K Number
K031808
Device Name
MEDRAD SWABBABLE VALVE TRANSFER SET
Manufacturer
Date Cleared
2003-07-11

(29 days)

Product Code
Regulation Number
880.5440
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
Device Description
The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.
More Information

Not Found

No
The summary describes a disposable medical device for transferring fluids and makes no mention of AI or ML.

No
The device is described as a medical disposable device used to transfer contrast media and saline into a syringe, not to treat or diagnose a disease or condition.

No

The device is described as a "Swabbable Valve Transfer Set" intended for "delivery of contrast media and saline into a syringe" and for "transfer contrast media and saline from a spikeable container to a power injector syringe." Its function is to facilitate the delivery/transfer of substances, not to diagnose medical conditions.

No

The device description explicitly states it is a "medical disposable device" and describes physical components like a "swabbable valve" and its function in transferring liquids, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to transfer contrast media and saline into a syringe for delivery into a patient. This is a direct interaction with the patient's body (delivery of substances), not the examination of specimens derived from the human body.
  • Device Description: The description reinforces its use in transferring substances for injection, not for analyzing biological samples.
  • Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information based on in vitro testing.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a person's health. This device's function is to prepare substances for introduction into the human body.

N/A

Intended Use / 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.

Product codes

FPK, FPA

Device Description

The Medrad Swabbable Valve Transfer Set (SVTS) is a modified Medrad Transfer Set (K022431). The SVTS is a medical disposable device used to transfer contrast media and saline from a spikeable container to a power injector syringe. The SVTS is works in conjunction with the MR-CT Fill Station, and facilitates the delivery of contrast agent and/or saline into a syringe.

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

Not Found

Key Metrics

Not Found

Predicate Device(s)

Medrad Transfer Set (K022431)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 880.5440 Intravascular administration set.

(a)
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.(b)
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.

0

K 031808

JUL 1 1 2003

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

| OFFICIAL CONTACT: | Andrew P. Zeltwanger
Regulatory Affairs Analyst
Medrad, Inc.
One Medrad Drive
Indianola, PA 15051
(412) 767-2400 ext. 3005 |
|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| CLASSIFICATION NAME: | Tubing, Fluid Delivery [21 CFR 880.5440] |
| COMMON NAME(s): | SVTS
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)
is a modified Medrad Transfer Set (K022431). The
SVTS is a medical disposable device used to
transfer contrast media and saline from a spikeable
container to a power injector syringe. The SVTS is
works in conjunction with the MR-CT Fill Station,
and facilitates the delivery of contrast agent and/or
saline into a syringe. |
| 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. |
| COMPARISON TO PREDICATE: | The following table shows a comparison between
the device components of the SVTS and the
predicate device, the Medrad Transfer Set
(K022431). |

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

1

Predicate DeviceModified Device
Medrad Stellant Transfer Set
[equivalent to the Medrad
Transfer Set (K022431)]Swabbable Valve Transfer Set
Device
ComponentsIllustrationImage: Predicate Device IllustrationImage: Modified Device Illustration
SpikeHyperal Vented SpikeSame
Tubing20.0 in. Length
.160 in. Outer Diameter
.110 in. Inner Diameter
PVC - Medical Grade23.0 in. Length
.160 in. Outer Diameter (Same)
.120 in. Inner Diameter
PVC - Medical Grade (Same)
Female LuerNonePolycarbonate, Clear, Merit
Medical Female Luer
Dust CapPolypropylene Dust CapNo Dust Cap
ValveOne-way Stopcock,
Pinch ClampSwabbable Threaded Valve
(Halkey-Roberts)
Adhesive3321 Light Cure Adhesive
Cyclohexanone SolventSame
Same
Safety
RequirementsBiocompatibilityTested to ISO/AAMI 10993-7Same
SterilityEthylene Oxide (EtO) SterilizedSame
  • · Medrad, Inc. · Special 510(k) Device Modification ·
  • Medrad Swabbable Valve Transfer Set Confidential •

2

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.

3

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 (301) 594-4618. 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 (800) 638-2041 or (301) 443-6597 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

4

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 ·