(111 days)
Not Found
No
The summary describes a standard fluoroscopic imaging device and does not mention any AI or ML capabilities. The performance studies focus on image quality and cybersecurity, not AI/ML performance metrics.
No
The device is used for medical imaging and visualization, which assists in diagnosis and surgical procedures, but it does not directly treat or prevent a disease or condition.
Yes
The device is described as providing imaging for "diagnostic, interventional and surgical procedures" and helps "assist the physician in localizing pathological areas," which indicates a diagnostic function.
No
The device description clearly states it is an X-ray imaging system consisting of a mobile stand, generator, X-ray tube, detector, and optional viewing station, all of which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Ziehm Solo FD Function: The Ziehm Solo FD is an X-ray imaging system. It uses X-rays to visualize the internal structures of the human body in vivo (within the living body). It captures and displays images of anatomical structures to assist physicians during procedures.
The description clearly states that the device provides "contactless fluoroscopic image capture" and "visualization of in vivo surgical procedures." This is the opposite of an in vitro diagnostic.
N/A
Intended Use / 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, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use in any MRI environments.
Product codes
OWB, JAA, OXO
Device Description
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 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 image acquisition as well as visualization of in vivo surgical procedures and post-operative results.
The Ziehm Solo FD consist of one mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric populations
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison with the predicate system. Anthropomorphic phantoms so-called "sectional phantoms" were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and Validation testing were successfully conducted on the device in compliance with FDA requirements as stated in the following text.
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, IEC 60601-1-2, IEC 60601-2-43 and IEC 60601-2-54.
The image comparison between the system settings of the predicate device and the optimized system settings (including 2k imaging chain) of the modified device shows that the image quality acquired with the test device is better or at least equal. The same applies to images acquired with newly introduced 12 inch flat panel detector. Almost all images generated by the test device show more details, improved detectability and are sharper than the corresponding reference images. From a radiological point of view the image quality of the presented images that were acquired fulfil the requirements as stated by the intended use.
Software and cybersecurity testing was performed as required by "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
Cybersecurity testing comprises vulnerability scanning, penetration testing an static code analysis. Vulnerability scanning has been performed on the devices SBOMs and additionally using Tenable Nessus. The findings have been assessed and found acceptable. Two separate penetration tests have been conducted and displayed a good cybersecurity posture of the results from the static code analysis indicate some code locations that might benefit from a code adaption, but no stability nor any security issue could be identified that would require immediate action. The points for insequent software releases. Overall the testing activities demonstrate a good level of cybersecurity for the device, complying with the FDA requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
March 17, 2025
Ziehm Imaging GmbH % Cornelia Schildbach Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, 90471 GERMANY
Re: K243646
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 25, 2024 Received: November 26, 2024
Dear Mrs. Schildbach:
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.
1
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
2
See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K243646
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, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use in any MRI environments.
| 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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4
510(k) #: K243646
510(k) Summarv
Prepared on: 2025-02-17
| Applicant Name | Ziehm Imaging GmbH |
|---|---|
| Applicant Address | Lina-Ammon-Strasse 10 Nuremberg 90471 Germany |
| Applicant Contact Telephone | +4991166067258 |
| Applicant Contact | Mrs. Cornelia Schildbach |
| Applicant Contact Email | Zie-Regulatory@ziehm.com |
21 CFR 807.92(a)(2)
| Device Trade Name | Ziehm Solo FD |
|---|---|
| Common Name | Image-intensified fluoroscopic x-ray system |
| Classification Name | Image-intensified fluoroscopic x-ray system |
| Regulation Number | 892.1650 |
| Product Code(s) | OWB, JAA, OXO |
Legally Marketed Predicate Devices 21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K234109 | Ziehm Solo FD | OWB |
Device Description Summary 21 CFR 807.92(a)(4)
Ziehm Solo FD uses X-ray imaging technology to visualize the human anatomy. The X-ray tube in the generator produces X-rays thatZiehm Solo FD uses X-ray imaging 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 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 image acquisition as well as visualization of in vivo surgical procedures and post-operative results.
The Ziehm Solo FD consist of one mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making 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 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 comparison of the predicate device shows that the scientific and technical characteristics of the Ziehm Solo FD are substantially equivalent as those of the Ziehm Solo FD predicate device.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Ziehm Solo FD is intended for use in providing mediatric populations, using pulsations, using pulsed and continuous fluoroscopic imaging.
The device provides contactless fluoroscopic image capture, temporarily storing, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
5
The visualization of such anatomical structures assists the clinical outcome. This device does not support direct radiographic film exposures and is not in performing mammography. The system is not intended for use in any MRI environments.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use of the predicate and modified devices are substantial equivalent. Only the wording has been updated.
Technological Comparison
21 CFR 807.92(a)(6)
The key modification refers to an software update to software version 7.10.0, which incorporates the 2k imaging chain "QuantumStream", along with the corresponding new "Image Insights" overlay. In addition to the already introduced 8 inch IGZO flat panel detector, the modified Ziehm Solo FD offers an 12 inch IGZO panel. The manufacturing technology (IGZO, Indium-Gallium-Zinc-Oxide) of both detectors 8 inch and 12 inch as well as the image quality are equivalent.
The predicate Ziehm Solo FD (K234109) and the modified Ziehm Solo FD share substantially equivalent design, technology, functionality and have substantially equivalent Indications for Use.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The design of the modified Ziehm Solo FD was combleted 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 text.
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, IEC 60601-1-2, IEC 60601-2-43 and IEC 60601-2-54.
The image quality testing was performed with anthropomorphic as well as motion-induced phantoms for the analysis and comparison with the predicate system. Anthropomorphic phantoms so-called "sectional phantoms" were used and are constructed with a natural human skeleton cast inside a proprietary urethane material that has the same number as the body's soft tissue. The image comparison between the system settings of the predicate device and the optimized system settings (including 2 kimaging chain) of the modified device shows that the image quality acquired with the test device is better or at least equal. The same applies to images acquired with newly introduced 12 inch flat panel detector. Almost all images generated by the test device show more details, improved detectability and are sharper than the corresponding reference images. From a radiological point of view the image quality of the presented images that were acquired fulfil the requirements as stated by the intended use.
Software and cybersecurity testing was performed as required by "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions".
Cybersecurity testing comprises vulnerability scanning, penetration testing an static code analysis. Vulnerability scanning has been performed on the devices SBOMs and additionally using Tenable Nessus. The findings have been assessed and found acceptable. Two separate penetration tests have been conducted and displayed a good cybersecurity posture of the results from the static code analysis indicate some code locations that might benefit from a code adaption, but no stability nor any security issue could be identified that would require immediate action. The points for insequent software releases. Overall the testing activities demonstrate a good level of cybersecurity for the device, complying with the FDA requirements.
After review of the modified device Ziehm Solo FD risk control assessment, the verification activities which successfully confirmed device requirements have been fulfilled, system functionality is consistent with the user needs, intended use, and performs as designed and raises no new questions regarding either safety or effectiveness. Ziehm Imaging GmbH therefore believes the modified device Ziehm Solo FD to be substantial equivalent to the predicate device Ziehm Solo FD (K234109).