HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE

K070630 · Health Line International Corporation (Hlic) · FPA · Aug 31, 2007 · General Hospital

Device Facts

• Record ID: K070630
• Device Name: HEALTH LINE INTERNATIONAL CORPORATION'S PRIMARY IV SOLUTION ADMINISTRATION SET WITH CHECK VALVE
• Applicant: Health Line International Corporation (Hlic)
• Product Code: FPA · General Hospital
• Decision Date: Aug 31, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 requlator, 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.

Device Story

IV solution administration set with check valve; facilitates fluid delivery from container to patient vascular system. Components include tubing, flow regulator, drip chamber, infusion filter, stopcock, connectors, injection site, and hollow spike for bag access. Used in clinical settings by healthcare professionals to manage fluid therapy. Check valve prevents backflow. Device provides physical pathway for infusion; does not involve electronic processing or software.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical IV administration set. Components: tubing, flow regulator, drip chamber, filter, stopcock, connectors, injection site, hollow spike, and check valve. Materials are standard medical-grade plastics/polymers typical for IV sets. Non-electronic; no software; no energy source. Sterilized per standard industry practices for Class II administration sets.

Indications for Use

Indicated for the administration of fluids from a container to a patient's vascular system via an intravenous needle or catheter.

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 3 1 2007

Ms. Denice Wroe ASQ-Certified Quality Auditor Manager of Quality Assurance Health Line International Corporation P.O. Box 160435 Freeport Center Building E-13 Door 21 Clearfield, Utah 84016

Re: K070630

Trade/Device Name: Health Line International Corporation's IV Solution Administration Set with Check Valve Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 15, 2007 Received: August 16, 2007

Dear Ms. Wroe:

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 Federal Register.

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Page 2 - Ms. Wroe

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,

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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K OICUCC

Image /page/2/Picture/1 description: The image shows the logo for Health Line International Corporation. The logo features the company name in bold, uppercase letters, with the words "International Corporation" stacked below "Health Line". Underneath the company name is the tagline "Quality Medical Products" in a smaller font. A black circle is on the left side of the text, and a curved line extends from the circle over the top of the text and down the right side.

## Indications for Use Attachment II

## 510(k) Number (if known): N/A

Device Name: Health Line International Corporation's IV Solution Administration Set with Check Valve

## Indications for Use:

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 requlator, 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.

Prescription Use (Part 21 CFR 801 Subpart D)

1070630

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

(Division Sign-Off) forell Fer ADW 8/31/07
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number:

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Freeport Center Bldg E-13, Door 21, PO Box 160435, Clearfield, UT 84016-0435 Phone [phone]; Fax [phone]