(90 days)
The Bard® Endoscopic Suturing System is used for endoscopic placement of suture(s) in the soft tissue of the esophagus and stomach and for the approximation of tissue for the treatment of symptomatic Gastroesophageal Reflux Disease.
The Bard® Endoscopic Suturing System consists of a capsule assembly with suction tubing and a fixed head knotpusher that attaches to the distal end of a flexible endoscope or a through-the-scope knot pusher, plus a needle assembly, pusher wire, guidewire and suture cutter that all pass through an endoscope's biopsy channel. Also, included is a suture loader to facilitate loading suture tags into the needle, a syringe for flushing the suction tubing, and an detachable knot pusher handle. Only Bard® Suture Tags and the Bard® Endoscopic Handle may be used with the Bard® Endosocpic Suturing System.
The provided document is a 510(k) summary for the Bard® Endoscopic Suturing System, indicating its substantial equivalence to predicate devices. It does not contain the specific acceptance criteria or a detailed study justifying how the device meets those criteria, largely because 510(k) submissions typically focus on demonstrating equivalence rather than establishing new safety and effectiveness through extensive performance studies against pre-defined acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred regarding performance data:
The document states: "Performance Data: Biocompatibility, in vitro bench testing, animal and clinical testing has been completed and supports the safety and effectiveness of the Bard® Endoscopic Suturing System for its intended use."
Here's an attempt to structure the answer based on the prompt's requirements, noting significant limitations due to the nature of the provided text:
Acceptance Criteria and Device Performance Study for Bard® Endoscopic Suturing System
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Not explicitly stated (implied to meet relevant biocompatibility standards) | "The biocompatibility test results show that the materials used in the design and manufacture of the device are non-toxic and non-reactive to biologic tissues consistent with their intended use." |
| Bench Testing | Established specifications for consistent performance | "Bench test results show that the materials chosen and the design utilized in manufacturing the Bard® Endoscopic Suturing System, meet the established specifications necessary for consistent performance during their intended use." |
| Animal Studies | Safety and effectiveness in placing sutures in soft tissues without complications/adverse reactions | "The animal studies support the safety and effectiveness of the Bard® Endoscopic Suturing System. The studies document there were no complications/adverse reactions reported, and that the system is capable of safely and consistently placing sutures in the soft tissues within the stomach and esophagus." |
| Human Clinical Experience | Safety and effectiveness for its intended use | "Finally, the summary of human clinical experience under a 64 patient prospective randomized investigation and the non-U. S. patient experience supports the safety and effectiveness of the Bard® Endoscopic Suturing System for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
- Human Clinical Experience (Test Set): 64 patients.
- Data Provenance: "64 patient prospective randomized investigation" (likely multi-center or within a specific region, though not explicitly stated as US or international for this specific 64-patient cohort). There was also "non-U. S. patient experience" mentioned, indicating some international data. The study type is explicitly prospective and randomized.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the document. The document describes a clinical investigation but does not detail how the clinical outcomes (ground truth) were adjudicated or by whom.
4. Adjudication Method for the Test Set
- This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- This information is not provided. The device is an endoscopic suturing system, not an imaging AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable in this context. The clinical study mentioned is for the device's performance, not an AI component.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This information is not applicable. The Bard® Endoscopic Suturing System is a medical device used by a human operator, not an autonomous algorithm.
7. Type of Ground Truth Used
- Clinical Outcomes/Safety and Effectiveness: For the human clinical experience and animal studies, the "ground truth" would be related to clinical endpoints such as:
- Absence of complications/adverse events.
- Successful placement of sutures.
- Approximation of tissue.
- Treatment of symptomatic Gastroesophageal Reflux Disease.
- These are based on observations, clinical assessments, and potentially follow-up data from the patients and animals.
8. Sample Size for the Training Set
- This information is not provided and is not applicable in the context of this device. "Training set" refers to data used to train machine learning models. This device is a mechanical/manual instrument, not an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided and is not applicable for the reasons stated above.
§ 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.