HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS

K060352 · Health Line International Corporation · FPA · May 31, 2006 · General Hospital

Device Facts

• Record ID: K060352
• Device Name: HEALTH LINE INTERNATIONAL CORPORATIONS,S IV ADMINISTRATIVE SETS
• Applicant: Health Line International Corporation
• Product Code: FPA · General Hospital
• Decision Date: May 31, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The intended use of health Line International Corporation's IV Administration Sets and Extensions Sets is for the safe and effective administration of fluids from a container to the patents vascular system and/or to draw blood from the patient's vascular system. Product is DEHP free for use on all patient populations

Device Story

Gravity-fed intravascular administration and extension sets; used to deliver fluids from container to patient vascular system or to draw blood. Operated by clinicians in clinical settings. Device consists of tubing and spike components; DEHP-free materials. Spike dimensions compliant with ISO 8536-4:2004. Output is fluid delivery or blood collection. Benefits include safe, effective fluid administration across all patient populations.

Clinical Evidence

Bench testing only. Compliance with ISO 8536-4:2004 (spike dimensions) and ISO 10993 (biocompatibility) demonstrated. No clinical data provided.

Technological Characteristics

Gravity-fed IV administration and extension sets. Materials are DEHP-free. Spike dimensions compliant with ISO 8536-4:2004. Biocompatibility compliant with ISO 10993. No electronic or software components.

Indications for Use

Indicated for administration of fluids from a container to the patient's vascular system and/or blood withdrawal. Suitable for all patient populations. Prescription use only.

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 (K925126)
• Baxter (K89098)

Reference Devices

• McGaw (B. Braun) Needle Free Injection Site Caps

Submission Summary (Full Text)

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#### MAY 3 1 2006 510(K) SUMMARY

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(K) number is: KC663 2 Device Name:

Proprietary Name: Health Line International Corporation's IV Administration and Extension Sets

Common/Usual Name: Intravascular Administration Sets

## Classification:

| Class II: | Per 21 CFR 880.5440 |
|-------------------|---------------------|
| Panel Number: | Panel 88 |
| Product Code: | FPA |
| Predicate Device: | |

The HLIC IV Administration Sets are substantially equivalent to Baxter K925126 and the HLIC Extension Sets are substantially equivalent to Baxter K89098 Predicate Devices.

## Device Description:

HLIC's IV Administration Sets covered by this submission are gravity feed Intravascular Administration Sets. They are to be used for administering fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein.

## Intended Use

The intended use of health Line International Corporation's IV Administration Sets and Extensions Sets is for the safe and effective administration of fluids from a container to the patents vascular system and/or to draw blood from the patient's vascular system. Product is DEHP free for use on all patient populations The technical characteristics of HLIC's IV Administration Sets and Extension Sets and Baxter's predicate device are substantially equivalent. HLIC's spike dimensions are slightly different from Baxter's predicate devices. HLIC's spike length is more compliant to ISO 8536-4:2004 dimensions than Baxter's predicate devices.

The performance data and the safety data indicated that HLIC's devices are substantially equivalent to Baxter's IV Administration Sets, Extension Sets. And McGaw (B. Braun Needle Free Injection Site Caps. HLIC's devices were all compliant with ISO 8536-4:2004 and ISO 10993 requirements.

#### Conclusion:

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K060352

The following conclusions can be drawn from reviewing the safety and efficacy data of the 510(K) and physical dimensional data all indicated that HLIC's IV Administration Sets and Extension Sets are substantially equivalent to Baxter's predicate devices.

: ·

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus.

MAY 3 1 2006

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jack Speer, MS, RAC V.P. Business Development and Regulatory Health Line International Corporation Freeport Center Building E-13 Drive 21 P.O. Box 160435 Clearfield, Utah 84016-0435

Re: K060352

Trade/Device Name: IV Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 11, 2006 Received: May 12, 2006

Dear Mr. Speer:

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 - Mr. Speer

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.

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

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# Indication for Use Statement

510(K) Number (K060352) Device Name: IV Administration Set

Indication for Use:

The indicated use of health Line International Corporation's IV Administration Sets and Extensions Sets is for administration of fluids from a container to the patents vascular system.

(Signature
of Verifier)

Jack R. Speer

may 11, 2006

Prescription Use: Yes X (Part 21 CFR 801 Subpart D)

Over The Counter Use AND/OR

No

(21 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sign-Off)
ion of Anesthesiology, General Hospital,
action Control, Dental Devices

) Number: