The RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapentic 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 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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the RenovoCath device, based on the provided text:

Key Takeaway: This submission is for a device that is substantially equivalent to a previously cleared device. The "study" here refers to bench testing performed to demonstrate that the new device performs comparably to the predicate device (the previously cleared version) despite minor design changes. Therefore, there isn't a typical "study" in the sense of a clinical trial with human subjects, AI assistance, or complex ground truth establishment as might be seen for novel AI/ML devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission seeking substantial equivalence to a predicate device, the "acceptance criteria" are implicitly that the subject device performs functionally the same as the predicate device across various performance measures. The "reported device performance" demonstrates this equivalence.

Acceptance Criteria (Implicit: Performance same as Predicate)	Reported Device Performance (Subject Device)
Indications for Use: Identical to Predicate	Identical: Intended for isolation of blood flow & delivery of fluids (diagnostic/therapeutic) to peripheral vascular system; temporary vessel occlusion (arteriography, preoperative occlusion, chemotherapeutic drug infusion); general intravascular use in peripheral vasculature in arteries 3mm+; occludes vessels 3mm-11mm. Diagnostic/therapeutic agents used per manufacturer.
Contraindications: Identical to Predicate	Identical: Physician determines physical impairment/vascular abnormality/contrast medium reaction contraindicates use. Not for use in coronary/intracranial arteries. Not for embolic protection or as an aspiration catheter.
Single Use: Identical to Predicate	Yes
Patient Contacting Materials: Identical to Predicate	Silicone, Pebax, Platinum Iridium
Effective Length: Meets specification	Adjustable, 75cm-85cm (Predicate: 76cm-86cm). Slight difference but considered equivalent as per statement "changes impacted the balloon to balloon distance and effective length" and overall conclusion of substantial equivalence.
Sheath Compatibility: Identical to Predicate	6Fr
Catheter Size: Identical to Predicate	0.076" (1.93mm) Max diameter
Guidewire Compatibility: Identical to Predicate	Long 0.014"
Balloon Configuration: Identical to Predicate	Dual: Distal and Proximal
Balloon Type: Identical to Predicate	Compliant, low pressure
Balloon Distance: Meets specification	Adjustable, 15mm-109mm (Predicate: 25mm-120mm). Slight difference but considered equivalent as per statement "changes impacted the balloon to balloon distance and effective length" and overall conclusion of substantial equivalence.
Balloon Occlusion Vessel Range: Identical to Predicate	Proximal and Distal: 3mm-11mm
Recommended Balloon Inflation Volume: Identical to Predicate	0.10cc-1.07cc
Radiopaque Marker: Identical to Predicate	Two markers
Shaft Design: Identical to Predicate	Dual lumen inner shaft within a multi-lumen shaft (one lumen for distal balloon inflation, one for guidewire); outer catheter is multi-lumen shaft (one houses inner shaft, one for proximal balloon inflation, one for drug infusion).
Fluid Delivery: Identical to Predicate	Dual Lumen - one for saline, one for diagnostic/therapeutic fluid.
Contrast Medium Ratio: Identical to Predicate	70/30 saline to contrast
Accessories: Identical to Predicate	Not applicable; no syringes included.
Functional Performance: Same as Predicate	Bench testing confirmed that "functionally the RenovoCath performs the same as the predicate device in facilitating the delivery of fluids to the peripheral vasculature." This was demonstrated through: Dimensional Inspection, Insertion and Tracking Testing, Balloon Testing, Infusion Flow Rate Testing, and Simulated In-Vivo Testing. The collective results demonstrate it "meets its specifications and performs as intended."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify exact sample sizes for each of the bench tests (Dimensional Inspection, Insertion and Tracking Testing, Balloon Testing, Infusion Flow Rate Testing, Simulated In-Vivo Testing). It generally refers to these as "testing" using "the same methods previously established."
Data Provenance: The data is from bench testing performed by RenovoRx, Inc. It is prospective testing designed to evaluate the new device against the predicate. The country of origin for the testing would be the USA, where RenovoRx, Inc. is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This type of information is generally not applicable to this 510(k) submission. The "ground truth" for this device, which is a physical catheter, is its physical and functional specifications. The "ground truth" for its performance is derived from bench testing that measures physical characteristics and operational performance against predefined engineering specifications and comparison to the predicate device's known performance. This does not involve clinical "experts" establishing ground truth in the way an AI/ML diagnostic device would.

4. Adjudication Method for the Test Set

Not applicable. The 'adjudication' in this context is the comparison of bench testing results to the predicate device's performance and to engineering specifications. There is no mention of a human adjudication process for interpreting results in a subjective manner.

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 medical device (catheter), not an AI-powered diagnostic tool. No MRMC study or AI assistance is mentioned or relevant to this submission.

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

Not applicable. This is a physical medical device. There is no algorithm or AI component.

7. The Type of Ground Truth Used

The ground truth used for the subject device is its engineering specifications and the established performance characteristics of the legally marketed predicate device (RenovoCath® K191606). The goal of the testing was to demonstrate that the new device met its own specifications and performed comparably to the predicate.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device. There is no training set in the context of AI/ML.

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

Not applicable. As there is no training set in the AI/ML sense, this question is not relevant.

Summary

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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

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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

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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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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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.

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PRODUCT DESCRIPTION

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. RenovoCathK191606	RenovoRx, Inc.RenovoCathK212324
IndicationsforUse	The RenovoCath is intended for theisolation of blood flow and delivery offluids, including diagnostic and/ortherapeutic agents, to selected sites in theperipheral vascular system. TheRenovoCath is also indicated fortemporary vessel occlusion in applicationsincluding arteriography, preoperativeocclusion, and chemotherapeutic drug	The RenovoCath is intended for theisolation of blood flow and delivery offluids, including diagnostic and/ortherapeutic agents, to selected sites in theperipheral vascular system. TheRenovoCath is also indicated fortemporary vessel occlusion in applicationsincluding arteriography, preoperativeocclusion, and chemotherapeutic drug
Feature	Predicate DeviceRenovoRx, Inc. RenovoCathK191606	Subject DeviceRenovoRx, Inc.RenovoCathK212324
	infusion. The RenovoCath is intended forgeneral intravascular use in the peripheralvasculature in arteries 3mm and larger.The RenovoCath is intended for use inarteries from 3mm in diameter for vesselentry and to occlude vessels rangingbetween 3mm to 11mm in diameter.The diagnostic and/or therapeutic agentsare to be used in accordance withspecifications outlined by the respectiveagent manufacturer.	infusion. The RenovoCath is intended forgeneral intravascular use in the peripheralvasculature in arteries 3mm and larger.The RenovoCath is intended for use inarteries from 3mm in diameter for vesselentry and to occlude vessels rangingbetween 3mm to 11mm in diameter.The diagnostic and/or therapeutic agentsare to be used in accordance withspecifications outlined by the respectiveagent manufacturer.
Contraindications	It is the responsibility of the physician todetermine whether any physicalimpairment, including any vascularabnormality or reaction to contrastmedium, of the patient wouldcontraindicate the use of this device.The RenovoCath is not intended for use incoronary and intracranial arteries.The RenovoCath is not intended forembolic protection or as an aspirationcatheter.	It is the responsibility of the physician todetermine whether any physicalimpairment, including any vascularabnormality or reaction to contrastmedium, of the patient wouldcontraindicate the use of this device.The RenovoCath is not intended for use incoronary and intracranial arteries.The RenovoCath is not intended forembolic protection or as an aspirationcatheter.
Single Use	Yes	Yes
PatientContactingMaterials	Silicone, Pebax, Platinum Iridium	Silicone, Pebax, Platinum Iridium
Effective Length	Adjustable, 76cm-86cm	Adjustable, 75cm-85cm
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, 25mm-120mm	Adjustable, 15mm-109mm
Balloon OcclusionVessel Range	Proximal and Distal: 3mm-11mm	Proximal and Distal: 3mm-11mm
RecommendedBalloon InflationVolume	0.10cc-1.07cc	0.10cc-1.07cc
RadiopaqueMarker	Two markers	Two markers
	Predicate Device	Subject Device
Feature	RenovoRx, Inc. RenovoCathK191606	RenovoRx, Inc.RenovoCathK212324
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

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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).