MEDRAD QWIK-FIT SYRINGE

K013815 · Medrad, Inc. · DXT · Dec 13, 2001 · Cardiovascular

Device Facts

• Record ID: K013815
• Device Name: MEDRAD QWIK-FIT SYRINGE
• Applicant: Medrad, Inc.
• Product Code: DXT · Cardiovascular
• Decision Date: Dec 13, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1650
• Device Class: Class 2

Intended Use

Medrad Qwik-Fit Syringes are intended to assist in the intravascular delivery of contrast media and flushing solutions at controlled flow rates and volumes.

Device Story

Medrad Qwik-Fit Syringe is a disposable angiographic syringe; consists of clear plastic barrel and plunger assembly. Used with compatible injectors to deliver contrast media and flushing solutions into humans for CT and MRI diagnostics. Modifications involve plunger assembly materials (thermoplastic elastomer and ABS polymer). Device is single-use; intended for clinical settings. Healthcare providers operate the injector system to control flow rates and volumes of contrast media. Benefits include controlled delivery of diagnostic agents for imaging procedures.

Clinical Evidence

Bench testing only.

Technological Characteristics

Clear plastic syringe barrel; plunger assembly materials: thermoplastic elastomer and ABS polymer. Latex-free. Sterilized via Ethylene Oxide (EtO) at 8.4% and 91.6% HCFC-124. Designed for use with compatible angiographic injectors.

Indications for Use

Indicated for containing and holding contrast media to assist in delivery for CT and MRI diagnostics. Indicated for single-use only.

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

• Medrad Disposable Syringes (K964642)

Submission Summary (Full Text)

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K013815

## DEC 1 3 2001

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

Submitter's Name: Submitter's Address: Telephone Number: Fax Number: Contact Person: Date:

Proprietary Name: Common Name: Classification: Classification Name:

Medrad Inc. One Medrad Drive, Indianola, PA 15051 USA [phone], ext. 3536 [phone] Frank Pelc November 15, 2001

Quik-Fit Syringe Syringe, Angiographic Class II, DXT Injector and Syringe, Angiographic

Predicate Device:

Medrad Disposable Syringes: K964642

Device Description - The Medrad Quik-Fit Syringe comprises a clear plastic syringe barrel with anta Device Description - The Mourad Quilt in by mgo confige of the syringe fits onto plunger assembly that moved within the need and flushing solutions for delivery by the injector into humans.

Description of Changes - This Special 510(k) premarket notification is being submitted due to modifications to the syringe plunger assembly.

Substantial Equivalence - The modified Medrad Quik-Fit Syringe described in this 510(k) ourseanthan Equivaloneo - The mountent to the Medrad Quik-Fit Syringes described in premarket notification is oubotantially oqtin intended use, labeling, packaging, and sterilization RS04042. The proposed, modified device are unchanged from the current, predicate device. procode for the proposalive to the modifications have been satisfactorily completed to show that it is as safe and effective as the current device.

A table comparing the features of the predicate device and modified device is provided below.

| Feature | Predicate Device (K964642) | Proposed Device |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|
| Packaging | Same | Same |
| Labeling | Same | Same |
| Shelf Life | 5 Years | Same |
| Single Use | Yes | Yes |
| Intended Use | Medrad Qwik-Fit Syringes are<br>intended to assist in the<br>intravascular delivery of contrast<br>media and flushing solutions at<br>controlled flow rates and volumes. | Same |
| Indications for Use | Medrad Qwik-Fit Syringes are<br>indicated to contain and hold<br>contrast media and assist in<br>delivery of same, to effect CT and<br>MRI diagnostics. They are<br>indicated for single-use only. | Same |
| Sterility | Ethylene Oxide (EtO) at 8.4% and<br>91.6% HCFC-124 | Same |
| Plunger Materials In Contact With<br>Fluid Path | Synthetic Polyisoprene | Thermoplastic Elastomer and<br>ABS polymer |
| Latex Content | Latex Free | Same |
| Parameters for Use | All available Injector/Syringe<br>configurations & volume options | Same |
| Pressure Capabilities<br>Compatible With Intended<br>Injectors | Yes | Yes |

## Comparison of Features

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Frank W. Pelc III Regulatory Affairs Coordinator Medrad, Inc. One Medrad Drive Indianola, PA 15051-0780

DEC 1 3 2001

K013815 Re:

Medrad Qwik-Fit Syringe Regulation Number: 870.1650 Regulation Name: Angiographic injector and syringe. Regulatory Class: Class II Product Code: DXT Dated: November 15, 2001 Received: November 16, 2001

Dear Mr. Pelc:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaused the device is substantially equivalent (for the indications for referentour above and narro to legally marketed predicate devices marketed in interstate commerce use sured in the encreated of the Medical Device Amendments, or to devices that provision in the 77, 1970, and candance with the provisions of the Federal Food, Drug, and Cosmetic nat (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good ecan of provision practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Frank W. Pelc III

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter wifi anow you to ough and inding of substantial equivalence of your device to a legally prematics notification: "The PDF milling sification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and II you desire specific ad rios for you in vitro diagnostic devices), please contact the Office of additionally 21 CHC Fur 6071 o Additionally, for questions on the promotion and advertising of Compliance at [phone]. Iffice of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). It guiation entitied, "Misoranainities of responsibilities under the Act may be obtained from the Division Other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

X. Walter Tell

ram Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATION FOR USE

KO13815 510(k) Number:

Device Name: Medrad Qwik-Fit Syringe

Indications for Use/Intended Use:

Medrad Qwik-Fit Syringes are indicated to contain and hold contrast media and assist in delivery of same, to effect CT and MRI diagnostics. They are indicated for single-use only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013815

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)