifiedZiehm Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| DataOrganization | • Patient-based data managementwith 16-image mosaic display• Pre-registration via DICOM Worklist(option)• Manual input or emergencyregistration• Calculated Dose Area Product (DAP)• DAP value tagged to stored image• Air Kerma dose display• Air kerma value tagged to thestored image• HIPAA security package (option)• Radiation Dose Structured Report(RDSR)• Video Output- Full HD SDI (split display)- 1920 x 1080p- 60Hz• Measured dose area product (DAP)with digital display (option) | • Patient-based data managementwith 16-image mosaic display• Pre-registration via DICOMWorklist (option)• Manual input or emergencyregistration• Calculated Dose Area Product(DAP)• DAP value tagged to storedimage• Air Kerma dose display• Air kerma value tagged to thestored image• HIPAA security package (option)• Radiation Dose StructuredReport (RDSR)• Measured dose area product(DAP) with digital display(option) | Substantialequivalent.As required by theIEC 60601-2-43the modifieddevice Ziehm SoloFD displays dosearea product(DAP), air kermarate andcumulative airkerma at thesame time.An optimizationhave been madethrough the Videooutput, whichhave no influenceon the devicesafety andeffectiveness. |
| Device Options List | |||
| Summaryof above-describedOptions(detailsabove) | • X-ray generator in different variants• Removable anti-scatter grid• Laser positioning device on thegenerator• Different locations and sizes ofdisplay monitor• Remote Solo Center• Footswitch with customer-specificswitch assignment in variant cablebound or wireless• Cine loop with up to 30 frames persecond• Measuring functions• Vascular package• Anatomical Marking Tool (AMT)• User administration (HIPAA)• Calculated or measured dose areaproduct (DAP) and calculated AirKerma• video printer• DICOM viewer software• Ziehm NetPort: DICOM 3.0 interfacefor digital network integration | • X-ray generator in differentvariants• Removable anti-scatter grid• Laser positioning device on thegenerator• Motor-driven angulation (A-Axis)• Variant "Portable"• Different locations and sizes ofdisplay monitor• Remote Solo Center• Footswitch with customer-specificswitch assignment in variantcable bound or wireless• Cine loop with up to 30 framesper second• Measuring functions• Vascular package AnatomicalMarking Tool (AMT)• User administration (HIPAA)• Calculated or measured dosearea product (DAP) or calculatedAir Kerma• video printer | SubstantialequivalentBoth optionsmotor-drivenangulation (A-axis) and Variant"Portable" werediscontinued. |
| Model | ModifiedZiehm Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| • WLAN interface for wireless datatransfer• Viewing Station• Field Transport Solution, incl. all-terrain wheels, towing andmounting device bar | • DICOM viewer software• Ziehm NetPort: DICOM 3.0interface for digital networkintegration• WLAN interface for wireless datatransfer• Viewing Station | ||
| FurtherOptions | • video connector(s) for external flat-screen monitors (right and leftmonitor), optionally with analog ordigital signal (DVI)• Key switch Power on/off• Interface for external separateradiation indication lamp | • video connector(s) for externalflat-screen monitors (right andleft monitor), optionally withanalog or digital signal (DVI)• Key switch Power on/off or X-rayon/off• Interface for external separateradiation indication lamp | Substantialequivalent.Key switch Poweron/off replaces X-ray on/off. |
| Model | ModifiedZiehm Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| OptionalAccessories | • Sterile disposable covers• Skin protection | • Sterile disposable covers• Hand surgery table• Skin protection | Substantialequivalent.The optional Handsurgery table is nolonger available.Note: ZiehmImaging GmbH isnot themanufacturer ofthe optionalaccessories |
| Software | |||
| LevelofConcern | Enhanced | Moderate | Identical;The term of levelof concern haschangedaccording to theGuidance"Content ofPremarketSubmissions forDevice SoftwareFunctions", butthere have beenno additionalchanges to thedevice that haveincreased thelevel of concern. |
| Software | • 7.06.11• Linux-based OS Ubuntu | • 7.00.3• Linux-based OS Ubuntu | Updates andoptimization ofsoftware features,which does nothave influence onsafety andeffectiveness ofthe device. |
| Model | ModifiedZiehm Solo FD | PredicateZiehm Solo FD (K161976) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| Indications for Use | The Ziehm Solo FD is intended for usein providing medical imaging for adultsand pediatric populations, using pulsedand continuous fluoroscopic imaging.The device provides contactlessfluoroscopic image capture,temporarily storing, and display ofdigital subtraction, and acquisition ofcine loops during diagnostic,interventional and surgical procedures.Examples of clinical application mayinclude pediatric, cholangiography,endoscopic, urologic, lithotripsy,orthopedic, neurologic, vascular,cardiac, angiographic, critical care, andemergency room fluoroscopyprocedures.The visualization of such anatomicalstructures assists the clinician in theclinical outcome. This device does notsupport direct radiographic filmexposures and is not intended for usein performing mammography. Thesystem is not intended for usenear MRI systems. | The Ziehm Solo FD is intended foruse in providing medical imaging foradults and pediatric populations,using pulsed and continuousfluoroscopic imaging.The device provides contactlessfluoroscopic image capture,temporarily storing, and display ofdigital subtraction, and acquisitionof cine loops during diagnostic,interventional and surgicalprocedures. Examples of clinicalapplication may include pediatric,cholangiography, endoscopic,urologic, lithotripsy, orthopedic,neurologic, vascular, cardiac,angiographic, critical care, andemergency room fluoroscopyprocedures.The visualization of such anatomicalstructures assists the clinician in theclinical outcome. At the discretion ofa physician, the device may be usedfor other imaging applications.This device does not support directradiographic film exposures and isnot intended for use in performingmammography. | SubstantialequivalentThe wording ofthe indications foruse were updated.These changes donot raise newsafety oreffectivenessconcerns withregard to thepredicate device. |
| Standards | |||
| Standards | • ANSI/AAMIES60601-1:2005/AMD1:2012• IEC 60601-1-2: 2014• IEC 60601-1-3: 2008/AMD1:2013• IEC 60601-1-6:2013/AMD2:2020• IEC60601-2-43: 2010/AMD2:2019• IEC60601-2-54:2009/AMD2:2018• IEC 60852-1:2007• ISO 14971:2019 | • IEC 60601-1:2005• IEC 60601-1-2:2007• IEC 60601-1-3:2008• IEC 60601-1-6:2013• IEC 60601-2-43:2010• IEC 60601-2-54:2009• IEC 60825-1:2007• ISO 14971:2007 | Applicablestandards for themodified ZiehmSolo FD and theSolo FD predicate(K161976) remainas before. Newerversions of thestandards havebeen applied. |
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Image /page/7/Picture/0 description: The image shows 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 teal sans-serif font. The overall design is clean and modern.
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Image /page/8/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a stylized globe-like icon on the left, followed by the text "ziehmimaging" in a teal color. The globe icon features abstract lines and a human-like figure within a circular border, giving it a modern and technological appearance.
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Image /page/9/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the company name "ziehmimaging" in a teal sans-serif font. The globe is also teal, and the overall design is clean and modern.
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Image /page/10/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a teal-colored globe-like icon on the left, followed by the text "ziehmimaging" in a matching teal color. The text is written in a sans-serif font and appears to be the name of the company.
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Image /page/11/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic features a stylized human figure inside of a globe. The text is in a teal color.
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Image /page/12/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The circular graphic contains a stylized image of a person inside of a globe. The text is in a teal color.
For the comparison between a-Si and IGZO the Ziehm Vision FD (K193230) is used as reference device:
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| Model | ModifiedZiehm Solo FD | Reference DeviceZiehm Vision FD (K193230) | ComparablePropertiesSubstantialEquivalenceDiscussion |
|---|---|---|---|
| 510(k)Number | K231669 | K193230 | |
| ProductCodes | OWB (interventional fluoroscopic x-raysystem )Subsequent:JAA (system, x-ray, fluoroscopic,image-intensified),OXO (image-intensified fluoroscopic x-ray system, mobile) | OWB (interventional fluoroscopic x-ray system)Subsequent:JAA (system, x-ray, fluoroscopic,image-intensified),OXO (image-intensified fluoroscopicx-ray system, mobile) | Identical |
| DeviceImage/GeneralOverview | Image: Ziehm Solo FD | Image: Ziehm Vision FD (K193230) | |
| Beam Limiter/ Collimator | |||
| Collimator System | • Dedicated pre-collimator for flatpanel detector• Collimator Rotation:+/- 90°• Iris and Asymmetric Slot Collimator• Virtual Collimation without radiation | • Dedicated pre-collimator for flatpanel detector• Collimator Rotation:+/- 90°• Iris and Asymmetric SlotCollimator• Virtual Collimation withoutradiation | Identicalcollimator system.Themaximumcollimator openingis adjusted to theflat panel type. |
| Image Detector | |||
| ImageDetector | Flat Panel Detector | Flat Panel Detector | They are identicalin the outerproduct design ofthe housing, bothdevices use safetyshielding forradiation |
| Model | ModifiedZiehm Solo FD | Reference DeviceZiehm Vision FD (K193230) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| Image: Ziehm Solo FD | Image: Ziehm Vision FD | suppression anduse solid state x-ray imagereceptor (SSXI /FPD) Themodified ZiehmSolo FD hasadditionally new 8inch IGZO(Indium galliumzinc oxide) flatpanel detector. | |
| DetectorTechnology | • Type: CMOS Flat Panel Detector• Scintillator: Cesium-Iodide (CsI)• Alternative Type: IGZO• Scintillator: Cesium-Iodide (CsI) | • Type aSi (AmorphousSilicon) Flat Panel Detector• Scintillator: Cesium-Iodide(CsI)• Type CMOS Flat PanelDetector:• Scintillator: Cesium-Iodide(CsI) | IGZO baseddetectors aremanufacturedusing processesthat are similar toaSi detectors. Theslight differencesin used sensorglass technologydoes not haveinfluence onsafety andeffectiveness ofthe C-armproduct. |
| DetectorSizes | CMOS:Size: 21 cm x 21 cm (8"x 8")Detector matrix: 2,053 x 2,051 pixelsMagnifier 1: 1,536 x 1,536 pixelsMagnifier 2: 1,024 x 1,024 pixelsDynamic Range:1 x 1 binning: 84 dB2 x 2 binning: 95 dBSystem resolution: 5,0 lp/mmIGZO:Size: 21 cm x 21 cm (8"x 8")Detector matrix: 1,536 x 1,536pixelsMagnifier 1: 1,024 x 1,024 pixels | Variant 20.5cm x 20.5cm (8"x 8")CMOS• Size: 20.5 cm x 20.5 cm• Detector matrix: 2,048 x 2,048pixels• 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): 5lp/mmVariant 20cm x 20cm (8"x 8") a-Si: | The active pixelarea of thedetector types arenot identical butare very similar inimage area ofapprox. 8 inch x 8inch. The modifieddevice Ziehm SoloFD with IGZO hasa higherresolution size incomparison toreference deviceZiehm Vision FDwith a-Si FPD,which leads to |
| Model | ModifiedZiehm Solo FD | Reference DeviceZiehm Vision FD (K193230) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| Magnifier 2: 768 x 768 pixelsDynamic Range:1x1 binning: 84dB2x2 binning: 95dBSystem resolution: 3,7 lp/mm | • Size: 19.9 cm x 19.9 cm• Detector matrix: 1,024 x 1,024pixels• Magnifier 1: 768 x 768 pixels• Magnifier 2: 512 x 512 pixels• Dynamic Range: 94 dB• System resolution (Nyquist): 2.6lp/mmVariant 30cm x 30cm (12" x 12")aSi:• Size: 29.8 cm x 29.8 cm• Detector matrix: 1,536 x 1,536pixels• Magnifier 1: 1,024 x 1,024 pixels• Magnifier 2: 768 x 768 pixels• Dynamic Range: 94 dB• System resolution (Nyquist): 2.6lp/mmVariant 30.7cm x 30.7cm (12" x12") aSi:• Size: 31 cm x 31 cm• Detector matrix: 2,048 x 2,048pixels• Magnifier 1: 1,536 x 1,536 pixels• Magnifier 2: 1,024 x 1,024 pixels• Dynamic Range: ≥86 dB• System resolution (Nyquist):3.3lp/mm | betterimagequality.Allotherdifferences withregard to the usedtechnology haveno influence onsafety andeffectiveness ofthe C arm. | |
| Anti-Scatter Grids | |||
| Fixedanti-scattergrid | fixed anti-scatter grid:CMOS (8inch)• Pb 8/70IGZO (8inch)• Pb 8/70 | fixed anti-scatter grid:CMOS (8inch)• Pb 8/70a-Si (8inch)• Pb 8/70a-Si (12inch)• Pb 6/80 | Identical valuesand material forboth modified andreference devicewith 8 inch flatpanel detectors. |
| Model | ModifiedZiehm Solo FD | Reference DeviceZiehm Vision FD (K193230) | ComparablePropertiesSubstantialEquivalenceDiscussion |
| optionalremovable anti-scattergrid | Image: Ziehm Solo FD | Image: Ziehm Vision FD | Identical valuesand material forboth modified andreference devicewith 8 inch flatpanel detectors. |
| Removable Grid:CMOS (8inch)• Pb 8:1/70lines/cmIGZO (8inch)• Pb 8:1/70 lines/cm | Removable Grid:CMOS (8inch)• Pb 8/70a-Si (8inch)• Pb 8/70a-Si (12inch)• Pb 6/80 |
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Image /page/14/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 circle with intersecting lines, and the text is in a teal color.
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Image /page/15/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font.
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Image /page/16/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 circle with intersecting lines. The text is in a teal color and appears to be a sans-serif font.
- Conclusion of Table The changes of the proposed modified device Ziehm Solo 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 Solo FD (K161976) in accordance with its labeling. Safety and Performance: The proposed Ziehm Solo 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 Solo FD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Solo FD (K161976). The design of the modified Ziehm Solo 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 reqarding electrical safety according to ANSI/AAMI ES60601-1 and reqarding electromagnetic compatibility according to IEC 60601-1-2 was performed. The test results show compliance with both standards.
510(k) Summary
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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 Solo 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 beam-limiting alignment to device image receptor. Further, this performance testing confirmed that the modified Ziehm Solo 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), documentation provided in this submission demonstrates compliance of the modified device Ziehm Solo 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 Solo 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 Imaging GmbH believes the modified device Ziehm Solo FD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Solo FD (K161976).
Compliance to FDA Guidance and Standards
FDA/CDRH From 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems (5/11) and Their Major Components.
21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems.
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Image /page/18/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic on the left and the company name "ziehmimaging" on the right. The text is in a teal color and appears to be a sans-serif font. The graphic on the left appears to be a stylized representation of a globe or a human figure within a circle.
General Standards / Requlations
Medical Device Single Audit Program (MDSAP) MDSAP Requlation (EU) Annex IX Chapter I, Section2 and 3 and Chapter III 2017/745 EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes Date: 2016
Recognized Consensuses Standards
| ANSI/AAMI ES60601-1: | Medical Electrical Equipment, Part 1: General Requirements for Basic |
|---|---|
| Safety and Essential Performance | (IEC 60601-1:2005, mod) |
| Date: | 2012 |
| Conformance Standard | #19-4 |
- IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General Requirements for Safety, Electromagnetic Compatibility Edition 4.0, Date: 2014-02 Conformance Standard #19-8
- IEC 60601-1-3: Medical Electrical Equipment, Part 1-3: Radiation Protection in Diagnostic X-ray Equipment Edition 2.1, Date: 2013-04 Conformance Standard #12-269
- IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: Usability Edition 3.2, Date: 2020-07 Conformance Standard #5-132
- IEC 60601-2-43: Medical electrical equipment, Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures Edition 2.2, Date: 2019-10 Conformance Standard #12-239
- IEC 60601-2-54: Medical electrical equipment, Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Edition 1.2, Date: 2018-06 Conformance Standard #12-317
- IEC 61304: Medical device software Software life cycle processes Edition 1.1, Date 2015-06 Conformance Standard #13-79
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Image /page/19/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and is slightly faded.
- 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 60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.
The modified Ziehm Solo 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 employed. 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 Solo 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 Solo FD C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Solo FD (K161976).
- Conclusion Ziehm Imaging GmbH considers the Ziehm Solo FD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Solo FD (K161976) 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.