HANSEN MEDICAL ARTISAN S CONTROL CATHETER

K090365 · Hansen Medical, Inc. · DXX · May 7, 2009 · Cardiovascular

Device Facts

• Record ID: K090365
• Device Name: HANSEN MEDICAL ARTISAN S CONTROL CATHETER
• Applicant: Hansen Medical, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: May 7, 2009
• Decision: SESU
• Submission Type: Special
• Regulation: 21 CFR 870.1290
• Device Class: Class 2

Intended Use

The Hansen Medical Artisan ™ S Control Catheter is 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. The Control Catheter is intended to be used with the Hansen Medical Sensei® Robotic Catheter System.

Device Story

Artisan S Control Catheter facilitates manipulation/positioning of mapping catheters within heart atria; consists of inner and outer guide catheters. Designed for use with Sensei Robotic Catheter System. Operates as robotic-assisted interface for electrophysiological data collection; physician controls catheter via workstation. Output provides precise catheter positioning for electro-anatomic mapping/recording. Benefits include enhanced control during mapping procedures. Warning: safety/effectiveness for cardiac ablation not established.

Clinical Evidence

No clinical data provided; substantial equivalence based on design and engineering data.

Technological Characteristics

Steerable catheter system consisting of inner and outer guide catheters. Designed for integration with Sensei Robotic Catheter System. Class II device (21 CFR 870.1290).

Indications for Use

Indicated for facilitating manipulation, positioning, and control of percutaneous mapping catheters (Polaris-Dx or Livewire) within heart atria for electrophysiological data collection. Used with Sensei Robotic Catheter System. Contraindicated for cardiac ablation catheter use in 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

• Hansen Medical Steerable Guide Catheter (SGC) and Sheath ("Artisan Control Catheter") (K073225)

Submission Summary (Full Text)

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SECTION 7

MAY - 7 2009 K090365
page 1/2

#### 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: | 800 East Middlefield Road |
| | Mountain View, CA 94043 |
| | Office: 650-404-5800 |

Contact Person: Kate Whitin 650 404 5800 Phone Number: Facsimile Number: 650 404 2773

Date Prepared: 2/10/2009

#### Device Information:

Classification: Class II Hansen Medical Artisan TMS Control Catheter Trade Name: Common name: Control Catheter Classification name: Catheter, Steerable, (21 CFR 870.1280/DRA)

#### Predicate Devices:

The Hansen Medical Artisan S Control Catheter is substantially equivalent in intended use and method of operation to the Hansen Medical Steerable Guide Catheter (SGC) and Sheath ("Artisan Control Catheter") (K073225).

#### Device Description:

The Hansen Medical Artisan S Control Catheter is designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The Control Catheter consists of an Inner Guide and an Outer Guide Catheter.

Hansen Medical Artisan S Control Catheter Special 510(k) Submission

Section 7, Page 1 of 2 510(k) Summary

COMPANY CONFIDENTIAL DO NOT COPY

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K090365
page 2/2

The Control Catheter is designed to be used with the Hansen Medical Sensei® Robotic Catheter System.

#### Intended Use:

The Hansen Medical Artisan ™ S Control Catheter is 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.

The Control Catheter is intended to be used with the Hansen Medical Sensei® Robotic Catheter System.

#### Comparison to Predicate Device(s):

The Hansen Medical Artisan S Control Catheter is a minor modification to the Artisan Control Catheter. The modifications described herein do not affect the intended use of the device or alter the fundamental scientific technology associated with the device.

#### Substantial equivalence:

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

Hansen Medical Artisan S Control Catheter Special 510(k) Submission

Section 7, Page 2 of 2 510(k) Surnmary

COMPANY CONFIDENTIAL DO NOT COPY

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

#### Public Health Service

od and Drug Administration 200 Corporate Boulevard Rockville MD 20850

## MAY = 7 2009

Hansen Medical, Inc. c/o Ms. Kate Whitin Director, Regualtory Affairs 800 E. Middlefield Road Mountain View, CA 94043

Re: K090365

Trade/Device Name: Hansen Medical Artisan S Control Catheter Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System i Regulatory Class: Class II Product Codc: DXX and DRA Dated: April 6, 2009 Received: April 7, 2009

Dear Ms. Whitin:

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.

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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 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. ﺮ

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 contact the Center for Devices and Radiological Health's (CDRH's) Office of . Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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You may obtain other general information on your responsibilities under the Act from the Tour may other 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,

Nil R.P. Ogle for

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

Enclosure

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#### SECTION 6

### Indications for Use

# 510(k) Number (if known): K 090365

Hansen Medical Artisan™S Control Catheter Device Name:

#### Indications for Use:

The Hansen Medical Artisan S Control Catheter is 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.

The Control Catheter is intended to be used with the Hansen Medical Sensei® Robotic Catheter System.

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)

(Division Sign-Off)

Division of Cardiovascular Devices

| 510(k) Number | K090365 |
|---------------|---------|
|---------------|---------|

| Hansen Medical<br>Artisan S Control Catheter | COMPANY CONFIDENTIAL DO NOT COPY | Section 6, Page 1 of 1<br>Indication for Use |
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