MEDRAD SWABBABLE VALVE TRANSFER SET

K031808 · Medrad, Inc. · FPK · Jul 11, 2003 · General Hospital

Device Facts

• Record ID: K031808
• Device Name: MEDRAD SWABBABLE VALVE TRANSFER SET
• Applicant: Medrad, Inc.
• Product Code: FPK · General Hospital
• Decision Date: Jul 11, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Medrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Device Story

Medical disposable device; transfers contrast media and saline from spikeable containers to power injector syringes. Used in conjunction with MR-CT Fill Station. Replaces one-way stopcock/pinch clamp of predicate with swabbable threaded valve (Halkey-Roberts) and adds female luer. Facilitates needle-free fluid transfer; reduces risk of needle-stick injuries. Operated by clinical staff in imaging environments.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO/AAMI 10993-7.

Technological Characteristics

Fluid delivery tubing set. Materials: Medical grade PVC tubing, polycarbonate female luer. Components: Vented spike, swabbable threaded valve (Halkey-Roberts). Sterilization: Ethylene Oxide (EtO). Biocompatibility: ISO/AAMI 10993-7 compliant. Dimensions: 23.0 in. length, 0.160 in. OD, 0.120 in. ID.

Indications for Use

Indicated for the delivery of contrast media and saline into a syringe. Intended for use as a needle-free system to aid in the prevention of needle-stick injuries.

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

• Medrad Transfer Set (K022431)

Submission Summary (Full Text)

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K 031808

## JUL 1 1 2003

## Special 510(k) Summary – Medrad Swabbable Valve Transfer Set

| OFFICIAL CONTACT: | Andrew P. Zeltwanger<br>Regulatory Affairs Analyst<br>Medrad, Inc.<br>One Medrad Drive<br>Indianola, PA 15051<br>[phone] ext. 3005 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Tubing, Fluid Delivery [21 CFR 880.5440] |
| COMMON NAME(s): | SVTS<br>Transfer Set |
| PROPRIETARY NAME(s): | Medrad Swabbable Valve Transfer Set |
| PREDICATE DEVICE(s): | Medrad Transfer Set (K022431) |
| DEVICE DESCRIPTION: | The Medrad Swabbable Valve Transfer Set (SVTS)<br>is a modified Medrad Transfer Set (K022431). The<br>SVTS is a medical disposable device used to<br>transfer contrast media and saline from a spikeable<br>container to a power injector syringe. The SVTS is<br>works in conjunction with the MR-CT Fill Station,<br>and facilitates the delivery of contrast agent and/or<br>saline into a syringe. |
| INTENDED USE: | The Medrad Swabbable Valve Transfer Set (SVTS)<br>is intended to be used in the delivery of contrast<br>media and saline into a syringe. |
| COMPARISON TO PREDICATE: | The following table shows a comparison between<br>the device components of the SVTS and the<br>predicate device, the Medrad Transfer Set<br>(K022431). |

- · Medrad, Inc. · Special 510(k) Device Modification ·
• Medrad Swabbable Valve Transfer Set • Confidential •

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| | | Predicate Device | Modified Device |
|------------------------|------------------|----------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| | | Medrad Stellant Transfer Set<br>[equivalent to the Medrad<br>Transfer Set (K022431)] | Swabbable Valve Transfer Set |
| Device<br>Components | Illustration | Image: Predicate Device Illustration | Image: Modified Device Illustration |
| | Spike | Hyperal Vented Spike | Same |
| | Tubing | 20.0 in. Length<br>.160 in. Outer Diameter<br>.110 in. Inner Diameter<br>PVC - Medical Grade | 23.0 in. Length<br>.160 in. Outer Diameter (Same)<br>.120 in. Inner Diameter<br>PVC - Medical Grade (Same) |
| | Female Luer | None | Polycarbonate, Clear, Merit<br>Medical Female Luer |
| | Dust Cap | Polypropylene Dust Cap | No Dust Cap |
| | Valve | One-way Stopcock,<br>Pinch Clamp | Swabbable Threaded Valve<br>(Halkey-Roberts) |
| | Adhesive | 3321 Light Cure Adhesive<br>Cyclohexanone Solvent | Same<br>Same |
| Safety<br>Requirements | Biocompatibility | Tested to ISO/AAMI 10993-7 | Same |
| | Sterility | Ethylene Oxide (EtO) Sterilized | Same |

- · Medrad, Inc. · Special 510(k) Device Modification ·
- Medrad Swabbable Valve Transfer Set Confidential •

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

Public Health Service

JUL I 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Andrew P. Zeltwanger Regulatory Affairs Analyst Medrad, Incorporated One Medrad Drive Indianola, Pennsylvania 15051

Re: K031808

Trade/Device Name: Medrad Swabbable Valve Transfer Set Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPK, FPA Dated: June 6, 2003 Received: June 18, 2003

Dear Mr. Zeltwanger:

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.

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Page 2 - Mr. Zeltwanger

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 (OS) 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 vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at [phone]. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Susan Runne

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

ﺔ ﺍﻟﻤﺘ

Enclosure

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K03/808

Intended Use

There has been no change to the indications of use as a result of the proposed modifications described in this submission.

## Indications for Use Statement

510(k) Number:

Device Name: Medrad Swabbable Valve Transfer Set

Indications for Use:

The Modrad Swabbable Valve Transfer Set (SVTS) is intended to be used in the delivery of contrast media and saline into a syringe. The SVTS is a needle-free system. Use of a needle-free system may aid in the prevention of needle-stick injuries.

Concurrence of CDRH, Office of Device Evaluation (OL

Patricia Cicente

Prescription Use

or

· Medrad, Inc. · Special 510(k) Device Modification · · Medrad Swabbable Valve Transfer Set · Confidential ·