LogoFDA 510(k) Search
K Number
K993913
Device Name
TRUE
Manufacturer
INFINITY EXTRUSION & ENGINEERING, INC.
Date Cleared
2000-08-09

(266 days)

Product Code
LIT
Regulation Number
870.1250
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
Predicate For
K083139
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Intended for Percutaneous Dilatation of the iliac, femoral, popliteal, tibial, renal, infra popliteal, ilio femoral, and tibiopernoeal arteries.

Device Description

The TRUE PTA Balloon Catheter is a non-reusable multiple lumen catheter with a balloon mounted on its distal tip. The TRUE PTA Balloon Catheter is packaged sterile and intended for single use only.

AI/ML Overview

The provided text is a 510(k) summary for the TRUE PTA Balloon Catheter. It outlines the device's intended use, description, and states its substantial equivalence to a predicate device. However, it does not contain the specific information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, accuracy, or reader improvement.

The "Testing" section mentions various engineering tests conducted (e.g., balloon burst strength, bond strengths, biocompatibility), which are general product and material testing, not a clinical study or performance evaluation against specific acceptance criteria for diagnostic or therapeutic efficacy.

Therefore, I cannot provide the requested information in the tabular format or detailed descriptions because the provided document does not contain:

  • Specific acceptance criteria related to clinical performance. The document focuses on engineering specifications and substantial equivalence to a predicate device based on manufacturing, materials, and overall function.
  • A study that measures device performance against clinical or diagnostic metrics. There is no mention of sensitivity, specificity, accuracy, human reader performance, or ground truth establishment.
  • Details about sample sizes for test or training sets, data provenance, expert qualifications, or adjudication methods.

The document primarily focuses on demonstrating that the TRUE PTA Balloon Catheter is substantially equivalent to a legally marketed predicate device (Smash™ PTA Catheter) based on its design, materials, and intended use, rather than presenting a study proving its performance against pre-defined clinical acceptance criteria.

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).