PEREGRINE SYSTEM INFUSION CATHETER

K140637 · Ablative Solutions, Inc. · KRA · Mar 26, 2014 · Cardiovascular

Device Facts

• Record ID: K140637
• Device Name: PEREGRINE SYSTEM INFUSION CATHETER
• Applicant: Ablative Solutions, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Mar 26, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area.

Device Story

The Peregrine System Infusion Catheter is a percutaneous device used to deliver diagnostic and therapeutic agents into the perivascular space of peripheral vessels (5-7 mm diameter). Operated by a physician, the catheter is compatible with 7F guide catheters. The device features three distal needles deployed via a control handle; mechanical actuation of the handle advances the needles to a pre-specified depth, allowing for circumferential fluid delivery in a single injection. The needles and guide tubes are radiopaque for fluoroscopic guidance. By enabling targeted perivascular delivery, the device aims to provide therapeutic benefits to the vessel wall or surrounding tissue. The system is used in a clinical setting, such as a catheterization lab, where the physician monitors placement via fluoroscopy.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical bench testing, including biocompatibility (ISO 10993), functional testing (ISO 10555-1), visual/dimensional inspection, air ingress, tensile strength, leakage, flexibility, kink resistance, tip stiffness, deployment force, torque, corrosion resistance, chemical compatibility, simulated-use testing, and in-vivo testing.

Technological Characteristics

Percutaneous infusion catheter; 3 distal needles; mechanical handle actuation; radiopaque needles and guide tubes; compatible with 7F guide catheters. Materials tested for biocompatibility per ISO 10993. Functional testing per ISO 10555-1. No software or electronic components.

Indications for Use

Indicated for infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature in vessels 5-7 mm in diameter.

Regulatory Classification

Identification

A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.

Predicate Devices

• Mercator MicroSyringe II Infusion Catheter (K062752)
• Rex Medical Quadra-Fuse Multi-pronged Injection Needle (exempt)

Submission Summary (Full Text)

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# 510(K) SUMMARY (21 CFR 807.92)

## ABLATIVE SOLUTIONS, INC. PEREGRINE SYSTEM™ INFUSION CATHETER

- Ablative Solutions, Inc. 510(k) Owner: 801 Hermosa Way Menlo Park, CA 94025 Tel: [phone] Fax: [phone]
- Contact Person: Sharon Rockwell Tel: [phone] Fax: [phone] E-mail: [e-mail]
- February 2014 Date Prepared:

Trade Name: Peregrine System™ Infusion Catheter

- Common Name: Continuous flush catheter
- Classification Name: Continuous flush catheter per 21 CFR 870.1210, KRA
- Predicate Devices: Mercator MicroSyringe II Infusion Catheter K062752 Rex Medical Quadra-Fuse Multi-pronged Injection Needle (exempt)
- Device Description: The Peregrine System Infusion Catheter is a percutaneous catheter designed to deliver diagnostic and therapeutic agents through a vessel wall and into the perivascular space. The catheter contains three distal needles which are deployed using the control handle. Fluids are administered through the proximal injection lumen in the handle, which delivers the fluid through the needles at the distal end of the device. The micro-needles and the guide tubes are radiopaque for fluoroscopic visibility. The device is intended for vessels 5-7 mm in diameter and is compatible with guide catheters of at least 7F.
- The Peregrine System Infusion Catheter is intended for the Indications for Use: infusion of diagnostic and therapeutic agents into the perivascular area of the peripheral vasculature.

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The indications are substantially equivalent to the indications for the Mercator MedSystems MicroSyringe II Infusion Catheter. The MicroSyringe II is additionally indicated for use in the coronary vessels and for injection of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall. Technological

Characteristics: The Peregrine System Infusion Catheter has three equally circumferentially spaced needles which deliver a diagnostic or therapeutic agent to a pre-specified depth by actuating the handle. A fluid can therefore be delivered to the perivascular area with complete circumferential coverage using a single injection. The needles are advanced mechanically from the handle.

> The technological characteristics are comparable to the predicate device, which delivers drugs through a single micro-needle to a pre-specified depth. The micro-needle in the predicate device punctures the vessel wall using the force of a balloon at the distal Multiple, circumferential micro-needle end of the catheter. technology also exists in commercially available injection needles, which are 510(k) exempt.

> The technological characteristics of the Peregrine System Infusion Catheter are comparable to the predicate device, and can be validated with bench testing. There are no technological differences which could raise new questions of safety or efficacy.

### Non-Clinical

Performance Data:

Non-clinical testing included biocompatibility testing of the assembled device as defined in ISO 10993, functional testing as defined in ISO 10555-1 with Amendments 1 and 2, and customized testing for performance. Testing performed on the proposed device included:

- Visual/Dimensional Inspection .
- Air Ingress/Negative Collapse .
- Tensile Strength .
- . Liquid Leakage under Pressure/Leakage at Hub
- Flexibility and Kink .
- . Tip Stiffness
- Guide Tube Deployment Force ●
- . Catheter Torque
- . Guidewire Torque
- Corrosion Resistance .
- Chemical Compatibility .
- Simulated Use Testing ●
- Biocompatibility: ●

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- Cytotoxicity o
- o Sensitization
- Irritation/Intracutaneous O
- Acute systemic toxicity O
- Materials mediated pyrogenicity o
- Hemocompatibility hemolysis by direct contact O
- Hemocompatibility hemolysis by extract o
- O Complement activation of C3a and SC5b-9
- O Thrombogenicity in Sheep
- Packaging/Simulated Shipping Testing .
- Sterilization validation .
- In-vivo testing .

#### Conclusions:

The non-clinical bench testing, simulated-use testing and in-vivo testing demonstrate that the Peregrine System Infusion Catheter functions as intended, meets the requirements of ISO 10555-1, and performs equivalent or better than the predicate device. The testing supports a determination of substantial equivalence to products previously cleared by FDA.

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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 26, 2014

Ablative Solutions, Inc. c/o Sharon Rockwell Regulatory Affairs Consultant 801 Hermosa Way Menlo Park, CA 94025

Re: K140637

Trade/Device Name: Peregrine System™ Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA Dated: February 26, 2014 Received: March 12, 2014

Dear Ms. Rockwell:

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

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Page 2 - Ms. Sharon Rockwell

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] 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" (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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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 STATEMENT

510(k) Number (if known): K140637 ....

Device Name: Peregrine System™ Infusion Catheter

Indications for Use: The Peregrine System is intended for the infusion of diagnostic and therapeutic agents into the perivascular area.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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