(26 days)
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on a flexible fiber endoscope and standard imaging components.
Yes
The device is described as being used for "treatment of a variety of urological endoscopic procedures," which indicates a therapeutic purpose rather than solely diagnostic.
Yes
The device is intended for "visual examination and treatment," which includes the diagnostic function of visual examination.
No
The device description explicitly states it consists of a "flexible fiber endoscope" and accessories, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients." This describes a procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The device is a "flexible fiber endoscope" used for "visual examination and treatment." This aligns with a medical device used for direct visualization and intervention within the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. IVDs are specifically designed to perform tests on samples to diagnose diseases or conditions.
Therefore, the KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are a medical device used for endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Product codes (comma separated list FDA assigned to the subject device)
FBO
Device Description
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Number: 11274BCU1) 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 visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Pediatric patients
Intended User / Care Setting
Physician / healthcare facilities/hospitals
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)
Bench Performance Testing: Bench testing was performed to ensure that the device met its design specifications and is substantially equivalent to the predicate device. This testing referenced below 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. A summary of bench performance test results referenced in the submission is listed below: Bench testing – Optical Performance Verification, Bench testing – Thermal Safety / Photobiological Safety.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K241945 KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories (11278ACU1 / 11278AC2)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2024
Karl Storz Se & Co. Kg Thomas Ostrowski Senior Regulatory Affairs Specialist Dr.-Karl-Storz-Straße 34 Tuttlingen, BW 78532 GERMANY
K243409 Re:
Trade/Device Name: KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FBO Dated: October 31, 2024 Received: November 1, 2024
Dear Thomas Ostrowski:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
1
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
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 Rue"). 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-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
2
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-device-advice-comprehensive-regulatoryassistance/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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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
KARL STORZ Pediatric Cysto-Urethro-Fiberscope (11274BCU1)
Indications for Use (Describe)
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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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510(k) Summary
This 510(k) Summary is being submitted in accordance with the requirements of the Safe Medical Devices Act (SMDA) of 1990 and 21 CFR 807.92. All data included in this document is accurate and complete to the best of KARL STORZ' knowledge.
| Submitter: | KARL STORZ SE & CO. KG
Dr.-Karl-Storz-Straße 34
Tuttlingen, BW 78532
Germany |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Thomas Ostrowski
Senior Regulatory Affairs Specialist
thomas.ostrowski@karlstorz.com
Tel: +1 (508) 248-2420 |
| Date of Preparation: | November 26, 2024 |
| Type of 510(k) Submission: | Special |
| Device Identification: | Trade Name: KARL STORZ Pediatric Cysto-Urethro-Fiberscope
Models: 11274BCU1 |
| Common Name: | Cystourethroscope |
| Classification Name: | Cystourethroscope |
| Regulatory Class: | II |
| Product Code: | FBO |
| Regulation: | 876.1500 - Endoscope and accessories |
| Device Panel: | Gastroenterology & Urology |
| Predicate Device(s): | Primary Predicate Device: K241945 KARL STORZ Pediatric Cysto-
Urethro-Fiberscope and Accessories (11278ACU1 / 11278AC2) |
| | The predicate device has not been subject to a design-related recall. |
| Device Description: | The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and
Accessories consists of a flexible fiber endoscope (Model Number:
11274BCU1) 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 visual
examination and treatment of a variety of urological endoscopic
procedures for pediatric patients. |
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| Environment of Use: | The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories is intended to be used only in healthcare facilities/hospitals. | ||
|---|---|---|---|
| Indications for Use: | The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories are intended for use by a physician in the visual examination and treatment of a variety of urological endoscopic procedures for pediatric patients. | ||
| Technological | |||
| Characteristics: | The comparison of technological characteristics is as follows: | ||
| Subject Device | Predicate Device | ||
| K241945 | |||
| Type of Scope | Flexible | Same as the subject device | |
| Diameter of working channel | 1.2 mm | Same as the subject device | |
| Working shaft length | 250 mm | 450 mm | |
| Working shaft diameter | 2.78 mm | 2.85 mm | |
| Light source | External | Same as the subject device | |
| Direction of view | 0° | Same as the subject device | |
| Field of view | 90° | Same as the subject device | |
| Viewer | Eyepiece | Same as the subject device | |
| Distal Tip Deflection | 170° Up | ||
| 120° Down | 285° Up | ||
| 285° Down | |||
| Non-Clinical | |||
| Performance Data | Non-Clinical performance data is provided in this submission for the technical characteristics of the subject device and predicate device that differ in value. Where differences exist, the subject device test methods are equivalent to those of the predicate device. Design equivalency in optical features of the subject and predicate device supports reliance on previously submitted and cleared Optical performance test reports. | ||
| 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 testing provided or referenced meets the following recognized standards and FDA guidance: | |||
| Biocompatibility Testing | |||
| 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. |
6
| 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 FDA Guidance Document: Use of International Standard ISO
10993-1, "Biological evaluation of medical devices - Part 1:
| Evaluation and testing within a risk management process" | |
|---|---|
| Reprocessing Validation Summary | |
| The reprocessing data submitted and referenced complies with the | |
| following standards and guidance with regards to cleaning and | |
| sterilization: | |
| 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 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 | |
| | |
| | • FDA Guidance Document: Reprocessing Medical Devices in
Health Care Settings: Validation Methods and Labeling |
| | Bench Performance Testing
Bench testing was performed to ensure that the device met its design
specifications and is substantially equivalent to the predicate device.
This testing referenced below 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 PerformanceVerification |
| | A summary of bench performance test results referenced in the
submission is listed below:
• Bench testing – Optical Performance Verification
• Bench testing – Thermal Safety / Photobiological Safety |
| Clinical
Performance Data | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate device. |
| Conclusion | The similarity of technological characteristics between the subject
device and the predicate device supports substantial equivalence and the
results of testing on the subject device support safety and effectiveness.
We conclude that the substantial equivalence of the subject and the
predicate device has been demonstrated, and differences between the
subject and predicate device do not raise new questions of safety or
effectiveness. |
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