(22 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 Deflectable Brush Biopsy Set is 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 Deflectable Brush Biopsy Set consists of a stainless steel shaft, radiopaque polytetrafluoroethylene catheter, and a nylon brush at the distal tip. The Deflectable Brush Biopsy Set is 3.2 French with a length of 115 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 6 centimeters from the distal tip of the catheter.
The sets will be supplied sterile and are intended for one-time use. The sets are packaged in a tray with lid in a peel-open pouch with a three-year shelf life.
The Deflectable Brush Biopsy Set subject of this submission have the same intended use, materials, dimensions, sterilization method, and shelf life as the Cook devices subject of reference submission Brush Biopsy Sets and Deflectable Brush Biopsy Set (K182231).
The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "Deflectable Brush Biopsy Set." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device's efficacy through extensive clinical trials or AI performance evaluations.
Therefore, the information requested in your prompt regarding acceptance criteria, study design for AI models, ground truth establishment, expert consensus, and human reader performance with AI assistance is not typically found or required in a 510(k) submission for a non-AI medical device like the Deflectable Brush Biopsy Set.
The document describes the device, its intended use, comparison to predicate devices, and "Performance Data" which, in this context, refers to engineering and biological testing to ensure the device meets its design specifications and is safe for use, not performance metrics of an AI algorithm.
Let's break down why this document doesn't contain the requested information about AI performance:
- Device Type: The "Deflectable Brush Biopsy Set" is a mechanical medical device used to obtain pathology specimens. It's a physical tool, not a software algorithm or an AI-powered system for diagnosis or analysis.
- Regulatory Pathway (510(k)): The 510(k) pathway is for devices that are "substantially equivalent" to predicate devices. This typically involves demonstrating similar technological characteristics, intended use, and safety/performance through bench testing, biocompatibility, and sometimes limited clinical data, but not usually large-scale performance studies like those required for novel AI/ML devices.
However, I can extract the "performance data" that is mentioned in the document, which pertains to the physical device's characteristics and safety:
Acceptance Criteria and Device Performance (as described for a physical medical device, not an AI model):
The document lists the types of testing performed to demonstrate that the Deflectable Brush Biopsy Set met applicable design and performance requirements. These are typically internal acceptance criteria based on engineering specifications and regulatory standards. The document states that the "results of these tests support a conclusion that the Deflectable Brush Biopsy Set will perform as intended."
While specific numeric acceptance criteria values are not provided in this public summary, the categories of testing performed imply the criteria that were met.
| Acceptance Criteria Category (Implied) | Reported Device Performance (Summary Statement) |
|---|---|
| Biocompatibility | Testing was performed to demonstrate that the device met applicable design and performance requirements. |
| Dimensional Verification of the Catheter | Testing was performed to demonstrate that the device met applicable design and performance requirements. (Implies the catheter dimensions were within specified tolerances). |
| Bristle Integrity | Testing was performed to demonstrate that the device met applicable design and performance requirements. (Implies bristles remained intact and functional). |
| Corrosion Following Exposure to Artificial Urine | Testing was performed to demonstrate that the device met applicable design and performance requirements. (Implies the device showed acceptable resistance to corrosion in relevant body fluids). |
| Tensile Strength (Catheter Shaft, Wire Shaft to Distal Tip, Handle-to-Wire Shaft) | Testing was performed for these components to demonstrate that the device met applicable design and performance requirements. (Implies the device components could withstand specified tensile forces without failure). |
| Sterilization | Testing was performed to demonstrate that the device met applicable design and performance requirements. (Implies the sterilization method achieved the required sterility assurance level). The device is supplied sterile and intended for one-time use. |
| Packaging/Distribution | Testing was performed to demonstrate that the device met applicable design and performance requirements. (Implies the packaging protects the device during distribution and maintains sterility). |
| Shelf Life/Stability | Testing was performed to demonstrate that the device met applicable design and performance requirements. (Implies the device maintains its properties and sterility over its stated shelf life). The device has a three-year shelf life. |
| Overall Conclusion | "The results of these tests support a conclusion that the Deflectable Brush Biopsy Set will perform as intended. The subject device does not raise new questions of safety or effectiveness as compared to the predicate devices. Therefore, the data provided in this submission support a determination of substantial equivalence." |
Since this is a filing for a mechanical device and not an AI/ML-driven diagnostic tool, the following points from your prompt are not applicable and therefore not found in the provided document:
- Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI test set. Performance testing likely involved a number of physical units, but not "data provenance."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic AI algorithm needing ground truth.
- Adjudication method for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- 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.