(168 days)
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imuging, as well as digital subtraction and cine image capture during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required, such procedures may included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional electrophysiology, angiography, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic ficids. The visualization of such unatomical 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.
The ZIEIIM VISION RFD Mobile Stand incorporates a small compact design making the positioning of the c-arm in relation to the patient easier for the operator. The C-profile provides fixed distance mounting of the generator and Flat-panel Detector (SSXI) and manual rotation around a non iso-centric location. The mobile stand allows manual rotational and linear movements with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of pation's anatomical structures. The high frequency generator with dual focus rotating anode x-ray lube, advanced active cooling, x-ray control, are assembled in one housing in a single mono-block generator tube housing assembly, with the virtual collimator mounting to the housing assemble. The Zichm Vision RFD can have one of the following two generators 7.5 kW or optional 20 kW. They both provide pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The VisionCenter is a ccuralized touch screen panel providing the uscr/operator with a clear graphicul user Interface including the xray control panel. The ZIEHM VISION RFD Monitor Cart workstation consists of a mechanical cart assembly, supporting dual high-resolution flat panel LCD display monitors and interfaces are provided for preinherial devices such as external monitors, video printers, injectors and storage devices (USB, DVD).
This K083545 submission pertains to a conventional medical device (X-ray system), not an AI/ML-driven device. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (like sensitivity, specificity, or reader studies) is not directly applicable.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices by complying with established performance standards for X-ray systems and ensuring safety and effectiveness.
Here's how the provided information relates to your request, interpreted for a conventional medical device submission:
1. A table of acceptance criteria and the reported device performance
The document lists several international and federal standards that the device must meet. These standards themselves define the "acceptance criteria" for various aspects of the X-ray system's performance, safety, and electromagnetic compatibility. The "reported device performance" is implicitly that the device has been tested and shown to meet all applicable requirements of these standards.
| Acceptance Criteria (Standard) | Reported Device Performance (Implied) |
|---|---|
| 21 CFR 1020.30-32 (Federal Performance Standard for Diagnostic X-ray Systems) | Device has been tested and shown to meet these requirements. |
| 93/42/EEC - Annex II (EC directive of the Medical Devices Directive) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1 (Medical Electrical Equipment, General Requirements for Safety) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1-2 (Medical Electrical Equipment, Electromagnetic Compatibility) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1-3 (Medical Electrical Equipment, Radiation Protection in Diagnostic X-ray Equipment) | Device has been tested and shown to meet these requirements. |
| IEC 60601-1-4 (General requirements for safety, Programmable electrical medical systems) | Device has been tested and shown to meet these requirements. |
| IEC 60601-2-7 (Medical Electrical Equipment, Safety of HV/X-ray Generators) | Device has been tested and shown to meet these requirements. |
| IEC 60601-2-28 (Medical Electrical Equipment, Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnosis) | Device has been tested and shown to meet these requirements. |
| IEC 60601-2-32 (Medical Electrical Equipment, Safety of Associated X-ray Equipment) | Device has been tested and shown to meet these requirements. |
| IEC60601-2-43 (Particular requirements for the safety of X-Ray equipment for interventional procedures) | Device has been tested and shown to meet these requirements. |
| IEC 60825-1 (Safety of laser products, Equipment Safety, requirements, and user guide) | Device has been tested and shown to meet these requirements. |
| IEC 14971 (Risk Management) | Device has been tested and shown to meet these requirements. |
The study that "proves the device meets the acceptance criteria" in this context would be the detailed testing and verification reports that demonstrate compliance with each listed standard. These reports are typically part of the full 510(k) submission, though not fully detailed in this summary. The summary concludes that the device "shall be tested and be shown to meet the appropriate requirements of the following standards prior to being marketed," implying that these tests were conducted and compliance was achieved.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable and therefore, not provided in this 510(k) summary for a conventional X-ray system. These details are pertinent to AI/ML diagnostic or prognostic devices that analyze medical images or data. For an X-ray machine, the "test set" would be the physical device itself undergoing engineering and performance tests according to the standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable to this type of device. "Ground truth" for an X-ray machine's performance involves objective physical measurements (e.g., radiation output, image resolution, dose levels) evaluated against engineering specifications and regulatory standards, not expert clinical interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this type of device. Adjudication methods are relevant in clinical studies where human interpretation of medical data is being evaluated, particularly for AI/ML devices.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable to this type of device. MRMC studies are specific to evaluating the clinical impact of AI/ML systems on human reader performance. This submission is for the X-ray imaging hardware itself.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable to this type of device. "Standalone" performance refers to AI algorithms operating independently, which is not the function of an X-ray machine.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As mentioned, "ground truth" for this device refers to objective physical and technical specifications and compliance with regulatory standards. For example, the accuracy of the X-ray tube output, the resolution of the flat-panel detector, radiation leakage, and electrical safety are all measured against defined engineering and regulatory benchmarks.
8. The sample size for the training set
This is not applicable to this type of device. A "training set" is used in the development of AI/ML algorithms, not for the manufacturing and testing of conventional medical hardware.
9. How the ground truth for the training set was established
This is not applicable to this type of device.
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Section 7 - 510(k) Summary
The following information is being submitted in accordance with the requirements of 21 CFR §807.92
Date: April 30, 2009
Name of Submitter:
Ziehm Imaging, Inc. 4181 Latham Street Riverside, CA 92501 (951) 718-2020
Contact Person:
Richard L. Westrich Vice President of Regulatory Affairs and Quality Assurance 4181 Latham Street Riverside, CA 92501 Office phone: +951-781-2020 ext 140 Fux: +951-781-6457
Device Proprietary Name:
Zichm Vision RFD
Clussification Name:
Regulation Description: System, X-Ray, Fluoroscopic, Image Intensifier, Product Code: JAA Regulation number: 892.1650 Subsequent Product Code: MOB Regulation number: 892.1650
Common/Usual Names:
Digital Mobile C-Arm Mobile Surgical C-Arm Mobile C-Arm
Substantial Equivalence:
The ZIEHM VISION RFD mobile c-arm has been found to be subsumially equivalent to the following current legally marketed devises.
- Zichmi Imaging, ZIEHM VISION R K061203 Product Code JAA & IZL .
- ZIEHM VISION2 FD K073346 Product Code JAA, MQB & IZL Zichm Imaging,
These devices are mobile C-arm type x-ray systems intended for fluoroscopic imaging. The systems include high-voltage x-ray generator, and can control, fixed anode and rotating x-ray tubes, Flat-panel Detector SSXI, or Image Intensifier, and monitor cart/workstations with video image displays, digital image processing and image storage capability, as well as image export functionality.
Section 7 - 510(k) Summary
Page 1 of 3-SUM
MAY 15 2009
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Device Description:
Indications for Use
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital inaging, as well as digital subtraction and cine image caplure during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density arc required, such procedures may included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional angiography, electrophysiology, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical carc, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine und joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic fields. The visualization of such anatomical structures assists the clinical outcome. At the discrction of a plysiciun 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.
User Characteristics
The ZIEHM VISION RFD docs 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 is intended for use by health care professionals such as but not limited to physicians, orthopedic surgeons, vascular surgeons, neuro-vascular surgeous, cardiologists, 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.
General Description
The ZIEIIM VISION RFD Mobile Stand incorporates a small compact design making the positioning of the c-arm in relation to the patient easier for the operator. The C-profile provides fixed distance mounting of the generator and Flat-panel Detector (SSXI) and manual rotation around a non iso-centric location. The mobile stand allows manual rotational and linear movements with a motorized vertical movement for positioning the c-arm at various angles and distances for visualization of pation's anatomical structures. The high frequency generator with dual focus rotating anode x-ray lube, advanced active cooling, x-ray control, are assembled in one housing in a single mono-block generator tube housing assembly, with the virtual collimator mounting to the housing assemble. The Zichm Vision RFD can have one of the following two generators 7.5 kW or optional 20 kW. They both provide pulsed and continuous fluoroscopy operations including a special digital radiography (snapshot) mode. The VisionCenter is a ccuralized touch screen panel providing the uscr/operator with a clear graphicul user Interface including the xray control panel. The ZIEHM VISION RFD Monitor Cart workstation consists of a mechanical cart assembly, supporting dual high-resolution flat panel LCD display monitors and interfaces are provided for preinherial devices such as external monitors, video printers, injectors and storage devices (USB, DVD).
Section 7 - 510(k) Summary
Page 2 of 3-SUM
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Standards:
The ZIEHM VISION RFD mobile x-ray devices shall be tested and be shown to mcct the appropriate requirements of the following standards prior to being marketed.
| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems |
|---|---|
| 93/42/EEC - | Annex II of EC directive of the Medical DevicesDirective (MDD) |
| 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 DiagnosticX-ray Equipment |
| IEC 60601-1-4, | General requirements for safety, Programmable electricalmedical systems. |
| IEC 60601-2-7, | Medical Electrical Equipment, Safety of HV/X-rayGenerators |
| 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 |
| IEC60601-2-43, | Particular requirements for the safety of X-Rayequipment for interventional procedures. |
| IEC 60825-1, | Safety of laser products, Equipment Safety, requirements, anduser guide |
| IEC 14971 | Risk Management |
Conclusion:
The ZIEHM VISION RFD does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed devices Zichm Vision2 FD (K073346) and Ziehm Vision R (K061203)
End of 510(k) Summary
Section 7 - 510(k) Summary
Page 3 of 3-SUM
Richard L. Westrich Vice President Regulatory Affairs and Quality Assurance Zichm Imaging, Inc.
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Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a blue emblem on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The emblem features a stylized human figure within a circle, and the text is written in a clear, sans-serif font.
Public Health Service
JUL 30 2012
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Richard Westrich V. P. Regulatory Affairs and Quality Assurance Ziehm Imagine, Inc. 4181 Latham Street RIVERSIDE CA 92501
Re: K083545 Trade/Device Name: ZIEHM VISION RFD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB and JAA Dated: March 25, 2009 Received: April 6, 2009
Dear Mr. Westrich:
This letter corrects our substantially equivalent letter of May 15, 2009.
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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/5/Picture/0 description: The image contains the logo and name of a company called "ziehm imaging". The logo is a circular design with a stylized figure inside. The text "ziehm imaging" is written in a simple, sans-serif font to the right of the logo.
Indications for Use Statement
Applicant:
Zichm Imaging, Inc.
510(k) Number (if known):
Device Name:
ZIEHM VISION RFD
Indications for Use:
The ZIEHM VISION RFD is intended for use in providing medical imaging, using pulsed and continuous fluoroscopic digital imuging, as well as digital subtraction and cine image capture during diagnostic interventional, and surgical procedures where intra-operative imaging and visualization of complex anatomical structures of both lower and higher contrast density are required, such procedures may included but are not limited to those of interventional cardiology, heart surgery, hybrid procedures, interventional radiology, interventional electrophysiology, angiography, pediatrics, endoscopic, urological, gastroenterology, orthopedic, maxillofacial surgery, neurology, neurosurgery, critical care, emergency room procedures, and those procedures visualizing structures of the cervical, thoracic, and lumber regions of the spine and joint fractures of the upper and lower extremities, and where digital image data is required for computer aided surgery procedures and whenever the clinician benefits from the high degree of geometric imaging accuracy, and where such fluoroscopic, cine and DSA imaging is required in and around high magnetic ficids. The visualization of such unatomical 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
loam mwham
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Device 510(k) Number
April 29, 2009
Page 1 of 1
§ 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.