Magellan Robotic System: The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

Magellan Robotic Catheter 9Fr. The Hansen Medical Magellan Robotic Catheter 9Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

Device Description

The Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr and Accessory Components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. 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 vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Magellan System were made to expand system-quide wire compatibility, provide alternate quide wire navigation using the Master Input Device in addition to the existing Workstation and Bedside Controllers and to provide support for future compatible Hansen vascular catheters.

AI/ML Overview

This document describes a Special 510(k) submission for modifications to the Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr. This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device, rather than proving new clinical effectiveness. Therefore, the information typically associated with studies proving device performance against acceptance criteria (like sample sizes, ground truth establishment, or clinical effectiveness studies) is largely absent or stated as not required.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based device. This is because the submission is for a robotic catheter system, not an AI diagnostic tool.

Instead, the "acceptance criteria" are implied by the comprehensive design verification and validation testing performed to ensure the modified system continues to meet design specifications and customer requirements. The reported device performance is that it successfully passed these tests and was found to be substantially equivalent to the predicate device.

Acceptance Criteria Category (Implied)	Reported Device Performance
System Set Up	Test Passed
Catheter Installation	Test Passed
System-Guide Wire Compatibility	Test Passed
Procedure Simulation (Catheter & Guide Wire Navigation)	Test Passed
Magellan Catheters Drive Modes	Test Passed
User Interface	Test Passed
3D Controller	Test Passed
System Status and Error Message Handling	Test Passed
System Power Cycle	Test Passed
Emergency and Configuration	Test Passed
Electrical Safety	Test Passed
Risk analysis (ISO 14971 compliance)	Activities Completed
Substantial Equivalence to Predicate Device	Demonstrated through non-clinical testing and comparison of characteristics, indicating successful performance in all modified aspects.

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

The document does not specify a "test set" in the context of an AI algorithm with data samples. The testing described is verification and validation of a physical/software system. Therefore, details like country of origin or retrospective/prospective data are not applicable. The testing would involve a combination of simulated scenarios, bench testing, and potentially animal/cadaveric studies (though not detailed here for this specific submission).

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

This information is not applicable. The "ground truth" for a robotic catheter system's performance is typically established through engineering specifications, regulatory standards, and objective measurements during verification and validation testing, not through expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this submission for a robotic system.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC study was done, nor would it typically be expected for this type of device modification submission. The device is a robotic system to facilitate navigation, not a diagnostic tool that humans would use to interpret cases. The focus is on the functional equivalence of the system, not on comparing human reading performance with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The Magellan system is a master/slave control system, inherently designed for human-in-the-loop operation. It is not an autonomous algorithm operating without human intervention for diagnostic or treatment decisions.

7. The Type of Ground Truth Used

The "ground truth" for the verification and validation tests performed for this robotic system would be based on:

Engineering Specifications: Whether the system performs according to its design parameters (e.g., catheter tip movement, guide wire compatibility).
Customer Requirements: Whether the system meets the functional needs for which it was designed.
Regulatory Standards: Compliance with relevant standards like electrical safety (implied by "Electrical Safety Test") and risk management (ISO 14971).
Performance against Predicate Device: Demonstration of substantial equivalence in intended use, technological characteristics, and safety/effectiveness.

8. The Sample Size for the Training Set

This is not applicable. The Magellan system is not an AI/machine learning model in the sense of requiring a "training set" of data samples. Its software modifications relate to system functionality, user interface, and compatibility, not learning from a dataset.

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

This is not applicable, as there is no "training set." The software modifications were likely developed and tested against established engineering requirements and functional specifications based on the device's intended use and the predicate device's performance.

Summary

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KI32369

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:

Applicant Information:

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

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

P 2 7 2013

Date Prepared: 9/26/2013

Device Information:

Classification:	Class II
Trade Name:	Hansen Medical Magellan™ Robotic System;
	Magellan ™ Robotic Catheter 9Fr ( Formerly known as
	NorthStar™ Robotic Catheter )
Common name:	Steerable Catheter Control System;
	Steerable catheter
Classification name:	System, Catheter Control, Steerable (21 CFR 870.1290/DXX);
	Catheter, Steerable (21 CFR 870.1280/DRA)

Predicate Devices:

The modified Hansen Medical Magellan System (Magellan Robotic System and the Magellan Robotic Catheter 9Fr), is substantially equivalent in intended use and method of operation to the cleared Magellan System (Magellan Robotic System and Magellan Robotic Catheter 9Fr) cleared under K111004.

Special 510(k) Submission

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Device Description:

Intended Use:

Maqellan Robotic System: The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

Magellan Robotic Catheter 9Fr: The Hansen Medical Magellan Robotic Catheter 9Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

Summary of Technological Characteristics in Comparison to Predicate Device:

The Magellan System is substantially equivalent to the predicate device. The Magellan Robotic System software modifications to expand system-quide wire compatibility, to enhance user interface and clinical procedural workflow and to expand system support for an additional Hansen Medical vascular control catheter do not affect the intended use of the device or alter the fundamental scientific technology associated with the device. Both the proposed and predicate device facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual

Hansen Medical Magellan ™ System Special 510(k) Submission

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placement of therapeutic devices, while allowing the physician to perform the procedure from a position beyond the radiation filed.

Substantial equivalence:

Based upon the indications for use and the design and engineering data provided in this pre-market notification, the Hansen Medical Magellan System has been shown to be substantially equivalent to a currently marketed predicate device.

Summary of Non-Clinical Testing:

Design verification and validation testing was performed to ensure that the Magellan System met design specifications and customer requirements. Testing activities included software and catheter verification and validation tests. Verification and Validation testing includes the following:

System Set Up Test .
Catheter Installation Test .
. System -Guide Wire Compatibility Test
Procedure Simulation (Catheter and . Guide Wire navigation) Test
Magellan Catheters Drive Modes .
User Interface Test .
. 3D Controller Test
System Status and Error Message . Test
· System Power Cycle Test
. Emergency and Configuration Tests
. Electrical Safety Test

Risk analysis activities were completed based on ISO 14971.

Summary of Clinical Testing:

No additional clinical evaluation of the Magellan System is required as a result of these changes.

Hansen Medical Magellan™ System Special 510(k) Submission

Section 7, Page 3 of 4 510(k) Summary

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Substantial equivalence:

The modified Magellan Robotic System and Magellan Robotic Catheter 9Fr have the following similarities to the predicate devices which previously received clearance under K111004.

have the same indication for use, .
. have the same fundamental scientific technology,
. incorporate the same catheter design,
. catheter incorporate the same materials, and
. catheter uses the same sterilization processes.

In summary, the Magellan System (Magellan Robotic System and the Magellan Robotic Catheter 9Fr) subject to this submission is substantially equivalent to the predicate device.

Hansen Medical Magellan ™ System Special 510(k) Submission

Section 7, Page 4 of 4 510(k) Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.

Public Health Service

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

September 27, 2013

Hansen Medical, Inc. Hassan Labay 800 East Middlefield Road Mountain View, CA 94043 US

Re: K132369

Trade/Device Name: Magellan Robotic System, Magellan Robotic Catheter 9Fr Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System, Steerable Catheter Regulatory Class: Class II Product Code: DXX, DRA Dated: August 28, 2013 Received: August 29, 2013

Dear Hassan 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.

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

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Page 2 - Hassan Labay

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/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 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,

Owen P. Faris -S

for Bram D. Zuckerman, Ph.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: K132369

Device Name: Hansen Medical Magellan Robotic System, Magellan Robotic Catheter 9Fr (Formerly known as NorthStar Robotic Catheter)

Indications for Use:

The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

The Magellan Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

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)

Digitally signed by
Owen P. Faris -5
Date: 2013.09.27
12:59-31-04'00'
Special 510(k) Submission

Hansen Medical Magellan™ System Section 6. Page 1 o! 1 Indication for Use

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).