(84 days)
The Bonee Needle for Bladder Injections is used to deliver injectable materials into the urinary bladder wall during the transurethral endoscopic procedures.
The needle for bladder injections is designed for a working endoscope channel inner diameter of 5 French or larger. This product is 35 cm (ref: NBI035) or 70 cm (ref: NBI070) length and is made of thermoplastic tubing polyamide (PA) marked by ink, a stainless steel cystoscopic needle, a polyamide Luer Lock connector and a Tuohy Borst adapter to allow connection with the cystoscope. The assembly of the different components is being insured by gluing (UV process). A blue protective cap in Neoplex® is also supplied to prevent cystoscope channel degradation during needle insertion. Shelf life of the full range of the needle for bladder injections is 2 years. The needle for bladder injections is provided sterile and is intended for single use.
The provided text describes a 510(k) premarket notification for a medical device called the "Bonee Needle for Bladder Injections." A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance studies in the way you might find for novel device approvals (PMA) or algorithm-based AI/ML devices.
Therefore, many of the requested points cannot be answered from the provided document as it focuses on demonstrating equivalence through bench testing and material comparisons, not extensive clinical or performance studies with ground truth, expert adjudication, or large sample sizes for AI/ML.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance:
The document does not specify formal "acceptance criteria" for the Bonee Needle in the sense of performance metrics (e.g., accuracy, sensitivity, specificity, or specific mechanical thresholds beyond general safety and effectiveness). Instead, the device's performance is demonstrated through comparison to a predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate in performance, indication, design, and materials. | "Substantial equivalence is supported by bench testing comparing Bonee Injection needle to the predicate devices and biocompatibility testing performed on the Bonne Needle." |
| - (Specific performance metrics are not detailed) | - (Specific performance metrics are not detailed) |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The studies mentioned are "bench testing" and "biocompatibility testing." These generally involve a limited number of devices or material samples for specific tests (e.g., tensile strength, flow rate).
- Data Provenance: Not specified. "Bench testing" typically refers to in-vitro laboratory testing, not human or animal studies with provenance like country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the provided document. Ground truth as typically understood for AI/ML performance evaluation (e.g., expert consensus on image annotations, pathology reports) is not relevant for bench testing of a mechanical device.
4. Adjudication method for the test set:
Not applicable. There's no mention of a test set requiring adjudication in the context of human expert review.
5. 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:
No. This is not an AI/ML device, and no MRMC study with human readers is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This is not an AI/ML device.
7. The type of ground truth used:
The concept of "ground truth" as it applies to clinical outcomes or expert labels for diagnostic AI is not used here. Instead, the "ground truth" for this device's performance validation would be established by:
- Engineering specifications and validated test methods (for bench testing).
- Recognized standards for biocompatibility (e.g., ISO standards).
- The performance characteristics of the predicate device.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device that requires a training set.
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.