KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO

K082046 · KARL STORZ Endoscopy-America, Inc. · FBO · Oct 10, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082046
• Device Name: KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO
• Applicant: KARL STORZ Endoscopy-America, Inc.
• Product Code: FBO · Gastroenterology, Urology
• Decision Date: Oct 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and accessories are intended used for by a physican in thevisual examination and treatment of a variety of a variety of arological endoscopic procedures for pediatric patients.

Device Story

The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope is a flexible endoscope used by physicians for the visual examination and treatment of urological conditions in pediatric patients. The device functions as a visualization tool, allowing the clinician to navigate the urinary tract to perform endoscopic procedures. It is used in a clinical setting, such as a hospital or specialized urology clinic. The output is a direct visual image provided to the physician, which informs clinical decision-making during diagnostic or therapeutic interventions. By providing a minimally invasive means of viewing and treating the pediatric urinary tract, the device assists in the management of urological disorders.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and intended use comparisons.

Technological Characteristics

Flexible endoscope and accessories. Class II device under 21 CFR 876.1500. Product code FBO. Mechanical visualization device.

Indications for Use

Indicated for pediatric patients undergoing urological endoscopic procedures for visual examination and treatment. For use by physicians.

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.

Submission Summary (Full Text)

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K082046

## 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>600 Corporate Pointe Drive<br>Culver City, CA 90230<br>[phone] |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Monika Campbell<br>Senior Regulatory Affairs Specialist<br>Telephone [phone]<br>Fax [phone]<br>E-mail: [e-mail] |
| Device Identification: | Common Name:<br>Karl Storz Pediatric Flex-X2™<br>Trade Name:<br>Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope |

Accessories

Indication: The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories are intended used for by a physican in thevisual examination and treatment of a variety of a variety of arological endoscopic procedures for pediatric patients.

Device Description: The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories includes a flexible endoscope and accessory items designed for treatment of urological endoscopic procedures. The Karl Storz Pediatric Flexible Cysto-Urethnel Fiberscope is a Class II device under 21CFR876.1500, Endoscope and accessories.

Substantial Equivalence: The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope is substantially equivalent to the predicate device since the basic features and intended uses

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The minor differences between the Karl Storz Pediatric Flexible Cystoare the same. are the battler - The Marcelicate device raise no new issues of safety and effectiveness, as these differences have no effect on the performance, function or general intended use of these devices.

KO82046

Signature:

Monika Campbell Senior Regulatory Affairs Specialist

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 0 2008

Ms. Monika Campbell Senior Regulatory Affairs Specialist Karl Storz Endoscopy - America, Inc. 600 Corporate Pointe CULVER CITY CA 90230

Re: K082046

Trade/Device Name: Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: September 30, 2008 Received: October 1, 2008

Dear Ms. Campbell:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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## Page 2

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to procced to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

loque M. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): IBD K 682046

Device Name: _ Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Accessories

The Karl Storz Pediatric Flexible Cysto-Urethro-Fiberscope and Indications for Use: accessories are intended used for by a physican in thevisual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Aomi M. Whim

(Divisi Division of Reproductive, Abdomi and Radiological D 510(k) Number

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