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.

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.

AI/ML Overview

This document is a 510(k) premarket notification for the RenovoCath™ RC120 Catheter. It claims substantial equivalence to a predicate device, the Boston Scientific Equalizer™ Occlusion Balloon Catheter (K140273), rather than providing detailed acceptance criteria and a study to prove a device meets those criteria from scratch. Therefore, the information you're requesting, particularly specific acceptance criteria with numerical performance data like sensitivity/specificity, sample sizes for test and training sets, details on expert ground truthing, and MRMC studies, is not present in this type of regulatory submission.

Instead, the document focuses on demonstrating that the RenovoCath has the same intended use and similar technological characteristics as the predicate device, and that any differences do not raise new issues of safety or effectiveness.

Here's an analysis based on the information provided in the document, framed by your request, explaining why certain details are missing for this type of submission:

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

This document does not present quantitative acceptance criteria or reported device performance in the format of a table with specific metrics like sensitivity, specificity, or AUC, as would be common for diagnostic AI algorithms.

Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device and the results of the bench testing. The "performance" is described in qualitative terms:

Implied Acceptance Criteria (via Substantial Equivalence and Bench Testing)	Reported Device Performance (RenovoCath™ RC120)
Similar Intended Use	The RenovoCath has the same intended use for isolation of blood flow and delivery of fluids, and temporary vessel occlusion, matching the predicate.
Similar Technological Characteristics	The RenovoCath is a multi-lumen, dual-balloon catheter with adjustable distance between balloons, and uses 3cc syringes for balloon inflation under fluoroscopic guidance, similar to the predicate.
Functional Equivalence (Bench Testing)	Balloon Inflation Time: Tested using the same methods as previously performed on RenovoCath, and results confirm similar design features to the predicate.
	Infusion Flow Rate: Tested using the same methods as previously performed on RenovoCath, and results confirm similar design features to the predicate.
Biocompatibility	Previous testing (for K141175) confirmed biocompatibility.
Sterilization Validation	Previous testing (for K141175) confirmed sterilization validation.
Shipping and Packaging Stability	Previous testing (for K141175) confirmed shipping and packaging stability.
Accelerated Aging	Previous testing (for K141175) confirmed accelerated aging performance.
Design Verification Testing	Previous testing (for K141175) confirmed design verification.
Material Integrity/Safety (Additional Testing)	Extractables/Leachables Profile: Determined after exposure to simulated use conditions (pre-conditioning to simulate expected clinical and infusate properties). Results collectively demonstrate the device meets specifications.
	Material Changes Evaluation: Functional testing and SEM analysis confirm material integrity. Results collectively demonstrate the device meets specifications.
Overall Performance	"The collective results of the testing demonstrate that the RenovoCath meets its specifications and performs as intended." "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes bench testing for physical characteristics of the device, not clinical studies involving patient data or images. Therefore, the concepts of "test set sample size" and "data provenance" (country/retrospective/prospective) related to patient data are not applicable here. The testing was conducted on devices and materials in a laboratory setting. No information on the specific number of units tested for each bench test is provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable as the study involves bench testing of a physical medical device, not evaluation of an AI algorithm based on human expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as point 3.

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

This is not applicable. The device is a physical catheter, not an AI-powered diagnostic or assistive tool for human readers.

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

This is not applicable. The device is a physical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench testing described, the "ground truth" would be established by engineering specifications, validated test methods, and industry standards for medical device performance. For example, a balloon inflation time would be measured against a specified range, or an infusion flow rate against a required minimum, rather than an expert consensus or pathology report.

8. The sample size for the training set

This is not applicable as this document describes bench testing for a physical device, not an AI algorithm requiring a training set.

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

This is not applicable for the same reasons as point 8.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K160067

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)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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

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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

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.

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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.

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).