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510(k) Data Aggregation
(158 days)
The SiO2 Coated Syringe 3 mL is intended to be used to inject fluids into, or withdraw fluids from, the body.
SiO2 Coated Syringe 3 mL is a plastic disposable standard 3 mL piston syringe without needle is made of a cyclic olefin polymer (COP) and coated internally with silica glass layers. The layer is deposited by plasma enhanced chemical vapor deposition (PECVD) process.
This is a standard 3 mL single use, disposable syringe without needle.
This document describes the non-clinical testing for the SiO2 Coated Syringe 3 mL to demonstrate its substantial equivalence to a predicate device. Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists numerous tests and standards to which the device conforms. Instead of specific numerical acceptance criteria (which are typically defined within the standards themselves and not fully detailed here), the document generally states "Complies" or describes the test performed and implies compliance by its inclusion in the summary of successful non-clinical testing.
| Acceptance Criteria (Standard & Section/Test) | Reported Device Performance |
|---|---|
| ISO 7886-1: Sterile hypodermic syringes for single use | |
| Section 5, Cleanliness | Complies (Test Performed) |
| Section 6 & Annex A, Limits for Acidity or Alkalinity | Complies (Test Performed) |
| Section 7 & Annex A, Limits for Extractable Metals | Complies (Test Performed) |
| Section 8, Lubricant | Complies (Test Performed) |
| Section 9, Tolerance on Graduated Capacity | Complies (Test Performed) |
| Section 10.1, Scale | Complies (Test Performed) |
| Section 10.2, Numbering of Scale | Complies (Test Performed) |
| Section 10.3, Overall Length of Scale to Nominal Capacity Line | Complies (Test Performed) |
| Section 10.4, Position of Scale | Complies (Test Performed) |
| Section 11.1, Dimensions | Syringe Dimensions (Test Performed) |
| Section 11.2, Finger Grips | Complies (Test Performed) |
| Section 12.1, Design | Complies (Test Performed) |
| Section 12.2, Fit of Piston in Barrel | Complies (Test Performed) |
| Annex G, Force to Operate | Plunger Withdraw: Fi=2.11 N, Fm=2.39 N; Plunger Deploy: Fi=2.35 N, Fm=0.58 N (Reported values) |
| Section 12.3, Fiducial Line | Complies (Test Performed) |
| Section 13.2, Position of Nozzle on End of Barrel | Complies (Test Performed) |
| Section 13.3, Nozzle Lumen | Complies (Test Performed) |
| Section 14.1 - Annex C, Dead Space | Complies (Test Performed) |
| Section 14.2 - Annex D, Liquid Leakage Compression | Complies (Test Performed) |
| Section 14.2 - Annex B, Air Leakage past Syringe Piston during Aspiration | Complies (Test Performed) |
| ISO 594 - 1 and -2: Conical fittings with a 6 % (Luer) taper | |
| Section 5.1, Gauging | Complies (Test Performed) |
| Section 5.2, Liquid Leakage | Complies (Test Performed) |
| Section 5.3, Air Leakage | Complies (Test Performed) |
| Section 5.4, Separation Force | Complies (Test Performed) |
| Section 5.5, Unscrewing Torque | Complies (Test Performed) |
| Section 5.6, Ease of Assembly | Complies (Test Performed) |
| Section 5.7, Resistance to Overriding | Complies (Test Performed) |
| Section 5.8, Stress Cracking | Complies (Test Performed) |
| Biocompatibility Testing (ISO 10993-1, G95-1) | |
| Cytotoxicity: Elution Test, Serum Supplemented MEM Extract | Materials found to be non-reactive (Test Performed) |
| Skin Sensitization Test Protocol, Guinea Pig Maximization Test | Materials found to be non-reactive (Test Performed) |
| Intracutaneous (Intradermal) Reactivity Test | Materials found to be non-reactive (Test Performed) |
| Systemic Toxicity: Saline and Vegetable Oil Extracts | Materials found to be non-reactive (Test Performed) |
| Hemolysis Test (NIH Method) Saline Extract | Materials found to be non-reactive (Test Performed) |
| Extractable and Leachables (ISO 7886-1 coated/uncoated) | Complies (Test Performed) |
| USP Rabbit Pyrogen Test (Material Mediated) | Complies (Test Performed) |
| Bacterial Endotoxin-Mediated Pyrogen test (Limulus Amebocyte Lysate Test) | Complies (Test Performed) |
| Other Non-Clinical Testing | |
| ASTM D4169-14: Performance Testing of Shipping Containers and Systems | Complies (Test Performed) |
| ASTM F1980-07 (2011): Accelerated Aging of Sterile Barrier Systems | Complies (Test Performed) |
| Real-time aging (24 months) | Complies (Test Performed) |
| Oxygen Transmission Rate ("OTR") | Complies (Test Performed) |
| Container compatibility with certain drug products | Complies (Test Performed) |
| Mechanical stressor | Complies (Test Performed) |
| Environmental stressor - freeze-thaw study | Complies (Test Performed) |
| Ink adhesion and Wipe & Tape Test Report | Complies (Test Performed) |
| Physical Characteristics Test | Complies (Test Performed) |
| Syringe Dimensions | ID: 8.62mm, OD: 11.34mm (Reported values) |
| Plunger Force Test | Fi=2.11 N, Fm=2.39 N, Fi=2.35 N, Fm=0.58 N (Reported values) |
| FTIR Test method for coating chemistry | Complies (Test Performed) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample sizes for each of the non-clinical tests. It lists the tests performed, implying that appropriate sample sizes per the respective standards (ISO, ASTM, etc.) were used. The data provenance is non-clinical bench testing, conducted by or on behalf of SiO2 Medical Products. The document does not specify countries of origin for the data, but it is implied to be from the manufacturer's testing or accredited labs. All data presented appears to be prospective in the sense that it was generated for this specific submission to demonstrate conformance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable to this submission. The tests are non-clinical engineering and biocompatibility tests against established international standards (ISO, ASTM, USP). Ground truth is established by the methods defined in these standards, not by expert consensus on clinical observations. The "experts" in this context would be laboratory technicians and engineers qualified to perform these specific tests according to the standard operating procedures.
4. Adjudication Method for the Test Set
This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to clinical or diagnostic studies involving human interpretation. For non-clinical bench testing, results are typically determined by measurements against predefined acceptance criteria from the relevant 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
This section is not applicable. This submission is for a physical medical device (syringe) and does not involve AI, human readers, or diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. This submission is for a physical medical device and does not involve an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests listed is defined by the acceptance criteria specified within the referenced international standards (e.g., ISO 7886-1, ISO 594, ISO 10993-1, ASTM D4169-14, ASTM F1980-07). For biocompatibility, this includes outcomes of biological assays (e.g., cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity). For physical tests, it refers to quantitative measurements (e.g., dimensions, forces, leakage rates) meeting specified ranges or thresholds.
8. The Sample Size for the Training Set
This section is not applicable. This submission is for a physical medical device and does not involve a training set for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable. This submission is for a physical medical device and does not involve a training set for an algorithm.
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