(107 days)
The Sterile Safety Syringes for Single Use are intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to mimize risk of accidental needle sticks. The Sterile Safety Syringes for Single Use are single use, disposable devices, provided sterile.
The proposed device consists of a safety hypodermic needle and a luer slip or luer lock syringe. Models of Sterile Safety Syringes for Single Use shown in Table 11.1 and 11.2 are available in various models according to different syringe volume and needle specifications.
The provided text describes the 510(k) premarket notification for "Sterile Safety Syringes for Single Use." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria in the manner one would see for an AI/ML medical device or a novel product requiring a clinical trial.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" (especially those related to clinical studies, human expert involvement, ground truth, and training data for AI/ML) are not applicable to this type of submission.
However, I can extract information related to the technical performance tests conducted to show equivalence.
Here's a breakdown based on the provided document:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" as pass/fail thresholds for clinical outcomes, but rather lists the standards to which the device conforms and the results of the tests confirming that conformity. The "acceptance" is that the device's performance meets the requirements of these recognized standards.
| Acceptance Criterion (Standard Compliance) | Reported Device Performance (Test Conclusion) |
|---|---|
| Biocompatibility: | |
| ISO 10993-1 (Evaluation & testing within risk management) | Conforms (device not adverse to human tissue) |
| ISO 10993-2 (Animal welfare) | Conforms |
| ISO 10993-4 (Interactions with blood) | Conforms |
| ISO 10993-5 (In vitro cytotoxicity) | Conforms (No Cytotoxicity) |
| ISO 10993-10 (Irritation & delayed-type hypersensitivity) | Conforms (No Irritation to Skin, No significant evidence of sensitization) |
| ISO 10993-11 (Systemic toxicity) | Conforms (No systemic toxicity) |
| ISO 10993-12 (Sample preparation/reference) | Conforms |
| ASTM 756-17 (Hemolytic properties) | Conforms (No Hemolysis) |
| Sterilization & Packaging: | |
| ISO 10993-7 (Ethylene Oxide Sterilization Residuals) | Conforms |
| USP 43-NF38:2020 (Bacterial Endotoxins) | Conforms (Non pyrogenic) |
| USP 43-NF38:2020 (Pyrogen Test) | Conforms (Non pyrogenic) |
| ASTM F88/F88M-15 (Seal Strength) | Conforms |
| ASTM F1929-15 (Detecting Seal Leaks) | Conforms |
| ASTM F1980-16 (Accelerated Aging) | Conforms |
| Device Performance & Safety Feature: | |
| ISO 7864:2016 (Sterile hypodermic needles) | Conforms |
| ISO 7886-1:2017 (Sterile hypodermic syringe) | Conforms |
| ISO 9626:2016 (Stainless steel needle tubing) | Conforms |
| ISO 80369-7:2021 (Small-bore connectors) | Conforms |
| ISO 23908:2011 (Sharps injury protection) | Conforms |
| FDA Guidance "Medical Devices with Sharps Injury Prevention Features" | Simulated clinical use study conducted; device complies with requirements. |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the exact number of units tested for each standard. This level of detail is typically found in the full test reports, which are summarized in the 510(k) submission.
- Data Provenance: The tests were non-clinical performance tests conducted for the purpose of demonstrating substantial equivalence. The document doesn't explicitly state the country of origin for the testing data, but the manufacturer is based in Shanghai, China. The tests are "retrospective" in the sense that they were completed prior to this submission for regulatory review.
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):
- Not applicable. This submission refers to a traditional medical device (syringes), not an AI/ML device or one requiring human expert interpretation of complex data for "ground truth" establishment. The "ground truth" for these tests is defined by the objective measurements and pass/fail criteria specified within the referenced ISO and ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 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:
- No. This type of study is relevant for diagnostic devices interpreting complex data (e.g., radiology images) and involving human readers. It is not applicable to a safety syringe.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This isn't an algorithm. The "performance" is mechanical and material integrity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" is established by the objective, quantitative requirements and methods defined in the listed international and national standards (ISO, ASTM, USP) for sterility, biocompatibility, and physical performance of hypodermic needles and syringes. For instance, a test for "Force to activate safety mode" would have a defined NMT (Not More Than) value (e.g., 10N), and passing means the device operates within that mechanical specification.
8. The sample size for the training set:
- Not applicable. This refers to machine learning. No training set was used for a physical syringe.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
§ 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).