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K Number
K022584
Device Name
CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
Manufacturer
CARDIOTECH INTL.
Date Cleared
2002-12-30

(147 days)

Product Code
MGQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K930457,K943314
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full- thickness wounds. They may be used on the following wounds: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites

Device Description

CardioTech Antibiotic Hydrogel Wound Dressings are semi-occlusive, and absorptive. The wound contact surface is composed of an antibiotic containing hydrogel. The OTC antibiotic mixture used consists of the following components: Neomycin Sulfate, 3.5mg, Bacitracin Zinc 500 Units and Polymyxin B Sulfate, 10,000 Units. The antibiotic mixture is present to help prevent bacterial contamination of the dressing. A second outer layer consists of a polymeric film.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "CardioTech Antibiotic Hydrogel Wound Dressing." This type of document is for regulatory clearance and focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a detailed study of the device's performance against specific acceptance criteria. Therefore, the document does not contain the information requested in questions 1 through 9 regarding acceptance criteria and a study demonstrating performance.

Here's why and what the document does provide:

  • Substantial Equivalence: The core of a 510(k) submission is to show that a new device is as safe and effective as a legally marketed predicate device. This is typically done by comparing characteristics like intended use, technology, materials, and performance data if relevant.
  • Lack of Performance Study Details: The provided text does not describe a specific clinical or performance study that rigorously tests the CardioTech Antibiotic Hydrogel Wound Dressing against predefined acceptance criteria. Instead, it relies on the established safety and efficacy of its predicate devices to argue for its own.
  • Focus on Description and Indication: The document details the device's components (hydrogel with antibiotics, polymeric film), its indications for use (various types of wounds), and its classification.

Therefore, I cannot populate the table or answer questions 2-9 based on the provided text. The information simply isn't present in this regulatory summary.

N/A