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.

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.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary describe a medical device (FLEX XC ureteroscope), not an AI or software-based medical device. Therefore, the information requested about acceptance criteria and studies that apply to AI/Software as a Medical Device (SaMD) are not present in this document.

The clearance is based on the substantial equivalence of the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) to a previously cleared predicate device (K141250 KARL STORZ Flexible Video-Uretero-Renoscope).

Here's an analysis of the provided information concerning the device's performance, but it does not include any of the AI/SaMD specific criteria you requested as the device is a physical endoscope.

Device: KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC)
Product Code: FGB
Regulatory Class: Class II

Acceptance Criteria and Reported Device Performance (Non-AI/SaMD)

Since this is a physical medical device (endoscope), the "acceptance criteria" primarily relate to its physical and functional specifications, and its compliance with relevant performance and safety standards.

Acceptance Criteria Category (Derived from document)	Assumed Acceptance Criteria for Substantial Equivalence (General)	Reported Device Performance (Subject Device FLEX XC)	Predicate Device Performance (K141250)
Endoscope Type	Flexible CMOS video endoscope	Flexible CMOS video endoscope	Same as subject
Camera Control Unit	Image 1 S CCU (Connect and Link modules required)	Image 1 S CCU (Connect and Link modules required)	Same as subject
Deflection	Adequate deflection for urinary tract access (e.g., comparable to predicate)	285° up/down, 270° with instruments in the working channel	270° up/down
Working Length	Suitable for urological procedures	675mm	Same as subject
Working Channel Diameter	Adequate for instrumentation	1.2mm	Same as subject
Outer Diameter	Maximally small for patient comfort/safety, but sufficient for function	2.9mm	Same as subject
Light Source	Internal LED for illumination	Internal LED	Same as subject
Direction of View	Standard direct view	0°	Same as subject
Field of View	Adequate for visualization	80-110°	80-95°
Biocompatibility	Compliance with ISO 10993 series	Complies with ISO 10993-1, -2, -5, -10, -11, -12, -18, -23	(Assumed compliant, as it's the predicate)
Reprocessing Validation	Compliance with relevant sterilization/cleaning standards	Complies with ISO 14937, ISO 17665-1, ANSI/AAMI ST98, ASTM F3208-20, ISO 17664-1, ANSI/AAMI ST77, ISO 22441:2022	(Assumed compliant, as it's the predicate)
Bench Performance	Compliance with endoscope-specific performance standards	Complies with ISO 8600-1, ISO 8600-3, IEC 62471	(Assumed compliant, as it's the predicate)

Note on Differences: The subject device (FLEX XC) shows an improved deflection range (285° up/down vs. 270°) and a potentially wider field of view range (80-110° vs. 80-95°) compared to the predicate. The submission argues these differences do not raise new questions of safety and effectiveness, supported by non-clinical bench testing.

Study Details (Based on provided document)

The document explicitly states: "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."

Therefore, the following information, which is typically relevant for AI/SaMD clinical validation studies, is not applicable or not provided in this document:

Sample sizes used for the test set and the data provenance: Not applicable, as no clinical test set for AI/SaMD performance was used. The reported "performance" comes from bench testing of the physical device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for AI/SaMD performance was not established.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical device, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this medical device is its compliance with recognized performance standards and its physical and functional characteristics being comparable (or superior, without raising new concerns) to a cleared predicate.
The sample size for the training set: Not applicable. This device is not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Conclusion: The provided FDA 510(k) clearance documentation for the KARL STORZ Flexible Video-Uretero-Renoscope (FLEX XC) pertains to a traditional physical medical device, not a software-as-a-medical-device (SaMD) or AI-enabled device. The clearance is based on a demonstration of substantial equivalence to a predicate device through non-clinical bench testing, not through clinical studies involving human readers or AI algorithm performance analysis. Therefore, the specific criteria and study details related to AI/SaMD validation are absent from this document.

Summary

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

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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
Food and Drug Administration
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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."

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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. KGDr.-Karl-Storz-Straße 3478532 Tuttlingen, Germany
Contact:	Emily RhielSenior Regulatory Affairs SpecialistPhone: (774) 318-2820Email: 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 DeviceFlexible Video-Uretero-Renoscope	Predicate Device Videoscope:K141250Flexible Video-Uretero-Renoscope
Endoscope Type	Flexible CMOS video endoscope	Same as subject

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K243550
Page 2 of 3

	Subject DeviceFlexible Video-Uretero-Renoscope	Predicate Device Videoscope:K141250Flexible Video-Uretero-Renoscope
Camera Control Unit	Image 1 S CCU (Connect and Link modules required)	Same as subject
Deflection	285° up/down270° 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
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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.

Regulation Number and Section

§ 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.