MEDCORP FLOW I.V. REGULATOR EXTENSION SET

K971004 · Medcorp Intl. · FPA · Oct 2, 1997 · General Hospital

Device Facts

• Record ID: K971004
• Device Name: MEDCORP FLOW I.V. REGULATOR EXTENSION SET
• Applicant: Medcorp Intl.
• Product Code: FPA · General Hospital
• Decision Date: Oct 2, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

To provide fluid path connection and flow regulation from fluid delivery set to venipucture device.

Device Story

The Medcorp Flow I.V. Regulator Extension Set is a sterile, single-use, nonpyrogenic intravenous extension set. It consists of flexible tubing equipped with Luer lock connectors at both ends for attachment to a fluid delivery system and a venipuncture device. The device incorporates a manual flow regulator to control infusion rates and a Y-site on the lower tubing segment to allow for the administration of secondary medications. It is intended for use in clinical settings by healthcare professionals to facilitate controlled fluid delivery to a patient's venous access site.

Clinical Evidence

Bench testing only. Testing included flow rate verification, static tensile strength of fittings, toxicity testing, and pyrogenicity testing to confirm equivalence to the predicate device.

Technological Characteristics

Sterile, single-use, nonpyrogenic I.V. extension set. Components include flexible tubing, Luer lock connectors, a manual flow regulator, and a Y-site for medication injection. Materials were subjected to toxicity and pyrogenicity testing. No electronic or software components.

Indications for Use

Indicated for providing a fluid path connection and flow regulation between a fluid delivery set and a venipuncture device for patients requiring intravenous therapy.

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

• DIAL-A-FLOW Regulatory I.V. Extension Set

Submission Summary (Full Text)

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K971004

MEDCORP INTERNATIONAL
A Health Care Export
Management Company
OCT - 2 1997
25612 Stratford
Laguna Hills, CA 92653 USA
Telephone: [phone] FAX: [phone]

## Attachment 1

### 510(k) Summary
### Medcorp Flow I.V. Regulator Extension Set

**Name and Address:** Medcorp International
25612 Stratford Place
Laguna Hills, CA 92653

**Contact Person:** Dave Berberian
**Phone:** [phone]
**Fax:** [phone]

**Date Prepared:** March 1, 1997

**Tradename Name:** Medcorp Flow I.V. Regulator Extension Set
**Common Name:** I.V. Extension Set
**Classification Name:** Intravascular Administration Set (per 21 CFR 880.5440)
**Classification Name:** Intravascular Administration Set

**Predicate Device:** DIAL-A-FLOW Regulatory I.V. Extension Set

**Description:** The device is a sterile, nonpyrogenic, single use, I.V. extension set which has flexible tubing that connects to a fluid delivery system by a Luer lock connector, a flow regulator, and flexible tubing that connects to a venipuncture device by a Luer lock connector. A Y-site on the lower length of tubing allows for infusion of medication below the regulator.

**Indicated Use:** To provide fluid path connection and flow regulation from fluid delivery set to venipuncture device.

**Substantial Equivalence:** Medcorp International believes that the Medcorp Flow I.V. Regulator Extension Set is substantially equivalent to the DIAL-A-FLO Regulator I.V. Extension Set in intended use, labeling, design, components, performance, and biocompatibility. To establish the claim of equivalence to the predicate device, physical testing (flow rates and static tensile strength of fittings), toxicity testing, and pyrogenicity testing) have been performed using the device. The flow rates for the device are equivalent to those indicated by the calibrations for the predicate device. The toxicity testing indicate the device, after manufacturing and sterilization, is nontoxic. Pyrogenicity testing supports the claim for the device which is the same as the claim for the predicate device. Tests support the claim that the proposed device is equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20856

Mr. Dave Berberian
President
Medcorp International
25612 Stratford
Laguna Niguel, California 92653

OCT - 2 1997

Re: K971004
Trade Name: Medcorp Flow I.V. Regulator Extension Set
Regulatory Class: II
Product Code: FPA
Dated: July 29, 1997
Received: August 1, 1997

Dear Mr. Berberian:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, 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

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Page 2 - Mr. Berberian

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.

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

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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K 97/004

510(k) Number (if known): _________________________________________________________

Device Name: Medcorp Flow I.V. Regulator Extension Set

Indications For Use:

To provide fluid path connection and flow regulation from fluid delivery set to venipucture device.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucinita
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K97/004

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ____