FLOCONTROL , MODEL 1028

K090970 · Coaxia, Inc. · MJN · Jun 12, 2009 · Cardiovascular

Device Facts

• Record ID: K090970
• Device Name: FLOCONTROL , MODEL 1028
• Applicant: Coaxia, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Jun 12, 2009
• 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 which includes the descending aorta.

Device Story

7F multi-lumen catheter; two distal balloons (2 cm length, 8 cm apart); hydrophilic coating; multi-port proximal manifold for balloon inflation, guide wire insertion, and pressure monitoring. Inserted over .035" guide wire via 7F introducer sheath. Used in peripheral vasculature/descending aorta to divert cardiac output to upper torso and core organs (cardiac, spinal, cerebral). Physician-operated; provides temporary flow control. Benefits include redirected blood flow to vital organs during procedures. No clinical data; bench testing only.

Clinical Evidence

No clinical data. Bench testing only, including tensile strength, balloon characterization, dimensional verification, accessory compatibility, trackability, coating integrity, pressure monitoring, shelf life, and biocompatibility per ISO/EN standards and FDA guidance.

Technological Characteristics

7F multi-lumen catheter; 62 cm working length; two 2 cm balloons; hydrophilic coating; 3 marker bands; EtO sterilized; single-use. Mechanical occlusion principle via independent balloon inflation.

Indications for Use

Indicated for selective occlusion or control of blood flow in the peripheral vasculature, including the descending aorta.

Regulatory Classification

Identification

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

Predicate Devices

• CoAxia FloControlTM Catheter (K023914)

Submission Summary (Full Text)

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CoAxia FloControl Catheter K09xxxxx

K090970 page ( ot 2 CONFIDENTIAL SPECIAL 510(k)

JUN 1 2 2009

# 510(k) Summary

### Sponsor

Name & Address:

CoAxia, Inc. 10900 73rd Avenue N. Suite 102 Maple Grove, MN 55369 Office: 763-315-8383 Cell: 612-309-4836 FAX: [phone]

Contact:

Sharon Kvistad Vice President - Regulatory Affairs

Date Prepared:

April 3, 2009

# Name and Classification

| Trade Name: | CoAxia FloControlTM Catheter |
|----------------------|----------------------------------------|
| Common Name: | Peripheral Vascular Occlusion Balloon |
| Predicate Device(s): | CoAxia FloControlTM Catheter (K023914) |

Classification Name: Device Classification: Product Code:

Catheter, Intravascular Occluding, Temporary Class II MIN

#### Intended Use:

The CoAxia FloControl Catheter is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature which includes the descending aorta.

#### Device Description

The CoAxia FloControl™ Catheter is a 7F multi-lumen device with two balloons mounted near the distal tip. The catheter is inserted over a .035" guide wire through a 7F vascular introducer sheath. The device has a working length of 62 cm and is coated with a hydrophilic 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 8 cm. Each balloon can be inflated independently to a variable diameter to control blood flow in the selected vessel. When used in the descending aorta, balloon inflation results in diversion of cardiac output to the upper torso and core organs, e.g., cardiac, spinal and cerebral vasculature. The device has 3 marker bands to aid in balloon placement. The catheter is EtO sterilized and is intended for single use only.

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CoAxia FloControl Catheter K09xxxxx

K090970 page 2 of 2

CONFIDENTIAL

SPECIAL 510(k)

# Summary of Studies

The CoAxia FloControl™ Catheter was tested in accordance with relevant ISO and EN standards 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.

#### Equivalence Statement:

The testing performed demonstrates the CoAxia FloControl Catheter is substantially equivalent to the predicate device in terms of the intended use, design, materials, and performance attributes, and raises no new issues of safety or effectiveness.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circular pattern around the eagle. The eagle is depicted in black and white, and the text is also in black.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2009

CoAxia, Inc. c/o Ms. Sharon D. Kvistad VP Regulatory Affairs 10900 73td Avenue North, Suite 102 Maple Grove, MN 55369

Re: K090970

Trade/Device Name: FloControl Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II (two) Product Code: MJN Dated: April 3, 2009 Received: April 6, 2009

#### Dear Ms. Kvistad:

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. Iisting 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 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. Sharon D. Kvistad

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 yours.

R. Vochner

Image /page/3/Picture/6 description: The image contains a close-up of a handwritten symbol or character. It features a small, closed loop at the bottom, resembling the number '6' or a lowercase 'q'. A curved line extends upwards and to the right from the loop, creating a flowing, calligraphic appearance. The symbol is drawn with a dark, bold line, suggesting it was created with a pen or marker.

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 FloControl Catheter K09xxxxx

## CONFIDENTIAL SPECIAL 510(k)

# Indications for Use

# 510(k) Number (if known): KO 90970

Device Name: CoAxia FloControl™ Catheter

The CoAxia FloControl™ Catheter is intended for Indications For Use: use in selectively stopping or controlling flow in the peripheral vasculature, which includes the descending aorta.

Prescription Use X (Part 21 CFR 801 Subpa

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

buna R. James

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(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K090970

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