AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES

K113628 · Catheter Robotics, Inc. · DXX · Jun 12, 2012 · Cardiovascular

Device Facts

• Record ID: K113628
• Device Name: AMIGO REMOTE CATHETER SYSTEM (RCS) & ACCESSORIES
• Applicant: Catheter Robotics, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2

Intended Use

The Amigo Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle. The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established. The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.

Device Story

Amigo RCS is a steerable catheter control system; provides remote interface for commercially available catheters. Physician uses remote controller to insert, withdraw, rotate, and deflect catheter tip; enables operation from outside x-ray radiation field. System includes disposable components to maintain sterile field. Used in clinical settings for cardiac electrophysiology procedures; facilitates catheter positioning for tissue stimulation and data recording. Benefits include reduced radiation exposure for physician and improved stability during catheter placement. Output is physical manipulation of the catheter; physician visualizes placement via standard imaging equipment.

Clinical Evidence

Clinical evaluation confirmed the device is safe and effective and operates as designed for its intended use. Bench testing included electrical/mechanical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), biocompatibility (ISO 10993-1), cleaning, sterilization, shelf life, and transit studies. Risk analysis performed per ISO 14971.

Technological Characteristics

Steerable catheter control system; electromechanical actuation. Includes disposable components for sterile field maintenance. Complies with IEC 60601-1 (electrical/mechanical safety), IEC 60601-1-2 (EMC), and ISO 10993-1 (biocompatibility). System is designed for use with specific diagnostic catheters (e.g., Boston Scientific Blazer™ Dx-20).

Indications for Use

Indicated for patients requiring electrophysiological data recording or cardiac tissue stimulation in the right atrium and right ventricle using percutaneous diagnostic catheters. Contraindicated for ablation procedures and cardiac mapping with catheters other than the Boston Scientific Blazer™ Dx-20.

Regulatory Classification

Identification

A steerable catheter control system is a device that is connected to the proximal end of a steerable guide wire that controls the motion of the steerable catheter.

Predicate Devices

• Hansen Medical Catheter Control System (CCS) & Accessories (K052480)
• Stereotaxis Niobe MNS Catheter Control System & Accessories (K021555)

Submission Summary (Full Text)

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K113628

#### 510(k) Summary (As required by section 21 CFR 807.92(c))

| Contact: | Catheter Robotics, Inc.<br>Jennifer Englund<br>Vice President, Clinical Affairs and Regulatory<br>Telephone: [phone] / Fax: [phone]<br>Email: [e-mail] |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 6, 2011 |
| Product Trade Name: | Amigo Remote Catheter System (RCS) & Accessories,<br>Model 1012 |
| Common/Usual Name: | Steerable Catheter Control System |
| Classification Name: | System, Catheter Control, Steerable, Class II<br>(21 CFR 870.1290, Product Code DXX) |
| Predicate Devices: | Hansen Medical Catheter Control System (CCS)<br>& Accessories, Hansen Medical, Inc. (K052480) |
| | Stereotaxis Niobe MNS Catheter Control System &<br>Accessories, Stereotaxis, Inc. (K021555) |
| Manufacturer: | Catheter Robotics, Inc.<br>500 International Drive<br>Mount Olive, NJ 07828 |

3008365050 Establishment Registration:

### Device Description:

તે જે

ે જેવાં છે.
વર્ષના વિશ્વ

The Amigo RCS is designed to create a simple interface with commercially available catheters allowing the physician to insert, withdraw and rotate the catheter, and deflect the catheter tip via the remote controller. Catheter placement and positioning is performed under direct visualization using standard imaging equipment, while enabling the physician to remain seated and away from the x-ray radiation field. The Amigo RCS system includes several disposable components which help to maintain the sterile field.

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#### Statement of Intended Use:

The Amigo Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.

The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established.

The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.

### Summary of Technological Characteristics in Comparison to the Predicate Device:

The Amigo RCS is substantially equivalent to the predicated devices. Both the proposed and predicate devices provide stability for positioning of EP catheters, while allowing the physician to perform the procedure from a position beyond the radiation field.

#### Substantial Equivalence:

Based upon the intended use and technical information provided in this pre-market notification, the Amigo RCS and accessories have been shown to be substantially equivalent to currently marketed predicate devices.

### Summary of Non-Clinical Testing:

Design verification and validation testing was performed to ensure that the Amiqo RCS and accessories met design specifications and customer requirements. Testing activities included electrical/mechanical safety tests and functional performance tests as well as cleaning, biocompatibility, sterilization, shelf life and transit studies.

Risk analysis activities were completed based on ISO 14971. Electrical/mechanical device safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1 and 60601-1-2, respectively. Supporting biocompatibility studies were performed in accordance with ISO 10993-1.

### Summary of Clinical Testing:

The clinical evaluation confirmed that Amigo RCS is safe and effective and operates as designed for its intended use and as described in its proposed labeling.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a graphic representation of an eagle or bird-like figure, with three curved lines forming its body and wings.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

JUN 1 2 2012

Catheter Robotics Inc. c/o Ms. Jennifer Englund Vice President-Clinical and Regulatory Affairs 500 International Drive, Suite 120 Mount Olive, NJ 07828

Re: K113628

> Trade Name: Amigo Remote Catheter System & Accessories, Model 1012 Regulatory Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (Two) Product Code: DXX Dated: May 31, 2011 Received: June 4. 2011

Dear Ms. Englund:

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 Gontrols) or class-III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Ms. Jennifer Englund

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 (reporting of medical device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportaProblem/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,

fo. 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

510(k) Number (if known): _ K113628

Device Name:

# Catheter Robotics, Inc. Amigo Remote Catheter System (RCS) & Accessories, Model 1012

Indications for Use:

The Amigo Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.

The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established.

The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.

Prescription Use X Over-The-Counter Use Prescription Ose ____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
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| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |

**510(k) Number** K113628