(29 days)
No
The summary describes a standard videoscope and its compatible control units. There is no mention of AI, ML, image processing beyond basic video signal handling, or any performance metrics typically associated with AI/ML algorithms. The performance studies focus on electrical safety, optical performance, and reprocessing, not algorithmic performance.
No.
The device description states its use is to "provide visualization and operative access" for procedures, which indicates it is a diagnostic tool and a conduit for other therapeutic instruments, rather than a therapeutic device itself.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is used "during diagnostic and therapeutic endoscopic procedures of urinary tract."
No
The device description explicitly states it is a "Flexible Video Cysto-Urethroscope" and mentions it is a videoscope that outputs video signals, requiring connection to a CCU (hardware) for operation. The performance studies also include testing related to hardware aspects like electrical safety, EMC, optical performance, and reprocessing.
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 used for "visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract". This describes a device used in vivo (within the body) for direct observation and intervention, not for testing samples in vitro (outside the body).
- Device Description: The description details a videoscope that provides video signals for display, consistent with an endoscopic device used for internal visualization.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostic testing.
Therefore, the Flexible Video Cysto-Urethroscope C-VIEW is a medical device used for endoscopic procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Flexible Video Cysto-Urethroscope C-VIEW is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
Product codes (comma separated list FDA assigned to the subject device)
FAJ, FBO
Device Description
The Flexible Video Cysto-Urethroscope C-VIEW (Part Number: 11272VUE) is intended to be used with multiple compatible CCUs: C-MAC (8403ZX, cleared via K182186) and C-HUB II (20290301, cleared via K182186). Identical to the predicates, the scope cannot be operated on its own because it is a videoscope whose image data output is provided in the form of video signals and sent to the CCU for decoding and display. Therefore, when the scope is connected to the compatible CCUs, it becomes the Flexible Video Cysto-Urethroscope C-VIEW System, which provides visualization and operative access in the urinary tract.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary tract including the urethra, bladder, ureters, 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 (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 FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Optical Performance Testing Color Reproduction and Color Contrast Illumination Detection Uniformity Spatial Resolution & Depth of Field Latency 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 Flexible Video Cysto-Urethroscope (C-view) has met all its design specification and is substantially equivalent to its predicate devices.
Clinical Performance Data: Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence.
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.
Flexible HD Cysto-Urethroscope (K191357), Flexible CMOS-Video-Cysto-Urethroscope (K131364)
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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October 29, 2020
KARL STORZ Endoscopy-America, Inc Winkie Wong Regulatory Affairs Manager 2151 E. Grand Avenue EI Segundo, CA 90245
Re: K202957 Trade/Device Name: Flexible Video Cysto-Urethroscope (C-view) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FAJ, FBO Dated: September 29, 2020 Received: September 30, 2020
Dear Winkie Wong:
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. 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
1
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-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 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,
for Mark Antonino Acting 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)
Device Name Flexible Video Cysto-Urethroscope (C-view)
Indications for Use (Describe)
The Flexible Video Cysto-Urethroscope C-VIEW is used to provide visualization and operative access during diagnostic and therapeutic endoscopic procedures of urinary tract including the urethra, bladder, ureters, and kidneys.
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 text "KARL STORZ - ENDOSKOPE" in a smaller font.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information 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.
| Applicant: | KARL STORZ Endoscopy-America, Inc
2151 E. Grand Avenue
El Segundo, CA 90245 | |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Contact: | Winkie Wong
Regulatory Affairs Manager
310-658-3427 (phone) | |
| Date of
Preparation: | October 20th, 2020 | |
| Type of 510(k)
Submission: | Special | |
| Device
Identification: | Trade Name: | Flexible Video Cysto-Urethroscope (C-view) |
| | Common Name: | Cystoscope and accessories, Flexible/Rigid (FAJ)
Cystourethroscope (FBO) |
| Product Code: | FAJ, FBO | |
| Classification
Number and
Name: | 21 CFR 876.1500 (Endoscope and Accessories) | |
| Predicate
Device(s): | Flexible HD Cysto-Urethroscope (K191357) – Primary
Flexible CMOS-Video-Cysto-Urethroscope (K131364) – Secondary
The above predicate devices have not been subject to any recall | |
| Device
Description: | The Flexible Video Cysto-Urethroscope C-VIEW (Part Number: 11272VUE) is
intended to be used with multiple compatible CCUs: C-MAC (8403ZX, cleared via
K182186) and C-HUB II (20290301, cleared via K182186). Identical to the
predicates, the scope cannot be operated on its own because it is a videoscope | |
4
| | | | K202957
Page 2 of 4 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|----------------------------------------------|-----------------------------------------------|
| whose image data output is provided in the form of video signals and sent to the CCU
for decoding and display. Therefore, when the scope is connected to the compatible
CCUs, it becomes the Flexible Video Cysto-Urethroscope C-VIEW System, which
provides visualization and operative access in the urinary tract. | | | | |
| Indications for
use: | The Flexible Video Cysto-Urethroscope C-VIEW is used to provide visualization and
operative access during diagnostic and therapeutic endoscopic procedures of
urinary tract including the urethra, bladder, ureters, and kidneys.
The indications for use are identical to the primary predicate device. The subject | | | |
| | device includes kidneys when compared to the secondary predicate. This difference
does not have different intended use because the kidney is part of the urinary tract. | | | |
| Technological
Characteristics: | The subject device is a modification of the primary predicate, 11272VHU, cleared via
K182723 and most recently via K191357 for the addition of HLD for reprocessing. It
is also the next generation of the secondary predicate device, 11272VU, cleared via
K131364 as lower cost alternative imaging systems when compared to the primary
predicate. | | | |
| | The comparison of technological characteristics is as follow: | | | |
| | | Subject Device | Primary Predicate
K191357 | Secondary Predicate
K131364 |
| | | Flexible Video Cysto-
Urethroscope System | Flexible HD Cysto-
Urethroscope
System | Flexible CMOS
Video Cysto
Uretheroscope |
| | Type of scope | Flexible | Same as the subject
device | Same as the subject
device |
| | Insertion Shaft Diameter | 5.2 mm | 5.5 mm | 5.5 mm |
| | Insertion Shaft Length | 37 cm | Same as the subject
device | Same as the subject
device |
| | Working Channel
Diameter | 2.3 mm | 2.3 mm | 2.2 mm |
| | Suction Port/Channel | Via working channel | Yes | Via working channel |
| | Deflection (°) | Up: 210°
Down: 140° | Same as the subject
device | Same as the subject
device |
| | (C1) Type of Imager | CMOS | CMOS | CMOS |
| | (C2) Field of View | 100° | Same as the subject
device | Same as the subject
device |
| | (C3) Direction of View | 0° | Same as the subject
device | Same as the subject
device |
| | (C4) Depth of Field | 5-50 mm | Same as the subject
device | Same as the subject
device |
| | (C5) On-axis Resolution
(minimal) | 1.8 lp/mm @ 5 mm
16 lp/mm @50 mm | 2.5 lp/mm @3 mm
40 lp /mm@50 mm | 1.1 lp/mm @ 5 mm
11 lp/mm @ 50mm |
| | (C6) Light Source | Internal LED | Same as the subject
device | Same as the subject
device |
| | (C7) Compatible CCUs | C-MAC (8403ZX)
C-HUB II (P/N20290301) | IMAGE1 S | C-MAC (8402ZX) |
| 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 FDA Guidance Document Reprocessing Medical Devices in Health Care Settings: Validation
Methods and Labeling Optical Performance Testing Color Reproduction and Color Contrast Illumination Detection Uniformity Spatial Resolution & Depth of Field Latency 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 Flexible
Video Cysto-Urethroscope (C-view) has met all its design specification and is
substantially equivalent to its predicate devices. | | | |
| Substantial
Equivalence: | The indications for use, operating principles, technological characteristics and
features are similar, if not identical, between that subject device and the predicate
devices, Flexible HD Cysto-Ureteroscope (K191357) and CMOS Flexible Video
Endoscope (K131364). The minor difference between the subject and predicate
devices that does not raise new or different questions or safety and effectiveness are
listed above in Technological Characteristics section. | | | |
| | As proven by the comparisons, the differences do not raise different questions of
safety and effectiveness because the intended use, operating principles. | | | |
5
6
technological characteristics, and features are similar, if not identical. Both systems also comply with identical standards and safety testing, where applicable. | |
---|---|
Substantial equivalence on the effectiveness of the subject device is supported by the comparison of the images and standard image quality characteristics including, but not limited to the performance testing listed above. | |
Clinical | |
Performance | |
Data: | Clinical performance is not required to demonstrate substantial equivalence to the predicate devices. Non-clinical bench testing was sufficient to establish substantial equivalence. |
Conclusion: | The Flexible Video Cysto-Urethroscope C-VIEW is substantially equivalent to its predicate device. The non-clinical bench and comparative testing demonstrate that the device is as safe and effective as the legally marketed devices. |