(21 days)
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is intended for palliation of malignant strictures in the biliary tree.
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is indicated for the treatment of biliary strictures resulting from malignant neoplasms.
The Bard® CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip is a stenting device designed to maintain the patency of biliary ducts obstructed by malignant neoplasms. The device includes the self-expanding Nitino! CONFORMEXX™ Stent preloaded on a flexible, multifunctional stent deployment system, the BARD S.A.F.E. ™ Delivery System with the PerforMAXX™ Grip. It is preloaded into the delivery system and is available in two delivery system lengths, and various device diameters and lengths.
The provided document does not report any acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical format of a clinical study or performance testing with quantitative metrics.
Instead, the document is a 510(k) summary for the CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance against predefined acceptance criteria.
Here's an breakdown of why the requested information cannot be fully provided from this document and what is stated:
Overall Summary:
The document asserts that the modified device (CONFORMEXX™ Biliary Stent with the PerforMAXX™ Grip) is substantially equivalent to its predicate device (CONFORMEXX™ Biliary Stent and Delivery System, K021994). This equivalence is based on the intended use, application, user population, basic design, performance, labeling, and sterilization method. The changes made (addition of the PerforMAXX™ Grip, an additional delivery system length, and modified packaging) are presented as not significantly altering the safety or effectiveness.
Key takeaway regarding "acceptance criteria" and "study":
The "acceptance criteria" in this context refer to the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance documents (specifically, "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998"), test protocols, and customer inputs. The "study" mentioned is the non-clinical performance data (design verification and validation testing) which "confirm the modified device to be substantially equivalent to the predicate devices." No specific quantitative metrics or results from these tests are provided in this summary.
Here's an attempt to answer your questions based only on the provided text, highlighting where information is absent:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to FDA Guidance for Metal Expandable Biliary Stents | Design verification and validation was done with conformance to or evaluated based on "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents, February 5, 1998." |
| Substantial Equivalence to Predicate Device (Bard® CONFORMEXX™ Biliary Stent and Delivery System, K021994) in terms of: | "All test results confirm the modified device to be substantially equivalent to the predicate devices." The device "met all the predetermined performance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs." The device "is substantially equivalent to the legally marketed predicate device, the Bard® CONFORMEXX™ Biliary Stent and Delivery System." |
| - Intended Use | The technological characteristics are "substantially equivalent ... in terms of intended use." |
| - Application | The technological characteristics are "substantially equivalent ... in terms of application." |
| - User Population | The technological characteristics are "substantially equivalent ... in terms of user population." |
| - Basic Design | The technological characteristics are "substantially equivalent ... in terms of basic design." (Note: this refers to other aspects that remained the same, despite the stated changes like the PerforMAXX™ Grip, new delivery system length, and packaging modification.) |
| - Performance | The technological characteristics are "substantially equivalent ... in terms of performance." |
| - Labeling | The technological characteristics are "substantially equivalent ... in terms of labeling." |
| - Sterilization Method | The technological characteristics are "substantially equivalent ... in terms of sterilization method." |
Information Not Found in the Provided Text:
- Sample size used for the test set and the data provenance: This information is not provided. The document only mentions "non-clinical performance data" and "design verification and validation," which typically involve bench testing, but no details on sample sizes or data origin are given.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. This is not a clinical study involving expert assessment of images or patient conditions.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not provided.
- 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 is not medical imaging AI device, but a physical medical device (biliary stent).
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the traditional sense. For a physical device like a stent, "ground truth" would be related to engineering specifications and functional performance (e.g., patency, deployment force, material integrity) against accepted standards. The document states "applicable standards, guidance, test protocols and/or customer inputs" were used to define performance criteria.
- The sample size for the training set: Not applicable. This is not a machine learning or AI device.
- How the ground truth for the training set was established: Not applicable.
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.