(181 days)
The Cytology Brush is used to collect cells from the bronchi and upper and lower gastrointestinal tracts.
The main component of the proposed device is Brush Head, Outer Sheath and Handle. The main operation is move the Finger Ring back and forth to achieve the movement of Brush Head, then the Brush Head can collect cells from the target site. The proposed device has seven (7) specifications, the main differences of these specifications are Diameter of Brush Head, Diameter of Outer Sheath and Working Length, Color of Finger Ring. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10° and placed in a sterility maintenance package to ensure a shelf life of 2 years.
This document, K172663, is a 510(k) Premarket Notification for a Cytology Brush. It compares the proposed device to a predicate device and demonstrates substantial equivalence.
It does not describe an AI/ML-based medical device. Therefore, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
Specifically, it lacks the following information that would typically be present for an AI/ML device:
- A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC).
- Sample sizes for test sets used for evaluating AI performance.
- The number and qualifications of experts for ground truth establishment.
- Adjudication methods for AI training/test sets.
- MRMC studies or effect sizes of AI assistance on human readers.
- Standalone algorithm performance.
- Types of ground truth (e.g., pathology, outcomes data).
- Sample size and ground truth establishment for training sets.
The document discusses performance in terms of:
- Biological safety: Meeting ISO standards for biocompatibility and sterilization.
- Mechanical performance: Dimension testing, tensile strength testing.
These are standard for physical medical devices but not AI/ML performance.
Therefore, based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria as requested, because this document pertains to a physical medical device (cytology brush), not an AI/ML 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.