ARTISAN EXTEND CONTROL CATHETER

K122275 · Hansen Medical · DRA · Aug 29, 2012 · Cardiovascular

Device Facts

• Record ID: K122275
• Device Name: ARTISAN EXTEND CONTROL CATHETER
• Applicant: Hansen Medical
• Product Code: DRA · Cardiovascular
• Decision Date: Aug 29, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1280
• Device Class: Class 2

Intended Use

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

Device Story

Artisan Extend Control Catheter facilitates manipulation, positioning, and control of percutaneous mapping catheters within heart atria; used for collecting electrophysiological data via electro-anatomic mapping and recording systems. Device consists of steerable guide catheter and sheath; designed for integration with Hansen Medical Sensei X Robotic Catheter System. Operates as robotic-assisted interface; physician controls catheter movement via robotic system to navigate atria. Simplifies proximal flush assembly compared to predicate. Benefits include precise catheter positioning for electrophysiological procedures. Used in clinical settings by physicians.

Clinical Evidence

No clinical data; bench testing only. Verification testing included pressure leak, vacuum, tensile strength, flush, and compatibility with Sensei X system. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, hemolysis, thrombogenicity, and complement activation.

Technological Characteristics

Steerable guide catheter and sheath; simplified proximal flush assembly. Biocompatibility per ISO 10993-1; ASTM hemolysis testing. Designed for robotic integration with Sensei X system. Sterilization process identical to predicate.

Indications for Use

Indicated for patients requiring electrophysiological data collection within the heart atria using compatible percutaneous mapping catheters (Polaris-Dx or Livewire) in conjunction with the Sensei X Robotic Catheter System.

Regulatory Classification

Identification

A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.

Predicate Devices

• Artisan Control Catheter (K073225)

Submission Summary (Full Text)

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K12275

### SECTION 7

# AUG 2 9 2012

## 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<br>Mountain View, CA. 94043<br>Office: 650-404-5800 |

| Contact Person: | Hassan Labay |
|-------------------|--------------|
| Phone Number: | 650 404 5888 |
| Facsimile Number: | 650 404 2773 |

Date Prepared: 7/25/2012

#### Device Information:

| Classification: | Class II |
|----------------------|----------------------------------------------|
| Trade Name: | Artisan® Extend Control Catheter : |
| Common name: | Steerable Guide Catheter |
| Classification name: | Catheter, Steerable, (21 CFR 870.1280 / DRA) |

#### Predicate Devices:

The Hansen Medical Artisan Extend 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 Extend Control Catheter is designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. The Artisan Extend Control Catheter consists of a Steerable Guide Catheter (SGC) and Sheath. The Control Catheter is designed to be used with the Hansen Medical Sensei® X Robotic Catheter System.

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

Section 7, Page 1 of 3 510(k) Summary

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#### Intended Use:

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

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

The Hansen Medical Artisan Extend Control Catheter consists of a simplified proximal flush assembly when compared to Artisan Control Catheter's flush assembly. The modifications described herein do not affect the intended use of the device or alter the fundamental scientific technology associated with the device.

#### Technological Characteristics/Performance Data:

The Artisan Extend Control Catheter is substantially equivalent to the predicate device in intended use, fundamental scientific technology, and performance specifications. Design verification testing was performed to verify that the performance of the Artisan Extend Control Catheter remains substantially equivalent to the predicate device. The catheter has been tested for biocompatibility according to ISO10993-1 and was determined to be biocompatible. Testing performed on the Artisan Extend Control Catheter included the following:

- Pressure Leak Test .
- Vacuum Test ●
- Tensile Strength Test ●
- Flush Test .
- Compatibility with Sensei X ● Test
- Biocompatibility Testing
- > ISO MEM Elution Cytotoxicity Test
- > ISO Kligman Maximization Test
- > ISO Intracutaneous Reactivity Study
- > ISO Acute Systemic Toxicity Study
- > ASTM Hemolysis
- > ISO Thrombogenicity Study
- > ISO Complement Activation Assay

All of the pre-determined acceptance criteria were met with passing results.

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

Section 7 Page 2 of 3 510(k) Summary

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### Clinical Testing:

Clinical evaluation was not required for this device.

#### Substantial equivalence:

The Artisan Extend Control Catheter with the modified proximal flush assembly has the following similarities to the predicate device which previously received clearance under K073225.

- has the same indication for use, .
- has the same fundamental scientific technology, .
- incorporate the same basic catheter design, .
- incorporate the same materials, .
- has the same shelf life, and .
- is sterilized using the same sterilization processes. .

In summary, the Artisan Extend Control Catheter subject to this submission is substantially equivalent to the predicate device.

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

Section 7, Page 3 of 3 510(k) Summary

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is positioned to the right of a circular seal that contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### Public Health Service

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

AUG 2 9 2012

Hansen Medical Inc. c/o Mr. Hassan Labay Senior Regulatory Affairs Associate 800 East Middlefield Road Muntain View, CA 94043

Re: K122275

Trade/Device Name: Artisan Extend Control Catheter Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter. Regulatory Class: Class II (two) Product Code: DRA Dated: July 25, 2012 Received: July 30, 2012

Dear Mr. Labay:

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 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 - Mr. Hassan Labay

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.html 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,

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) Number (if known):

Hansen Medical Artisan® Extend Control Catheter Device Name:

Indications for Use:

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

Prescription Use x. (Part 21 CFR 801 Subpart D) AND/OR · Over-The-Counter User
(21 CER 801 Submert (21 CER 801 Submart ( (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)

(Bivision Sign-Off) Division of Cardiovascular Devices

510(k) Number__

K 122275