(85 days)
The Instylla Delivery Kit is intended to be used for the intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link).
The Instylla Delivery Kit with modified packaging is a sterile, single patient use device intended to be used for the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions. The device consists of a double-barreled syringe holder which holds and couples two (2) commercially available needleless syringes with calibrated hollow barrels and movable plungers. A single plunger clip is attached to both syringe plungers to facilitate the simultaneous injection of two distinct fluids when depressed.
The syringes of the Instylla Delivery Kit are composed of polycarbonate. The plunger clip and holder are composed of Acrylonitrile Butadiene Styrene (ABS).
I am sorry, but the provided text does not contain the detailed information needed to construct the complete response regarding acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter and summary for a delivery kit, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed performance study with specific acceptance criteria and detailed study parameters as requested.
While the document mentions "Performance testing... met the predetermined acceptance criteria," it does not explicitly list these criteria in a table or describe the study in the comprehensive manner you've outlined (e.g., sample size, data provenance, expert details, adjudication, MRMC studies, standalone performance details, ground truth specifics, training set details).
Based on the available text, I can only provide the following:
Device: Instylla Delivery Kit
Regulatory Class: Class II
Product Code: FMF (Piston Syringe)
Intended Use: For the intra-arterial or intra-venous administration of radiographic contrast media, saline and other aqueous solutions.
Performance Data Summary (from the text):
- Performance testing of the final, sterilized Instylla Delivery Kit with modified packaging included bench testing and functional testing.
- Tests Conducted:
- Syringe Force Performance
- Fluids Compatibility
- Delivery Integrity
- Outcome: "The Instylla Delivery Kit with modified packaging met the predetermined acceptance criteria ensuring substantial equivalence to the predicate devices. No new safety or performance issues were raised during testing."
- Standards Compliance: The syringes are compliant with FDA recognized standards ISO 7886-1 and ISO 594-2.
- Biocompatibility: Evaluation conducted per FDA Guidance Document Use of International Standard ISO 10993-1. No new testing was performed on the subject device as contact materials and manufacturing processes were identical to predicate devices.
- Sterility: Sterilized via validated ethylene oxide (EO) process to a Sterility Assurance Level (SAL) of 10^-6, per ISO 11135. EO and ECH levels acceptable per ISO 10993-7. Bacterial endotoxin test (BET) validated for
§ 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).