(175 days)
The Sterile Hypodermic Syringes for Single Use with Needles is intended for use in the aspiration of fluids for medical purpose.
The Sterile Hypodermic Syringes for Single Use with Needles is intended for manual and single use only to aspirate and inject of fluids for medical purpose, which consists of piston, barrel, plunger and a hypodermic needle. The proposed device is available in a variety combination of syringe volume and needle size.
The provided text describes a 510(k) premarket notification for "Sterile Hypodermic Syringes for Single Use with Needles." This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study or a standalone algorithm evaluation.
Therefore, many of the requested sections about acceptance criteria, clinical studies, reader studies, and ground truth establishment are not applicable to this type of regulatory submission and the provided document.
Here's an analysis based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of acceptance criteria and reported device performance in the way a clinical study or standalone algorithm study would. Instead, it demonstrates compliance with recognized international standards for medical devices. The "reported device performance" is essentially that the device complied with these standards.
| Acceptance Criteria (Standards Met) | Reported Device Performance |
|---|---|
| ISO 7886-1:2017 (Syringes for Manual Use) | Complied with ISO 7886-1 (Syringe Performance) |
| ISO 80369-7:2016 (Small-bore connectors) | Complied with ISO 80369-7 (Luer Connector Performance) |
| ISO 80369-20:2015 (Common test methods for connectors) | Complied with ISO 80369-20 |
| ISO 7864:2016 (Sterile Hypodermic Needles) | Complied with ISO 7864 (Needle performance) |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Complied with ISO 9626 (Needle performance) |
| ISO 10993-1 (Biocompatibility) | Biocompatibility testing conducted, no adverse effects shown |
| USP (Particulate Matter in Injections) | Met USP acceptance criteria for particulate matter |
| ISO 11135:2014 (EO Sterilization) | Validated to achieve SAL of 10^-6 |
| ISO 10993-7:2008 (EO and ECH residuals) | Residuals below specified limits |
| USP (Bacterial Endotoxin Levels) | Below level of 20 EU/device |
| ASTM F1886 / F1886M-16 (Visual Inspection) | Performed |
| ASTM F88/F88-15 (Seal Strength) | Performed |
| ASTM F1929-15 (Dye penetration) | Performed |
| ASTM D4169-16 (Simulated Transportation) | Performed |
| ASTM F1980-16 (Accelerated Aging for Shelf-life) | Shelf-life of 5-years validated |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document describes non-clinical laboratory testing (e.g., physical performance, biocompatibility, sterilization validation) but does not detail the sample sizes for these tests or the data provenance. The tests are general in nature for medical device components and manufacturing processes, not related to patient data.
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 submission. Ground truth established by medical experts (like radiologists) is relevant for diagnostic devices or AI algorithms that interpret medical data. This submission is for a physical medical device (syringes and needles). The "ground truth" here is compliance with engineering and material standards, which is assessed through laboratory testing by qualified personnel, not by medical experts establishing diagnostic ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable to this submission. Adjudication methods are typically used in clinical trials or reader studies where multiple human readers or algorithms provide interpretations that need to be resolved to establish a definitive ground truth. The testing described here is based on objective measurements against established international 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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices or decision support systems. The device in question is a sterile hypodermic syringe with needles, which is a physical device used for aspiration and injection, not an AI or diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm was not done. This device is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by international standards and regulations for the physical, chemical, and biological properties of sterile hypodermic syringes and needles. This includes:
- Physical performance requirements (e.g., according to ISO 7886-1, ISO 7864, ISO 9626)
- Biocompatibility (e.g., according to ISO 10993-1)
- Sterility Assurance Level (SAL) (e.g., according to ISO 11135)
- Particulate matter levels (e.g., according to USP )
- Endotoxin levels (e.g., according to USP )
These are objective, measurable criteria, not subjective interpretations requiring expert consensus or pathology reports.
8. The sample size for the training set
This is not applicable. This device is a physical medical product, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As stated above, this device is not an AI algorithm and therefore does not have a "training set" or "ground truth for a training set."
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).