(60 days)
This device is used to collect cells from the bronchi or upper and lower gastrointestinal tracts.
The Bronchi and Gastrointestinal Cytology Brush (subject device) is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel coil spring terminating in a nylon brush at the distal end. The coil spring and brush are secured inside an extruded polytetrafluoroethylene sheath. The brush is advanced from and retracted into the sheath.
The provided text describes a 510(k) premarket notification for a medical device and outlines its comparison to a predicate device and performance data. However, it does not contain the detailed acceptance criteria and the study that proves the device meets those criteria in the format requested.
Here's a breakdown of why the requested information cannot be fully extracted:
- Acceptance Criteria and Reported Device Performance Table: The document states that the device "meets the performance requirements to fulfill the intended use," but it does not list specific numerical acceptance criteria (e.g., minimum brush cell collection efficiency, maximum material degradation over time) or the quantitative results from testing against those criteria.
- Sample Size and Data Provenance (Test Set): No information regarding sample size for a test set, country of origin, or whether data was retrospective or prospective is present. The document mentions "performance testing," but no specifics on the test set are given.
- Number of Experts and Qualifications (Test Set Ground Truth): The document does not describe any study involving experts establishing ground truth for a test set. This type of information would typically be found in a clinical study report.
- Adjudication Method: Since there's no mention of a study involving experts and ground truth establishment, there is no information on an adjudication method.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: The device is a physical cytology brush, not an AI or imaging diagnostic tool, so an MRMC study is not applicable to its evaluation.
- Standalone (Algorithm Only) Performance: Similar to the MRMC study, this is not relevant as the device is a physical tool and not an algorithm.
- Type of Ground Truth Used: No information on what type of ground truth was used for performance validation is provided, as specific study details are absent.
- Sample Size for Training Set: The document does not mention any training set, as it refers to a physical device rather than a machine learning model.
- How Ground Truth for Training Set was Established: Again, this is not applicable for the described device.
What the document does provide regarding performance:
The document states:
"Performance testing consisting of sterilization, shelf life, biocompatibility, and nonclinical bench testing demonstrate that the Bronchi and Gastrointestinal Cytology Brush meets the performance requirements to fulfill the intended use of the device."
This indicates that a range of tests were performed, but the specific details requested are not disclosed in this summary. These details would typically be found in the full technical documentation submitted as part of the 510(k) application, which is not included here.
§ 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.