FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The sterile syringe bulk tray is designed for manual and single use. It includes multiple syringes and a bulk tray. Each syringe consists of a barrel, plunger stopper (piston). The barrel and plunger are made from polypropylene, while the plunger stopper is made from lsoprene rubber. The device is available in different syringe volumes and offers both Luer slip (1mL) and Luer lock (1, 3, 5, 10, 20, 30, 50, 60mL) connectors. The Luer connector is used to connect the syringe to a hypodermic needle for liquid injection or withdrawal.

The medical device is enclosed in a thermal-formed plastic tray that is protected by dialyzing paper. It is sterilized using EO gas to ensure a shelf life of 5 years. The bulk tray packaging of the device is advantageous for performing batch liquid injections or withdrawals.

In order to maintain sterility, it is advised to utilize the device within 5 hours after the bulk tray has been opened. This device is specifically designed for application in aseptic environments and should only be handled by medical professionals.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device: "Sterile Syringe Convenience Tray" (K230447). This document demonstrates substantial equivalence to a predicate device, focusing on the device's technical specifications, non-clinical performance, and biocompatibility, rather than clinical efficacy studies.

Therefore, the specific information requested about acceptance criteria, a study proving the device meets them, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment (which are typical for AI/ML-based medical devices or diagnostics) is not present in this document.

The document discusses performance through non-clinical testing against established ISO standards for syringes and biocompatibility, as well as sterility and packaging integrity. It does not involve human interaction or interpretation of data in the way an AI/ML diagnostic device would.

Here's why the requested information cannot be extracted from this document:

Device Type: This is a physical medical device (syringe tray), not a software or AI-based diagnostic tool.
Approval Pathway: The 510(k) pathway for this type of device primarily relies on demonstrating substantial equivalence to a legally marketed predicate device through engineering specifications, material properties, manufacturing processes, and compliance with performance and safety standards (like ISO standards for sterile syringes). It does not typically require clinical trials in the sense of demonstrating diagnostic accuracy or treatment effectiveness on human patients.
"Acceptance Criteria" in this context: For this device, "acceptance criteria" are met by demonstrating compliance with the referenced ISO standards for syringe performance (e.g., flow rate, leakage, plunger operation, tolerance on graduated capacity) and biocompatibility, as well as sterility and packaging integrity. There's no "algorithm performance" to be evaluated against a human expert panel.

General Summary of Acceptance in this Document's Context (as much as can be inferred):

The acceptance of this device for 510(k) clearance is based on the satisfactory completion of non-clinical tests that demonstrate its safety and performance align with established international standards for syringes. The "study" proving this involves a series of laboratory tests as detailed below.

Regarding your specific points, based on the provided document:

A table of acceptance criteria and the reported device performance:
The document lists the standards the device was tested against. The "reported device performance" is that the results met the requirements of these standards.

Acceptance Criteria (Standards Met)	Reported Device Performance
ISO 7886-1:2017 (Syringe Performance)	Met requirements
ISO 80369-7:2016 (Luer Connectors)	Met requirements
ISO 80369-20:2015 (Luer Connectors)	Met requirements
ISO 10993-1 (Biocompatibility)	Complied (Cytotoxicity, Irritation, Sensitization, Systemic toxicity, Hemolysis, Pyrogen)
USP (Residual Particles)	Tested, compliant
USP (Endotoxin)	Tested, compliant
ISO 11135 (Sterilization)	Validated, compliant (EO/ECH residuals)
ASTM F1980-16 (Accelerated Aging/Shelf-Life)	Verified 5 years shelf-life
ASTM D4169-16 (Shipping Conditions/Package Integrity)	Deemed acceptable
ASTM F88/F88-15 (Seal Strength)	Tested, compliant
ASTM F1929-15 (Dye Penetration)	Tested, compliant
USP (Sterility)	Tested, compliant

Sample sized used for the test set and the data provenance: Not specified in the document. These would refer to the number of syringes tested for each specific non-clinical test (e.g., how many syringes were tested for leakage or force to operate the piston). The data provenance is implied to be from laboratory testing conducted as part of the device manufacturer's validation process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device like a syringe is established by engineering specifications, material science, and performance standards, measured by calibrated equipment, not by human expert interpretation or consensus.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No. This is a physical device, not a diagnostic AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not an algorithm. Standalone performance refers to the device meeting its performance specifications independently, which is implied by the testing against ISO standards.
The type of ground truth used: Engineering specifications, material properties, and compliance with established performance standards (e.g., ISO 7886-1 for syringe performance, ISO 10993 for biocompatibility).
The sample size for the training set: Not applicable. This is not an AI/ML device with a "training set."
How the ground truth for the training set was established: Not applicable.

Summary

Regulation Number and Section

§ 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).