(87 days)
The MTI 1 ml Syringe is intended for injection and aspiration of fluids. The syringe is designed for manual use.
The MTI 1 ml Syringe is a long stroke syringe designed for injection or aspiration of fluids during diagnostic and/or therapeutic procedures. The syringe will have a male conical lock fitting to facilitate attachment to various catheters and accessories. The syringe will be provided sterile and is for single-use only.
The transparent barrel is made of a heat and chemical resistant polyolefin. The plunger is composed of a polymer resin and the piston is a silicone, non-latex rubber with a liquid silicone lubricant.
The syringe is provided as a set of three, in a sterile Tyvek peel pouch and chipboard carton. The syringes are for general use.
The provided text describes the MTI 1 ml Syringe and its regulatory review, focusing on biocompatibility and in-vitro performance testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from recognized international standards, and the reported performance indicates conformance to these standards.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Biocompatibility: ISO 10993-1, Biological Evaluation of Medical Devices (for externally communicating, blood path indirect, limited exposure device) | Confirmed biocompatibility of the syringe (tested as an externally communicating, blood path indirect, limited exposure device) |
| In-vitro Performance: ISO 7886-1: Sterile Hypodermic Syringes for Single Use - Part I: Syringes for Manual Use (May 1997) | Yielded results in conformance for leakage, forces required to operate, and volume accuracy |
| In-vitro Performance: ISO 594: Conical Fittings with a 6% (Luer) Taper for Syringes, Needles and Certain Other Medical Equipment - Part 1 and 2 (6/86 and 5/91 resp.) | Yielded results in conformance for dimensional inspection tests |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the in-vitro performance testing. It mentions "Testing of the product yielded results," implying a set of samples were tested, but no specific numbers are provided.
The data provenance is not specified. It is an internal company report (Micro Therapeutics, Inc.) from April 1999, so the testing would have been conducted by or for the manufacturer. The data is retrospective in the sense that it describes tests already performed to support the 510(k) submission. No country of origin for the data is mentioned, but the manufacturer is based in Irvine, CA, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device and testing. The "ground truth" for the performance tests (leakage, operating forces, volume accuracy, dimensions) is established by the objective measurements performed according to the specified ISO standards, not by expert consensus or interpretation.
4. Adjudication Method for the Test Set
This is not applicable to the type of testing performed. The in-vitro performance tests are objective measurements against defined standards, not subjective assessments requiring adjudication.
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
This is not applicable. The MTI 1 ml Syringe is a manual medical device, not an AI software/system that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The MTI 1 ml Syringe is a manual medical device, not an algorithm, and does not involve AI or human-in-the-loop performance in the context of an algorithm.
7. The Type of Ground Truth Used
The ground truth for the device's performance is based on objective measurements compared against the specifications and limits defined within recognized international standards (ISO 10993-1, ISO 7886-1, ISO 594).
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" for this device. The MTI 1 ml Syringe is a physical medical device, not an AI model or software that requires training data.
9. How the Ground Truth for the Training Set was Established
This is not applicable as there is no training set for this device.
§ 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).