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.

AI/ML Overview

The CoAxia FloControl Catheter (K090970) is intended for use in selectively stopping or controlling blood flow in the peripheral vasculature, including the descending aorta. The provided text indicates that no clinical testing of the FloControl catheter was performed to establish its performance against specific acceptance criteria. Instead, substantial equivalence to a predicate device (CoAxia FloControl™ Catheter (K023914)) was demonstrated through non-clinical studies.

Therefore, I cannot provide a table of acceptance criteria and reported device performance for clinical use, nor can I describe a study proving the device meets clinical acceptance criteria based on this document. The document explicitly states: "Clinical testing of the FloControl catheter was not performed."

However, I can describe the non-clinical studies performed and how performance was deemed acceptable as per the provided text.

Here's a breakdown of the information that can be extracted from the provided text, addressing your points where possible, and indicating where information is not available:

1. A table of acceptance criteria and the reported device performance

Based on the provided text, a table of clinical acceptance criteria and reported performance cannot be generated, as no clinical testing was performed. However, the document states that the device was tested against relevant ISO and EN standards and FDA guidance for intravascular catheters. These non-clinical tests serve as the basis for "acceptable performance."

Acceptance Criteria Category (Non-Clinical)	Reported Device Performance
Tensile Strength	Demonstrated acceptable performance in accordance with device specifications.
Balloon Characterization	Demonstrated acceptable performance in accordance with device specifications.
Dimensional Verification	Demonstrated acceptable performance in accordance with device specifications.
Accessory Compatibility	Demonstrated acceptable performance in accordance with device specifications.
Trackability	Demonstrated acceptable performance in accordance with device specifications.
Coating Integrity	Demonstrated acceptable performance in accordance with device specifications.
Pressure Monitoring Capability	Demonstrated acceptable performance in accordance with device specifications.
Shelf Life	Demonstrated acceptable performance in accordance with device specifications.
Biocompatibility	Demonstrated acceptable performance in accordance with device specifications.

2. Sample size used for the test set and the data provenance

The document does not provide details on the sample sizes used for the non-clinical tests (tensile strength, balloon characterization, etc.). It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). These details are typically found in more comprehensive study reports, which are not included in this 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable as no clinical studies were performed. The "ground truth" for the non-clinical tests would be the established engineering and materials science standards and specifications.

4. Adjudication method for the test set

This question is not applicable as no clinical studies were performed.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, a multi-reader multi-case comparative effectiveness study was not performed, as no clinical studies were undertaken.

6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done

This question is not applicable as the device is a physical catheter, not an algorithm.

7. The type of ground truth used

For the non-clinical studies, the "ground truth" was established by device specifications, relevant ISO and EN standards, and FDA's Guidance for Use of Short-term and Long-term Use Intravascular Catheters. These standards and specifications define what constitutes acceptable performance for each tested attribute (e.g., tensile strength, balloon inflation characteristics, biocompatibility).

8. The sample size for the training set

This question is not applicable as no clinical studies were performed, and the device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This question is not applicable as no clinical studies were performed, and the device is not an AI/ML algorithm that requires a training set.

Summary

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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: 763-315-3660

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

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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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

Page 1 of __

(Division Sign-Off) (Division of Cardiovascular Devices

510(k) Number K090970

. .

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).