(160 days)
The TERUMO® Needle is a hypodermic single lumen needle intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.
The TERUMO® NEEDLE is a hypodermic sterile single lumen needle, consisting of a stainless tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe or an intravascular administration set.
The provided text describes the 510(k) summary for the TERUMO® Needle, a hypodermic single lumen needle. The focus of this document is to demonstrate substantial equivalence to previously cleared devices rather than to present a de novo study with detailed acceptance criteria and performance metrics for a new device.
Therefore, many of the specific details requested in your prompt regarding acceptance criteria and performance studies, such as sample sizes for test sets, number and qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training sets, are not applicable to this type of submission. This document primarily relies on the equivalency of the new device to existing devices based on several performance tests.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with specific quantitative acceptance criteria or detailed reported device performance in the format typically seen for novel device efficacy studies. Instead, it states that:
- Performance Tests Performed:
- Protector Pit
- Adhesive Hold
- Conical Fitting
- Seal Strength
- Outcome Statement: "None of the data raises any new issues on safety and effectiveness." This implies that the device met the internal specifications and standards set by Terumo (Philippines) Corporation for these tests, which are presumably deemed equivalent to those of the predicate devices. However, the specific numerical acceptance thresholds and the quantitative results are not disclosed in this summary.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document only mentions that performance tests were "performed on the TERUMO® Needle manufactured by Terumo (Philippines) Corporation."
- Data Provenance: The device is manufactured by Terumo (Philippines) Corporation. The data would therefore originate from their internal testing. It's a prospective internal test for the new device variant to confirm its manufacturing quality and performance against established specifications.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable. The performance tests listed are mechanical and material engineering tests (e.g., strength of adhesive, fit of conical parts, seal integrity). These do not typically involve human expert interpretation or "ground truth" establishment in the way that diagnostic imaging or clinical decision support AI devices would. The "ground truth" for such tests would be defined by engineering specifications and objective measurements.
4. Adjudication method
- Not applicable, for the same reasons as #3.
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
- Not applicable. This is a physical medical device (a hypodermic needle), not an AI algorithm or a diagnostic imaging system. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used
- For the listed performance tests (Protector Pit, Adhesive Hold, Conical Fitting, Seal Strength), the "ground truth" would be established by engineering specifications and objective measurements against industry standards (e.g., ISO standards for Luer connectors) and the manufacturer's internal quality control criteria, rather than expert consensus, pathology, or outcomes data in a clinical sense.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/machine learning device. The device's design and manufacturing processes are informed by established engineering principles and prior experience with similar devices, not by a data-driven training process.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
In summary, the 510(k) process for a device like a hypodermic needle heavily relies on demonstrating equivalence to predicate devices through design, materials, intended use, and a set of standard performance and safety tests. The detail of these tests, while crucial for the submission, is often summarized at a high level in the public 510(k) summary, with the most critical information being the confirmation that "None of the data raises any new issues on safety and effectiveness," thereby establishing substantial equivalence.
§ 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).