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.

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.

AI/ML Overview

The provided documentation describes the RenovoCath™ RC120 Catheter, a medical device, and its 510(k) premarket notification (K141175). This type of notification focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing extensive clinical study data proving performance against specific acceptance criteria in the same way a new drug or novel medical imaging AI might.

Therefore, the information provided does not contain acceptance criteria and a study proving the device meets those criteria in the typical sense of a detailed clinical performance study with statistical metrics. Instead, it focuses on demonstrating equivalence through bench testing.

Here's an analysis based on the available information:

1. A table of acceptance criteria and the reported device performance:

Since this is a 510(k) for a physical medical device (catheter) based on substantial equivalence, the "acceptance criteria" are primarily related to passing various engineering and materials tests to demonstrate it functions similarly and safely to the predicate device. The document states:

Acceptance Criteria (Implied from testing categories)	Reported Device Performance (Summary)
Bench Testing Categories: - Biocompatibility - Sterilization - Shipping and Packaging - Accelerated Aging - Design Verification (Visual, Dimensional, Insertion/Tracking, Balloon Performance, Infusion Flow Rate, Simulated Use, Bonds Strength, Infusion Port Burst)	"All necessary bench testing was conducted on the RenovoCath to support a determination of substantial equivalence to the predicate device." "The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended." "The collective bench testing demonstrates that the RenovoCath does not raise new questions of safety or effectiveness as compared to the predicate device."

Acceptance Criteria (Implied from testing categories)

Reported Device Performance (Summary)

Bench Testing Categories: - Biocompatibility - Sterilization - Shipping and Packaging - Accelerated Aging - Design Verification (Visual, Dimensional, Insertion/Tracking, Balloon Performance, Infusion Flow Rate, Simulated Use, Bonds Strength, Infusion Port Burst)

"All necessary bench testing was conducted on the RenovoCath to support a determination of substantial equivalence to the predicate device." "The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended." "The collective bench testing demonstrates that the RenovoCath does not raise new questions of safety or effectiveness as compared to the predicate device."

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. For bench testing of physical devices, sample sizes are typically determined by engineering and quality assurance standards relevant to the specific test (e.g., number of catheters tested for burst pressure, number of samples for biocompatibility). These details are not provided in this summary document.
Data Provenance: The testing was conducted by or for RenovoRx, Inc. in the USA. It is prospective testing designed to support the 510(k) application.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable in the context of this 510(k) submission. Bench testing for device functionality does not typically involve "experts" establishing a "ground truth" in the way clinical studies or AI algorithm evaluations do. The "truth" is determined by engineering specifications and physical measurements.

4. Adjudication method for the test set:

Not applicable. This is not a study requiring adjudication of expert opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a physical medical device (catheter), not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device.

7. The type of ground truth used:

For the bench testing, the "ground truth" or reference for performance is established by engineering specifications, industry standards, and comparison to the predicate device's known performance characteristics. For example, a balloon must inflate to a certain diameter without bursting, or a catheter must withstand a certain tensile force.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning algorithm.

9. How the ground truth for the training set was established:

Not applicable. This is a physical medical device.

In summary: The RenovoCath™ RC120 Catheter received 510(k) clearance based on demonstrating "substantial equivalence" to a predicate device (ThermopeutiX, Inc. TAPAS Catheters, K112219). This was supported by a range of bench tests (biocompatibility, sterilization, shipping/packaging, accelerated aging, and various design verification tests) that collectively confirmed the RenovoCath met its specifications, performed as intended, and did not raise new questions of safety or effectiveness compared to the predicate. The documentation does not provide specific quantitative acceptance criteria or detailed sample sizes for each test but indicates that "all necessary bench testing was conducted."

Summary

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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

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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 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)
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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 diagnostic and/or therapeutic agents are to be used in accordance with specifications outlined by the respective agent manufacturer.

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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

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.

Regulation Number and Section

§ 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).