RenovoCath

K191606 · Renovorx, Inc. · MJN · Aug 7, 2019 · Cardiovascular

Device Facts

• Record ID: K191606
• Device Name: RenovoCath
• Applicant: Renovorx, Inc.
• Product Code: MJN · Cardiovascular
• Decision Date: Aug 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4450
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 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 Story

Multi-lumen, dual-balloon catheter; adjustable distance between proximal and distal balloons; radiopaque markers for fluoroscopic positioning. Used in peripheral vasculature; physician-operated under fluoroscopic guidance. Input: manual inflation of balloons via syringes; delivery of diagnostic/therapeutic fluids via infusion lumen. Output: localized vessel occlusion and targeted fluid delivery. Benefits: enables site-specific drug delivery and blood flow isolation. Compatible with 6 Fr guide sheaths, 7 Fr guide catheters, and 0.014" guidewires.

Clinical Evidence

Bench testing only. Testing included flow rate, vessel occlusion, fluoroscopic visibility, dimensional verification, insertion/tracking, balloon performance, infusion flow rate, simulated use, bond strength, and infusion port burst testing. Results demonstrate device meets specifications and performs as intended.

Technological Characteristics

Multi-lumen, dual-balloon catheter; materials: Silicone, Pebax, Platinum Iridium. Energy: manual hydraulic (balloon inflation). Dimensions: 76-86cm adjustable length, 0.076" max diameter. Connectivity: none. Sterilization: Ethylene Oxide. Design: dual-lumen inner shaft for distal balloon/guidewire; outer shaft for proximal balloon and drug infusion.

Indications for Use

Indicated for isolation of blood flow and delivery of diagnostic/therapeutic agents to peripheral vascular sites; temporary vessel occlusion for arteriography, preoperative occlusion, and chemotherapeutic infusion. For use in peripheral arteries >=3mm diameter; occludes vessels 3mm-11mm. Contraindicated for coronary and intracranial arteries; not for embolic protection or aspiration.

Regulatory Classification

Identification

A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.

Predicate Devices

• RenovoCath RC120 Catheter (K160067)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 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.

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: [phone]

Contact Person Debra Cogan Regulatory Consultant for RenovoRx, Inc. Phone: [phone]

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

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.

## 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.<br>RenovoCath RC120 Catheter<br>(K160067) | RenovoRx, Inc.<br>RenovoCath |
| Feature | | |
| Indications for<br>Use | The RenovoCath™ RC120 Catheter is<br>intended for the isolation of blood flow<br>and delivery of fluids, including<br>diagnostic and/or therapeutic agents, to<br>selected sites in the peripheral vascular<br>system. The RenovoCath™ RC120 is also<br>indicated for temporary vessel occlusion<br>in applications including arteriography,<br>preoperative occlusion, and<br>chemotherapeutic drug infusion. The<br>RenovoCath™ RC120 is intended for<br>general intravascular use in the<br>peripheral vasculature in arteries 3mm<br>and larger. The RenovoCath™ RC120 is<br>intended for use in arteries from 3mm<br>in diameter for vessel entry and to<br>occlude vessels ranging between 4mm<br>to 11mm in diameter.<br>The diagnostic and/or therapeutic<br>agents are to be used in accordance<br>with specifications outlined by the<br>respective agent manufacturer.<br>The RenovoCath™ RC120 Catheter is<br>not intended for use in coronary and<br>intracranial arteries.<br>The RenovoCath™ RC120 Catheter is<br>not intended for embolic protection or<br>as an aspiration catheter. | The RenovoCath is intended for the<br>isolation of blood flow and delivery of<br>fluids, including diagnostic and/or<br>therapeutic agents, to selected sites in<br>the peripheral vascular system. The<br>RenovoCath is also indicated for<br>temporary vessel occlusion in<br>applications including arteriography,<br>preoperative occlusion, and<br>chemotherapeutic drug infusion. The<br>RenovoCath is intended for general<br>intravascular use in the peripheral<br>vasculature in arteries 3mm and larger.<br>The RenovoCath is intended for use in<br>arteries from 3mm in diameter for<br>vessel entry and to occlude vessels<br>ranging between 3mm to 11mm in<br>diameter.<br>The diagnostic and/or therapeutic<br>agents are to be used in accordance<br>with specifications outlined by the<br>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 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 |
| Patient<br>Contacting<br>Materials | Silicone, Pebax, Platinum Iridium | Silicone, Pebax, Platinum Iridium |
| Effective Length | Adjustable, 76-86cm | Adjustable, 76-86cm |
| Sheath<br>Compatibility | 6Fr | 6Fr |
| Catheter Size | 0.076" (1.93mm) Max diameter | 0.076" (1.93mm) Max diameter |
| Guidewire<br>Compatibility | Long 0.014" | Long 0.014" |
| Balloon<br>Configuration | 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 Occlusion<br>Vessel Range | Proximal and Distal: 4-11mm | Proximal and Distal: 3-11mm |
| Recommended<br>Balloon Inflation<br>Volume | 0.12-1.07cc | 0.10-1.07cc |
| Radiopaque<br>Marker | 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.