LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.

K030002 · Abbott Laboratories · FPA · Jan 27, 2003 · General Hospital

Device Facts

• Record ID: K030002
• Device Name: LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT.
• Applicant: Abbott Laboratories
• Product Code: FPA · General Hospital
• Decision Date: Jan 27, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For administration of I.V. fluids from a container to a patient's vascular system. The safety feature of this device aids in the prevention of needlestick injuries.

Device Story

Lifeshield Primary IV Set is a medical tubing assembly used to deliver intravenous fluids from a container to a patient's vascular system. The device incorporates a safety feature designed to prevent needlestick injuries during clinical use. It is intended for use in hospital or clinical settings by healthcare professionals. The device functions as a conduit for fluid transfer; it does not involve electronic processing, software, or automated decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Intravascular administration set with integrated safety mechanism for needlestick prevention. Mechanical device; no electronic components, software, or energy source. Materials and construction consistent with standard IV administration sets under 21 CFR 880.5440.

Indications for Use

Indicated for patients requiring administration of I.V. fluids from a container to the vascular system.

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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JAN 2 7 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

·Mr. Thomas P. Sampogna Acting Director Abbott Laboratories Hospital Products Division D-389K, Bldg J-45 200 Abbott Park Road Abbott Park, Illinois 60064-6133

Re: K030002

Trade/Device Name: Lifeshield Primary IV Set Convertible Pin with Clave L12591 and L12592, L12589, L12593, L12590 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Regulatory Class: II Product Code: FPA Dated: December 31, 2002 Received: January 2, 2003

Dear Mr. Sampogna:

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. Sampogna

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 (OS) 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 vou 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/dsma/dsmamain.html

Sincerely yours.

Susan Rnares

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Eyaluation Center for Devices and Radiological Health

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K030002

## Indications for Use Statement

| 510(k) Number (If known) | |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Lifeshield Primary IV Set Convertible Pin with Clave L12591 and L12592, L12589, L12593, L12590 |
| Indications For Use: | For administration of I.V. fluids from a container to a patient's vascular system. The safety feature of this device aids in the prevention of needlestick injuries. |

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

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(per 21 CFR 801.109) | |
|------------------------------------------|--|
|------------------------------------------|--|

OR

| Over-The Counter Use | |
|----------------------|--|
|----------------------|--|

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

510(k) Number. K030002