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 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 an enhancement to the motion scaling feature.

AI/ML Overview

The provided document is a 510(k) summary for the Hansen Medical Sensei® X Robotic Catheter System. This document focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a performance study in the way one would expect for a new, non-substantially equivalent device.

Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not present in this 510(k) summary.

Key takeaways from the document:

Device: Hansen Medical Sensei® X Robotic Catheter System.
Purpose: To facilitate manipulation, positioning and control of robotically steerable catheters for collecting electrophysiological data within the heart atria.
Modification: An enhancement to the motion scaling feature.
Predicate Device: Earlier Sensei System (K091808).
Basis for Approval: Substantial equivalence, meaning the modified device performs as safely and effectively as the previously cleared (predicate) device, and the modifications do not affect its intended use or fundamental scientific technology.

Since the submission is a "Special 510(k)" for a modification, the focus is on demonstrating that the change does not raise new safety or effectiveness concerns, rather than conducting a full performance study as if it were a novel device. The FDA typically relies on the established safety and effectiveness of the predicate device.

To directly answer your questions based only on the provided text, many fields will be "Not Reported" or "Not Applicable" for this type of submission:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not Reported	Not Reported
	The device is considered "substantially equivalent" to its predicate, meaning it performs as safely and effectively.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size (Test Set): Not reported.
Data Provenance: Not reported. (For a Special 510(k) focusing on a modification, often internal verification and validation data are used rather than clinical studies in the traditional sense, but the specifics are not disclosed here.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not reported. This type of performance study for ground truth establishment is typically not part of a Special 510(k) submission for a device modification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Not reported.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a robotic catheter system, not an AI-assisted diagnostic tool. No human reader study is mentioned.

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

Not applicable. This is a robotic system, not a standalone algorithm. The performance evaluation focuses on the safety and functionality of the robotic system itself and its interaction with compatible catheters, implicitly with a human operator.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable/Not reported. The submission focuses on demonstrating substantial equivalence, often through engineering and functional testing rather than direct clinical ground truth comparison in the context of diagnostic accuracy.

8. The sample size for the training set

Not applicable/Not reported. (This is not an AI/machine learning device that would have a "training set" in that context.)

9. How the ground truth for the training set was established

Not applicable/Not reported.

Summary

{0}------------------------------------------------

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:

ﻤﺮﺍﺭ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺮﺍﺟﻊ

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:

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

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

{1}------------------------------------------------

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

{2}------------------------------------------------

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.

{3}------------------------------------------------

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

{4}------------------------------------------------

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:

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

سم

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).