(127 days)
No
The summary describes a standard fluoroscopic X-ray system with digital imaging and software for controlling the imaging and the patient table. There is no mention of AI or ML capabilities for image analysis, diagnosis, or any other function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "may be used for urological treatment" and lists numerous "Endourological interventions," "Percutaneous interventions," "Laparoscopy," "Application of fistula," "Simple procedures," and "Introcorporeal shock wave lithotripsy," and "Pediatric radiological and therapeutic applications," all of which are therapeutic in nature.
Yes
The "Intended Use / Indications for Use" section explicitly states "functional x-ray-diagnostics" and lists numerous diagnostic procedures such as "X-ray examination of the urogenital area" and "Ultrasound examinations (in conjunction with a stand-alone ultrasound system)".
No
The device description clearly outlines a physical X-ray system including a table, generator, X-ray tube, detector, and other hardware components. While it includes software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Uroview FD Function: The Uroview FD is an X-ray system that performs imaging and interventions directly on the patient's body. It uses fluoroscopic X-rays to visualize internal structures and is used for procedures like cystoscopy, kidney stone removal, and prostate treatment.
The device's function is entirely focused on imaging and treating the patient in vivo (within the living body), not on analyzing samples in vitro.
N/A
Intended Use / Indications for Use
The Uroview FD 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" 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 table called 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 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 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 (Pixium RF4343 FL, originally cleared under K080859)
- . Digital imaging workstation
- Video monitors
- . Accessories
The Uroview FD X-ray System includes the following two software programs: HIRIS RF43 and Uroview FD software; these are explained briefly.
The Hiris RF43 software controls the digital imaging system in fluoroscopy and radiography modes using the flat panel detector. The software is specifically designed for remote controlled fluoroscopy and radiography and emergency equipment and performs real-time X-ray diagnostics of the gastro-intestinal tract and the urogenital system.
The Uroview FD software controls the patient table Uroview FD (Skeleton) and does not interact with the HIRIS RF43 software. It allows the user comprehensive control of the patient table via hand control and foot switch allowing operator to activate movement of the Uroview FD.
The Uroview FD system is designed to meet the requirements in accordance with relevant sections of 21CFR 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. cystoscopy, kidney, bladder, ureter, urethra), prostate, scrotum, abdomen
Indicated Patient Age Range
Pediatric, Adult
Intended User / Care Setting
Trained health care professionals, urological treatment, planning and diagnostic procedures, endourology and minimal invasive urology/surgery
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 tests were conducted to demonstrate safety and effectiveness and substantial equivalence. The Uroview FD passed all testing in accordance with internal, national, and international standards, including: Biocompatibility testing (ISO 10993-1, 5, 10), Electrical safety testing (IEC 60601-1, IEC 60601-2-2), Electromagnetic Compatibility testing (IEC 60601-1-2), Electromagnetic Safety testing (IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54), Radiation dose documentation (IEC 61910-1), Usability engineering testings (IEC 62366), Software verification and validation testing (IEC 62304/FDA Guidance), Shelf Life Testing for 10 years/13000 life cycles, Packaging and Transport Testing, and Risk Management (ISO 14971). No human clinical testing was required as the device's indications for use are equivalent to the predicate device, which has proven safety and efficacy.
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.
UROSKOP Omnia (K101491, 06/30/2010)
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 17,2017
Pausch Medical GmbH % Oliver Eikenberg, Ph.D. Senior Consultant OA & RA EMERGO Global Consulting LLC 816 Congress Avenue, Suite 1400 AUSTIN TX 78701
Re: K161019
Trade/Device Name: Uroview FD Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA Dated: July 04, 2016 Received: July 07, 2016
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D.'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)
Device Name Uroview FD
Indications for Use (Describe)
The Uroview FD 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
510(k) Summary
Uroview FD
K161019
1. Submission Sponsor
Pausch Medical GmbH Graf-Zeppelin-Str. 1 Erlangen Bavaria, D-91056 GERMANY Office Phone number: +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 Phone: (512) 327.9997 Contact: Oliver Eikenberg, PhD, Senior Consultant, QA / RA Email: project.management@emergogroup.com
3. Date Prepared
15 August 2016
4. Device Identification
| Trade/Proprietary Name: | Uroview FD |
|---|---|
| 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 |
5. Legally Marketed Predicate Device
UROSKOP Omnia (K101491, 06/30/2010) from Siemens Medical Solutions USA Inc.
4
6. Device Description
The "Uroview FD" 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 table called 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 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 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 (Pixium RF4343 FL, originally cleared under K080859)
- . Digital imaging workstation
- Video monitors
- . Accessories
The Uroview FD X-ray System includes the following two software programs: HIRIS RF43 and Uroview FD software; these are explained briefly.
The Hiris RF43 software controls the digital imaging system in fluoroscopy and radiography modes using the flat panel detector. The software is specifically designed for remote controlled fluoroscopy and radiography and emergency equipment and performs real-time X-ray diagnostics of the gastro-intestinal tract and the urogenital system.
The Uroview FD software controls the patient table Uroview FD (Skeleton) and does not interact with the HIRIS RF43 software. It allows the user comprehensive control of the patient table via hand control and foot switch allowing operator to activate movement of the Uroview FD.
The Uroview FD system is designed to meet the requirements in accordance with relevant sections of 21CFR 1020.30-1020.33.
5
7. Indication for Use Statement
The "Uroview FD" 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, and 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
- Paediatric radiological and therapeutic applications
8. Substantial Equivalence Discussion
The following table compares the Uroview FD to the predicate device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The Uroview FD shares similar X-ray components (basic table unit, generator, X-ray tube and housing, beamlimiting device flat detector, digital imaging processing) to that of the predicate UROSKOP Omnia. X-ray generation and control equipped within the Uroview FD system is also similar to specifications used in the UROSKOP Omnia. Many of the components used in the Uroview FD system are commercially available and FDA-listed or FDA-cleared X-ray components. Detailed instructions for use including safety features are included within the device labeling and design and enable the user to operate the device in a safe and effective manner. The operators are trained health care professionals familiar with X-ray examinations to be performed. The following comparison Table 5A of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate device.
6
Table 5A – Comparison of Characteristics for Uroview FD versus UROSKOP Omnia
| | Proposed Device
Uroview FD | Predicate Device
UROSKOP Omnia | Similarities /
Differences |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Manufacturer | Pausch Medical GmbH | Siemens Medical Solutions USA, Inc. | N/A |
| Product/Trade Name: | Uroview FD | UROSKOP Omnia | N/A |
| 510(k): | Pending | K101491 | N/A |
| Establishment
Registration No. | 9610903 | 2240869 | N/A |
| Product Code: | JAA | JAA | Same |
| Regulation Number | 892.1650 | 892.1650 | Same |
| Device Classification
Name | Image-intensified fluoroscopic x-ray
system | Image-intensified fluoroscopic x-ray
system | Same |
| Class: | II | II | Same |
| Indications for use | The Uroview FD 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 examination of the urogenital area
(e.g. cyctoscopy, kidney, bladder, ureter,
urethra) including KUB, IVP, vasovesiculo-
graphy, 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. | The UROSKOP Omnia 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, gastroenterological and
gynecological treatment, planning and
diagnostic procedures including but not
limited to:
Querying and retrieving patient history
information and /or previous diagnosis and
images from other modalities. X-ray examination of the urogenital area
(e.g. cyctoscopy, kidney, bladder, ureter,
urethra) including KUB, IVP, vasovesiculo-
graphy, 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,
brachytherapy, as well as gynecological
procedures requiring radiological support). 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. | Similar, only
reduced for
gastroentero-
logical and
gynecological
treatment
applications |
| | Proposed Device
Uroview FD | Predicate Device
UROSKOP Omnia | Similarities /
Differences |
| Major Components
Basic Unit | 1. Basic Unit (urological table) | 1. Basic Unit (urological table) | Same |
| | 2. Detector , 3. Collimator | 2. Detector , 3. Collimator | |
| | 4. X-ray Generator | 4. X-ray Generator | |
| | 5. X-ray tube and housing | 5. X-ray tube and housing | |
| | 6. Measuring chamber | 6. Measuring chamber | |
| | 7. Digital image workstation | 7. Digital image workstation | |
| Uroview FD Basic Unit (urological table) | | | |
| Basic Unit System | Optional right-handed or left
handed version | Optional right-handed or left handed
version | Same |
| Tube Unit/Flat
detector | Synchronized longitudinal travel:
20 cm (8") | Synchronized longitudinal travel:
15 cm (5.9") | Similar, other
dimensions |
| Tilt range | Motorized tilt: +/- 88 °
lsocentric tilt: +/- 20 ° | Motorized tilt: +/- 90 °
lsocentric tilt: +/- 15 ° | Similar, other
dimensions |
| Tube Assembly
park position | Manual travel : 36.1 cm (14.2") | Motorized travel : 32 cm (12.6") | Similar, other
dimensions |
| Source-detector
distance | 115 cm (45.3 ") | 116 cm (45.7") | Similar, other
dimensions |
| Tabletop-detector
distance | 6.4 cm (2.5 ") | 7 cm (2.8") | Similar, other
dimensions |
| Power
requirements: | 1/N 115/200/208/230/240 VAC
at 50 or 60 Hz | 3/PE~ 380/400/440/480 VAC (± 10%)
at 50 or 60 Hz | Similar, other
dimensions |
| Temperature
range: | +10°C to +40°C | +15°C to +35°C | Similar, higher
temperature
working range |
| Relative humidity: | 20 % to 80% | 20 % to 75% | Similar, higher
humidity working
range |
| Barometric
pressure: | 700 hPa to 1100 hPa | 700 hPa to 1060 hPa | Similar, higher
pressure working
range |
| Sterile: | N/A | N/A | N/A |
| Battery Operated | N/A | N/A | N/A |
| Complies with
Applicable
Voluntary
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 62304
IEC 62366
ISO 14971 | 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 62304
IEC 62366
ISO 14971 | Same |
| Complies with
ISO 10993-1 for
Biocompatibility | yes | yes | Same |
| Electrical Safety
Testing Passed | Yes | yes | Same |
| Usable lifetime | Ten years | unknown | n/a |
7
Table 5A – Comparison of Characteristics for Uroview FD versus UROSKOP Omnia - Continued for Technological Characteristics
8
Table 5A – Comparison of Characteristics for Uroview FD versus UROSKOP Omnia
| - Continued for Technological Characteristics | |
|---|---|
| ----------------------------------------------- | -- |
| | Proposed Device
Uroview FD | Predicate Device
UROSKOP Omnia | Similarities /
Differences |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| | Uroview FD Patient table and table top | | |
| Table top | Radiolucent carbon-fiber
tabletop with foam mattress,
allows controlled drainage of
fluids:
120 cm (46.8 ") x 75.9 cm (29.9 ") | Radiolucent carbon-fiber tabletop
with foam mattress, allows
controlled drainage of fluids:
115 cm (45.3 ") x 76 cm (29.9") | Similar, other
dimensions |
| Tabletop extensions | 78 cm (30.7 ") x 75.9 cm (29.9 ") | 95 cm (37.4 ")x 76 cm (29.9 ") | Similar, other
dimensions |
| Height adjustable
table top | Continuously adjustable by
motor drive: 64 cm to 116 cm
(25.2" to 45.7") , floating | Continuously adjustable by
motor drive: 72 cm to 122 cm
(28.3" to 48 ") floating | Similar, other
dimensions |
| Longitudinal
movement | Motorized, continuous travel:
+/- 18.8 cm (7.9") | Motorized, continuous travel:
+/-20 cm (7.9") | Similar, other
dimensions |
| Transverse
movement | Motorized, continuous travel:
+/- 7.1 cm (2.8") | Motorized, continuous travel:
+/-12.5 cm (4.9") | Similar, other
dimensions |
| Table load | Max. 285 kg (628 lbs) | Max. 272 kg (600 lbs) | Similar |
| Display support arm | Spring-articulated arm mounted
on the basic unit with 2 x 19"
TFT color displays | Spring-articulated arm mounted
on the basic unit with 2 x 19"
TFT color displays | Same |
| TFT color display | Size 24"
Image Matrix 1900 x 1200
Maximum brightness 600 cd/m² | Size 19"
Image Matrix 1280 x 1024
Maximum brightness 280 cd/m² | Similar |
| Flat detector | | | |
| 43cm x 43cm | High-resolution 2840 x 2880
matrix with 148 μm pixel size
and 16-bit digitization depth | High-resolution 2840 x 2880
matrix with 148 μm pixel size
and 16-bit digitization depth | Same |
| Input fields | 42 x 42 cm / 30 x 30 cm /
20 x 20 cm / 15 x 15 cm | 42 x 42 cm / 30 x 30 cm/
22 x 22 cm/15 x 15 cm | Similar |
| Material | aSI with Csl scintillator | aSI with Csl scintillator | Same |
| Pixel size | 148 μm | 148 μm | Same |
| Generator | | | |
| Description | Microprocessor-controlled
high-frequency generator for
radiography and fluoroscopy | Microprocessor-controlled
high-frequency generator for
radiography and fluoroscopy | Same |
| Power | 65 kW (650 mA at 100 kV) | 65 kW (650 mA at 100 kV) | Same |
| Exposure voltage | 40 kV to 150 kV | 40 kV to 150 kV | Same |
| X-ray tube | | | |
| Nominal voltage | 150 kV | 150 kV | Same |
| Nominal output | 40/80 kW | 40/80 kW | Same |
| Focal spot nominal
value | 0.6/1.2 | 0.6/1.0 | Similar |
| X-ray tube assembly | Dual focus | Dual focus | Same |
| collimator | Automatic | Automatic | Same |
| Digital Imaging System | | | |
| 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 |
9
9. Non-Clinical Performance Data
As part of demonstrating safety and effectiveness of the Uroview FD and in showing substantial equivalence to the predicate device that is subject to this 510(k) submission, Pausch Medical GmbH completed a number of non-clinical performance tests. The Uroview FD 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 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 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 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 unit including testings 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 to maintain integrity through normal shipping and handling: PASSED all testing
- Risk Management per 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 devices, 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 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 and the predicate device UROSKOP Omnia 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 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 system, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate device(s).