(100 days)
The Wilson-Cook Double Lumen Biliary Cytology Brush is intended to collect cells in the biliary system.
The proposed Cytology Brush is a modification to existing cytology brushes currently marketed by Wilson-Cook. The Double Lumen Cytology Brush is supplied sterile and intended for single use only.
This 510(k) summary for the Wilson-Cook Double Lumen Biliary Cytology Brush does not include acceptance criteria or a detailed study proving the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (Wilson-Cook Cytology Brushes, K896318).
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance
- No specific acceptance criteria or performance data are provided. The document states: "We believe the proposed device to be substantially equivalent to the named predicate in terms of Intended Use, performance characteristics tested and biocompatibility." This implies that the performance characteristics were compared to the predicate, but the specific metrics and targets (acceptance criteria) for this comparison are not detailed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- No information provided. The document does not describe any specific test set, its sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- No information provided. Since no specific test set is detailed, there is no mention of experts or ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- No information provided.
5. 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
- Not applicable. This device is a physical cytology brush, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human readers and AI is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical cytology brush.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- No information provided.
8. The sample size for the training set
- No information provided.
9. How the ground truth for the training set was established
- No information provided.
Summary of what is present:
The document focuses on establishing substantial equivalence based on the following:
- Identical materials of basic composition: The new brush uses the same materials as the predicate.
- Same operating principal: Both devices function in the same way to collect cells.
- Same technological characteristics: The underlying technology is considered equivalent.
- Intended Use: Both devices are for collecting cells in the biliary system.
- Biocompatibility: This is mentioned as a characteristic where the devices are considered equivalent, implying that biocompatibility testing was either conducted for the new device or referenced from the predicate.
In essence, this 510(k) submission is a "modification to existing cytology brushes" where the manufacturer believes the changes are minor enough that the new device shares the same fundamental characteristics and performance as the previously cleared predicate, thus not requiring new, extensive performance data with specific acceptance criteria beyond demonstrating this equivalence. The FDA concurred with this assessment.
§ 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.