Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432

K042182 · Icu Medical, Inc. · FPA · Sep 1, 2004 · General Hospital

Device Facts

• Record ID: K042182
• Device Name: Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Sep 1, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The ICU Needleless Connector is a single use , sterile, non pyrogenic The FOO Reculeress Commonton to Intravascular Administration Set for the administration of fluids to a patient through a cannula placed In the vein or artery

Device Story

The Y Clave Connector with Integrated Check Valve is a single-use, sterile, needleless connector designed for use within intravascular administration sets. It facilitates fluid delivery to patients through venous or arterial cannulas. The device incorporates an integrated check valve to manage fluid flow. It is intended for clinical use by healthcare professionals in hospital or clinical settings. The device functions as a component of an IV administration system, allowing for safe, needle-free access to the patient's circulatory system, thereby reducing the risk of needlestick injuries and maintaining a closed system during fluid administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, sterile, non-pyrogenic needleless connector with an integrated check valve. Designed for integration into intravascular administration sets. Class II device (Product Code: FPA).

Indications for Use

Indicated for the administration of fluids to patients via an intravascular cannula placed in a vein or artery.

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 is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three birds in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 1 2004

Mr. Dale L. Fairchild Manager, Regulatory Affairs ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673

Re: K042182

Trade/Device Name: Y Clave Connector Will Integrated Check Valve, Model XI-3432 Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 11, 2004 Received: August 11, 2004

Dear Mr. Fairchild

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 ecuirements 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 (1 mr), it may of 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. Fairchild

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/dsma/dsmamain.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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Indications for Use

510(k) Number (if known):_K042182

Device Name: Y Clave Connector with Integrated Check Valve,

Indications For Use: The ICU Needleless Connector is a single use , sterile, non pyrogenic The FOO Reculeress Commonton to Intravascular Administration Set for the administration of fluids to a patient through a cannula placed In the vein or artery

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Auy Melour

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

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510(k) Number: K042182