(168 days)
Not Found
No
The device description details standard video processing and conversion, with no mention of AI or ML algorithms for image analysis or other functions. The performance studies focus on standard endoscope performance metrics and electrical safety, not AI/ML performance.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "can be used to examine the interior of the kidney, and using additional accessories, to perform various diagnostic and therapeutic procedures."
Yes
The "Intended Use / Indications for Use" section explicitly states that the system is "indicated for endoscopic examination in the urinary tract and can be used to examine the interior of the kidney," and "to perform various diagnostic and therapeutic procedures." Examination and diagnosis are key functions of a diagnostic device.
No
The device description clearly outlines physical hardware components including a flexible video-endoscope with a CMOS imaging sensor and LED light source, and an E-Box adaptor with a PCB. These are not software-only components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "endoscopic examination in the urinary tract" and for performing "various diagnostic and therapeutic procedures" using additional accessories. This describes a device used in vivo (within the body) for direct visualization and intervention.
- Device Description: The description details a flexible video-endoscope with an imaging sensor and light source at the distal tip, designed to be inserted into the body. It describes the processing of the video signal for display. This aligns with the function of an endoscope used for internal examination.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information about a person's health. The description of this device does not involve the analysis of such specimens.
The device is a medical device used for direct visualization and procedures within the urinary tract, which falls under the category of an endoscope, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The SSU Felxible Video-Uretero-Renoscope System 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.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
Product codes (comma separated list FDA assigned to the subject device)
FGB
Device Description
The videoscopes in the modified Flexible Video-Uretero-Renoscope SSU System are sterile single-use, flexible video-endoscopes. The distal tip houses the CMOS (Complementary Metal Oxide Semiconductor) imaging sensor and the LED light source. The raw data captured at the distal tip CMOS imaging censor is transferred to the E-Box adaptor, where it is converted to a standard NTSC (National Television System Committee) video signal by the PCB (Printed Circuit Board), which is then driven into one of the CCUs (C-MAC, C-HUB II, or X-LINK + IMAGE 1S Connect) for further processing and video formatting for output to a display monitor. The videoscopes and E-Box are powered by the CCUs through the connecting cords.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Video
Anatomical Site
Urinary tract, interior of the kidney
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18
IEC 62471
ISO 10993
ISO 8600
Performance Testing
Color Contrast Enhancement
Image intensity uniformity
Depth of field & Spatial Resolution
Distortion
Signal-to-Noise Ratio (SNR) & Sensitivity
Additional bench testing was performed to ensure the device met its design specifications. The bench testing performed verified and validated that the SSU Flexible Video-Uretero-Renoscope has met all its design specification and is substantially equivalent to its predicate devices.
Clinical Performance Data:
Clinical testing was not required to demonstrate the substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish the substantial equivalence of the modifications.
Conclusion:
The conclusions drawn from the nonclinical tests demonstrate that the subject devices, the SSU Flexible Video-Uretero-Renoscope performs as well as or better than the predicate devices that are currently marketed for the same intended use.
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.
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.
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 20, 2022
KARL STORZ Endoscopy-America, Inc. Mario Trujillo Regulatory Affairs Specialist 2151 E. Grand Avenue El Segundo, CA 90245
Re: K212458
Trade/Device Name: SSU Flexible Video-Uretero-Renoscope System Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FGB Dated: December 20, 2021 Received: December 21, 2021
Dear Mario Trujillo:
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 (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 located 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.
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 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, 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
2
Indications for Use
510(k) Number (if known) K212458
Device Name
SSU Flexible Video-Uretero-Renoscope System
Indications for Use (Describe)
The SSU Felxible Video-Uretero-Renoscope System 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.
E-Box: the product serves as an adaptor for operating the flexible single-use videoscope on the compatible CCU.
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/3/Picture/0 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.
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. KG
Dr.-Karl-Storz-Straße 34
78532 Tuttlingen, Germany |
|----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mario Trujillo
Associate Regulatory Affairs Specialist
Tel.: (424) 218-8481
Email: Mario.Trujillo@karlstorz.com |
| Date of Preparation: | September 7, 2021 |
| Type of 510(k) Submission: | Traditional |
| Device Identification: | Trade Name: SSU Flexible Video-Uretero-Renoscope System
Classification Name: Endoscope and Accessories
(21 CFR Part 876.1500); |
| Regulatory Class: | II |
| Product Code: | FGB |
| Guidance Document: | Not Applicable |
| Predicate Device: | KARL STORZ Flexible Video-Uretero-Renoscope System (K141250). |
| Device Description: | The videoscopes in the modified Flexible Video-Uretero-Renoscope
SSU System are sterile single-use, flexible video-endoscopes. The
distal tip houses the CMOS (Complementary Metal Oxide
Semiconductor) imaging sensor and the LED light source. The raw
data captured at the distal tip CMOS imaging censor is transferred to
the E-Box adaptor, where it is converted to a standard NTSC
(National Television System Committee) video signal by the PCB
(Printed Circuit Board), which is then driven into one of the CCUs (C-
MAC, C-HUB II, or X-LINK + IMAGE 1S Connect) for further
processing and video formatting for output to a display monitor. The
videoscopes and E-Box are powered by the CCUs through the
connecting cords. |
| Intended Use: | The SSU Flexible Video-Uretero-Renoscope is intended for
visualization purposes during urological procedures. |
4
Image /page/4/Picture/0 description: The image shows the logo for Karl Storz Endoskope. The word "STORZ" is in large, bold, blue letters on the top line. The words "KARL STORZ - ENDOSKOPE" are in smaller, blue letters on the bottom line.
| Indications For Use: | The SSU 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.
E-Box: the product serves as an adaptor for operating the flexible
single-use videoscope on the compatible CCU. | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------------|
| Technological
Characteristics: | Comparison Table: Subject vs. Predicate Devices | | |
| | Subject Device | Predicate Device, K141250 | |
| | Flexible Video-
Uretero-Renoscope
SSU System | Flexible Video-Uretero-
Renoscope System | |
| | Maximal Outer diameter
Insertion Portion | 3.2 mm | Same as subject device |
| | Outer diameter Insertion
Tube | 2.9 mm | Same as subject device |
| | Outer diameter Distal End | 3.2 mm | Same as subject device |
| | Insertion portion length | 700 mm | 675 mm |
| | Working channel | Present | Same as subject device |
| | Inner diameter Working
Channel | 1.2 mm | Same as subject device |
| | Tip deflection up/down | 270°/270° | Same as subject device |
| | Field of view | 110° | 90° |
| | Direction of View | 0° | Same as subject device |
| | Depth of Field | 5 - 50 mm | 4 - 60mm |
| | On-axis Resolution | 12.5 Lp/mm at 5 mm
4.5 Lp/mm at 15 mm
1.25 Lp/mm at 50 mm | 11.0 Lp/mm at 4 mm
4.0 Lp/mm at 12 mm
1.0 Lp/mm at 60 mm |
| | Chip type | CMOS | Same as subject device |
| | Chip location | Distal | Same as subject device |
| | Illumination source | LED | Same as subject device |
| | Compatible CCU | C-MAC
C-HUB II
Image 1S | Image 1S |
| | How device is provided | Sterile single-use | Unsterile, reusable |
| | EO Sterilization cycle | EO, Overpressure 2.7
bar absolute, 8.5 % ETO
in 91.5 % C02 | N/A |
| | Sterilizing Agent | Ethylene Oxide (EO) | N/A |
| 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:
Electrical Safety and EMC IEC 60601-1 IEC 60601-1-2 IEC 60601-2-18 | | |
| | ο | IEC 62471 | |
| | ο | ISO 10993 | |
| | ο | ISO 8600 | |
| | • | Performance Testing | |
| | ο | Color Contrast Enhancement | |
| | ο | Image intensity uniformity | |
| | ο | Depth of field & Spatial Resolution | |
| | ο | Distortion | |
| | ο | Signal-to-Noise Ratio (SNR) & Sensitivity | |
| Additional bench testing was performed to ensure the device met its design
specifications. The bench testing performed verified and validated that the
SSU Flexible Video-Uretero-Renoscope has met all its design
specification and is substantially equivalent to its predicate devices. | | | |
| Clinical Performance
Data: | Clinical testing was not required to demonstrate the substantial
equivalence to the predicate devices. Non-clinical bench testing was
sufficient to establish the substantial equivalence of the
modifications. | | |
| Conclusion: | The conclusions drawn from the nonclinical tests demonstrate that
the subject devices, the SSU Flexible Video-Uretero-Renoscope
performs as well as or better than the predicate devices that are
currently marketed for the same intended use. | | |
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Image /page/5/Picture/0 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 a smaller, less bold font.