(210 days)
The MV intradermic needles are intended to inject fluids intradermally.
The device is comprised of a metal tube. On one end the tip is closed and blunt, while the cannula has an opening laterally at a lower point under the tip. On the other end the device is joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe.
The MV intradermic needle is marketed alone or combined with a pilot needle. The pilot needle is an hypodermic single lumen needle intended to prepare the site for injection. The tip of the pilot needle is sharpened at one end, while the other end is joined to a hub. The pilot needle can be any traditional legally marketed hypodermic needle.
The MV intradermic needles are single-use devices sold as sterile.
This document describes a 510(k) submission for the "MV Intradermic Needles," a medical device. The submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a de novo clinical study with specific acceptance criteria and detailed performance metrics as one might see for novel AI/ML devices.
Here's an analysis based on your requested information, acknowledging the nature of this particular 510(k):
1. A table of acceptance criteria and the reported device performance
For this type of device (a hypodermic needle), acceptance criteria are primarily based on established consensus standards and material properties, demonstrating that the device functions as intended and is safe. There isn't a "performance" metric in the sense of accuracy, sensitivity, or specificity as seen with diagnostic AI/ML devices. Instead, performance relates to compliance with physical and biological standards.
| Acceptance Criteria (from Recognized Consensus Standard ISO 7864) | Reported Device Performance |
|---|---|
| Cleanness | Compliant; No issues |
| Acidity or alkalinity limits | Compliant; No issues |
| Limits for extractable metals | Compliant; No issues |
| Needle tube - Length requirements | Compliant; No issues |
| Needle tube - Absence of defects | Compliant; No issues |
| Execution - Hub/tube bond strength | Compliant; No issues |
| Execution - Evidence of lumen | Compliant; No issues |
Biocompatibility Acceptance Criteria (after STERILE finished device tests):
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Cytotoxicity | Compliant; No issues |
| Sensitization | Compliant; No issues |
| Intracutaneous reactivity | Compliant; No issues |
| Systemic toxicity | Compliant; No issues |
| Haemocompatibility | Compliant; No issues |
The study that "proves" the device meets these criteria is a series of non-clinical (laboratory-based) tests and risk analysis, as outlined in the "DISCUSSION OF NON CLINICAL TESTS" section. The document states: "None of the data raised any issues of safety and effectiveness" for the performance tests and "None of the result of the tests arised any issues of biocompatibility" for the biological tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a quantitative sample size for the non-clinical or biological tests. It states "Following performance tests were performed on the MV Intradermic Needles" and "Following biological tests were performed on the sterile finished device," implying that samples were tested to demonstrate compliance.
- Sample Size: Not explicitly stated (likely adequate for standard testing per ISO norms, but not specified in the document).
- Data Provenance: Not explicitly stated, but the tests were performed by the manufacturer (M.V. s.r.l.) or a testing lab in Italy, where the company is located. Given the nature of a 510(k) for a medical device like a needle, these are prospective tests conducted specifically for this submission.
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 is not applicable to this type of device submission. Ground truth, in the context of expert consensus, is typically relevant for diagnostic devices that interpret images or data. For a hypodermic needle, "ground truth" is established by physical measurements and standard biological assays according to recognized standards, not by expert interpretation of clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve disagreements among human readers or experts in complex diagnostic tasks. The tests described here are objective, pass/fail measurements against defined 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
Not applicable. MRMC studies are used for evaluating the performance of diagnostic AI/ML algorithms, particularly in improving human reader performance. This submission is for a physical medical device (a needle) and does not involve AI or human interpretation tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" here is adherence to recognized consensus standards (ISO 7864 for performance, and standard biocompatibility test protocols for biological safety). These standards define objective criteria (e.g., specific limits for cleanness, extractable metals, bond strength, and biological responses like cytotoxicity).
8. The sample size for the training set
Not applicable. "Training set" refers to data used to train AI/ML models. This device is a physical product and does not involve machine learning.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this 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).