(92 days)
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.
This document describes a 510(k) premarket notification for the NIO-P device, a hypodermic single lumen needle intended for pediatric intraosseous access. The submission aims to demonstrate substantial equivalence to existing predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it lists several validations and studies performed to demonstrate the device's performance characteristics. The "Reported Device Performance" is implied through the successful completion of these validations and bench testing, confirming the device functions as intended and meets safety and effectiveness requirements.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Proper Insertion Point Detection | Validated by Insertion Point and Penetration Depth Validation |
| Accurate Needle Penetration Depth (adjustable for age group) | Validated by Insertion Point and Penetration Depth Validation |
| Adequate Spring Force for Bone Penetration | Validated by Adequate Spring Force and Bone Integrity Following Activation Validation |
| Preservation of Bone Integrity after Activation | Validated by Adequate Spring Force and Bone Integrity Following Activation Validation |
| Needle Stabilizer Effectiveness | Validated by Needle Stabilizer Validation |
| Hub-Cannula/Hub-Needle Bond Strength | Tested in Hub-Cannula/Hub-Needle Bond Strength Testing (According to ISO 7864) |
| Structural Integrity during use | Tested in Structural Deformation and Needle Integrity Test |
| Substantial Equivalence to predicate/reference devices | Demonstrated through performance testing and comparison to NIO-A and BIG-P, confirming that modifications do not raise new safety/effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes bench testing and validation studies. It does not specify sample sizes for these tests. The data provenance is implied to be from the manufacturer's internal testing (Waismed Ltd.). There is no mention of country of origin for test data, nor whether it is retrospective or prospective, as it pertains to engineering and product validation rather than clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies listed are bench tests evaluating physical properties and functionalities of the device (e.g., spring force, bond strength, structural deformation). These types of tests typically rely on engineering specifications and laboratory measurements rather than expert human assessment for ground truth.
4. Adjudication Method for the Test Set
Given that the studies are bench tests of physical characteristics, an adjudication method in the context of expert consensus or disagreement is not applicable and therefore not mentioned. The "ground truth" for these tests would be defined by the pre-established engineering specifications and validated measurement techniques.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence through bench testing of the device's physical and functional characteristics.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a mechanical hypodermic needle for intraosseous access. It is not an algorithm-based device or software, so the concept of "standalone (algorithm only)" performance is not applicable. The device's performance is inherently tied to its mechanical function, albeit with features designed to aid the human user (e.g., detecting proper injection point, adjustable penetration depth).
7. The Type of Ground Truth Used
The ground truth used for the performance studies is based on:
- Engineering specifications and design requirements: For aspects like proper insertion point, penetration depth, spring force, bone integrity, bond strength, and structural deformation.
- Established standards: E.g., ISO 7864 for Hub-Cannula/Hub-Needle Bond Strength Testing.
- Comparison to predicate device characteristics: To demonstrate that the modified device's characteristics are consistent with or improved upon the predicate and reference devices, without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
This information is not applicable. The NIO-P is a mechanical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. The design and validation are based on engineering principles and physical testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as #8. There is no training set for a mechanical device.
§ 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).