K233372 · Karl Storz SE & CO. KG · FGB · Jul 25, 2024 · Gastroenterology, Urology
Device Facts
Record ID
K233372
Device Name
KARL STORZ Fiber Telescopes for Urology
Applicant
Karl Storz SE & CO. KG
Product Code
FGB · Gastroenterology, Urology
Decision Date
Jul 25, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1500
Device Class
Class 2
Attributes
Real-World Evidence, Pediatric
Real-World Evidence
Submission
Device
Sponsor
RWD Sources
RWE Use Summary
Key Tags
K233372 · Jul 25, 2024
KARL STORZ Fiber Telescopes for Urology
Karl Storz SE & CO. KG
Published clinical literature
Published literature was provided to support the safety and effectiveness of the KARL STORZ Fiber Telescopes for Urology for use in pediatrics during minimal invasive urological endoscopic procedures.
Pediatric use; Literature review; Clinical performance
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Published literature; Literature review
Pediatric patients
Not applicable for this study
Safety and effectiveness
Indications for Use
For devices (27033C, 27033CR, 27033D, 27033F, 27033CRO, 27033CO, 27033DO, 27001E, 27001G, 27001GH, 27001GF, 27014Y) The sheaths, obturators, and accessories when used with compatible endoscopes are intended to provide visualization and access to operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27000K, 27000L, 27010K, 27010L, 27002KP, 27030KA, 27030KB) The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27001K, 27001L, 27002K, 27002L, 27003L, 27011K, 27011L) The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults.
Device Story
Manually operated reusable semi-rigid fiber optic telescopes; includes sheaths, obturators, and accessories. Operates by transmitting light to operative site via fiber bundles; transmits images from distal end to eyepiece via central optical fiber bundle. Provides working channel for instrument access. Used in hospital settings by physicians/surgeons for upper urinary tract procedures. Enables direct visualization of operative site to facilitate minimally invasive urological interventions. Benefits include access and visualization for surgical procedures.
Clinical Evidence
No clinical trials performed. Safety and effectiveness for pediatric use supported by published literature.
Indicated for visualization and access to operative site during minimally invasive urological endoscopic procedures in adults and pediatric populations.
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
KARL STORZ Uretero Renoscopes/Ureteroscopes (K940464)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
July 25, 2024
Karl Storz SE & Co. Kg
% Jordan Lydia Verla
Senior Regulatory Affairs Specialist
Karl Storz Endoscopy-America, Inc.
2151 E. Grand Avenue
El Segundo, CA 90245
Re: K233372
Trade/Device Name: KARL STORZ Fiber Telescopes for Urology
Regulation Number: 21 CFR§ 876.1500
Regulation Name: Endoscope and Accessories
Regulatory Class: II
Product Code: FGB
Dated: June 14, 2024
Received: June 14, 2024
Dear Jordan Lydia Verla:
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" (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).
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K233372 - Jordan Lydia Verla
Page 2
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 QS 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 (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-reporting-combination-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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 the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark R. Kreitz -S
for 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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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF
| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K233372 | |
| Device Name KARL STORZ Fiber Telescopes for Urology | |
| Indications for Use (Describe) For devices (27033C, 27033CR, 27033D, 27033F, 27033CRO, 27033CO, 27033DO, 27001E, 27001G, 27001GH, 27001GF, 27014Y) The sheaths, obturators, and accessories when used with compatible endoscopes are intended to provide visualization and access to operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27000K, 27000L, 27010K, 27010L, 27002KP, 27030KA, 27030KB) The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27001K, 27001L, 27002K, 27002L, 27003L, 27011K, 27011L) The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults. | |
| Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | |
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K233372
Page 1 of 5
STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Fiber Telescopes for Urology
510(k) Summary
# 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 KSEA's knowledge.
| Submitter: | KARL STORZ SE & CO. KG Dr.-Karl-Storz-Straße 34 TUTTLINGEN, Baden-Wurttemberg GERMANY, 78532 |
| --- | --- |
| Contact: | Jordan Lydia Verla Senior Regulatory Affairs Specialist Tel: (424) 218-8100 ext. 8382 Email: Jordan.Verla@karlstorz.com |
| Date of Preparation: | September 30, 2023 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ Fiber Telescopes for Urology Common Name: Ureteroscope and accessories, flexible/rigid Classification Name: Endoscope and accessories (21 CFR 876.1500) |
| Regulatory Class: | II |
| Product Code: | FGB |
| Classification Panel: | Gastroenterology/Urology |
| Predicate Device(s): | KARL STORZ Uretero Renoscopes/Ureteroscopes (K940464) |
| Device Description: | KARL STORZ Fiber Telescopes for Urology are manually operated reusable surgical devices that fall into the following categories: Urethroscopes / Ureteroscope / Uretero-Renoscope, modular scope, sheaths, telescopic bridges, luer lock tube connectors, obturators, insertion aids, adapters. The KARL STORZ Fiber Telescopes for urology are semi-rigid telescopes that utilize fiber optic technology. The shaft of the endoscopes consists of phynox or stainless steel. An optical fiber bundle runs through a central lumen in the shaft and transmits the image received at the distal end to the eyepiece. Other fibers illuminate the operative site by transmitting light. An operating, or working channel, provides instruments access to the operative site. The |
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K233372
Page 2 of 5
STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Fiber Telescopes for Urology
510(k) Summary
| | KARL STORZ Fiber Telescopes are available in the following: | | |
| --- | --- | --- | --- |
| | Direction of View | 0°, 7° | |
| | Field of View | 95,5°, 96.5° | |
| | Diameter | Graduated 7Fr, 8Fr, 10Fr, 12Fr | |
| | Working Length | 13cm, 25cm, 34cm, 43cm | |
| | Working Channel | 3.5Fr, 4.5Fr, 5Fr, 6Fr | |
| Indications for Use: | Indications for Use are in the Technological Characteristics section, below. | | |
| Technological Characteristics: | The subject and predicate device have similar technological characteristics and similar operating principles as the subject device. | | |
| | | KARL STORZ Fiber Telescopes for Urology Subject Device | KARL STORZ Uretero-Renoscopes / Ureteroscopes Predicate Device K940464 |
| | Indications for Use | For devices (27033C, 27033CR, 27033D, 27033F, 27033CRO, 27033CO, 27033DO, 27001E, 27001G, 27001GH, 27001GF, 27014Y) The sheaths, obturators, and accessories when used with compatible endoscopes are intended to provide visualization and access to operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27000K, 27000L, 27010K, 27010L, 27002KP, 27030KA, 27030KB) The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults and pediatrics. For telescopes (27001K, 27001L, 27002K, 27002L, 27003L, 27011K, 27011L) | The Storz Uretero-Renoscopes Ureteroscopes are designed to permit a physician or surgeon to view the operative site during minimally invasive urological endoscopic or laparoscopic procedures. |
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K233372
Page 3 of 5
STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Fiber Telescopes for Urology
510(k) Summary
| | The endoscopes are intended to provide visualization of the operative site during minimal invasive urological endoscopic procedures in adults. | |
| --- | --- | --- |
| Product Code(s) | FGB | FGB |
| Target Population | Adults & Pediatrics | Adults & Pediatrics |
| Anatomical Site | Upper Urinary Tract | Upper Urinary Tract |
| Where Used | Hospital | Hospital |
| Endoscope Type | Semi-Rigid | Semi-Rigid |
| Optical Design / Technology | Fiber Optic | Fiber Optic |
| Direction of View | 0°, 7° | 0° |
| Diameter | Graduated 7Fr, 8Fr, 10Fr, 12Fr | Graduated 7Fr, 9.5Fr, 10.5Fr, 11Fr, 13Fr |
| Working Length | 13cm, 25cm, 34cm, 43cm | 11cm, 34cm, 43cm, 44.5cm |
| Working Channel | 3.5Fr, 4.5Fr, 5Fr, 6Fr | 3.5Fr, 5Fr |
| Field of View | 95,5°, 96.5° | 0°, 74°, 96.5° |
| Light Source | External | External |
| Patient Contacting Material | Scopes: Cobalt-Chromium-Nickel Alloy, Stainless Steel, Silver Solder, Epoxy Adhesive, Sapphire Glass, Glass Fibers,
Sheaths: Surgical Stainless Steel, Silver Brazing Alloy, Epoxy Adhesive, Lubricant, Ester + PTFE
Bridges: Surgical Stainless Steel
Luer Lock Connectors: Stainless Steel, Lubricant, Ester + PTFE, Coating | Chromium Plated Monel 400 |
| Cleaning | Manual | Manual |
| Sterilization | Scopes: (27003L, 27030KA, 27030KB, 27002KP, 27000L, 27001L, 27011L, 27002L, 27000K, 27001K, 27011K, 27002K): Steam Sterilization | EO, HLD (2% glutaraldehyde) |
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K233372
Page 4 of 5
STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Fiber Telescopes for Urology
510(k) Summary
| | (27010L, 27010K): Steam Sterilization; STERRAD 100NX; V-PRO 1 Cycle, V-PRO 1 Plus Lumen Cycle, V-PRO Max Lumen Cycle, V-PRO Max 2 Lumen Cycle Sheaths: Steam Sterilization Bridges: Steam Sterilization Luer-Lock Connectors: Steam Sterilization Obturators: Steam Sterilization Insertion Aids: Steam Sterilization Adapters/Instrument Ports: Steam Sterilization | |
| --- | --- | --- |
| Non-Clinical Performance Data: | There are no performance standards or special controls developed under Section 514 of the FD&C Act for endoscopes. However, the HOPKINS Telescopes follows the FDA recognized consensus standards and is tested according to the following standards and FDA Guidance: ISO Endoscopic Standards • ISO 8600-1 • ISO 8600-3 • ISO 8600-5 • ISO 8600-6 Biocompatibility Summary • Cytotoxicity (ISO 10993-5) • Acute Systemic Toxicity (ISO 10993-11) • Intracutaneous Irritation (ISO 10993-10) • Maximization Sensitization (ISO 10993-10) Electrical Safety and EMC • IEC 60601-2-18 (3RD Edition) Reprocessing (Cleaning and Sterilization) • AAMI TIR12: 2010 | |
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K233372
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STORZ
KARL STORZ—ENDOSKOPE
KARL STORZ Premarket Notification
KARL STORZ Fiber Telescopes for Urology
510(k) Summary
| | • AAMI TIR30: 2011 • ANSI/AAMI ST8: 2013 • ANSI/AAMI ST77:2013 • ANSI/AAMI ST79:2017 • ANSI/AAMI ST81:2004/(R)2010 • AAMI/ISO 14937:2009 • ANSI/AAMI/ISO 17655-1:2006/2013 • Reprocessing Medical Device in Health Care Settings: Validation Methods and Labeling
Comparative bench testing between the subject and predicate device demonstrated that the KARL STORZ Fiber Telescopes for Urology has met all its design specification and is substantially equivalent to its predicate device. |
| --- | --- |
| Clinical Performance Data: | Published literature was provided to support the safety and effectiveness of the KARL STORZ Fiber Telescopes for Urology for use in pediatrics during minimal invasive urological endoscopic procedures. |
| Conclusion: | The conclusions drawn from the nonclinical test demonstrate that the subject device is as safe and effective as the predicate device. |
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