(175 days)
The Sterile Hypodermic Syringes for Single Use are intended to be used for medical purpose to inject fluid into or withdraw fluid from body.
The Sterile Disposable Syringe is intended for manual and single use only, which consists of barrel, plunger and piston. The syringe is available in luer slip and luer lock two connector types which are intended to be connected with a hypodermic needle. The proposed device is available in a variety syringe volume. Syringe volume: 1ml, 2ml, 3ml, 5ml, 20ml, 30ml, 50ml, 60ml, 100ml
The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10th and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of 5 years.
This document is a 510(k) Summary for a medical device called "Sterile Hypodermic Syringes for Single Use" (K221079). It focuses on demonstrating substantial equivalence to a predicate device (K180417) rather than providing detailed acceptance criteria and a study proving device performance in the context of an AI/algorithm-based device.
Therefore, many of the requested categories for acceptance criteria and study details for an AI/algorithm device (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable to this submission.
However, I can extract the relevant information regarding the performance criteria and the non-clinical studies conducted to demonstrate its safety and effectiveness against recognized standards.
Here's the breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7886-1: 2017 (Syringes for Manual Use) | Complied with (Test results demonstrate syringe meets requirements) |
| ISO 80369-7: 2016 (Connectors for intravascular or hypodermic applications) | Complied with |
| ISO 80369-20:2015 (Common test methods for small-bore connectors) | Complied with |
| Biocompatibility (ISO 10993-1, Externally Communicating Device, Blood Path Indirect, Limited Contact) | |
| Cytotoxicity | Testing conducted |
| Irritation | Testing conducted |
| Skin Sensitization | Testing conducted |
| Acute Systemic Toxicity | Testing conducted |
| Pyrogenicity | Testing conducted |
| Hemolysis | Testing conducted |
| Particulate Matter (USP ) | Met USP acceptance criteria |
| Sterility (ISO 11135:2014) | Achieved a Sterility Assurance Level (SAL) of 10^-6 |
| EO and ECH Residuals (ISO 10993-7:2008) | Below specified limits |
| Bacterial Endotoxin Levels (USP ) | Below 20EU/device |
| Packaging & Shelf-life | |
| Visual Inspection (ASTM F1886 / F1886M-16) | Performed |
| Seal Strength (ASTM F88/F88-15) | Performed |
| Dye penetration (ASTM F1929-15) | Performed |
| Simulated transportation testing (ASTM D4169-16) | Performed |
| Shelf-life (ASTM F1980-16) | 5-years validated |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document pertains to a physical medical device (syringes), not an AI/algorithm. Performance is demonstrated through non-clinical laboratory testing of the manufactured product, not data analysis of a test set in the context of AI. The country of origin for the device manufacturer is China (Sichuan Prius Biotechnology Co., Ltd.). The studies are non-clinical, involving physical testing of the device.
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. Ground truth, in the context of AI/algorithm performance, is not relevant here. Performance is measured against recognized industry standards and validated laboratory methods for physical device characteristics (e.g., sterility, biocompatibility, mechanical performance).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication is a method for resolving discrepancies in expert labeling or diagnoses used in AI/algorithm studies. It is not relevant for the non-clinical testing of a physical device.
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 is a physical medical device, not an AI-assisted diagnostic tool. Therefore, MRMC studies and the concept of human reader improvement with AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to the performance of an AI algorithm. This submission is for a physical syringe.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the performance of this physical device, the "ground truth" is defined by compliance with established international and national standards (e.g., ISO for syringe performance, biocompatibility, sterility; USP for particulate matter and endotoxins) and validated test methodologies.
8. The sample size for the training set
- Not Applicable. Training sets are used for machine learning. This submission is for a sterile syringe.
9. How the ground truth for the training set was established
- Not Applicable. This question relates to AI/machine learning model development, which is not relevant to this medical device submission.
§ 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).