(59 days)
Not Found
No
The description focuses on mechanical components and fluid delivery, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for the infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature, which is a therapeutic intervention.
No
The device is described as being used for the infusion of fluids and temporarily occluding a vessel, which are therapeutic actions, not diagnostic ones.
No
The device description clearly outlines physical components such as a catheter body, occlusion balloon, and Luer connection hub, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "infusion of physician specified fluids... into the peripheral vasculature." This describes a therapeutic intervention performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a catheter with a balloon and elution holes designed for delivering fluids within a blood vessel. This is consistent with a medical device used for treatment, not for diagnostic testing of a sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The InfusionCath's function is to deliver fluids for treatment, not to perform diagnostic tests on samples.
N/A
Intended Use / Indications for Use
The InfusionCath is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 870.5150 Embolectomy catheter.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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, (301) 796-6075, 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
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that create a sense of movement and dynamism.
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 (301) 594-4648. 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,
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
4
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: (305) 716-7000
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
Bacchus Vascular, Inc. |
|---------|--------------------------------------------------------------|
| K992940 | LeMaitre Balloon Catheter with Irrigation
Vascutech, Inc. |
| K913517 | Isolate Infusion Catheter
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
5
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.