(265 days)
Not Found
No
The description focuses on the optical and mechanical components of a flexible fiberscope and does not mention any computational or algorithmic features indicative of AI/ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" sections are explicitly marked as "Not Found".
Yes
The "Intended Use / Indications for Use" section states that the device can "perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "examination of the upper urinary tract including the ureter and kidneys" and, "using additional accessories, to perform various diagnostic and therapeutic procedures." The term "diagnostic procedures" directly implies that the device has a diagnostic function.
No
The device description clearly outlines physical components like a light post connection, fiber optic light conductor, optical image bundle, flexible shaft, working channel, and deflection lever, indicating it is a hardware device. The performance studies also focus on hardware-related testing like biocompatibility and reprocessing validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the examination of the upper urinary tract and to perform diagnostic and therapeutic procedures using accessories. This involves direct visualization and intervention within the body.
- Device Description: The description details an optical instrument with a flexible shaft, working channel, and deflection mechanism. These are characteristics of an endoscope used for internal examination and procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples. IVDs are designed to analyze these types of samples to provide diagnostic information.
- Performance Studies: The performance studies focus on biocompatibility, reprocessing validation, and bench testing related to the physical and optical properties of the endoscope, not on the analytical performance of testing biological samples.
Therefore, the KARL STORZ Flexible Uretero-Reno-Fiberscope is a medical device used for internal examination and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.
Product codes
FGB
Device Description
The optical component of the KARL STORZ flexible ureteroscope consists of:
• A light post connection with screw-on adapters for fiberoptic light cables.
• A fiber optic light conductor
• An optical image bundle behind an objective lens
• A flexible shaft housing
• A magnifying eyepiece with a focusing ring that rotates to adjust to the appropriate diopter correction for the user
• A reticle, or marker in the field of view, that indicates the 12 o'clock position as a point of reference
The insertable portion of the instrument is divided into a flexible shaft section and a deflection section. The features of the shaft include:
• A working channel that accepts flexible accessories at the proximal end and features a T-LUER Lock fitting for irrigation
• A deflection lever, for active distal tip deflection
• A proximal strain relief that connects the flexible shaft to the handpiece
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
upper urinary tract including the ureter and kidneys
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
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 Guidance:
Biocompatibility testing
The system complies with the following standards:
• ISO 10993
Reprocessing Validation Summary
The reprocessing data submitted complies with the following standards and guidance with regards to cleaning and sterilization:
• AAMI ST91:2021
• ANSI/AAMI/ISO 14937:2009
• FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Additional bench testing was performed to ensure that the device met its design specifications and is substantially equivalent to its predicate devices. This data complies with the following standards:
• IEC 60601-2-18:2009
• IEC 62471:2006
• ISO 8600-5:2020
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.
Key Metrics
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.
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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.
June 10, 2024
Karl Storz Endovision, Inc % Jennifer Downing Senior Regulatory Affairs Specialist Karl Storz Endoscopy America, Inc 2151 E. Grand Avenue El Segundo, California 90245
Re: K232911
Trade/Device Name: KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2), STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FGB Received: May 15, 2024
Dear Jennifer Downing:
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.
1
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 (OS) 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 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 medical devices and radiation-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 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
3
Indications for Use
Submission Number (if known)
Device Name
KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [positive deflection] (11278A2); KARL STORZ Flexible Uretero-Reno-Fiberscope FLEX-X2S [contra-positive deflection] (11278AU1)
Indications for Use (Describe)
The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for examination of the upper urinary tract including the ureter and kidneys and, using additional accessories, to perform various diagnostic and therapeutic procedures.
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)
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Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters. Below that, the words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters. The logo is simple and professional.
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 KSEA's knowledge.
| Submitter: | KARL STORZ Endoscopy America, Inc.
2151 E. Grand Avenue
EI Segundo, CA 90245 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jennifer Downing
Senior Regulatory Affairs Specialist
jennifer.downing@karlstorz.com
Tel.: 1-424-218-8115 |
| Date of Preparation: | September 18th, 2023 |
| Type of 510(k)
Submission: | Traditional |
| Device
Identification: | Trade Name: KARL STORZ Flexible Uretero-Reno-Fiberscope
Models: 11278A2/AU1 |
| Common Name: | Ureteroscope and Accessories |
| Regulatory Class: | II |
| Product Code: | FGB |
| Classification
Name: | 876.1500 - Endoscope and accessories |
| Device Panel: | Gastroenterology & Urology |
| Predicate Device(s): | Primary Predicate Device: K982905 -MVM 7.5 French Flexible
Ureteroscope
Secondary Predicate Device: K925128 - 11274 Series Flexible
Fiberscope
These predicate devices have not been subject to a design-related
recall. K982905 was subject to a reprocessing-related recall, which
was resolved via a labeling update to discontinue use of HLD
reprocessing for the affected ureteroscopes. HLD reprocessing is not
used for the subject device in this 510(k) submission. |
| Device Description: | The optical component of the KARL STORZ flexible ureteroscope
consists of:
• A light post connection with screw-on adapters for fiberoptic light
cables. |
5
Image /page/5/Picture/1 description: The image shows the logo for Karl Storz Endoskope. The logo is in blue and features the word "STORZ" in large, bold letters. Below the word "STORZ" is the phrase "KARL STORZ - ENDOSKOPE" in smaller letters.
| | | | • A fiber optic light conductor
• An optical image bundle behind an objective lens
• A flexible shaft housing
• A magnifying eyepiece with a focusing ring that rotates to adjust to
the appropriate diopter correction for the user
• A reticle, or marker in the field of view, that indicates the 12 o'clock
position as a point of reference
The insertable portion of the instrument is divided into a flexible shaft
section and a deflection section. The features of the shaft include:
• A working channel that accepts flexible accessories at the proximal
end and features a T-LUER Lock fitting for irrigation
• A deflection lever, for active distal tip deflection
• A proximal strain relief that connects the flexible shaft to the
handpiece | | | |
|-----------------------------------|--|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------------------|-------------------------------|
| Indications For Use: | | | The KARL STORZ Flexible Uretero-Reno-Fiberscope is indicated for
examination of the upper urinary tract including the ureter and kidneys
and, using additional accessories, to perform various diagnostic and
therapeutic procedures. | | | |
| Technological
Characteristics: | | | The comparison of technological characteristics is as follows: | | | |
| | | | Subject Device | Primary Predicate
K982905 | Secondary
Predicate
K925128 | |
| | | | Type of
Scope | Flexible | Same as the subject
device | Same as the
subject device |
| | | | Diameter of
working
channel | 1.2 mm | Same as the subject
device | Same as the
subject device |
| | | | Working
shaft length | 675 mm | 700 mm | 400, 600, 800 mm |
| | | | Working
shaft
diameter | 2.85 mm | Same as the subject
device | 2.79 mm |
| | | | Light
source | External | Same as the subject
device | Same as the
subject device |
| | | | Direction of
view | 0° | Same as the subject
device | Same as the
subject device |
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Image /page/6/Picture/0 description: The image shows 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.
Page 3 of 4 KARL STORZ Premarket Notification KARL STORZ Flexible Uretero-Reno-Fiberscope 510(k) Summary
| Field of View | 90° | Same as the subject device | 70° | |
|---|---|---|---|---|
| Viewer | Eyepiece | Integrated Video Module | Same as the subject device | |
| Distal Tip Deflection | 285° Up | |||
| 285° Down | 120° Up | |||
| 170° Down | 120° Up | |||
| 120° 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 Guidance: |
Biocompatibility testing
The system complies with the following standards:
• ISO 10993
Reprocessing Validation Summary
The reprocessing data submitted complies with the following standards and guidance with regards to cleaning and sterilization:
• AAMI ST91:2021
• ANSI/AAMI/ISO 14937:2009
• FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
Additional bench testing was performed to ensure that the device met its design specifications and is substantially equivalent to its predicate devices. This data complies with the following standards:
• IEC 60601-2-18:2009
• IEC 62471:2006
• ISO 8600-5:2020 | | | |
| 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 nonclinical tests demonstrate that the | | | |
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Image /page/7/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, are the words "KARL STORZ - ENDOSKOPE".
K232911 Page 4 of 4 KARL STORZ Premarket Notification KARL STORZ Flexible Uretero-Reno-Fiberscope 510(k) Summary
subject device, the KARL STORZ Flexible Uretero-Reno-Fiberscope, performs as well as or better than the predicate devices that are currently marketed for the same intended use.