Uroview FD

K161019 · Pausch Medical GmbH · JAA · Aug 17, 2016 · Radiology

Device Facts

• Record ID: K161019
• Device Name: Uroview FD
• Applicant: Pausch Medical GmbH
• Product Code: JAA · Radiology
• Decision Date: Aug 17, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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, 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). - Uroflow/urodynamics. - · Pediatric radiological and therapeutic applications.

Device Story

Uroview FD is a solid-state detector fluoroscopic X-ray system for urological diagnostics and minimally invasive surgery. System comprises a cantilevered, isocentric tilting patient table, high-frequency RF X-ray generator, rotating anode X-ray tube, collimator, and dynamic flat panel detector. Input: X-ray radiation attenuated by patient; processed via digital imaging workstation. Output: Real-time fluoroscopic and radiographic images displayed on monitors. Used in clinical settings by trained healthcare professionals. System includes automatic exposure control (AEC) via a measuring chamber to ensure consistent image quality. Benefits include ergonomic patient access, reduced X-ray scattering via moveable grid, and digital imaging replacing traditional film/CR plates. Supports retrieval of patient data from other modalities.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance testing, including biocompatibility (ISO 10993), electrical safety (IEC 60601-1), electromagnetic compatibility, radiation dose documentation, and software verification/validation.

Technological Characteristics

Solid-state fluoroscopic X-ray system. Components: aSI flat panel detector with CsI scintillator (148 μm pixel size), high-frequency RF generator (65 kW), rotating anode X-ray tube (dual focus), and motorized isocentric tilting table. Connectivity: Digital imaging workstation. Software: HIRIS RF43 (imaging) and Uroview FD software (table control). Biocompatible materials per ISO 10993. Standards: IEC 60601-1, 60601-1-2, 60601-2-28, 60601-2-43, 60601-2-54, IEC 62304, IEC 62366, ISO 14971.

Indications for Use

Indicated for urological, diagnostic, and interventional procedures including urogenital X-ray exams (cystoscopy, KUB, IVP, etc.), endourological interventions (resections, catheter/implant placement, brachytherapy), percutaneous interventions (nephrostomy), laparoscopy, and pediatric radiological applications. Used in conjunction with stand-alone ultrasound systems for urological imaging.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• UROSKOP Omnia (K101491)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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

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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 [phone] or [phone] or at its Internet address

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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

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## Indications for Use

510(k) Number (if known)

K161019

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)

| <span style="font-size:120%">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------|
| <span style="font-size:120%">☐</span> 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: [phone] Contact: Oliver Eikenberg, PhD, Senior Consultant, QA / RA Email: [e-mail]

#### 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<br>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.

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#### 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.

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#### 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 Device<br>Uroview FD | Predicate Device<br>UROSKOP Omnia | Similarities /<br>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<br>Registration No. | 9610903 | 2240869 | N/A |
| Product Code: | JAA | JAA | Same |
| Regulation Number | 892.1650 | 892.1650 | Same |
| Device Classification<br>Name | Image-intensified fluoroscopic x-ray<br>system | Image-intensified fluoroscopic x-ray<br>system | Same |
| Class: | II | II | Same |
| Indications for use | The Uroview FD is a solid state detector<br>fluoroscopic X-ray system, primarily for<br>urological applications (functional x-ray-<br>diagnostics, endourology and minimal invasive<br>urology/surgery). The system, which includes<br>a radiologic/ urologic treatment table, may be<br>used for urological, treatment, planning and<br>diagnostic procedures including but not<br>limited to:<br>Querying and retrieving patient information<br>and /or images from other modalities. X-ray examination of the urogenital area<br>(e.g. cyctoscopy, kidney, bladder, ureter,<br>urethra) including KUB, IVP, vasovesiculo-<br>graphy, reflux-cystogram,<br>cystourethrogram, and micturation<br>cystourethrogram combined with uroflow<br>measurements. Ultrasound examinations (in conjunction<br>with a stand-alone ultrasound system) of<br>the kidney, bladder, prostate, scrotum. Endourological interventions (e.g. of the<br>urethra, prostate, bladder, sphincter, ostium,<br>kidney and ureter, catheter placement , penile<br>implant placement, transurethral resection of<br>prostate or bladder, alternative treatment of<br>the BPH and brachytherapy). Percutaneous interventions (e.g. PCN<br>nephrolithotomy, resection, percutaneous<br>nephrostomy). Laparoscopy (e.g. cholecystectomy,<br>nephrectomy, lymph node dissection,<br>abdominal testis detection/correction,<br>varicocele). Application of fistula (kidney/bladder). Simple procedures (e.g. urethra, testis,<br>phimosis). Intracorporeal shock wave lithotripsy. Uroflow/urodynamics. | The UROSKOP Omnia is a solid state detector<br>fluoroscopic X-ray system, primarily for<br>urological applications (functional x-ray-<br>diagnostics, endourology and minimal invasive<br>urology/surgery). The system, which includes<br>a radiologic/urologic treatment table, may be<br>used for urological, gastroenterological and<br>gynecological treatment, planning and<br>diagnostic procedures including but not<br>limited to:<br>Querying and retrieving patient history<br>information and /or previous diagnosis and<br>images from other modalities. X-ray examination of the urogenital area<br>(e.g. cyctoscopy, kidney, bladder, ureter,<br>urethra) including KUB, IVP, vasovesiculo-<br>graphy, reflux-cystogram,<br>cystourethrogram, and micturation<br>cystourethrogram combined with uroflow<br>measurements. Ultrasound examinations (in conjunction<br>with a stand-alone ultrasound system) of<br>the kidney, bladder, prostate, scrotum. Endourological interventions (e.g. of the<br>urethra, prostate, bladder, sphincter,<br>ostium, kidney and ureter, catheter<br>placement , penile implant placement,<br>transurethral resection of prostate or<br>bladder, alternative treatment of the BPH,<br>brachytherapy, as well as gynecological<br>procedures requiring radiological support). Percutaneous interventions (e.g. PCN<br>nephrolithotomy, resection, percutaneous<br>nephrostomy). Laparoscopy (e.g. cholecystectomy,<br>nephrectomy, lymph node dissection,<br>abdominal testis detection/correction,<br>varicocele). Application of fistula (kidney/bladder). Simple procedures (e.g. urethra, testis,<br>phimosis). Intracorporeal shock wave lithotripsy. Uroflow/urodynamics. | Similar, only<br>reduced for<br>gastroentero-<br>logical and<br>gynecological<br>treatment<br>applications |
| | Proposed Device<br>Uroview FD | Predicate Device<br>UROSKOP Omnia | Similarities /<br>Differences |
| Major Components<br>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<br>handed version…