Flexible Video-Uretero-Choledochoscope System

K142556 · KARL STORZ Endoscopy-America, Inc. · FGB · Oct 23, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K142556
• Device Name: Flexible Video-Uretero-Choledochoscope System
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Oct 23, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The KARL STORZ Flexible Video-Uretero- Choledochoscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Uretero-Choledochoscope System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Device Story

System comprises flexible video-uretero-choledochoscope and Image 1 SPIES Camera Control Unit (CCU). Device uses integrated LED light and fiber light guides for cavity illumination; CMOS imaging sensor at insertion shaft tip captures video. Sensor signals processed by CCU for display on standard HD monitor. Used by physicians in clinical settings for visualization during diagnostic/therapeutic procedures. No design changes from predicate; update reflects expanded indications and labeling. Benefits include visualization of urinary tract and bile ducts to facilitate minimally invasive interventions.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical performance data, including optical characteristics (ISO 8600), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993), and validation of cleaning/sterilization methods.

Technological Characteristics

Flexible endoscope with CMOS sensor, LED illumination, and fiber light guides. Connects to Image 1 SPIES CCU for HD display. Biocompatible materials per ISO 10993. Tested for electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and optical performance (ISO 8600).

Indications for Use

Indicated for endoscopic examination of the urinary tract, percutaneous examination of the kidney interior, and examination of bile ducts during cholecystectomy, including use with accessories for diagnostic and therapeutic procedures.

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

• DUR-Digital Ureteroscope and Choledochoscope System (DUR-D) (K060269)
• KARL STORZ Flexible Video-Uretero-Renoscope System (K141250)

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

October 23, 2014

Karl Storz Endoscopy-America, Inc. Mike Samuels Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245

Re: K142556

> Trade/Device Name: Flexible Video-Uretero-Choledochoscope System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Codes: FGB, FBN Dated: September 10, 2014 Received: September 11, 2014

Dear Mike Samuels,

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [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 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) K142556

Device Name

Flexible Video-Uretero-Choledochoscope System

#### Indications for Use (Describe)

The KARL STORZ Flexible Video-Uretero- Choledochoscope System is indicated for endoscopic examination in the urinary tract and can be used percutaneously to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures. The Flexible Video-Uretero-Choledochoscope System is also indicated for the examination of bile ducts, and using additional accessories, to perform various diagnostic and therapeutic procedures during cholecystectomy.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Image /page/3/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the text "KARL STORZ - ENDOSKOPE" in a smaller font.

# 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>El Segundo, CA 90245 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mike Samuels |
| | Regulatory Affairs Specialist |
| | Phone: [phone] |
| | Fax: [phone] |
| Date of Preparation: | September 10, 2014 |
| Device Identification: | Trade Name: Flexible Choledochoscope |
| | Common Name: Flexible Video-Uretero-Choledochoscope<br>System |
| | Classification Name: Choledochoscope and Accessories,<br>Flexible/ Rigid |
| Product Code: | FGB and FBN |
| Regulation: | 21 CFR part 876.1500 |
| Predicate Device(s): | The primary predicate device is the DUR-Digital<br>Ureteroscope and Choledochoscope System (DUR®-D),<br>K060269, manufactured by ACMI Corporation. The<br>secondary predicate is the KARL STORZ Flexible Video-<br>Uretero-Renoscope System, K141250. |
| Device Description: | The Flexible Video-Uretero-Choledochoscope System is used<br>for visualization purposes during diagnostic and therapeutic<br>procedures. The system components are the Flexible Video-<br>Uretero-Choledochoscope and the Image 1 SPIES Camera<br>Control Unit (CCU). The Flexible Video-Uretero-<br>Choledochoscope uses an LED light integrated in the handle<br>and fiber light guides to illuminate the cavity under<br>examination. The video image is produced by a<br>complementary metal-oxide-semiconductor (CMOS)<br>imaging sensor located at the tip of the insertion shaft. The<br>imaging sensor transfers the video signal to the Image 1 |
| | SPIES CCU via electronics in the handle. The Image1 HD<br>CCU processes the sensor images and displays them on a<br>standard HD display monitor. |
| | This change is to expand the indications for the currently<br>cleared secondary predicate Flexible Video-Uretero-<br>Renoscope System (K141250) to allow it to also be<br>marketed as a Choledochoscope used for examination of the<br>bile duct and to allow the ability to percutaneously access<br>the abdominal cavity for examination of the kidney. No<br>changes were made to the device design as part of this<br>update. Only the model number and applicable labeling<br>were updated. |
| Indications For Use: | The Flexible Video-Uretero-Choledochoscope System is<br>indicated for endoscopic examination in the urinary tract<br>and can be used percutaneously to examine the interior of<br>the kidney, and using additional accessories, to perform<br>various diagnostic and therapeutic procedures. The Flexible<br>Video-Uretero-Choledochoscope System is also indicated for<br>the examination of bile ducts, and using additional<br>accessories, to perform various diagnostic and therapeutic<br>procedures during cholecystectomy. |
| Technological<br>Characteristics: | The Karl Storz Flexible Video-Uretero-Choledochoscope<br>System has the same indications for use as the originally<br>cleared primary predicate ACMI Corporation DUR-Digital<br>Ureteroscope and Choledochoscope System (DUR®-D),<br>K06026. The Flexible Video-Uretero-Choledochoscope<br>System and the secondary predicate Flexible Video-Uretero-<br>Renoscope System (K141250), both manufactured by KARL<br>STORZ, are exactly the same and share the same<br>fundamental technology and physical characteristics. The<br>methods of operation, design and materials used are either<br>identical or substantially equivalent to existing legally<br>marketed predicate devices. |
| Non-Clinical<br>Performance Data: | The Flexible Video-Uretero-Choledchoscope System and the<br>secondary predicate Flexible Video-Uretero-Renoscope<br>System (K141250), both manufactured by KARL STORZ, are<br>exactly the same and share the same fundamental<br>technology and physical characteristics. Therefore, the<br>performance data described in the cleared Flexible Video-<br>Uretero-Renoscope System, K141250, is also applicable to<br>the Flexible Video-Uretero-Choledochoscope System. No<br>changes were made to the device design as part of this<br>update. Only the model number and applicable labeling<br>were updated. The KARL STORZ secondary predicate<br>Flexible Video-Uretero-Renoscope System has been<br>evaluated according to ISO 14971 risk management process<br>and the system was successfully tested for its functions and |
| | performance; including verification of optical characteristics<br>per ISO 8600 (image quality, illumination). Safety testing<br>was performed including electrical safety IEC 60601-1,<br>electromagnetic compatibility per IEC 60601-1-2, and<br>biocompatibility of the patient contacting materials per ISO<br>10993. Additional validations were conducted for the<br>manual cleaning method, sterilization process. |
| Clinical<br>Performance Data: | Clinical testing was not required to demonstrate substantial<br>equivalence to the predicate devices. |
| Conclusion: | The Flexible Video-Uretero-Choledochoscope System is<br>substantially equivalent to its predicate devices. The non-<br>clinical testing demonstrates that the device is as safe, as<br>effective and performs as well as or better than the legally<br>marketed devices. |

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