The Proxis System 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 System has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter, and an Evacuation syringe.

The Evacuation Sheath Catheter has two low-pressure compliant sealing 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 sufficiently large inner diameter to accommodate standard therapeutic devices within its size range. The balloons are inflated using the Inflation Svstem.

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

Alternatively, while the vessel is occluded, 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.

The Evacuation syringe is provided for the removal of the fluid and the emboli/thrombi during aspiration. The infusion catheter may be used to infuse saline to augment the retrograde flow of fluid and the removal the emboli/thrombi.

AI/ML Overview

This document describes a 510(k) premarket notification for the Velocimed Proxis System, a percutaneous catheter. The submission primarily focuses on demonstrating substantial equivalence to a predicate device and does not contain a study demonstrating device performance against specific acceptance criteria for diagnostic or clinical effectiveness. Instead, it describes compliance with various performance requirements and standards for medical devices.

Here's an analysis of the provided text in relation to your request:

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

The document does not present specific acceptance criteria in a quantitative table format for clinical performance or diagnostic accuracy. Instead, it lists broader performance requirements and compliance with international standards for medical devices.

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance
Product Specification	Meets performance requirements of the product specification.	"The Proxis System has been shown to meet the performance requirements of the product specification."
International Standards	ISO 10555 (Sterile, single-use intravascular catheter Part 1 & 4)	Complies
	ISO 10993 (Biological evaluation of medical devices)	Complies
	ASTM D-4169 (Packaging Integrity Testing)	Complies
	ISO 11607 (Packaging for terminally sterilized medical devices)	Complies
	ISO 11135: 1994(E) (Validation and routine control of ETO sterilization)	Complies
Physical/Mechanical Tests	Dimensional verification	Test results demonstrate device meets or exceeds requirements.
	Balloon compliance and integrity	Test results demonstrate device meets or exceeds requirements.
	Catheter tensile strength	Test results demonstrate device meets or exceeds requirements.
	Torque strength	Test results demonstrate device meets or exceeds requirements.
	Flexibility and trackability	Test results demonstrate device meets or exceeds requirements.
Substantial Equivalence	To the predicate device without hydrophilic coating (K023548), except for the addition of hydrophilic coating.	"The Proxis System with hydrophilic coating, ...is substantially equivalent to the Proxis System without hydrophilic coating (predicate device)..."
Intended Use	The addition of hydrophilic coating does not alter the intended use.	"The addition of the hydrophilic coating does not alter the intended use the Proxis System."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes performance testing of the device, primarily focusing on physical and mechanical properties, and biological safety. It does not describe a clinical study with a "test set" in the context of diagnostic accuracy or clinical effectiveness on patients. Therefore, information on sample size, data provenance, and study design for such a "test set" (e.g., patient data) is not applicable or provided in this submission for this type of device. The testing described would typically involve laboratory-based testing of device units.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document does not describe a study involving expert-established ground truth on patient data for diagnostic or clinical performance. The "ground truth" for the performance tests described (dimensional, tensile, etc.) would be established by engineering specifications and objective measurements against those specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as there is no mention of a "test set" requiring expert adjudication for clinical or diagnostic outcomes.

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 applicable. The Proxis System is a medical device (a catheter) for controlling fluid flow and temporary occlusion, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

This information is not applicable. The Proxis System is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Given the nature of the device and the performance data described, the "ground truth" would be based on:

Engineering specifications and objective physical measurements for dimensional verification, balloon compliance, tensile strength, torque, flexibility, and trackability.
Established biological testing protocols for ISO 10993 (biological evaluation).
Standardized testing procedures for packaging integrity and sterilization validation.

8. The sample size for the training set

This information is not applicable. The Proxis System is a physical medical device, not an AI model, and therefore does not have a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for Velocimed. The logo consists of a stylized image of a circle with three curved lines inside it, and a small dot below the circle. Below the image is the word "Velocimed" in a sans-serif font, with the trademark symbol to the right of the word.

11400 73rd Ave North, Suite 134 Minneapolis, MN 55369

K0421.17

763-463-4742 · Phone 763-488-9780 • Fax

510(K) SUMMARY SECTION 3.

3.1 ADMINISTRATIVE INFORMATION

Name and address 3.1.1

Submitted by:	Velocimed Inc11400 73rd Avenue North, Suite 134Minneapolis, MN 55369
---------------	------------------------------------------------------------------------------

Contact Person:	John Carline
Telephone No.:	763-463-4742
Facsimile No.:	763-488-9780

Jan 4, 2005 Date Prepared:

3.1.2 Device Name

Trade Name	Proxis System
Common Name	Percutaneous Catheter
Classification Name	Catheter, Percutaneous
Classification	Class II, DQY

3.2 SUBSTANTIAL EQUIVALENCE

The Proxis System with hydrophilic coating, the subject of this submission, is substantially equivalent to the Proxis System without hydrophilic coating (predicate device) which had been found to be substantially equivalent through the 510(k) notification process (K023548).

The Proxis System with hydrophilic coating is the same as the predicate device except for the addition of the hydrophilic coating.

The addition of the hydrophilic coating does not alter the intended use the Proxis System.

3.3 INDICATION FOR USE

{1}------------------------------------------------

3.4 DEVICE DESCRIPTION

The Proxis System has four major components: The Evacuation Sheath Catheter, the Inflation System, Infusion Catheter, and an Evacuation syringe.

3.5 Performance Data

The Proxis System has been shown to meet the performance requirements of the product specification. Additionally, the Proxis System complies with the applicable section of the following product standards:

ISO 10555 (Sterile, single-use intravascular catheter Part 1: General requirements . and Part 4: balloon dilation catheter)
ISO 10993 (Biological evaluation of medical devices) .
ASTM D-4169 (Packaging Integrity Testing) .
ISO 11607 (Packaging for terminally sterilized medical devices) .
ISO 11135: 1994(E) (Validation and routine control of ETO sterilization) .

Performance testing included dimensional verification, balloon compliance and integrity, catheter tensile strength, torque strength, flexibility and trackability. Test results demonstrate that the device meets or exceeds the requirements of these standards and performs substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN - 7 2005

Velocimed Inc. c/o Mr. John Carline Senior RA Specialist 11400 73td Avenue North, Suite 134 Minneapolis, MN 55369

K042117 Proxis System Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: December 21, 2004 Received: December 28, 2004

Dear Mr. Carline:

Re:

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. Ilsting 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.

{3}------------------------------------------------

Page 2 – Mr. John Carline

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualles of a succession complies with other requirements of the Act
that FDA has made a determination that your device complies with other mast that FDA has made a decionmation an administered by other Federal agencies. You must of any Federal statures and regulations daminitives but not limited to: registration and listing (21 comply with the Act 3 requirements, mercesses canafacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); good if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Decizens over device as described in your Section 510(k) I his letter will anow you to oegin maneting your antial equivalence of your device to a legally premarket notification. The PDA midning of basification 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 If you desire specific acrive for your acon 2011-01-20120. Also, please note the regulation entitled, Contact the Office of Obilipinance an (21 transmit (21CFR Part 807.97). You may obtain Misolaliung by reference to premainterial international the Act from the Division of Small other general 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,

Donna R. Lochner

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

Enclosure

{4}------------------------------------------------

Attachment A. Indications for use

510(k) Number: ¥042117

Device Name: Proxis System

Indication for Use:

Prescription Use: X (Part 21 CFR 801 Subpart D)

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)

Duna R. Willing

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_k642117

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).