SENSEI CATHETER CONTROL SYSTEM

K073225 · Hansen Medical, Inc. · DXX · Jun 30, 2008 · Cardiovascular

Device Facts

• Record ID: K073225
• Device Name: SENSEI CATHETER CONTROL SYSTEM
• Applicant: Hansen Medical, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Jun 30, 2008
• Decision: SESU
• Submission Type: Traditional
• Regulation: 21 CFR 870.1290
• Device Class: Class 2

Intended Use

The Sensei Robotic Catheter System, Artisan Catheter, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

Device Story

Sensei Catheter Control System is a master/slave robotic system for percutaneous catheter manipulation in heart atria. Physician operates system from a remote workstation, remaining seated away from x-ray radiation source. System enables precise positioning and visualization of steerable catheter tips. Modified version integrates 3D electro-anatomic maps from third-party mapping systems onto the central workstation screen. Device facilitates electrophysiological data collection; does not perform ablation. Benefits include reduced radiation exposure for physicians and improved catheter control. Used in clinical electrophysiology settings.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design and engineering data.

Technological Characteristics

Master/slave robotic catheter control system. Includes Artisan steerable guide catheter, remote catheter manipulator, and workstation. Integrates third-party 3D electro-anatomic mapping data. Connectivity includes interface with external mapping/recording systems. Class II device.

Indications for Use

Indicated for facilitating manipulation, positioning, and control of percutaneous mapping catheters (Polaris-Dx or Livewire) to collect electrophysiological data within the heart atria. Contraindicated for use with cardiac ablation catheters for treating cardiac arrhythmias, including atrial fibrillation.

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

• Sensei system (K052480)

Submission Summary (Full Text)

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# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

## 510(k) Number:

## Applicant Information:

| Owner Name: | Hansen Medical, Inc. |
|-------------------|--------------------------------------------------------------------------|
| Address: | 380 N. Bernardo Ave.<br>Mountain View, CA. 94043<br>Office: 650-404-5800 |
| Contact Person: | Doug Worth, RAC |
| Phone Number: | 650 404 5800 |
| Facsimile Number: | 650 404 5901 |
| Date Prepared: | 11/14/2007 (revised 1/7/08) |

## Device Information:

| Classification: | Class II |
|----------------------|------------------------------------------------------------|
| Trade Name: | Sensei Catheter Control System |
| Common name: | Steerable Catheter Control System |
| Classification name: | System, Catheter Control, Steerable, (21 CFR 870.1290/DXX) |

## Predicate Devices:

The modified Hansen Medical Sensei Catheter Control system is substantially equivalent in intended use and method of operation to the earlier Sensei system (K052480).

## Device Description:

The Hansen Medical Sensei Catheter Control, Artisan Catheter and accessories and are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart, whilst enabling a physician to remain seated and away

K073225 Hansen Medical

Attachment 2, Page 2 of 3 Indication for Use and 510(k) Summary

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from the x-ray radiation source The Catheter Control System has been modified to display 3D electroanotomic maps from a 30 party mapping system in the center screen of the Sensei system.

### Intended Use:

The Sensei Robotic Catheter System, Artisan Catheter, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

### Comparison to Predicate Device(s):

The modified Hansen Medical Sensei Catheter Control System is substantially equivalent to the predicate device.

#### Substantial equivalence:

Based upon the indications for use and the design and engineering data provided in this pre-market notification, the Hansen Medical Sensei Robotic Catheter System, Artisan Catheter and have been shown to be substantially equivalent to a currently marketed predicate device.

K073225 Hansen Medical

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.

Public Health Service

JUN 3 0 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Hansen Medical, Inc. c/o Doug Worth, RAC Manager, Regulatory Affairs 380 N. Bernardo Ave. Mountain View, CA 94043

Re: K073225

> Trade/Device Name: Sensei Catheter Control System, Model 02057 Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX and DRA Dated: May 29, 2008 Received: May 30, 2008

Dear Mr. Worth:

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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling, on the packaging for the Artisan Steerable Guide Catheter and Sheath, on the Remote Catheter Manipulator, and the Workstation:

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

Furthermore, this warning must be prominently displayed on the Remote Catheter Manipulator, Workstation, all labeling, including pouch box, and carton labels, instructions for use and other

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Page 2 -- Mr. Doug Worth, RAC

promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

NOCETIN

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): Ko13225

- Hansen Medical Sensei Catheter Control System Device Name: Hansen Medical Artisan Steerable guide Catheter
#### Indications for Use:

The Sensei Robotic Catheter System, Artisan Catheter, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Deeth

K073225 Hansen Medical

Attachment 2, Page 1 of 3 Indication for Use and 510(k) Summary