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The NIO-P for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients between 3 and 12 years of age.

The NIO product family (Adult and Pediatric) is an upgrade in terms of design and structure to the company's B.I.G. Bone Injection Gun product family. The NIO product family has already one cleared model, for the adult population NIO Adult (K142086). Both product families NIO and BIG are composed of a trocar needle, spring, piston, and housing that contains safety mechanisms to prevent accidental device activation. Both devices are positioned onto the appropriate insertion site. Both product families have the same principle of operation. The device resembles a syringe and, when activated, a loaded spring is released and the device injects a needle to a predetermined depth into the bone marrow cavity. The user then pulls out the trocar needle, leaving the cannula inside the bone marrow cavity. Through the cannula, fluids and drugs can be delivered to the vascular system via the bone marrow cavity. The NIO-P device is designed to detect the proper injection point. In addition, the NIO-P is also equipped with a unique, adjustable needle penetration depth according to the age group, as part of the stabilizer. Both features are designed to improve accuracy in detecting the insertion point and needle penetration depth.

The NIO Adult is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only. The NIO Adult is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

The NIO Adult device is a modification to the company's cleared Adult B.I.G - Bone Injection Gun (K981853 and K062940) to permit intraosseous access through the Proximal Tibia and the Humeral Head. Like the cleared Adult B.I.G., the NIO Adult device is comprised of a trocar needle, spring, piston and housing. Likewise, both devices resemble a syringe and when activated, a loaded spring is released and the device injects the needle to a predetermined depth into the bone marrow cavity. The difference between the NIO Adult device and the cleared B.I.G. device is primarily the safety latch and trigger mechanism which is designed to provide a safer device and the minor design modifications to the plastic housing and needle dimensions in order to accommodate the modified safety mechanism.

The B.I.G. - Bone Injection Gun is indicated for use in providing intraosseous access as an alternative to IV access during emergencies. Humeral head IO access is indicated when rapid fluid or pharmacological resuscitation is required and intravenous access is not possible. The device is for use in adult patients only.

The B.I.G. - Bone Injection Gun consists of a trocar needle held by a piston. The piston is surrounded by a compressed spring. All components are contained in the device's housing. When the device is operated, the compressed spring is released and propels the trocar needle into the bone marrow.

The B.I.GTM. Bone injection Gun for Pediatrics is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in pediatric patients up to 12 years of age.

The B.I.GTM. Bone injection Gun for Pediatrics is an instant, intravascular (IV) access device. The device comprises a housing with a spring loaded mechanism that inject a trocar needle into the bone marrow of a patient and allows for subsequent connection of a syringe or intravascular administration set.

The Bone Injection Gun (B.I.G.) is intended to provide intraosseous access in the proximal tibia, as an alternative to IV access during emergencies. The device is for use in adult patients only.

Bone Injection Gun (B.I.G.)