(26 days)
The Bard® AquaGuide™ Ureteral Access Sheath is indicated for use in endoscopic urology procedures where ureteral dilation and continued ureteral access is desired for injection and aspiration of fluids and insertion and removal of endoscopes and related instruments.
The Bard® AquaGuide™ Ureteral Access Sheath is a twocomponent ureteral dilation system which contains multiple lumens for injection and aspiration of fluids as well as passage of endoscopes and related instruments. The auptram consists of a hydrophilic-coated introducer with female luer connector and a hydrophilic-coated dual-lumen sheath with multi-function access hub. The system is available in Introducer sizes 10-13, Sheath sizes 12-16 and lengths: 25 - 55cm.
The submitted text is a 510(k) summary for the Bard® AquaGuide™ Ureteral Access Sheath. It describes the device, its intended use, and states that performance data was submitted, but does not provide details on specific acceptance criteria or the results of a study demonstrating the device meets those criteria.
Here's an analysis based on the provided text, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document. | The document states, "The Bard® AquaGuide™ Ureteral Access Sheath is constructed of biocompatible materials. The additional lumen reduces the potential for hypervolemia (excess fluid build-up)." This is a general statement about material and a benefit, not a performance metric against a specific criterion. |
Missing Information: Comprehensive acceptance criteria (e.g., specific dimensions, tensile strength, flow rates, biocompatibility test results, etc.) and quantitative or qualitative results against these criteria are not included.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not specified.
- Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, the performance data would typically be generated from internal testing, possibly in vitro or bench testing. There is no mention of human clinical data or animal studies as a "test set" in the context of device performance testing. The document states it's "constructed of biocompatible materials," implying relevant testing was done, but details are absent.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts: Not applicable/Not specified. The performance data mentioned (biocompatibility, reduced hypervolemia) typically doesn't rely on expert ground truth in the same way an AI diagnostic device would. It's based on objective measurements and scientific principles.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/Not specified. As mentioned above, the type of "test set" for this device's performance data likely doesn't involve expert adjudication.
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:
- MRMC Study: No. This device is a medical instrument (ureteral access sheath), not an AI diagnostic device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For biocompatibility, the ground truth would be established through standardized in vitro and in vivo biocompatibility testing (e.g., ISO 10993 series). For "reducing the potential for hypervolemia," the ground truth would likely be established through fluid dynamics testing and potentially animal models demonstrating the efficacy of the additional lumen for fluid aspiration. The document does not provide details on these.
8. The Sample Size for the Training Set:
- Training Set Sample Size: Not applicable. As this is a physical medical device and not an AI/ML algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set: Not applicable.
In summary, the provided document is a 510(k) summary for a physical medical device and lacks the kind of detailed performance study information typically requested for AI/ML-based devices. It confirms the device's identity, intended use, and regulatory classification, but it does not present acceptance criteria or detailed study results in the format requested. The "Performance Data Summary" section is very brief and high-level.
§ 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.