(28 days)
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.
This is a 510(k) premarket notification for a medical device called "NIO Adult," a hypodermic single lumen needle intended for intraosseous access. The document does not describe a study that uses acceptance criteria and reports device performance in the way a clinical trial or a machine learning algorithm validation would. Instead, it focuses on demonstrating substantial equivalence to a previously cleared predicate device (B.I.G. Adult Bone Injection Gun) through a series of engineering and performance tests.
Therefore, many of the requested categories for acceptance criteria and study design are not applicable in the context of this 510(k) submission.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists several performance tests, but it does not explicitly state quantitative acceptance criteria or detailed numerical performance results for each test in a table format. It generally states that the device "functions as intended" and "inserts the needle to the same penetration depth as the predicate device."
| Test Name | Implied Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Trigger Safety Mechanism Test | Device safety mechanism functions correctly. | Functions correctly, improves device safety. |
| Needle Stabilizer (Mechanical Stopper) Performance Test | Stabilizer performs as intended. | Performs as intended. |
| Needle Penetration Depth Test | Penetration depth is consistent with the predicate device. | Inserts the needle to the same penetration depth as the predicate device. |
| Compressed Spring Force Test | Spring force is within specified limits for proper needle insertion. | Functions as intended. |
| Bone Fracture Test | Device does not cause undue bone fracture during use. | Functions as intended. |
| Biocompatibility Testing (ISO 10993-5, -10, -11) | Materials are biocompatible (non-cytotoxic, non-irritating, non-sensitizing). | Meets ISO 10993 standards. |
| Hub-Cannula/Hub-Needle Bond Strength Testing (ISO 7864) | Bond strength meets ISO 7864 requirements to prevent separation. | Meets ISO 7864 standards. |
| Structural Deformation and Needle Integrity Test | Device structure and needle maintain integrity during use. | Maintains integrity. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify general "sample sizes" in the way a clinical study would (e.g., number of patients or cases). The tests described are engineering and bench tests, likely performed on a small number of device units or components.
- Sample Size: Not specified for each test. Typically, these types of tests involve a limited number of devices or components to demonstrate consistency and compliance.
- Data Provenance: The tests were conducted to demonstrate substantial equivalence to the predicate device, also manufactured by Waismed Ltd. The document does not specify a country of origin for the testing data itself, but the applicant company (Waismed Ltd.) is located in Herzliya, Israel. The data is retrospective in the sense that it's comparing against an existing predicate, but the testing itself would have been conducted more recently.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study involving expert human interpretation or diagnosis. The "ground truth" for these engineering tests is established by objective measurements against predefined specifications or comparison to the predicate device's characteristics.
4. Adjudication Method for the Test Set
Not applicable. There is no expert adjudication process described, as the tests are objective engineering measurements.
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. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the subject of this medical device submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The NIO Adult is a physical medical device (a needle system), not an algorithm or software-based device.
7. The type of ground truth used
The "ground truth" for the performance tests is based on:
- Engineering Specifications: Designed performance characteristics for components (e.g., spring force, depth of penetration).
- International Standards: Compliance with standards like ISO 10993 (biocompatibility) and ISO 7864 (bond strength).
- Predicate Device Performance: Direct comparison to the established performance characteristics of the B.I.G. Adult Bone Injection Gun in areas like needle penetration depth.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model, so there is no training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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).