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 to the Magellan Robotic System is software update referred to as Magellan v1.9.1.

AI/ML Overview

This document is a 510(k) premarket notification for the Hansen Medical Magellan Robotic System and Accessory Components (K151730). It primarily details a software update (Magellan v1.9.1) to an already cleared device (K141614). The core argument for substantial equivalence relies on the fact that the modifications do not change the intended use, fundamental scientific technology, or operating principles.

As such, this submission does not describe a study to prove a device meets acceptance criteria in the way a new or significantly modified device submission might. Instead, it aims to demonstrate that a software update to an existing device does not degrade performance and maintains substantial equivalence.

Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC studies, standalone performance details, training set size, etc.) are not applicable or not provided in this type of submission because the focus is on maintaining existing safety and effectiveness rather than establishing new performance benchmarks.

However, I can extract information related to the acceptance criteria and the study type that was mentioned:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria Type	Reported Device Performance
Software Verification Testing	All pre-determined acceptance criteria were met.
System Validation Testing	All pre-determined acceptance criteria were met.

Important Note: The document states that "All of the pre-determined acceptance criteria were met," but it does not explicitly list what those specific acceptance criteria were (e.g., specific thresholds for accuracy, reliability, or safety metrics). The document focuses on confirming that the updated software did not introduce new risks or deviations from the predicate device's expected performance.

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

Sample Size: Not specified.
Data Provenance: Not specified. Given the nature of software verification and system validation, these would typically be internal laboratory tests.

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

Not applicable/Not specified. This type of information is typically relevant for clinical studies or studies involving human interpretation of data, which was not the focus here. The performance was assessed through engineering and system-level tests.

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

Not applicable/Not specified. Adjudication methods are typically used in clinical trials where multiple human readers assess cases, which is not the case for this software update submission.

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. An MRMC comparative effectiveness study was not done. This submission concerns a software update to a robotic navigation system, not an AI-assisted diagnostic tool for human readers.

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

Yes, in a sense. The "Software Verification Testing" and "System Validation Testing" represent standalone evaluations of the updated software and system to confirm they perform as expected without human intervention impacting the robotic movement or calculations directly. However, the performance is evaluated against the system's designed specifications, not necessarily an "algorithm only" in the AI sense.

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

For "Software Verification Testing" and "System Validation Testing," the ground truth would be based on the design specifications, functional requirements, and safety standards established for the device. For example, a navigation system's ground truth could be its ability to accurately move the catheter to a programmed position within a defined tolerance. It does not involve medical ground truth like pathology or expert consensus on a diagnosis.

8. The sample size for the training set

Not applicable/Not specified. This document pertains to a software update to an existing robotic control system, not a machine learning or AI model that uses a training set in the conventional sense.

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

Not applicable. (See #8)

Summary

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

Public Health Service

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

July 23, 2015

Hansen Medical, Inc. Todd Milholland Senior Manager, Regulatory Affairs 800 East Middlefield Road Mountain View, CA 94034

Re: K151730

Trade/Device Name: Magellan Robotic System and Accessory Components Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX Dated: June 25, 2015 Received: June 26, 2015

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

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

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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,

Mitchell Stein

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

SECTION 6.0

Indications for Use

510(k) Number (if known): K151730

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)

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

SECTION 7.0

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:	Hansen Medical, Inc.
Address:	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:	June 25, 2015

Device Information:

Regulatory Class:	Class II
Trade/Device Name:	Hansen Medical Magellan Robotic CatheterSystem and Accessory 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 Hansen Medical Magellan Robotic Catheter System is substantially equivalent in intended use and method of operation to the earlier Magellan Robotic Catheter System cleared under K141614.

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

Device Description:

Intended Use:

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

Comparison to Predicate Device(s):

The modified Hansen Medical Magellan Robotic 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 Magellan Robotic 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 Magellan Robotic System remains substantially equivalent to the predicate device. Testing performed on the modified Magellan Robotic System included the following:

o Software Verification Testing
. System Validation Testing

All of the pre-determined acceptance criteria were met.

{5}------------------------------------------------

Clinical Testing:

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

Substantial Equivalence:

The modified Magellan Robotic System has the following similarities to the predicate Magellan Robotic System cleared under K141614:

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

Summary:

Based on the above similarities, the Magellan Robotic 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).