(29 days)
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 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.
The provided text describes a 510(k) premarket notification for a medical device, the Flexible Video Cysto-Urethroscope (C-view). This type of submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving efficacy through extensive clinical trials as would be required for a PMA. As such, the information typically provided to meet acceptance criteria, specifically for software-based medical devices or AI/ML-driven devices, is not present here.
Based on the provided document, the "device" in question is a hardware endoscope, not an AI/ML-driven device or a device that typically has "acceptance criteria" for software performance. The document focuses on demonstrating substantial equivalence to predicate devices through technical specifications, physical characteristics, and compliance with recognized standards.
Therefore, many of the requested items (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone algorithm performance, ground truth type) are not applicable to this submission as they pertain to the evaluation of AI/ML software or diagnostic image processing, which is not the primary function of this endoscope.
However, I can extract and interpret the available information relevant to device performance and the study conducted.
Here's an analysis of the provided information in relation to your request:
Acceptance Criteria and Device Performance (Interpreted)
Since this is a hardware device submission focused on substantial equivalence, the "acceptance criteria" are implicitly defined by the technical specifications and performance characteristics compared to the predicate devices. The "study" proving it meets these involves non-clinical bench testing and adherence to recognized standards.
Table 1: Acceptance Criteria (Implied) and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implied by Predicate/Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| Device Type | Flexible Video Cysto-Urethroscope | Flexible Video Cysto-Urethroscope |
| Insertion Shaft Diameter | Similar to predicates (5.5 mm) | 5.2 mm |
| Insertion Shaft Length | Same as primary predicate (37 cm) | 37 cm |
| Working Channel Diameter | Similar to primary predicate (2.3 mm) | 2.3 mm |
| Suction Port/Channel | Present (via working channel) | Via working channel |
| Deflection (°) - Up | Similar to predicates (210°) | 210° |
| Deflection (°) - Down | Similar to predicates (140°) | 140° |
| Type of Imager | CMOS | CMOS |
| Field of View | Similar to predicates (100°) | 100° |
| Direction of View | Similar to predicates (0°) | 0° |
| Depth of Field | Similar to predicates (5-50 mm) | 5-50 mm |
| On-axis Resolution (minimal) | Comparable to predicates (e.g., 2.5 lp/mm @ 3mm, 40 lp/mm @ 50mm for primary predicate) | 1.8 lp/mm @ 5 mm, 16 lp/mm @ 50 mm |
| Light Source | Internal LED | Internal LED |
| Compatible CCUs | Ability to connect to compatible CCUs | C-MAC (8403ZX), C-HUB II (P/N20290301) |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, etc. | Compliant |
| EMC | Compliance with IEC 60601-1-2 | Compliant |
| Biocompatibility | Compliance with ISO 10993 | Compliant |
| Performance (Optical) | Color Reproduction & Color Contrast, Illumination Detection Uniformity, Spatial Resolution & Depth of Field, Latency, Distortion, Signal-to-Noise Ratio (SNR) & Sensitivity | Tested and met design specifications |
| Reprocessing Validation | Compliance with FDA Guidance Document | Compliant |
Note on "Acceptance Criteria" for this specific device: For a 510(k) of a hardware device like an endoscope, acceptance criteria are generally not explicitly stated as performance thresholds in the same way they would be for an AI/ML algorithm (e.g., "sensitivity must be >X%"). Instead, the acceptance criteria are implicitly met by demonstrating that the device is as safe and effective as the predicate devices and meets applicable consensus standards. The "study" mainly involves engineering tests and comparisons.
Study Details
-
Sample Size Used for the Test Set and Data Provenance:
- Not applicable in the context of a typical "test set" for an AI/ML algorithm. The "test set" for this hardware device primarily refers to the physical units subjected to bench testing and measurements. No specific sample size (e.g., N=X images or patient cases) is provided as it's not a software performance study.
- Data Provenance: The "data" comes from engineering measurements and tests performed on the device itself, not from patient studies or image datasets.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. "Ground truth" in the sense of expert annotation for images or clinical outcomes is not relevant here. The "ground truth" for the device's physical and optical properties is established by objective engineering measurements and validated against industry standards and the predicate device's specifications.
-
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among human readers/annotators in clinical studies, particularly for creating ground truth for AI algorithms. This is a hardware validation.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. An MRMC study is a clinical study design used to evaluate the diagnostic performance of a system (often AI-assisted) by comparing multiple readers' interpretations of cases. This device is an endoscope providing visualization; it's not an AI-based diagnostic tool. Therefore, an MRMC study was not performed, nor is it relevant to demonstrate substantial equivalence for this type of device.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This is a hardware device (an endoscope). There is no "algorithm only" performance to be evaluated. Its function is to provide real-time visualization for a human operator.
-
The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- For this hardware device, the "ground truth" for its performance characteristics (e.g., resolution, field of view, deflection angles) is established by objective engineering measurements and adherence to recognized industry standards (e.g., IEC, ISO standards for electrical safety, biocompatibility, optical performance). The comparison to the predicate devices also serves as a benchmark for "ground truth" in terms of what is "safe and effective."
-
The Sample Size for the Training Set:
- Not applicable. There is no AI/ML algorithm training involved with this hardware device.
-
How the Ground Truth for the Training Set Was Established:
- Not applicable. As there is no training set, this question is not relevant.
In summary: The provided document is a 510(k) submission for a conventional medical device (an endoscope). The "acceptance criteria" and "study" described are focused on engineering performance, safety, and substantial equivalence to existing predicate devices, rather than the rigorous statistical evaluation and ground truth establishment typically required for AI/ML-driven diagnostic software.
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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
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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
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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, Inc2151 E. Grand AvenueEl Segundo, CA 90245 | |
|---|---|---|
| Contact: | Winkie WongRegulatory Affairs Manager310-658-3427 (phone) | |
| Date ofPreparation: | October 20th, 2020 | |
| Type of 510(k)Submission: | Special | |
| DeviceIdentification: | Trade Name: | Flexible Video Cysto-Urethroscope (C-view) |
| Common Name: | Cystoscope and accessories, Flexible/Rigid (FAJ)Cystourethroscope (FBO) | |
| Product Code: | FAJ, FBO | |
| ClassificationNumber andName: | 21 CFR 876.1500 (Endoscope and Accessories) | |
| PredicateDevice(s): | Flexible HD Cysto-Urethroscope (K191357) – PrimaryFlexible CMOS-Video-Cysto-Urethroscope (K131364) – SecondaryThe above predicate devices have not been subject to any recall | |
| DeviceDescription: | The Flexible Video Cysto-Urethroscope C-VIEW (Part Number: 11272VUE) isintended to be used with multiple compatible CCUs: C-MAC (8403ZX, cleared viaK182186) and C-HUB II (20290301, cleared via K182186). Identical to thepredicates, the scope cannot be operated on its own because it is a videoscope |
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| K202957Page 2 of 4 | ||||
|---|---|---|---|---|
| whose image data output is provided in the form of video signals and sent to the CCUfor decoding and display. Therefore, when the scope is connected to the compatibleCCUs, it becomes the Flexible Video Cysto-Urethroscope C-VIEW System, whichprovides visualization and operative access in the urinary tract. | ||||
| Indications foruse: | The Flexible Video Cysto-Urethroscope C-VIEW is used to provide visualization andoperative access during diagnostic and therapeutic endoscopic procedures ofurinary 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 differencedoes not have different intended use because the kidney is part of the urinary tract. | ||||
| TechnologicalCharacteristics: | The subject device is a modification of the primary predicate, 11272VHU, cleared viaK182723 and most recently via K191357 for the addition of HLD for reprocessing. Itis also the next generation of the secondary predicate device, 11272VU, cleared viaK131364 as lower cost alternative imaging systems when compared to the primarypredicate. | |||
| The comparison of technological characteristics is as follow: | ||||
| Subject Device | Primary PredicateK191357 | Secondary PredicateK131364 | ||
| Flexible Video Cysto-Urethroscope System | Flexible HD Cysto-UrethroscopeSystem | Flexible CMOSVideo CystoUretheroscope | ||
| Type of scope | Flexible | Same as the subjectdevice | Same as the subjectdevice | |
| Insertion Shaft Diameter | 5.2 mm | 5.5 mm | 5.5 mm | |
| Insertion Shaft Length | 37 cm | Same as the subjectdevice | Same as the subjectdevice | |
| Working ChannelDiameter | 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 subjectdevice | Same as the subjectdevice | |
| (C1) Type of Imager | CMOS | CMOS | CMOS | |
| (C2) Field of View | 100° | Same as the subjectdevice | Same as the subjectdevice | |
| (C3) Direction of View | 0° | Same as the subjectdevice | Same as the subjectdevice | |
| (C4) Depth of Field | 5-50 mm | Same as the subjectdevice | Same as the subjectdevice | |
| (C5) On-axis Resolution(minimal) | 1.8 lp/mm @ 5 mm16 lp/mm @50 mm | 2.5 lp/mm @3 mm40 lp /mm@50 mm | 1.1 lp/mm @ 5 mm11 lp/mm @ 50mm | |
| (C6) Light Source | Internal LED | Same as the subjectdevice | Same as the subjectdevice | |
| (C7) Compatible CCUs | C-MAC (8403ZX)C-HUB II (P/N20290301) | IMAGE1 S | C-MAC (8402ZX) | |
| Non-ClinicalPerformanceData: | There are no performance standards or special controls developed under Section514 of the FD&C Act for endoscopes. However, the subject device follows the FDArecognized consensus standards and is tested according to the following standardsand 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: ValidationMethods 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 designspecifications. The bench testing performed verified and validated that the FlexibleVideo Cysto-Urethroscope (C-view) has met all its design specification and issubstantially equivalent to its predicate devices. | ||||
| SubstantialEquivalence: | The indications for use, operating principles, technological characteristics andfeatures are similar, if not identical, between that subject device and the predicatedevices, Flexible HD Cysto-Ureteroscope (K191357) and CMOS Flexible VideoEndoscope (K131364). The minor difference between the subject and predicatedevices that does not raise new or different questions or safety and effectiveness arelisted above in Technological Characteristics section. | |||
| As proven by the comparisons, the differences do not raise different questions ofsafety and effectiveness because the intended use, operating principles. |
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| 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. | |
| ClinicalPerformanceData: | 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. |
§ 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.