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K Number
K990079
Device Name
FASTSEAL CHEST WOUND DRESSING
Manufacturer
GREENFIELD MEDICAL TECHNOLOGIES, INC.
Date Cleared
1999-12-23

(346 days)

Product Code
MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
    1. To be used as a temporary bandage to treat penetrating chest wounds that could compromise the pleural space of the chest cavity, such as: gunshot wounds, stab wounds and fragment wounds.
    1. To be used on a temporary and emergency basis in the management of an open pneumothorax condition.
    1. To prevent a tension pneumothorax, and for reinflate a collapsed lung without using invasive procedures.
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text from the FDA letter about the "FastSeal Chest Wound Dressing" (K990079) does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment.

The letter is a 510(k) clearance document, which confirms that the device is substantially equivalent to a legally marketed predicate device. It defines the intended use of the device but does not include details on performance studies or their methodologies.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details based on the provided text.

N/A