Ziehm Solo FD
Device Facts
| Record ID | K161976 |
|---|---|
| Device Name | Ziehm Solo FD |
| Applicant | Ziehm Imaging GmbH |
| Product Code | OWB · Radiology |
| Decision Date | Oct 6, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1650 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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 of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
Device Story
Mobile fluoroscopic C-arm system; utilizes mono-block high voltage generator and flat panel detector (SSXI/CMOS) for 2D medical imaging. Input: X-ray radiation passing through patient anatomy. Transformation: X-ray capture via flat panel detector; processing via Ziehm Adaptive Image Processing (ZAIP) for noise reduction; digital subtraction and cine loop storage. Output: High-resolution fluoroscopic images displayed on integrated monitors. Used in OR, clinic, or emergency settings by physicians/technicians. Provides real-time visualization of anatomical structures to assist in surgical/interventional guidance. Features include manual/motorized C-arm movement, touch screen control, and optional wireless footswitch. Connectivity via DICOM, USB, and DVD. Benefits include improved image quality for moving objects via variable pulse widths/frame rates and optimized surgeon positioning.
Clinical Evidence
Bench testing only. No clinical data. Verification and validation testing included internal functional specifications, software risk hazards, and non-clinical image comparisons against the Ziehm Vision² FD (K073346). Compliance demonstrated for DQE, resolution, dynamic range, beam alignment, dose rates, and frame rates per FDA guidance for solid-state X-ray imaging devices.
Technological Characteristics
Mobile C-arm with mono-block generator (stationary anode). Flat panel detector (SSXI/CMOS, 20.5cm x 20.5cm, 100µm pixel size, 2048x2048 matrix). 16-bit grayscale. ZAIP (Ziehm Adaptive Image Processing) for noise filtering. Connectivity: DICOM, USB, DVD, wireless/wired network. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-43, IEC 60601-2-54, IEC 60825-1, ISO 14971.
Indications for Use
Indicated for adults and pediatric populations requiring medical imaging via pulsed and continuous fluoroscopic imaging for diagnostic, interventional, and surgical procedures, including pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room applications. Not for direct radiographic film exposures or mammography.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Ziehm Imaging Gmbh % Mr. Richard L. Westrich Director of Regulatory Affairs and Quality Assurance Ziehm Imaging, Inc. 6280 Hazeltine National Drive ORLANDO FL 32822
Re: K161976 Trade/Device Name: Ziehm Solo FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Dated: July 15, 2016 Received: July 18, 2016
Dear Mr. Westrich:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K161976
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 of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists the clinical outcome. At the discretion of a physician, the device may be used for other imaging applications. 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) |
|-------------------------------------------------|
|-------------------------------------------------|
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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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
Sep 15, 2016
In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:
| Submitter Address: | Ziehm Imaging GmbH<br>Donaustrasse 31<br>90451 Nuremberg<br>Germany<br>Phone: + 49.911.2172-219<br>Fax: +49.911.2172-390 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person /<br>Agent: | Richard L. Westrich<br>Director of Requlatory Affairs and Quality Assurance<br>Ziehm Imaging, Inc.<br>Phone: (407) 615-8560 Ext 140<br>Fax: (470) 615-8561<br>Cell Phone: (909) 262 9930 |
| Secondary Contact Person: | Stefan Fiedler<br>Director QM/RA<br>Ziehm Imaging GmbH<br>Phone: + 49.911. 2172-219<br>Fax: +49.911.2172-390 |
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| Device (Trade Name): | Ziehm Solo FD |
|-----------------------|---------------------------------------------|
| 510(k) Number | K161976 |
| Common /Usual Names: | Mobile Fluoroscopic C-Arm |
| Classification(s) | 21CFR 892.1650 |
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, OXO, JAA |
| Predicate Device: | Ziehm Solo (K092438) |
| Classification(s) | 21CFR 892.1650 |
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, OXO, JAA |
| Predicate Device: | Ziehm Vision² FD (K073346) |
| Classification(s) | 21CFR 892.1650 |
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, JAA, JAK |
General Description: The Ziehm Solo 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. Additionally the device has the option of additional motorized axes of rotational movement for the (A-Axes C-profile motorization of the single A-axes provides the user an alternative for visualizing anatomical structures when performing certain procedures such as but not limited to working with lithotripsy procedures. A user touch screen provides for concise user selectable anatomical programs and X-ray technique control. Integrated highresolution flat panel display monitors directly mounted on the horizontal arm of the mobile stand providing the clinician with a precise angle for visualization of live
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fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surqical 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 Solo 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.
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, 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. At the discretion of
a physician, the device may be used for other imaging applications. This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
Summary of Technological The comparisons of the predicate devices show the Characteristics: scientific and technology characteristics of the Ziehm Solo FD are substantial equivalence to that of the predicate devices.
| Differences<br>Features/Technology | Subject Device<br>Ziehm Solo FD<br>(K161976) | Predicate Device<br>Ziehm Solo<br>(K092438) | Predicate Device<br>Ziehm Vision2 FD<br>(K073346) |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Mobile fluoroscopic c-arm | Yes | Yes | Yes |
| Classification | 21CFR 892.1650 | 21CFR 892.1650 | 21CFR 892.1650 |
| Mobile stand user touch control<br>panel | Yes, same design | Yes, same design | Yes, same design |
| X-ray generator and tube<br>housing assembly monoblock<br>technology | Yes, same<br>monoblock design,<br>stationary anode<br>tube | Yes, same<br>monoblock design,<br>stationary anode<br>tube | Similar monoblock<br>design,<br>stationary anode<br>tube |
| KV Range 40-110 kV | Yes | Yes | Yes |
| KV Optional Range 40-120 kV | Yes | Yes | No |
| Max power output<br>2.4 kW has the ability to provide<br>higher mA at lower kV levels<br>allowing shorter pulse widths at<br>variable frame rates to increase<br>the image quality of moving<br>objects by reducing or<br>eliminating the movement during | 2.0 kW<br>Optional 2.4 kW | 2.0 kW<br>No | 2.0 kW<br>No |
| each single pulse.<br>Collimator/beam limiter shutters | Yes, same design<br>Asymmetric Slot | No, IRIS with Slot<br>Collimator for<br>circular image<br>receptor | Yes, same design<br>Asymmetric Slot |
| Pre Collimator | Square | Round | Square |
| Virtual collimation | Yes | Yes | Yes |
| X-ray Image Receptor | SSXI/CMOS<br>20.5 cm x 20.5 cm | I.I./cesium iodide<br>Ø 23 cm or Ø 31<br>cm | SSXI/Amorphous<br>silicon<br>20 cm x 20 cm |
| Flat Panel Detector (SSXI) | Yes | No | Yes |
| FPD FOV | Square FOV | Round FOV | Square FOV |
| Pixel Size | $100 \_\text{μm}$ | N/A | $194 \text{ μm}$ |
| Detector Matrix | 2,048 x 2,048 pixels | N/A | 1,024 x 1,024<br>pixels |
| Camera Matrix | NA | 1,024 x 1,024 pixels | NA |
| Grayscale: | 16 bit (65,536<br>shades of gray) | 12 bit (4,096<br>shades of gray) | 16 bit (65,536<br>shades of gray) |
| Dynamic range | 68 dB | N/A for image<br>intensifier devices | 94 dB |
| DQE | 70 % | 65 % | 77 % |
| System resolution | 4 lp/mm | 5.2-6.8 lp/mm | 2.4 lp/mm |
| ZAIP (Ziehm Adaptive Image<br>Processing) | Adaptive noise filter<br>adapts to the<br>physical<br>characteristics of<br>the input signal | No,<br>recursive noise<br>filtering | Adaptive noise<br>filter adapts to the<br>physical<br>characteristics of<br>the input signal |
| Removable anti-scatter grid | Yes | Yes | No |
| AERC Dose control system | Similar design and<br>control | Similar design and<br>control | Similar design<br>and control |
| Image Post Processing | Yes, same design | Yes, same design | Yes, same design |
| DICOM functionality including<br>RSDR | Yes, same design | Yes, same design | Yes, same design |
| TFT Flat Screen Displays | Yes | Yes | Yes |
| Orbital movement | 165°<br>Geometry with new<br>Flat Panel required | 135° | 135° |
| SID | 109 cm<br>Geometry with<br>new Flat Panel<br>requires larger<br>SID | 95 cm | 111 cm |
| Motorized Angulation | Yes, optional | Yes, optional | No |
| Option to dismantle the<br>device in several modules | Variant<br>"Portable" | Variant<br>"Portable" | No |
| Monitor Cart | Optional<br>"Viewing<br>Station" | Optional<br>"Viewing<br>Station" | Mandatory<br>Monitor Cart |
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Summary of Non-Clinical Test Data:
Ziehm Solo FD is based on the direct modifications to cleared predicate devices Ziehm Solo (K092438) and Ziehm Vision2 FD (K073346); The design changes were completed in accordance with Ziehm Imaging GmbH Quality Management System Design Controls and Engineering, standards compliance, and Verification and Validation testing were successfully conducted on the Ziehm Solo FD. Further compliance testing for the modified device to all FDA requirements as stated in "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" as applicable including software requirements and software risk hazards was done.
Tests performed on the Ziehm Solo FD, demonstrated that the device is safe and effective, performs comparably to the predicate devices, and substantially equivalent to the predicate devices.
Tests included verification/validation testing to internal functional specifications (including software) and nonclinical image comparisons involving flat panel display images taken with the new device and the predicate device Ziehm Vision2 FD (K073346). Documentation
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provided in this submission demonstrates compliance of the modified device Ziehm Solo FD to all 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 Ziehm Solo FD complies with 21 CFR 1020.30-32 Federal Performance Standards for X-Ray Fluoroscopic equipment and with relevant voluntary safety standards for Electrical Safety and Electromaqnetic Compatibility testing, specifically IEC standards listed in the table below. With regard to the flat panel detector (SSXI), test 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". This includes but is not limited to DQE, resolution, image quality of comparative sets of images, dynamic range, beam alignment, dose rates, frame rate, geometry, and resolution to predicate device.
The verification/validation activities successfully confirmed device requirements have been fulfilled, system functionality is consistent with the user needs, intended uses, and the Ziehm Solo FD device correctly performs as designed, and raises no new questions regarding either safety or effectiveness.
Therefore, when compared to the predicate devices the Ziehm Solo FD supports a determination of substantial equivalence to the predicate devices.
| FDA/CDRH<br>From 3626 (1/14) | "A Guide for the Submission of Initial Reports on Diagnostic X-<br>Ray Systems and Their Major Components" |
|------------------------------|------------------------------------------------------------------------------------------------------------|
| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems. |
| MDD 93/42/EEC | Annex II of the European Medical Devices Directive (MDD)<br>93/42/EEC. |
| EN ISO 13485 | Medical devices - Quality management systems -<br>Requirements for regulatory purposes |
#### Compliance Standards:
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| AAMI/ANSI ES60601-1 | Medical Electrical Equipment -- Part 1: General Requirements<br>for Basic Safety and Essential Performance (IEC 60601-<br>1:2005, mod)<br>Date: 2010<br>Conformance Standard #19-5 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1 | Medical Electrical Equipment, General Requirements for Safety<br>Edition 3.0 (+Corr.1+Corr.2), Date: 2005-12-15 |
| IEC 60601-1-2 | Medical Electrical Equipment, General Requirements for<br>Safety, Electromagnetic Compatibility<br>Edition 3.0, Date: 2007-03-30,<br>Conformance Standard #19-1 |
| IEC 60601-1-3 | Medical Electrical Equipment, Radiation Protection in<br>Diagnostic X-ray Equipment<br>Edition 2.0, Date: 2008-01-22<br>Conformance Standard #12-210 |
| IEC 60601-2-43 | Medical electrical equipment, Part 2-43: Particular<br>requirements for basic safety and essential performance of X-<br>ray equipment for interventional procedures<br>Edition 2.0, Date: 2010-03-25<br>Conformance Standard #12-202 |
| IEC 60601-2-54 | Medical electrical equipment, Part 2-54: Particular<br>requirements for the basic safety and essential performance<br>of X-ray equipment for radiography and radioscopy<br>Edition 1.0, Date: 2009-06-29<br>Conformance Standard #12-274 |
| IEC 60825-1 | Safety of laser products, Equipment Safety, requirements, and<br>user guide<br>Edition 2.0, Date: 2007-03-30<br>Conformance Standard #12-273 |
| ISO 14971 | Medical devices - Application of risk management to medical<br>devices<br>Edition 2.0, Date: 2007-03-01<br>Conformance Standard #5-40 |
- Ziehm Imaging GmbH considers the Ziehm Solo FD to be Conclusion: as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Vision² FD (K073346) and Ziehm Solo (K092438) in accordance with its labeling.
End of 510(k) Summary
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Richard A. Fiene
Richard L. Westrich Official Agent and Correspondent for Ziehm Imaging GmbH. Ziehm Imaging Inc, 6280 Hazeltine National Drive Orlando, Fl. 32822
