TEGO NEEDLE FREE ACCESS ACCESS DEVICE

K040710 · Icu Medical, Inc. · FPA · Aug 11, 2004 · General Hospital

Device Facts

• Record ID: K040710
• Device Name: TEGO NEEDLE FREE ACCESS ACCESS DEVICE
• Applicant: Icu Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 11, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Indications for Use

The TEGO is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Adminstration Set for the adminstration of fluids or withdraw of fluids from a patient through a cannula or needle placed in the vein or artery. The Gumby is a needle-free, closed capping device which will prevent blood loss or air entrainment through the 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 is a one-piece, swab-able, needle-free catheter patency device; functions as a closed capping device for venous and arterial access. Features low deadspace, straight fluid path, and high flow rate. Upon removal of fluid administration device, TEGO provides automatic positive displacement of fluid to prevent blood reflux. Permits routine saline flushing and patency maintenance. Used in clinical settings by healthcare providers to access catheters without needles, reducing needlestick injury risk. Prevents blood loss and air entrainment.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Materials: polycarbonate, silicone rubber, polyethylene, and trace silicone lubricant. Design: one-piece, swab-able, needle-free valve. Features: low deadspace, straight fluid path, automatic positive displacement mechanism for reflux prevention. Non-powered, mechanical device.

Indications for Use

Indicated for use as an accessory to vascular access devices (catheters) in hemodialysis or as an accessory to intravascular administration sets for fluid administration or withdrawal via venous or arterial cannulas/needles. Used for capping catheters to prevent blood loss or air entrainment.

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.

Predicate Devices

• CLC 2000 Ultra-Site Valve

Submission Summary (Full Text)

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K040710 192

# AUG 1 1 2004

## SUMMARY OF SAFETY AND EFFECTIVENESS TEGO (NEEDLE- FREE ACCESS DEVICE)

5807.92(a)(1)

Contact Person

Date of Summary Preparation:

8807.92(a)(2)

Trade Name:

Common Name:

Classification Name:

8807.92(a)(3)

Legally Marketed Substantially Equivalent Devices:

8807.92(a)(4)

Description of Device:

Regulatory Manager August 10, 2004

Dale Fairchild

TEGO

Needle-Free Access Device

Intravascular administration set (21 CFR 880.5440

CLC 2000 Ultra-Site Valve

The TEGO is a one piece, swab-able, needle-free catheter patency device. The TEGO is intended for the capping of venous and arterial access devices. The TEGO has a low deadspace, a straight fluid path, high flow rate and straight hale purchant and ergonomically pleasing profile. When a fluid

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K0407/0

adminstration device is removed from the TEGO an automatic positive displacement of fluid will exit the device and provent blood reflux. The TEGO will permit the use of normal saline for what is known as a rountine flush and patency rodintenance of the venous or arterial access device.

The materials include polycarbonate, silicone rubber, polyethlene and trace amounts of silicone as a lubricant. All of these materials are typically used in medical devices.

### 8807.92(a)(5)

#### Intended Use:

The TEGO is intended for use as an accessory to a vascular access device (catheter) used in Hemodialysis or as an accessory to an Intravascular Adminstration Set for the adminstration of fluids or withdraw of fluids from a patient through a cannula or needle placed in the vein or artery. The Gumby is a needle-free, closed capping device which will prevent blood loss or air entrainment through the catheter. The TEGO will permit access to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.

#### 8807.92(a)(6)

Comparison of Technical Characteristics:

The TEGO is similar to legally marketed devices with the same intended use and design.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2004

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

Re: K040710

Trade/Device Name: TEGO™ Needle Free Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administrative Set Regulatory Class: II Product Code: FPA Dated: June 24, 2004 Received: June 25, 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 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/dsma/dsmamain.html

Sincerely yours,

Carls

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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K640710

### Indications For Use Statement

510(k) Number: K040710

TEGO™ Needle Free Access Device Device Name:

The TEGO™ Needle Free Access Device is intended for use Indications For Use: rndreations I of Or Ober - access device (catheter) used in Hemodialysis or as an as an accessory to a vascular Administration Set for the administration or withdraw of accessory to an intravascular Fiammistically of a cartery. The TEGY'' is a a needle-free capping device which close the end of the catheter. The TEGO™ will permit a necess to the catheter without the use of needles and therefore passively aid in the reduction of needlestick injuries.

| Prescription Use X | OR | Over-The-Counter-Use |
|----------------------|----|-------------------------|
| (Per 21 CFR 801.109) | | (optional format 1-2-9) |

(Please do not write below this line-continue on another page if needed.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Antr ioz

ision Sigr ion of Anesthesiologi Division Control, Dent

510(k) Number: