(29 days)
Not Found
N/A
No
The summary describes a flexible fiber endoscope and associated imaging equipment, but there is no mention of AI or ML capabilities for image analysis, diagnosis, or any other function. The focus is on visual examination and image transfer.
Yes
The device is described as being used for "treatment of a variety of urological endoscopic procedures," indicating a therapeutic purpose in addition to visual examination.
Yes
Explanation: The device is intended for "visual examination and treatment," indicating it's used to identify conditions (diagnosis) as well as intervene.
No
The device description explicitly states it consists of a "flexible fiber endoscope" and accessories, which are hardware components. It also mentions connection to camera heads and CCUs, further indicating hardware involvement.
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 directly on the patient's body for visualization and intervention, not a test performed on a sample taken from the body.
- Device Description: The device is a "flexible fiber endoscope" used for "visual examination and treatment." This aligns with an in-vivo (within the living body) procedure.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on direct visualization and potential treatment within the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
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
FGB, FBO
Device Description
The KARL STORZ Pediatric Cysto-Urethro-Fiberscope and Accessories consists of a flexible fiber endoscope (Model Numbers: 11278ACU1 and 11278AC2) 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
urological
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
Non-Clinical performance data is not provided in this submission as the majority of the technological characteristics of the subject device and predicate device are equivalent. Where differences exist, the results of testing on the reference device are leveraged in support of safety and effectiveness. Clinical testing was not required to demonstrate the substantial equivalence to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Primary Predicate Device: KARL STORZ Pediatric Flexible Cysto-Urethro-Fiberscope (Flex-X2) and Accessories
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.
0
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.
August 1, 2024
Karl Storz Se & Co. Kg Thomas Ostrowski Senior Regulatory Affairs Specialist Dr.-Karl-Storz-Straße 34 Tuttlingen, BW 78532 GERMANY
K241945 Re:
Trade/Device Name: KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB. FBO Dated: July 2, 2024 Received: July 3, 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
K241945 - 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 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.
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 Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
2
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 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
3
Indications for Use
510(k) Number (if known) K241945
Device Name
KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278AC2); KARL STORZ Ped. Cysto-Urethro-Fiberscope (11278ACU1)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/4/Picture/0 description: The image displays the logo for Karl Storz Endoskope. The word "STORZ" is written in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are written in smaller, blue letters.
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: | July 2, 2024 | |
| Type of 510(k) Submission: | Special | |
| Device Identification: | Trade Name: KARL STORZ Pediatric Cysto-Urethro-Fiberscope
Models: 11278ACU1/AC2 | |
| Common Name: | Ureteroscope and Accessories | |
| Regulatory Class: | II | |
| Product Code: | FGB, FBO | |
| Regulation: | 876.1500 - Endoscope and accessories | |
| Device Panel: | Gastroenterology & Urology | |
| Predicate Device(s): | Primary Predicate Device: KARL STORZ Pediatric Flexible Cysto-
Urethro-Fiberscope (Flex-X2) and Accessories
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 Numbers:
11278ACU1 and 11278AC2) 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. | |
| 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
K082046 |
| Type of Scope | Flexible | Same as the subject device |
| Diameter of
working
channel | 1.2 mm | Same as the subject device |
| Working shaft
length | 450 mm | Same as the subject device |
| Working shaft
diameter | 2.85 mm | Same as the subject device |
| 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 | 285° Up
285° Down | Same as the subject device |
| Non-Clinical
Performance Data | Non-Clinical performance data is not provided in this submission as the
majority of the technological characteristics of the subject device and
predicate device are equivalent. Where differences exist, the results of
testing on the reference device are leveraged in support of safety and
effectiveness. | |
| 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 and reference devices supports substantial
equivalence to the predicate device and the results of testing on the
reference device are leveraged in support of 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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Image /page/5/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, in smaller blue letters, is the text "KARL STORZ - ENDOSKOPE".