(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.
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Image /page/0/Picture/0 description: The image shows a logo with the letters "sdm" inside of a circle. There are two curved lines above and below the circle. To the left of the circle are two horizontal lines.
scientific device manulac
8 AUG
999 Andersen Drive, Suile 110 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
SUMMARY OF SAFETY AND AFFECTIVENESS
SDM CONTROL SYRINGES
510(k) Premarket Notification
| Trade Name: | SDM Control Syringes |
|---|---|
| Generic Name: | High Pressure Syringes |
| Manufacturer: | Scientific Device Manufacturer, Inc.999 Andersen Drive, Suite 110San Rafael, CA 94901Establishment Registration Number: TBD |
Classification:
In preparation of this PreMarket Notification, it was determined that devices of this generic type have been previously classified as Class II devices. No performance standards have yet been established for these products.
Product Description:
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.
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Image /page/1/Picture/0 description: The image shows a symbol that appears to be a stylized representation of an eye or a lens. The symbol consists of a circle with the letters 'sdm' inscribed inside. The circle is surrounded by two curved shapes that resemble eyelids or brackets, and there are horizontal lines on either side of the symbol, giving it a symmetrical appearance. The overall design is simple and graphic, with a focus on the central letters and the surrounding shapes.
999 Andersen Drive, Suite 110 San Rafael, California 94901 Phone 415-454-9370 Fax 415-454-9380
Intended Use:
This device is intended for hand injection of contrast media during angiography.
Rationale for Substantial Equivalence:
Scientific Device Manufacturer's Control Syringes are substantially equivalent to currently marketed "Control" and "Angiographic" syringes with regard to intended use, materials, and design. Predicate devices include those made by Medex, Namic, Becton Dickinson and Merit. No significant changes or modifications were made from those predicate devices. SDM therefore posits that its devices are equivalent in safety and effectiveness to those devices.
Biocompatability Evaluations:
Materials used in Scientific Device Manufacturer's Control Syringes were chosen to be generically of the same type and grade as those present in the substantially equivalent devices. Testing performed by SDM for this externally communicating device (blood path indirect) shows this device to be biocompatible per requirements of ISO Standard 109993, Part I.
Summary:
Based upon the product description, its intended use, and comparative features of predicate devices, the Scientific Device Manufacturer's Control Syringes are substantially equivalent to other high pressure syringes currently approved for use.
Richard C. Ball
Richard C. Ball Vice President Regulatory Affairs and Quality Assurance
§ 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.