(15 days)
For endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.
The Bard® EndoCinch™ Suturing System is a multi-component system consisting of a reusable handle, disposable capsule assembly, needle assembly, guidewire, pusher wire, clip delivery device, suture clip loader, suture clips, suture loader, suture loop tools and suture tag assemblies. Only the Bard® Endoscopic Handle and Bard® Suture Tags may be used with the Bard® EndoCinch™ Suturing System.
This document is a 510(k) premarket notification for the Bard® EndoCinch™ Suturing System. It describes the device and its intended use but primarily focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed study report of accuracy or performance in the way an AI/ML device would be evaluated.
Therefore, many of the requested categories are not applicable or cannot be extracted from this type of regulatory submission. The information that can be extracted or inferred is as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Comparative Testing) | Reported Device Performance (from "Performance Data" section) |
|---|---|
| Clip Delivery Device Functionality: Ability to deliver the suture clips to cinch and cut the suture. | "The clip delivery device was tested to assure that the suture clips can be delivered to cinch and cut the suture." (No specific quantitative metric provided, but implies successful function.) |
| Suture Clip Joint Integrity: Critical joints of the clip delivery device withstand tensile forces. | "the critical joints of the clip delivery device underwent tensile testing." (No specific quantitative metric (e.g., specific tensile strength) provided, but implies successful performance.) |
| Suture Security (under simulated conditions): Suture remains secure when exposed to conditions of food swallowing, lower esophageal sphincter forces, and gastric environment without degradation or loss of integrity. | "Comparative testing of the suture clips to the current knot demonstrated that the suture remains secure when exposed to the simulated conditions of food swallowing, lower esophaged sphincter forces and the gastric environment without degradation or loss of integrity." (No specific quantitative metrics for "secure" or "loss of integrity" are given, but implies equivalence or superiority to the predicate knot.) |
| Suture Clip Delivery and Cutting Efficiency: Suture clip can be delivered to the intended location, secure the suture, and cut the suture in fewer intubations. | "Testing also demonstrated that the suture clip can be delivered to the intended location, and can secure and cut the suture in three versus nine intubations of the endoscope as compared to the current knot tying method used." (Demonstrates improved efficiency.) |
2. Sample Size Used for the Test Set and Data Provenance
This document describes comparative performance testing for a mechanical device. It does not refer to a "test set" in the context of an AI/ML model. Therefore, specific sample sizes for data (e.g., images for an AI system) and data provenance (country of origin, retrospective/prospective) are not applicable and not provided. The testing appears to be laboratory or bench-top testing rather than clinical study data involving patients.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in the context of this device would be established by engineering specifications and physical measurements, and performance against defined parameters (e.g., tensile strength, number of intubations). It does not involve expert interpretation or consensus on data like an AI/ML system would.
4. Adjudication Method for the Test Set
Not applicable. The testing methods for mechanical performance and material integrity would be based on engineering standards and measurements, not 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
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a surgical instrument used by a human operator, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance would be derived from:
- Engineering specifications and measurements: For device functionality, tensile strength, and cutting mechanisms.
- Simulated conditions: For assessing suture security under conditions mimicking the physiological environment (food swallowing, LES forces, gastric environment).
- Direct observation and count: For efficiency metrics like the number of endoscope intubations.
8. The Sample Size for the Training Set
Not applicable. This is a mechanical surgical device, not an AI/ML model requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is a mechanical surgical device, not an AI/ML model.
§ 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.