TAMARYN I.V. FLOW REGULATOR EXTENSION SET

K971066 · Tamaryn Medical Systems, Inc. · FPA · Jun 4, 1997 · General Hospital

Device Facts

• Record ID: K971066
• Device Name: TAMARYN I.V. FLOW REGULATOR EXTENSION SET
• Applicant: Tamaryn Medical Systems, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tamaryn I.V. Flow Regulator Extension Set is used to control the flow rate of administration infusion fluids to a patient during a gravity intravenous infusion.

Device Story

The Tamaryn I.V. Flow Regulator Extension Set is a medical tubing device designed to regulate the flow rate of intravenous fluids during gravity-fed administration. It is used in clinical settings by healthcare professionals to manage fluid delivery to patients. The device functions as an extension set with an integrated flow control mechanism, allowing for manual adjustment of infusion rates without the need for an electronic pump. By providing a consistent, adjustable flow, it assists clinicians in maintaining prescribed fluid administration protocols, thereby supporting patient safety and therapeutic efficacy during IV therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Extension set for gravity IV infusion; manual flow regulation mechanism; standard medical-grade tubing materials.

Indications for Use

Indicated for patients requiring controlled gravity intravenous infusion of fluids.

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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 4 1997

Mr. Jim Keane
*President
Tamaryn Medical Systems, Incorporated
6539 South 2475 East
Salt Lake City, Utah 84121

Re: K971066
Trade Name: Tamaryn I.V. Flow Regulator Extension Set
Regulatory Class: II
Product Code: FPA
Dated: March 21, 1997
Received: March 24, 1997

Dear Mr. Keane:

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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Keane

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 regulation (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 at [phone].

Sincerely yours,

Timothy A. Ulatowski
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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K971066

# INDICATIONS FOR USE

510(k) Number: ___________________________

Device Name: **Tamaryn I.V. Flow Regulator Extension Set**

Indications For Use:

The Tamaryn I.V. Flow Regulator Extension Set is used to control the flow rate of administration infusion fluids to a patient during a gravity intravenous infusion.

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) *Delaware Cucinda*
Division of Dental, Infection Control,
and General Hospital Devices
Number *K971066*

Prescription Use: ☑ (Per 21 CFR 801.109)
OR
Over-The-Counter Use: ___________________________