(127 days)
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, 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.
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.
It appears there's a misunderstanding in the prompt's request for acceptance criteria and study details for an AI/Software as a Medical Device (SaMD). The provided text is a 510(k) summary for a physical medical device, the Uroview FD, which is an X-ray fluoroscopic system.
This document does not describe an AI/SaMD product or a clinical study evaluating its performance with respect to specific acceptance criteria in the way typically required for AI/SaMD. Instead, it focuses on demonstrating substantial equivalence of the Uroview FD X-ray system to a predicate physical device (UROSKOP Omnia) based on technological characteristics and non-clinical performance data.
Therefore, most of the requested information regarding AI/SaMD acceptance criteria, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance for an AI model cannot be extracted from this document, as it pertains to a different type of device and different regulatory pathway.
The document explicitly states:
- "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." (Section 10. Clinical Performance Data)
- The software mentioned (HIRIS RF43 and Uroview FD software) controls the digital imaging system and patient table, respectively, and is verified at a "Moderate Level of Concern" for functionality, compatibility, risk analysis, and user interface. This is standard software validation for a hardware device, not an AI algorithm performing diagnosis or detection.
Given this, I cannot provide the requested table and study details as they are framed for an AI/SaMD. I can, however, summarize the non-clinical performance acceptance criteria and proof of adherence as outlined in the document for the physical Uroview FD X-ray system:
Summary of Acceptance Criteria and Performance for the Uroview FD X-ray System (Non-AI/SaMD)
The Uroview FD is a physical X-ray fluoroscopic system, not an AI/SaMD. Its acceptance criteria and performance demonstration are based on non-clinical testing to prove substantial equivalence to a legally marketed predicate device (UROSKOP Omnia).
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Category | Acceptance Criterion (Standard or Internal Requirement) | Reported Device Performance (Proof of Adherence) |
|---|---|---|
| Biocompatibility | ISO 10993-1, 5, 10 (Cytotoxicity, Sensitization, Irritation reactivity) | PASSED all testing |
| Electrical Safety | IEC 60601-1, IEC 60601-2-2 | PASSED required testing |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 | PASSED required testing |
| Electromagnetic Safety (Specific to X-ray) | IEC 60601-1-6, IEC 60601-2-28 (X-ray tube assemblies), IEC 60601-2-43 (Interventional procedures), IEC 60601-2-54 (Radioscopy) | PASSED required testing |
| Radiation Dose Documentation | IEC 61910-1 | PASSED required testing |
| Usability Engineering | IEC 62366 | PASSED required testing |
| Software Verification & Validation | IEC 62304 / FDA Guidance (for Moderate Level of Concern software, including system compatibility, risk analysis, user interface) | PASSED required testing |
| Shelf Life Testing | Internal requirement: 10 years based on 13,000 life cycles for unit components (tube arm support, cassette box, vertical system movement, table tilt, longitudinal movement, transversal table top movement) | PASSED all testing |
| Packaging and Transport Testing | Internal requirement for humidity, temperature, and vibration testing to maintain integrity through normal shipping and handling | PASSED all testing |
| Risk Management | ISO 14971 | All requirements met and risks reduced as far as possible |
| General Compliance | 21 CFR 1020.30-1020.33 | System designed to meet requirements |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of AI/SaMD performance evaluation. The data for these tests are derived from laboratory and engineering tests of the physical device and its components, not from patient data or clinical imaging test sets.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable. Ground truth as typically understood for AI models (e.g., diagnostic labels on medical images) is not relevant here. The "ground truth" for these tests refers to the engineering specifications and performance standards.
4. Adjudication Method for the Test Set
Not applicable. There is no adjudication process involving multiple human reviewers for these non-clinical engineering and electrical tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device." This study type is for evaluating the impact of AI on human reader performance, which isn't relevant for this physical X-ray system.
6. If a Standalone (Algorithm Only) Performance was done
No, a standalone algorithm performance study was not done. The software components are for controlling the hardware and imaging process, not for performing diagnostic tasks independently.
7. The Type of Ground Truth Used
The ground truth for this device's performance demonstration is based on engineering specifications, recognized national and international standards (e.g., IEC, ISO), and validated internal test procedures. This is typical for a hardware medical device seeking substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set" for an algorithm.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for an AI algorithm.
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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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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 onDiagnostic 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.
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Table 5A – Comparison of Characteristics for Uroview FD versus UROSKOP Omnia
| Proposed DeviceUroview FD | Predicate DeviceUROSKOP 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 |
| EstablishmentRegistration No. | 9610903 | 2240869 | N/A |
| Product Code: | JAA | JAA | Same |
| Regulation Number | 892.1650 | 892.1650 | Same |
| Device ClassificationName | Image-intensified fluoroscopic x-raysystem | Image-intensified fluoroscopic x-raysystem | Same |
| Class: | II | II | Same |
| Indications for use | The Uroview FD is a solid state detectorfluoroscopic X-ray system, primarily forurological applications (functional x-ray-diagnostics, endourology and minimal invasiveurology/surgery). The system, which includesa radiologic/ urologic treatment table, may beused for urological, treatment, planning anddiagnostic procedures including but notlimited to:Querying and retrieving patient informationand /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 micturationcystourethrogram combined with uroflowmeasurements. Ultrasound examinations (in conjunctionwith a stand-alone ultrasound system) ofthe kidney, bladder, prostate, scrotum. Endourological interventions (e.g. of theurethra, prostate, bladder, sphincter, ostium,kidney and ureter, catheter placement , penileimplant placement, transurethral resection ofprostate or bladder, alternative treatment ofthe BPH and brachytherapy). Percutaneous interventions (e.g. PCNnephrolithotomy, resection, percutaneousnephrostomy). 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 detectorfluoroscopic X-ray system, primarily forurological applications (functional x-ray-diagnostics, endourology and minimal invasiveurology/surgery). The system, which includesa radiologic/urologic treatment table, may beused for urological, gastroenterological andgynecological treatment, planning anddiagnostic procedures including but notlimited to:Querying and retrieving patient historyinformation and /or previous diagnosis andimages 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 micturationcystourethrogram combined with uroflowmeasurements. Ultrasound examinations (in conjunctionwith a stand-alone ultrasound system) ofthe kidney, bladder, prostate, scrotum. Endourological interventions (e.g. of theurethra, prostate, bladder, sphincter,ostium, kidney and ureter, catheterplacement , penile implant placement,transurethral resection of prostate orbladder, alternative treatment of the BPH,brachytherapy, as well as gynecologicalprocedures requiring radiological support). Percutaneous interventions (e.g. PCNnephrolithotomy, resection, percutaneousnephrostomy). 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, onlyreduced forgastroentero-logical andgynecologicaltreatmentapplications |
| Proposed DeviceUroview FD | Predicate DeviceUROSKOP Omnia | Similarities /Differences | |
| Major ComponentsBasic 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 lefthanded version | Optional right-handed or left handedversion | Same |
| Tube Unit/Flatdetector | Synchronized longitudinal travel:20 cm (8") | Synchronized longitudinal travel:15 cm (5.9") | Similar, otherdimensions |
| Tilt range | Motorized tilt: +/- 88 °lsocentric tilt: +/- 20 ° | Motorized tilt: +/- 90 °lsocentric tilt: +/- 15 ° | Similar, otherdimensions |
| Tube Assemblypark position | Manual travel : 36.1 cm (14.2") | Motorized travel : 32 cm (12.6") | Similar, otherdimensions |
| Source-detectordistance | 115 cm (45.3 ") | 116 cm (45.7") | Similar, otherdimensions |
| Tabletop-detectordistance | 6.4 cm (2.5 ") | 7 cm (2.8") | Similar, otherdimensions |
| Powerrequirements: | 1/N 115/200/208/230/240 VACat 50 or 60 Hz | 3/PE~ 380/400/440/480 VAC (± 10%)at 50 or 60 Hz | Similar, otherdimensions |
| Temperaturerange: | +10°C to +40°C | +15°C to +35°C | Similar, highertemperatureworking range |
| Relative humidity: | 20 % to 80% | 20 % to 75% | Similar, higherhumidity workingrange |
| Barometricpressure: | 700 hPa to 1100 hPa | 700 hPa to 1060 hPa | Similar, higherpressure workingrange |
| Sterile: | N/A | N/A | N/A |
| Battery Operated | N/A | N/A | N/A |
| Complies withApplicableVoluntaryStandards | IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54IEC 62304IEC 62366ISO 14971 | IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54IEC 62304IEC 62366ISO 14971 | Same |
| Complies withISO 10993-1 forBiocompatibility | yes | yes | Same |
| Electrical SafetyTesting Passed | Yes | yes | Same |
| Usable lifetime | Ten years | unknown | n/a |
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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 DeviceUroview FD | Predicate DeviceUROSKOP Omnia | Similarities /Differences | |
|---|---|---|---|
| Uroview FD Patient table and table top | |||
| Table top | Radiolucent carbon-fibertabletop with foam mattress,allows controlled drainage offluids:120 cm (46.8 ") x 75.9 cm (29.9 ") | Radiolucent carbon-fiber tabletopwith foam mattress, allowscontrolled drainage of fluids:115 cm (45.3 ") x 76 cm (29.9") | Similar, otherdimensions |
| Tabletop extensions | 78 cm (30.7 ") x 75.9 cm (29.9 ") | 95 cm (37.4 ")x 76 cm (29.9 ") | Similar, otherdimensions |
| Height adjustabletable top | Continuously adjustable bymotor drive: 64 cm to 116 cm(25.2" to 45.7") , floating | Continuously adjustable bymotor drive: 72 cm to 122 cm(28.3" to 48 ") floating | Similar, otherdimensions |
| Longitudinalmovement | Motorized, continuous travel:+/- 18.8 cm (7.9") | Motorized, continuous travel:+/-20 cm (7.9") | Similar, otherdimensions |
| Transversemovement | Motorized, continuous travel:+/- 7.1 cm (2.8") | Motorized, continuous travel:+/-12.5 cm (4.9") | Similar, otherdimensions |
| Table load | Max. 285 kg (628 lbs) | Max. 272 kg (600 lbs) | Similar |
| Display support arm | Spring-articulated arm mountedon the basic unit with 2 x 19"TFT color displays | Spring-articulated arm mountedon the basic unit with 2 x 19"TFT color displays | Same |
| TFT color display | Size 24"Image Matrix 1900 x 1200Maximum brightness 600 cd/m² | Size 19"Image Matrix 1280 x 1024Maximum brightness 280 cd/m² | Similar |
| Flat detector | |||
| 43cm x 43cm | High-resolution 2840 x 2880matrix with 148 μm pixel sizeand 16-bit digitization depth | High-resolution 2840 x 2880matrix with 148 μm pixel sizeand 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-controlledhigh-frequency generator forradiography and fluoroscopy | Microprocessor-controlledhigh-frequency generator forradiography 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 nominalvalue | 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 ImagingSystem | Fluoroscopy and radiographymodes (remote control) - using alarge flat panel detector | Fluoroscopy and radiographymodes (remote control) - using alarge flat panel detector | Similar |
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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.
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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).
§ 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.