MEDRAD TRANSFER SET

K022431 · Medrad, Inc. · FPK · Sep 5, 2002 · General Hospital

Device Facts

• Record ID: K022431
• Device Name: MEDRAD TRANSFER SET
• Applicant: Medrad, Inc.
• Product Code: FPK · General Hospital
• Decision Date: Sep 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.

Device Story

Medrad Transfer Set is a sterile, single-patient use disposable device for transferring contrast media and saline from a spikeable container to a power injector syringe. Components include a vented spike, connector tube, manual flow stop, and female luer. Used in clinical imaging settings; operated by healthcare professionals. Device facilitates multi-fill operations from a single reservoir for up to 6 hours. Unlike the predicate, this device does not include a patient-side tubing component; it must be removed from the syringe before patient connection, preventing contact with patient fluids. Benefits include efficient contrast media management during diagnostic imaging.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Materials: Polyvinyl chloride (PVC) tubing, Acrylonitrile-butadiene-styrene (ABS). Connection: ISO 594 Luer. Sterilization: Ethylene Oxide (EtO). Configuration: 1-part system with vented spike, connector tube, manual flow stop, and female luer. Shelf life: 1 year.

Indications for Use

Indicated for the delivery of contrast media and saline into a syringe for diagnostic imaging procedures.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Merit Contrast Management System (K961794)

Submission Summary (Full Text)

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KO22 431

# SEP 5 2002

## 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 Name: Classification:

Medrad Inc. One Medrad Drive, Indianola, PA 15051 USA [phone], ext. 3536 [phone] Frank Pelc July 24, 2002

Medrad Transfer Set Intravascular Administration Set Intravascular Administration Set 80 FPK, Class II

Predicate Device:

Merit Contrast Management System (K961794)

Device Description - The Medrad Transfer Set is medical disposable device used to transfer intravascular contrast media and saline from a spikeable container to a power injector syringe. The device components consist of a vented spike, connector tube, a means of manually stopping flow, female luer, and individually packaged sterile caps.

Substantial Equivalence - The information provided in this premarket notification demonstrates that the proposed device is substantially equivalent to legally marketed devices. The proposed Medrad Transfer Set is substantially equivalent to the Merit Contrast Management System (K961794). Both devices have the same intended use to deliver contrast media (and saline solutions) for diagnostic imaging procedures, and both allow multiple filling from one reservoir up to a 6 hour time limit.

A comparison of features and principles of operation between the proposed device and predicate device is provided in the table below.

| Feature | Predicate Device (Merit<br>Contrast Management<br>System) K961794 | Proposed Device: Medrad<br>Transfer Set |
|---------------------------------------------------------------------|--------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Intended Use | Contrast media delivery system | Same |
| System<br>Configuration | 2 Part System<br>- multi-fill spike system<br>- per patient administration set | 1 Part System<br>- multi-fill spike system |
| Multi-fill | Yes, until reservoir is empty or<br>time limit exceeded. | Same |
| Time limit | 6 hours maximum | Same |
| Materials | Clear flexible plastic tubing, rigid<br>plastic spike and stopcock | Polyvinyl chloride tubing,<br>Acylontrile-butadiene-styrene |
| Packaging | Pouch, sealed | Same |
| Sterility | Ethylene Oxide (EtO) Sterilized | Same |
| Shelf Life | 5 Years | 1 Year (The shelf life will be<br>extended to 5 years when<br>satisfactory test results are<br>completed.) |
| Connection method | ISO 594 Luer | ISO 594 Luer |
| Sterile caps provided<br>to cap connection<br>port between fillings | Yes | Yes |

#### COMPARISON DATA

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#### Summary of differences between predicate and proposed devices -

The predicate device includes a separate disposable single-patient use tubing component. This component is attached to the open port on the administration set and leads to the patient, allowing fluid to be delivered to the patient without removing the filling component.

Medrad's transfer set will not include a separate tubing section. Medrad's transfer set must be removed from the syringe before the syringe can be connected to the patient; therefore it cannot come in contact with patient fluid through the syringe or administration set tubing. Additionally, the product labeling will state that the product is for single patient use only.

Intended Use – The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

5 2002 SEP

Mr. Frank W. Pelc III Regulatory Affairs Coordinator Medrad, Incorporated One Medrad Drive Indianola, Pennsylvania 15051

Re: K022431

Trade/Device Name: Medrad Transfer Set Regulation Number: 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: LHI and FPK Dated: July 24, 2002 Received: July 25, 2002

Dear Mr. Pelc:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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 manufacturing 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.

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Page 2 -- Mr. Pelc

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, 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,

Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K022431

#### INDICATION FOR USE

. . .

510(k) Number: K022 431

·

Device Name: Medrad Transfer Set

Indications for Use/Intended Use:

The Medrad Transfer Set is intended to be used in the delivery of contrast media and saline into a syringe.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Viola Hubbard for Pat Ciuente

(Division Sigr Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. k022431

Prescription Use (Per 21 CFR 801.109) OR

. .

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)