(111 days)
The Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
The Instylla Delivery Kit is comprised of two 1mL delivery syringes, a syringe holder, and a plunger clip (link).
This document describes a 510(k) premarket notification for the "Instylla Delivery Kit," a piston syringe for administering medical solutions. The document does not contain any information about acceptance criteria or a study proving the device meets said criteria in the context of performance metrics like sensitivity, specificity, accuracy, or any AI/algorithm performance. The provided text details bench and functional testing for mechanical and material properties, rather than clinical performance or AI evaluation.
Therefore, I cannot provide the requested information regarding acceptance criteria and performance data in the context of an AI device.
However, I can extract information related to the device's non-AI performance testing, as detailed in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document lists performance testing that was conducted, but it does not explicitly state specific acceptance criteria values or detailed quantitative reported performance metrics. It generally states that these tests were performed "to verify specifications fundamental to the device" and that the syringes are "compliant against FDA recognized standards ISO 7886-1 and ISO 594-2."
| Performance Test | Acceptance Criteria (Not explicitly stated with values in document, generally "meets specifications" or "compliant") | Reported Device Performance |
|---|---|---|
| Visual Inspection | To verify specifications fundamental to the device | Performed |
| Dimensional Verification | To verify specifications fundamental to the device | Performed |
| Functional Testing: | ||
| - Syringe Holder and Plunger Clip Connection Force | To verify specifications fundamental to the device | Performed |
| - Syringe Holder and Plunger Clip Disconnection Force | To verify specifications fundamental to the device | Performed |
| - Syringe Compatibility | To verify specifications fundamental to the device | Performed |
| - Syringe Glide Force and Break Force | To verify specifications fundamental to the device | Performed |
| - Fluids Compatibility | To verify specifications fundamental to the device | Performed |
| - Delivery Integrity | To verify specifications fundamental to the device | Performed |
| Particulate Matter Testing | To verify specifications fundamental to the device | Performed |
| Syringe Compliance | FDA recognized standards ISO 7886-1 and ISO 594-2 | Compliant |
| Biocompatibility Testing: | In accordance with ISO 10993-1 for indirect blood contact (≤24 hours) | Successfully completed |
| - Cytotoxicity | Meets ISO 10993-1 requirements | Performed |
| - Sensitization | Meets ISO 10993-1 requirements | Performed |
| - Irritation or Intracutaneous toxicity | Meets ISO 10993-1 requirements | Performed |
| - Acute Systemic Toxicity | Meets ISO 10993-1 requirements | Performed |
| - Material-Mediated Pyrogenicity | Meets ISO 10993-1 requirements | Performed |
| - Hemolysis | Meets ISO 10993-1 requirements | Performed |
| Sterility | Sterility Assurance Level (SAL) of 10-6 (validated per ISO 11135) | Achieved |
| Endotoxin Level |
§ 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).