Search Results

The Microliter Dosing Syringe is intended to inject fluid into, or withdraw fluid from the body. The Microliter Dosing Syringe is indicated for intravitreal use.

The Microliter Dosing Syringe is a single-use, piston syringe-based device consisting of a syringe barrel, plunger stopper, syringe tip cap and incorporates a plunger rod subassembly. It is intended for use by healthcare professionals for general purpose fluid aspiration/injection. Its operation is manual. The Microliter Dosing Syringe is single use only, non-toxic, non-pyrogenic and sterilized by e-beam irradiation. The Microliter Dosing Syringe is suitable for ophthalmic use.

The provided text is a 510(k) Summary for a medical device called the "Microliter Dosing Syringe." This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets a set of performance criteria for an AI/ML algorithm.

Therefore, the document does not contain the information requested in the prompt regarding:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML test or training set.

The document discusses the substantial equivalence of the Microliter Dosing Syringe to a predicate device (StaClear Syringe) based on:

• Intended Use and Indications for Use: Both are intended to inject or withdraw fluid from the body, and are specifically indicated for intravitreal use.
• Technological Characteristics: Comparisons are made across various characteristics like sterilization, shelf life, device materials, syringe volume, target dose volume, and connector type.
• Non-clinical Testing: Bench testing according to ISO 7886-1 and USP standards (e.g., , , ) was performed to demonstrate performance equivalence.
• Biocompatibility Testing: Tests were conducted according to ISO 10993 series standards (e.g., cytotoxicity, sensitization, irritation, acute systemic toxicity, pyrogenicity, hemolysis) to address material differences.

In summary, the provided text describes the regulatory clearance process for a physical medical device (syringe) by demonstrating substantial equivalence to a predicate, not the validation of an AI/ML-driven medical device against specific performance acceptance criteria.

Ask a specific question about this device