(188 days)
Output:
This device is intended for hand injection of contrast media during angiography.
The SDM Control Syringes consist of visibly clear high strength polycarbonate barrels, an elastomeric piston, and a high strength polymeric plunger terminating in a palm plate. The device is modeled in the European style in regard to the finger grips and palm plate. Each barrel is marked to 10cc's of volume in increments of 0.2cc and is very lightly coated with a medical grade silicone oil to enhance smootheness of operation. Two models will be available, one having a 0.5cc reservoir of internal volume remaining in the fully inserted position. The other model will leave no reservoir following full travel of plunger to the bottom of the barrel. These devices will be supplied single packaged and sterile. Packaging will consist of standard Tyvek/Poly pouches.
This document provides a Summary of Safety and Effectiveness for SDM Control Syringes, which are high-pressure syringes intended for hand injection of contrast media during angiography. However, the document does not describe any specific acceptance criteria or a study proving the device meets acceptance criteria.
Instead, it focuses on establishing substantial equivalence to currently marketed devices based on intended use, materials, and design.
Therefore, I cannot provide the requested information regarding acceptance criteria and studies from this document. The document primarily makes the following claims:
- Classification: Class II device; no performance standards established yet.
- Product Description: Visibly clear high-strength polycarbonate barrels, elastomeric piston, polymeric plunger with palm plate. Two models with different internal volume reservoirs. Supplied single-packaged and sterile.
- Intended Use: Hand injection of contrast media during angiography.
- Rationale for Substantial Equivalence: Similar to predicate devices (Medex, Namic, Becton Dickinson, Merit) in intended use, materials, and design. No significant changes or modifications from predicates.
- Biocompatibility: Materials are same type and grade as substantially equivalent devices. Testing performed per ISO Standard 10993, Part I, shows the device to be biocompatible for an externally communicating device (blood path indirect).
The document concludes that, based on these factors, the SDM Control Syringes are substantially equivalent in safety and effectiveness to other high-pressure syringes currently approved for use. None of the detailed study information you requested (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, training set details) is present in this regulatory submission summary.
§ 870.1650 Angiographic injector and syringe.
(a)
Identification. An angiographic injector and syringe is a device that consists of a syringe and a high-pressure injector which are used to inject contrast material into the heart, great vessels, and coronary arteries to study the heart and vessels by x-ray photography.(b)
Classification. Class II (special controls). The device, when it is a non-patient contacting balloon inflation syringe intended only to inflate/deflate balloon catheters and monitor pressure within the balloon, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.