K131369 · KARL STORZ Endoscopy-America, Inc. · FGB · Nov 26, 2013 · Gastroenterology, Urology
Device Facts
Record ID
K131369
Device Name
FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
Applicant
KARL STORZ Endoscopy-America, Inc.
Product Code
FGB · Gastroenterology, Urology
Decision Date
Nov 26, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The Karl Storz Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Device Story
System provides visualization for urological procedures; consists of Flexible Video-Uretero-Renoscope and Image 1 HD Camera Control Unit (CCU). Scope uses integrated LED and fiber light guides for illumination; CMOS imaging sensor at insertion shaft tip captures video. Sensor signals transmitted to CCU via handle electronics; CCU processes images for display on standard SD/HD monitors. Used in clinical settings by physicians; enables real-time visualization of urinary tract/kidney interior. Output allows clinicians to perform diagnostic and therapeutic interventions; benefits include improved visualization for minimally invasive procedures.
Clinical Evidence
Bench testing only. Performance verified per ISO 8600 (image quality, illumination) and mechanical standards (bend, deflection, articulation). Safety testing included electrical (IEC 60601-1, IEC 60601-2-18), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993). Validations performed for software, cleaning, and sterilization.
Technological Characteristics
CMOS imaging sensor; LED illumination; 2.9mm outer shaft diameter; 700mm working length; 1.2mm working channel; 270° up/down deflection. Connectivity via Image 1 HD CCU supporting NTSC/PAL/VGA/DVI/SDI. Biocompatible materials per ISO 10993. Sterilization via validated methods.
Indications for Use
Indicated for endoscopic examination of the urinary tract and kidney interior, and for performing diagnostic and therapeutic procedures with accessories. No specific age or gender restrictions provided.
Regulatory Classification
Identification
An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.
Special Controls
*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.
In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls:
1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following:
1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures.
2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use.
3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use.
2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes.
3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches
4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error.
5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program.
(6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms.
(7) Labeling must include:
(i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified;
(ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA;
(iii) Identification of compatible devices;
(iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification;
(v) Reprocessing instructions for reusable components;
(vi) A shelf life for any sterile components;
(vii) A description of the device-specific use training program;
(viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and
(ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance.
(8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include:
(i) Device motion accuracy and repeatability;
(ii) System testing;
(iii) Instrument reliability;
(iv) Crosstalk;
(v) Table motion control;
(vi) Thermal effects on tissue;
(vii) User-device interface performance;
(viii) Workspace access testing; and
(ix) Performance testing with compatible devices.
(9) Software verification, validation, and hazard analysis must be performed.
(10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed.
(11) Performance data must demonstrate the sterility of all patient-contacting device components.
(12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(13) Performance data must validate the reprocessing instructions for the reusable components of the device.
(14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible.
(15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic.
(16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information:
(i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and
(ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.
Predicate Devices
ACMI Dur-Digital Ureteroscope and Choledochoscope System (K060269)
Karl Storz Imaging, New Camera Architecture (NCA) Video Imaging System (K003325)
Submission Summary (Full Text)
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Image /page/0/Picture/2 description: The image shows the logo for Karl Storz Endoskope. The logo is in black and white and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOP" in smaller letters.
### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KSEA's knowledge.
| Applicant: | Karl Storz Endoscopy-America, Inc<br>2151 E. Grand Avenue<br>EI Segundo, CA 90245 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Leigh Spotten<br>Regulatory Affairs Manager<br>Phone: 424-218-8738 |
| Device Identification: | Trade Name:<br>Karl Storz Flexible Video-Uretero-Renoscope System<br>Common Name:<br>Ureteroscope and Accessories, Flexible Rigid<br>Classification Name:<br>Endoscope and Accessories |
| Date of Preparation | April 22, 2013 |
| Regulation: | 21 CFR 876.1500 |
| Product Code: | FGB |
| Predicate Devices: | The Karl Storz Flexible Video-Uretero-Renoscope System is<br>substantially equivalent to the ACMI Dur-Digital Ureteroscope<br>and Choledochoscope System (K060269, including the Invisio<br>Digital Controller) and the Karl Storz Imaging , New Camera<br>Architecture (NCA) Video Imaging System (K003325) |
| Indications For Use: | The Karl Storz Flexible Video-Uretero-Renoscope System is<br>indicated for endoscopic examination in the urinary tract and<br>can be used to examine the interior of the kidney, and using<br>additional accessories, to perform various diagnostic and<br>therapeutic procedures. |
| Device Description: | The Flexible Video-Uretero-Renoscope System is used for<br>visualization purposes during diagnostic and therapeutic<br>procedures. The crucial components of the system are the<br>Flexible Video-Uretero-Renoscope and the Image 1 HD Camera<br>Control Unit. The Flexible Video-Uretero-Renoscope uses an<br>LED light integrated in the handle and fiber light guides to<br>illuminate the cavity under examination. The video image is<br>produced by a complementary metal-oxide-semiconductor<br>(CMOS) imaging sensor is located at the tip of the insertion<br>shaft. The imaging sensor transfers the video signal to the<br>Image1 HD CCU via electronics in the handle. The Image1 HD<br>CCU processes the sensor images and displays them on a<br>standard SD or HD monitor. The Karl Storz Flexible Video-<br>Uretero-Renoscope System is a Class II device under 21 CFR<br>876.1500. |
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### Technological Characteristics:
| Device Name | Karl Storz Flexible Video-Uretero-<br>Renoscope System (Subject<br>Device) | ACMI DUR-Digital Ureteroscope and<br>Choledochosope System<br>(Predicate) K060269 |
|----------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Digital video technology | CMOS | CMOS |
| Illumination Source | LED | LED |
| Field of View (Diagonal) | 90 | 80 |
| Outer Shaft Diameter (mm) | 2.9 | 3.1 |
| Working Length (mm) | 700 | 650 |
| Working Channel Diameter<br>(mm) | 1.2 | 1.2 |
| Up/Down Deflection (°) | Up: 270 | Up: 250 |
| | Down: 270 | Down: 250 |
| Field of View | 90° | 80° |
| Direction of View | 0° | 9° |
| Device Name | Image1 HD HUB CCU<br>(Subject Device) | Invisio Digital Controller<br>(Predicate Device) K060269 |
|--------------------------------------------------|---------------------------------------|----------------------------------------------------------|
| Brightness Control | Yes | Yes |
| Enhancement Control<br>(contrast and definition) | Yes | Yes |
| Shutter Speed | 1/60 - 1/17000 sec | 1/60 - 1/10000 sec |
| White Balance | Yes | Yes |
| Zoom | Yes | Yes |
| Output Formats | NTSC/PAL/VGA/DVI/SDI | NTSC/PAL/VGA/DVI |
| Image/Video Capture | Yes | No |
| Device Name | Image1 HD HUB CCU<br>(Subject Device) | Karl Storz New Camera Architecture<br>CCU (Predicate Device), K003325 |
|--------------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------|
| Video Format Inputs<br>(Cameras) | SD and HD | SD |
| Video Format Outputs | SD and HD | SD |
| Brightness Control | Yes | Yes |
| Enhancement Control<br>(contrast and definition) | Yes | Yes |
| Shutter Speed | 1/60 - 1/17000 sec | 1/60 - 1/17000 sec |
| White Balance | Yes | Yes |
| Zoom | Yes | Yes |
| Output Formats | Analog and Digital<br>NTSC/PAL/VGA/DVI/SDI | Analog - NTSC/PAL/VGA/ |
| Image/Video Capture | Yes (with ICM) | No |
| Camera Head Configurable | Yes | Yes |
### Technological Comparison Summary
The Karl Storz Flexible Video-Uretero-Renoscope System is has the same indications for use, methods of operation, design and materials used are either identical or substantially equivalent to existing legally marketed predicate devices.
The Karl Storz Flexible Video-Uretero-Renoscope System has been Non-Clinical successfully tested for its functions and performance, including Performance Data: verification of optical characteristics per ISO 8600 (image quality,
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illumination) and mechanical characteristics (bend, deflection, articulation), leak testing, and insertion testing). Safety testing was performed including electrical safety IEC 60601-1 and IEC 60601-2-18, electromagnetic compatibility per IEC 60601-1-2 and biocompatibility of the patient contacting materials per ISO 10993. Additional validations were conducted for the system software, the manual cleaning method, sterilization process, and sterilant rinsing efficacy.
Conclusion:
The Karl Storz Flexible Video-Uretero-Renoscope System is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as or better than the legally marketed devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which is a stylized representation of a human figure embracing a double helix. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 26, 2013
Karl Storz Endoscopy America, Inc. Leigh Spotten Regulatory Affairs Manager 2151 E. Grand Avenue El Segunado, CA 90245
Re: K 131369
> Trade/Device Name: Flexible Video-Uretero-Renoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Dated: October 23, 2013 Received: October 25, 2013
Dear Leigh Spotten,
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. Iisting 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
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Page 2 - Leigh Spotten
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
# Herbert P. Lerner -S
for
Benjamin R. Fisher, Ph.D: Director Division of Reproductive, Gastro-Renal. and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known):
Device Name: Flexible Video-Uretero-Renoscope System
#### Indications for Use:
The Karl Storz Flexible Video-Uretero-Renoscope System is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Herbert P.Lerner=S
2013.11.26 08:01:10 -05'00'
