(129 days)
The Sterile Syringe with Safety Needle is 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 minimize risk of accidental needle sticks.
The Sterile Disposable Syringe with Safety Needle is intended for manual and single use only. It consists of a hypodermic needle with a safety sheath attached to the needle hub and a luer slip or luer lock syringe. The subject device is available in a variety of syringe volumes and needle sizes. The safety sheath is manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The provided FDA 510(k) summary (K211753) is for a Sterile Syringe with Safety Needle. This document outlines the premarket notification for a Class II medical device, comparing it to a predicate device (K193526) to demonstrate substantial equivalence.
It's important to note that this document does not describe AI/ML device performance or studies proving such performance. This is a traditional medical device submission, focusing on compliance with established engineering and safety standards for the physical product.
Therefore, many of the requested elements pertaining to AI/ML device performance, such as sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment for AI models, are not applicable to this document.
The document primarily focuses on:
- Indications for Use: The device is for aspiration and injection of fluids, with a safety shield to prevent needle sticks.
- Technological Characteristics: Comparison of physical attributes like syringe volume, needle gauge, length, and material.
- Performance Standards: Compliance with international standards for syringes, needles, luer connectors, and sterilization.
- Biocompatibility: Leveraged from a previously cleared device (K163161) due to identical patient contact materials.
However, I can extract information related to the physical device's "acceptance criteria" and the "study that proves the device meets the acceptance criteria" in the context of this traditional medical device submission.
Here's the breakdown based on the provided text, focusing on the physical device performance and safety, not AI/ML:
Acceptance Criteria and Study for Sterile Syringe with Safety Needle (K211753)
The acceptance criteria for this device are primarily defined by compliance with recognized international and national standards for medical devices, particularly those related to syringes, needles, luer connectors, biocompatibility, and sterility. The studies proving the device meets these criteria are non-clinical bench tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Standard/Requirement | Device Performance (How compliance was demonstrated) |
|---|---|---|
| Syringe Performance | ISO 7886-1: 2017 | Tested and demonstrated conformance to the standard. |
| Needle Performance | ISO 7864: 2016 | Tested and demonstrated conformance to the standard. |
| ISO 9626:2016 | Tested and demonstrated conformance to the standard. | |
| Luer Connector Performance | ISO 80369-7: 2016 | Tested and demonstrated conformance to the standard for small-bore connectors. |
| ISO 80369-20: 2015 | Used for common test methods for small-bore connectors. | |
| Sharps Injury Protection | ISO 23908: 2011 | Tested and demonstrated conformance (for sharps protection features for single-use hypodermic needles). |
| Biocompatibility | ISO 10993 standards | Leveraged existing data from predicate device K163161 due to identical patient contact materials and manufacturing processes. Implies no cytotoxicity, no intracutaneous reactivity, no sensitization, no systemic toxicity, no hemolysis, no pyrogenicity. (Specific tests for K163161 not detailed in K211753) |
| USP Bacterial Endotoxins Test | Bacterial endotoxin limit evaluated on proposed device. | |
| USP Particulate Matter in Injections | Particulate testing evaluated on proposed device. | |
| Sterility | ISO 11135:2014, Annex B | EO Sterilized with a SAL of 10^-6 validated via an overkill method. |
| Packaging Integrity | ASTM F1886/1886M-16 | Visual inspection performed. |
| ASTM F88/F88-15 | Seal strength tested. | |
| ASTM F1929-15 | Dye penetration tested. | |
| Shipping Performance | ASTM D4169-16 | Simulated transportation testing performed. |
| Shelf-life | ASTM F1980-16 | Shelf life of 3 years validated using accelerated aging. |
| EO Residuals | ISO 10993-7:2008 | EO ECH residue testing performed. |
| Labeling | 21 CFR part 801 | Complies with regulations. |
2. Sample size used for the test set and the data provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual non-clinical bench test. These are typically defined by the testing standards (e.g., ISO, ASTM).
- Data Provenance: The tests were conducted to demonstrate compliance with international standards (ISO, ASTM, USP). The manufacturing entity is Jiangxi Hongda Medical Equipment Group Ltd. in China. The testing would have been conducted by the manufacturer or a certified testing laboratory. The data is retrospective in the sense that the testing was completed prior to submission for clearance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This is a traditional medical device (syringe with safety needle), not an AI/ML device relying on expert consensus for ground truth. Compliance is determined by objective physical and chemical testing against established engineering and biological standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As above, this is a traditional medical device; "adjudication" in the context of clinical reads or expert consensus for AI models is not relevant here. Test results are compared directly against the quantitative and qualitative requirements of the referenced 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
- Not Applicable. This document refers to a physical medical device (syringe), not an AI/ML diagnostic or assistive tool. MRMC studies are irrelevant for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. There is no algorithm or software component described in this submission that would require standalone performance testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Testing Standards and Specifications: The "ground truth" for this device is its adherence to the performance requirements stipulated in the referenced international and national standards (e.g., ISO 7886-1 for syringe performance, ISO 9626 for needle tubing, ISO 80369-7 for luer connectors, ISO 10993 for biocompatibility, etc.). These standards define the acceptable mechanical, physical, chemical, and biological properties of the device.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no AI/ML 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).