SENSEI X ROBOTIC CATHETER SYSTEM

K102168 · Hansen Medical, Inc. · DXX · Oct 22, 2010 · Cardiovascular

Device Facts

• Record ID: K102168
• Device Name: SENSEI X ROBOTIC CATHETER SYSTEM
• Applicant: Hansen Medical, Inc.
• Product Code: DXX · Cardiovascular
• Decision Date: Oct 22, 2010
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1290
• Device Class: Class 2

Intended Use

The Hansen Medical Sensel® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters 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

The Hansen Medical Sensei X Robotic Catheter System is a master/slave robotic platform designed to facilitate the manipulation, positioning, and control of steerable catheters within the heart atria. The system allows a physician to operate the catheter remotely from a seated position, away from the x-ray radiation source. The system integrates with electro-anatomic mapping and recording systems to collect electrophysiological data. The device utilizes a master/slave control mechanism to translate physician inputs into precise catheter tip movements. The Sensei X includes an enhanced motion scaling feature compared to the predicate. It is intended for use in a clinical setting by physicians.

Clinical Evidence

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

Technological Characteristics

Robotic master/slave catheter control system. Features include motion scaling for catheter manipulation. Compatible with specific third-party percutaneous mapping catheters (Polaris-Dx, Livewire).

Indications for Use

Indicated for patients requiring electrophysiological data collection within the heart atria using compatible percutaneous mapping catheters.

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 (K091808)

Submission Summary (Full Text)

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K102168

## SECTION 7

OCT 2 2 2010

## 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:

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#### Applicant Information:

Owner Name: Hansen Medical, Inc. Address: 800 East Middlefield Road Mountain View, CA. 94043 Office: 650-404-5800

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

Date Prepared: 7/29/2010

## Device Information:

| Classification: | Class II . |
|----------------------|-----------------------------------------------------------|
| Trade Name: | Hansen Medical Sensei® X Robotic Catheter 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 X Robotic Catheter System is substantially equivalent in intended use and method of operation to the earlier Sensei System (K091808).

## Device Description:

The Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen Control Catheters, 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

Special 510(k) Submission Hansen Medical Sensei X Robotic Catheter System

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

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heart, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei X Robotic Catheter System include an enhancement to the motion scaling feature.

### Intended Use:

The Hansen Medical Senseit X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters 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 X Catheter Control System is substantially equivalent to the predicate device. 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 Sensei X Robotic Catheter System has been shown to be substantially equivalent to a currently marketed predicate device.

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

4102168

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized depiction of an eagle or bird-like symbol, composed of three curved lines that suggest wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

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

OCT 2 2 2010

Re: K102168

Trade/Device Name: Hansen Medical Sensei® X Robotic Catheter System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: DXX Dated: September 24, 2010 Received: September 27, 2010

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) 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 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.

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Page 2 - Ms. Kate Whitin

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
W. M. D.

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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## SECTION 6

# Indications for Use

OCT 2 2 2010

510(k) Number (if known):

Hansen Medical Sensei® X Robotic Catheter System Device Name:

### Indications for Use:

The Hansen Medical Sensel® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters 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) | |

Over-The-Counter Use AND/OR (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 | K102168 |

l o FSpecial 510(k) Submission

Hansen Medical Sensei X Robotic Catheter System Section 6, Page 1 of 1 Indication for Use

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