(213 days)
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush are used for collection of cells in the biliary system.
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush (subject devices) represent modifications made to the Wilson-Cook Double Lumen Biliary Cytology Brush (predicate device) currently cleared to market via 510K K040324 by Wilson-Cook Medical, Inc.
The Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brushes consist of a double lumen catheter with ink markings, a cytology brush assembly with either a coil spring or bullet tip, a pin vise handle, wire guide hub, and a detachable connecting tube, which can be used for flushing of the wire guide hub. The endoscopic cytology brush is used by passing the device through an endoscope, over a prepositioned wire guide to the target location. The endoscopic cytology brush assembly is located at the distal (patient contacting) end with the pin vise handle located at the proximal (non-patient contacting) end. The handle is actuated by pushing the pin vise handle forward to extend the cytology brush and then pulling backward to retract the brush.
The provided text describes a 510(k) premarket notification for two cytology brushes, the Fusion® Cytology Brush and CytoMax II® Double Lumen Cytology Brush. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing rather than presenting a study to prove acceptance criteria for device performance in a clinical setting.
Therefore, many of the requested details regarding clinical study design, acceptance criteria, and performance metrics are not available in the provided text.
However, based on the information provided, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document mentions "performance requirements" were met through non-clinical bench testing. However, specific numerical acceptance criteria or reported performance values are not provided in the text. The non-clinical tests performed include:
| Test Type | Reported Outcome (General) |
|---|---|
| Shelf Life Testing | Met performance requirements (specifics not provided) |
| Packaging Validation | Met performance requirements (specifics not provided) |
| Biocompatibility | Performed in accordance with ISO 10993-1 |
| Bench Testing (General) | Demonstrated the subject device performs as intended |
2. Sample sized used for the test set and the data provenance:
- Sample Size: Not specified in the document. The testing mentioned is "non-clinical bench testing."
- Data Provenance: Not applicable as no clinical study or patient data is reported. The tests are benchtop tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document describes non-clinical bench testing, not a study involving human experts to establish ground truth.
4. Adjudication method for the test set:
- Not applicable. This pertains to clinical studies involving expert review and is not relevant to the described non-clinical bench testing.
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:
- No. The document describes a 510(k) submission for cytology brushes, not an AI-powered device, and no MRMC study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI device.
7. The type of ground truth used:
- Not applicable. For the non-clinical tests mentioned (shelf life, packaging validation, biocompatibility, and other performance bench tests), the "ground truth" would be established by the defined test methods and specifications for the device's physical and material properties, not from clinical outcomes or expert consensus on diagnostic interpretations.
8. The sample size for the training set:
- Not applicable. This is not an AI device and no "training set" is mentioned or implied.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI device.
§ 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.