US FDA 510(k) clearance K160805 for NIO P (classified as hypodermic single Lumen needle, product code FMI, Class II).
CE Marked medical device under the EU Medical Device Directive/Regulation (CE mark and notified body number shown on labelling).
Biocompatibility testing of patient Contacting materials performed in accordance with ISO 10993 series standards (including cytotoxicity, sensitisation, irritation and systemic toxicity evaluations).
US FDA 510(k) clearance K160805 for NIO P (classified as hypodermic single Lumen needle, product code FMI, Class II).
CE Marked medical device under the EU Medical Device Directive/Regulation (CE mark and notified body number shown on labelling).
Biocompatibility testing of patient Contacting materials performed in accordance with ISO 10993 series standards (including cytotoxicity, sensitisation, irritation and systemic toxicity evaluations).
Gamma irradiation sterilisation validated in accordance with ISO 11137 and related standards for terminally sterilised medical devices.
Description
The NIO Paediatric™ 18g Intraosseous Access Device (NIO-P) is a spring-powered, automatic intraosseous (IO) device designed to provide rapid vascular access in paediatric patients when conventional intravenous (IV) access is difficult or delayed. It is specifically indicated to provide IO access in the proximal tibia as an alternative to IV access during emergencies in children aged 3–12 years. The single-use, sterile device is fully assembled, pocket-sized and lightweight, with an 18G needle and an adjustable needle penetration depth (14 mm or 18 mm) controlled by a removable red spacer to accommodate different paediatric age groups. NIO Paediatric™ incorporates locating arrows to aid in accurate landmarking of the proximal tibia, a stabiliser hub that helps secure the needle, redundant safety mechanisms to prevent accidental activation, and a design that leaves no exposed needle after use. It requires no batteries, drills or external power, allowing IO access to be established in less than 10 seconds for rapid delivery of fluids, medications and blood products in both pre-hospital and in-hospital paediatric emergency care.
Bnefits
Rapid vascular access: enables intraosseous access and initiation of resuscitation fluids and medications in typically less than 10 seconds when used correctly.
Paediatric-specific design: indicated for children aged 3–12 years, with an 18G needle and adjustable penetration depth tailored to paediatric tibial anatomy.
Adjustable depth via red spacer: removable red depth spacer allows two preset penetration depths (approximately 14 mm for 3–9 years and 18 mm for 9–12 years) using a single device for the full intended age range.
Automatic, spring-powered mechanism: semi-automatic, self-contained unit requiring no drills, batteries, assembly or external power source.
Proximal tibia targeting with locating arrows: built-in location arrows on the stabiliser hub aid identification of the correct proximal tibial insertion site and alignment parallel to the tibial shaft.
Integrated stabiliser hub: needle stabiliser helps secure the needle to the limb, reducing the risk of dislodgement during resuscitation and patient movement.
Redundant safety features: rotating safety latch and activation sequence (downward pressure and trigger wings) minimise accidental deployment and unintended needle firing.
No exposed needle after activation: design eliminates an exposed needle post-deployment, reducing needlestick injury risk and contamination.
Gamma irradiation sterilisation validated in accordance with ISO 11137 and related standards for terminally sterilised medical devices.
Packaging and shelf Life validation consistent with ISO 11607 and transport simulations to ensure maintenance of sterile barrier integrity over the 5 Year shelf life.
Standard Luer Lock connection in accordance with ISO 594 requirements, allowing secure connection to standard syringes and infusion systems.
Single Use, prescription Only (Rx only) medical device with labelling and indications aligned with FDA and EU regulatory frameworks for intraosseous devices.
Performance and safety characteristics (insertion point accuracy, penetration depth, bone safety, stabiliser function, structural integrity) validated by bench testing and supported by published clinical and simulation studies of NIO Paediatric™ usage.
Packaging and shelf Life validation consistent with ISO 11607 and transport simulations to ensure maintenance of sterile barrier integrity over the 5 Year shelf life.
Standard Luer Lock connection in accordance with ISO 594 requirements, allowing secure connection to standard syringes and infusion systems.
Single Use, prescription Only (Rx only) medical device with labelling and indications aligned with FDA and EU regulatory frameworks for intraosseous devices.
Performance and safety characteristics (insertion point accuracy, penetration depth, bone safety, stabiliser function, structural integrity) validated by bench testing and supported by published clinical and simulation studies of NIO Paediatric™ usage.
Intraosseous Access Device
Compact and lightweight: pocket-sized device (approx. 14.8 × 5.7 × 2.7 cm) that fits easily into EMS kits, hospital crash carts and military medic pouches.
Extended shelf life: 5-year shelf life at room temperature, supporting long-term storage for emergency preparedness.
Clinically validated: IO access performance and device safety (including bone safety, spring force, needle stabiliser and penetration depth) validated in bench and clinical studies, with high first-attempt success rates reported in the literature.
Indications
Intended to provide intraosseous access in the proximal tibia as an alternative to intravenous (IV) access during emergencies in paediatric patients aged 3–12 years.
Use in situations where rapid vascular access is required for fluid resuscitation and/or drug administration and conventional IV access is difficult, delayed or impossible.
Suitable for use in hospital and clinic environments (e.g., emergency departments, paediatric intensive care, operating theatres, wards) and emergency care settings (pre-hospital EMS, ambulance services, retrieval teams, search and rescue, disaster response and military medicine) where paediatric patients require urgent vascular access.
Indicated for the administration of crystalloids, colloids, blood products and medications approved for intraosseous delivery, in line with local protocols and paediatric resuscitation guidelines.
Intended for prescription use only by trained healthcare professionals authorised to perform intraosseous access in paediatric patients.
Composition
Trocar needle and cannula: stainless steel needle tubing and cannula meeting ISO 9626 and ISO 7153-1 requirements (hypodermic single-lumen needle classification).
Hub and mechanical components: brass 360, nickel-plated metal hub and spring mechanism housed within the device body.
Patient-contacting plastic parts: Makrolon® Rx2530 medical-grade polycarbonate used for plastic components in direct contact with the patient’s skin.
Non-patient-contacting housing and structural plastics: medical-grade polymers designed for mechanical durability and housing the spring mechanism and safety features.
Standard Luer-lock cannula hub: metal Luer-lock hub compatible with standard syringes and IV infusion systems.
Sterile barrier and packaging: rigid or semi-rigid PET/PETG blister pack with Tyvek® lid, validated for gamma irradiation terminal sterilisation.
Mechanical, spring-powered intraosseous access device with no medicinal product, coating or active pharmacological substance.
Semi-automatic operation: a loaded internal spring is released when the device is pressed against the skin and trigger wings are activated, delivering the needle to a predetermined depth into the proximal tibial bone marrow cavity.
Adjustable needle penetration depth via removable red spacer: depth settings of approximately 14 mm and 18 mm to match age/size groups within the 3–12 year range.
Integrated stabiliser hub and Luer-lock cannula: after activation, the cannula and stabiliser remain in place to permit connection to standard Luer-lock syringes and infusion sets for fluid and drug delivery.
Single-use, sterile design: device components (outer housing, spring, trocar needle, cannula, stabiliser) are pre-assembled, used once on a single patient and then disposed of; the internal trocar is removed after successful placement, leaving the cannula in situ.
Packaging
Supplied individually in a sterile, peel-back blister pack (PET/PETG blister with Tyvek® lid) to maintain sterility until use.
Each blister contains a fully assembled, ready-to-use NIO Paediatric™ device with integrated stabiliser hub and safety features.
Pocket-sized dimensions of approximately 5.8 × 2.24 × 1.06 inches (14.8 × 5.7 × 2.7 cm), optimised for storage in emergency kits, bags and crash carts.
Single-use device, clearly labelled as disposable and sterile, with instructions for use (IFU) provided in the packaging or as a separate IFU document.
Labelling includes trade name (NIO Pediatric™ / NIO-P), manufacturer (WaisMed Ltd.), distributor (e.g., PerSys Medical/Safeguard Medical), needle gauge (18G), age range (3–12 years), prescribed insertion site (proximal tibia), CE mark and relevant regulatory information.
Shelf life of 5 years from date of manufacture when stored at room temperature within the recommended conditions.
Usage
Use only by healthcare professionals who are trained and authorised in paediatric intraosseous access and familiar with local policies and protocols.
Verify that the device is within its expiry date and that the sterile blister packaging is intact and undamaged before use. Do not use if packaging is compromised.
Perform standard patient assessment and confirm indication for intraosseous access (e.g., failed or delayed IV access in critically ill/injured paediatric patients requiring urgent resuscitation).
Prepare equipment including NIO Paediatric™ device, appropriate personal protective equipment (PPE), antiseptic skin preparation, extension set, syringe, IV/IO fluids and medications, and a fixation dressing if available.
Position the child and expose the proximal tibial area of the selected leg. Choose the appropriate insertion site on the proximal tibia according to the IFU, typically approximately 2 cm medial and 1–2 cm distal to the tibial tuberosity, in line with landmarking guidance.
Use the locating arrows on the stabiliser hub: place the designated locating arrow (R for right leg, L for left leg if present) over the tibial tuberosity, aligned parallel to the long axis of the tibia and pointing towards the knee, then slide slightly distally to the recommended insertion point as per IFU poster or manufacturer guidance.
Select needle penetration depth according to the patient’s age: for children aged 3–9 years, keep the red spacer in place for an approximate depth of 14 mm; for children aged 9–12 years, remove the red spacer to increase penetration depth to approximately 18 mm.
Prepare the skin with an appropriate antiseptic solution and allow to dry, ensuring aseptic technique is observed throughout.
Remove the device from the sterile blister pack. Rotate or disengage the safety latch according to the IFU to unlock the device.
Hold the device perpendicular (approximately 90°) to the skin over the selected insertion site. Place the palm of the dominant hand on top of the cap while the other hand stabilises the limb, and apply firm downward pressure to compress soft tissue and appose the stabiliser hub to the skin.
While maintaining downward pressure, activate the device by squeezing or pulling the trigger wings as described in the IFU; this releases the internal spring and automatically advances the needle and cannula into the bone marrow cavity to the preset depth.
After activation, continue to hold the stabiliser hub against the skin with the non-dominant hand. With the dominant hand, gently pull the device housing straight up with a slight twisting motion, leaving the needle stabiliser and cannula in place in the bone.
Remove the internal stylet/trocar from the cannula (using the removal notch or handle as directed) and dispose of it immediately in an appropriate sharps container.
Attach a syringe to the Luer-lock hub and gently aspirate for marrow; absence of aspirate does not exclude correct placement, so confirm by flushing with a small volume of fluid and observing for free flow without soft tissue swelling.
Secure the IO needle using the stabiliser hub and, if available, a dedicated fixation dressing to minimise movement and reduce the risk of dislodgement. Ensure the limb is further stabilised as necessary.
Connect the IO line or extension set and commence infusion of fluids and/or medications in accordance with paediatric resuscitation guidelines and local protocols. Consider using a pressure bag or infusion device for higher flow rates.
In conscious patients, consider administration of intraosseous local anaesthetic (e.g., lidocaine) prior to flushing and infusion to reduce pain, following local protocols and drug guidance.
Monitor the insertion site and limb frequently for signs of infiltration, swelling, erythema, increased pain, decreased perfusion, or compartment syndrome, and stop infusion immediately if complications are suspected.
Remove the IO cannula as soon as adequate alternative vascular access has been established or within 24 hours of insertion, whichever occurs first. To remove, release the fixation dressing, stabilise the limb and gently twist and pull the cannula out along its axis; then apply pressure until haemostasis and dress the site with a sterile occlusive dressing.
Document the insertion details, including time, site, needle depth setting, any complications and time of removal, in the patient’s record.
Contraindications
Fracture of the target bone (tibia) or fracture of any bone in the same limb as the intended insertion site.
Suspected or confirmed infection at or near the proposed insertion site (e.g., cellulitis, osteomyelitis).
Previous orthopaedic procedure, hardware or prosthesis in the targeted limb or at the intended insertion site that could alter anatomy or compromise IO placement.
Previous intraosseous access attempt in the same bone within the preceding 48 hours.
Inability to palpate anatomical landmarks reliably or excessive soft tissue at the insertion site that prevents accurate landmarking and safe depth assessment.
Underlying significant bone disease or congenital bone fragility (e.g., osteogenesis imperfecta, severe osteopenia or metabolic bone disease) where safe use has not been established and fracture risk may be increased.
Presence of a local bone tumour or lesion at or adjacent to the intended insertion site.
Contraindications specific to institutional protocols or local regulations regarding intraosseous access in paediatric patients.
Adverse Effects
Extravasation or infiltration of fluids and medications into surrounding soft tissue if the needle is malpositioned, dislodged or penetrates the opposite cortex; this may result in swelling, tissue injury and, in severe cases, compartment syndrome.
Local infection at the insertion site or deeper bone infection (osteomyelitis), particularly if aseptic technique is compromised or if the IO cannula is left in place beyond recommended dwell time.
Bone injury, including microfracture or fracture of the tibia, especially in patients with underlying bone fragility or if inserted inappropriately.
Local pain or discomfort at the insertion site, especially in awake paediatric patients; pain may increase with flushing and infusion and can be mitigated with appropriate local anaesthetic and analgesia.
Bleeding or haematoma at the insertion site, usually minor and self-limiting with appropriate local pressure and dressing.
Risk of fat or air embolism, as with other IO techniques, although clinically significant events are rare when standard protocols are followed.
Potential device-related complications such as difficulty flushing, poor flow, partial insertion or dislodgement if the stabiliser hub is not adequately seated or secured.
Psychological distress and anxiety in children related to the procedure, requiring age-appropriate communication, reassurance and, where appropriate, sedation or analgesia in line with local practice.
Storage Conditions
Store the NIO Paediatric™ device at room temperature within the range specified in the IFU and on the packaging; avoid storage in conditions outside the validated temperature range (e.g., excessive heat, freezing).
Keep in the original sterile blister packaging until immediately before use; do not use if the blister or Tyvek® sterile barrier is opened, torn or otherwise compromised.
Protect from moisture, direct sunlight and mechanical damage during storage and transport.
Observe the expiry date printed on the packaging and device label; do not use the device after the labelled expiration date.
Do not attempt to re-sterilise or reuse the device; it is intended strictly for single use.
Store as part of an emergency or resuscitation kit in a clean, dry environment according to institutional policy, ensuring the device is easily accessible during emergencies.
Duration
The NIO Paediatric\u2122 intraosseous access is intended for short-term emergency use only. In line with IO access best practice and institutional policies, the IO cannula should generally be removed within 24 hours of insertion or as soon as alternative suitable vascular access is established.
Onset
When used correctly, intraosseous vascular access can typically be established in less than 10 seconds from activation of the device, allowing immediate initiation of fluid and pharmacologic resuscitation after confirmation of correct IO placement.
