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.

AI/ML Overview

The sponsor, CoAxia, Inc., submitted a 510(k) premarket notification for the CoAxia FloControl™ Catheter.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that 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. The testing covered specific performance aspects, and the results are reported to have met the device's specifications.

Acceptance Criteria Category	Reported Device Performance
Mechanical Properties
Tensile Strength	Acceptable performance
Balloon Characterization	Acceptable performance
Physical Characteristics
Dimensional Verification	Acceptable performance
Coating Integrity	Acceptable performance
Functional Performance
Accessory Compatibility	Acceptable performance
Trackability	Acceptable performance
Pressure Monitoring Capability	Acceptable performance
Other
Shelf Life	Acceptable performance
Biocompatibility	Acceptable performance

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

The document does not specify the exact sample sizes used for each individual test (tensile strength, balloon characterization, etc.). It only broadly states "Testing included..." without providing numerical details for the test sets.

The data provenance is from retrospective testing performed by CoAxia, Inc. in accordance with various standards and guidance documents. The country of origin of the data is implicitly the United States as CoAxia, Inc. is located in Maple Grove, MN, and the submission is to the FDA.

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

This information is not provided in the document. The document describes laboratory and engineering tests, not evaluations by human experts for establishing ground truth as one might see in a clinical study for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not applicable and therefore, not provided. The testing described is primarily laboratory-based engineering and performance testing against predefined specifications, not requiring an adjudication method involving human expert reviewers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not provided and is not applicable. The device described is a physical catheter for controlling blood flow, not an AI-powered diagnostic or assistive tool for human readers. The document explicitly states: "Clinical testing of the FloControl catheter was not performed."

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

This information is not provided and is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used:

The ground truth for the performance testing described (tensile strength, balloon characterization, dimensional verification, etc.) was based on device specifications, engineering standards (ISO, EN), and FDA guidance for intravascular catheters. These standards and specifications define the acceptable limits and performance characteristics for each test.

8. The sample size for the training set:

This information is not provided and is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

This information is not provided and is not applicable as there is no training set for this type of device.

Summary

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FEB 2 1 2003

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510(k) Summary

Sponsor

Name & Address:	CoAxia, Inc.10900 73rd Avenue N. Suite 102Maple Grove, MN 55369Telephone: 763-315-8383FAX: 763-315-3660
Contact person:	Gregory W. SachsVice 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)Heartport® Endoaortic Clamp™ Catheter (K974175)MedComp® DUO-COAT Catheter Double Lumen (K991320)SetPoint® Endovascular Temperature Management System (K012512)

Device Description

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 (301) 594-4646. 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 (800) 638-2041 or (301) 443-6597 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

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).