MERCATOR MICROSYRINGE II INFUSION CATHETER

K062752 · Mercator Medsystems, Inc. · KRA · Dec 7, 2006 · Cardiovascular

Device Facts

• Record ID: K062752
• Device Name: MERCATOR MICROSYRINGE II INFUSION CATHETER
• Applicant: Mercator Medsystems, Inc.
• Product Code: KRA · Cardiovascular
• Decision Date: Dec 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1210
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Device Story

Wire-guided endovascular catheter; features perpendicular microneedle delivery port; sheathed within semi-rigid polymer balloon actuator; includes compliant low-pressure forcing balloon opposite microneedle. Advanced over 0.014" guidewire; single operator method. Mechanical actuation deploys microneedle into vessel wall/perivascular structures for targeted agent delivery. Used in clinical settings by physicians for peripheral and coronary interventions. Enables localized drug delivery to specific vessel sites; potentially improves therapeutic efficacy compared to systemic or standard intraluminal delivery.

Clinical Evidence

Bench testing only. Testing included mechanical performance, fluid delivery, biocompatibility, sterilization validation, and in-vivo safety. All components and full devices met pre-determined specifications.

Technological Characteristics

Endovascular catheter; 0.014" guidewire compatible; features microneedle delivery port and compliant balloon actuator. Materials are biocompatible and previously cleared. Sterilization method not specified. Mechanical actuation principle.

Indications for Use

Indicated for infusion of diagnostic and therapeutic agents into vessel walls, perivascular areas, or intraluminally within peripheral and coronary vessels.

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 Infusion Catheter (K040139)
• Dispatch Coronary Infusion Catheter (K932616)
• Selective Infusion II Catheter (K914751)
• Isolate Infusion Catheter System (K913517)

Submission Summary (Full Text)

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\$\qquad 1062752\$

510(k) Notification Mercator MicroSyringe II Infusion Catheter August 15, 2006

## Appendix A 510(k) Summary of Safety and Effectiveness

UEU = 7 2006

| Submitted by | Kirk P. Seward, Ph.D<br>President and Chief Technology Officer<br>Mercator MedSystems, Inc.<br>3077 Teagarden Street<br>San Leandro, CA 94577<br>Telephone: [phone]<br>Facsimile: 510 667-0435 | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person | Same as above | |
| Date Summary Prepared | August 15, 2006 | |
| Trade Name | Mercator MicroSyringe II Infusion Catheter | |
| Common Name | Continuous Flush Infusion Catheter (per 21 CFR 870.1210) | |
| Performance Standards | Not promulgated for Continuous Flush Infusion Catheters | |
| Classification | KRA/Class II | |
| Panel | Cardiovascular | |
| Predicate Devices | | |
| | Mercator MicroSyringe Infusion Catheter<br>Manufactured by Mercator MedSystems, Inc. | K040139 |
| | Dispatch Coronary Infusion Catheter<br>Manufactured by SCIMED® Life Systems, Inc. | K932616 |
| | Selective Infusion II Catheter<br>Manufactured by ACS®/Guidant, Inc. | K914751 |
| | Isolate Infusion Catheter System<br>Manufactured by Lake Region, Inc. | K913517 |

#### Device Description

The Mercator MicroSyringe II is a wire-guided endovascular catheter that consists of a perpendicular microneedle delivery port, which is sheathed by and consists of a
semi rigid nolymor halless sollyery port, which is sheathed within a semi-rigid polymer balloon actuator with an integrated compliant low-pressure forcing balloon opposite the microneedle. The device is advanced over a 0.014" guidewire, using a single operator method. The device is advanced over a 0.014 guidewire, use the needle delivery port into the troutinent vossel and nythanically actualed to
ctructures structures.

### Intended Use

In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the infaction of diagricult area. The MicroSyringe II Infusion Catheter is also internet was of diagnostic and therapeutic agents
infraluminally intraluminally.

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510(k) Notification Mercator MicroSyringe II Infusion Catheter August 15, 2006

Technological Characteristics

All materials used in the manufacture of the MicroSyringe II are suitable for this use and have been used in several previously cleared products.

Testing

Testing of mechanical and fluid delivery performance, biocompatibility, sterilization validation, and in-vivo safety were conducted to ensure the MicroSyringe II met all of its pre-determined specifications.

All components, subassemblies and/or full devices met the required specifications for the tests. The results of these tests demonstrated that the device is as safe and effective as the legally marketed predicate devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mercator MedSystems, Inc. c/o Kirk P. Seward, Ph.D. President and Chief Technology Officer 3077 Teagarden Street San Leandro, CA 94577

DEC - 7 2006

Re: K062752

Mercator MicroSyringe II Infusion Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: November 20, 2006 Received: December 1, 2006

Dear Dr. Seward:

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, Orug, 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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, RDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Kirk P. Seward, Ph.D.

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/industry/support/index.html.

Sincerely yours,

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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510(k) Notification Mercator MicroSyringe II Infusion Catheter August 15, 2006

# Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Mercator MedSystems MicroSyringe II Infusion Catheter____________________________________________________________________________________________________________

Indications For Use:

In selective areas of peripheral and coronary vessels, the MicroSyringe II Infusion Catheter is intended for the infusion of diagnostic and therapeutic agents that are indicated for delivery into the vessel wall or perivascular area. The MicroSyringe II Infusion Catheter is also intended for the infusion of diagnostic and therapeutic agents intraluminally.

Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K062752

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