(171 days)
Not Found
No
The 510(k) summary describes a mechanical catheter with adjustable balloons for fluid delivery and blood flow isolation. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on mechanical and material properties, not algorithmic performance.
Yes.
Explanation: The device is intended for the delivery of fluids, including therapeutic agents, to selected sites in the peripheral vascular system, indicating its use in therapeutic procedures.
Yes
The device's intended use explicitly states "delivery of fluids, including diagnostic and/or therapeutic agents." The "Device Description" also mentions it is "designed for targeted delivery of fluids, including diagnostic agents." This indicates its role in facilitating diagnostic procedures by delivering diagnostic agents.
No
The device description clearly states it is a "multi-lumen, dual-balloon catheter" and mentions physical components like syringes, indicating it is a hardware device.
Based on the provided information, the RenovoCath™ RC120 Catheter is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- RenovoCath's Function: The RenovoCath is a catheter designed for direct use within the peripheral vascular system (inside the body). Its purpose is to isolate blood flow and deliver fluids (including diagnostic or therapeutic agents) to specific sites within the body.
- No Specimen Testing: The description does not mention the device being used to test specimens taken from the body. The diagnostic agents mentioned are delivered into the body, not used to test samples from the body.
Therefore, the RenovoCath™ RC120 Catheter is a medical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.
The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. The RenovoCath is designed for targeted delivery of fluids, including diagnostic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The RenovoCath is provided with two off-the-shelf 3cc syringes that facilitate precise inflation of the balloons under fluoroscopic guidance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular system, peripheral vasculature in arteries 3mm and larger, vessels ranging between 4mm to 11mm in diameter. Not intended for use in coronary and intracranial arteries.
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)
All necessary bench testing was conducted on the RenovoCath to support a determination of substantial equivalence to the predicate device. Testing included biocompatibility, sterilization, shipping and packaging, accelerated aging, and design verification testing. Design verification testing included the following:
- Visual inspection
- Dimensional verification
- Insertion and tracking testing
- Balloon performance verification
- Infusion flow rate testing
- Simulated use testing
- Bonds strength testing
- Infusion port burst testing
The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended. In addition, the collective bench testing demonstrates that the RenovoCath does not raise new questions of safety or effectiveness as compared 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
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 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 featuring three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 24, 2014
RenovoRx. Inc. C/O Ronald S. Warren Experien Group, LLC. 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085
Re: K141175
Trade/Device Name: RenovoCath™ RC120 Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: II Product Code: MJN Dated: August 29, 2014 Received: September 2, 2014
Dear Ronald S. Warren:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Kenneth J. Cavanaugh -S
for
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) K141175
Device Name RenovoCath™ RC120 Catheter
Indications for Use (Describe)
The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.
The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Notification: K141175
GENERAL INFORMATION
Applicant:
RenovoRx, Inc. 3705 Haven Avenue, Suite 102 Menlo Park, CA 94025 U.S.A. Phone: 1-650-284-4433
Contact Person:
Ronald S. Warren Regulatory Consultant for RenovoRx, Inc. Experien Group, LLC. 755 N. Mathilda Ave, Suite 100 Sunnyvale, CA 94085 U.S.A. Phone: 1-408-505-3926 FAX: 1-408-400-0865
Date Prepared: May 5, 2014
DEVICE INFORMATION
Trade/Proprietary Name: RenovoCath™ RC120 Catheter
Generic/Common Name: Catheter, Intravascular Occluding, Temporary
Classification: 21 CFR§870.4450, Vascular clamp
Product Code: MJN, Catheter, Intravascular Occluding, Temporary
PREDICATE DEVICE(S)
ThermopeutiX, Inc. TAPAS Catheters (K112219) ("TAPAS Catheter")
INDICATIONS FOR USE
The RenovoCath™ RC120 Catheter is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. The RenovoCath™ RC120 is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath™ RC120 is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 4mm to 11mm in diameter.
The diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.
4
The RenovoCath™ RC120 Catheter is not intended for use in coronary and intracranial arteries.
The RenovoCath™ RC120 Catheter is not intended for embolic protection or as an aspiration catheter.
PRODUCT DESCRIPTION
The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. The RenovoCath is designed for targeted delivery of fluids, including diagnostic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The RenovoCath is provided with two off-the-shelf 3cc syringes that facilitate precise inflation of the balloons under fluoroscopic guidance.
SUBSTANTIAL EQUIVALENCE
The indications for use for the predicate device are substantially equivalent to the proposed indications for use for the RenovoCath. Both devices have intended use and similar technological characteristics. Any differences in the technological characteristics between the devices do not raise of safety or effectiveness. Thus, the RenovoCath is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
All necessary bench testing was conducted on the RenovoCath to support a determination of substantial equivalence to the predicate device. Testing included biocompatibility, sterilization, shipping and packaging, accelerated aging, and design verification testing. Design verification testing included the following:
- Visual inspection
- Dimensional verification
- Insertion and tracking testing
- Balloon performance verification
- Infusion flow rate testing
- Simulated use testing
- Bonds strength testing
- Infusion port burst testing
The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended. In addition, the collective bench testing demonstrates that the RenovoCath does not raise new questions of safety or effectiveness as compared to the predicate device.
CONCLUSION
The RenovoCath has the same intended use and similar technological characteristics as the TAPAS Catheter predicate device. The RenovoCath has been tested to ensure that it performs as intended and that the technological difference does not raise new issues of safety or effectiveness. As such, the RenovoCath is substantially equivalent to the TAPAS Catheter predicate device.
SUMMARY
The RenovoCath is substantially equivalent to the predicate device.