(30 days)
Uroview FD (K161019)
Not Found
No
The document describes a standard fluoroscopic X-ray system with digital imaging capabilities and does not mention any AI or ML components or functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "may be used for urological treatment" and lists several "therapeutic applications" and "interventions" such as "Endourological interventions," "Percutaneous interventions," "Laparoscopy," "Introcorporeal shock wave lithotripsy," and "Pediatric radiological and therapeutic applications."
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the system may be used for "diagnostic procedures," and lists several diagnostic procedures such as "X-ray examination of the urogenital area" and "Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum."
No
The device description explicitly lists numerous hardware components including an X-ray generator, X-ray tube, collimator, detector, and a physical table, indicating it is a hardware system with integrated software.
Based on the provided information, the Uroview FD II is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Uroview FD II Function: The Uroview FD II is an X-ray system used for imaging and interventions within the human body (in vivo). It uses fluoroscopy and can be used in conjunction with ultrasound. Its purpose is to visualize anatomical structures and guide procedures, not to analyze biological samples.
The intended use and device description clearly indicate that the Uroview FD II is a medical imaging and treatment system that operates directly on the patient, not on samples taken from the patient.
N/A
Intended Use / Indications for Use
The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional xray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to:
- · Querying and retrieving patient information and /or images from other modalities.
- · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements.
- · Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum.
- · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy).
- · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy).
- · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction. varicocele).
- · Application of fistula (kidney/bladder).
- · Simple procedures (e.g. urethra, testis, phimonis).
- · Introcorporeal shock wave lithotripsy.
- · Uroflow/urodynamics.
- · Pediatric radiological and therapeutic applications.
Product codes (comma separated list FDA assigned to the subject device)
JAA
Device Description
The Uroview FD II is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient the Uroview FD Skeleton, which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD II X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid.
The Uroview FD II X-ray system includes the following major components:
- . Uroview FD Skeleton (urological table incl. tilting table)
- High Frequency RF X-ray generator
- X-ray tube incl. housing
- Collimator
- . Measuring chamber
- . Grid
- Dynamic flat panel detector
- Digital imaging workstation
- . Video monitors
- Accessories
The Uroview FD II is considered as an update to the model Uroview FD with some new components as part of the continuous X-ray system evolution. Major X-ray components are identical to the Uroview FD and new components use FDA-cleared or FDA-registered X-ray components. Therefore the Uroview FD II is considered similar by properties and technological characteristics.
The Uroview FD II system is designed to meet the requirements in accordance with relevant sections of 21 CFR 1020.30-1020.33.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Ultrasound
Anatomical Site
urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra), prostate, scrotum
Indicated Patient Age Range
Pediatric
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Data:
The Uroview FD II passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing for the Uroview FD II patient-contacting materials including cytotoxicity, sensitization and irritation reactivity per ISO 10993-1, 5, 10: PASSED all testing
- . Electrical safety testing per IEC 60601-1: PASSED required testing
- Electrical safety testing per IEC 60601-2-2: PASSED required testing
- Electromagnetic Compatibility testing per IEC 60601-1-2: PASSED required testing
- . Electromagnetic Safety testing per IEC 60601-1-6: PASSED required testing
- . Electromagnetic Safety testing for X-ray tube assemblies for medical diagnosis per IEC 60601-2-28: PASSED required testing
- . Electromagnetic Safety testing for X-ray equipment for interventional procedures per IEC 60601-2-43: PASSED required testing
- . Electromagnetic Safety testing for X-ray equipment for radiography and radioscopy per IEC 60601-2-54: PASSED required testing
- . Radiation dose documentation per IEC 61910-1: PASSED required testing
- . Usability engineering testings per IEC 62366: PASSED required testing
- . Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis and user interface testing per IEC 62304/FDA Guidance: PASSED required testing
- . Shelf Life Testing for a period of ten (10) years based upon a 13000 life cycles for the Uroview FD II unit including testing for tube arm support, cassette box, vertical system movement, table tilt, longitudinal movement, transversal table top movement: PASSED all testing
- . Packaging and Transport Testing including humidity, temperature and vibration testing for Uroview FD II to maintain integrity through normal shipping and handling: PASSED all testing
- . Risk Management per ISO 14971 and EN ISO 14971: all requirements were met and risks reduced as far as possible.
Clinical Performance Data:
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
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.
Uroview FD (K161019)
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.
Not Found
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
April 12, 2018
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 Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Pausch Medical GmbH % Oliver Eikenberg, Ph.D. Senior Consultant, QA & RA EMERGO Global Consulting LLC 2500 Bee Cave Road, Building 1, Suite 300 AUSTIN TX 78746
Re: K180651
Trade/Device Name: Uroview FD II Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: February 23, 2018 Received: March 13, 2018
Dear Dr. Eikenberg:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976. the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K180651
Device Name Uroview FD II
Indications for Use (Describe)
The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional xray-diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures including but not limited to:
- · Querying and retrieving patient information and /or images from other modalities.
- · X-ray examination of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements.
- · Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum.
- · Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy).
- · Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy).
- · Laparoscopy (e.g. cholecystectomy, lymph node dissection, abdominal testis detection/correction. varicocele).
- · Application of fistula (kidney/bladder).
- · Simple procedures (e.g. urethra, testis, phimonis).
- · Introcorporeal shock wave lithotripsy.
- · Uroflow/urodynamics.
- · Pediatric radiological and therapeutic applications.
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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3
Section 5 – 510(k) Summary
Uroview FD II
K 180651
1. Submission Sponsor
Pausch Medical GmbH
Graf-Zeppelin-Straße 1
Erlangen
Bavaria, D-91056
Germany
Office Ph: +49 (0)9131 / 99 92 - 0
Contact: Christian Stoian
Title: CEO
2. Submission Correspondent
Emergo Global Consulting, LLC 816 Congress Avenue, Suite 1400 Austin, TX 78701 Office Ph: (512) 327.9997 Contact: Dr. Oliver Eikenberg, Senior Consultant, RA/QA Email: project.management@emergogroup.com
3. Date Prepared
February, 23 2018
4. Device Identification
| Trade/Proprietary Name: | Fluoroscopic, Image Intensified X-ray System |
|---|---|
| Common/Usual Name: | X-ray System |
| Classification Name: | Image-intensified fluoroscopic x-ray system |
| Regulation Number: | 892.1650 |
| Product Code: | JAA |
| Device Class: | Class II |
| Classification Panel: | Radiology |
| Guidance: | FORM FDA 3626 (1/14), A Guide for the Submission of Initial Reports on |
| Diagnostic X-Ray Systems and Their Major Components |
4
5. Legally Marketed Predicate Device
Uroview FD (K161019) from Pausch Medical GmbH, Germany
6. Device Description
The Uroview FD II is a solid state detector fluoroscopic, X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The basic unit is a cantilevered, continuously adjustable, isocentric tilting patient the Uroview FD Skeleton, which can be raised and tilted to provide convenient access for the patient as well as optimum and ergonomic operating conditions for the user. The Uroview FD II X-ray system is a completely mounted system and is equipped with a digital imaging system with a dynamic flat detector, designed to replace traditional spot film devices using screen-film cassettes or "CR" plates and fluoroscopy with image intensifier CCD cameras. The system is also equipped with a generator and automatic, multilayer, square field collimation system intended for installation on stationary X-ray equipment. A rotating anode X-ray tube is mounted. The measuring chamber is placed between the patient and the detector in order to detect the actual dose value for the automatic exposure control (AEC), to provide consistent x-ray film appearance and to guarantee error-free images even at low kV values. Attenuation factor is low and X-ray scattering is reduced to minimum by using a moveable grid.
The Uroview FD II X-ray system includes the following major components:
- . Uroview FD Skeleton (urological table incl. tilting table)
- High Frequency RF X-ray generator
- X-ray tube incl. housing
- Collimator
- . Measuring chamber
- . Grid
- Dynamic flat panel detector
- Digital imaging workstation
- . Video monitors
- Accessories
The Uroview FD II is considered as an update to the model Uroview FD with some new components as part of the continuous X-ray system evolution. Major X-ray components are identical to the Uroview FD and new components use FDA-cleared or FDA-registered X-ray components. Therefore the Uroview FD II is considered similar by properties and technological characteristics.
The Uroview FD II system is designed to meet the requirements in accordance with relevant sections of 21 CFR 1020.30-1020.33.
5
7. Indication for Use Statement
The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for urological applications (functional x-ray diagnostics, endourology and minimal invasive urology/surgery). The system, which includes a radiologic/urologic treatment table, may be used for urological treatment, planning and diagnostic procedures, including but not limited to:
- Querying and retrieving patient information and/or images from other modalities .
- . X-ray examinations of the urogenital area (e.g. cystoscopy, kidney, bladder, ureter, urethra) including KUB, IVP, vasovesiculography, reflux-cystogram, cystourethrogram, and micturation cystourethrogram combined with uroflow measurements.
- Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of the kidney, bladder, prostate, scrotum.
- . Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter, ostium, kidney and ureter, catheter placement, penile implant placement, transurethral resection of prostate or bladder, alternative treatment of the BPH and brachytherapy).
- Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous nephrostomy) ●
- . Laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection, abdominal testis detection/correction, varicocele)
- . Application of fistula (kidney/bladder)
- Simple procedures (e.g. urethra, testis, phimosis)
- Intracorporeal shock wave lithotripsy ●
- . Uroflow/urodynamics
- Pediatric radiological and therapeutic applications
8. Substantial Equivalence Discussion
The update of the model Uroview FD to the new X-ray system Uroview FD II is identical by technological characteristics, design and mode of operation for the components "Tube, Measuring Chamber, Anti Scatter Grid".
The Uroview FD II further shares optimized component features or equivalent X-ray components to that of the predicate Uroview FD for Urological Table Uroview FD Skeleton, Generator, Digital Imaging System and Monitor beam- limiting device flat detector and digital imaging processing. The changes refer to design/size variations, image resolution, workstation functionalities and use of FDA-registered or FDA-cleared commercially available X-ray components, which are specifically designed for use in X-ray systems and therefore include standardized values and settings for electrical, mechanical and radiation requirements. As such the identified differences are considered to be optimized system variations, which are adequately controlled by testing of this X-ray system. The modifications of the Uroview FD II compared to the previous model Uroview FD are within the controls and predetermined specifications and are supported with verification and validation testing. The following table compares the Uroview FD II to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing.
The comparison chart reveals that the technological characteristics and as such the functions performed by the Uroview FD II offer substantially the same data and technology as the Uroview FD. The subject device is as safe and effective as its predicate device without raising any new safety and/or effectiveness concerns.
6
| | Proposed Device
Uroview FD II | Predicate Device
Uroview FD | Similarities /
Differences |
|----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pausch Medical GmbH | Pausch Medical GmbH | N/A |
| Product/Trade Name: | Uroview FD II | Uroview FD | N/A |
| 510(k): | Pending | K161019 | N/A |
| Establishment
Registration No. | 9610903 | 9610903 | N/A |
| Product Code: | JAA | JAA | Same |
| Regulation Number | 21 CFR 892.1650 | 21 CFR 892.1650 | Same |
| Device Classification | Solid State x-ray imager
(flat panel/digital imager) | Solid State x-ray imager
(flat panel/digital imager) | Same
classification |
| Class | II | II | Same |
| Indications for use | The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily for
urological applications (functional x-ray-diagnostics, endourology and minimal
invasive urology/surgery). The system, which includes a radiologic/urologic treatment
table, may be used for urological, treatment, planning and diagnostic procedures
including but not limited to:
• Querying and retrieving patient information and/or images from other modalities.
• X-ray examinations of the urogenital area (e.g. cyctoscopy, kidney, bladder, ureter,
urethra) including KUB, IVP, vasovesiculography, reflux-cystogram,
cystourethrogram, and micturation cystourethrogram combined with uroflow
measurements.
• Ultrasound examinations (in conjunction with a stand-alone ultrasound system) of
the kidney, bladder, prostate, scrotum.
• Endourological interventions (e.g. of the urethra, prostate, bladder, sphincter,
ostium, kidney and ureter, catheter placement, penile implant placement,
transurethral resection of prostate or bladder, alternative treatment of the BPH
and brachytherapy)
• Percutaneous interventions (e.g. PCN nephrolithotomy, resection, percutaneous
nephrostomy).
• Laparoscopy (e.g. cholecystectomy, nephrectomy, lymph node dissection,
abdominal testis detection/correction, varicocele).
• Application of fistula (kidney/bladder).
• Simple procedures (e.g. urethra, testis, phimosis).
• Intracorporeal shock wave lithotripsy.
• Uroflow/urodynamics.
• Pediatric radiological and therapeutic applications | | Same
The intended
use definition
is identical
except for the
device name
Uroview FD
versus
Uroview FD II |
| Complies with
Applicable Voluntary
EC, EMC-Standards | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-28
IEC 60601-2-43
IEC 60601-2-54 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-3
IEC 60601-1-6
IEC 60601-2-28
IEC 60601-2-43
IEC 60601-2-54 | Same |
| Complies with ISO 10993-1
for Biocompatibility | yes | yes | Same |
| Sterile: | N/A | N/A | N/A |
| Shelf Life (usable lifetime) | Ten years | Ten years | Same |
| | Proposed Device | Predicate Device | Similarities / |
| | Uroview FD II | Uroview FD | Differences |
| Overview of Component Specifications | | | |
| Major Components | 1. Uroview FD Skeleton | 1. Uroview FD Skeleton | Same |
| Basic Unit | Basic Unit (urological table) | (basic unit, urological table) | |
| | 2. X-ray Generator | 2. X-ray Generator | |
| | 3. X-ray tube and housing | 3. X-ray tube and housing | |
| | 4. Collimator | 4. Collimator | |
| | 5. Measuring chamber | 5. Measuring chamber | |
| | 6. Digital image workstation | 6. Digital image workstation | |
| | 7. Detector | 7. Detector | |
| Basic Unit | Uroview FD Skeleton | Uroview FD Skeleton | Similar |
| (urological table) | | | Newly designed
with similar
functionality |
| Basic Unit System | Optional right-handed or left-
handed version | Optional right-handed or left-
handed version | Same |
| Table height | Continuously adjustable by
motor drive: 64 to 116.5 cm
(25.2 to 45.9"), floating | Continuously adjustable by motor
drive: 64 to 116.5 cm
(25.2 to 45.9"), floating | Same |
| Tabletop extensions | 78 cm (30.7") x 75.9 cm (29.9") | 78 cm (30.7") x 75.9 cm (29.9") | Same |
| Tabletop-detector distance | 6.4 cm (2.5") | 6.4 cm (2.5") | Same |
| Source-detector distance | 115 cm (45.3") | 115 cm (45.3") | Same |
| Manual / Motorized
movement park position to
exposure position | 27 cm (10.6")
park position 27 cm (10.6") | 27 cm (10.6") | Similar,
additional park
position function |
| Tilt range | Motorized tilt: ± 88 °
Isocentric tilt: ± 20 ° | Motorized tilt: ± 88 °
Isocentric tilt: ± 20 ° | Same |
| Tilting speed | 3.5 °/s ± 0.3 °/s
Isocentric tilting speed (0°-20°)
2 °/s ± 0.5 °/s | 3.5 °/s ± 0.3 °/s
Isocentric tilting speed (0°-20°)
2 °/s ± 0.5 °/s | Same |
| longitudinal movement of
table top | 47.75 cm (18.8")
max. 23.88 cm (9.4"), each direction
Motorized, continuous travel | 47.75 cm (18.8")
max. 23.88 cm (9.4"), each direction
Motorized, continuous travel | Same |
| transversal
movement of
table top | 14 cm (5.6")
max. 7 cm (2.8"), each direction
Motorized, continuous travel | 14 cm (5.6")
max. 7 cm (2.8"), each direction
Motorized, continuous travel | Same |
| Movement Tube Unit/Flat
detector,
Speed of Movement | 20 cm (8")
$4 \pm 0.6$ cm/s
(1.57 ± 0.24 Inch/s) Synchronized
longitudinal travel | 20 cm (8")
2 cm/s ± 0.3 cm/s
(0.79 ± 0.12 Inch/s) Synchronized
longitudinal travel | Similar,
new designed
with faster
movement |
| Tube Assembly park
position | Manual travel : 36.1 cm (14.2") | Manual travel : 36.1 cm (14.2") | Same |
| Table load | Max. 285 kg (628 lbs) | Max. 285 kg (628 lbs) | Same |
Table 5A – Comparison of Characteristics for Uroview FD II to Legally Marketed Device Uroview FD
7
Table 5A – Comparison of Characteristics for Uroview FD II to Legally Marketed Device Uroview FD - Continued for Technological Characteristics
8
| | Proposed Device
Uroview FD II | | Predicate Device
Uroview FD | | | Similarities /
Differences |
|-----------------------------|-------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------|--------------|--|------------------------------------------------------------------------------------------------------|
| Generator | CPI INDICO IQ | | Editor HFe 601 | | | Similar |
| Type | Microprocessor-controlled high-
frequency generator for
radiography and fluoroscopy | | Microprocessor-controlled
high-frequency generator for
radiography and fluoroscopy | | | Same |
| Power | 80 kW | | 65 kW | | | Similar
higher power
input |
| Radiographic
range/steps | 40 to 150 kV in 1 kV increments | | 40 to 150 kV in 1 kV increments | | | Similar |
| Radiographic
mA range | 10-1000 mA (20 steps),
1 mA steps,
0.1 mA steps optional | | 10-500 mA (18 steps),
10-650 mA (19 steps),
10-800 mA (20 steps),
1-630 mA (38 steps).
0.5-600 mAs (32 steps) | | | Newly features
with additional
steps to adjust
range |
| Fluoroscopic kV/mA range | 40-125 kV / 0.5-20.0 mA | | 40-125 kV / 0.5-5.0 mA | | | Similar
Extended mA range |
| Active Dose Reduction (ADR) | yes | | yes | | | Same |
| Automatic Exposure Control | yes | | yes | | | Same |
| X-ray tube | RAD-60 + Sapphire housing | | RAD-60 + Sapphire housing | | | Same |
| Collimator | Optica 40 | | R225 ACS DHHS | | | Similar |
| Field Type | Square Field: without
potentiometer | | Square Field: without
potentiometer | | | Same |
| Light Source | White LED | | White LED | | | Same |
| X-ray rating up | 150 kVp | | 150 kVp | | | Same |
| Aluminium equivalent | 1.2 mm Al equivalence | | 2 mm Al equivalence | | | Similar, smaller Al
equivalent |
| Measuring Chamber | SSMC601 | | SSMC601 | | | Same |
| Detector | PaxScan 4343CB | | Pixium RF4343 FL | | | Similar |
| Type | Flat Panel Detector | | Flat Panel Detector | | | Similar |
| Input fields | 42.7 x 42.7 cm / 28.5 x 28.5 cm | | 43 x 43 cm / 30 x 30 cm /
20 x 20 cm / 15 x 15 cm | | | Similar, small input
field differences |
| Pixel Pitch | 139 μm | | 148 μm | | | Similar |
| A/D conversion | 16 bits | | 16 bits | | | Same |
| Cooling | Ambient air flow
(NO water cooling required) | | Ambient air flow
(NO water cooling required) | | | Same |
| Digital Imaging System | Nexus DRF Digital
(Option 1) | | HIRIS RF43FL
(Option 2) | HIRIS RF43FL | | Similar for
Nexus DRF Digital
Same for HIRIS RF43FL |
| Digital Imaging System | Fluoroscopy and
radiography modes
(remote control) – using a
large flat panel detector | | Fluoroscopy and radiography
modes (remote control) –
using a large flat panel detector | | | Similar, same flat panel
detector specifications,
more up to date digital
imagingc features |
| Digital Imaging | Continuous Fluoroscopy
Pulsed Fluoroscopy
Radiography | | Continuous Fluoroscopy
Pulsed Fluoroscopy
Radiography | | | Same |
| Network Interface | DICOM 3.0 | | DICOM 3.0 | | | Same |
Table 5A – Comparison of Characteristics for Uroview FD II to Legally Marketed Device Uroview FD - Continued for Technological Characteristics - continued
9
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the Uroview FD II that is the subject to this 510(k) submission and in showing substantial equivalence to the predicate device (Uroview FD K160119), Pausch Medical GmbH completed a number of non-clinical performance tests. The Uroview FD II meets all the requirements for overall design, biocompatibility, and electrical safety results confirming that the design output meets the design inputs and specifications for the device.
The Uroview FD II passed all the testing in accordance with internal requirements, national standards, and international standards shown below to support substantial equivalence of the subject device:
- . Biocompatibility testing for the Uroview FD II patient-contacting materials including cytotoxicity, sensitization and irritation reactivity per ISO 10993-1, 5, 10: PASSED all testing
- . Electrical safety testing per IEC 60601-1: PASSED required testing
- Electrical safety testing per IEC 60601-2-2: PASSED required testing
- Electromagnetic Compatibility testing per IEC 60601-1-2: PASSED required testing
- . Electromagnetic Safety testing per IEC 60601-1-6: PASSED required testing
- . Electromagnetic Safety testing for X-ray tube assemblies for medical diagnosis per IEC 60601-2-28: PASSED required testing
- . Electromagnetic Safety testing for X-ray equipment for interventional procedures per IEC 60601-2-43: PASSED required testing
- . Electromagnetic Safety testing for X-ray equipment for radiography and radioscopy per IEC 60601-2-54: PASSED required testing
- . Radiation dose documentation per IEC 61910-1: PASSED required testing
- . Usability engineering testings per IEC 62366: PASSED required testing
- . Software verification and validation testing has been completed on a functional level for a Moderate Level of Concern software including system compatibility testing, risk analysis and user interface testing per IEC 62304/FDA Guidance: PASSED required testing
- . Shelf Life Testing for a period of ten (10) years based upon a 13000 life cycles for the Uroview FD II unit including testing for tube arm support, cassette box, vertical system movement, table tilt, longitudinal movement, transversal table top movement: PASSED all testing
- . Packaging and Transport Testing including humidity, temperature and vibration testing for Uroview FD II to maintain integrity through normal shipping and handling: PASSED all testing
- . Risk Management per ISO 14971 and EN ISO 14971: all requirements were met and risks reduced as far as possible.
10
10. Clinical Performance Data
There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate device, have been on the market for many years with proven safety and efficacy for the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.
11. Statement of Substantial Equivalence
By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Or the device has the same intended use and different technological characteristics that can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise additional questions regarding its safety and effectiveness as compared to the predicate device(s).
It has been shown in this 510(k) submission that the difference between the Uroview FD II and the predicate device Uroview FD does not raise any questions regarding its safety and effectiveness. Technological product characteristics, performance testing and compliance with voluntary standards, demonstrate that the Uroview FD II device is substantially equivalent to the relevant aspects of the predicate device in terms of design, components, materials, principals of operation, performance characteristics, and intended use.
The Uroview FD II system, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).