(22 days)
The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval of cells for cytological evaluation.
The MDT Cell Recovery System™ (CRS) is an automated cytology brush for use with a rigid or flexible cystoscope in the collection and retrieval of cells for cytological evaluation. The brush, consisting of nylon bristles secured by twisted stainless steel wires fused and blunted at the tip, is attached to a nickel-titanium shaft and housed in a Teflon sheath. The brush and sheath are designed for single use with cystoscopes having a 6 French working channel. The brush diameter is 10 mm, the brush length is 6.4 mm, and the sheath is 156 cm long. This cytology brush is similar in size, features and components to other commercially available cytology brushes, including the previous CRS version, and has the same intended use. The CRS facilitates brushing of cells by automating the rotation of the cytology brush and aspiration of dislodged cells using a battery operated console coupled to the brush. The console is operated using a foot pedal for hands free operation. The operator can maneuver the brush to the desired location and initiate the brushing procedure as well as the sample retrieval into a 60 cc syringe.
This report, K965037, describes a medical device, the Cell Recovery System™ (CRS), and its substantial equivalence to a previously cleared version. However, it does not contain the kind of detailed information typically found in studies designed to establish acceptance criteria for a diagnostic device or an AI algorithm, nor does it provide performance data in the context of such criteria.
Specifically, the document focuses on the device's mechanical and operational aspects and its similarity to a previous version, rather than its performance in terms of diagnostic accuracy or effectiveness in collecting cells for cytological evaluation with defined performance metrics.
Therefore, for almost all of your requested categories, the information is not available in the provided text. I will indicate "Not applicable" or "Information not provided" for each point.
Acceptance Criteria and Study Information
| Category | Description |
|---|---|
| 1. Table of acceptance criteria and reported device performance | Acceptance Criteria: No specific quantitative acceptance criteria (e.g., sensitivity, specificity, F1-score, retrieval yield) for cell collection efficacy or diagnostic accuracy are provided. The "acceptance" in this document refers to demonstrating substantial equivalence to a previously marketed device in terms of safety and intended use, not performance against specific diagnostic metrics. |
Reported Device Performance: The document states: "Results from bench-top testing showed the modified CRS is substantially equivalent to the previous version of the CRS device cleared for marketing on March 20, 1996. These studies have demonstrated that the modified CRS features do not pose new safety questions when compared to the currently marketed CRS device." This is a statement of substantial equivalence regarding safety, not a performance metric for cell recovery or diagnostic accuracy. |
| 2. Sample size for the test set and data provenance | Information not provided. The "bench-top testing" mentioned is likely mechanical/functional testing, not clinical performance testing with patient samples. |
| 3. Number of experts and their qualifications | Not applicable, as this is not a study assessing diagnostic performance requiring expert interpretation of results. |
| 4. Adjudication method for the test set | Not applicable. |
| 5. MRMC comparative effectiveness study | Not applicable. This device is a cell collection system, not an AI or diagnostic algorithm that would be used in an MRMC study to compare reader performance with and without AI assistance. |
| 6. Standalone (algorithm only) performance study | Not applicable. This is a physical medical device, not a standalone algorithm. |
| 7. Type of ground truth used | Not applicable, as this is not a diagnostic performance study where ground truth (e.g., pathology, expert consensus) would be established for the interpretation of collected samples. The "ground truth" for the substantial equivalence claim would relate to the mechanical and safety features of the device itself. |
| 8. Sample size for the training set | Not applicable. This document describes a medical device, not a machine learning model, so there is no concept of a "training set" in the conventional sense. |
| 9. How the ground truth for the training set was established | 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.