The VariCath Peripheral Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

Device Description

The VeinRx VariCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a variable infusion length catheter body with infusion holes, and a proximal trifurcated Luer connection hub. The trifurcated hub allows connection to three main systems of the device. The VariCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.

AI/ML Overview

This document is a 510(k) summary for the VariCath Peripheral Infusion Catheter. 510(k) summaries are primarily focused on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results or performance metrics in the same way a PMA (Premarket Approval) would.

Based on the provided text, here's an analysis against your requested information:

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

This information is not provided in the document. The submission is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device (InfusionCath Peripheral Infusion Catheter). It does not typically require the establishment of new acceptance criteria for clinical performance or present a detailed study comparing numerical performance metrics against such criteria.

The document states:

"The VariCath Peripheral Infusion Catheter was tested in the same manner as the InfusionCath Peripheral Infusion Catheter."
"All components, subassemblies, and/or full devices met the required specifications for the completed tests."

This indicates that internal performance testing was conducted and met specifications, but the specifics of those specifications (acceptance criteria) and the numerical results (reported device performance) are not included in this public summary.

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

This information is not provided in the document. The submission references "testing" but does not detail a clinical test set, its sample size, or its provenance. This level of detail is usually found in a full 510(k) submission, not the summary.

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/not provided. The device is an infusion catheter, not an AI diagnostic tool that requires ground truth established by experts for a test set.

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

This information is not applicable/not provided for the same reasons as point 3.

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/not provided. The device is a medical catheter and does not involve AI or human readers for diagnostic interpretation.

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

This information is not applicable/not provided. The device is a medical catheter and does not involve an algorithm with standalone performance.

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

This information is not applicable/not provided. The device is a medical catheter and does not involve diagnostic ground truth.

8. The sample size for the training set

This information is not applicable/not provided. The device is a medical catheter and does not involve an AI training set.

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

This information is not applicable/not provided. The device is a medical catheter and does not involve an AI training set or its associated ground truth.

In summary:

This 510(k) summary indicates that the VariCath Peripheral Infusion Catheter was found substantially equivalent to its predicate, the InfusionCath Peripheral Infusion Catheter. The basis for this equivalence is stated to be similar indications for use, function, manufacturing methods, and materials. The testing referenced is primarily for device specifications (mechanical, material, etc.), not a clinical performance study with human subjects, expert adjudication, or AI performance metrics. Therefore, most of the detailed questions regarding acceptance criteria, study design, and ground truth for AI-related device evaluation are not relevant or answered in this type of submission.

Summary

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510(k) Summary

General InformationClassification	Class II
Trade Name	VariCath™ Peripheral Infusion Catheter
Submitter	VeinRx Inc8200 N.W. 27th StreetSuite 102Miami, FL 33122305-716-7005
Contact	Aaron Perlmutter, MDVice President -- Medical & Scientific Affairs

Intended Use

The VariCath Peripheral Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

Predicate Devices

InfusionCath Peripheral Infusion Catheter Manufactured by VeinRx, Inc.

K041517 & K052738

Device Description

Materials

All materials used in the manufacture of the VariCath Peripheral Infusion Catheter are suitable for this use and have been used in numerous previously cleared products.

Testing Summary

TheVariCath Peripheral Infusion Catheter was tested in the same manner as the InfusionCath Peripheral Infusion Catheter. All components, subassemblies, and/or full devices met the required specifications for the completed tests.

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Summary of Substantial Equivalence

The VariCath Peripheral Infusion Catheter is equivalent to the predicate product, the InfusionCath Peripheral Infusion Catheter. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. VeinRx, Inc. believes the VariCath Peripheral Infusion Catheter is substantially equivalent to existing legally marketed devices

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus-like symbol with three abstract human figures intertwined. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

DEC 2 0 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

VeinRx Inc. c/o Mr. Gregory J. Mathison Regulatory Affairs 8210 NW 27th Street Miami, FL 33122

Re: K073400

Trade/Device Name: VariCath Peripheral Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: November 26, 2007 Received: December 4, 2007

Dear Mr. Mathison:

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 J. Mathison

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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):	This application K073400
Device Name:	VariCath Peripheral Infusion Catheter
Indications for Use:	The VariCath Peripheral Infusion Catheter is intendedfor infusion of physician specified fluids, includingthrombolytics, into the peripheral vasculature.

Prescription Use _X

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Division Stop-Off

Division of Cardiovascular Devices
510(k) Number	KO 73400

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).