INFUSIONCATH

K041517 · Id, LLC · QEY · Aug 5, 2004 · Cardiovascular

Device Facts

• Record ID: K041517
• Device Name: INFUSIONCATH
• Applicant: Id, LLC
• Product Code: QEY · Cardiovascular
• Decision Date: Aug 5, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.5150
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

Device Story

InfusionCath is a peripheral vascular catheter used to temporarily occlude a vessel and deliver physician-specified fluids (e.g., thrombolytics). Device consists of a distal occlusion balloon, a variable treatment length catheter body with elution holes, and a proximal trifurcated Luer connection hub. Hub provides connections for balloon inflation, infusion valve operation, and fluid infusion. Used by clinicians in a clinical setting. Device is provided sterile for single-patient use. By occluding the vessel and delivering fluids locally, the device facilitates targeted therapeutic delivery, potentially improving treatment efficacy for peripheral vascular conditions.

Clinical Evidence

Bench testing included mechanical strength, bond strength, balloon inflation/deflation, and fluid infusion testing. In vivo animal testing compared the InfusionCath to a commercially available predicate device, demonstrating equivalent performance.

Technological Characteristics

Catheter with distal occlusion balloon, variable treatment length body with elution holes, and proximal trifurcated Luer hub. Materials are biocompatible and previously cleared for similar use. Sterile, single-use device.

Indications for Use

Indicated for the infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

Regulatory Classification

Identification

An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.

Predicate Devices

• Trellis Infusion System (K013635)
• LeMaitre Balloon Catheter with Irrigation (K992940)
• Isolate Infusion Catheter (K913517)

Submission Summary (Full Text)

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February 3, 2022

VeinRx, Inc. Scott Jahrmarkt President & CEO 8210 Nw 27th St. Miami. Florida 33122

Re: K041517

Trade/Device Name: InfusionCath Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA

Dear Scott Jahrmarkt:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated August 5, 2004. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, [phone], Gregory.Oconnell(@FDA.HHS.gov.

Sincerely,

Image /page/0/Picture/9 description: The image shows the name Gregory W. O'connell -S. Next to the name is the text "Digitally signed by Gregory W. O'connell -S Date: 2022.02.03 14:26:39 -05'00'". This text indicates that the document was digitally signed by Gregory W. O'connell on February 3, 2022 at 2:26 PM.

Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG = 5 2004

VeinRx, Inc. c/o Mr. Scott Jahrmarkt President & CEO 8210 NW 27th Street Miami, FL 33122

Re: K041517 InfusionCath Regulation Number: 21 CFR 870.1210 Regulation Name: Infusion Catheter Regulatory Class: Class II (two) Product Code: KRA Dated: June 7, 2004 Received: June 9, 2004

Dear Mr. Jahrmarkt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becalled is relay personalially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regard to the Medical Device Amendments, or to contineres prof to may 20, 1978, are eccordance with the provisions of the Federal Food, Drug, devices that have been receasined in autre approval of a premarket approval application (PMA). and Costience Act (110t) that to her subject to the general controls provisions of the Act. The 1 ou may, merclore, manel als act include requirements for annual registration, listing of general controls provisions of wactice, 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 If your device is classified (600 a00 70) as a major regulations affecting your device can may be subject to such adated and egulations, 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. Scott Jahrmarkt

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 [phone]. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Duna R. Vahner

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

510(k) Number (if known):

This application K04151 7

510(k) Number (if known):

InfusionCath

Indications For Use:

Device Name:

The InfusionCath is intended for the infusion of The InfusionCath is Intendou for the messes into the peripheral vasculature.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dmm R. be Aunes

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number Korin 17

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041517

# AUG - 5 2004

510(k) Summary

General Information

| Classification | Class II |
|----------------|----------|
|----------------|----------|

InfusionCath Trade Name

Submitter

VeinRx, Inc. 8210 NW 27th Street Miami, FL 33122

Tel: [phone]

Contact

Scott Jahrmarkt President & CEO

## Intended Use

The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.

### Predicate Devices

| K013635 | Trellis Infusion System<br>Bacchus Vascular, Inc. |
|---------|--------------------------------------------------------------|
| K992940 | LeMaitre Balloon Catheter with Irrigation<br>Vascutech, Inc. |
| K913517 | Isolate Infusion Catheter<br>Lake Region, Inc. |

### Device Description

The VeinRx InfusionCath is used to temporarily occlude a vessel in the peripheral vasculature and then deliver a predetermined dose of a physician specified fluid proximally along the inner lumen of the vessel. The VeinRx InfusionCath is comprised of a distal occlusion balloon, a

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variable treatment length catheter body with elution holes, and a proximal trifurcated Luer connection hub. The Trifurcated hub allows connections for to the following three main systems of the device. The Luer Lock connections for balloon inflation, infusion valve operation and fluid infusion. The device is provided sterile and for single patient use.

#### Materials

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

#### Testing

Product testing was conducted to evaluate conformance to product specification. Testing included mechanical strength testing, bond strength, balloon inflation / deflation and fluid infusion.

In vivo animal testing comparing the InfusionCath to a commercially available predicate product was conducted. The products were used per their respective Instructions for Use. The results showed the InfusionCath was equivalent to the predicate device.

#### Summary of Substantial Equivalence

The InfusionCath is equivalent to the predicate products. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent.