(265 days)
The Ziehm 8000 mobile C-arm is intended for use in providing medical imaging for general populations. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction of cine loops during diagnostic, interventional and surgical procedures requiring X-ray imaging both inside and outside the operating room. Examples of clinical application may include cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy procedures.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
The Ziehm 8000 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 Image Intensifier. 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. A user keyboard provides for concise user selectable anatomical programs and X-ray technique control. Integrated high-resolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports a cable bound fluoroscopic footswitch. The optional interface panel of the Ziehm 8000 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.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
The document (510(k) K190497 for the Ziehm 8000) does not explicitly state "acceptance criteria" in a quantitative table format that is separate from the "reported device performance." Instead, it focuses on demonstrating substantial equivalence to a predicate device (Ziehm Quantum K051064) by comparing technological characteristics and overall performance. The "acceptance" is implied by demonstrating that the new device is either identical, similar, or improved in ways that do not raise new safety or effectiveness concerns compared to the predicate.
Given this, I will construct a table that reflects the comparison of features, where the predicate's performance or characteristic serves as the de facto "acceptance criteria" for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Characteristic | Acceptance Criteria (Predicate: Ziehm Quantum K051064) | Reported Device Performance (Ziehm 8000) | Comparison to Predicate / Comments |
|---|---|---|---|
| General Design | Mobile Stand, Imaging & Display System | Mobile Stand, Imaging & Display System (on monitor cart) | Same general design; monitor cart (workstation) supports imaging/display but functionality is essentially the same. No new safety/effectiveness concerns. |
| Intended Use | Same as described in K051064 | Provides medical imaging for general populations; contactless fluoroscopic image capture, temporary storage, display of digital subtraction, cine loops during diagnostic, interventional, surgical procedures requiring X-ray imaging. Examples: cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, neurologic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy. No direct radiographic film exposures or mammography. | Identical. |
| Product Codes | OWB, OXO, JAA | OWB, OXO, JAA | Identical. |
| Regulation Number | 21CFR 892.1650 | 21CFR 892.1650 | Identical. |
| X-ray Generator/Tube | Monoblock technology | Monoblock technology | Identical. |
| KV Range | 40-110 kV | 40-110 kV | Identical. |
| Max Power Output | 2.2 kW | 2.2 kW | Identical. |
| Fluoroscopy Output | up to 660 W | up to 605 W | Similar output rating. No new safety/effectiveness concerns. |
| Collimator/Beam Limiter | Yes, +/ - 90 deg rotation, Iris | Yes, +/ - 90 deg rotation, Iris, Virtual Collimation | Ziehm 8000 has new virtual collimator function which may help reduce dose. No new safety/effectiveness concerns. |
| I.I. Size | I.I. Cesium Iodide 23cm | I.I. Cesium Iodide 23cm | Identical. |
| Image Intensifier DQE | 65% | ≥61% | Not identical, but similar image receptor technology. No new safety/effectiveness concerns. |
| Image Intensifier Contrast | 30:1 | 27:1 | Not identical, but similar image receptor technology. No new safety/effectiveness concerns. |
| I.I. Magnification Modes | 15cm | 15cm and 10cm | Ziehm 8000 offers more modes (10cm). No new safety/effectiveness concerns. |
| FPD FOV | Round FOV | Round FOV | Identical. |
| Camera Matrix | 768 x 494 pixels | 1024 x 1024 pixels | Ziehm 8000 resolution provides slightly better image quality. No new safety/effectiveness concerns. |
| Grayscale | 12 bit (4,096 shades of gray) | 12 bit (4,096 shades of gray) | Identical. |
| Removable Anti-Scatter Grid | No | Yes | Allows removal to lower skin dose in certain imaging protocols. No new safety/effectiveness concerns. |
| Image System Display | 1k x 1k | 1k x 1k | Identical. |
| Recursive Noise Filtering | Yes | Yes | Identical. |
| Image Post Processing | Yes | Yes | Identical. |
| Post-Processing Functions | Edge enhancement (4 levels), Zoom (2 levels), rotation, windowing, inversion | Edge enhancement (5 levels), Zoom (6 levels), rotation, windowing/step windowing, inversion | Ziehm 8000 has updated range of edge enhancement and digital magnification as improvement. No new safety/effectiveness concerns. |
| Digital Memory Storage | up to 10,000 images (option: 20,000) | 150,000 images | Ziehm 8000 has larger storage capacity; other memory specs (matrix, processing) similar. No new safety/effectiveness concerns. |
| Archiving External Media | Video printer port, USB port, USB DVD-RW drive | Video Printer (option), USB port (option), DVD/CD-RW drive (option) | Identical user available options for printer and multi film/paper archiving. |
| AERC Dose Control | Yes | Yes | Identical. |
| DICOM Functionality | Yes | Yes | Identical. |
| TFT Flat Screen Displays | Yes | Yes | Identical. |
| Air Kerma Meter | Calculated Air Kerma, Rate mGy/min, Cumulative mGy | Calculated Air Kerma, Rate mGy/min, Cumulative mGy | Identical. |
| SID | 97 cm | 95 cm | Very similar. No new safety/effectiveness concerns. |
| Vertical Free Space | 76 cm | 75 cm | Not identical, but does not raise new safety/effectiveness concerns. |
| C-arm Depth | 68 cm | 68 cm | Identical. |
| C-arm Width | 80 cm | 80 cm | Identical. |
| C-arm Length | 160 / 182 cm | 162 / 184 cm | Identical. |
| C-arm Height | 170 / 214 cm | 174 / 216 cm | Identical. |
| Manually Operated A-Axis | +/- 225° (450°) | +/- 225° (450°) | Identical. |
| Manually Operated B-Axis | +/- 10° (20°) | +/- 10° (20°) | Identical. |
| Manually Operated C-Axis | -90° / +45° (135°) | -90° / +45° (135°) | Identical. |
| Manually Operated Y-Axis | 22 cm | 22 cm | Identical. |
| Motor Driven Z-Axis | 43 cm | 42 cm | Not identical, but does not raise new safety/effectiveness concerns. |
| Weight | Mobile & Monitor Support: Max 264 kg (580 lbs) | Mobile Stand: max. 286 kg (629 lbs); Monitor Cart: max. 122 kg (286 lbs) | Similar in mechanical weight for the mobile stand portion of the device. No new safety/effectiveness concerns. |
| Applicable Standards | UL/IEC 60601-1:1995, IEC 60601-1-2:2001, etc. | ANSI/AAMI ES60601-1:2012, IEC 60601-1-2:2014, IEC 60601-1-3:2008 + A1:2013, IEC 60601-2-43:2010, IEC 60601-2-54:2009, IEC 60825-1:2007, ISO 14971:2007, etc. | Use of same (updated versions) standards for both devices. Compliance to FDA recognized consensus standards is presented. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document indicates that anthropomorphic (PMMA material) phantoms and anatomical simulation phantoms were used. It does not specify an exact number of phantoms or image sets, but states that "image comparison sets taken were representative of both the adult and pediatric populations." It refers to "individual image sets" being assessed.
- Data Provenance: The data was generated through non-clinical imaging and dose testing methods conducted in a lab setting by Ziehm Imaging GmbH. The document does not specify a country of origin for the data (beyond Ziehm Imaging GmbH being a German company and Ziehm Imaging, Inc. being in Orlando, FL), but it is implied to be internal testing. The study was retrospective in the sense that it compared the new device's performance to the existing predicate.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: One expert was used.
- Qualifications of Expert: A board-certified Radiologist performed the assessment of individual image sets. No specific number of years of experience is provided.
4. Adjudication Method for the Test Set
- The adjudication method was "none" in the sense of a multi-reader consensus process. The document states, "A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm 8000 results in a comparable patient care to the Predicate device (K051064)." This suggests a single expert's opinion formed the basis of the conclusion regarding image quality comparison.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focused on technical comparisons and the assessment of image quality by a single radiologist using phantom data.
- Effect Size of Human Readers: Not applicable, as no MRMC study was performed with human readers using AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Yes, a standalone performance study was done, but it's important to clarify the context. The "device" in this case is a fluoroscopic X-ray system, which is hardware, not an AI algorithm. The performance evaluation was of the imaging system as a whole (X-ray monoblock generator, image intensifier, software for image processing/control). The "algorithm" aspect would refer to the device's inherent image processing capabilities. The comparison included non-clinical imaging and dose testing, evaluating the device's ability to provide reduced dose while maintaining image quality compared to the predicate, and confirming it met design inputs and user needs.
7. Type of Ground Truth Used
- The ground truth was established through expert assessment (Radiologist's conclusion) of images derived from anthropomorphic and anatomical simulation phantoms, alongside objective laboratory performance data (e.g., DQE, Contrast Ratio, Camera Matrix, dose measurements). The comparison was anchored to the performance of the legally marketed predicate device.
8. Sample Size for the Training Set
- The document does not specify a training set sample size. This is expected for a traditional medical device (like an X-ray system) rather than an AI/Machine Learning device that undergoes explicit "training." The device's "software architecture design is nearly identical" to the predicate, with modifications for "lower dose functionality, processing applications related to the optional low dose range, image, Variable beam limiting device, and device specific features." These refer to software features and processing rather than a learned AI model.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there's no mention of an explicit AI/ML component with a training set, the concept of a "ground truth for the training set" does not apply in the context of this 510(k) submission for the Ziehm 8000. The device's performance was evaluated against physical and historical (predicate) benchmarks.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2019
Ziehm Imaging GmbH % Steve Seeman Director of Regulatory Affairs and Quality Assurance Ziehm Imaging, Inc. 6280 Hazeltine National Drive ORLANDO, FL 32822
Re: K190497
Trade/Device Name: Ziehm 8000 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, OXO Dated: October 16, 2019 Received: October 18, 2019
Dear Steve Seeman:
We have reviewed vour 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. 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 located 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.
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
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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 803) for devices or post-marketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Michael D. O'Hara
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure
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Indications for Use
510(k) Number (if known) K190497
Device Name Ziehm 8000
Indications for Use (Describe)
The Ziehm 8000 mobile C-arm is intended for use in providing medical imaging for general populations. The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction of cine loops during diagnostic, interventional and surgical procedures requiring X-ray imaging both inside and outside the operating room. Examples of clinical application may include cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy procedures.
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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Image /page/3/Picture/1 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized human figure inside of a globe-like structure.
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
Oct 06, 2019
In accordance with 21 CFR §807.92 the following 510(k) summary information is provided:
| Submitter Address: | Ziehm Imaging GmbHDonaustrasse 3190451 NurembergGermany |
|---|---|
| Primary Contact Person /Agent: | Steve SeemanDirector of Regulatory Affairs and Quality AssuranceZiehm Imaging, Inc.E-Mail: Steve.Seeman@Ziehm.com |
| Secondary Contact Person: | Stefan FiedlerDirector QM/RAZiehm Imaging GmbH |
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Image /page/4/Picture/1 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, next to the company name "ziehmimaging" in a teal-colored font. The font color appears to transition from a lighter teal to a darker teal from left to right.
| Device (Trade Name): | Ziehm 8000 |
|---|---|
| 510(k) Number: | unknown |
| Common /Usual Names: | Mobile Fluoroscopic C-Arm |
| Regulation number: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, JAA, OXO |
| Predicate Device: | Ziehm Quantum (K051064) |
| Regulation number: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
| Device: | Interventional fluoroscopic x-ray system |
| Product Code: | OWB, JAA, OXO |
| General Description: | The Ziehm 8000 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 Image Intensifier. 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. A user keyboard provides for concise user selectable anatomical programs and X-ray technique control. Integrated highresolution flat panel display monitors directly mounted on the monitor cart providing the clinician with a precise angle for visualization of live fluoroscopic images of the patient's anatomy. This visualization helps to localize regions of pathology for surgical procedures. The mobile stand supports a cable bound fluoroscopic footswitch. The optional interface panel of the Ziehm 8000 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.
- The Ziehm 8000 is a mobile C-arm providing image data Intended Use by means of a non-contact noninvasive x-ray technique during medical procedures and stores them
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Image /page/5/Picture/0 description: The image shows the text 'K190497' in a simple, sans-serif font. The text is black against a white background, providing a clear contrast. The alphanumeric string appears to be a code or identifier.
Image /page/5/Picture/1 description: The image contains the word "imaging" in a stylized font. The word is in a teal color, and it appears to be part of a larger logo or brand name. To the left of the word is a circular graphic with a human figure inside.
temporarily.
The system can be used for all medical indications where fluoroscopy is required.
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 system is intended for use with human bodies covering structures such as but not limited to the following, e.g. organs, tissue, bones, implants depending on the medical indication.
Indications for Use: The Ziehm 8000 mobile C-arm is intended for use in providing medical imaging for general populations. 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 or guidance procedures requiring X-ray imaging both inside and outside the operating room. Examples of clinical application may include cholangiography, endoscopic, urologic, lithotripsy, cardiac, orthopedic, neurologic, vascular, pain management, angiographic, critical care, and emergency room fluoroscopy procedures.
This device does not support direct radiographic film exposures and is not intended for use in performing mammography.
- Technology: The proposed modified device Ziehm 8000 C-arm employs the same fundamental control, and scientific technology as that of our predicate device Ziehm Quantum C-arm (K051064).
The radiation control, X-Ray monoblock generator, power supplies as well as our advanced imaging system are very similar to the predicate device Ziehm Quantum C-arm (K051064).
Software architecture design is nearly identical to that of the predicate device Ziehm Quantum C-arm (K051064)
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Image /page/6/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, next to the company name "ziehmimaging" in a teal, serif font. The overall design is clean and professional.
with modification of the software to support, lower dose functionality, processing applications related to the optional low dose range, image, Variable beam limiting device, and device specific features.
The primary modifications of the C-Arm include a larger but virtually the same medical grade Image receptor as that of the predicate device Ziehm Quantum C-arm (K051064), virtual beam limiting device for precise collimating to anatomical structures, new pre-filter for lower skin entrance dose imaging, incorporation of mechanical design improvements in the C-Arm and mobile workstation balancing, locks, and maneuverability improving operator workflow during extended procedures while keeping the essential profile of our predicate device Ziehm Quantum C-arm (K051064)
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Image /page/7/Picture/1 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 text and graphic are in a teal color.
Summary of Technological Characteristics:
The comparisons of the technological characteristics of the proposed device Ziehm 8000 C-Arm to that of the predicate device demonstrates that the scientific and technology characteristics are substantial equivalence to the predicate device Ziehm Quantum C-arm (K051064)
| DifferencesFeatures/Technology | Subject DeviceZiehm 8000 | Predicate DeviceQuantum (K051064) | Comparison toPredicate, Commentsto Differences |
|---|---|---|---|
| The new Ziehm 8000and the predicateZiehm Quantum(K051064) share thesame general design ofthe Mobile Stand.The new Ziehm 8000 incomparison to thepredicate has a monitorcart (workstation)which supports theimaging and displaysystem. Functionality isessentially the same forimaging and display.They also share asubstantial equivalencewith regard to but notlimited to the intendeduse, operationalfunctionality of imaging,use of a mono blockgenerator, radiation doscontrol, user interfacecontrol keyboards, 2Dimaging acquisition,general dimensionalfeatures, scientifictechnologies, safety, andeffectiveness.These changes do notraise new safety oreffectiveness concerns. | |||
| Mobile fluoroscopic c-arm | Yes | Yes | Identical |
| Product Codes | OWB, OXO, JAA | OWB, OXO, JAA | Identical |
| Classification | 21CFR 892.1650 | 21CFR 892.1650 | Identical |
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Image /page/8/Picture/1 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular emblem on the left and the text "ziehmimaging" on the right. The emblem features a stylized human figure inside a circle with orbital lines, and the text is in a teal color.
| Mobile stand |
|---|
| Control Elements |
| Touch Panel |
Control Panel on Mobile Stand:
Image /page/8/Picture/4 description: The image shows a close-up of the top portion of a medical device, likely an anesthesia machine or similar equipment. The control panel is visible, featuring a digital display with numerical readouts and various buttons with iconographic labels. An emergency stop button is located on the left side of the panel, and handles are attached on both sides for easy maneuverability. The device appears to be well-maintained and designed for precision control in a medical setting.
Control Panel on Monitor Cart:
Image /page/8/Picture/6 description: The image shows a control panel with a variety of buttons and symbols. The panel is light blue and has a grid of small, square buttons at the top, each with a different symbol. There are also larger buttons on the right side of the panel, some of which are green and orange. In the center of the panel, there is a logo that says "Ziehm Imaging".
Electrical Requirements
| • Power supply: |
|---|
| 100-240 VAC (± 10%) |
| 50/60 Hz |
| • Current consumption: |
Current consumption: 100-120 V: 14 A continuous, 22 A shorttime 200-240 V: 10 A continuous, 16 A shorttime
- Max. impedance: 100-120 V: ≤ 0.3 Ω 200-240 V: ≤ 0.6 Ω
- · Class I equipment, Type B
| X-ray generator and tube Yes,housing assemblymonoblock technology | Yes | |
|---|---|---|
| KV Range 40-110 kV | Yes | Yes |
| Max power output | 2.2 kW | 2.2 kW |
| Fluoroscopy:Output | up to 605 W | up to 660 W |
| Collimator/beam limitershutters | Yes | Yes |
| • Collimator Rotation,+/- 90° and IrisCollimator | ||
| Virtual collimation | Yes | No |
Control Panel on Mobile Stand:
Image /page/8/Picture/14 description: The image shows a control panel with various buttons and digital displays. The left display reads "75 37 0.1", while the right display reads "88 0.1 0.00". The panel also features an array of buttons with different symbols and functions, arranged in a grid-like pattern on both sides of the displays. The panel is light blue and has a white handle in the center.
Touch control panel "DeskView" on Mobile Stand:
Image /page/8/Picture/16 description: The image shows a close-up of a medical imaging device, likely a C-arm X-ray system. The focus is on the control panel and display screen, which shows a grayscale image, possibly an X-ray or fluoroscopic image. The device has a white and light blue color scheme, and the image is well-lit, highlighting the details of the equipment.
- · Power supply: 120/240 Vac (± 10%), 50/60 Hz Current consumption: . 12 A continuous, 30 A
- short-time • Max. impedance:
< 0.6 Ω Class I equipment, Type B The general user interface of Ziehm 8000 and the predicate is identical. Both devices have a control panel on the Mobile Stand which allows the control of all device functionalities. Quantum has user touch interface which mimics the same functions as the keyboard. These changes do not raise new safety or effectiveness concerns. Although not identical
the electrical specifications are similar for the predicate and Ziehm 8000. The new device provides the same Class I Equipment, Type B electrical safety.
When reviewed by Ziehm this change does not add any additional risk or change the intended or indication for use to predicate. These changes do not raise new safety or effectiveness concerns. Identical
Identical
Identical
Similar output rating of fluoroscopic power These changes do not raise new safety or effectiveness concerns. Identical
Ziehm 8000 has a new collimator function compared to the
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Image /page/9/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a figure inside of a circle with lines around it. The company name is written in a teal color.
| predicate ZiehmQuantum K051064. Thevirtual collimatorprovides pre location ofcollimator edge in theimage. May help reducedose.These changes do notraise new safety oreffectiveness concerns. | |||
|---|---|---|---|
| X-ray Image ReceptorSize | I.I. Cesium Iodide23cm | I.I./cesium iodideØ 23 cm | Identical |
| Image Detector(Image Intensifier) | Image Intensifier tubeType: Cesium-Iodide (Csl)DQE (IEC): ≥61%Contrast ration: 27:1 | Image Intensifier tubeType: Cesium-Iodide (Csl)DQE (IEC): 65%Contrast ration: 30:1 | Although they are notidentical the predicateand new Device Ziehm8000 provide Similarimage receptortechnologyThese changes do notraise new safety oreffectiveness concerns. |
| I.I. Sizes MagnificationModes | 15cm and 10cm | 15cm | Predicate ZiehmQuantum K051064 couldonly provide a singleImage receptor size.These changes do notraise new safety oreffectiveness concerns. |
| FPD FOV | Round FOV | Round FOV | Identical |
| Camera Matrix | 1024 x 1024 pixels | 768 x 494 pixels | Although the resolutionof the Ziehm 8000provides slightly betterimage quality Than thepredicate.These changes do notraise new safety oreffectiveness concerns. |
| Grayscale: | 12 bit (4,096 shades ofgray) | 12 bit (4,096 shades of gray) | Identical |
| Removable anti-scattergrid | Yes | No | Although the resolutionof the Ziehm 8000provides slightly betterimage quality Than thepredicate. it wasimplemented to allowremoval to lower skindose in certain imagingprotocols.These changes do notraise new safety oreffectiveness concerns. |
| Image System Display | 1k x 1k | 1k x 1k | Identical |
| Recursive NoiseFiltering | Yes | Yes | Identical |
| Image Post Processing | Yes | Yes | Identical |
| Post-ProcessingFunctions | • Edge enhancement: 5levels• Zoom: 6 levels• Image rotation• Windowing and stepwindowing• Grayscale inversion | • Edge enhancement: 4levels• Zoom: 2 levels• Image rotation• Windowing/ leveling• Grayscale inversion | Although not Identicalthe Ziehm 8000 andpredicate have similarfeatures of postprocessing. Ziehm 8000has an updated rangeof edge enhancementand digital imagemagnification asimprovement.These changes do notraise new safety oreffectiveness concerns. |
| Digital Memory | • Storage capacity:150,000 images• Memory matrix:1,024 x 1,024 pixels• Image matrix:1,024 x 1,024 pixelsDigital image processing:16 bit | • Storage capacity:up to 10,000 images(option: 20,000 images)• Memory matrix:1,024 x 1,024 pixels• Image matrix:1,024 x 1,024 pixelsDigital image processing:16 bit | Although not Identicalthe Ziehm 8000 imagestorage capacity islarger the rest of thememory specificationare similar in imagematrix and imageprocessing of 16 bits.These changes do notraise new safety oreffectiveness concerns. |
| Archiving ExternalMedia | • Video Printer (option):paper / film, paper• USB port (option)• DVD/CD-RW drive(option) | • Video printer port• USB port• USB DVD-RW drive | Identical user availableoption for printer andmulti film/paperarchiving capabilities. |
| AERC Dose controlsystem | Yes | Yes | Identical |
| DICOM functionalityincluding RSDR | Yes | Yes | Identical |
| TFT Flat Screen Displays | Yes | Yes | Identical |
| Monitor Cart | Yes | No | Identical |
| Monitor support | Yes, integrated onmonitor cart | Yes, integrated on mobilestand | Identical |
| Air Kerma meter | • Calculated Air Kerma• Air Kerma ratemGy/min:• Air Kerma CumulativemGy | • Calculated Air Kerma• Air Kerma Rate mGy/min• Air Kerma cumulativemGy | Identical |
| Source-ImageReceptor Distance(SID) | 95 cm | 97 cm | Although not identicalthe SID is very similarand does not raise newsafety or effectivenessconcerns |
| Vertical Free Space | 75 cm | 76 cm | Although free spaceis not identical to thepredicate K190497the new device |
| raise new safety oreffectivenessconcerns | |||
| C-arm Depth | 68 cm | 68 cm | Identical |
| Width | 80 cm | 80 cm | Identical |
| Length | 162 / 184 cm | 160 / 182 cm | Identical |
| Height | 174 / 216 cm | 170 / 214 cm | Identical |
| Manually OperatedA-Axis (angulation) | +/- 225° (450°) | +/- 225° (450°) | Identical |
| Manually OperatedB-Axis(swiveling) | +/- 10° (20°) | +/- 10° (20°) | Identical |
| Manually OperatedC-Axis (orbital) | -90° / +45° (135°) | -90° / +45° (135°) | Identical |
| Manually OperatedY-Axis (horizontal) | 22 cm | 22 cm | Identical |
| Motor DrivenZ-Axis (vertical) | 42 cm | 43 cm | Although Drive Z-Axis is not identicalto the predicateK190497 the newdevice Ziehm 8000does not raise newsafety oreffectivenessconcerns |
| Weight | Mobile Stand: max. 286 kg(629lbs)Monitor Cart: max. 122kg (286lbs) | Mobile & Monitor Support:Max 264 kg(580lbs) | Although not exactlythe same they aresimilar in mechanicalweight for the mobilestand portion of thedevice.These changes do notraise new safety oreffectiveness concerns |
| Standards met | • ANSI/AAMI ES60601-1:2012• IEC 60601-1-2:2014• IEC 60601-1-3:2008 +A1:2013• IEC 60601-2-43:2010• IEC 60601-2-54:2009• IEC 60825-1:2007ISO 14971:2007 | • UL/IEC 60601-1:1995• IEC 60601-1-1:1995• IEC 60601-1-2:2001• IEC 60601-1-3:1994• IEC 60601-1-4:1999• IEC 60601-2-7:1998• IEC 60601-2-28:1993• IEC 60601-2-32:1994• IEC 60825-1:2001ISO 14971:2001 | Use of same Standardsfor both devices |
| Conclusion | The changes and similarities of the proposed Ziehm 8000 C-arm described |
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Image /page/10/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 globe-like structure, and the text is in a teal color gradient, with the left side being lighter and the right side being darker.
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Image /page/11/Picture/0 description: The image contains 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 text is slightly faded, giving it a modern and clean appearance.
Ziehm 8000 does not
of Table Information:
in the table do not change the control mechanism, operating principle, energy type, or intended use found on predicate device and supports substantially equivalents to the predicate device Ziehm Quantum (K051064) in accordance with its labeling.
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Image /page/12/Picture/1 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 features a stylized human figure inside a circular design, and the text is in a teal color.
Adverse Effects on Health: The proposed Ziehm 8000 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.
Compliance Standards:
Compliance to FDA Guidance and Standards:
Applicable Standards:
| FDA/CDRH | "A Guide for the Submission of Initial Reports on Diagnostic X- |
|---|---|
| From 3626 (8/17) | Ray Systems and Their Major Components" |
| 21 CFR 1020.30-32 | Federal Performance Standard for Diagnostic X-ray Systems asthey may apply. |
General Consensus Standard
| MDSAP | Medical Device Single Audit Program (MDSAP)Please see MDSAP conformance letter inVolume 009 File 009. |
|---|---|
| MDD 93/42/EEC | Annex II of the European Medical Devices Directive(MDD) 93/42/EECSee EC Certificate in Volume 009 File 011 andEC Declaration of Conformity in Volume 009 File013. |
| EN ISO 13485 | Medical devices - Quality management systems -Requirements for regulatory purposesPlease see Certificate in Volume 009 File 015. |
| Date: 2012Conformance Standard #19-4 | |
| IEC 60601-1-2 | Medical Electrical Equipment, Part 1-2: General Requirementsfor Safety, Electromagnetic CompatibilityEdition 4.0, Date: 2014-02Conformance Standard #19-8 |
| IEC 60601-1-3 | Medical Electrical Equipment, Part 1-3: Radiation Protection inDiagnostic X-ray EquipmentEdition 2.1, Date: 2013-04Conformance Standard #12-269 |
| IEC 60601-1-6 | Medical Electrical Equipment, Part 1-6: UsabilityEdition 3.1, Date: 2013-10Conformance Standard #5-89 |
| IEC 60601-2-43 | Medical electrical equipment, Part 2-43: Particularrequirements for basic safety and essential performance of X-ray equipment for interventional proceduresEdition 2.0, Date: 2010-03Conformance Standard #12-202 |
| IEC 60601-2-54 | Medical electrical equipment, Part 2-54: Particularrequirements for the basic safety and essential performance ofX-ray equipment for radiography and radioscopyEdition 1.1, Date: 2015Conformance Standard #12-296 |
| IEC 60825-1 | Safety of laser products, Equipment Safety, requirements, anduser guideEdition 2.0, Date: 2007Conformance Standard #12-273 |
| ISO 14971 | Medical devices - Application of risk management to medicaldevicesEdition 2.0, Date: 2007Conformance Standard #5-40 |
| Determination ofSubstantial Equivalence: | Summary Bench Testing |
| Verification and Validation including hazard mitigationsexecuted resulted in demonstrated system met DesignInput and user needs. | |
| The device was tested by the notified test laboratoryresulting in device being certified compliant withANSI/AAMI ES6060-1-1 series, including IEC 60601-2-54. Further device met all applicable sections of 21 CFRSubchapter J performance standards. | |
| The Ziehm 8000 development occurred under our designcontrol processes, software development processes, andoverall quality management system. They included butare not limited to, |
FDA recognized Consensus Standards
AAMI/ANSI ES60601-1 Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (IEC 60601-1:2005, mod)
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Image /page/13/Picture/0 description: The image shows the text 'K190497' in a simple, sans-serif font. The text is black and appears against a white background. The numbers and letters are evenly spaced and clearly legible.
Image /page/13/Picture/1 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, accompanied by the text "ziehmimaging" in a light teal color. The text is in a sans-serif font and is positioned to the right of the circular graphic.
- Risk Analysis •
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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 text "ziehmimaging" on the right. The graphic is a stylized representation of a person inside of a circle with other circular shapes around it. The text is in a teal color and appears to be a sans-serif font.
- Required reviews ●
- Design reviews ●
- Component testing ●
- Integration testing ●
- Performance testing
- Safety testing
- Product use testing ●
Performance bench testing included: Non-clinical imaqing 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. Anthropomorphic (PMMA material) phantoms and anatomical simulation 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 8000 results in a comparable patient care to the Predicate device (K051064). and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm 8000 C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Quantum (K051064).
Summary of Clinical Test Data:
Ziehm 8000 mobile fluoroscopic C-arm system did not require live human clinical studies to support substantial equivalence in accordance with the FDA quidance Documents, 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.
Therefore, Ziehm Imaging GmbH conducted an image comparison study employing the use of anthropomorphic phantoms in establishing substantial equivalence based on the modifications to the proposed device and the bench data taken. Evaluation of the individual images
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Image /page/15/Picture/1 description: The image shows the logo for ziehmimaging. The logo consists of a circular graphic on the left and the text "ziehmimaging" on the right. The text is in a teal color and appears to be a sans-serif font. The graphic is a teal-colored globe with a figure in the center.
arranged in image sets was conducted by a boardcertified Radiologist. His conclusion was the image quality combined with a reduced patient dosage will result in a comparable patient care to the Predicate device Ziehm Quantum (K051064). His comparison of the dose and images provided further evidence in addition to the laboratory performance data that the complete system works as intended and is substantially equivalent to the predicate device
Conclusion:
Ziehm Imaging GmbH considers the Ziehm 8000 to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Quantum (K051064) 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.