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NIO Adult™ 15g Intraosseous Access Device

NIO Adult™ 15g Intraosseous Access Device

NIO

Injection & Infusion
  • US FDA 510(k) cleared as a hypodermic single Lumen needle/intraosseous infusion device (predicate device NIO A; subsequent NIO+ clearance referencing NIO A).
  • CE marked medical device with notified body identification number as indicated on the device labeling and IFU.
  • Biocompatibility demonstrated to ISO 10993 series standards for body Contacting materials (including ISO 10993 1, 4, 5, 10, 11).
  • Sterilization validated in accordance with ISO 11137 (radiation sterilization) and related standards for terminally sterilized medical devices.
  • Packaging and shelf Life validated to ISO 11607 and ASTM F1980/ASTM D4169 for sterile barrier integrity and transport.
  • Conical fitting (Luer) compliant with ISO 594 1 and ISO 594 2 for syringe and needle connections.
  • Single Use only, gamma Irradiated, sterile device with labelling confirming non Reuse and MR Unsafe status.
  • Designed and indicated for use only by trained and authorized medical personnel under prescription (Rx only).
Intraosseous Access Device

Description

The NIO Adult™ 15g Intraosseous Access Device (NIO-A) is a single-use, automatic, spring-loaded intraosseous (IO) device designed to provide rapid vascular access in adult patients when conventional intravenous (IV) access is difficult or impossible in emergency situations. It is intended for use in the proximal tibia and humeral head as an alternative to emergency IV access, enabling rapid administration of fluids and medications, including blood products. The device is pre-assembled, sterile, pocket-sized and lightweight, with a 15G needle and integrated stabilizer base and safety mechanisms. NIO Adult™ achieves vascular access in less than 10 seconds, requires no batteries or external power, has no exposed needle post-deployment, and offers a 5-year shelf life at room temperature. It is FDA-cleared, CE-marked, and designed for use by trained healthcare professionals in pre-hospital, in-hospital, military, and other critical care environments.

Bnefits

  • Rapid vascular access in less than 10 seconds for critically ill or injured adult patients when IV access is difficult or delayed.
  • Automatic, spring-loaded mechanism with pre-set 15G needle and 25 ± 3 mm penetration depth into the bone marrow cavity for consistent IO placement.
  • Single-use, sterile and self-contained device with no need for assembly, drills, batteries or external power sources.
  • Integrated safety mechanisms including a rotating safety cap, trigger wings and stabilizer base to reduce accidental deployment and enhance secure placement.
  • No exposed needle after use, reducing risk of needlestick injury and cross-contamination.
  • Dual approved insertion sites (proximal tibia as primary, humeral head as secondary) providing flexibility in different clinical scenarios.
  • High documented success rates in clinical and tactical settings, with performance comparable or superior to other leading IO systems.
  • Pocket-sized and lightweight (approx. 19.4 x 8.4 x 3.3 cm) for easy carriage in responder kits, EMS bags and military pouches.
  • 5-year shelf life at room temperature, supporting long-term storage for emergency preparedness.
  • Standard Luer-compatible cannula hub, allowing connection to common syringes and infusion systems for fluid and drug delivery, including blood transfusion.

Indications

  • Intended to provide intraosseous (IO) access in the proximal tibia and humeral head as an alternative to emergency IV access in adult patients (above 12 years of age).
  • Use when rapid vascular access is required for fluid resuscitation and/or pharmacologic therapy and conventional IV access is difficult, delayed, or impractical.
  • Humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required and IV access is not possible or would significantly delay treatment.
  • Suitable for emergency, pre-hospital, in-hospital, and tactical environments including EMS, ambulance services, emergency departments, intensive care, operating theatres, retrieval teams, search and rescue, and military battlefield care.
  • Intended for single-patient, single-use IO access with dwell time up to 24 hours or until alternative vascular access has been established.

Composition

  • Needle assembly: stainless steel (trocar and cannula needle) complying with ISO 7153-1 and ISO 9626 requirements for metallic materials and stainless steel needle tubing.
  • Metallic components: brass, nickel-plated (non-patient-contacting mechanical elements).
  • Plastic components: polycarbonate for non-body contacting parts; high-performance thermoplastics (e.g., Ultem/polymer body) for structural components as per device variant.
  • Spring mechanism: steel spring (music wire or stainless steel depending on version) providing the stored energy to deliver the needle to the predetermined IO depth.
  • Sterile barrier and packaging: PET/PETG rigid or semi-rigid blister sealed with Tyvek® sterile barrier, validated for gamma irradiation sterilization.
  • Sterilization method: terminal sterilization by gamma irradiation.

Formulation

  • Mechanical, spring-loaded intraosseous access device with no medicinal substance or drug coating.
  • Semi-automatic design: a pre-loaded internal spring deploys the 15G needle to a penetration depth of approximately 25 mm (± 3 mm) into the bone marrow cavity when the device is pressed against the bone and trigger wings are squeezed.
  • Standard Luer-compatible cannula hub to connect to syringes and IV infusion sets for delivery of fluids, medications, and blood products.
  • Single-use, sterile device designed to remain in situ with the cannula and stabilizer base while the internal trocar and outer housing are removed post-deployment.
  • Biocompatible materials for patient-contacting components evaluated to ISO 10993 series standards.

Packaging

  • Individually packaged sterile device in a blister pack (PET/PETG rigid blister sealed with Tyvek®) to maintain sterility until point of use.
  • Pocket-sized and lightweight device, approximate overall dimensions of packaged unit: 7.64 x 3.3 x 1.3 inches (19.4 x 8.4 x 3.3 cm).
  • Single-use, single-sterile unit with integrated cap, locking tabs, stabilizer base, trocar, cannula, jacket and trigger wings pre-assembled.
  • Labeling includes product name, model NIO-A, NSN code, manufacturer (WaisMed Ltd), distributor (PerSys Medical), CE mark with notified body number, and FDA clearance statement.
  • Outer packaging and instructions for use (IFU) provided in multiple languages for international distribution.
  • Packaged and validated for a 5-year shelf life under recommended storage conditions at room temperature.

Usage

  • Use only by suitably trained and authorized healthcare professionals familiar with intraosseous access and institutional protocols.
  • Wear appropriate personal protective equipment (PPE), including gloves. Disinfect the skin at the chosen insertion site according to local aseptic technique and protocol.
  • Open the blister pack by peeling off the Tyvek® lid and remove the NIO Adult (NIO-A), ensuring it is free of any packaging remnants.
  • Select one of the approved insertion sites in adult patients (above 12 years of age): primary site – proximal tibia (approximately 2 cm medial and 1 cm proximal to the tibial tuberosity); secondary site – humeral head (adduct arm, locate the greater tubercle next to the head of the humerus, palpate the surgical neck, then move approximately 1 cm toward the greater tubercle).
  • Stabilize the chosen site and position the device at a 90° angle to the skin. Hold the NIO-A by the textured dots with the non-dominant hand, maintaining firm contact at the insertion site.
  • Unlock the device by rotating the cap 90° in either direction to disengage the safety mechanism.
  • Place the palm of the dominant hand over the cap and apply firm downward pressure to compress the soft tissue and seat the device. While maintaining downward pressure, squeeze the trigger wings to deploy the needle automatically into the bone.
  • After deployment, maintain stabilizer base contact with the skin using the non-dominant hand. With the dominant hand, lift the NIO-A housing straight up with a gentle twisting motion, leaving the cannula and stabilizer base in place.
  • Apply the NIO fixation dressing (if available) by adhering its tabs over and around the stabilizer base to secure the IO cannula to the skin and minimize movement.
  • Remove the internal trocar by pulling it straight out (twisting if necessary), using the trocar removal notch at the distal end of the device if required. Dispose of the trocar immediately in an appropriate sharps/biohazard container.
  • Attach a syringe to the Luer hub, confirm secure connection, and aspirate for bone marrow if desired. Confirm proper placement by flushing with up to 20 mL of fluid (or per institutional protocol); observe for ease of flush and absence of soft tissue swelling.
  • Connect the IO cannula to the desired infusion system (e.g., extension set, IV tubing) and commence fluid and/or medication administration, using a pressure bag if higher flow rates are required.
  • Frequently monitor the limb and insertion site for signs of infiltration, swelling, pain, or other complications—initially at least every 10 minutes for the first 30 minutes, then regularly thereafter while in use.
  • For conscious patients, consider intraosseous local anaesthetic (e.g., lidocaine) prior to flushing and infusion according to institutional protocols and drug guidelines.
  • Remove the IO cannula within 24 hours of insertion or as soon as alternative vascular access is established. To remove, release the fixation dressing, hold the stabilizer base, and twist and pull the cannula upward. Apply manual pressure until hemostasis, then dress with a sterile occlusive dressing, documenting the time and date of removal and noting no further IO access in that bone for at least 48 hours.
  • Dispose of the used device, cannula, and any contaminated materials in accordance with local regulations and institutional biohazard waste protocols.

Contraindications

  • Fracture of the bone selected for insertion or fracture of any bone within the limb selected for insertion.
  • Infection at the intended insertion site (e.g., cellulitis, osteomyelitis in the region).
  • Previous orthopedic procedure near the insertion site, or presence of a prosthetic limb or joint in the intended limb.
  • Any previous intraosseous access attempt in the same bone within the preceding 48 hours.
  • Inability to reliably locate anatomical landmarks or presence of excessive soft tissue at the insertion site that prevents accurate landmarking.
  • Presence of a tumor at or near the intended insertion site.
  • Osgood–Schlatter disease at or near the proximal tibial insertion area.
  • Deformation or significant abnormality of the intended insertion site.
  • Abnormalities of bone strength such as osteogenesis imperfecta, osteopetrosis, or significant osteoporosis, where safe use has not been established and landmarks may be obscured.

Adverse Effects

  • Potential for infiltration and extravasation of infused fluids into surrounding soft tissues if the needle is malpositioned or becomes displaced, which may lead to swelling and, in severe cases, compartment syndrome.
  • Risk of infection at the insertion site or deeper bone infection (osteomyelitis) if aseptic technique is not maintained or if the device remains in situ beyond recommended dwell time.
  • Risk of fracture or microfracture of the targeted bone, particularly in patients with underlying bone pathology or if used in a limb with existing fracture.
  • Risk of air embolism or fat embolism associated with intraosseous access, as with other IO devices.
  • Local pain and discomfort at the insertion site, particularly in conscious patients; this can be mitigated by appropriate use of local anaesthetic in line with protocol.
  • Bleeding or hematoma at the insertion site, typically minor and self-limiting when appropriate pressure is applied after removal.
  • Potential device-related issues such as difficulty flushing, poor flow or dislodgement if the stabilizer base or fixation dressing is not adequately secured.

Storage Conditions

  • Store at room temperature as indicated in the IFU; avoid extreme temperatures outside the validated storage range.
  • Keep in original sterile blister packaging until point of use; do not use if the package or sterile barrier (Tyvek® seal) is damaged or opened.
  • Protect from direct sunlight and moisture; handle as a fragile medical device.
  • Observe the expiry date printed on the device label and outer packaging; do not use beyond the indicated expiration date.
  • Handle the device with care to avoid mechanical damage to the housing, spring mechanism, and sterile barrier.
  • Dispose of expired or damaged devices in accordance with local medical device and biohazard waste regulations.

Duration

Intraosseous access established with NIO Adult\u2122 is intended for short-term emergency use. The IO cannula should generally be removed within 24 hours of insertion or as soon as alternative venous access has been secured, in line with the device IFU and institutional protocols.

Onset

Vascular access is typically achieved in under 10 seconds from device deployment when properly positioned, allowing immediate initiation of fluid and drug administration after confirmation of correct IO placement and flushing.

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