IV ADMINISTRATION SET

K080660 · U.S. Safety Syringes Co., Inc. · FPA · May 13, 2008 · General Hospital

Device Facts

• Record ID: K080660
• Device Name: IV ADMINISTRATION SET
• Applicant: U.S. Safety Syringes Co., Inc.
• Product Code: FPA · General Hospital
• Decision Date: May 13, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The US Safety Syringes IV Administration set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, filter, drip chamber, Y port, needless injection port, 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.

Device Story

The US Safety Syringes IV Administration Set is a fluid delivery system designed for clinical use. It consists of tubing, a flow regulator, a filter, a drip chamber, Y-ports, a needless injection port, a backflow valve, and a hollow spike for connection to IV or medication bags. The device facilitates the gravity-fed or regulated transfer of fluids from a container into a patient's venous system. It is operated by healthcare professionals in clinical settings to manage fluid therapy. The device provides a physical pathway for fluid administration, allowing for controlled delivery and access for medication injection.

Clinical Evidence

Bench testing only.

Technological Characteristics

The device is an intravascular administration set comprising medical-grade tubing, flow regulator, filter, drip chamber, Y-port, needless injection port, backflow valve, and hollow spike. It functions as a passive fluid delivery system. No electronic components, software, or energy sources are utilized.

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 and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is a symbol of medicine and healing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

U.S. Safety Syringes Company, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

Re: K080660

Trade/Device Name: US Safety Syringes IV Administration Set with flow Regulator & Filter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 5, 2008 Received: May 6, 2008

MAY 13 2008

Dear Mr. Devine:

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. Devine

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,

Ove

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): K083466

Device Name: US Safety Syringes IV Administration Set with Flow Regulator & Filter

Indications for Use:

The US Safety Syringes IV Administration set is used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the vein. The device may include the tubing, a flow regulator, filter, drip chamber, Y port, needless injection port, 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.

Prescription Use マ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

unkhor - - - -

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

Korobbo 510(k) Number:

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