VITALCARE I.V. ADMINISTRATION SET

K050906 · Vitalcare Group, Inc. · FPA · Aug 23, 2005 · General Hospital

Device Facts

• Record ID: K050906
• Device Name: VITALCARE I.V. ADMINISTRATION SET
• Applicant: Vitalcare Group, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 23, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.

Device Story

Single-use, sterile IV administration set; delivers fluids from container/syringe to patient vascular system. Features integrated flow regulator allowing selection of 10, 15, or 60 drops/cc without breaking line. Components include hollow spike, drip chamber, backflow valve, tubing, connectors, needleless injection site, Y port, and extension set. Operated by healthcare providers in clinical settings. Output is controlled fluid infusion; enables flexible treatment based on patient condition. Benefits include simplified flow rate adjustment and secure vascular access.

Clinical Evidence

Bench testing only. Performance data includes pull testing, pressure testing, joint strength testing, and drop testing. Biocompatibility and sterilization/residuals testing performed.

Technological Characteristics

Materials: ABS (Polylac PA-747), Polypropylene (R701G), DEHP-free PVC (2228GBF-65S). Components: Spike, drip chamber, flow regulator, backflow valve, needleless Y port, extension tube. Sterilization: Ethylene Oxide (EO) gas. Connectivity: None. Software: None.

Indications for Use

Indicated for patients requiring intravenous fluid administration via needle or catheter inserted into a vein.

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

• IV Set (K925465)

Submission Summary (Full Text)

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K050906

**AUG 23 2005**

510(k) Summary VitalCare Group, Inc. 8935 NW 27th Street Miami. FL 33172 Tel [phone] Fax [phone] Contact: Ramzi Abulhaj, President Date: August 15, 2005

#### Device: "3 In 1" I V Administration Set I.

| Common Name: | I. V. Administration Set |
|------------------------|------------------------------------|
| Classification Name: | Set, Administration, Intravascular |
| Panel: | General Hospital and Personal Use |
| Product Code: | FPA |
| Device Classification: | II |

#### DEVICE DESCRIPTION II.

The 3 in 1 IV Administration Set is a single use, sterile, device sterilized with Ethylene Oxide gas. The 3 in 1 set is used to administer fluids from an IV container or syringe to a patient's vascular system through a needle or catheter. A choice can be easily made between 10, 15, or 60, drops/cc volume without breaking the line. This feature allows the healthcare provider the flexibility to treat the patient condition by turning the selector. The device may include a flow regulator, a drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set, needleless injection site, Y port, extension set, and a hollow spike to penetrate and connect the tubing to an IV bag or other infusion fluid container. VitalCare Group Inc. will offer standard sets and custom sets to meet customer requirements and specifications.

#### INTENDED USE OF THE DEVICE III.

The 3 in 1 IV Administration Set is used to administer fluids front a container to a patients vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, drip chamber, backflow valve, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag or medication bag.

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KD50906

# 2

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## Comparison Table

| Feature | Detail | Predicate<br>K925465 |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|
| Intended Use | The VitalCare 3 in 1 IV Administration Set is used to<br>administer fluids from a container to a patient's vascular<br>system through a needle or catheter inserted into the vein.<br>The device may include the tubing, a flow regulator, drip<br>chamber, Y port, needleless injection port, backflow valve,<br>fluid delivery tubing, connectors between parts of the set and<br>a hollow spike to connect the tubing to an IV bag or<br>medication bag. | Identical |
| Components | Spike, ABS, Polylac PA-747<br>Spike Cover, PE<br>Luer Locks, Male and Female, ABS, Polylac PA-747<br>Luer Protective Covers, Polypropylene R701G<br>PVC Tubing, Medical Grade DEHP free, 2228GBF-65S<br>Clear<br>Y Port/Split Septum, ABS, Polylac PA-747<br>Needleless Y Port, ABS, Polylac PA-747<br>Extension Tube, Medical Grade DEHP free PVC/ABS<br>3 in 1 Flow Regulator, ABS, Polylac PA-747<br>Back Flow Valve, ABS, Polylac PA-747<br>Roller Clamp, ABS, Polylac PA-747<br>Tube Clamp, ABS, Polylac PA-747<br>Pouch, Polypropylene R701G<br>Kraft triple wall Corrugated fiberboard | Similar<br>components and<br>materials |
| Performance<br>Tests | Biocompatibility<br>Bench Testing<br>Sterilization/Residuals | Similar |
| Labeling | Reorder Number<br>Size<br>Quantity<br>Lot Number<br>Sterile<br>Bar Code<br>DEHP Free<br>Latex Free<br>Single Use Only<br>Pouch and Shipping case<br>Manufacturer Address | Similar |
| Packaging | 50 pouches per case | Similar |
| Sterilization | Sterile (EO) | Sterile (EO) |

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K050906

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### 510(k) Summary VitalCare Group, Inc.

#### IV Performance Data

Pull testing, pressure testing, joint strength testing, and drop testing has been performed.

#### V. Conclusion

The VitalCare "3 in 1" IV Administration Set is substantially equivalent to the above products by having the identical indication for use and similar materials used for construction.

The materials used to manufacture the VitalCare IV Administration Set are used in legally marketed devices under comparable conditions.

Comparison of the predicate device to the VitalCare IV Administration Set for technological differences showed no significant difference.

#### VI. Description of the Marketed Equivalent Device:

| Common Name: | IV Administration Set |
|----------------------|-----------------------------------------------------------------------------|
| Classification Name: | Set, Administration, Intravascular |
| Product Code: | FPA |
| Applicant: | Biomedix Inc.<br>23 South Main Street<br>P. O. Box 231<br>Spencer, IN 47460 |
| Equivalent Device | K925465, IV Set |

#### Intended Use of the Marketed Equivalent Device: VII

The Selec-3 is an adjustable 3 in 1 volume IV Set is used to administer fluids from a container to a patients vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, drip chamber, an infusion line filter, backflow valve an IV set stopcock, fluid delivery tubing, connectors between parts of the set and a hollow spike to connect the tubing to an IV bag.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an eagle-like symbol with three stylized lines forming the body and head, and two curved lines representing the legs. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# AUG 2 3 2005

VitalCare Group, Incorporated C/O Daniel Kamm, P.E. Regulatory Engineer Kamm & Associates P.O. Box 7007 Deerfield, Illinois 60015

Re: K050906

Trade/Device Name: VitalCare I.V. Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: July 7, 2005 Received: July 7, 2005

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Kamm

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Susan Huang
Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications For Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:_VitalCare I. V. Administration Set

Indications For Use: The Intravascular Administration Set is a single use, sterile device that provides access for the administration of fluids from a container to the patients vascular system through the administration set's needle or catheter, which is inserted into a vein.

Prescription Use V

AND/OR

Over-The-Counter Use

. . . . . . . . . . . . . . . . . . . . . . . . .

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cintur ve, me

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

510(k) Number:___________________________________________________________________