MEDRAD DISPOSABLE SYRINGES

K964642 · Medrad, Inc. · DXT · Apr 29, 1997 · Cardiovascular

Device Facts

• Record ID: K964642
• Device Name: MEDRAD DISPOSABLE SYRINGES
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Apr 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

The intended use of the proposed device(s) duplicates the predicate device(s), in that, the proposed synthetic rubber cover, a component of the disposable syringe(s) device is used with a powered injector to assist the hospital clinician in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes, to effect computerized tomography, magnetic resonance, and angiographic diagnostic imaging.

Device Story

Disposable syringe assembly; components include plastic barrel, plastic plunger, synthetic rubber cover, elastomeric seal. Used with automatic injector head to deliver contrast media/flushing solutions at controlled rates/volumes. Clinical setting: hospital imaging departments (CT, MRI, angiography). Operated by clinicians. Benefit: enables precise contrast delivery for diagnostic imaging. Device is latex-free.

Clinical Evidence

Bench testing and design verification data provided; no clinical data.

Technological Characteristics

Components: plastic barrel, plastic plunger, synthetic rubber cover, elastomeric seal. Latex-free. Sterilization: EtO. Form factor: disposable syringe for powered injector.

Indications for Use

Indicated for hospital clinicians to facilitate intravascular delivery of contrast media and flushing solutions during CT, MRI, and angiographic diagnostic imaging procedures.

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.

Submission Summary (Full Text)

{0}

K964642

APR 29 1997

510(k)

SUMMARY

21 CFR 807.92

**Date Prepared**

November 11, 1996

**Submitter’s Name**

Medrad, Inc.
One Medrad Drive
Indianola, PA 15051

Mary Ann Greenawalt, J.D.
Sr. Regulatory Affairs Associate
[phone] x 3111

**Device Name**

Classification Name: Injector & Syringe, Angiographic
Common/Usual Name: Disposable Syringe
Proprietary Name: Medrad Disposable Syringe

**Predicate Devices**

See attached reference list, Addendum 1.

**Device Description**

The Device is an assembly consisting of a plastic barrel, a plastic plunger, a synthetic rubber cover, and an elastomeric seal. Fluid is drawn into or expelled from the syringe by its piston which is powered and controlled by an automatic injector head. See drawing and labeling, Addendum 2.

The Device is designed to contain and hold contrast media and assist in delivery of same, to effect computerized tomography and magnetic resonance imaging, as well as, angiographic diagnostics.

The product is to be packaged in a white opaque vacuum formed plastic tray, heat sealed to a Tyvek lid. The entire package is compatible with an EtO Sterilization Cycle. See Addendum 3.

**Intended Use**

The intended use of the proposed device(s) duplicates the predicate device(s), in that, the proposed synthetic rubber cover, a component of the disposable syringe(s) device is used with a powered injector to assist the hospital clinician in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes, to effect computerized tomography, magnetic resonance, and angiographic diagnostic imaging.

{1}

# Technological Characteristics

| Comparisons/Distinctions: | See comparison chart, Addendum 4. |
| --- | --- |
| Performance Data: | See laboratory and design verification data, Addendum 5. |

This substantially equivalent device excludes latex as an element of its formulation. However, there is no change in the function of the device(s), no changes in the safety or efficacy of the device(s), and the intended use remains the same.