COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105

K983411 · Valnet Medical Corp. · FPA · Feb 9, 1999 · General Hospital

Device Facts

• Record ID: K983411
• Device Name: COLORVEES IV SET 20 DROPS/ML 105, 60 DROPS/ML 105, VENTED 20 DROPS 105, VENTED 60 DROPS 105
• Applicant: Valnet Medical Corp.
• Product Code: FPA · General Hospital
• Decision Date: Feb 9, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

colorVees Intravascular Administration Set will be used to administer fluids from a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments.

Device Story

Intravascular administration set used to deliver fluids from container to patient vascular system via needle or catheter; features multi-colored tubing to assist practitioners in identifying and tracking individual lines when multiple sets are used simultaneously. Operated by clinicians in clinical settings; color-coding aids in tracing tubing from source to venipuncture site, reducing risk of identification errors during complex IV therapy.

Clinical Evidence

No clinical data; bench testing only. Biocompatibility verified per FDA Blue Book Memorandum #G95-1 and ISO 10993-1.

Technological Characteristics

Intravascular administration set with colored tubing. Materials comply with ISO 10993-1 biocompatibility requirements. Standard gravity-fed fluid delivery mechanism.

Indications for Use

Indicated for patients requiring administration of intravenous fluids or medicaments via needle or catheter. Used by practitioners to facilitate identification of multiple IV lines.

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

• BAXTER McGaw V 1424
• McGaw V1515-15

Submission Summary (Full Text)

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

# Re: K983411, colrVees IV Sets

K983411

# 510K Summary

| Company Name: | VALNET Medical Corp. |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | Felicia Industrial Park (Playa)<br>Street B Lot 16<br>PO Box 859<br>Santa Isabel, Puerto Rico<br>00757-0859 |
| Telephone: | [phone] |
| Contact Person: | Víctor Ortíz, Vice-President and General Manager |
| Date: | 09/18/98 |
| Name of Device: | Intravascular Administration Set |
| Trade Name: | colorVees IV Set 20 drops/ml 105"<br>colorVees IV Set 60 drops/ml 105"<br>colorVees IV Set Vented 20 drops/ml 105"<br>colorVees IV Set Vented 60 drops/ml 105" |
| Usual Name: | Intravascular Administration Set |
| Classification: | FPA Class II Device<br>For discussion only<br>Solo para discutirse |
| Predicate on legally marked device: | |

2C5435s BAXTER McGaw V 1424 McGaw V1515-15

# Description of the device:

# Function:

colorVees Intravascular Administration Set will be used to administer fluids from t a container to a patient's vascular system through a needle or catheter. The

. .

colorVees Intravascular Administration Set Section E-R2.doc, 2/3/99

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

#### Re: K983411, colrVees IV Sets

proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments. Basic Scientific Concept:

This device is manufactured using different colored tubes. Its difference from predicated legally marked devices relies in this multiplicity of colored tubing. These colored tubes assist the practitioner to instantaneously identify and follow the delivery tubing when there is a need to run a plurality of intravascular administration sets to the same patient. The fundamental value added concept is to enlist color as an additional means of identification of tubing. This will greatly aid in preventing a practitioner from failing to make the proper identification of an IV tube from point of source (the IV solution itself) to point of delivery (venipuncture site on patient's body).

### Significant Physical and Performance Characteristics:

There are no significant physical differences or performance characteristics from predicated devices. The only difference from predicated legally marked devices relies in its coloring. These colored tubes comply with biocompatibility requirements of FDA Blue Book Memorandum #G95-1 ISO 10993-1.

Statement of how the technological characteristics compare to predicate or legally marked devices:

The colorVees Intravascular Administration Set's technological characteristics are similar or compare to those of predicated devices. The only difference between the colorVees Intravascular Administration Sets and predicated legally marked devices relies in its coloring.

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

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 9 1999

Mr. Victor Ortiz Vice-President and General Manager VALNET Medical Corporation Felicia Industrial Park (Playa) Street B Lot 16 P.O. Box 859 Santa Isabel, Puerto Rico 00757-0859

Re : K983411 ColorVees IV Sets Trade Name: Requlatory Class: II Product Code: FPA October 27, 1998 Dated: Received: November 16, 1998

Dear Mr. Ortiz:

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 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). 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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ਮ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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

Paqe 2 - Mr. Ortiz

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" (21CFR 807.97). Other qeneral 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/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

K983411

Re: K983411. colorVoes IV Sets

Ver/3 - 4/24/96

Applicant: VALNET Medical Corp.

510 (k) Number (if known):

Device Name: colorVees Intravascular Administration Set

Indications for Use:

colorVees Intravascular Administration Set will be used to administer fluids from a container to a patient's vascular system through a needle or catheter. The proposed device will enable the practitioner to identify and follow the colored multiple lines during the administration of intravenous solutions/medicaments.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR Over-The-Counter_ Prescription Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Patricia Crescenti

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices

K 983411 510(k) Number _