(138 days)
The Ziehm Solo is intended to provide contactless fluoroscopy Imaging, capturing, temporarily storing, and display of non-invasive x-ray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.
The Ziehm Solo Mobile Stand incorporates a single arm monitor assembly providing a more adaptable positioning of the display monintors to the clinician and the C-arm in relation to the patient. The C-profile provides fixed distance mounting of the generator and Image Intensifier and manual rotation around a non iso-centric location. The mobile stand allows the manual rotational and linear movements of the C-arm with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of patient's anatomical structures. Optional 120kV and or 20mA Fluoro operations are available. The 2.02 kW high frequency generator incorporates a single focus fixed anode x-ray tube, and high voltage generator is a single mono-block generator tube housing assembly. The virtual collimator and x-ray control mount to the generator housing assemble and provides pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The SoloCenter is a centralized touch screen providing the user/operator with a graphical user Interface including the x-ray control panel. The Ziehm Solo does not have a conventional Monitor Cart, the workstation consists of a mechanical arm assembly supporting a single or dual high-resolution flat panel LCD display monitor(s). Ceiling or wall monitors can be added by means of two external monitor connectors. Other conventional external interfaces are provided on the mobile stand for preipherial devices such as video printers, and storage devices such as USB and DVD.
This document is a 510(k) Summary for the Ziehm Solo, a Digital Mobile C-Arm X-ray system. It outlines the device's description, indications for use, contraindications, technology, user characteristics, and the standards it meets. Importantly, it emphasizes substantial equivalence to a predicate device (ZIEHM VISION2 K073346) based on non-clinical performance test data.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not specify quantitative acceptance criteria or detailed performance metrics. Instead, it relies on substantial equivalence to a predicate device and compliance with various international and federal standards. The reported "performance" is that the device meets these standards and is equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1-2 (Medical Electrical Equipment, EMC) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1-3 (Radiation Protection in Diagnostic X-ray Equipment) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-1-4 (Programmable electrical medical systems) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-2-7 (Safety of HV/X-ray Generators) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-2-28 (Safety of X-Ray Source and Tube Assemblies) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60601-2-32 (Safety of Associated X-ray Equipment) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 60825-1 (Safety of laser products) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Compliance with IEC 14971 (Risk Management) | The Ziehm Solo shall be tested and shown to meet this standard. |
| Substantial equivalence to predicate device (ZIEHM VISION2 K073346) | Performs in an equivalent manner to the predicate device and in accordance with its labeling; does not raise new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify any sample size for a test set in the context of clinical performance or diagnostic accuracy. The evaluation is based on "non-clinical performance test data" and a comparison to a predicate device. The data provenance is not explicitly stated beyond being "non-clinical performance test data" included in the submission. It does not refer to patient data or retrospective/prospective studies in the context of device performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
This information is not applicable and not provided in this document. The submission is for a fluoroscopic X-ray system, and its evaluation relies on engineering and regulatory standards compliance, along with substantial equivalence to a predicate device. There is no mention of a diagnostic accuracy study requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable and not provided. As there is no diagnostic accuracy study described, no adjudication method would be required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No MRMC comparative effectiveness study is mentioned or implied. The document focuses on the device's technical specifications and substantial equivalence to a predicate, not on improvements in human reader performance with or without AI assistance. This device is an imaging system, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The Ziehm Solo is a hardware device for X-ray imaging, not a standalone algorithm.
7. The type of ground truth used:
This information is not applicable and not provided. Given the nature of the device and the submission, there is no diagnostic accuracy study described that would require a "ground truth" in the typical sense (e.g., pathology, clinical outcomes). The evaluation focuses on meeting engineering standards and being equivalent to a predicate.
8. The sample size for the training set:
This information is not applicable and not provided. This device is not an AI/ML algorithm that would undergo a training phase with a specific dataset.
9. How the ground truth for the training set was established:
This information is not applicable and not provided. As there is no training set for an AI/ML algorithm, no ground truth establishment method is relevant.
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K0924358
Appendix 7 - 510(k) Summary Ziehm Solo
DEC 2 3 2009
The following information is being submitted in accordance with the requirements of 21 CFR §807.92
| Preparation Date: | Dec 17, 2009 |
|---|---|
| Name of Submitter: | Ziehm Imaging, Inc.4181 Latham StreetRiverside, CA 92501(951) 718-2020 |
| Contact Person: | Richard L. WestrichVice President of Regulatory Affairs and Quality Assurance4181 Latham StreetRiverside, CA 92501Office phone: +951-781-2020 ext 140Fax: +951-781-6457 |
| Device Trade Name: | Ziehm Solo |
| Classification Name: | 21 CFR 892.1650 System, X-Ray, Fluoroscopic, Image Intensifier,Product Code: JAA |
| Common/Usual Names: | Digital Mobile C-ArmMobile Surgical C-ArmMobile C-Arm |
| Predicate Device: | ZIEHM VISION2 K073346, 21CFR 892.1650, System, X-Ray, Fluoroscopic,Image Intensifier,Product Code JAA, IZL |
| Device Description: | The Ziehm Solo Mobile Stand incorporates a single arm monitor assemblyproviding a more adaptable positioning of the display monintors to the clinicianand the C-arm in relation to the patient. The C-profile provides fixed distancemounting of the generator and Image Intensifier and manual rotation around anon iso-centric location. The mobile stand allows the manual rotational and linearmovements of the C-arm with a motorized vertical movement for positioning thec-arm at various angles and distances for visualization of patient's anatomicalstructures. Optional 120kV and or 20mA Fluoro operations are available. The2.02 kW high frequency generator incorporates a single focus fixed anode x-raytube, and high voltage generator is a single mono-block generator tube housingassembly. The virtual collimator and x-ray control mount to the generatorhousing assemble and provides pulsed and continuous fluoroscopy operationsincluding a special digital radiography (snapshot) mode. The SoloCenter is acentralized touch screen providing the user/operator with a graphical user |
Interface including the x-ray control panel. The Ziehm Solo does not have a conventional Monitor Cart, the workstation consists of a mechanical arm assembly supporting a single or dual high-resolution flat panel LCD display monitor(s). Ceiling or wall monitors can be added by means of two external monitor connectors. Other conventional external interfaces are provided on the mobile stand for preipherial devices such as video printers, and storage devices such as USB and DVD.
Section 7 - 510(k) Summary
Page 1 of 3-SUM
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The Ziehm Solo is intended to provide contactless fluoroscopy Indications of Use: Imaging, capturing, temporarily storing, and display of non-invasive xray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.
Contraindications to The exposure of humans to ionizing radiation must always be medically justified. Especially when used on pregnant women, adolescents, children, the use of X-rays: and pediatric patients, all procedures using ionizing radiation should be used with caution or be avoided altogether. However, the final decision and responsibility lies with the attending physician or attending surgeon in deciding whether to use the system with such patients.
The system may only be used in heights up to 6561.7 ft (2000 m) above sea level and must be used within the limits defined by the technical specification. The use of the system is only allowed in rooms used for medical purposes in accordance 60601-1-2 with EMC class A as well as with protective earth conductor. The system may only be used in an environment with an oxygen saturation <25%. The system may only be used in faultless condition and in accordance with the terms set forth by the operating instructions.
The Ziehm Solo Employs the same fundamental scientific technology as Technology: the predicate device.
User Characteristics: The Ziehm Solo does not require nor is it intended to be used in contact with patients.
In some circumstances however, as part of its use in clinical environments the patient may come in contact with the device when operator moves or positions the device. The device is intended for use by health care professionals such as but not limited to physicians, orthopedic surgeons, vascular surgeons, neuro-vascular surgeons, radiologists, or other clinical physicians and technologists in hospitals, emergency rooms, out-patient clinics, and other clinical environments. Ziehm Imaging anticipates the device will be used on a nearly daily basis. Ziehm Imaging applications specialists and/or qualified site personnel provide on site operator training in the proper use of the device.
The Ziehm Solo mobile x-ray devices shall be tested and be shown to meet the Standards: appropriate requirements of the following standards prior to being marketed.
| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|---|---|
| IEC 60601-1, | Medical Electrical Equipment, General Requirements for Safety |
| IEC 60601-1-2 | Medical Electrical Equipment, General Requirements for Safety, Electromagnetic Compatibility |
| IEC 60601-1-3, | Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment |
Section 7 - Ziehm Solo 510(k) Summary
Page 2 of 3-SUM
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| IEC 60601-1-4, | General requirements for safety, Programmable electricalmedical systems. |
|---|---|
| IEC 60601-2-7, | Medical Electrical Equipment, Safety of HV/X-rayGenerators (FDA/CDRH Recognition Number 12-34: IEC60601-2-7 (1998), Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltagegenerators of diagnostic X-ray generators. (Radiology)) |
| IEC 60601-2-28, | Medical Electrical Equipment Part 2: ParticularRequirements for the Safety of X-Ray Source Assembliesand X-Ray Tube Assemblies for Medical Diagnosis |
| IEC 60601-2-32, | Medical Electrical Equipment, Safety of Associated X-rayEquipment |
| IEC 60825-1, | Safety of laser products, Equipment Safety, requirements,and user guide |
| IEC 14971 | Risk Management |
Determination of Substantial Equivalence:
The demonstration of substantial equivalence is based on a comparison of features to the predicate device and an assessment of non-clinical performance test data. Information is included with this submission that supports this determination.
The comparison table of the predicate device in Appendix 3 and the Performance Conclusion: testing, Clinical Evaluation Addendum, and Clinical Evaluation Ziehm Vision Family included in Appendix 5 demonstrates that the Ziehm Solo does not raise new questions of safety or effectiveness and performs in an equivalent manner to the predicate device and in accordance with its labeling.
End of 510(k) Summary
Richard L. Westrich Vice President Regulatory Affairs and Quality Assurance Ziehm Imaging, Inc. 4181 Latham St. Riverside, CA 92501
Section 7 - Ziehm Solo 510(k) Summary
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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
· Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
DEC 2 3 2009
Mr. Richard L. Westrich V. P. Regulatory Affairs & Quality Assurance Ziehm Imaging, Inc. Division of Ziehm LLC (based in the USA) 4181 Latham Street RIVERSIDE CA 92501
Re: K092438
Trade/Device Name: Ziehm Solo Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: October 29, 2009 Received: November 9, 2009
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.
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
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Page 2 -
Enclosure
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
Applicant: Ziehm Imaging, Inc.
K092438 510(k) Number (if known):
Device Name: Ziehm Solo
Indications for Use:
The Ziehm Solo is intended to provide contactless fluoroscopy Imaging, capturing, temporarily storing, and display of non-invasive x-ray imaging of the patient using pulsed and continuous fluoroscopy, during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care, and emergency room fluoroscopy procedures. Radiographic film examinations can be made with an accessory cassette device when attached to the Image Intensifier. This device does not support and is not intended for use in performing mammographic imaging.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | AND/OR | Over-The-Counter Use | |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) | ||
| (Division Sign-OffDivision of Reproductive, Abdominal, | |||
| and Radiological Devices 7510(k) Number_ | 1097438 |
§ 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.