(57 days)
The IntraStent™ Biliary Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree.
The IntraStent™ is a balloon expandable stainless steel stent with an open attisce design. The device is provided unmounted, to be manually crimped onto a noncompliant PTA I he device is provided uninounced, to be manadis computer luminal surface and inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
Here's a breakdown of the acceptance criteria and the study information for the IntraStent™ Biliary Catheter based on the provided 510(k) summary:
This device is not a typical AI/ML-enabled medical device, so many of the questions asked (like MRMC study, ground truth for training set, effect size of AI, etc.) are not applicable in this context. This is a physical medical device (a stent) and its submission focuses on demonstrating substantial equivalence to already marketed devices through bench testing and material comparisons.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Device Performance / How it's Met |
|---|---|---|
| Performance Equivalence | Meet the same performance characteristics as the predicate ITI Stent (K980290). | Bench tests were performed to verify that the IntraStent™ met the same performance characteristics as the predicate ITI Stent (K980290). |
| Material Equivalence | Identical in materials to predicate devices. | The IntraStent™ is "identical in materials" to the predicate ITI Stent and Cordis Corporation/Johnson & Johnson PALMAZ™, PALMAZ-SCHATZ™, and PERFLEX™ Balloon-Expandable Biliary Stents. (Implied by substantial equivalence claim). |
| Indication for Use | Identical in indication for use to predicate devices. | The IntraStent™ is "identical in... indication for use" to the predicate devices: "as a palliative treatment for malignant neoplasms in the biliary tree." |
| Technological Characteristics | Identical in technological characteristics to predicate devices. | The IntraStent™ is "identical in... technological characteristics" to the predicate devices. Both are balloon expandable, made from 316L stainless steel hypotubes with laser-cut slots, cleaned, electro-polished, packaged in double sterile barriers, and sterilized. |
| Sterility/Biocompatibility | Nonpyrogenic. | Pyrogenicity testing performed on a lot-to-lot basis supports the nonpyrogenic claim. |
Study Information
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical trials or AI/ML validation. The "test" mentioned refers to bench tests.
- Data Provenance: Bench testing data would be generated in a laboratory setting, likely in the US (where the company is based). It's a prospective generation of data specifically for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for AI/ML or clinical imaging studies (expert consensus) is not relevant here. The "ground truth" for bench testing is defined by engineering specifications and predicate device performance.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This concept is for clinical or imaging review, not bench testing.
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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 a physical medical device (a stent), not an AI-enabled diagnostic or assistive system.
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If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this submission is based on the established performance characteristics and design of predicate devices, combined with engineering specifications and bench testing results. The goal is substantial equivalence, meaning the new device performs as well as, or comparably to, already approved devices.
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The sample size for the training set: Not applicable. This is not an AI/ML device where a "training set" in that sense would exist.
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How the ground truth for the training set was established: Not applicable. See point 7.
§ 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.