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 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.

AI/ML Overview

The Hansen Medical Artisan Extend Control Catheter is a Class II steerable guide catheter, a modification of an existing device (K073225). The device is intended to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart, specifically with the Hansen Medical Sensei® X Robotic Catheter System and certain Boston Scientific and St. Jude Medical catheters.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states, "All of the pre-determined acceptance criteria were met with passing results." However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.

Test Category	Acceptance Criteria (Implied)	Reported Device Performance
Functional Tests	Device performs as intended, no leaks, proper flush, adequate tensile strength, compatibility with Sensei X.	Met all pre-determined criteria and passed.
Pressure Leak Test	(Presumably no leaks or within acceptable leak rate)	Passed
Vacuum Test	(Presumably no failure under vacuum)	Passed
Tensile Strength Test	(Presumably maintains structural integrity under specified load)	Passed
Flush Test	(Presumably allows proper flushing)	Passed
Compatibility with Sensei X Test	(Presumably proper integration and function with the robotic system)	Passed
Biocompatibility Tests	No adverse biological reactions beyond accepted levels	Met all pre-determined criteria and passed.
ISO MEM Elution Cytotoxicity Test	(Presumably non-cytotoxic)	Passed
ISO Kligman Maximization Test	(Presumably non-sensitizing)	Passed
ISO Intracutaneous Reactivity Study	(Presumably non-irritating)	Passed
ISO Acute Systemic Toxicity Study	(Presumably non-toxic systemically)	Passed
ASTM Hemolysis	(Presumably acceptable levels of hemolysis)	Passed
ISO Thrombogenicity Study	(Presumably low thrombogenic potential)	Passed
ISO Complement Activation Assay	(Presumably low complement activation)	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample sizes used for each of the performance and biocompatibility tests. It only states that design verification testing was performed.

Regarding data provenance: The tests were conducted by the manufacturer, Hansen Medical, Inc., as part of a 510(k) submission to the FDA. This indicates the data is from an internal testing environment rather than a clinical setting. Given the nature of these engineering and biocompatibility tests, they are inherently prospective for the device being evaluated. There is no information regarding the country of origin of the data beyond the manufacturer's location in Mountain View, CA, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to the type of testing performed. The "ground truth" for these engineering and biocompatibility tests is established by industry standards (e.g., ISO, ASTM) and internal design specifications, not by expert consensus on clinical findings. For example, a leak test has an objective pass/fail criterion based on measurable parameters, not on an expert's interpretation.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective human interpretation of data, typically in clinical evaluations or image analysis. The tests described are objective, pass/fail engineering and laboratory tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical evaluation was not required for this device." This device is a modification of a previously cleared predicate device, and the changes (simplified proximal flush assembly) were determined not to affect the intended use or fundamental scientific technology, precluding the need for clinical studies.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable here. This is a medical device (a catheter), not a software algorithm or AI model. The performance is assessed through physical and biological testing, not through standalone algorithm evaluation.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed is based on:

Industry Standards: Many tests refer to ISO (International Organization for Standardization) and ASTM (American Society for Testing and Materials) standards, which define methodologies and acceptable ranges for performance and biocompatibility.
Manufacturer Design Specifications: The "pre-determined acceptance criteria" would have been set by Hansen Medical based on the functional requirements of the device and comparison to the predicate device.
Objective Measurement: For tests like Pressure Leak, Vacuum, and Tensile Strength, the ground truth is based on measurable physical properties and compliance with a defined range or threshold.

8. The Sample Size for the Training Set

This is not applicable. This device is not an AI/ML algorithm that requires a "training set." It is a physical medical device.

9. How the Ground Truth for the Training Set was Established

This is not applicable as there is no training set for a physical medical device.

Summary

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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 RoadMountain View, CA. 94043Office: 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:

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 (800) 638-2041 or (301) 796-7100 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 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

Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).