(28 days)
The NIO+ Adult is intended to provide intraosseous (IO) access in the proximal tibia and the humeral head as an alternative to emergency IV access. Per urgent mecessity, humeral head IO access may be used when rapid fluid or pharmacological resuscitation is required. The device is intended for use in adult patients only.
The NIO+ Adult (NIO+) is intended to be used with the same patient population and same age range. The NIO+ utilizes the very same technology and has the same operation method. The main difference is that the NIO+ provides a more physically robust version of the NIO Adult (NIO-A) which was selected to serve as the primary predicate device for this submission. The NIO+ was designed to better serve in tactical settings, such as battlefields, as the device and its package are more durable. It should be noted that the NIO-A is currently in use for all segments and settings that the NIO+ is targeted for. The additional robustness of the NIO+ is achieved by utilizing raw materials that have higher mechanical properties. The sterile single unit packaging robustness was increased, by using a rigid-blister and rigid plastic cover to protect the Tyvek paper. In addition, the maximal storage temperature was increased to 50°C versus room temperature, in order to assure that the device can function such extreme temperatures.
All NIO products are intended to be used by skilled, authorized medics, nurses, paramedics and doctors who are trained to use the device in military, emergency services and hospitals environments. The products are for single use and supplied sterile.
The provided text is a 510(k) Summary for the NIO+ Adult device. It focuses on demonstrating substantial equivalence to a predicate device (NIO Adult) through non-clinical testing, rather than presenting a study that proves the device meets specific acceptance criteria in a clinical or AI-driven context.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" as it pertains to AI/algorithm performance (e.g., sample size for test/training set, expert ground truth, MRMC study, standalone performance, effect size) cannot be extracted from this document because it describes a medical device (a hypodermic needle) and its regulatory clearance process, not an AI or algorithm-driven diagnostic or treatment device.
The document details the device's technical characteristics, its intended use, and the non-clinical tests performed to ensure its safety and effectiveness. It explicitly states: "No clinical Study is included in this submission."
However, I can extract the non-clinical acceptance criteria and their proven performance based on the provided document.
Non-Clinical Acceptance Criteria and Reported Device Performance
The NIO+ Adult device is a hypodermic single lumen needle intended for intraosseous (IO) access. The approval relied on non-clinical performance testing to demonstrate substantial equivalence to a predicate device (NIO Adult, K142086). The acceptance criteria are implicit in the "Discussion of Technological Characteristics" and "Non-Clinical Performance Testing" sections, where the subject device's performance is compared to the predicate or to relevant standards.
1. Table of Acceptance Criteria and the Reported Device Performance (Non-Clinical Focus)
| Acceptance Criteria (What was tested or demonstrated) | Reported Device Performance (How the device met the criteria) |
|---|---|
| Biocompatibility (no adverse effects on human tissue) | Complies with ISO 10993-1, 10993-4, 10993-5, 10993-10, 10993-11. The NIO+ uses the same needles and raw materials for body-contacting components as the predicate NIO-A, for which biocompatibility tests (sensitization, hemolysis, pyrogenicity, cytotoxicity, acute systemic toxicity, intracutaneous reactivity) were performed and apply to NIO+. |
| Trigger Mechanism Reliability and Penetration Depth Consistency | Tests conducted by WaisMed V&V team demonstrated compliance. (Specific quantitative results not provided in this summary, but implied to be within acceptable limits for substantial equivalence.) The device injects the needle to a penetration depth of 25±3mm into the bone marrow cavity. |
| Compressed Spring Force | Tests conducted by WaisMed V&V team demonstrated compliance. (Specific quantitative results not provided, but implied to be within acceptable limits.) |
| Trigger Safety Mechanisms Functionality (prevention of accidental activation) | The device has a rotational cap and requires simultaneous pressing against bone and pulling of the trigger mechanism; these safety features are equivalent to the predicate and demonstrated to function as intended. |
| Cannula Effective Length | Complies with ISO 9626 and ISO 7864. Needle length is 42mm. |
| Environmental and Transportation Testing (robustness to conditions) | Complies with ASTM D4332-14 and ASTM D4169. The NIO+ is designed to be more robust, serving in tactical settings and capable of use under extreme temperature conditions (50°C), an improvement over the predicate (room temperature). |
| Shelf Life | Complies with ISO 11607-1 and ASTM F1980-16. The NIO+ has a shelf life of 5 years at room temperature and 5 years at 50°C (an improvement over the predicate which was 5 years at room temperature). |
| Sterilization Validation (device sterility) | Complies with ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72 (for bacterial endotoxins). Sterilization method is Gamma irradiation. |
| Conical Fitting Standard Compliance (Luer taper for connection) | Complies with ISO 594-1 and ISO 594-2. The cannula hub is a standard Luer hub. |
| Needle Dwelling Time | The device meets the requirement for a needle dwelling time of |
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).