KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)

K241945 · Karl Storz SE & CO. KG · FGB · Aug 1, 2024 · Gastroenterology, Urology

Device Facts

• Record ID: K241945
• Device Name: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
• Applicant: Karl Storz SE & CO. KG
• Product Code: FGB · Gastroenterology, Urology
• Decision Date: Aug 1, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

Device Story

Flexible fiber endoscope; used for visual examination and treatment of urological procedures in pediatric patients. Device operates as standalone or connects to FDA-cleared camera heads and Computer Control Units (CCUs) to transfer images. Used in healthcare facilities/hospitals by physicians. Provides direct visualization via eyepiece or external camera/CCU system to assist in clinical decision-making and procedural guidance.

Clinical Evidence

No clinical data provided; substantial equivalence demonstrated through technological comparison and leveraging of reference device testing.

Technological Characteristics

Flexible fiber endoscope; 1.2 mm working channel; 450 mm working shaft length; 2.85 mm working shaft diameter; 0° direction of view; 90° field of view; 285° up/down distal tip deflection; external light source; eyepiece viewer; compatible with external camera heads/CCUs.

Indications for Use

Indicated for use by physicians for visual examination and treatment of urological endoscopic procedures in pediatric patients.

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 Pediatric Flexible Cysto-Urethro-Fiberscope (Flex-X2) (K082046)

Submission Summary (Full Text)

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August 1, 2024

Karl Storz Se & Co. Kg Thomas Ostrowski Senior Regulatory Affairs Specialist Dr.-Karl-Storz-Straße 34 Tuttlingen, BW 78532 GERMANY

K241945 Re:

> Trade/Device Name: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB. FBO Dated: July 2, 2024 Received: July 3, 2024

Dear Thomas Ostrowski:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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## K241945 - Thomas Ostrowski

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See

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the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mark J. Antonino -S

Mark J. Antonino, M.S. Assistant Director DHT3B: Division of Reproductive, Gynecology, and Urology Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K241945

#### Device Name

KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)

Indications for Use (Describe)

The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image displays the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.

## 510(k) Summary

This 510(k) Summary 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 KARL STORZ' knowledge.

| Submitter: | KARL STORZ SE & CO. KG<br>Dr.-Karl-Storz-Straße 34<br>Tuttlingen, BW 78532<br>Germany | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Contact: | Thomas Ostrowski<br>Senior Regulatory Affairs Specialist<br>[e-mail]<br>Tel: [phone] | |
| Date of Preparation: | July 2, 2024 | |
| Type of 510(k) Submission: | Special | |
| Device Identification: | Trade Name: KARL STORZ Pediatric Cysto-Urethro-Fiberscope<br>Models: 11278ACU1/AC2 | |
| Common Name: | Ureteroscope and Accessories | |
| Regulatory Class: | II | |
| Product Code: | FGB, FBO | |
| Regulation: | 876.1500 - Endoscope and accessories | |
| Device Panel: | Gastroenterology & Urology | |
| Predicate Device(s): | Primary Predicate Device: KARL STORZ Pediatric Flexible Cysto-<br>Urethro-Fiberscope (Flex-X2) and Accessories<br>The predicate device has not been subject to a design-related recall. | |
| Device Description: | The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and<br>Accessories consists of a flexible fiber endoscope (Model Numbers:<br>11278ACU1 and 11278AC2) which can be used standalone or<br>connected to compatible FDA-cleared camera heads which transfer<br>images to compatible FDA-cleared Computer Control Units (CCUs) for<br>the purposes of visual examination and treatment of a variety of<br>urological endoscopic procedures for pediatric patients. | |
| Environment of Use: | The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and<br>Accessories is intended to be used only in healthcare facilities/hospitals. | |
| Indications for Use: | The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and<br>Accessories are intended for use by a physician in the visual<br>examination and treatment of a variety of urological endoscopic<br>procedures for pediatric patients. | |
| Technological<br>Characteristics: | The comparison of technological characteristics is as follows: | |
| | Subject Device | Predicate<br>K082046 |
| Type of Scope | Flexible | Same as the subject device |
| Diameter of<br>working<br>channel | 1.2 mm | Same as the subject device |
| Working shaft<br>length | 450 mm | Same as the subject device |
| Working shaft<br>diameter | 2.85 mm | Same as the subject device |
| Light source | External | Same as the subject device |
| Direction of<br>view | 0° | Same as the subject device |
| Field of view | 90° | Same as the subject device |
| Viewer | Eyepiece | Same as the subject device |
| Distal Tip<br>Deflection | 285° Up<br>285° Down | Same as the subject device |
| Non-Clinical<br>Performance Data | Non-Clinical performance data is not provided in this submission as the<br>majority of the technological characteristics of the subject device and<br>predicate device are equivalent. Where differences exist, the results of<br>testing on the reference device are leveraged in support of safety and<br>effectiveness. | |
| Clinical<br>Performance Data | Clinical testing was not required to demonstrate the substantial<br>equivalence to the predicate device. | |
| Conclusion | The similarity of technological characteristics between the subject<br>device and the predicate and reference devices supports substantial<br>equivalence to the predicate device and the results of testing on the<br>reference device are leveraged in support of safety and effectiveness.<br>We conclude that the substantial equivalence of the subject and the<br>predicate device has been demonstrated, and differences between the<br>subject and predicate device do not raise new questions of safety or<br>effectiveness. | |

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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the text "KARL STORZ - ENDOSKOPE".