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510(k) Data Aggregation
K Number
K024018Device Name
AVANT GUARDIAN 101
Manufacturer
Date Cleared
2003-01-17
(44 days)
Product Code
Regulation Number
880.5430Why did this record match?
Applicant Name (Manufacturer) :
AVANT MEDICAL CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Avant Guardian™ 101 is designed to deliver various liquid medications and vaccines by penetrating the skin with a high-speed fluid jet and delivering the medication or vaccine to the underlying subcutaneous tissue.
Device Description
The Avant Guardian™ 101 allows a medication or vaccine to be injected subcutaneously without the use of a needle. The system is designed to mimic the best clinical practices for iniecting medications, namely, a slow injection of medication into tissue that is not compressed.
The product consists of a single-use medication reservoir (syringe) and a reusable injector. The operator employs an offthe-shelf vial adapter to fill the single-use medication reservoir with medication. The injector device is reset by compressing the spring-loaded push-rod. The medication reservoir is then placed in the Avant injector, which has an integral, batteryoperated vacuum source. The patient places the reservoir against his skin and activates the vacuum by depressing the safety switch. To prevent an accidental discharge, the safety switch must be depressed and held until the injection is initiated by the operator depressing the inject button. As the vacuum is formed, skin is drawn up to and securely held in contact with the reservoir tip. Suction generated by the injector stabilizes the reservoir against the patient's skin to create a subcutaneous pocket (thereby avoiding muscle), eliminating the need to force the injector against the skin and compress the underlying tissue. The suction creates a seal around the tip that allows slow delivery of the medication, and stabilizes the device to prevent lacerations and movement of the orifice.
The medication is delivered in two stages. The patient depresses the inject button, causing a mechanism in the device to impact the medication reservoir plunger. Initially a high pressure, high speed jet of medication exits the reservoir orifice, puncturing the skin and the underlying tissue. The injection force quickly falls to a low level as the spring-loaded mechanism forces the medication into the subcutaneous tissue. The injector automatically stops the vacuum pump at the end of the injection, thereby indicating when the injector can be removed from the skin.
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