CONTROL SYRINGE

K960430 · Scientific Device Manufacturer, LLC · DXT · Aug 6, 1996 · Cardiovascular

Device Facts

• Record ID: K960430
• Device Name: CONTROL SYRINGE
• Applicant: Scientific Device Manufacturer, LLC
• Product Code: DXT · Cardiovascular
• Decision Date: Aug 6, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

This device is intended for hand injection of contrast media during angiography.

Device Story

SDM Control Syringes are high-pressure syringes used for manual injection of contrast media during angiography; operated by clinicians in clinical settings. Device consists of clear high-strength polycarbonate barrel, elastomeric piston, and high-strength polymeric plunger with palm plate. Available in two models: one with 0.5cc residual volume, one with zero residual volume. Barrel marked to 10cc in 0.2cc increments; lightly coated with medical-grade silicone oil for smooth operation. Supplied sterile in Tyvek/Poly pouches. Device facilitates controlled delivery of contrast agents to enhance imaging during angiographic procedures.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993, Part I for externally communicating, blood-path indirect devices.

Technological Characteristics

Materials: high-strength polycarbonate barrel, elastomeric piston, high-strength polymeric plunger. Lubricant: medical-grade silicone oil. Volume: 10cc capacity with 0.2cc increments. Configuration: European-style finger grips and palm plate. Sterilization: sterile, single-packaged in Tyvek/Poly pouches. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for use in patients undergoing angiography requiring hand injection of contrast media.

Regulatory Classification

Special Controls

*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.

Predicate Devices

• Medex Control/Angiographic Syringes
• Namic Control/Angiographic Syringes
• Becton Dickinson Control/Angiographic Syringes
• Merit Control/Angiographic Syringes

Submission Summary (Full Text)

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K960430

scientific device manufacturer, inc.

AUG 6 1996

999 Andersen Drive, Suite 110

San Rafael, California 94901

Phone [phone] Fax [phone]

# 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 110
San Rafael, CA 94901
Establishment 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 smoothness 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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scientific device manufacturer, inc.

999 Andersen Drive, Suite 110

San Rafael, California 94901

Phone [phone] Fax [phone]

## 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.

## Biocompatibility 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
Vice President Regulatory Affairs and Quality Assurance