SA-EF MULTI-LUMEN EXTENSION SET

K972957 · Vlv Associates, Inc. · FPA · Sep 29, 1997 · General Hospital

Device Facts

• Record ID: K972957
• Device Name: SA-EF MULTI-LUMEN EXTENSION SET
• Applicant: Vlv Associates, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SA.ER Multi-Lumen Extension Sets are to be used for the intravascular administration of fluids to the patient's vascular system.

Device Story

SA.EF Multi-Lumen Extension Set is a medical tubing assembly designed for intravascular fluid administration. Device connects to existing vascular access lines to provide multiple access ports for fluid delivery. Used in clinical settings by healthcare professionals to facilitate simultaneous or sequential infusion of medications, fluids, or blood products. Benefits include increased flexibility in patient therapy management by allowing multiple lines to be connected to a single vascular access point.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Multi-lumen tubing assembly for intravascular use. Materials and specific dimensions not disclosed in the provided text. Device functions as a passive fluid conduit.

Indications for Use

Indicated for intravascular administration of fluids to the patient's vascular system. Prescription use only.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Vincent L. Vaillancourt President VLV Associates, Incorporated 30-C Ridgedale Avenue East Hanover, New Jersey 07936

SEP 2 9 1997

Re: K972957 SA.EF Multi-Lumen Extension Set Trade Name: Requlatory Class: II Product Code: FPA Dated: August 8, 1997 Received: August 11, 1997

Dear Mr. Vaillancourt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Vaillancourt

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
U. Alatoush

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

Enclosure

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510(K) Number (if known): K972957

SA.EF Multi-Lumen Extension Set Device Name:

Indications for Use:

The SA.ER Multi-Lumen Extension Sets are to be used for the intravascular The SA.ER Multi-Lumen Extension Sets are to be used Icro the intravascular system.

| | ference of CDHR, Office of Device Evaluation (ODE) |
|--|----------------------------------------------------|
|--|----------------------------------------------------|

(Division Sign-Off)

| Division of Dental Infection Control, | |
|---------------------------------------|------------------------------|
| | spital Devices |
| Number | K972957 |
| Prescription Use: | YES |
| (Per 21 CFR 801.109) | OR Over-The-Counter Use: N/A |

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