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K Number
K173687
Device Name
Strange Bile Duct Stone Exploration Set
Manufacturer
Cook Incorporated
Date Cleared
2017-12-15

(14 days)

Product Code
LQR,GBZ,GCB,GCD,LOR,OCY,SEC,STR
Regulation Number
876.5010
Type
Traditional
Panel
GU
Reference & Predicate Devices
K173009
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Strange Bile Duct Stone Exploration Set is intended to be used for cholangiography and bile duct stone retrieval using fluoroscopy. The device is indicated for adults only.

Device Description

The Strange Bile Duct Stone Exploration Set is provided sterile for single-use only. The set consists of:

  • a 115 centimeter long NCompass Nitinol Tipped Stone Extractor with Tuohy Borst adapter
  • a 7.5 French, double lumen, 40 centimeter long radiopaque polyurethane cholangiography catheter with a preloaded inner catheter;
  • a 10 French, 12 centimeter long introducer catheter with preloaded needle stylet; and
  • a 125 centimeter long, polytetrafluoroethylene coated wire guide.
AI/ML Overview

The provided text is a 510(k) summary for the Cook Incorporated "Strange Bile Duct Stone Exploration Set." It details the device's characteristics, intended use, and comparison to a predicate device for the purpose of demonstrating substantial equivalence to the FDA.

However, the document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of AI/ML-driven medical devices.

Instead, the "Technological Characteristics" section briefly mentions:

  • "Dimensional and Compatibility Evaluation of subject device set (Accelerated Aged)"
  • "All pre-determined acceptance criteria were met."

This phrasing indicates that standard engineering and functional tests were performed on the device itself (e.g., verifying dimensions, compatibility of components, and integrity after accelerated aging). It does not refer to a clinical study involving human or AI performance data, ground truth establishment, or expert reviews as would be relevant for an AI/ML product.

Therefore, I cannot fulfill the request to provide information regarding acceptance criteria and a study proving an AI/ML device meets them, specifically:

  1. A table of acceptance criteria and reported device performance (for AI/ML).
  2. Sample size and data provenance (for AI/ML test sets).
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC study details.
  6. Standalone performance.
  7. Type of ground truth used.
  8. Training set sample size.
  9. Ground truth establishment for the training set.

This document pertains to a traditional medical device (a mechanical set for bile duct exploration), not an AI/ML system.

§ 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.