TEGO, MODEL D1000

K053106 · Icu Medical, Inc. · FPA · Jan 10, 2006 · General Hospital

Device Facts

• Record ID: K053106
• Device Name: TEGO, MODEL D1000
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jan 10, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The TEGO™ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The TEGO™ is a needle-free capping device, which close the end of a catheter. The TEGO" will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.

Device Story

TEGO Needle Free Access Device functions as a mechanical accessory for vascular access catheters; used in hemodialysis or general IV fluid administration/withdrawal. Device acts as a needle-free cap for catheter ends; allows fluid access without needles; passively reduces needlestick injury risk. Operated by clinicians in clinical settings. Device provides a closed system interface for fluid transfer; facilitates patient care by maintaining catheter patency and safety during access.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Needle-free mechanical access device; functions as a catheter cap. Designed for integration with vascular access devices and IV administration sets. No software or electronic components.

Indications for Use

Indicated for patients requiring hemodialysis or intravenous fluid administration/withdrawal via vascular access catheters. Used as a needle-free capping device to facilitate access and reduce needlestick risk.

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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## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 0 2006

Mr. Dale Fairchild ICU Medical, Incorporated 951 Calle Amanecer San Clemente, California 92673

Re: K053106

Trade/Device Name: TEGO Needle Free Access Device Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: December 9, 2005 Received: December 12, 2005

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 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. 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/industry/support/index.html.

Sincerely yours,

Smitte Y. Michie, MD.

Chiú 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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K053104

## Indications for Use

510(k) Number (if known): K040710

Device Name: TEGO™ Needle Free Access Device

Indications For Use: The TEGO™ Needle Free Access Device is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Administration Set for the administration or withdraw of fluids to a patient through a cannula or needle placed in the vein or artery. The TEGO™ is a needle-free capping device, which close the end of a catheter. The TEGO" will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anthony D. nut

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