(257 days)
The Brush Biopsy Sets are intended to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula or calyces under direct vision.
The Brush Biopsy Set and Deflectable Brush Biopsy Set are designed to be used through rigid or flexible endoscopes in order to obtain pathology specimens from lesions in the ureter, renal pelvis, infundibula, or calyces under direct vision. The Brush Biopsy Set consists of a stainless steel shaft, a catheter, and a nylon brush at the distal tip. The Brush Biopsy Set is available in two sizes: 3.2 French with a length of 115 centimeters, or 5 French with a length of 67 centimeters. The 3.2 French version has a stainless steel wire shaft, a catheter constructed of radiopaque polytetrafluoroethylene, and a connector cap and pin vise located at the proximal end. The 5 French version has a stainless steel coil shaft, a catheter constructed of vinyl radiopaque tubing, and a side-arm adapter attached to the proximal end.
The Deflectable Brush Biopsy Set consists of a stainless steel shaft, a radiopaque vinyl catheter, and a nylon brush at the distal tip. The Deflectable Brush Biopsy Set is 5 French with a length of 67 centimeters. The Deflectable Brush Biopsy Set has a 3-ring handle at the proximal end that allows for deflection of the brush tip to within 15° from the shaft.
The stainless steel shaft of the brush assembly is straight for the length of the catheter, and protrudes 7 centimeters from the distal tip of the catheter on the 5 French Deflectable Brush Biopsy Set to allow for deflection.
The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a peel-open pouch with a three-year shelf life.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Brush Biopsy Set and Deflectable Brush Biopsy Set, as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text describes performance testing rather than specific, quantified acceptance criteria with corresponding numerical results. Instead, it lists the types of tests performed to demonstrate that the device "met applicable design and performance requirements." It concludes that the device "will perform as intended" based on these tests.
Therefore, I cannot create a table with specific numerical acceptance criteria and reported device performance. The document only lists the categories of tests conducted.
| Acceptance Criteria (Category) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Met applicable design and performance requirements |
| Dimensional Verification of the Catheter | Met applicable design and performance requirements |
| Simulated Use and Bristle Integrity | Met applicable design and performance requirements |
| Corrosion Following Exposure to Artificial Urine | Met applicable design and performance requirements |
| Tensile Strength (Catheter Shaft, Wire Shaft to Distal Tip, Proximal Wire Shaft) | Met applicable design and performance requirements |
| Sterilization | Met applicable design and performance requirements |
| Packaging/Distribution | Met applicable design and performance requirements |
| Shelf Life/Stability | Met applicable design and performance requirements |
| Acute Performance in a Porcine Urinary Model | Performed as intended |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests (e.g., number of devices tested for tensile strength, number of porcine models used, etc.). It also does not explicitly state the provenance of the data (country of origin, whether retrospective or prospective). The testing appears to be conducted by the manufacturer, Cook Incorporated.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of device and testing described. The Brush Biopsy Set and Deflectable Brush Biopsy Set are physical medical devices used for specimen collection. The "ground truth" in this context would relate to the physical properties and functionality of the device itself (e.g., did it break, did it corrode, did it successfully collect a specimen in a model). Expert interpretation of images or clinical data (which is where expert ground truth and adjudication are typically relevant) is not mentioned as part of the performance data.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3. Adjudication methods like 2+1 or 3+1 are used for establishing a consensus ground truth among multiple experts, particularly in image interpretation or clinical diagnosis studies. The performance data here pertains to engineering and material testing of a physical device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human readers' performance in tasks like diagnostics. The device described is a physical tool for biopsy, not an AI-powered diagnostic system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done. The device is a physical medical instrument, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context would be based on:
- Engineering specifications and standards: For dimensional verification, tensile strength, and corrosion.
- Direct observation and measurement: For simulated use, bristle integrity, and acute performance in the porcine model (e.g., successful specimen collection, device integrity during use).
- Laboratory analysis: For biocompatibility and sterilization efficacy.
- Environmental testing: For packaging/distribution and shelf life/stability.
There is no mention of expert consensus, pathology (beyond the specimens collected by the device), or outcomes data used to establish the "ground truth" for the device's technical performance.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument; it does not involve a training set as would be used for machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
§ 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.