(30 days)
To be used with an endoscope when repeated endoscopic intubation is anticipated, e.g., esophageal ligation, change of endoscopes, removal of multiple polyps and/or foreign bodies.
The Bard® Endoscopic Overtube consists of a flange bonded to a plastic sheath and is inserted into the esophagus through an initially placed bite block.
Here's an analysis of the provided text regarding the Bard® Endoscopic Overtube VI, focusing on acceptance criteria and study details:
This document is a 510(k) summary for a premarket notification to the FDA. It does not contain detailed information about specific acceptance criteria or a comprehensive study with performance metrics in terms of a table of reported device performance. Instead, it describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical testing.
Therefore, many of the requested sections (e.g., sample sizes for test sets, number of experts, MRMC studies, standalone performance, specific performance metrics, training set details) are not available in this document because it reports on non-clinical performance testing rather than clinical trials with human subjects or AI-driven systems.
However, I will extract as much relevant information as possible from the provided text to address your request.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
Summary of Findings: The provided 510(k) summary indicates that the Bard® Endoscopic Overtube VI's safety and effectiveness were established through nonclinical, tensile performance testing and biocompatibility testing. The submission aims to demonstrate substantial equivalence to existing predicate devices (Bard® Endoscopic Overtube and Olympus Splinting Tube ST-C3) based on similar design, materials, intended use, and performance characteristics in these nonclinical tests. No clinical study data (e.g., related to reader performance or diagnostic accuracy) or AI algorithm performance data is presented, as this is a medical device, not an AI/medical imaging software product.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria or detailed reported performance values (like sensitivity, specificity, accuracy) are not explicitly stated. The document broadly claims safety and effectiveness based on nonclinical testing.
| Acceptance Criteria Category (Inferred) | Reported Device Performance Summary (from text) |
|---|---|
| Mechanical Performance | "Tensile performance testing" conducted. |
| Biocompatibility | "Biocompatibility testing" conducted. |
| Durability/Reuse | Indicated for twenty-five (25) reuses. |
| Material Composition | Flange bonded to plastic sheath, UV bonded to polyvinyl chloride sheath, distal tapered tip, encapsulated stainless steel tempered wire coiled internally. |
| Design Characteristics | Similar design to predicate Bard® Overtube, employs encapsulated stainless steel wire coil similar to Olympus Splinting Tube. |
| Protection Characteristics | Designed to protect the hypopharynx from trauma, airway from aspiration, and esophagus during extraction of sharp objects. |
| Labeled Warnings/Contraindications | Labeled warnings and contraindications remain the same as predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable for the type of testing reported. The document refers to "nonclinical, tensile performance testing and biocompatibility testing." These types of tests typically involve a certain number of device units or material samples, but specific sample sizes are not disclosed in this summary.
- Data Provenance: Not applicable in the context of human data. The tests are nonclinical, likely conducted in a lab environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Not applicable. No human "ground truth" or expert adjudication for performance metrics is relevant here as this relates to non-clinical device testing, not an AI or diagnostic imaging study.
4. Adjudication Method for the Test Set
- Not applicable. No adjudication method is described as this is non-clinical device testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC study was not done. This device is an endoscopic overtube, not an AI-driven diagnostic tool where human reader performance would be a primary focus.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No. This is not an AI algorithm. It is a physical medical device.
7. The Type of Ground Truth Used
- Engineering/Material Specifications & Benchmarking: The "ground truth" for the nonclinical tests would have been established against engineering specifications, material standards, and performance benchmarks derived from the predicate devices. For example, tensile strength measured against a predefined minimum requirement, or biocompatibility assessed against established ISO or FDA standards for medical device materials.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. No training set exists for this type of device.
§ 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.