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K Number
K030334
Device Name
T-SCIENTIFIC T-PAD
Manufacturer
T-SCIENTIFIC, INC.
Date Cleared
2003-04-21

(80 days)

Product Code
QSY,FRO,LYA
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K972914,K984177
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The T-Scientific T-Pad™ is intended for use in the:

    1. Local management of bleeding wounds such as lacerations, abrasions, nose bleeds, vascular access site, percutaneous catheters or tubes and surgical debridement, and
    1. The promotion of rapid control of bleeding in patients following hemodialysis and in patients on anticoagulation therapy.
Device Description

The T-Scientific T-Pad™ is a soft, non-woven pad of poly-N-acetylglucosamine. T-Pad™ is packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.

AI/ML Overview

The provided documents are a 510(k) summary for the T-Scientific T-Pad™. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria based on a clinical study with detailed performance metrics.

Therefore, the documents do not contain the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or expert involvement. The 510(k) summary focuses on demonstrating that the T-Pad™ is technologically equivalent and has the same intended use as its predicate devices (Marine Polymer Technologies' Syvek Patch, K972914 and K984177).

Specifically, the document states:

  • "The T-Scientific T-Pad™ technological characteristics are the same as the Marine Polymer Technologies predicate devices. The T-Scientific T-Pad™ works in the same manner as the approved predicate devices."

This indicates that the main "proof" of meeting performance expectations is through demonstrating equivalent technology and mechanism of action to already approved devices. There is no mention of a de novo study with acceptance criteria and performance results for the T-Pad™ itself.

N/A