(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
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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.
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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.
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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.
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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.
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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.
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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."
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The Sample Size for the Training Set:
- Not applicable. There is no AI/ML algorithm training involved with this hardware device.
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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.
§ 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.