LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE

K971293 · Abbott Mfg., Inc. · FPA · Jun 27, 1997 · General Hospital

Device Facts

• Record ID: K971293
• Device Name: LIFESHIELD PRIMARY I.V. SET WITH BACKCHECK VALVE
• Applicant: Abbott Mfg., Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 27, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.

Device Story

Primary I.V. set with integrated backcheck valve; facilitates delivery of fluids from primary and secondary containers. Backcheck valve prevents fluid intermixing during secondary infusion; automatically restores primary flow upon secondary container depletion. Used in clinical settings by healthcare professionals for fluid administration. Benefits include simplified multi-line fluid management and prevention of backflow.

Clinical Evidence

Bench testing only.

Technological Characteristics

I.V. administration set featuring an integrated mechanical backcheck valve. Materials and sterilization methods are standard for Class II I.V. sets.

Indications for Use

Indicated for the delivery of I.V. fluids in patients requiring primary and secondary fluid administration. No specific age or disease state contraindications provided.

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
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

Mr. Thomas P. Sampogna
Manager, Regulatory Affairs
Hospital Products Division
Abbott Manufacturing, Incorporated
200 Hundred S. Abbott Park Road D 389, Building AP 30
Abbott Park, Illinois 60064-3500

Re: K971293
Trade Name: Primary I.V. Set With Backcheck Valve
Regulatory Class: II
Product Code: FPA
Dated: April 4, 1997
Received: April 7, 1997

Dear Mr. Sampogna:

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 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 against 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Mr. Sampogna

not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 regulation (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" (21 CFR 807.97). Other general 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/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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510(k) Number(if known): ___________________________

Device Name: **Primary I.V. Set with Backcheck Valve**

## Indications For Use:

The Primary I.V. Set with Backcheck Valve is used for the delivery of I.V. fluids through the primary line or through the attachment of a secondary line into the backcheck valve. A backcheck valve prevents the intermixing of fluids while the secondary line is running. Then, when the secondary line is emptied, the valve automatically restores flow from the primary container.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) *Patricia Cucurla*
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number *K971293*

Prescription Use ________ OR Over-The-Counter Use ________
(Per 21 CFR 301.109)