LogoFDA 510(k) Search
K Number
K222184
Device Name
Introducer Sheath Kits
Manufacturer
Beijing Demax Medical Technology Co., Ltd.
Date Cleared
2023-02-21

(214 days)

Product Code
DYB
Regulation Number
870.1340
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Introducer Sheath Kits are intended for use to facilitate the introduction of guide wires, catheters and other accessory medical devices through the skin into a vern or artery and minimize blood loss associated with such introduction.

Device Description

Not Found

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for an "Introducer Sheath Kits." This type of document does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria for a medical imaging device utilizing AI.

The letter focuses on the regulatory clearance process, establishing substantial equivalence to a predicate device, and outlining general controls and regulations that the manufacturer must adhere to. It concerns a physical medical device (introducer sheath kits) used for facilitating the introduction of guidewires and catheters.

Therefore, I cannot provide the requested information based on the given text.

To answer your questions about acceptance criteria and device performance studies, you would typically need a clinical study report or a data summary from a premarket submission (e.g., PMA or 510(k) summary for an AI/ML medical device), which would detail:

  1. Acceptance criteria and reported performance: Specific metrics (e.g., sensitivity, specificity, AUC) and predefined thresholds.
  2. Sample size and data provenance: Details of the dataset used for validation.
  3. Experts for ground truth: Number and qualifications of readers/experts.
  4. Adjudication method: How disagreements were resolved.
  5. MRMC study information: If applicable, details on human reader performance with and without AI.
  6. Stand-alone performance: Algorithm-only performance metrics.
  7. Type of ground truth: How the "truth" was established for the test data.
  8. Training set size: Number of cases used for model training.
  9. Training set ground truth: How ground truth was established for the training data.

§ 870.1340 Catheter introducer.

(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).