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510(k) Data Aggregation
K Number
K203193Device Name
BD Intraosseous Infusion System
Date Cleared
2021-03-04
(127 days)
Product Code
Regulation Number
880.5570Why did this record match?
Applicant Name (Manufacturer) :
Bard Access Systems, Inc(BAS)[Wholly-owned subsidiary of BD]
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BD Intraosseous Infusion System provides intraosseous access in the proximal tibia, distal tibia and humeral head (proximal humerus) of adult and pediatric patients, and the distal femur in pediatric patients when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically necessary cases for up to 24 hours.
Device Description
The BD Intraosseous Infusion System provides clinicians and emergency personnel with access to the intraosseous space for resuscitation and lifesaving fluid delivery for up to 24 hours. The BD Intraosseous Infusion System consists of the following: a single use hypodermic needle (with needle safety cap), a powered or manual driver to assist with needle insertion, an extension set, and; an adhesive-backed securement dressing. For insertions using the powered driver, the hypodermic needle includes a needle hub that mates with a stylet connected to a drive adapter hub. The drive adapter hub includes a magnetic insert that attaches to the powered driver prior to needle insertion. The BD Intraosseous Infusion System is an easy-grip, hand-held, battery-powered device with a rechargeable lithium battery used to assist in the insertion of the subject device needle through the bone cortex. The assembly of the hypodermic needle and stylet with connected drive adapter hub is referred to as the needle set. For insertions using the manual driver, the needle and the needle hub mate with a stylet in the same way as the needle set that is used with the powered driver, except the stylet is integrated into the handle of the manual driver instead of a drive adaptor hub (i.e. the manual driver needle assembly does not include a drive adapter hub). The stylet was designed to include a passive safety feature to protect the placer from sharps injury. After the needle is inserted, the stylet is separated from the needle and needle hub. Upon separation of the stylet from the needle hub, the passive safety feature is released onto the stylet tip and can be safely discarded into a sharps container. Following needle insertion, the securement dressing can be applied to secure the needle hub to the skin. An extension set is available for access to the needle hub to support fluid exchange. The subject device BD Intraosseous Infusion System will be offered in needle set (for use with the powered driver) and manual driver needle kit configurations. Each kit configuration will include a securement dressing and an extension set.
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