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K Number
K041269
Device Name
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT
Manufacturer
ATRIUM MEDICAL CORP.
Date Cleared
2004-09-14

(125 days)

Product Code
JCT
Regulation Number
878.3720
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The iCAST Covered Stent is indicated for the treatment of tracheobronchial strictures produced by malignant neoplasms.

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for the Atrium iCAST Covered Stent, not a study report or clinical trial document. Therefore, it does not contain the detailed information necessary to answer the questions about acceptance criteria, study design, expert qualifications, or ground truth establishment.

A 510(k) clearance letter focuses on establishing substantial equivalence to a predicate device, and while it confirms the device is safe and effective for its indicated use, it does not typically include the specifics of a clinical study or performance data in the level of detail requested.

Therefore, based solely on the provided text, I cannot answer the questions. The document does not contain information on:

  1. Acceptance criteria and reported device performance: This letter is a regulatory clearance, not a performance report.
  2. Sample size, data provenance: Not mentioned.
  3. Number/qualifications of experts, ground truth establishment: Not mentioned.
  4. Adjudication method: Not mentioned.
  5. MRMC comparative effectiveness study: Not mentioned and not typically part of a 510(k) summary for this type of device.
  6. Standalone performance study: Not mentioned.
  7. Type of ground truth: Not mentioned.
  8. Training set sample size: Not mentioned.
  9. Ground truth for training set: Not mentioned.

To obtain this information, one would typically need to review the premarket notification (510(k) submission) itself, including any clinical data or bench testing summaries submitted by the manufacturer to the FDA.

§ 878.3720 Tracheal prosthesis.

(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”