(16 days)
No
The summary describes a mechanical catheter for fluid infusion and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the infusion of fluids, including thrombolytics, into the peripheral vasculature, which is a therapeutic intervention.
No
The intended use of the VariCath Peripheral Infusion Catheter is for the infusion of fluids, not for diagnosing conditions.
No
The device description clearly outlines physical components like a catheter body, balloon, and 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, including thrombolytics, into the peripheral vasculature." This describes a therapeutic or interventional procedure performed directly on a patient's body.
- Device Description: The description details a catheter with a balloon and infusion holes designed for delivering substances into blood vessels. This is consistent with a device used for direct patient treatment.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to deliver substances into the body for treatment.
N/A
Intended Use / Indications for Use
The VariCath 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 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.
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 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.
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
510(k) Summary
| General Information
| Classification | Class II |
|---|---|
| Trade Name | VariCath™ Peripheral Infusion Catheter |
| Submitter | VeinRx Inc |
| 8200 N.W. 27th Street | |
| Suite 102 | |
| Miami, FL 33122 | |
| 305-716-7005 | |
| Contact | Aaron Perlmutter, MD |
| Vice 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.
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.
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.
1
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
2
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.
3
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 intended |
| for infusion of physician specified fluids, including | |
| thrombolytics, 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) ..............................................................................................................................................................................
:
OR
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Division Stop-Off
| Division of Cardiovascular Devices | |
|---|---|
| 510(k) Number | KO 73400 |