EVA EMPTY SOLUTION CONTAINER

K030888 · Metrix Co. · KPE · Apr 2, 2003 · General Hospital

Device Facts

• Record ID: K030888
• Device Name: EVA EMPTY SOLUTION CONTAINER
• Applicant: Metrix Co.
• Product Code: KPE · General Hospital
• Decision Date: Apr 2, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5025
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

Device Story

EVA Empty Solution Container; sterile fluid path container for holding/administering compatible fluid admixtures. Used in clinical settings; operated by healthcare professionals. Facilitates medication delivery to patients. Device serves as a receptacle for fluids; ensures sterile environment for admixture. Benefits include safe, controlled fluid administration.

Clinical Evidence

Bench testing only.

Technological Characteristics

Empty solution container with sterile fluid path; Class II device (Regulation 880.5025, Product Code KPE).

Indications for Use

Indicated for use as an empty container with a sterile fluid path to hold compatible fluid admixtures for patient administration via aseptic medication transfer.

Regulatory Classification

Identification

An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## APR 0 2 2003

Mr. James Oldham Product Engineer The Matrix Company 4400 Chavenelle Road Dubugue, Iowa 52002-2655

Re: K030888

Trade/Device Name: EVA Empty Solution Container Regulation Number: 880.5025 Regulation Name: IV Container Regulatory Class: II Product Code: KPE Dated: March 18, 2003 Received: March 21, 2003

Dear Mr. Oldham:

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 - Ms. Oldham

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,

Susan Runnes

Susan Runner, DDS, MA Interim 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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510(k) Number (if known): _K030888

Device Name: EVA Empty Solution Container

Indications for Use:

An empty container with sterile fluid path used to hold an admixture of compatible fluids for administration to a patient. Medication transfer is done using aseptic technique.

Jem Oldham
The Matrix Company
3-31-03

Patacie Cucente

510(k) Number. K030888

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Concurrence of CDRH, Office of Device Evaluation (ODE)