(30 days)
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 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 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.
The provided text is a 510(k) premarket notification for a medical device called Uroview FD II. It extensively details the device's characteristics and compares it to a predicate device, Uroview FD. However, it 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. 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."
Therefore, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or human-in-the-loop performance with AI assistance. The focus is solely on non-clinical performance and demonstrating substantial equivalence to a predicate device through technical specifications and compliance with standards.
Here's a breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance:
Since no clinical study based on explicit acceptance criteria for diagnostic performance is described, a table like this cannot be created from the provided text. The performance reported relates to compliance with engineering and safety standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable as no clinical test set was used for a clinical performance study. The "test set" here refers to the physical device and its components undergoing non-clinical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable as no human interpretation or "ground truth" establishment by experts was part of the non-clinical testing for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable as no human-based assessment requiring adjudication was conducted.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No. The document explicitly states "There was no human clinical testing required." This device is an X-ray system, and the submission focuses on its hardware and software compliance, not on AI assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as the device is a fluoroscopic X-ray system, not an AI algorithm. Its performance is inherent to its physical operation and image quality, not an independent algorithmic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. For the non-clinical tests conducted, the "ground truth" was established by engineering specifications, validated test methods, and industry standards (e.g., whether the device passed a given electrical safety test).
8. The sample size for the training set:
Not applicable. The device is hardware and software for image acquisition and processing, not a machine learning model that requires a training set in the typical sense.
9. How the ground truth for the training set was established:
Not applicable as per point 8.
Summary of available information regarding compliance and "acceptance criteria" from the document:
The primary "acceptance criteria" for the Uroview FD II, as demonstrated in this 510(k) submission, revolve around its non-clinical performance and compliance with relevant national and international standards, and substantial equivalence to a legally marketed predicate device (Uroview FD).
Here's a table summarizing the reported device performance against these non-clinical acceptance criteria (which are essentially compliance with standards):
| Acceptance Criteria (Compliance with Standards/Requirements) | Reported Device Performance (as stated in Non-Clinical Performance Data) |
|---|---|
| Biocompatibility (ISO 10993-1, 5, 10) | PASSED all testing (cytotoxicity, sensitization, irritation reactivity) |
| Electrical safety (IEC 60601-1) | PASSED required testing |
| Electrical safety (IEC 60601-2-2) | PASSED required testing |
| Electromagnetic Compatibility (IEC 60601-1-2) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-1-6) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-2-28) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-2-43) | PASSED required testing |
| Electromagnetic Safety (IEC 60601-2-54) | 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) | PASSED required testing (system compatibility, risk analysis, user interface) |
| Shelf Life Testing (10 years / 13000 life cycles for unit components) | PASSED all testing (tube arm support, cassette box, vertical system movement, table tilt, longitudinal movement, transversal table top movement) |
| Packaging and Transport Testing (humidity, temperature, vibration) | PASSED all testing (to maintain integrity through normal shipping and handling) |
| Risk Management (ISO 14971 and EN ISO 14971) | All requirements were met and risks reduced as far as possible. |
Study Proving Device Meets Acceptance Criteria:
The "study" proving the device meets these non-clinical acceptance criteria is the comprehensive non-clinical performance testing program conducted by Pausch Medical GmbH. This is detailed in Section 9 of the 510(k) submission, "Non-Clinical Performance Data."
- Sample size: Not applicable in the traditional sense for these engineering and safety tests. The "sample" is the manufactured device (Uroview FD II) and its components.
- Data provenance: Not specified in terms of country of origin for the test results, but the submission is from Pausch Medical GmbH in Germany. The tests are "non-clinical," meaning they were conducted in a lab environment or on the device itself, not on human subjects.
- Experts/Ground Truth/Adjudication: For these non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the standards (e.g., maximum radiation leakage, acceptable temperature range, etc.). Expertise lies in the engineers performing the tests and interpreting the results against these established quantitative and qualitative criteria. There's no "adjudication" in the sense of reconciling human interpretations.
In essence, the device's acceptance is based on demonstrating that its technical specifications and physical performance meet established safety and performance standards for X-ray systems, and that any differences from its predicate device do not raise new safety or effectiveness concerns. No new clinical performance claims, particularly those involving AI or human reader improvement, are made or substantiated.
{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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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 onDiagnostic 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 DeviceUroview FD II | Predicate DeviceUroview 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 |
| EstablishmentRegistration 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) | Sameclassification |
| Class | II | II | Same |
| Indications for use | The Uroview FD II is a solid state detector fluoroscopic X-ray system, primarily forurological applications (functional x-ray-diagnostics, endourology and minimalinvasive urology/surgery). The system, which includes a radiologic/urologic treatmenttable, may be used for urological, treatment, planning and diagnostic proceduresincluding 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 uroflowmeasurements.• Ultrasound examinations (in conjunction with a stand-alone ultrasound system) ofthe 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 BPHand brachytherapy)• Percutaneous interventions (e.g. PCN nephrolithotomy, 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.• Pediatric radiological and therapeutic applications | SameThe intendeduse definitionis identicalexcept for thedevice nameUroview FDversusUroview FD II | |
| Complies withApplicable VoluntaryEC, EMC-Standards | IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54 | IEC 60601-1IEC 60601-1-2IEC 60601-1-3IEC 60601-1-6IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54 | Same |
| Complies with ISO 10993-1for 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 designedwith similarfunctionality | ||
| Basic Unit System | Optional right-handed or left-handed version | Optional right-handed or left-handed version | Same |
| Table height | Continuously adjustable bymotor drive: 64 to 116.5 cm(25.2 to 45.9"), floating | Continuously adjustable by motordrive: 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 / Motorizedmovement park position toexposure position | 27 cm (10.6")park position 27 cm (10.6") | 27 cm (10.6") | Similar,additional parkposition function |
| Tilt range | Motorized tilt: ± 88 °Isocentric tilt: ± 20 ° | Motorized tilt: ± 88 °Isocentric tilt: ± 20 ° | Same |
| Tilting speed | 3.5 °/s ± 0.3 °/sIsocentric tilting speed (0°-20°)2 °/s ± 0.5 °/s | 3.5 °/s ± 0.3 °/sIsocentric tilting speed (0°-20°)2 °/s ± 0.5 °/s | Same |
| longitudinal movement oftable top | 47.75 cm (18.8")max. 23.88 cm (9.4"), each directionMotorized, continuous travel | 47.75 cm (18.8")max. 23.88 cm (9.4"), each directionMotorized, continuous travel | Same |
| transversalmovement oftable top | 14 cm (5.6")max. 7 cm (2.8"), each directionMotorized, continuous travel | 14 cm (5.6")max. 7 cm (2.8"), each directionMotorized, continuous travel | Same |
| Movement Tube Unit/Flatdetector,Speed of Movement | 20 cm (8")$4 \pm 0.6$ cm/s(1.57 ± 0.24 Inch/s) Synchronizedlongitudinal travel | 20 cm (8")2 cm/s ± 0.3 cm/s(0.79 ± 0.12 Inch/s) Synchronizedlongitudinal travel | Similar,new designedwith fastermovement |
| Tube Assembly parkposition | 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
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Table 5A – Comparison of Characteristics for Uroview FD II to Legally Marketed Device Uroview FD - Continued for Technological Characteristics
{8}------------------------------------------------
| Proposed DeviceUroview FD II | Predicate DeviceUroview FD | Similarities /Differences | ||||
|---|---|---|---|---|---|---|
| Generator | CPI INDICO IQ | Editor HFe 601 | Similar | |||
| Type | Microprocessor-controlled high-frequency generator forradiography and fluoroscopy | Microprocessor-controlledhigh-frequency generator forradiography and fluoroscopy | Same | |||
| Power | 80 kW | 65 kW | Similarhigher powerinput | |||
| Radiographicrange/steps | 40 to 150 kV in 1 kV increments | 40 to 150 kV in 1 kV increments | Similar | |||
| RadiographicmA 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 featureswith additionalsteps to adjustrange | |||
| Fluoroscopic kV/mA range | 40-125 kV / 0.5-20.0 mA | 40-125 kV / 0.5-5.0 mA | SimilarExtended 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: withoutpotentiometer | Square Field: withoutpotentiometer | 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 Alequivalent | |||
| 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 inputfield 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 forNexus DRF DigitalSame for HIRIS RF43FL | ||
| Digital Imaging System | Fluoroscopy andradiography modes(remote control) – using alarge flat panel detector | Fluoroscopy and radiographymodes (remote control) –using a large flat panel detector | Similar, same flat paneldetector specifications,more up to date digitalimagingc features | |||
| Digital Imaging | Continuous FluoroscopyPulsed FluoroscopyRadiography | Continuous FluoroscopyPulsed FluoroscopyRadiography | 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
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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.
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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 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).
§ 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.