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.

Device Description

The Hansen Medical Magellan Robotic System 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 modification adds a mechanical joint between the Magellan Robotic System Rail and Adapter Plate to facilitate removal.

The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.

AI/ML Overview

This document describes a 510(k) premarket notification for the Hansen Medical Magellan Robotic System, which is a steerable catheter control system. The submission is for a modification to an already cleared device (K132369).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Visual and Dimensional Verification Testing	All pre-determined acceptance criteria were met.
IEC 606061-1 Testing	All pre-determined acceptance criteria were met.
Table Compatibility	All pre-determined acceptance criteria were met.
Life cycle Testing	All pre-determined acceptance criteria were met.

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

The document does not detail specific sample sizes for the visual, dimensional, IEC, table compatibility, or life cycle testing. It simply states that testing was performed and all pre-determined acceptance criteria were met. The data provenance is not explicitly mentioned (e.g., country of origin or retrospective/prospective). Given that the testing categories are related to engineering and regulatory standards, it's highly likely this was internal, prospective testing performed by the manufacturer or a contracted lab.

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

Not applicable. The testing described (visual, dimensional, IEC, table compatibility, life cycle) are engineering and technical verification tests, not clinical performance tests requiring expert ground truth establishment for a test set in the traditional sense of AI/clinical studies.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or clinical adjudication. The acceptance criteria were met based on the results of the specified engineering and technical tests.

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

No MRMC comparative effectiveness study was performed or described. This submission is for a robotic system for facilitating navigation in the peripheral vasculature, not an AI-assisted diagnostic or interpretative device that would typically involve human readers. The document explicitly states: "No additional clinical evaluation of the Magellan Robotic System is required as a result of these changes."

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

This is not directly applicable in the context of an algorithm's standalone performance for diagnostic or interpretive tasks. The "device" itself (the Magellan Robotic System) operates in a master/slave control system with a physician-in-the-loop for navigation. The testing performed was "Design verification testing," which focuses on the device's technical specifications and adherence to standards rather than an algorithm's standalone clinical accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the engineering and technical tests would be the established specifications, standards (e.g., IEC 606061-1), and design requirements for the device. For example, for dimensional verification, the ground truth would be the engineering drawings and specified tolerances. For IEC testing, the ground truth would be the pass/fail criteria defined by the standard.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product developed using a training set in the typical sense. It is a robotic system with physical and operational characteristics verified through engineering tests.

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

Not applicable, as there is no training set for this type of device and submission.

Summary

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

August 7, 2014

Hansen Medical Kate Whitin Sr. Director, Regulatory Affairs 800 East Middlefield Road Mountain View, California 94043

Re: K141614

Trade/Device Name: Magellan Robotic System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX Dated: June 12, 2014 Received: June 16, 2014

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. 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

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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 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/Resourcesfor You/Industry/default.htm. 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 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.

Image /page/1/Picture/8 description: The image shows a logo with the letters "K" and "l" in a stylized, handwritten font. Below the letters, the text "Ken Skodacek for" is visible. The background features a faint, blurred image of the FDA logo, suggesting a connection to the Food and Drug Administration.

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): K141614

Device Name: Hansen Medical Magellan Robotic System and accessory components

Indications for Use:

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

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/12 description: The image shows a logo with the letters "K" and "I" in a stylized, handwritten font. Below the logo, the text "Ken Skodacek for" is printed in a smaller, sans-serif font. The logo is simple and modern, with a personal touch due to the handwritten style of the letters.

Bram Zuckerman

Special 510(k) Submission

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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 21 CFR 807.92(c).

510(k) Number: K141614

Applicant Information:

Owner Name:	Hansen Medical, Inc.
Address:	800 East Middlefield RoadMountain View, CA. 94043Office: 650-404-5800
Establishment
Registration Number:	3006026430
Contact Person:	Kate Whitin Lee
Phone Number:	650 404 5841
Facsimile Number:	650 404 2773
Date Prepared:	August 5, 2014

Device Information:

Regulatory Class:	Class II
Trade/Device Name:	Hansen Medical Magellan Robotic System andAccessory Components
Common name:	Steerable Catheter Control System
Classification name:	System, Catheter Control, Steerable
Regulation number:	21 CFR 870.1290
Product Code:	DXX

Predicate Device:

The modified Hansen Medical Magellan System (Magellan Robotic System), is substantially equivalent in intended use and method of operation to the cleared Magellan System (Magellan Robotic System) cleared under K132369.

Hansen Medical Magellan Robotic System Traditional 510(k) Submission

Page 7-1 of 4 510(k) Summary

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Image /page/4/Picture/0 description: The image shows the logo for Hansen Medical. The logo features a blue, stylized heart shape on the left, followed by the word "hansen" in black, lowercase letters. Below "hansen" are the words "MEDICAL" in smaller, black, uppercase letters. The logo is clean and modern, with a focus on the company name and its association with the medical field.

Device Description:

The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.

Intended Use:

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

Comparison to Predicate Device(s):

The Magellan Robotic System and accessory components are 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. Both the proposed and predicate device facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, while allowing the physician to perform the procedure from a position beyond the radiation field.

Technological Characteristics/Performance Data:

The Magellan Robotic System and accessory components are substantially equivalent to the predicate device in intended use, fundamental scientific technology, and performance specifications. Design verification testing was

Hansen Medical Magellan Robotic System Traditional 510(k) Submission

Page 7-2 of 4 510(k) Summary

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performed to verify that the performance of the Magellan Robotic System remains substantially equivalent to the predicate device. Testing performed on the Magellan Robotic System included the following:

Visual and Dimensional Verification Testing ●
IEC 606061-1 Testing ●
Table Compatibility
Life cycle Testing ●

All of the pre-determined acceptance criteria were met.

Clinical Testing:

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

Substantial Equivalence:

The Magellan Robotic System has the following similarities to the predicate device cleared under K132369:

. has the same intended use, although the indications for use are limited to the robotic system and accessory components,
has the same fundamental scientific technology, ●
has the same technological characteristics, and ●
has the same principles of operation.

Traditional 510(k) Submission

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Image /page/6/Picture/0 description: The image shows the logo for Hansen Medical. The logo consists of a blue, stylized heart shape on the left, followed by the words "hansen" in black, with a registered trademark symbol. Below "hansen" is the word "MEDICAL" in smaller, black letters.

Summary:

In summary, the Magellan Robotic System and accessory components subject to this submission are as safe and effective as the predicate device. They have the same intended use, the same fundamental technological characteristics, and the same principles of operation as the predicate device. The differences between the Magellan Robotic System and the predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Magellan Robotic System and accessory components are as safe and effective as the predicate device and are therefore substantially equivalent.

Hansen Medical Magellan Robotic System Traditional 510(k) Submission

Page 7-4 of 4 510(k) Summary

800 East Middlefield Road · Mountain View, CA 94043 · T 650.4040.5800 www.hansenmedical.com

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).