(127 days)
The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
Based on the provided FDA 510(k) clearance letter for the KARL STORZ Cysto-Urethro-Fiberscope, it's clear that no clinical performance data was provided or required for this 510(k) submission. The submission relies entirely on non-clinical (bench) performance data.
Therefore, many of the requested elements pertaining to acceptance criteria and clinical study design (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for clinical data) are not applicable to this particular device clearance.
The 510(k) summary explicitly states:
Clinical Performance Data Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to support substantial equivalence.
Given this, I will describe the acceptance criteria as implied by the non-clinical tests conducted and the proof that the device met these criteria based on the information provided.
Acceptance Criteria and Study Proving Device Meets Acceptance Criteria for KARL STORZ Cysto-Urethro-Fiberscope
As per the submitted 510(k) summary (K244001), the substantial equivalence of the KARL STORZ Cysto-Urethro-Fiberscope was established through non-clinical performance data only. No clinical studies were conducted or required for this clearance.
Therefore, the "acceptance criteria" are derived from the successful completion of various bench tests and compliance with recognized standards designed to ensure the safety and effectiveness of the device. The "study" proving the device meets these criteria refers to the non-clinical (bench) performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to the successful completion and passing results of the tests conducted in accordance with the listed standards and internal design specifications. The performance is reported as meeting these standards.
| Acceptance Criterion (Implied by Test Performed) | Reported Device Performance |
|---|---|
| Biocompatibility (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, chemical characterization, animal welfare) | Complies with FDA 2023 biocompatibility guidance and ISO 10993 series standards (ISO 10993-1, -2, -5, -10, -11, -12, -18, -23). |
| Reprocessing Validation (Cleaning and Sterilization) | Complies with ANSI/AAMI/ISO 14937, ANSI/AAMI ST98, ASTM F3208-20, ISO 17664-1, ISO 22441, AAMI TIR12:2020/(R)2023, and FDA Guidance Document: Reprocessing Medical Devices in Health Care Settings. (Details on specific cleaning/sterilization efficacy were not provided in the summary, but successful validation is stated.) |
| Mechanical Performance (e.g., shaft length, diameter, deflection, working channel) | Meets design specifications; functionally similar to predicate device (e.g., Working shaft length: 370 mm, Deflection: 210˚ Up, 140˚ Down). Successful completion of "Bench testing – Mechanical Performance Verification" is reported. |
| Optical Performance (e.g., field of view, direction of view, image quality through eyepiece) | Field of view: 116˚, Direction of view: 0˚. Successful completion of "Bench testing – Optical Performance Verification" is reported. |
| Photobiological Safety | Successful completion of "Bench testing – Photobiological Safety" in compliance with IEC 62471:2006. |
| Thermal Safety | Successful completion of "Bench testing – Thermal Safety" in compliance with IEC 60601-2-18:2009. |
| General Electrical Safety | Compliance with IEC 60601-2-18:2009. |
| Optical Instrument Standards | Compliance with ISO 8600-3:2019 and ISO 8600-5:2020. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set was used. The "test set" in this context refers to the physical units of the device subjected to bench testing. The specific number of units tested for each non-clinical performance test is not detailed in the 510(k) summary, but it would have been sufficient to meet the requirements of the cited standards and internal quality procedures.
- Data Provenance: Not applicable for a clinical study. The non-clinical testing was conducted by KARL STORZ SE & CO. KG, which is based in Tuttlingen, Germany. The data is from laboratory (bench) testing, not patient data.
3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications
Not applicable. No clinical test set requiring expert ground truth establishment was used. Bench testing relies on objective measurement against predefined specifications and standard requirements, not subjective expert assessment of clinical data.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. An MRMC study was not conducted as no clinical performance study was performed or required.
6. If a Standalone Performance Study (Algorithm Only) Was Done
Not applicable. This device is a medical instrument (fiberscope), not an AI algorithm. Therefore, a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
- For Non-Clinical Testing: The "ground truth" for the bench tests is the objective, measurable performance of the device against established engineering specifications, safety standards (e.g., IEC, ISO, ANSI/AAMI), and the functional capabilities of the predicate device. This is determined through physical measurements, chemical analyses, and standardized test protocols.
8. The Sample Size for the Training Set
Not applicable. No clinical training set was used as this is a physical medical device (fiberscope), not an AI/ML algorithm requiring data-driven training.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No clinical training set was used.
FDA 510(k) Clearance Letter - KARL STORZ Cysto-Urethro-Fiberscope
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 2, 2025
Karl Storz SE & CO. Kg
Thomas Ostrowski
Senior Regulatory Affairs Specialist
Dr.-Karl-Storz-Straße 34
Tuttlingen, BW 78532
GERMANY
Re: K244001
Trade/Device Name: KARL STORZ Cysto-Urethro-Fiberscope (11272CU1); KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Regulation Number: 21 CFR 876.1500
Regulation Name: Endoscope and accessories
Regulatory Class: II
Product Code: FBO
Received: April 2, 2025
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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K244001 - 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 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
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K244001 - Thomas Ostrowski
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 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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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.
Submission Number (if known)
K244001
Device Name
KARL STORZ Cysto-Urethro-Fiberscope (11272CU1);
KARL STORZ Cysto-Urethro-Fiberscope (11272C2)
Indications for Use (Describe)
The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
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.
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KARL STORZ Premarket Notification
KARL STORZ Cysto-Urethro-Fiberscope
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 KARL STORZ' knowledge.
| Submitter: | KARL STORZ SE & CO. KGDr.-Karl-Storz-Straße 34Tuttlingen, BW 78532Germany |
|---|---|
| Contact: | Thomas OstrowskiRegulatory Affairs Managerthomas.ostrowski@karlstorz.comTel: +1 (508) 248-2420 |
| Date of Preparation: | April 25, 2025 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: KARL STORZ Cysto-Urethro-FiberscopeModels: 11272CU1 / 11272C2Regulatory Class: IIProduct Code: FBO (Cystourethroscope)Regulation: 21 CFR 876.1500 – Endoscope and accessoriesDevice Panel: Gastroenterology & Urology |
| Predicate Device: | KARL STORZ CYSTOSCOPE ENDOSCOPE,FIBEROPTIC (11277A/AU) – K945185The K945185 device was subject to a reprocessing-related recall, which was resolved via a labeling update to discontinue use of high-level disinfection (HLD) reprocessing for the affected scopes. HLD reprocessing is not used for the subject device in this 510(k) submission. The predicate device has not been subject to any design-related recalls applicable to the current submission. |
| Reference Device: | OES CYSTONEPHROFIBERSCOPE OLYMPUS CYF-5; CYF-5R – K221690 |
| Device Description: | The KARL STORZ Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11272CU1 / 11272C2) which can be used standalone or connected to compatible FDA-cleared camera heads which transfer images to compatible FDA-cleared Computer Control Units (CCUs) for the purposes of |
K244001
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visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder.
| Environment of Use: | The KARL STORZ Cysto-Urethro-Fiberscope and accessories is intended to be used only in healthcare facilities/hospitals. |
|---|---|
| Indications for Use: | The KARL STORZ Cysto-Urethro-Fiberscope and accessories are indicated for visualization and operative access during diagnostic and therapeutic endoscopic procedures of the urinary tract including the urethra and bladder. |
Technological Characteristics:
The comparison of technological characteristics is as follows:
| Subject Device | Predicate K945185 | |
|---|---|---|
| Type of Scope | Flexible | Same as the subject device |
| Diameter of working channel | 2.33 mm | Same as the subject device |
| Working shaft length | 370 mm | Same as the subject device |
| Working shaft diameter | 5.25 mm | 5.07 mm |
| Light source | External | Same as the subject device |
| Direction of view | 0˚ | Same as the subject device |
| Field of view | 116˚ | Similar to the subject device |
| Viewer | Eyepiece | Same as the subject device |
| Distal Tip Deflection | 210˚ Up140˚ Down | 180˚ Up140˚ Down |
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 subject device follows the FDA recognized consensus standards and is tested according to the following standards and FDA guidances:
Biocompatibility Testing
The system complies with the following standards and guidance:
- FDA 2023 biocompatibility guidance "Use of International Standard ISO 10993-1, 'Biological evaluation of medical
K244001
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devices - Part 1: Evaluation and testing within a risk management process'".
- ISO 10993-2:2006/(R)2014: Biological evaluation of medical devices – Part 2: Animal welfare requirements
- ISO 10993-5:2009/(R)2014: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021: Biological evaluation of medical devices – Part 10: Tests skin sensitization
- ISO 10993-11:2017: Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- ISO 10993-12:2021: Biological evaluation of medical devices – Part 12: Sample preparation and reference materials
- ISO 10993-18:2020: Biological evaluation of medical devices – Part 18: Chemical characterization of materials
- ISO 10993-23:2021: Biological evaluation of medical devices – Part 23: Tests for irritation 2021
Reprocessing Validation Summary
The submitted reprocessing data complies with the following standards and guidance with regards to cleaning and sterilization:
- ANSI / AAMI / ISO 14937:2009/(R)2013 - 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
- ANSI / AAMI ST98:2022 - 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 17664-1:2021 - Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices
- 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
- AAMI TIR12:2020/(R)2023 - Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers
- FDA Guidance Document: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
K244001
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Bench Performance Testing
Additional bench testing was performed to ensure that the device met its design specifications and is substantially equivalent to the predicate devices. This testing complies with the following standards:
- IEC 60601-2-18:2009
- IEC 62471:2006
- ISO 8600-3:2019
- ISO 8600-5:2020
A summary of bench performance test results included in the submission is listed below:
- Bench testing – Mechanical Performance Verification
- Bench testing – Optical Performance Verification
- Bench testing – Photobiological Safety
A summary of bench performance test results referenced in the submission is listed below:
- Bench testing – Thermal Safety
| Clinical Performance Data | Clinical testing was not required to demonstrate substantial equivalence to the predicate device. Non-clinical bench testing was sufficient to assess safety and effectiveness and to support substantial equivalence. |
|---|---|
| Conclusion | The conclusions drawn from the non-clinical tests demonstrate that the subject device, the KARL STORZ Cysto-Urethro-Fiberscope and accessories is as safe and effective as the predicate device and supports substantial equivalence to the predicate device. |
K244001
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§ 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.