The Hansen Medical Sensei® 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 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 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 a series of software enhancements and a new E-Stop button.

AI/ML Overview

The provided document is a 510(k) summary for the Hansen Medical Sensei X Robotic Catheter System. It describes a device that is an updated version of a previously cleared device. Therefore, the "study" described is a design verification and validation testing to confirm that the modifications do not alter the substantial equivalence of the device to its predicate.

Here's an analysis of the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states: "All of the pre-determined acceptance criteria were met." However, it does not explicitly list the acceptance criteria themselves or the specific quantitative results for each test. It only lists the types of testing performed.

Acceptance Criteria	Reported Device Performance
(Not explicitly listed)	All pre-determined acceptance criteria were met for:
	- Software Testing
	- E-Stop Button functional testing
	- System testing

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

The document does not specify the sample sizes used for the software, E-Stop, or system testing. It also does not mention the country of origin of the data or whether the tests were retrospective or prospective.

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

This information is not mentioned in the provided text. The testing described appears to be engineering verification and validation against design specifications, rather than clinical efficacy studies requiring expert adjudication of ground truth.

4. Adjudication Method for the Test Set

This is not applicable as the tests described are engineering and functional checks, not involving interpretation by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted (or at least, not described in this document). The document explicitly states: "No additional clinical evaluation of the Sensei X Robotic Catheter System is required as a result of these changes." This indicates that no studies comparing human readers with and without AI assistance were performed or deemed necessary for this 510(k) submission.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

This is not applicable as the Sensei X Robotic Catheter System is a robotic control system for catheters, inherently designed for human-in-the-loop operation, not a standalone AI algorithm. The described testing is primarily focused on the functional performance of the system and its components (software, E-Stop).

7. Type of Ground Truth Used

The "ground truth" for the tests mentioned (Software Testing, E-Stop Button functional testing, System testing) would be based on the design specifications and requirements of the device. For example, for software testing, the ground truth would be that the software performs according to its functional and performance specifications. For E-Stop testing, the ground truth would be that the button successfully halts the system as designed. This is engineering verification, not clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not describe an AI model with a training set. The Sensei X Robotic Catheter System is a robotic control system with software enhancements, but it's not presented as an AI/ML device that learns from a training dataset in the way a diagnostic algorithm would.

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

This is not applicable as no training set for an AI model is described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

August 5, 2014

Hansen Medical, Inc. Todd Milholland Senior Manager, Regulatory Affairs 800 East Middlefield Rd Mountain View, California 94043

Re: K141822

Trade/Device Name: Sensei X Robotic Catheter System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: II Product Code: DXX Dated: July 3, 2014 Received: Julv 7, 2014

Dear Todd Milholland,

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Linda J. Ricci -S

for 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

510(k) Number (if known): K141822

Hansen Medical Sensei® X Robotic Catheter System Device Name:

Indications for Use:

The Hansen Medical Sensei 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) 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)

Image /page/2/Picture/11 description: The image shows the name "Linda J. Ricci -S" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.

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SECTION 7 510(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: To be determined

Applicant Information:

Owner Name:Address:	Hansen Medical, Inc.800 East Middlefield RoadMountain View, CA. 94043Office: 650-404-5800
Establishment
Registration Number:	3006026430
Contact Person:	Todd Milholland
Phone Number:	650 404 2777
Facsimile Number:	650 404 5901
Date Prepared:	July 3, 2014

Device Information:

Regulatory Class:Trade/Device Name:	Class IIHansen Medical Sensei® X Robotic CatheterSystem
Common name:	Steerable Catheter Control System
Classification name:	System, Catheter Control, Steerable
Regulation number:	21 CFR 870.1290
Product Code:	DXX

Predicate Device:

The Hansen Medical Sensei X Robotic Catheter System is substantially equivalent in intended use and method of operation to the earlier Sensei System (Sensei X Robotic Catheter System) cleared under K102168.

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Device Description:

Intended Use:

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.

Technological Characteristics/Performance Data:

The Sensei X Robotic Catheter System is substantially equivalent to the predicate device in intended use, fundamental scientific technology, and performance specifications. Design verification and validation testing was performed to verify that the performance of the Sensei X Robotic Catheter System remains substantially equivalent to the predicate device. Testing performed on the modified Sensei X System included the following:

Software Testing ●
. E-Stop Button functional testing
. System testing

All of the pre-determined acceptance criteria were met.

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Clinical Testing:

No additional clinical evaluation of the Sensei X Robotic Catheter System is required as a result of these changes.

Substantial Equivalence:

The modified Sensei X Robotic Catheter System has the following similarities to the predicate Sensei X Robotic Catheter System cleared under K102168:

have the same indication for use,
have the same fundamental scientific technology, ●
. have the same technological characteristics, and
. have the same operating principles.

Summary:

Based on the above similarities, the Sensei X Robotic Catheter System subject to this submission is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.1290 Steerable catheter control system.

(a)
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.(b)
Classification. Class II (performance standards).