(203 days)
Not Found
No. The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on its mechanical and optical functions for visualization.
Yes
The "Intended Use / Indications for Use" states that the device "can be used... to perform various diagnostic and therapeutic procedures."
Yes
Explanation: The "Intended Use / Indications for Use" states that the device is indicated for "endoscopic examination in the urinary tract" and can be used "to examine the interior of the kidney," and "to perform various diagnostic and therapeutic procedures." The term "examine" and "diagnostic procedures" clearly indicate a diagnostic function.
No
The device is a physical uretero-renoscope that is used for direct visualization and procedures. Its description explicitly details hardware components such as a luer with two ports and mechanisms for distal tip deflection, indicating it is a physical medical device, not software-only.
No. This device is an endoscope for direct visualization within the body, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
Flexible Video-Uretero-Renoscope (Flex XC)
The KARL STORZ Flexible Video-Uretero-Renoscope 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.
Product codes
FGB
Device Description
The KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract, kidney, ureters
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1500 Endoscope and accessories.
(a)
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.(b)
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.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 6, 2025
Karl Storz Se & Co. Kg
Emily Rhiel
Regulatory Affairs Specialist
Dr. Karl-Storz-Straße 34
Tuttlingen, BW 78532
GERMANY
Re: K243550
Trade/Device Name: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope And Accessories
Regulatory Class: Class II
Product Code: FGB
Dated: May 7, 2025
Received: May 7, 2025
Dear Emily Rhiel:
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.
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K243550 - Emily Rhiel Page 2
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).
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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
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K243550 - Emily Rhiel Page 3
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 J. Antonino -S
Mark 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
Page 4
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Submission Number (if known)
K243550
Device Name
KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Indications for Use (Describe)
Flexible Video-Uretero-Renoscope (Flex XC)
The KARL STORZ Flexible Video-Uretero-Renoscope is indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney, and using additional accessories,
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
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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."
Page 5
KARL STORZ Premarket Notification Flexible Video-Uretero-Renoscope 510(k) Summary
K243550
Page 1 of 3
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 and the FDA guidance document titled "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]" issued on July 28, 2014. All data included in this document is accurate and complete to the best of KARL STORZ SE & Co. KG knowledge.
| Submitter: | KARL STORZ SE & Co. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|---|---|
| Contact: | Emily Rhiel
Senior Regulatory Affairs Specialist
Phone: (774) 318-2820
Email: emily.rhiel@karlstorz.com |
| Date of Preparation: | June 6, 2025 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Flexible Video-Uretero-Renoscope (FLEX-XC) |
| Regulatory Class: | II |
| Product Code: | FGB |
| Classification Name: | Ureteroscope and accessories, Flexible/Rigid (21 CFR Part 876.1500) |
| Device Panel: | Gastroenterology & Urology |
| Predicate Device(s): | K141250 KARL STORZ Flexible Video-Uretero-Renoscope |
Device Description: The KARL STORZ Flexible Video-Uretero-Renoscope (PNs 11278VSE, 11278VSUE) is a video endoscope used for visualization within the upper urinary tract (ureters) and kidneys. The endoscope includes a luer with two ports to allow access for instrumentation, as well as irrigation. The Flexible Video-Uretero-Renoscope models 11278VSE and 11278VSUE differ only in the direction of the distal tip deflection. With 11278VSUE when the control lever is pushed forward towards the distal tip, the distal tip deflects down and with 11278VSE the deflection is opposite.
Indications for Use: Flexible Video-Uretero-Renoscope (Flex XC)
The KARL STORZ Flexible Video-Uretero-Renoscope 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.
Physical and Technological Characteristics:
| | Subject Device
Flexible Video-Uretero-Renoscope | Predicate Device Videoscope:
K141250
Flexible Video-Uretero-Renoscope |
|---|---|---|
| Endoscope Type | Flexible CMOS video endoscope | Same as subject |
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K243550
Page 2 of 3
| | Subject Device
Flexible Video-Uretero-Renoscope | Predicate Device Videoscope:
K141250
Flexible Video-Uretero-Renoscope |
|---|---|---|
| Camera Control Unit | Image 1 S CCU (Connect and Link modules required) | Same as subject |
| Deflection | 285° up/down
270° with instruments in the working channel | 270° up/down |
| Working Length | 675mm | Same as subject |
| Working Channel Diameter | 1.2mm | Same as subject |
| Outer Diameter | 2.9mm | Same as subject |
| Light Source | Internal LED | Same as subject |
| Direction of View | 0° | Same as subject |
| Field of View | 80-110° | 80-95° |
Non-Clinical Performance Data:
Biocompatibility Evaluation
The system complies with the following standards:
- ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 10993-2: Biological evaluation of medical devices – Part 2: Animal welfare requirements
- ISO 10993-5: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: Biological evaluation of medical devices – Part 10: Tests skin sensitization
- ISO 10993-11: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- ISO 10993-12: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
- ISO 10993-18: Biological evaluation of medical devices – Part 18: Chemical characterization of materials
- ISO 10993-23 Biological evaluation of medical devices – Part 23: Tests for irritation 2021
Reprocessing Validation
The reprocessing data submitted complies with the following standards:
- ISO 14937: Sterilization of health care products — General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
- ISO 17665-1: Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- ANSI / AAMI ST98: Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
- ASTM F3208-20: Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices.
- ISO 17664-1: Processing of health care products - Information to be provided by the medical device manufacturer for the processing of
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K243550
Page 3 of 3
medical devices - Part 1: Critical and semi-critical medical devices
- ANSI / AAMI ST77: Containment Devices for Reusable Medical Device Sterilization.
- ISO 22441:2022. Sterilization of Health Care Products – General Requirements for Characterization of a Sterilization Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
Bench Performance Testing
The bench performance data submitted complies with the following standards:
- ISO 8600-1: Endoscopes - Medical endoscopes and endotherapy devices -- Part 1: General requirements
- ISO 8600-3: Endoscopes - Medical endoscopes and endotherapy devices Part 3: Determination of field of view and direction of view of endoscopes with optics
- IEC 62471: Photobiological safety of lamps and lamp systems
Clinical Performance Data: Clinical testing was not required to demonstrate the substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to establish the substantial equivalence of the modifications.
Conclusion: The conclusions drawn from the non-clinical performance data demonstrates that the subject device is as safe as and as effective as the predicate device. As such, we conclude that the substantial equivalence of the subject and the predicate device has been met, and the differences between the subject and the predicate device do not raise new questions of safety and effectiveness.