(217 days)
The NIO-I is an Intraosseous device intended to provide vascular access in the proximal tibia of infants as an alternative to emergency IV access. It is indicated for use in infants between gestational age of 36 weeks and weight of at least 5 pounds (2.3 Kg) and up to 3 years of age.
The NIO-I is a manual intraosseous device. It includes a lightweight ergonomic handle for easy and fast manual insertion of the needle into the medullary cavity. The device is designed specifically for infants between 0 and 3 years of age. The NIO-I provides haptic feedback via the stepped-needle design that helps preventing over-penetration into the distal cortex. After insertion of the needle, the user disconnects the handle and pulls out the trocar leaving the cannula inside the medullary cavity. Through the cannula, the caregiver can infuse fluids and drugs that will reach the vascular system.
The provided text is a 510(k) premarket notification for the NIO-I intraosseous device. It does not contain a study comparing the device to acceptance criteria but rather a comparison to predicate devices and a summary of non-clinical performance testing. Therefore, I cannot fully answer your request.
However, I can extract the information related to the non-clinical performance testing which serves as evidence for the device's acceptable performance against established standards.
1. Table of Acceptance Criteria (from Standards) and Reported Device Performance:
The document lists several non-clinical tests and the standards they comply with. These standards implicitly contain the acceptance criteria. The reported device performance is that it successfully complied with these standards.
| Test Category | Specific Test / Standard | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1: Evaluation and testing within a risk management process | Complies with ISO 10993-1 and related standards (10993-4, 10993-5, 10993-10, 10993-11) |
| Sensitization, Hemolysis, Material-mediated pyrogenicity, Cytotoxicity, Acute systemic toxicity, Intracutaneous reactivity | Passed successfully all applicable biocompatibility tests. | |
| Physical/Mechanical | Force required for needle cover removal | (Implicitly passed design specifications) |
| Visual inspection for corrosion, per ISO 9626 | Complies with ISO 9626 | |
| Force required for needle insertion | (Implicitly passed design specifications) | |
| Minimal force for insertion of the needle | (Implicitly passed design specifications) | |
| Force for detachment of the needle housing from the needle gripper | (Implicitly passed design specifications) | |
| Maximum force for trocar removal after insertion to the platform | (Implicitly passed design specifications) | |
| Cannula effective length, per ISO 9626 and ISO 7864 | Complies with ISO 9626 and ISO 7864 | |
| Maximum force for cannula removal after insertion | (Implicitly passed design specifications) | |
| Usability | Usability study, per IEC 62366-1 | Complies with IEC 62366-1 |
| Shelf Life/Packaging | Shelf life, per ISO 11607-1 and ASTM F1980-16 | Complies with ISO 11607-1 and ASTM F1980-16 |
| Sterilization | Sterilization validation, per ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72 | Complies with ISO 11137-1, ISO 11137-2, ISO 13004, ANSI AAMI ST72 |
| Limits for acidity or alkalinity, per ISO 7864 | Complies with ISO 7864 | |
| Connection (Luer) | Conical fitting, per ISO 594-1 and ISO 594-2 | Complies with ISO 594-1 and ISO 594-2 |
2. Sample sized used for the test set and the data provenance:
The document does not explicitly state the sample sizes for the individual non-clinical tests. It refers to these as "Waismed V&V tests plan" and compliance with international standards. Data provenance is not described beyond stating "non-clinical tests were conducted".
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable as the document describes non-clinical performance testing and compliance with standards, not a study utilizing expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable as the document describes non-clinical performance testing and compliance with standards.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is not applicable. The device is a physical intraosseous needle and does not involve AI or human "readers".
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable. The device is a physical intraosseous needle.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the non-clinical tests, the "ground truth" is defined by the objective pass/fail criteria established within the international standards (e.g., ISO 10993, ISO 9626, IEC 62366, etc.).
8. The sample size for the training set:
This information is not applicable as the document describes non-clinical performance testing of a physical device, not an algorithm that requires a training set.
9. How the ground truth for the training set was established:
This information is not applicable as there is no training set for this type of 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).