DYE MANAGEMENT SYSTEM

K063784 · Icu Medical, Inc. · DQO · Apr 16, 2007 · Cardiovascular

Device Facts

• Record ID: K063784
• Device Name: DYE MANAGEMENT SYSTEM
• Applicant: Icu Medical, Inc.
• Product Code: DQO · Cardiovascular
• Decision Date: Apr 16, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Intended Use

Indicated for Contrast Media Administration in Angiographic procedures.

Device Story

Dye Management System consists of dye management sets with contrast spikes and in-line reservoirs; used in angiographic procedures for contrast media administration. System configured by attaching reservoir set to one or two spike sets. Device facilitates fluid management during clinical procedures; operated by healthcare professionals in clinical settings. No complex electronics or software involved.

Clinical Evidence

Bench testing only; alternate burette component passed all post-sterilization acceptance criteria.

Technological Characteristics

System comprises dye management sets with contrast spikes and in-line reservoirs. Includes an alternate burette component. Regulated under 21 CFR 870.1200. No performance standards established under Section 514.

Indications for Use

Indicated for contrast media administration during angiographic procedures.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Submission Summary (Full Text)

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K06 3784 page 1 of 2

APR 1 6 2007

ICU Medical, Inc. - Dye Management® System Special 510(k) / December 2006

## Special 510(k) Summary

Name of Submitter: ICU Medical, Incorporated 4455 Atherton Drive Salt Lake City, Utah 84123

# Manufacturer and Establishment Registration Number:

| Manufacturer: | Sterilization Sites: |
|-----------------------------------|-----------------------------------|
| ICU Medical (Utah), Inc | Sterigenics US, Inc - Utah |
| 4455 Atherton Drive | 5725 West Harold Gatty Drive |
| Salt Lake City, Utah 84123 | Salt Lake City, Utah 84116 |
| Site Registration Number: 1713468 | Site Registration Number: 1721676 |
| Or | |
| N/A | Steris Isomedix |
| | 7685 St. Andrews Ave |
| | San Diego, California 92154 |
| | Site Registration Number: 2032112 |

Proprietary or Trade Name of Proposed Device: The ICU Medical Dye Management® System.

Common Name: Catheter lab kit, angiography kit, dye management set.

Device Classification, Pancode and ProCode: Class II, 74 - DQO

Performance Standards: No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for Diagnostic Intravascular Catheters. Dye Management® sets are regulated within 21 CFR 870.1200.

Intended Use / Indications for Use: Indicated for Contrast Media Administration in Angiographic procedures.

Proposed Device Description: The Dye Management® System is comprised of two (2) components namely; 1) a dye management set with contrast spikes. 2) A dye management set with in-line reservoir. The Dye Management® system is configured by attaching the reservoir set to either the one (1) or two (2) spike set.

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K063784 page 2 of 2

ICU Medical, Inc. - Dye Management® System Special 510(k) / December 2006

# Summary of Substantial Equivalence:

Similarities:

- 1. The current and proposed sets have the same intended use
- 2. The current and proposed sets are assembled for customer convenience using currently manufactured components.
- 3. The current and proposed sets contain the same type of components.

#### Differences:

- 1. An alternate burette, made of different materials and construction, is being added for use in the assembly of this set.
## Statement of Safety and Effectiveness:

The alternate Burette has been tested post sterilization and passed all acceptance criteria. The Dye Management System™ meets the functional claims and intended use as described in the product labeling and is safe and effective in terms of substantial equivalence as the predicate set(s) described in this document.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. To the left of the eagle is a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 6 2007

ICU Medical, Inc. c/o Mr. Martin Maier Senior QA Engineer 4455 Atherton Dr. Salt Lake City, UT 84123

Re: K063784

Dye Management System™M Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: II Product Code: DQO Dated: March 15, 2007 Received: March 19, 2007

Dear Mr. Maier:

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 Act. The Act. The A 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. Martin Maier

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 vours.

una R. Vulnes

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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K063784

# Indications for Use

0(k) Number (if known): _____________________________________________________________________________________________________________________________________________________

avice Name: Dye Management System™

ications for Use: The Dye Management® System is indicated for Contrast Media Administration in giographic procedures.

Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Holmes

Division Sign-Off) Division of Cardiovascular Devices

:10(k) Number_KO63784

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