(90 days)
The Wilson-Cook Stricture Measuring Catheter is used to measure biliary and pancreatic strictures to determine stent size. This catheter allows injection of contrast and provides wire guide access to the desired duct. This device is supplied sterile and is intended for single use only.
The Wilson-Cook Stricture Measuring Catheter consists of a stylet wire and catheter. This device is designed for injection of contrast and to measure biliary and pancreatic strictures to determine stent size. This device is supplied sterile and is intended for single use only.
This document describes the premarket notification for the Wilson-Cook Stricture Measuring Catheter. Based on the provided text, here's a summary of the acceptance criteria and supporting study information:
Description of Acceptance Criteria and Study for the Wilson-Cook Stricture Measuring Catheter
The Wilson-Cook Stricture Measuring Catheter is designed for injecting contrast and measuring biliary and pancreatic strictures to determine stent size. The provided document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Wilson-Cook Glo-Tip ERCP Catheters, K851964) rather than presenting a performance study with specific acceptance criteria directly comparable to a disease detection or measurement algorithm.
The "acceptance criteria" here are implicitly related to the device meeting its stated performance characteristics and being safe and effective for its intended use, as validated by visual, dimensional, and functional analysis.
1. Table of Acceptance Criteria and Reported Device Performance
| Characteristic/Criterion | Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|---|
| Visual Analysis | No visual defects | All samples deemed acceptable, meeting test specifications |
| Dimensional Analysis | Conformance to specified dimensions (e.g., French size, length) | All samples deemed acceptable, meeting test specifications |
| Functional Analysis | Proper operation for intended use (e.g., contrast injection, wire guide access, stricture measurement capability) | All samples deemed acceptable, meeting test specifications |
| Biocompatibility | Established history of safe use in similar medical devices | Established through history of use in other similar devices |
| Sterility | Achieves SAL 10^-6^ | Validated EO cycle following AAMI Overkill Method to SAL 10^-6^ |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the context of clinical data or patient cases. The testing mentioned refers to performance characteristic studies of the device itself.
- Sample Size: "Samples" were subjected to visual, dimensional, and functional analysis. The exact number of samples is not specified, but it implies a representative number of units from the manufacturing process.
- Data Provenance: This is not applicable in the context of clinical data, as the tests relate to device characteristics. The tests were likely conducted internally by Wilson-Cook Medical Inc. as part of their product development and regulatory submission process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the type of device performance testing described. Ground truth in this context would refer to accurate physical measurements or functional capabilities of the catheter, which are determined by engineering specifications and testing, not expert clinical interpretation of patient data.
4. Adjudication Method for the Test Set
This is not applicable. The device performance testing involved direct measurement and verification against engineering specifications, rather than subjective interpretation requiring adjudication among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted or reported in this document. The submission is for a medical device (catheter) for its physical and functional capabilities, not for an algorithm that interprets or assists human readers with clinical cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical catheter, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance characteristics (visual, dimensional, functional) would be the established engineering specifications and manufacturing standards for the catheter components and its overall assembly. For sterility, the ground truth is the successful validation of the sterilization process to achieve a specified sterility assurance level (SAL). For biocompatibility, the ground truth is the history of safe use of the materials in similar medical devices.
8. The Sample Size for the Training Set
This is not applicable. The concept of "training set" applies to machine learning algorithms. This document describes a physical medical device.
9. How the Ground Truth for the Training Set was Established
This is not applicable.
§ 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.