(28 days)
Not Found
No
The summary describes a mechanical catheter device and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device's intended use explicitly states "delivery of fluids, including diagnostic and/or therapeutiv agents" and "chemotherapeutic drug infusion," indicating its direct involvement in the administration of therapeutic agents.
No
The device is a catheter intended for the delivery of fluids, including diagnostic and therapeutic agents, and for temporary vessel occlusion. While it can deliver diagnostic agents, it is not described as performing any diagnostic function itself. Its role is delivery and occlusion, not diagnosis.
No
The device description clearly describes a physical catheter with multiple lumens, balloons, a handle, and radiopaque markers, indicating it is a hardware device.
Based on the provided information, the RenovoCath is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease.
- The RenovoCath is a catheter designed for intravascular use within the peripheral vascular system. It is used to isolate blood flow, deliver fluids (including diagnostic and therapeutic agents), and temporarily occlude vessels inside the body.
The device's function and intended use are entirely focused on procedures performed within the patient's body, not on analyzing samples taken from the body. While it can deliver diagnostic agents, the device itself is not performing the diagnostic test on a sample.
N/A
Intended Use / Indications for Use
The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutiv agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.
The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.
Product codes (comma separated list FDA assigned to the subject device)
MJN
Device Description
The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 75cm to 85cm (adjustable). Radiopaque markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.
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, arteries from 3mm in diameter, vessels ranging between 3mm to 11mm in diameter
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)
For the purposes of establishing substantial equivalence to the predicate device, the RenovoCath was tested for the following using the same methods previously established:
- Dimensional Inspection
- Insertion and Tracking Testing
- Balloon Testing
- Infusion Flow Rate Testing
- Simulated In-Vivo Testing
The bench testing confirms that functionally the RenovoCath performs the same as the predicate device in facilitating 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.
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
August 23, 2021
RenovoRx, Inc. Debra Cogan Director Quality Assurance 4546 El Camino Real, Suite B1 Los Altos, California 94022
Re: K212324
Trade/Device Name: RenovoCath© Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: MJN Dated: July 23, 2021 Received: July 26, 2021
Dear Debra Cogan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
Enclosure
2
Indications for Use
510(k) Number K212324
Device Name RenovoCath© Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Indications for Use (Describe)
The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutiv agents, to selected sites in the peripheral vascular system. The RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vesses ranging between 3mm to 11mm in diameter.
The diagnostic and/or therapents are to be used in accordance with specifications outlined by the respective agent manufacturer.
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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3
510(k) SUMMARY [per 21 CFR 807.92]
GENERAL INFORMATION
Applicant RenovoRx, Inc. 4546 El Camino Real, Suite B1 Los Altos, CA 94022 USA Phone: 1-650-284-4433
Contact Person Debra Cogan, Director Quality Assurance RenovoRx, Inc. Phone: 1-408-515-0820
Date Prepared July 23, 2021
DEVICE INFORMATION
Trade/Proprietary Name RenovoCath®
Generic/Common Name Catheter, Intravascular Occluding, Temporary
Classification 21 CFR§870.4450, Vascular clamp
Product Code MJN, Catheter, Intravascular Occluding, Temporary
PREDICATE DEVICE RenovoCath® (K191606)
INDICATIONS FOR USE
The RenovoCath 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 is also indicated for temporary vessel occlusion including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. The RenovoCath is intended for general intravascular use in the peripheral vasculature in arteries 3mm and larger. The RenovoCath is intended for use in arteries from 3mm in diameter for vessel entry and to occlude vessels ranging between 3mm 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
PRODUCT DESCRIPTION
The RenovoCath is a multi-lumen, dual-balloon catheter with a two-part handle that is designed for targeted delivery of fluids, including radiopaque material and therapeutic agents, to selected sites in the peripheral vascular system. The distance between the proximal and distal balloons is adjustable. The effective length is 75cm to 85cm (adjustable). Radiopaque markers are located between the balloons to allow for identification of targeted site and position adjustment under fluoroscopic guidance. The RenovoCath is intended to be used with 6 Fr guide sheaths and 7 Fr guide catheters and is compatible with 0.014" guidewires.
SUMMARY OF INTENDED USE AND TECHNOLOGICAL CHARACTERISTICS COMPARISON
The indications for use for the RenovoCath are identical to the indications for use for the predicate device. Both devices have the same intended use and technological characteristics. In addition, bench testing confirms that functionally the RenovoCath performs the same as the predicate device in facilitating the delivery of fluids to the peripheral vasculature. The changes impacted the balloon to balloon distance and effective length.
TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION
For the purposes of establishing substantial equivalence to the predicate device, the RenovoCath was tested for the following using the same methods previously established:
- Dimensional Inspection
- Insertion and Tracking Testing ●
- Balloon Testing
- Infusion Flow Rate Testing
- Simulated In-Vivo Testing
The bench testing confirms that functionally the RenovoCath performs the same as the predicate device in facilitating the delivery of fluids to the peripheral vasculature.
Summary Table Substantial Equivalency
Predicate Device | Subject Device | |
---|---|---|
Feature | RenovoRx, Inc. RenovoCath | |
K191606 | RenovoRx, Inc.RenovoCath | |
K212324 | ||
Indications | ||
forUse | The RenovoCath 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 is also indicated for | ||
temporary vessel occlusion in applications | ||
including arteriography, preoperative | ||
occlusion, and chemotherapeutic drug | The RenovoCath 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 is also indicated for | ||
temporary vessel occlusion in applications | ||
including arteriography, preoperative | ||
occlusion, and chemotherapeutic drug | ||
Feature | Predicate Device | |
RenovoRx, Inc. RenovoCath | ||
K191606 | Subject Device | |
RenovoRx, Inc.RenovoCath | ||
K212324 | ||
infusion. The RenovoCath is intended for | ||
general intravascular use in the peripheral | ||
vasculature in arteries 3mm and larger. | ||
The RenovoCath is intended for use in | ||
arteries from 3mm in diameter for vessel | ||
entry and to occlude vessels ranging | ||
between 3mm to 11mm in diameter. | ||
The diagnostic and/or therapeutic agents | ||
are to be used in accordance with | ||
specifications outlined by the respective | ||
agent manufacturer. | infusion. The RenovoCath is intended for | |
general intravascular use in the peripheral | ||
vasculature in arteries 3mm and larger. | ||
The RenovoCath is intended for use in | ||
arteries from 3mm in diameter for vessel | ||
entry and to occlude vessels ranging | ||
between 3mm to 11mm in diameter. | ||
The diagnostic and/or therapeutic agents | ||
are to be used in accordance with | ||
specifications outlined by the respective | ||
agent manufacturer. | ||
Contraindications | It is the responsibility of the physician to | |
determine whether any physical | ||
impairment, including any vascular | ||
abnormality or reaction to contrast | ||
medium, of the patient would | ||
contraindicate the use of this device. | ||
The RenovoCath is not intended for use in | ||
coronary and intracranial arteries. | ||
The RenovoCath is not intended for | ||
embolic protection or as an aspiration | ||
catheter. | It is the responsibility of the physician to | |
determine whether any physical | ||
impairment, including any vascular | ||
abnormality or reaction to contrast | ||
medium, of the patient would | ||
contraindicate the use of this device. | ||
The RenovoCath is not intended for use in | ||
coronary and intracranial arteries. | ||
The RenovoCath is not intended for | ||
embolic protection or as an aspiration | ||
catheter. | ||
Single Use | Yes | Yes |
Patient | ||
Contacting | ||
Materials | Silicone, Pebax, Platinum Iridium | Silicone, Pebax, Platinum Iridium |
Effective Length | Adjustable, 76cm-86cm | Adjustable, 75cm-85cm |
Sheath | ||
Compatibility | 6Fr | 6Fr |
Catheter Size | 0.076" (1.93mm) Max diameter | 0.076" (1.93mm) Max diameter |
Guidewire | ||
Compatibility | Long 0.014" | Long 0.014" |
Balloon | ||
Configuration | Dual: Distal and Proximal | Dual: Distal and Proximal |
Balloon Type | Compliant, low pressure | Compliant, low pressure |
Balloon Distance | Adjustable, 25mm-120mm | Adjustable, 15mm-109mm |
Balloon Occlusion | ||
Vessel Range | Proximal and Distal: 3mm-11mm | Proximal and Distal: 3mm-11mm |
Recommended | ||
Balloon Inflation | ||
Volume | 0.10cc-1.07cc | 0.10cc-1.07cc |
Radiopaque | ||
Marker | Two markers | Two markers |
Predicate Device | Subject Device | |
Feature | RenovoRx, Inc. RenovoCath | |
K191606 | RenovoRx, Inc.RenovoCath | |
K212324 | ||
Shaft Design | Dual lumen inner shaft within a multi- lumen shaft. One lumen is provided for inflation of the distal balloon in the dual lumen inner shaft and the other is for the guidewire and terminates at the distal tip. The outer catheter is a multi- lumen shaft. One lumen houses the dual lumen inner shaft. A second lumen is provided for proximal balloon inflation. A third lumen is provided for drug infusion. | Dual lumen inner shaft within a multi- lumen shaft. One lumen is provided for inflation of the distal balloon in the dual lumen inner shaft and the other is for the guidewire and terminates at the distal tip. The outer catheter is a multi- lumen shaft. One lumen houses the dual lumen inner shaft. A second lumen is provided for proximal balloon inflation. A third lumen is provided for drug infusion. |
Fluid Delivery | Dual Lumen - one lumen for saline delivery and one lumen for infusion of diagnostic or therapeutic fluid. | Dual Lumen - one lumen for saline delivery and one lumen for infusion of diagnostic or therapeutic fluid. |
Contrast Medium Ratio | 70/30 saline to contrast | 70/30 saline to contrast |
Accessories | Not applicable; no syringes are included | Not applicable; no syringes are included |
Table 1. Substantial Equivalency Summary
5
6
CONCLUSION
The RenovoCath has the same intended use and technological characteristics as the predicate device. Functionally, the devices have the same design features to facilitate the delivery of fluids to the peripheral vasculature. The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended. Thus, the RenovoCath is substantially equivalent to the predicate device.