MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M

K973561 · Medical Components, Inc. · FOZ · May 11, 1998 · General Hospital

Device Facts

• Record ID: K973561
• Device Name: MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 12CM, MEDCOMP TRI-FLOW SOFT TIP TRIPLE LUMEN CATHETER 11.5F X 1M
• Applicant: Medical Components, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: May 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Medcomp Tri-Flow™ Triple Lumen Catheter is designed for acute central vein catheterization, TPN, fluid administration, drug infusion, and continuous therapies. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.

Device Story

Medcomp Tri-Flow™ Triple Lumen Catheter is a percutaneous device for acute central venous access. Used for TPN, fluid administration, drug infusion, and continuous therapies. Ideally placed in internal jugular vein; can be placed in subclavian or femoral veins. Operated by clinicians in clinical settings. Device facilitates multi-lumen access for simultaneous delivery of therapies. Benefits include efficient central venous access for acute care patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use.

Technological Characteristics

Triple lumen catheter design for percutaneous insertion. Intended for acute central venous access. No specific materials, energy sources, or software components described.

Indications for Use

Indicated for patients requiring acute central venous access for TPN, fluid administration, drug infusion, and continuous therapies. Preferred insertion site is the internal jugular vein; subclavian or femoral veins are alternative sites.

Regulatory Classification

Identification

An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY | | 1998

Ms. Jeanne M. Cush ·Technical Submissions Coordinator Medical Components®, Incorporated 1499 Delp Drive 19438 Harleysville, Pennsylvania

Re : K973561 Medcomp Tri-Flow™ Triple Lumen Catheter Trade Name: 11.5F × 12cm II Requlatory Class : Product Code: FOZ February 6, 1998 Dated: Received: February 17, 1998

Dear Ms. Cush:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Ms. Cush

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asboing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timotik 1 A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(K) Number (if known): K973561

Device Name: Medcomp Tri-Flow™ Soft Tip Triple Lumen Catheters

Indications for Use:

The Medcomp Tri-Flow™ Triple Lumen Catheter is designed for acute central vein catheterization, TPN, fluid administration, drug infusion, and continuous therapies. It may be inserted percutaneously and is ideally placed in the internal jugular vein. Although this catheter may be inserted into the subclavian or femoral vein, the internal jugular is the preferred site.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucenite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter

(Optional Format 1-2-96)

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