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 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.

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 76cm to 86cm (adjustable). Radiopague 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.

AI/ML Overview

The provided text is a 510(k) Premarket Notification from the FDA for the RenovoCath device. This document focuses on demonstrating substantial equivalence to a predicate device (RenovoCath™ RC120 Catheter K160067) rather than detailing a study that proves the device meets specific performance acceptance criteria in the manner one might see for a novel AI/software as a medical device (SaMD).

For a SaMD, acceptance criteria often relate to clinical performance metrics like sensitivity, specificity, AUC, or reader agreement improvement. For this medical device (a catheter), the "acceptance criteria" are demonstrated through engineering bench testing and comparison to an existing similar device.

Therefore, many of the requested items (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone performance of an algorithm) are not applicable to this type of medical device submission. This document highlights a predicate pathway where the primary goal is to show that the new device is as safe and effective as a legally marketed device, not to prove clinical superiority or novel diagnostic capabilities via extensive clinical studies involving human readers or AI algorithms.

Here's how to address the request based on the provided document:

Acceptance Criteria and Device Performance (as demonstrated for a medical device)

1. Table of "Acceptance Criteria" and Reported Device Performance

For this medical device, "acceptance criteria" are demonstrated by a battery of engineering and bench tests, ensuring the device functions as intended and is comparable to the predicate. The "reported device performance" is essentially that the new device passed these tests and functions similarly to the predicate.

"Acceptance Criteria" (Demonstration Type)	Reported Device Performance (Summary from Submission)	Notes/Comparison to Predicate
Flow Rate (40% Glycerol in distilled water)	"Flow Rate 40% Glycerol in distilled water: 10±6 mL/min"	Tested using the same methods as previously established for the predicate.
Vessel Occlusion (using 70% Saline and 30% Omnipaque 300)	Performed effectively. Bench testing confirms functional similarity.	Tested using the same methods as previously established for the predicate.
Visibility Under Fluoroscopy	Achieved. Radiopaque markers (two) are present and visible.	Tested using the same methods as previously established for the predicate.
Bench testing for 3mm occlusion	Confirmed successful occlusion of 3mm diameter vessels.	This expands the vessel size range from the predicate (4mm-11mm) to 3mm-11mm. Bench testing supports this new lower limit.
Visual inspection	Passed	Standard quality control.
Dimensional verification	Passed	Standard quality control. Catheter size and effective length are consistent with predicate.
Insertion and tracking testing	Passed	Standard performance testing.
Balloon performance verification	Passed, consistent with low pressure compliant balloons. Recommended inflation volume 0.10-1.07cc.	Predicate had recommended inflation volume 0.12-1.07cc, indicating minor adjustment but similar function.
Infusion flow rate testing	Passed	Consistent with intended fluid delivery.
Simulated use testing	Passed	Demonstrates functionality in a simulated environment.
Bonds strength testing	Passed	Ensures structural integrity.
Infusion port burst testing	Passed	Ensures integrity under pressure.
Material Compatibility	Silicone, Pebax, Platinum Iridium	Same as predicate.
Sterilization Method	Ethylene Oxide	Same as predicate. Change in contract sterilizer noted, but method remains the same.
Indication for Use and Technological Characteristics	Substantially equivalent to predicate.	Minor changes include removal of power injector contraindication, clarification of coronary/intracranial/embolic protection contraindications, revised contrast dilution ratio (70/30 vs 50/50), expanded vessel diameter for occlusion (3mm vs 4mm), and other minor IFU improvements. These changes were supported by the bench testing.

2. Sample Size for the Test Set and Data Provenance

Sample Size: The document does not specify a numerical sample size for each bench test (e.g., number of catheters tested for flow rate or bond strength). It refers to "the RenovoCath was tested for the following using the same methods previously established." This implies standard quality control and engineering test sample sizes appropriate for device manufacturing and validation, but not formal clinical study sample sizes.
Data Provenance: Not applicable in the context of clinical data for AI/SaMD. The data comes from internal engineering and bench testing. It's not clinical data from patients or a specific country.
Retrospective/Prospective: Not applicable. These are lab-based tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. Ground truth for a catheter's physical and functional performance is established by engineering specifications, validated test methods (often based on ISO or ASTM standards), and comparison to a predicate device's established performance, not by human experts interpreting clinical images or outcomes.

4. Adjudication Method for the Test Set

Not applicable. This is not a clinical study involving human interpretation or consensus. Performance is measured objectively through engineering tests.

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 device is a physical catheter, not an AI or software device. No human readers or AI assistance are involved in its primary function or evaluation for this submission.

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

Not applicable. There is no algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on:

Engineering Specifications: Defined parameters for flow rate, dimensions, material properties, etc.
Bench Testing Results: Objective measurements from controlled laboratory experiments (e.g., burst pressure, flow rate measurement).
Predicate Device Performance: The established safety and effectiveness of the legally marketed predicate device (RenovoCath™ RC120 Catheter K160067) serves as the reference for substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML product.

9. How the Ground Truth for the Training Set was Established

Not applicable. There is no training set.

Study Summary

The "study" in this context is the 510(k) Premarket Notification process, which demonstrates substantial equivalence to a predicate device.

Objective: To show that the RenovoCath is as safe and effective as the predicate device (RenovoCath™ RC120 Catheter K160067) for its stated indications for use.
Methodology: The manufacturer conducted a series of bench tests and engineering evaluations to compare the RenovoCath to its predicate and to ensure it met its own performance specifications. These tests included:
- Flow Rate
- Vessel Occlusion
- Visibility Under Fluoroscopy
- Bench testing for 3mm occlusion (specifically to support the expanded vessel diameter range)
- 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
Key Findings: The collective results of these tests demonstrated that the RenovoCath meets its specifications and performs as intended, and that its technological characteristics and performance are substantially equivalent to the predicate device, despite minor changes in indications for use/contraindications (e.g., expanded vessel diameter range, updated contrast ratio, moved contraindications).

In summary, for a traditional medical device like the RenovoCath, "acceptance criteria" are primarily related to engineering performance and functional equivalence to a predicate, rather than the statistical clinical performance metrics typical of an AI/SaMD. The "study" proving this is a series of comprehensive bench and engineering tests.

Summary

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August 7, 2019

RenovoRx, Inc. Ms. Debra Cogan Regulatory Consultant 4546 El Camino Real. Suite 223 Los Altos, California 94022

Re: K191606

Trade/Device Name: RenovoCath Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular clamp Regulatory Class: Class II Product Code: MJN Dated: June 14, 2019 Received: June 17, 2019

Dear Ms. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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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 (OS) 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 medical devices and radiation-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,

For

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

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Indications for Use

510(k) Number (if known)

K191606

Device Name RenovoCath®

Indications for Use (Describe)

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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510(k) Summary [per 21 CFR 807.92]

GENERAL INFORMATION

Applicant RenovoRx, Inc. 4546 El Camino Real, Suite 223 Los Altos, CA 94022 USA Phone: 1-650-284-4433

Contact Person Debra Cogan Regulatory Consultant for RenovoRx, Inc. Phone: 1-408-515-0820

Date Prepared June 14, 2019

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™ RC120 Catheter (K160067)

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.

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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 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.

Summary of changes:

Removal of the contraindication for use with a power injector. •
. Move the following language from the Indications for Use section to Contraindications:
- o The RenovoCath is not intended for use in coronary and intracranial arteries.
- o The RenovoCath is not intended for embolic protection or as an aspiration catheter.
. Change the recommended ration for dilution of contrast from 50/50 to 70/30 saline to contrast solution ratio.
. Expand vessel diameter range from 4mm to 11 mm diameter to 3mm to 11 mm diameter
Other improvements to operating the device provided within the Instructions for Use
Change in contract sterilizer.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

For purposes of establishing substantial equivalence to the predicate device, the RenovoCath was tested for the following using the same methods previously established:

Flow Rate 40% Glycerol in distilled water: 10±6 mL/min
. Vessel Occlusion using 70% Saline and 30% Omnipaque 300
. Visibility Under Fluoroscopy
. Bench testing for 3 mm occlusion
. 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

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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

Table 1. Substantial Equivalency Summary

	Predicate Device	Subject Device
	RenovoRx, Inc.RenovoCath RC120 Catheter(K160067)	RenovoRx, Inc.RenovoCath
Feature
Indications forUse	The RenovoCath™ RC120 Catheter isintended for the isolation of blood flowand delivery of fluids, includingdiagnostic and/or therapeutic agents, toselected sites in the peripheral vascularsystem. The RenovoCath™ RC120 is alsoindicated for temporary vessel occlusionin applications including arteriography,preoperative occlusion, andchemotherapeutic drug infusion. TheRenovoCath™ RC120 is intended forgeneral intravascular use in theperipheral vasculature in arteries 3mmand larger. The RenovoCath™ RC120 isintended for use in arteries from 3mmin diameter for vessel entry and toocclude vessels ranging between 4mmto 11mm in diameter.The diagnostic and/or therapeuticagents are to be used in accordancewith specifications outlined by therespective agent manufacturer.The RenovoCath™ RC120 Catheter isnot intended for use in coronary andintracranial arteries.The RenovoCath™ RC120 Catheter isnot intended for embolic protection oras an aspiration catheter.	The RenovoCath is intended for theisolation of blood flow and delivery offluids, including diagnostic and/ortherapeutic agents, to selected sites inthe peripheral vascular system. TheRenovoCath is also indicated fortemporary vessel occlusion inapplications including arteriography,preoperative occlusion, andchemotherapeutic drug infusion. TheRenovoCath is intended for generalintravascular use in the peripheralvasculature in arteries 3mm and larger.The RenovoCath is intended for use inarteries from 3mm in diameter forvessel entry and to occlude vesselsranging between 3mm to 11mm indiameter.The diagnostic and/or therapeuticagents are to be used in accordancewith specifications outlined by therespective 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 RC 120 Catheter is not intended for use with a power injector.	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
PatientContactingMaterials	Silicone, Pebax, Platinum Iridium	Silicone, Pebax, Platinum Iridium
Effective Length	Adjustable, 76-86cm	Adjustable, 76-86cm
SheathCompatibility	6Fr	6Fr
Catheter Size	0.076" (1.93mm) Max diameter	0.076" (1.93mm) Max diameter
GuidewireCompatibility	Long 0.014"	Long 0.014"
BalloonConfiguration	Dual: Distal and Proximal	Dual: Distal and Proximal
Balloon Type	Compliant, low pressure	Compliant, low pressure
Balloon Distance	Adjustable, 25-120mm	Adjustable, 25-120mm
Balloon OcclusionVessel Range	Proximal and Distal: 4-11mm	Proximal and Distal: 3-11mm
RecommendedBalloon InflationVolume	0.12-1.07cc	0.10-1.07cc
RadiopaqueMarker	Two markers	Two markers
Sterilization	Ethylene Oxide	Ethylene Oxide
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	50/50 saline to contrast	70/30 saline to contrast
Accessories	Two 3cc syringes	Not applicable; no syringes are included

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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.

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).