(187 days)
K161976 Ziehm Solo FD
No
The document mentions "Ziehm Adaptive Image Processing (ZAIP)" and other image processing functions, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The description focuses on standard X-ray imaging technology and image processing techniques.
No.
The device is used for medical imaging to assist clinicians in diagnosis and procedures, not to directly treat a medical condition.
Yes
This device is a fluoroscopy system used for medical imaging during diagnostic, interventional, and surgical procedures to visualize anatomical structures and assist clinicians in localizing pathological areas.
No
The device description explicitly details hardware components such as an X-ray tube, generator, flat panel detector, mobile stand, and optional viewing station. While it mentions software control and processing, it is clearly a system that includes significant hardware.
Based on the provided information, the Ziehm Solo FD is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Ziehm Solo FD Function: The Ziehm Solo FD is an X-ray imaging system that visualizes the human anatomy in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it provides medical imaging for adults and pediatric populations using fluoroscopic imaging during diagnostic, interventional, and surgical procedures. This is a direct imaging modality, not an in vitro analysis.
Therefore, the Ziehm Solo FD falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
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, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
The visualization of such anatomical structures assists the clinician in the clinical outcome. 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 near MRI systems.
Product codes (comma separated list FDA assigned to the subject device)
OWB, JAA, OXO
Device Description
The 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 control of 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 device enables real-time image acquisition as well as visualization of in vivo surgical procedures and post-operative results.
The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the positioning of 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 generator, 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 proposed modified device Ziehm Solo FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Solo FD (K161976). Software architecture design is substantially equivalent to that of the predicate Ziehm Solo FD
The primary modification of the C-Arm includes an 8 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD The new 8 inch IGZO FPD is an addition to already introduced CMOS FPD. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8 inch CMOS and the only difference to the predicate Ziehm Solo FD is the additional 8 inch IGZO panel.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Pulsed and continuous fluoroscopic imaging (X-ray)
Anatomical Site
human bodies covering such structures but not limited to the following, e.q., organs, tissue, bones, implants depending on the medical indication.
Indicated Patient Age Range
adults and pediatric populations, using pulsed and continuous fluoroscopic imaging. 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.
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
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality.
Anatomical phantoms were employed, image comparison sets taken were representative of both the adult and pediatric populations.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Non-clinical image and dose Lab testing, system verification and validation testing.
Sample Size: Not specified (anatomical phantoms used).
Key Results:
- Testing regarding electrical safety according to ANSI/AAMI ES60601-1 and regarding electromagnetic compatibility according to IEC 60601-1-2 was performed. The test results show compliance with both standards.
- Testing according to Guidance's "Radio Frequency Wireless Technology in Medical Devices" and "Design Considerations and Premarket Submissions Recommendations for Interoperable Medical Devices" show, neither the wireless features nor the interoperable interfaces of the device affect the safety and effectiveness.
- Documentation provided demonstrates compliance of the modified device Ziehm Solo FD to FDA requirements stated in "A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components" as applicable. This includes but is not limited to leakage radiation of diagnostic source assembly, peak tube potential (kV), tube current mA, fluoroscopic entrance exposure rates, and beam-limiting alignment to device image receptor. Further, this performance testing confirmed that the 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 60601-1-3, IEC 60601-2-43, IEC 60601-2-54.
- Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
- An assessment regarding the low dose functionality of the modified Ziehm Solo FD shows the ability to reduce dose for certain applications.
- Software testing was performed as required by "Content of Premarket Submissions for Device Software Functions".
- Non-clinical imaging and dose testing methods demonstrated the device capability to provide both reduced dose while maintaining image quality.
- A Radiologist performed an assessment of individual image sets. Radiologist conclusion, the image quality of the Ziehm Solo FD results in a comparable patient care to the reference device Ziehm Vision FD (K193230) and fulfils the requirements as stated by the intended use.
- The verification/validation activities successfully confirmed device requirements have been fulfilled, system functionality is consistent with the user needs, intended uses, and performs as designed, and raises no new questions regarding either safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K161976 Ziehm Solo FD
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K193230 Ziehm Vision FD
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
December 12, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
Ziehm Imaging GmbH % Tsvetelina Milanova Specialist Regulatory Affairs Lina-Ammon-Strasse 10 Nuremberg, Bavaria 90471 GERMANY
Re: K231669
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 13, 2023 Received: November 14, 2023
Dear Tsvetelina Milanova:
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.
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).
1
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.
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. 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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
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, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.
The visualization of such anatomical structures assists the clinician in the clinical outcome. 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 near MRI systems.
Type of Use (Select one or both, as applicable)
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/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 globe with a human figure inside. The text is in a teal color and a serif font.
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
December, 7 2023
In accordance with 21 CFR §807.92 the following 510(k) K231669 summary information is provided:
| Submitter Address: | Ziehm Imaging GmbH
Lina-Ammon-Strasse 10
90471 Nuremberg
Germany
Phone: +49 911 66067 0
Fax: +49 911 66067 390 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person | Tsvetelina Milanova
Specialist Regulatory Affairs
Ziehm Imaging GmbH
Phone: +49 911 66067 219
Fax: +49 172 8651712 |
| Secondary Contact
Person: | Stefan Fiedler
Director QM/RA
Ziehm Imaging GmbH
Phone: +49 911 66067 219
Fax: +49 172 8651712 |
| US Agent | Kevin Bridgman
VP Quality Assurance & Requlatory Affairs
Ziehm-Orthoscan, Inc.
14555 N 82nd St
Scottsdale AZ, 85260 |
| Device (Trade Name): | Ziehm Solo FD |
| Common /Usual
Names: | Mobile Fluoroscopic C-Arm |
| Requlation: | 21CFR 892.1650 |
| Regulation Description: | Image-intensified fluoroscopic x-ray system |
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Image /page/4/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a stylized globe-like icon on the left, followed by the company name "ziehmimaging" in a teal-colored sans-serif font. The globe icon features a human figure within intersecting circles, giving it a modern and technological appearance.
| Product Code: | OWB; JAA, OXO |
|---|---|
| Classification: | II |
| Predicate Device: | K161976 Ziehm Solo FD |
| Reference Device | K193230 Ziehm Vision FD |
| Decision Date: | 10/06/2016 |
| Regulation: | 21CFR 892.1650 |
| Regulation Description Name: | Image-intensified fluoroscopic x-ray system |
| Product Code: | OWB; JAA, OXO |
| Summary of Technological Characteristics | The 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 control of 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 device enables real-time image acquisition as well as visualization of in vivo surgical procedures and post-operative results. |
| The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the positioning of 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 generator, 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 proposed modified device Ziehm Solo FD employs the same fundamental control, and substantially equivalent scientific technology as that of our predicate device Ziehm Solo FD (K161976). Software architecture design is substantially equivalent to that of the predicate Ziehm Solo FD | |
| The primary modification of the C-Arm includes an 8 inch IGZO (Indium gallium zinc oxide) flat panel detector (FPD The new 8 inch IGZO FPD is an addition to already introduced CMOS FPD. The flat panel detectors have the same outer product design of the housing, both devices use safety shielding |
510(k) Summary
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for radiation suppression and use solid state x-ray image receptors (SSXI / FPD) 8 inch CMOS and the only difference to the predicate Ziehm Solo FD is the additional 8 inch IGZO panel.
The comparison of the predicate device and the modified devices shows that the scientific and technical characteristics of the Ziehm Solo FD are substantially equivalent as those of the Ziehm Solo FD predicate device (K161976).
- Intended Use The Ziehm Solo FD is a mobile C-arm providing image data by means of a noninvasive x-ray technique during medical procedures and stores them temporarily. The Ziehm Solo FD is intended for use in all medical indications requiring fluoroscopy. 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 svstem is intended for use with human bodies covering such structures but not limited to the following, e.q., organs, tissue, bones, implants depending on the medical indication.
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, cholanqiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome. 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 near MRI systems.
Device Comparison Table
The table below summarizes the substantive feature/technological differences between the predicate device and the proposed device:
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
|------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k)
Number | K231669 | K161976 | --- |
| Product
Codes | OWB (interventional fluoroscopic x-ray
system)
Subsequent:
JAA (system, x-ray, fluoroscopic) | OWB (interventional fluoroscopic x-ray system)
Subsequent:
JAA (system, x-ray, fluoroscopic) | Identical |
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Image /page/6/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a circular graphic to the left of the company name. The graphic contains a stylized human figure inside of a circle with curved lines. The company name is written in a teal sans-serif font.
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
|------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Image/
General
Overview | image-intensified),
OXO (image-intensified fluoroscopic x-
ray system, mobile)
Image: Modified Ziehm Solo FD | image-intensified),
OXO (image-intensified fluoroscopic
x-ray system, mobile)
Image: Predicate Ziehm Solo FD (K161976) | The flat panel
detectors are
identical in the
design of the
housing, both
devices use
safety shielding
for radiation
suppression and
use solid state x-
ray image
receptor (SSXI /
FPD) 8 inch CMOS
and the only
difference to the
predicate Ziehm
Solo FD is the
new 8 inch IGZO
FPD. |
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
| X-ray Generator | | | |
| Pulsed
Fluoroscopy:
Operating
values | kV range:
variant B0: 40 - 110 kV
variant B1+B2: 40 - 120 kV mA range:
variant B0: 0.2 - 16 mA
variant B1: 0.2 - 16 mA
variant B2: 0.2 - 20 mA | kV range:
variant B0: 40 - 110 kV
variant B1+B2: 40 - 120 kV mA range:
variant B0: 0.2 - 16 mA
variant B1: 0.2 - 16 mA
variant B2: 0.2 - 16 mA | Substantial
equivalent.
The characteristic
line was changed
to 20mA, which
has no effect on
the safety as it is
below the
maximum dose. |
| X-ray Tube | | | |
| Tube Type | stationary anode | stationary anode | Identical. |
| X-Ray
Tubes | for variants B0, B1, and B2 Avg. Power: 0.6 kW Peak Power: 2,4kW Max. Voltage: 125kV for variants B0+B1 Avg. Power:0.6 kW Peak Power: 2.02 kW Max. Voltage: 120 kV | for variants B0, B1, and B2 Avg. Power: 0.6 kW Peak Power: 2,4kW Max. Voltage: 120kV for variants B0+B1 Avg. Power:0.6 kW Peak Power: 2.02 kW Max. Voltage: 120 kV | Substantial
equivalent
The maximal
voltage of the X-
Ray tube for
variants B0, B1,
and B2 have the
max. Voltage up
to 125kV, but as
the generator is
up to 120kV the
value was given
as 120kV. |
| Monitors | | | |
| Display
Monitor | The device can be equipped with
monitors of different sizes 19" Duo flat-screen monitor
(optionally with Quick Release) 27" flat screen monitor | The device can be equipped with
monitors of different sizes 19" DUO flat-screen monitor 24" flat screen monitor | Substantial
equivalent.
The 24" flat
screen monitor
has been
discontinued by
the manufacturer
and have been
replaced by 27"
monitor. |
| | Radiation Switches | | |
| X-Ray
foot
switch | Cable bound footswitch (with or
without protective bracket) optional: Wireless footswitch with
an emergency cord the if battery is | Cable bound footswitch optional: Wireless footswitch
with an emergency cord the if
battery is low | Substantial
equivalent
All footswitches
are available with |
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
| | low (with or without protective
bracket) | | protective
bracket. |
| | Digital Imaging Processing | | |
| Real-Time
processing
functions | • Recursive filter: 4 levels
• Last Image Hold
• Edge enhancement filter: 5 levels
• Windowing and step windowing
• Digital image rotation and reversal
without radiation
• Grayscale inversion
• Digital collimators
• Ziehm Adaptive Image Processing
(ZAIP) | • Recursive filter: 4 levels
• Stack filter 'Last Image Hold': 5
levels
• Last Image Hold
• Edge enhancement filter:
5 levels
• Windowing and step windowing
• Digital image rotation and
reversal without radiation
• Grayscale inversion
• Digital collimators
• Ziehm Adaptive Image
Processing (ZAIP) | Substantial
equivalent.
Stack filter 'Last
Image Hold' was
discontinued. |
| Appli-
cation-
Oriented
Anato-
mical
Programs
(AOAP) | • Bone: Extremities, Trunk
• Heart, Abdomen, Soft, Uro (option)
• Vascular: Extremities, Trunk, Bolus | • Bone: Extremities, Trunk
• Abdomen, Soft, Uro (option),
Long Procedure Spine
• Vascular: Extremities, Trunk,
Bolus | Substantial
equivalent.
Long procedure
spine was
discontinued. |
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
| Data
Organizati
on | • Patient-based data management
with 16-image mosaic display
• Pre-registration via DICOM Worklist
(option)
• Manual input or emergency
registration
• Calculated Dose Area Product (DAP)
• DAP value tagged to stored image
• Air Kerma dose display
• Air kerma value tagged to the
stored image
• HIPAA security package (option)
• Radiation Dose Structured Report
(RDSR)
• Video Output
- Full HD SDI (split display)
- 1920 x 1080p
- 60Hz
• Measured dose area product (DAP)
with digital display (option) | • Patient-based data management
with 16-image mosaic display
• Pre-registration via DICOM
Worklist (option)
• Manual input or emergency
registration
• Calculated Dose Area Product
(DAP)
• DAP value tagged to stored
image
• Air Kerma dose display
• Air kerma value tagged to the
stored image
• HIPAA security package (option)
• Radiation Dose Structured
Report (RDSR)
• Measured dose area product
(DAP) with digital display
(option) | Substantial
equivalent.
As required by the
IEC 60601-2-43
the modified
device Ziehm Solo
FD displays dose
area product
(DAP), air kerma
rate and
cumulative air
kerma at the
same time.
An optimization
have been made
through the Video
output, which
have no influence
on the device
safety and
effectiveness. |
| Device Options List | | | |
| Summary
of above-
described
Options
(details
above) | • X-ray generator in different variants
• Removable anti-scatter grid
• Laser positioning device on the
generator
• Different locations and sizes of
display monitor
• Remote Solo Center
• Footswitch with customer-specific
switch assignment in variant cable
bound or wireless
• Cine loop with up to 30 frames per
second
• Measuring functions
• Vascular package
• Anatomical Marking Tool (AMT)
• User administration (HIPAA)
• Calculated or measured dose area
product (DAP) and calculated Air
Kerma
• video printer
• DICOM viewer software
• Ziehm NetPort: DICOM 3.0 interface
for digital network integration | • X-ray generator in different
variants
• Removable anti-scatter grid
• Laser positioning device on the
generator
• Motor-driven angulation (A-Axis)
• Variant "Portable"
• Different locations and sizes of
display monitor
• Remote Solo Center
• Footswitch with customer-specific
switch assignment in variant
cable bound or wireless
• Cine loop with up to 30 frames
per second
• Measuring functions
• Vascular package Anatomical
Marking Tool (AMT)
• User administration (HIPAA)
• Calculated or measured dose
area product (DAP) or calculated
Air Kerma
• video printer | Substantial
equivalent
Both options
motor-driven
angulation (A-
axis) and Variant
"Portable" were
discontinued. |
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
| | • WLAN interface for wireless data
transfer
• Viewing Station
• Field Transport Solution, incl. all-
terrain wheels, towing and
mounting device bar | • DICOM viewer software
• Ziehm NetPort: DICOM 3.0
interface for digital network
integration
• WLAN interface for wireless data
transfer
• Viewing Station | |
| Further
Options | • video connector(s) for external flat-
screen monitors (right and left
monitor), optionally with analog or
digital signal (DVI)
• Key switch Power on/off
• Interface for external separate
radiation indication lamp | • video connector(s) for external
flat-screen monitors (right and
left monitor), optionally with
analog or digital signal (DVI)
• Key switch Power on/off or X-ray
on/off
• Interface for external separate
radiation indication lamp | Substantial
equivalent.
Key switch Power
on/off replaces X-
ray on/off. |
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
| Optional
Accessories | • Sterile disposable covers
• Skin protection | • Sterile disposable covers
• Hand surgery table
• Skin protection | Substantial
equivalent.
The optional Hand
surgery table is no
longer available.
Note: Ziehm
Imaging GmbH is
not the
manufacturer of
the optional
accessories |
| Software | | | |
| Level
of
Concern | Enhanced | Moderate | Identical;
The term of level
of concern has
changed
according to the
Guidance
"Content of
Premarket
Submissions for
Device Software
Functions", but
there have been
no additional
changes to the
device that have
increased the
level of concern. |
| Software | • 7.06.11
• Linux-based OS Ubuntu | • 7.00.3
• Linux-based OS Ubuntu | Updates and
optimization of
software features,
which does not
have influence on
safety and
effectiveness of
the device. |
| Model | Modified
Ziehm Solo FD | Predicate
Ziehm Solo FD (K161976) | Comparable
Properties
Substantial
Equivalence
Discussion |
| Indication
s for Use | The Ziehm Solo FD is intended for use
in providing medical imaging for adults
and pediatric populations, using pulsed
and continuous fluoroscopic imaging.
The device provides contactless
fluoroscopic image capture,
temporarily storing, and display of
digital subtraction, and acquisition of
cine loops during diagnostic,
interventional and surgical procedures.
Examples of clinical application may
include pediatric, cholangiography,
endoscopic, urologic, lithotripsy,
orthopedic, neurologic, vascular,
cardiac, angiographic, critical care, and
emergency room fluoroscopy
procedures.
The visualization of such anatomical
structures assists the clinician in the
clinical outcome. 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
near MRI systems. | The Ziehm Solo FD is intended for
use in providing medical imaging for
adults and pediatric populations,
using pulsed and continuous
fluoroscopic imaging.
The device provides contactless
fluoroscopic image capture,
temporarily storing, and display of
digital subtraction, and acquisition
of cine loops during diagnostic,
interventional and surgical
procedures. Examples of clinical
application may include pediatric,
cholangiography, endoscopic,
urologic, lithotripsy, orthopedic,
neurologic, vascular, cardiac,
angiographic, critical care, and
emergency room fluoroscopy
procedures.
The visualization of such anatomical
structures assists the clinician in the
clinical outcome. At the discretion of
a physician, the device may be used
for other imaging applications.
This device does not support direct
radiographic film exposures and is
not intended for use in performing
mammography. | Substantial
equivalent
The wording of
the indications for
use were updated.
These changes do
not raise new
safety or
effectiveness
concerns with
regard to the
predicate device. |
| Standards | | | |
| Standards | • ANSI/AAMIES60601-
1:2005/AMD1:2012
• IEC 60601-1-2: 2014
• IEC 60601-1-3: 2008/AMD1:2013
• IEC 60601-1-6:2013/AMD2:2020
• IEC60601-2-43: 2010/AMD2:2019
• IEC60601-2-54:2009/AMD2:2018
• IEC 60852-1:2007
• ISO 14971:2019 | • IEC 60601-1:2005
• IEC 60601-1-2:2007
• IEC 60601-1-3:2008
• IEC 60601-1-6:2013
• IEC 60601-2-43:2010
• IEC 60601-2-54:2009
• IEC 60825-1:2007
• ISO 14971:2007 | Applicable
standards for the
modified Ziehm
Solo FD and the
Solo FD predicate
(K161976) remain
as before. Newer
versions of the
standards have
been applied. |
7
Image /page/7/Picture/0 description: The image shows 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 overall design is clean and modern.
8
Image /page/8/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a stylized globe-like icon on the left, followed by the text "ziehmimaging" in a teal color. The globe icon features abstract lines and a human-like figure within a circular border, giving it a modern and technological appearance.
9
Image /page/9/Picture/0 description: The image contains the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the company name "ziehmimaging" in a teal sans-serif font. The globe is also teal, and the overall design is clean and modern.
10
Image /page/10/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a teal-colored globe-like icon on the left, followed by the text "ziehmimaging" in a matching teal color. The text is written in a sans-serif font and appears to be the name of the company.
11
Image /page/11/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic on the left and the company name on the right. The circular graphic features a stylized human figure inside of a globe. The text is in a teal color.
12
Image /page/12/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 circular graphic contains a stylized image of a person inside of a globe. The text is in a teal color.
For the comparison between a-Si and IGZO the Ziehm Vision FD (K193230) is used as reference device:
13
Image /page/13/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a circular graphic with a stylized human figure inside, followed by the text "ziehmimaging" in a teal color. The text is in a sans-serif font and appears to be part of the overall branding for the company.
| Model | Modified
Ziehm Solo FD | Reference Device
Ziehm Vision FD (K193230) | Comparable
Properties
Substantial
Equivalence
Discussion |
|----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K231669 | K193230 | |
| Product
Codes | OWB (interventional fluoroscopic x-ray
system )
Subsequent:
JAA (system, x-ray, fluoroscopic,
image-intensified),
OXO (image-intensified fluoroscopic x-
ray system, mobile) | OWB (interventional fluoroscopic x-
ray system)
Subsequent:
JAA (system, x-ray, fluoroscopic,
image-intensified),
OXO (image-intensified fluoroscopic
x-ray system, mobile) | Identical |
| Device
Image/
General
Overview | Image: Ziehm Solo FD | Image: Ziehm Vision FD (K193230) | |
| Beam Limiter/ Collimator | | | |
| Collimator System | • Dedicated pre-collimator for flat
panel detector
• Collimator Rotation:
+/- 90°
• Iris and Asymmetric Slot Collimator
• Virtual Collimation without radiation | • Dedicated pre-collimator for flat
panel detector
• Collimator Rotation:
+/- 90°
• Iris and Asymmetric Slot
Collimator
• Virtual Collimation without
radiation | Identical
collimator system.
The
maximum
collimator opening
is adjusted to the
flat panel type. |
| Image Detector | | | |
| Image
Detector | Flat Panel Detector | Flat Panel Detector | They are identical
in the outer
product design of
the housing, both
devices use safety
shielding for
radiation |
| Model | Modified
Ziehm Solo FD | Reference Device
Ziehm Vision FD (K193230) | Comparable
Properties
Substantial
Equivalence
Discussion |
| | Image: Ziehm Solo FD | Image: Ziehm Vision FD | suppression and
use solid state x-
ray image
receptor (SSXI /
FPD) The
modified Ziehm
Solo FD has
additionally new 8
inch IGZO
(Indium gallium
zinc oxide) flat
panel detector. |
| Detector
Technology | • Type: CMOS Flat Panel Detector
• Scintillator: Cesium-Iodide (CsI)
• Alternative Type: IGZO
• Scintillator: Cesium-Iodide (CsI) | • Type aSi (Amorphous
Silicon) Flat Panel Detector
• Scintillator: Cesium-Iodide
(CsI)
• Type CMOS Flat Panel
Detector:
• Scintillator: Cesium-Iodide
(CsI) | IGZO based
detectors are
manufactured
using processes
that are similar to
aSi detectors. The
slight differences
in used sensor
glass technology
does not have
influence on
safety and
effectiveness of
the C-arm
product. |
| Detector
Sizes | CMOS:
Size: 21 cm x 21 cm (8"x 8")
Detector matrix: 2,053 x 2,051 pixels
Magnifier 1: 1,536 x 1,536 pixels
Magnifier 2: 1,024 x 1,024 pixels
Dynamic Range:
1 x 1 binning: 84 dB
2 x 2 binning: 95 dB
System resolution: 5,0 lp/mm
IGZO:
Size: 21 cm x 21 cm (8"x 8")
Detector matrix: 1,536 x 1,536
pixels
Magnifier 1: 1,024 x 1,024 pixels | Variant 20.5cm x 20.5cm (8"x 8")
CMOS
• Size: 20.5 cm x 20.5 cm
• Detector matrix: 2,048 x 2,048
pixels
• Magnifier 1: 1,536 x 1,536 pixels
• Magnifier 2: 1,024 x 1,024 pixels
• Dynamic Range:
- 1 x 1 binning: 84 dB
- 1 x 2 binning: 95 dB
• System resolution (Nyquist): 5
lp/mm
Variant 20cm x 20cm (8"x 8") a-
Si: | The active pixel
area of the
detector types are
not identical but
are very similar in
image area of
approx. 8 inch x 8
inch. The modified
device Ziehm Solo
FD with IGZO has
a higher
resolution size in
comparison to
reference device
Ziehm Vision FD
with a-Si FPD,
which leads to |
| Model | Modified
Ziehm Solo FD | Reference Device
Ziehm Vision FD (K193230) | Comparable
Properties
Substantial
Equivalence
Discussion |
| | Magnifier 2: 768 x 768 pixels
Dynamic Range:
1x1 binning: 84dB
2x2 binning: 95dB
System resolution: 3,7 lp/mm | • Size: 19.9 cm x 19.9 cm
• Detector matrix: 1,024 x 1,024
pixels
• Magnifier 1: 768 x 768 pixels
• Magnifier 2: 512 x 512 pixels
• Dynamic Range: 94 dB
• System resolution (Nyquist): 2.6
lp/mm
Variant 30cm x 30cm (12" x 12")
aSi:
• Size: 29.8 cm x 29.8 cm
• Detector matrix: 1,536 x 1,536
pixels
• Magnifier 1: 1,024 x 1,024 pixels
• Magnifier 2: 768 x 768 pixels
• Dynamic Range: 94 dB
• System resolution (Nyquist): 2.6
lp/mm
Variant 30.7cm x 30.7cm (12" x
12") aSi:
• Size: 31 cm x 31 cm
• Detector matrix: 2,048 x 2,048
pixels
• Magnifier 1: 1,536 x 1,536 pixels
• Magnifier 2: 1,024 x 1,024 pixels
• Dynamic Range: ≥86 dB
• System resolution (Nyquist):3.3
lp/mm | better
image
quality.
All
other
differences with
regard to the used
technology have
no influence on
safety and
effectiveness of
the C arm. |
| Anti-Scatter Grids | | | |
| Fixed
anti-
scatter
grid | fixed anti-scatter grid:
CMOS (8inch)
• Pb 8/70
IGZO (8inch)
• Pb 8/70 | fixed anti-scatter grid:
CMOS (8inch)
• Pb 8/70
a-Si (8inch)
• Pb 8/70
a-Si (12inch)
• Pb 6/80 | Identical values
and material for
both modified and
reference device
with 8 inch flat
panel detectors. |
| Model | Modified
Ziehm Solo FD | Reference Device
Ziehm Vision FD (K193230) | Comparable
Properties
Substantial
Equivalence
Discussion |
| optional
removabl
e anti-
scatter
grid | Image: Ziehm Solo FD | Image: Ziehm Vision FD | Identical values
and material for
both modified and
reference device
with 8 inch flat
panel detectors. |
| | Removable Grid:
CMOS (8inch)
• Pb 8:1/70lines/cm
IGZO (8inch)
• Pb 8:1/70 lines/cm | Removable Grid:
CMOS (8inch)
• Pb 8/70
a-Si (8inch)
• Pb 8/70
a-Si (12inch)
• Pb 6/80 | |
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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 company name "ziehmimaging" on the right. The graphic features a stylized human figure inside a circle with intersecting lines, and the text is in a teal color.
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Image /page/15/Picture/0 description: The image contains the logo for ziehmimaging. The logo consists of a circular graphic with a stylized human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font.
16
Image /page/16/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 circle with intersecting lines. The text is in a teal color and appears to be a sans-serif font.
- Conclusion of Table The changes of the proposed modified device Ziehm Solo FD described in the above: table do not change the fundamental control mechanism, operating principle or intended use found on predicate device and supports substantially equivalents to the predicate device Ziehm Solo FD (K161976) in accordance with its labeling. Safety and Performance: The proposed Ziehm Solo FD 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. Summary of Non-Ziehm Solo FD is based on direct modifications to cleared predicate device Clinical Test Data: Ziehm Solo FD (K161976). The design of the modified Ziehm Solo FD was completed 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 documentation. Testing reqarding electrical safety according to ANSI/AAMI ES60601-1 and reqarding electromagnetic compatibility according to IEC 60601-1-2 was performed. The test results show compliance with both standards.
510(k) Summary
17
Image /page/17/Picture/0 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 graphic is a stylized representation of a human figure inside a globe. The text is in a teal color and appears to be a sans-serif font.
Testing according to Guidance's "Radio Frequency Wireless Technology in Medical Devices" and "Design Considerations and Premarket Submissions Recommendations for Interoperable Medical Devices" show, neither the wireless features nor the interoperable interfaces of the device affect the safety and effectiveness.
Documentation provided demonstrates compliance of the modified device Ziehm Solo FD to FDA requirements stated in "A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components" as applicable. This includes but is not limited to leakage radiation of diagnostic source assembly, peak tube potential (kV), tube current mA, fluoroscopic entrance exposure rates, and beam-limiting alignment to device image receptor. Further, this performance testing confirmed that the 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 60601-1-3, IEC 60601-2-43, IEC 60601-2-54.
Non-clinical image comparison with sets of images with the modified device and the predicate shows equivalence regarding image quality.
With regard to the flat panel detector (SSXI), documentation provided in this submission demonstrates compliance of the modified device Ziehm Solo FD to "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices".
Furthermore, an assessment regarding the low dose functionality of the modified Ziehm Solo FD shows the ability to reduce dose for certain applications.
Software testing was performed as required by "Content of Premarket Submissions for Device Software Functions". Cybersecurity remains exactly the same as in the predicate device.
Determination of The verification/validation activities successfully confirmed device requirements Substantial Equivalence: have been fulfilled, system functionality is consistent with the user needs, intended uses, and performs as designed, and raises no new questions regarding either safety or effectiveness.
Therefore, Ziehm Imaging GmbH believes the modified device Ziehm Solo FD C-arm image quality, safety and effectiveness supports a determination of substantial equivalence to the predicate device Ziehm Solo FD (K161976).
Compliance to FDA Guidance and Standards
FDA/CDRH From 3626 A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems (5/11) and Their Major Components.
21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems.
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Image /page/18/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 text is in a teal color and appears to be a sans-serif font. The graphic on the left appears to be a stylized representation of a globe or a human figure within a circle.
General Standards / Requlations
Medical Device Single Audit Program (MDSAP) MDSAP Requlation (EU) Annex IX Chapter I, Section2 and 3 and Chapter III 2017/745 EN ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes Date: 2016
Recognized Consensuses Standards
| ANSI/AAMI ES60601-1: | Medical Electrical Equipment, Part 1: General Requirements for Basic |
|---|---|
| Safety and Essential Performance | (IEC 60601-1:2005, mod) |
| Date: | 2012 |
| Conformance Standard | #19-4 |
- IEC 60601-1-2: Medical Electrical Equipment, Part 1-2: General Requirements for Safety, Electromagnetic Compatibility Edition 4.0, Date: 2014-02 Conformance Standard #19-8
- IEC 60601-1-3: Medical Electrical Equipment, Part 1-3: Radiation Protection in Diagnostic X-ray Equipment Edition 2.1, Date: 2013-04 Conformance Standard #12-269
- IEC 60601-1-6: Medical Electrical Equipment, Part 1-6: Usability Edition 3.2, Date: 2020-07 Conformance Standard #5-132
- IEC 60601-2-43: Medical electrical equipment, Part 2-43: Particular requirements for basic safety and essential performance of X-ray equipment for interventional procedures Edition 2.2, Date: 2019-10 Conformance Standard #12-239
- IEC 60601-2-54: Medical electrical equipment, Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy Edition 1.2, Date: 2018-06 Conformance Standard #12-317
- IEC 61304: Medical device software Software life cycle processes Edition 1.1, Date 2015-06 Conformance Standard #13-79
19
Image /page/19/Picture/0 description: The image shows the logo for Ziehm Imaging. The logo consists of a stylized globe with a human figure inside, followed by the text "ziehmimaging" in a teal color. The text is written in a sans-serif font and is slightly faded.
- IEC 60825-1: Safety of laser products, Equipment Safety, requirements, and user guide Edition 2.0, Date: 2007-03 Conformance Standard #12-273
- ISO 14971: Medical devices Application of risk management to medical devices Edition 3.0, Date: 2019-12 Conformance Standard #5-40
Determination of Summary Bench Testing
Substantial Equivalence:
Verification and Validation including hazard mitigations executed resulted in demonstrated system met Design Input and user needs.
The device was tested by the notified test laboratory resulting in device being certified compliant with ANSI/AAMI ES6060-1-1 series, including IEC 60601-2-54. Further device met all applicable sections of 21 CFR Subchapter J performance standards.
The modified Ziehm Solo FD development occurred under our design control processes, software development processes, and overall quality management system. They included but are not limited to,
- Risk Analysis
- Required reviews ●
- Design reviews ●
- Component testing
- Integration testing .
- Performance testing ●
- . Safety testing
- Product use testing ●
Performance bench testing included:
Non-clinical imaging 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. Anatomical 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 Solo FD results in a comparable patient care to the reference device Ziehm Vision FD (K193230) and fulfils the requirements as stated by the intended use. Therefore, Ziehm Imaging GmbH believes the Ziehm Solo FD C-arm image quality, safety and effectiveness to be substantially equivalent to that of the predicate device Ziehm Solo FD (K161976).
- Conclusion Ziehm Imaging GmbH considers the Ziehm Solo FD to be as safe, as effective, and performs substantially equivalent to the predicate device Ziehm Solo FD (K161976) in accordance with its labeling.