PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS

K981382 · Catheter Innovations, Inc. · FOZ · May 1, 1998 · General Hospital

Device Facts

• Record ID: K981382
• Device Name: PASV DUAL LUMEN PERIPHERALLY INSERTED MIDLINE CATHETER MODEL NUMBER MIDLINE-NUMEROUS
• Applicant: Catheter Innovations, Inc.
• Product Code: FOZ · General Hospital
• Decision Date: May 1, 1998
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5200
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal. This product is effective for venous access in adults, children and infants who require intravenous therapy. Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following: - Hypertonic nutrition solutions with final glucose concentrations . greater than 10% - Continuously infused Vesicant Drugs . - Any medication contraindicated for infusion into the peripheral . system

Device Story

PASV™ Dual Lumen Peripherally Inserted Midline Catheter provides peripheral venous access for fluid infusion and blood withdrawal. Device inserted into peripheral venous system by healthcare professionals. Functions as conduit for intravenous therapy. Benefits include reliable venous access for patients requiring hydration, antibiotics, analgesics, or blood products. Not intended for hypertonic nutrition or vesicant drugs.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Dual lumen peripherally inserted midline catheter. Materials and construction consistent with predicate midline catheter technology. Designed for peripheral venous placement.

Indications for Use

Indicated for peripheral venous access in adults, children, and infants requiring intravenous therapy for fluid administration (hydration, antibiotics, analgesics, blood products) and blood specimen withdrawal. Contraindicated for hypertonic nutrition solutions (>10% glucose), continuously infused vesicant drugs, and medications contraindicated for peripheral infusion.

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.

Predicate Devices

• Single Lumen Midline Catheters (K963215)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

1 1658 MAY

Mr. Roger L. Richins Catheter Innovations Incorporated 3598 West 1820 South Salt Lake, Utah 84104-4959

Re : K981382 .. . PASV™ Dual Lumen Peripherally Inserted Trade Name: Midline Catheter Requlatory Class: II FOZ Product Code: Dated: April 8, 1998 Received: April 16, 1998

Dear Mr. Richins:

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 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 (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. A 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 requlatory 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 - Mr. Richins

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 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 requlation (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 (800) 638-20#1 or [phone] or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".

Sincerely yours

J. Cilliers

Timot 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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Page 1 of 1

510(k) Number (if known):

Device Name: PASV™ Dual Lumen Peripherally Inserted Midline Catheter

## Indications for Use:

Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheter is designed to establish peripheral access to the venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, analgesics, and blood products. It is also indicated for blood specimen withdrawal.

This product is effective for venous access in adults, children and infants who require intravenous therapy.

Warning: The PASV™ Dual Lumen Peripherally Inserted Midline Catheter is NOT indicated for infusion of the following:

- Hypertonic nutrition solutions with final glucose concentrations . greater than 10%
- Continuously infused Vesicant Drugs .
- Any medication contraindicated for infusion into the peripheral . system

Catheter Innovations, Inc. PASV™ Dual Lumen Peripherally Inserted Midline Catheters have the same intended use as our Single Lumen Midline Catheters (K963215).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Palaich
Division of Dar, lafection Control,
and General Fiospital Devices

510(k) Number ________________________________________________________________________________________________________________________________________________________________

Perscription Use

OR

Over-The-Counter Use

(Optional Format 1-2-96)