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K Number
K032457
Device Name
MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
Manufacturer
CORDIS CORP.
Date Cleared
2003-09-04

(24 days)

Product Code
FGE
Regulation Number
876.5010
Type
Special
Panel
GU
Reference & Predicate Devices
K021898,K031777
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.

Device Description

The device description of the proposed SMART™ Control™ Nitinol Stent Transhepatic Biliary System is as follows. 6 French stent delivery system profile; Stent material – Nickel Titanium alloy and tantalum micromarkers; Expanded stent diameters 6, 7, 8, 9, and10 mm; Stent lengths: 20, 30, 40, 60, 80, and 100 mm; Stent delivery system usable length 80 and 120 cm; and Guidewire lumen 0.035". Proximal Deployment Handle

AI/ML Overview

The provided text is a 510(k) summary for a medical device (SMART™ Control™ Nitinol Stent Transhepatic Biliary System) and a letter from the FDA. It does not include information about acceptance criteria or a study proving device performance in the context of the requested details about AI/algorithm performance.

The document discusses:

  • Device Name: SMART™ Control™ Nitinol Stent Transhepatic Biliary System
  • Predicate Devices: SMART™ Control Nitinol Stent Transhepatic Biliary System (K021898 and K031777)
  • Indications for Use: Palliation of malignant neoplasms in the biliary tree.
  • Device Description: Stent material (Nickel Titanium alloy and tantalum micromarkers), stent dimensions (diameters, lengths), delivery system (French profile, usable length, guidewire lumen), and proximal deployment handle.
  • Biocompatibility: Stated as biocompatible.
  • Substantial Equivalence: Confirmed through pre-clinical testing, comparing it to predicate devices.
  • FDA Communication: A letter affirming substantial equivalence but requiring specific warnings regarding use in the vascular system and prominent display of the biliary indication.

The document does not contain any information related to:

  • Acceptance criteria in the context of an algorithm or AI.
  • Reported device performance as would be detailed for an AI.
  • Sample sizes for test sets, training sets, or data provenance for an AI study.
  • Number of experts, their qualifications, or adjudication methods for ground truth establishment for an AI.
  • MRMC comparative effectiveness studies or human reader improvement with AI.
  • Standalone algorithm performance.
  • Type of ground truth (e.g., pathology, outcomes data) for an AI.

Therefore, I cannot provide the requested table and study details as they pertain to AI/algorithm performance based on the given input. The "study" mentioned is "pre-clinical testing" used to establish substantial equivalence for a physical medical device, not an AI evaluation.

§ 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.