(505 days)
The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The S.M.A.R.T. " Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree.
6 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters: 6, 7 and 8 mm; . Stent lengths: 120 and 150 mm; . Stent delivery system usable length: 120 cm; and . Guidewire lumen 0.035" ● The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.
The provided text describes a 510(k) premarket notification for a medical device, the S.M.A.R.T. Nitinol Stent Transhepatic Biliary System. This documentation is for demonstrating substantial equivalence to predicate devices, not for proving specific performance criteria through a study with acceptance criteria in the manner one might find for a novel device or software. Therefore, the information typically requested in your prompt (e.g., acceptance criteria table, sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies) is not present in the provided text, as it doesn't describe such a study.
The primary "proof" in this context is the demonstration of substantial equivalence to existing legally marketed predicate devices, supported by non-clinical in-vitro bench testing and animal testing.
Here's an analysis based on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance:
This information is not provided in the given text. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance acceptance criteria for a new device type.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/Not provided. The text does not describe a clinical "test set" for performance evaluation in the way a diagnostic AI device would. It mentions "non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct)" but does not specify sample sizes for these tests.
- Data Provenance: The testing mentioned (in-vitro bench testing and animal testing) would typically be conducted by the manufacturer (Cordis Corporation). The text does not specify country of origin for the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided. Since there's no mention of a clinical test set requiring ground truth established by human experts, this information is absent. Animal testing (stent placement in a biliary duct) would likely be evaluated by veterinary or medical professionals, but their number and specific qualifications are not detailed.
4. Adjudication method for the test set:
Not applicable/Not provided. No clinical test set requiring adjudication is described.
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/Not provided. This is a medical device (stent), not an AI/software device designed to assist human readers. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable/Not provided. This is a physical medical device (stent), not an algorithm or software. "Standalone performance" in this context refers to the device's functional integrity as a physical implant, which is assessed through bench and animal testing.
7. The type of ground truth used:
- For the non-clinical in-vitro bench testing, the "ground truth" would be engineering specifications and measurements (e.g., stent diameter, length, expansion force, material properties) compared against design requirements.
- For the animal testing (stent placement in a biliary duct), the "ground truth" would likely involve direct observation, imaging, and potentially histopathological analysis of the animal tissue to assess stent patency, migration, and tissue reaction.
- No explicit mention of "expert consensus," "pathology," or "outcomes data" in the typical AI/diagnostic study sense.
8. The sample size for the training set:
Not applicable/Not provided. The device is a physical stent, not a machine learning algorithm. There is no concept of a "training set" in this submission.
9. How the ground truth for the training set was established:
Not applicable/Not provided. As there is no training set, this information is not relevant.
Summary of Device and Approval Process based on Provided Text:
- Device Name: S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System
- Intended Use: Palliation of malignant neoplasms (strictures) in the biliary tree.
- Regulatory Pathway: 510(k) Premarket Notification.
- Mechanism of Proof: Substantial Equivalence to predicate devices (Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent Transhepatic Biliary System, Cordis S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System, Cordis PRECISE™ Nitinol Stent Transhepatic Biliary System, ev3 Protégé EverFlex Self-Expanding Nitinol Stent).
- Supporting Data for Substantial Equivalence: Non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct).
- FDA Conditions: The FDA required specific labeling limitations: "The safety and effectiveness of this device for use in the vascular system have not been established" and the biliary use indication must be prominently displayed.
The provided document is a regulatory approval document for a physical medical device (stent) via the 510(k) pathway, which focuses on demonstrating substantial equivalence, not on studies proving acceptance criteria for a diagnostic/AI device. Therefore, most of your requested information is not relevant or present in this context.
§ 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.