K Number
K013815
Device Name
MEDRAD QWIK-FIT SYRINGE
Manufacturer
Date Cleared
2001-12-13

(27 days)

Product Code
Regulation Number
870.1650
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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.
Device Description
The Medrad Quik-Fit Syringe comprises a clear plastic syringe barrel with anta plunger assembly that moved within the need and flushing solutions for delivery by the injector into humans.
More Information

Not Found

No
The summary describes a simple syringe for delivering contrast media and does not mention any AI/ML components or functions.

No
The device is used to hold and deliver contrast media for diagnostic imaging (CT and MRI), not for treating a disease or condition.

No
The syringe is used to assist in the delivery of contrast media for CT and MRI diagnostics, but it is not itself a diagnostic device; it only delivers a substance that aids in imaging.

No

The device description clearly states it is a physical syringe comprising a barrel and plunger assembly, which are hardware components.

Based on the provided information, the Medrad Qwik-Fit Syringes are not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to "contain and hold contrast media and assist in delivery of same, to effect CT and MRI diagnostics." This describes a device used in vivo (within the body) to facilitate imaging procedures.
  • Device Description: The description mentions a syringe barrel and plunger assembly used for delivering solutions into humans. This further supports the in vivo nature of the device.
  • Lack of IVD Characteristics: IVD devices are used to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The description of the Medrad Qwik-Fit Syringes does not involve the analysis of bodily specimens.

Therefore, the Medrad Qwik-Fit Syringes are considered a medical device used for the administration of substances into the body, not for in vitro diagnostic testing of bodily specimens.

N/A

Intended Use / Indications for 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.

Product codes

DXT

Device Description

The Medrad Quik-Fit Syringe comprises a clear plastic syringe barrel with an integral plunger assembly that moved within the barrel. The tip of the syringe fits onto the injector for delivery of contrast media and flushing solutions for delivery by the injector into humans.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K964642

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 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.

0

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 (412) 767-2400, ext. 3536 (412) 767-2499 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.

FeaturePredicate Device (K964642)Proposed Device
PackagingSameSame
LabelingSameSame
Shelf Life5 YearsSame
Single UseYesYes
Intended UseMedrad Qwik-Fit Syringes are
intended to assist in the
intravascular delivery of contrast
media and flushing solutions at
controlled flow rates and volumes.Same
Indications for UseMedrad 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.Same
SterilityEthylene Oxide (EtO) at 8.4% and
91.6% HCFC-124Same
Plunger Materials In Contact With
Fluid PathSynthetic PolyisopreneThermoplastic Elastomer and
ABS polymer
Latex ContentLatex FreeSame
Parameters for UseAll available Injector/Syringe
configurations & volume optionsSame
Pressure Capabilities
Compatible With Intended
InjectorsYesYes

Comparison of Features

Image /page/0/Picture/15 description: The image shows a logo with a stylized letter 'Q' in a bold, sans-serif font. The 'Q' is positioned above the words "Quality for Life" in a smaller, serif font. The logo appears to be designed to convey a sense of quality and purpose related to life.

1

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem, depicted with three curved lines representing the eagle's body and wings. The emblem is black, and the text is also in black.

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 (301) 591-1800. Iffice of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)