FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM

K141250 · KARL STORZ Endoscopy-America, Inc. · FGB · Jun 11, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141250
• Device Name: FLEXIBLE VIDEO-URETERO-RENOSCOPE SYSTEM
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Jun 11, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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

Flexible Video-Uretero-Renoscope System provides visualization for urological procedures. System includes flexible video-uretero-renoscope and Image 1 SPIES Camera Control Unit (CCU). Scope features integrated LED handle light, fiber light guides, and distal CMOS imaging sensor. Sensor captures video, transmitting signals through handle electronics to CCU. CCU processes images for display on standard HD monitor. Used in clinical settings by physicians for kidney and urinary tract examination/intervention. Modifications include conversion to Image 1 SPIES CCU, material changes for STERRAD compatibility, and insertion shaft length reduction to 675mm. Device enables minimally invasive visualization, assisting clinicians in diagnostic and therapeutic decision-making.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated through bench testing, including optical performance, electrical safety, electromagnetic compatibility, and biocompatibility testing.

Technological Characteristics

Flexible endoscope with distal CMOS sensor, LED illumination, and fiber light guides. Materials modified for STERRAD sterilization compatibility. Insertion shaft length 675mm. Connectivity via proprietary electronics to Image 1 SPIES CCU. Standards: ISO 8600 (optical), IEC 60601-1 (electrical), IEC 60601-1-2 (EMC), ISO 10993 (biocompatibility).

Indications for Use

Indicated for endoscopic examination of the urinary tract and kidney in patients requiring diagnostic or therapeutic urological procedures. Prescription use only.

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.

Predicate Devices

• KARL STORZ Flexible Video-Uretero-Renoscope System (K131369)

Reference Devices

• Image 1 SPIES CCU (K135319)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo consists of the word "STORZ" in large, bold letters, with a circle in the middle of the "O". Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font. The logo is black and white.

KARL STORZ Premarket Notification Flexible Video-Uretero-Renoscope System 008_Summary of Safety and Effectiveness

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

JUN 1 1 2014

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: [phone]<br>Fax: [phone] |
| Date of Preparation: | May 08, 2014 |
| Device Identification: | Trade Name: Flexible Ureteroscope<br>Common Name: Flexible Video-Uretero-Renoscope System<br>Classification Name: Ureteroscope and Accessories, Flexible/<br>Rigid |
| Product Code: | FGB |
| Regulation: | 21 CFR part 876.1500 |
| Predicate Device(s): | KARL STORZ Flexible Video-Uretero-Renoscope System,<br>K131369 |
| Device Description: | The Flexible Video-Uretero-Renoscope System is used for<br>visualization purposes during diagnostic and therapeutic<br>procedures. The system components are the Flexible Video-<br>Uretero-Renoscope and the Image 1 SPIES Camera Control<br>Unit (CCU). 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 SPIES CCU via electronics in the handle. The<br>Image1 HD CCU processes the sensor images and displays<br>them on a standard HD display monitor.<br>The modifications made to the Flexible Video-Uretero-<br>Renoscope System (K131369) are the conversion to the |

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Image 1 SPIES CCU (K135319), material changes for STERRAD compatibility, a reduction in the insertion portion from 700mm to 675mm, and revision of the reprocessing instructions.

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

Technological

Non-Clinical

Clinical

Conclusion:

Performance Data:

Performance Data:

Characteristics:

The Karl Storz modified Flexible Video-Uretero-Renoscope System has the same indications for use as the originally cleared Karl Storz Flexible Video-Uretero-Renoscope System (K131369). The methods of operation; design and materials used are either identical or substantially equivalent to existing legally marketed predicate devices

The modifications incorporated into the KARL STORZ Flexible Video-Uretero-Renoscope System have been evaluated according to ISO 14971 risk management process and the system was successfully tested for its functions and performance; including verification of optical characteristics per ISO 8600 (image quality, illumination). Safety testing was performed including electrical safety IEC 60601-1, electromagnetic compatibility per IEC 60601-1-2, and biocompatibility of the patient contacting materials per ISO 10993. Additional validations were conducted for the manual cleaning method, sterilization process.

Clinical testing was not required to demonstrate substantial equivalence to the predicate device.

The modified Flexible Video-Uretero-Renoscope System is substantially equivalent to its predicate devices. The nonclinical 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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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, and three bars underneath the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 11, 2014

Karl Storz Endoscopy-America, Inc. Leigh Spotten Regulatory Affairs Manager 2151 E. Grand Avenue El Segundo, CA 90245-5017

Re: K141250

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: May 13, 2014 Received: May 14, 2014

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, 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.

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Page 2 - Leigh Spotten

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.

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/ReportalProblem/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 [phone] or [phone] 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): _K141250

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
2014.06.11 17:46:51 -04'00'