The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and holding the column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.

Device Description

The Proxis Flow-Control device is a dual balloon catheter. It has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter System, and an Evacuation syringe.

The Evacuation Sheath also has two low-pressure compliant balloons that are inflated simultaneously. The proximal balloon stays within the guide catheter while the distal balloon resides in the arterial vessel. Radiopaque markers at the two balloon sites facilitate visualization and intravascular placement of the catheter prior to inflation. The Evacuation Sheath has an inner diameter of 0.058 inches and can accommodate standard therapeutic devices that have profiles of 0.058 inches or lower. The balloons are inflated using the Inflation System.

Devices can be deployed through the Evacuation sheath to the target site before, during or after the Proxis balloons are inflated, and the vessel occluded. Infusing less than 0.5cc of contrast dye through the guide catheter will produce a "roadmap" of the lesion as an aid for the physician in guiding the therapeutic device to the lesion site.

Alternatively, less than 0.5cc of therapeutic solutions like anticoagulant, cardioplegia and thrombolytics may be infused through the guide catheter and stagnated in the target vessel/lesion during the delivery of the therapeutic device or after the deployment of the therapeutic device while the vessel is occluded.

The Evacuation syringe is provided in the event that removal of contrast, or therapeutic solution is desired. If distal perfusion of fluid is needed during evacuation, the Infusion Catheter System may be used.

AI/ML Overview

Here's an analysis of the provided text regarding the Proxis Flow-Control Device, focusing on acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicitly based on standards)	Reported Device Performance (Summary)
Material & Physical Properties	ISO 10555 (Part 1 and Part 4) - Catheters, Sterile, Single-use	Device complies with applicable sections of ISO 10555. Performance testing included dimensional verification, balloon compliance and integrity, catheter tensile strength, torque strength, flexibility, and trackability.
Biocompatibility	ISO 10993-1 - Biological evaluation of medical devices	Device complies with applicable sections of ISO 10993-1.
Functional Performance	Product specification (internal)	Device meets or exceeds the requirements of these standards. Performance testing included dimensional verification, balloon compliance and integrity, catheter tensile strength, torque strength, flexibility, and trackability.
Packaging & Sterilization	ASTM D-4169 (Packaging Integrity Testing)	Device complies with applicable sections of ASTM D-4169.
	ISO 11607 (Packaging for terminally sterilized medical devices)	Device complies with applicable sections of ISO 11607.
	ISO 11135:1994(E) (Validation and routine control of ETO sterilization)	Device complies with applicable sections of ISO 11135:1994(E).
Pre-clinical Safety & Performance	Substantial equivalence to predicate devices (safety and efficacy)	Nine acute and eight chronic animals were used to test and validate the performance and safety of the device. Test results demonstrate that the device performs substantially equivalent to the predicate devices.

Important Note: The document provides very high-level summaries of performance. Specific numerical acceptance criteria (e.g., "tensile strength greater than X N") and their corresponding measured values are not detailed in this 510(k) summary. The statement "device meets or exceeds the requirements of these standards" implies that the specific criteria outlined within each standard were successfully met.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size:
- Animal Studies: Nine acute animals and eight chronic animals. This constitutes the primary "test set" for in-vivo performance and safety.
- Bench Testing: The sample sizes for dimensional verification, balloon compliance, tensile strength, torque strength, flexibility, and trackability are not specified in this summary. It simply states "performance testing included..."
Data Provenance: The document does not explicitly state the country of origin for the animal studies. It is likely that these studies were conducted in the country where Velocimed Inc. is based (Minneapolis, MN, USA) or in a country with established regulatory frameworks for medical device animal testing. The animal studies are prospective in nature, as they were conducted to validate the device's performance and safety before market clearance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable or not provided for this 510(k) summary. For a device like the Proxis Flow-Control Device, the "ground truth" during performance and safety testing is established through objective measurements (e.g., physical dimensions, strength tests, biocompatibility assays) and observation of physiological responses in animal models by veterinarians and researchers, rather than expert consensus on interpretive data (like radiology images).

4. Adjudication Method (for the test set)

This information is not applicable or not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical trials or studies where there is subjective interpretation of data that needs consensus or tie-breaking by experts. For the type of performance and animal testing described here, the results are generally objective and measured, or observed directly by the testing personnel.

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

There is no MRMC comparative effectiveness study mentioned in this document. This device is a physical medical device, not an AI or imaging diagnostic tool that would typically involve human readers and their performance with or without AI assistance.

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

This information is not applicable or not provided. This device is a physical catheter, not an algorithm. Standalone performance typically refers to the performance of an AI algorithm on its own, without human interaction.

7. The Type of Ground Truth Used

Bench Testing: Objective physical measurements, adherence to engineering specifications, and compliance with international standards (ISO, ASTM).
Animal Studies: Direct observation of physiological effects, safety assessments (e.g., lack of adverse tissue reactions, proper functioning within the vasculature), and performance characteristics (e.g., successful occlusion, delivery capability). The "ground truth" here is the biological and mechanical reality observed in the animal model.

8. The Sample Size for the Training Set

There is no "training set" mentioned or implied. This device is a physical medical device. The concept of a "training set" is primarily relevant to machine learning or AI algorithms, where data is used to train a model. For medical devices like this catheter, internal product specifications and engineering designs guide its development, and then independent testing (bench and animal) is conducted for validation.

9. How the Ground Truth for the Training Set was Established

As there is no "training set" for this physical device, this question is not applicable.

Summary

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AUG - 4 2003

KO23548 2. 510(K) SUMMARY

2.1 Administrative Information

2.1.1 Name and address

Submitted by:	Velocimed Inc11400 73rd Avenue North, Suite 134Minneapolis, MN 55369
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Contact Person:	John Carline
Telephone No.:	763-463-4742
Facsimile No.:	763-488-9780

October 21, 2002 Date Prepared:

2.1.2 Device Name

Trade Name	Proxis Flow-Control Device
Common Name	Occlusion Balloon Catheter,Infusion Catheter
Classification Name	Catheter, IntravascularOccluding, TemporaryIntravascular Diagnostic
Classification	Class IIMJN, DQY

2.1.3 Applicant

Applicant's Name: Velocimed Inc 11400 73rd Avenue North, Suite 134 Minneapolis, MN 55369

2.2 Predicate Devices

The Proxis Flow-Control Device is substantially equivalent to the Equinox Occlusion Balloon Catheter (K 990487), 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K932616), and the Isolate Infusion Catheter (K913517).

2.3 Indication for use

The Proxis Flow-Control device controls the flow of fluids in the coronary and periphery vasculature. This is achieved by the temporary occlusion of vessels and

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holding the column of fluid in the vessel stagnant. The stagnant column can be used to aid in the visualization of the lesion or be used as a means of local and temporary delivery of therapeutic solution(s). The safety and efficacy of this device as an embolic protection system has not been established. The Proxis Flow Control device is not indicated for use for embolic protection.

2.4 Device Description

The Proxis Flow-Control device is a dual balloon catheter. It has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter System, and an Evacuation syringe.

2.5 Substantial Equivalence

The Proxis Flow-Control device covered by this submission is substantially equivalent to other legally marketed Occlusion Balloon Catheters. Specifically, the Proxis Flow-Control device is substantially equivalent to the Parodi Catheter for Angiography (K 001917), the Equinox Occlusion Balloon Catheter (K 990487), the 4.5F ImageCath Coronary Angioscope (K952638), Dispatch Coronary Infusion Catheter (K932616) and the Isolate Infusion Catheter (K913517). The Proxis has the same general indication for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate devices. The differences between this device and its predicate devices do not raise new questions of safety or efficacy.

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2.6 Performance Data

The performance test data is provided in the 510(k) submission. The performance data demonstrates that the device complies with the applicable sections of:

o ISO 10555 (Part 1 and Part 4),
o ISO 10993-1,
o Product specification
O ASTM D-4169 (Packaging Integrity Testing)
ISO 11607 (Packaging for terminally sterilized medical devices) o
ISO 11135: 1994(E) (Validation and routine control of ETO o sterilization)

Performance testing included dimensional verification, balloon compliance and integrity, catheter tensile strength, torque strength, flexibility and trackability. Nine acute and eight chronic animals were used to test and validate the performance and safety of the device. Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three overlapping wings, suggesting movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

AUG - 4 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Velocimed, Inc. c/o John Carline Sr. RA Associate 11400 73td Avenue North Suite 134 Maple Grove, MN 55369

Re: K023548

Trade/Device Name: Proxis Flow-Control Device Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: May 13, 2003 Received: May 14, 2003

Dear Mr. Carline:

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.

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

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Page 2 - Mr. John Carline

forth in the quality systems (OS) 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) 594-4586. 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/dsmaldsmamain.html

Sincerely yours,

V.A. DeLeon, M.D.

Zuckerman, M.D. Bram D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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14. INDICATION FOR USE

K023548 510(k) Number;

Device Name: Proxis™ Flow-Control

Indication for Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number	K023548
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Prescription Use
(Per 21 CFR 801.109)

OR Over-The Counter Use _______

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).