MED-RX EXTENSION SETS

K990777 · Benlan, Inc. · FPA · Aug 25, 1999 · General Hospital

Device Facts

• Record ID: K990777
• Device Name: MED-RX EXTENSION SETS
• Applicant: Benlan, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 25, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.

Device Story

Med-Rx® Extension Sets are sterile, single-use medical devices designed to extend the fluid path of primary I.V. catheters. The device consists of fluid delivery tubing with capped luer connectors at the proximal ends; optional pinch or slide clamps are included. Tubing is available in various lengths and bore sizes (standard, mini, and micro). The device is used in clinical settings by healthcare professionals to facilitate I.V. therapy. It functions as a passive conduit for fluid or drug delivery, allowing for greater flexibility in positioning the infusion site relative to the primary I.V. administration set.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Fluid delivery tubing with luer connectors and optional pinch/slide clamps. Available in standard, mini, and micro-bore sizes. Sterile, single-use device. No electronic components or software.

Indications for Use

Indicated for patients requiring intravenous therapy where an extended fluid path is necessary for the administration of fluids or drugs.

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

• Medex Extension Sets, MX454-FL, MX448-L36 and 536040 (K990777)

Submission Summary (Full Text)

{0}------------------------------------------------

K990777

### Attachment 1

# 510(k) Summary of Safety and Effectiveness

## Med-Rx® Extension Sets

### Submitter Information:

Bill C.K. Lim Manager of Regulatory Affairs Benlan Inc. 2760 Brighton Road Oakville, Ontario L6H 5T4 Canada

905 829-5004 Phone Fax [phone]

## Date 510(k) Summary Prepared: March 3, 1999

#### Name/Classification of the Device:

| Classification Name: | Intravascular Administration Set |
|----------------------|-----------------------------------------------------------------------------------------------|
| Common Name: | I.V. Extension Sets |
| Propriety Name: | Med-Rx® Extension Set |
| Classification/Panel | Class II in CFR 880.5440,<br>Intravascular Administration Set<br>Panel: General Hospital (GH) |

### Identification of the Legally Marketed Device to which the Submitter Claims Equivalence:

The Med-Rx® Extension sets are substantially identical in materials, packaging, sterilization, and intended use to Medex Extension Sets, MX454-FL, MX448-L36 and 536040 manufactured by Medex Inc.

#### Description of the Subject Device:

The Med-RX® Extension Sets consist mainly of a fluid delivery tubing provided with capped luer connectors at the proximal ends. The extension sets can thus be connected to an I.V. administration sets whereby extending infusion site(s) of a primary I.V. catheter. The fluid delivery tubing can vary in lengths as well as bore sizes, i.e. standard bore, mini-bore and micro-bore.

{1}------------------------------------------------

The extension sets may include pinch or slide clamps.

# Intended Use of the Subject Device:

The extension sets are intended for use in I.V. therapy when extended fluid path is required in the administration of I.V. solutions or drugs. Benlan Inc. does not cause or promote new intended uses for these devices.

## Technological Characteristics of the Subject Device:

There are no differences in the characteristics of the subject device and the predicate(s).

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often used as a symbol of medicine. The caduceus is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 25 1999

Mr. Bill C.K. Lim Manager, Regulatory Affairs Benlan, Incorporated 2760 Brighton Road Oakville, Ontario CANADA L6H 5T4

K990777 Re :

> Med-Rx® Extension Set Trade Name: Regulatory Class: II Product Code: FPA June 18, 1999 Dated: Received: June 22, 1999

Dear Mr. Lim

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 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) requlation (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

{3}------------------------------------------------

Page 2 - Mr. Lim

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 debtired in your and equivalence of your device to a legally marketed predicate device results in a classification for your marice 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 yitro 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 obcarned from one [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

{4}------------------------------------------------

K990777

Med-Rx® Extension Sets Attachment 3

510(k) Number (if known) _

Device Name: Med-Rx® Extension Sets

Indications for Use:

These extension sets are sterile, single use, medical devices intended for use in LV. therapy when extended fluid path is required for fluid or drug administration. Benlan Inc. does not cause or promote new intended uses for these devices.

(Please Do Not Write Below This Line / Continue on Another Page if Needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Peterson Cusack
(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices

510(k) Number 494077

Prescription Use (per 21 CFR 801.109)

。 こ

OR

Over the Counter Use _

(Optional Format 1-2-96)