COAXIA FLOCONTROL CATHETER

K023914 · Coaxia, Inc. · MJN · Feb 21, 2003 · Cardiovascular

Device Facts

• Record ID: K023914
• Device Name: COAXIA FLOCONTROL CATHETER
• Applicant: Coaxia, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Feb 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.

Device Story

The CoAxia FloControl™ Catheter is a 9F multi-lumen catheter featuring two distal balloons. It is inserted over a .035" guide wire via a 9F introducer sheath. The device allows independent inflation of each 2 cm balloon to diameters between 10mm and 20mm to modulate peripheral blood flow. A proximal multi-port manifold facilitates balloon inflation, guide wire insertion, and pressure monitoring. Used in clinical settings, the device is operated by medical professionals. It provides clinicians with the ability to control local hemodynamics, potentially benefiting patients requiring temporary flow occlusion. The device is single-use and EtO sterilized.

Clinical Evidence

Bench testing only. Testing performed in accordance with ISO, EN, and FDA guidance for intravascular catheters included tensile strength, balloon characterization, dimensional verification, accessory compatibility, trackability, coating integrity, pressure monitoring capability, shelf life, and biocompatibility. All results met device specifications. No clinical data was performed.

Technological Characteristics

9F multi-lumen catheter; two 2 cm balloons (10-20 mm diameter); hydrophilic heparin coating; 62 cm working length; 3 marker bands; EtO sterilized; single-use. Mechanical operation via proximal manifold for inflation and pressure monitoring.

Indications for Use

Indicated for selective stopping or controlling of blood flow in the peripheral vasculature.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• Equinox™ Occlusion Balloon System (K990487)
• Heartport® Endoaortic Clamp™ Catheter (K974175)
• MedComp® DUO-COAT Catheter Double Lumen (K991320)
• SetPoint® Endovascular Temperature Management System (K012512)

Submission Summary (Full Text)

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FEB 2 1 2003

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# 510(k) Summary

# Sponsor

| Name & Address: | CoAxia, Inc.<br>10900 73rd Avenue N. Suite 102<br>Maple Grove, MN 55369<br>Telephone: [phone]<br>FAX: [phone] |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Gregory W. Sachs<br>Vice President - Clinical, Regulatory and Quality Assurance |
| Date Prepared: | November 21, 2002 |

# Name and Classification

| Trade Name: | CoAxia FloControl™ Catheter |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Peripheral Vascular Occlusion Balloon |
| Predicate Device(s): | Equinox™ Occlusion Balloon System (K990487)<br>Heartport® Endoaortic Clamp™ Catheter (K974175)<br>MedComp® DUO-COAT Catheter Double Lumen (K991320)<br>SetPoint® Endovascular Temperature Management System (K012512) |

### Device Description

The CoAxia FloControl™ Catheter is a 9F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 9F introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic, heparin coating. A multi-port manifold at the proximal end of the device allows balloon inflation, guide wire insertion and attachment of a pressure monitoring line. Each balloon is 2 cm (20 mm) in length, separated by a distance of 8cm. Each balloon can be inflated independently to a diameter from 10mm to 20mm to control blood flow in the selected vessel. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.

#### Intended Use

The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature.

#### Summary of Studies

The CoAxia FloControl™ Catheter was tested in accordance with ISO, EN and FDA's Guidance for Use of Short-term and Long-term Use Intravascular Catheters. Testing included tensile strength, balloon characterization, dimensional verification, accessory compatibility, trackability, coating integrity, pressure monitoring capability, shelf life and biocompatibility. All testing demonstrated acceptable performance in accordance with the device specifications. Clinical testing of the FloControl catheter was not performed.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 1 2003

CoAxia, Inc. c/o Mr. Gregory W. Sachs Vice President - Clinical, Regulatory and Quality Assurance 10900 73rd Avenue N., Suite 102 Maple Grove, MN 55369

Re: K023914 Trade Name: CoAxia FloControl™ Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Catheter, Intravascular Occluding, Temporary Regulatory Class: Class II (two) Product Code: MJN Dated: November 22, 2002 Received: November 25, 2002

Dear Mr. Sachs:

· 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. Gregory W. Sachs

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,

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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CoAxia, Inc.

KØ23914

Confidential

# Indications for Use

| 510(k) Number: | To be assigned |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | CoAxia FloControl™ Catheter |
| Indications for Use: | The CoAxia FloControl™ Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
OR
Over-The-Counter Use

(Per 21 CFR 801.109)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number K23914

# ORIC

November 22, 2002