(419 days)
No
The provided text describes a physical catheter device and its intended use, without mentioning any software, algorithms, or data processing that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as delivering "therapeutic agents" and being used for "chemotherapeutic drug infusion," indicating a clear therapeutic purpose.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is intended for the "delivery of fluids, including diagnostic and/or therapeutic agents." The inclusion of "diagnostic agents" directly indicates its use in diagnostic procedures.
No
The device description clearly states it is a "multi-lumen, dual-balloon catheter" and is provided with "two off-the-shelf 3cc syringes," indicating it is a physical medical device with hardware components.
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 derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- RenovoCath's Intended Use: The RenovoCath is an invasive catheter used within the peripheral vascular system. Its purpose is to isolate blood flow, deliver fluids (including diagnostic/therapeutic agents), and temporarily occlude vessels. It is a tool for in vivo procedures, not for analyzing samples in vitro.
- Lack of Specimen Analysis: The description focuses on the physical manipulation of blood flow and delivery of substances within the body, not on the analysis of biological specimens outside the body.
Therefore, the RenovoCath™ RC120 Catheter is a medical device used for interventional procedures, not an IVD.
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 also indicated for temporary vessel occlusions including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. 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 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, 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)
Bench testing was conducted on the RenovoCath and the predicate device (Equalizer Occlusion Balloon Catheter).
For purposes of establishing substantial equivalence to the Equalizer Occlusion Balloon Catheter, the predicate device was tested for the following using the same methods previously performed on RenovoCath:
- Balloon Inflation Time
- Infusion Flow Rate
RenovoCath underwent additional performance and characterization testing including:
- Determination of extractables/leachables profile after exposure to simulated use conditions (pre-conditioning to simulate expected clinical and infusate properties)
- Evaluation of material changes through functional testing and SEM analysis
The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended. In addition, the bench testing on the predicate device confirms that functionally the Equalizer Catheter and RenovoCath have similar design features to facilitate the delivery of fluids to the peripheral vasculature.
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.
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 7, 2017
RenovoRx, Inc. % Ronald S. Warren Sr. Director, Regulatory Affairs Experien Group, LLC 755 N. Mathilda Avenue, Suite 100 Sunnyvale, CA 94085
Re: K160067
Trade/Device Name: RenovoCath™ RC120 Catheter Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: February 23, 2017 Received: February 24, 2017
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Fernando
Aguel-S
Fernando Agnel
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K160067
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 also indicated for temporary vessel occlusions including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. 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 yessel 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Notification K160067
GENERAL INFORMATION
Applicant:
RenovoRx, Inc. 4546 El Camino Real, Suite 282 Los Altos, CA 94022 USA Phone: 1-650-284-4433
Contact Person:
Ronald S. Warren Regulatory Consultant for RenovoRx, Inc. Experien Group, LLC. 224 Airport Parkway, Suite 250 San Jose. CA 95110 U.S.A. Phone: 1-408-505-3926 FAX: 1-408-400-0865 Date Prepared: March 7, 2017
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)
Boston Scientific Equalizer™ Occlusion Balloon Catheter (K140273)
This predicate has not been subject to a design-related recall.
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 also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. 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
4
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 DESCRIPTION
The RenovoCath™ RC120 Catheter ("RenovoCath") is a multi-lumen, dual-balloon catheter. 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.
Summary of Intended Use and Technological Characteristics Comparison
The indications for use for the RenovoCath are substantially equivalent to the indications for use for the predicate device. Both devices have the same intended use and similar technological characteristics. In addition, the bench testing on the predicate device confirms that functionally the Equalizer Catheter and RenovoCath have similar design features to facilitate the delivery of fluids to the peripheral vasculature. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the RenovoCath is substantially equivalent to the predicate device.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
There are no design changes of the RenovoCath requiring new testing. Reference is made to previous bench testing conducted on the RenovoCath which supported the original 510(k) clearance of K141175. That testing included biocompatibility, sterilization validation, shipping and packaging, accelerated aging, and design verification testing. For purposes of establishing substantial equivalence to the Equalizer Occlusion Balloon Catheter, the predicate device was tested for the following using the same methods previously performed on RenovoCath:
- Balloon Inflation Time ●
- . Infusion Flow Rate
RenovoCath underwent additional performance and characterization testing including:
- . Determination of extractables/leachables profile after exposure to simulated use conditions (pre-conditioning to simulate expected clinical and infusate properties)
- Evaluation of material changes through functional testing and SEM analysis
The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended. In addition, the bench testing on the predicate device confirms that functionally the Equalizer Catheter and RenovoCath have similar design features to facilitate the delivery of fluids to the peripheral vasculature.
5
CONCLUSION
The RenovoCath has the same intended use and similar technological characteristics as the Equalizer Occlusion Balloon Catheter predicate device. Functionally, the Equalizer Catheter and RenovoCath have similar design features to facilitate the delivery of fluids to the peripheral vasculature. On this basis, the RenovoCath is substantially equivalent to the predicate device and the indications for use have been updated to reflect the indications for use of the predicate device.
SUMMARY
The RenovoCath is substantially equivalent to the predicate device.