(67 days)
No
The summary describes a physical medical device (catheter) and its components, with no mention of software, algorithms, or any terms related to AI or ML.
Yes
The device is described as an "Infusion Catheter" intended for "infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature," which directly implies its use in medical treatment to achieve a therapeutic effect.
No
This device, the VeinRx Infusion Catheter, is described as intended for the "infusion of physician specified fluids," which is a therapeutic action, not a diagnostic one. It functions to deliver substances into the body, not to identify a medical condition or disease.
No
The device description clearly outlines physical components like a catheter body, balloon, and Luer connection hub, indicating it is a hardware device, not software-only.
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 device used within the body for therapeutic purposes (delivering fluids), not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter with an occlusion balloon, infusion holes, and a connection hub. This is consistent with a device designed for direct patient intervention, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a disease or condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to deliver substances into the body.
N/A
Intended Use / Indications for Use
The VeinRx Infusion Catheter is intended for the infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature.
The InfusionCath Peripheral Infusion Catheter is intended for The infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature
Product codes
KRA
Device Description
The VeinRx InfusionCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a fixed 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 distal black marker indicates the proximal edge of the infusion length. The proximal black marker is used to properly align the device with the recommended introducer. The InfusionCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.
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
The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter. All components, subassemblies, and/or full devices met the required specifications for the completed tests.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
K 052738
VeinRx, Inc.
2005 DEC. 6
510(k) Summary
| General Information
| Classification | Class II |
|---|---|
| Trade Name | InfusionCath™ Peripheral Infusion Catheter |
| Submitter | VeinRx Inc |
| 8200 N.W. 27th Street | |
| Suite 102 | |
| Miami, FL 33122 | |
| 305-716-7005 | |
| Contact | Gregory J. Mathison |
| Vice President - Regulatory Affairs |
Intended Use
The VeinRx 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.
Device Description
The VeinRx InfusionCath Peripheral Infusion Catheter is comprised of a distal occlusion balloon, a fixed 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 distal black marker indicates the proximal edge of the infusion length. The proximal black marker is used to properly align the device with the recommended introducer. The InfusionCath is packaged inside a protective tube mounted on a card and placed in a sealed protective pouch.
Materials
All materials used in the manufacture of the InfusionCath Peripheral Infusion Catheter are suitable for this use and have been used in numerous previously cleared products.
Testing Summary
The modified InfusionCath Peripheral Infusion Catheter was tested in the same manner as the original InfusionCath Peripheral Infusion Catheter. All components, subassemblies, and/or full devices met the required specifications for the completed tests.
1
Summary of Substantial Equivalence
The modified InfusionCath Peripheral Infusion Catheter is equivalent to the predicate product, the original InfusionCath Peripheral Infusion Catheter. The indications for use, function, methods of manufacturing, and materials used are substantially equivalent. VeinRx, Inc. believes the modified InfusionCath Peripheral Infusion Catheter is substantially equivalent to existing legally marketed devices
2
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains an image of an eagle with three lines representing its body. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is written around the top of the circle. The text is written in a bold, sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2005 DEC 6
Mr. Gregory Mathison Vice President Vein RX, Inc. 8299 NW 27 St. Suite 102 Miami, FL, 33122
Re: K052738
Trade Name: Infusion Catl(TM Regulation Number: 21 CI R 870.3470 Regulation Name: Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: November 08, 2005 Received: November 11, 2005
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, 1971, 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 provisions of the Pederal Food, Drug,
You may, therefore, market the desire approval of a premarket approval applicat You may, therefore, market the device, subject to the general controls provisions of the Act. The gencral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing prictice, labeling, and prohibitions against misting 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 cool and class in opecial Confort of Class II (PMA), and (PMA), and Claim
be found in the Code of Foderal Revel, time Title of M. Bleving yo be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FiDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Gregory Mathison
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA S ISSuance of a succession of the requirements of the Act
that FDA has made a determination that your device and accracies. You must that FDA has made a decemination administered by other Federal agencies. You must a or any Federal statures and regulations administered of registration and listing (2)
comply with all the Act's requirements, including, but not limited to: est comply with an the Act 31equirements, moraans, were and and the requirements as set CrK Part 807), labeling (21 CFR Part 820), and if applicable, the electronic form in the quality systems (QD) regalantin (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections our device as described in your Section 510(k) I his letter will anow you to ocgin mankeang your and equivalence of your device to a legally premarket nother in the PDA miding of backers on the sice 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 advice for your acon (240) 276-0120. Also, please note the regulation entitled, colliact the Office of Comphanes an (21CFR Part 807.97). You may obtain Milsolanding by televelee to premainters in the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, Internet and Coliss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Dura R. Vochner
A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
InfusionCath Peripheral Infusion Catheter
K052738 510(k) Number (if known):
Device Name:
Indications For Use:
The InfusionCath Peripheral Infusion Catheter is intended for
The infusion of physician specified fluids, including thrombolytics, into the peripheral vasculature
Prescription Use _____________________________________________________________________________________________________________________________________________________________ X (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)
Ouma R. Vochmer
(Division Sign-Off) (Division Sign-On)
Division of Cardiovascular Devices
510(k) Number K0652738
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