(263 days)
The Sterile Syringe for Single Use is intended for use by health care professionals for general purpose aspiration and injection of fluids.
The Syringe with needle is intended for manual and single use only. It consists of six components 1) Barrel (luer lock or luer slip) 2) Plunger 3) Piston 4) Needle Tube 5) Protective Cap and 6) Needle Hub. The proposed device is available in various combination of syringe volume, connector type (luer lock or luer slip), connector location (central type or eccentric type) and needle size. The Syringe without needle is intended for manual and single use only. It consists of three components 1) Barrel (luer lock or luer slip) 2) Plunger and 3) Piston. The proposed syringe is available in various combination of syringe volume, connector type (luer lock or luer slip), and connector location (central type or eccentric type). The proposed device is sterilized by Ethylene Oxide to achieve a SAL of 106 and supplied in sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
The provided document is a 510(k) Summary for a Sterile Syringe for Single Use. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing an AI/ML powered device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, training set details, or ground truth establishment for AI models) are not applicable.
However, based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets those criteria, interpreted within the context of a medical device clearance:
1. A table of acceptance criteria and the reported device performance
The document defines "acceptance criteria" through compliance with recognized standards and the demonstration of substantial equivalence to a predicate device. The performance is reported as meeting these standards.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standard Reference or Characteristic) | Reported Device Performance (Compliance) |
|---|---|---|
| Biocompatibility | ISO 10993-5 (in Vitro Cytotoxicity) | No cytotoxicity |
| ISO 10993-10 (Irritation and skin sensitization) | No intracutaneous reactivity, No skin sensitization | |
| ISO 10993-11 (Systemic toxicity) | No systemic toxicity | |
| ISO 10993-4 & ASTM F756-17 (Interaction with Blood, Hemolytic Properties) | No Hemolysis | |
| Pyrogenicity Test | No Pyrogen (Implied acceptance criterion for sterile devices) | |
| Material Safety | Endotoxin Limit | 20 EU per device |
| Sterilization | Sterilization Method | EO Sterilization (Ethylene Oxide) |
| Sterility Assurance Level (SAL) | 10-6 | |
| Packaging Integrity | ASTM F88/F88M-15 (Seal Strength) | Complies |
| ASTM F1929-15 (Seal Leaks by Dye Penetration) | Complies | |
| Particulate Matter | USP (Particulate Matter for Injections, Method 1) | Complies |
| Syringe Performance | ISO 7886-1:2017 (Sterile hypodermic syringes for single use - Part 1: Syringes for manual use) | Complies with ISO 7886-1 |
| Needle Performance | ISO 7864:2016 (Sterile hypodermic needles for single use - Requirements and test methods) | Complies with ISO 7864 |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Complies with ISO 9626 | |
| ISO 6009:2016 (Hypodermic needles for single use - Colour coding) | Complies with ISO 6009 | |
| Connector Compatibility | ISO 80369-7:2016 (Small-bore connectors for intravascular or hypodermic applications) | Complies with ISO 80369-7 |
| ISO 80369-20:2015 (Common test methods for small-bore connectors) | Complies with ISO 80369-20 | |
| General Requirements | Operation Mode | For manual use only (Same as predicate) |
| Single Use | Single Use (Same as predicate) | |
| Label/Labeling | Complies with 21 CFR part 801 (Same as predicate) |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each non-clinical test conducted. It states "Non-clinical tests were conducted to verify that the proposed device met all design specifications." The data provenance is implied to be from internal testing conducted by Jiangsu Suyun Medical Material Co., Ltd. or its contracted labs, with the country of origin being China (where the manufacturer is located). The testing is prospective for the purpose of this submission, meaning the tests were performed on the proposed device to gather data for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The "ground truth" for a medical device like a sterile syringe is based on established engineering and biological standards (e.g., ISO, ASTM, USP) and laboratory measurements, not subjective expert assessment in the way it would be for an AI diagnostic tool. The "experts" involved are the certified laboratory technicians and quality control personnel who perform and interpret these standardized tests. Their qualifications are inherent in their ability to conduct these specific tests according to recognized protocols.
4. Adjudication method for the test set
This is not applicable in the context of this device and type of testing. The tests are typically objective measurements against defined pass/fail criteria in the standards. There is no mention of a human adjudication process for resolving conflicting results, as would be common in image interpretation studies.
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 is not applicable. The device is a physical sterile syringe, not an AI/ML-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical sterile syringe, not an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance relies on objective measurements from standardized non-clinical tests. These include:
- Biological/Chemical endpoint measurements: e.g., cell viability (cytotoxicity), skin reactions (irritation/sensitization), blood cell lysis (hemolysis), particulate counts, endotoxin levels.
- Physical performance measurements: e.g., seal strength, leak detection, plunger force, barrel integrity, needle sharpness and elasticity.
- Sterility verification: Growth/no-growth tests for sterility assurance.
The "ground truth" is defined by the Pass/Fail criteria specified within the referenced ISO, ASTM, and USP standards.
8. The sample size for the training set
This is not applicable. There is no AI/ML component or "training set" for this sterile syringe device. The document describes non-clinical performance testing.
9. How the ground truth for the training set was established
This is not applicable. As there is no AI/ML component, there is no training set and no ground truth established for one.
§ 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).