(201 days)
It is intended for use in the aspiration of fluids for medical purposes. When the safety shield is manually activated, it will cover the needle immediately after use to minimize risk of accidental needle stick.
The Verisafe Safety sterile needles are sterile, single use, standard hypodermic needle with a shield to enclose the needle after use. The Verisafe Safety sterile needles are for use with syringes. The device mainly consists of hub, needle cap and safety shield. It is packaged in a sealed sterility barrier. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control. Sterilized by ETO, shelf life 5 years.
The provided text describes a 510(k) premarket notification for the "Verisafe Safety sterile needles." This submission aims to demonstrate substantial equivalence to a predicate device, the "Sol-Care Safety Needle (K123684)." The document primarily focuses on explaining how the new device meets performance and biocompatibility standards rather than setting specific acceptance criteria with numerical targets against which device performance is reported.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly define acceptance criteria as numerical targets, but rather lists a series of tests and reference standards that the device "Complied with." For example, for "Cytotoxicity," the reported performance is "No cytotoxicity."
| Acceptance Criteria (Implied from Standard Requirement) | Reported Device Performance (as per document) |
|---|---|
| Appearance (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Cleanliness (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Color code (EN ISO 6009:2016) | Each color is in accordance with ISO 6009 |
| Dimensions (EN ISO 7864:2016, EN ISO 9626:2016) | Complied with EN ISO 7864:2016, EN ISO 9626:2016 |
| Length of the needle (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Lubricant (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Needle point (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Penetration force (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Bond between needle and hub (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Patency of lumen (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Needle cap | (No specific compliance statement given, but implied by overall compliance with relevant standards) |
| Stiffness (EN ISO 9626:2016) | Complied with EN ISO 9626:2016 |
| Resistance to breakage (EN ISO 9626:2016) | Complied with EN ISO 9626:2016 |
| Resistance to corrosion (EN ISO 9626:2016) | Complied with EN ISO 9626:2016 |
| Safety feature (Activate force) (EN ISO 23908:2013) | Complied with EN ISO 23908:2013 |
| Safety feature (Reuse Prevention) (EN ISO 23908:2013) | Complied with EN ISO 23908:2013 |
| Safety feature (Safety Performance) (EN ISO 23908:2013) | Complied with EN ISO 23908:2013 |
| Small-bore connector dimensions (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Positive pressure liquid leakage (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Sub-atmospheric pressure air leakage (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Stress cracking (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Resistance to separation from axial load (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Resistance to separation from unscrewing (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Resistance to overriding (ISO 80369-7:2021) | Complied with ISO 80369-7:2021 |
| Particulate contamination (USP 39 ) | Complied with USP 39 |
| Acidity and alkalinity (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Extractable metals (EN ISO 7864:2016) | Complied with EN ISO 7864:2016 |
| Package appearance (ASTM F1886/F1886M – 16) | Complied with ASTM F1886/F1886M – 16 |
| Seal strength (EN 868-5:2018) | Complied with EN 868-5:2018 |
| Dye penetration (ASTM F1929-15) | Complied with ASTM F1929-15 |
| Sterility (USP 39 ) | Complied with USP 39 |
| Bacterial endotoxin (USP 40 ) | Complied with USP 40 |
| Cytotoxicity (ISO 10993-5:2009) | No cytotoxicity |
| Skin Sensitization (ISO 10993-10:2021) | No evidence of sensitization |
| Intradermal reaction test (ISO 10993-23:2021) | No evidence of irritation |
| Acute systemic toxicity (ISO 10993-11:2017) | No systemic toxicity |
| Pyrogen study (ISO 10993-11:2017, USP43-NF37) | Non pyrogenic |
| In Vitro Hemolytic Properties Test (ASTM F756-17) | No effect |
| Ethylene Oxide residues (ISO 10993-7:2008) | Complied with ISO 10993-7:2008 |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document lists various performance and biocompatibility tests. For these types of tests (e.g., physical properties, chemical analysis, biological reactivity), sample sizes are not explicitly stated. These are typically bench tests conducted in a laboratory setting. The country of origin for the device manufacturer is China (Promisemed Hangzhou Meditech Co., Ltd.), so it's highly probable the testing was conducted there. The nature of these tests is prospective for the device being evaluated.
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 type of information is not applicable to the tests described. The tests are largely objective and based on established international and national standards (ISO, ASTM, USP). Ground truth is established by the methods outlined in these standards, not by expert consensus in a clinical diagnostic sense. For example, "No cytotoxicity" is a result of a lab test, not an expert's opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where subjective interpretation (e.g., image reading) requires consensus among experts. This is not relevant for the bench and lab tests described in the document for a hypodermic needle. The compliance to standards is determined by measuring objective parameters.
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
An MRMC study is performed in the context of diagnostic devices, often involving interpretation of medical images by human readers with or without AI assistance. This is not applicable to the "Verisafe Safety sterile needles," which is a medical device for fluid aspiration/injection and needle stick prevention, not a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question applies to AI/software as a medical device. The "Verisafe Safety sterile needles" is a mechanical medical device, not an AI or software product. Therefore, standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance and biocompatibility tests is based on the objective measurement and assessment against predetermined specifications and thresholds outlined in the referenced international standards (e.g., ISO, ASTM, USP). For example, a "No cytotoxicity" ground truth is established by a quantitative cell viability assay, and "Sterility" is determined by microbiological cultures. It's not based on expert consensus, pathology, or outcomes data in the clinical sense, but rather adherence to a scientifically established benchmark defined by the standards.
8. The sample size for the training set
This question is relevant for machine learning or AI models. Since the "Verisafe Safety sterile needles" is a physical medical device and not an AI or software product, there is no "training set."
9. How the ground truth for the training set was established
As there is no training set for this device, this question is 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).