The Hansen Medical Magellan™ Robotic Catheter 9Fr is intended 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 Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature.

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

Device Description

The proposed change to the Hansen Medical Magellan™ Robotic Catheter (MRC) 9Fr is to the Indications for Use only; there is no change to the fit, form, or function of the device or to any of its components and accessories cleared under K132369.

The MRC 9Fr is a telescoping design comprised of a steerable Leader within a steerable Guide and is designed to be used with the Hansen Medical Magellan™ Robotic System (Magellan System). The distal sections of each Hansen Catheter component articulate individually and the distal end of the Leader can extend up to 21cm beyond the distal end of the Guide.

The Leader is a tubular catheter with four pull wires articulating the distal 3cm. The Leader has a 6Fr outer diameter and 3Fr inner diameter, and is available in 125cm, 141cm, and 158cm lengths. The Leader fits inside the Guide and is only used in conjunction with the Guide. The distal end of the Leader has a 3cm flexible articulating section. The Leader has a radiopaque marker band between the articulating section and the atraumatic tip. The tip extends 4mm distal to the marker band.

The Guide is a tubular catheter with four pull wires articulating the distal 2.8cm. The Guide has a 6Fr inner diameter and 9Fr outer diameter. The Guide is available in 50cm, 65cm, or 80cm lengths. The Guide fits around the Leader and may be used with or without the Leader. When the Leader is removed from the Guide, a 6Fr compatible percutaneous catheter may be delivered through the Guide.

The Hansen Catheter family consists of three different lengths of Leader and Guide pairs, and all sizes are sterilized via EtO for single use only. However, the MRC 9Fr Short (50cm) and MRC 9Fr Medium (65cm) catheters are not included for the expanded indication as they are not long enough to access the target anatomy.

AI/ML Overview

This document is a 510(k) premarket notification for the Hansen Medical Magellan Robotic Catheter 9Fr, which is intended to facilitate navigation to anatomical targets and provide a conduit for therapeutic devices. The submission focuses on expanding the indications for use of the 80cm long version of the catheter to include neurovasculature.

Here's an analysis of the provided text with respect to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of a numerically defined threshold for performance for a new AI/medical device. Instead, it relies on demonstrating substantial equivalence to a predicate device. This is a common approach for Class II medical devices seeking 510(k) clearance in the US. The "performance" assessment is a comparison of technological characteristics and intended use.

Here's a table based on the "Performance Attribute and Characteristic Comparison" table (on page 8) for the expanded indication compared to the predicate device:

Performance Specification	Predicate Device: MicroVention Chaperon Guide (6Fr)	Predicate Device: MicroVention Chaperon Leader (5Fr)	Hansen Medical Magellan Robotic Catheter 9Fr Guide (Long)	Hansen Medical Magellan Robotic Catheter 9Fr Leader
Outer Diameter (OD)	6Fr (0.084 in)		9Fr (0.128 in)	6Fr (0.084 in)
Inner Diameter (ID)	5Fr (0.071 in)		6Fr (0.084 in)	3Fr (0.039 in)
Guidewire Compatibility	0.035 in, 0.018 in, 0.014 in	0.035 in	0.035 in, 0.018 in, 0.014 in	0.035 in, 0.018 in, 0.014 in
Total Insertion Length	95 cm	117 cm	80 cm	101 cm
Distal Flex Length	7 cm	7 cm	2.7 cm	3.0 cm
Hydrophilic Coating Length	N/A	15 cm	45 cm	85 cm
Tip Configuration	STR, MP2, BUR	VTR, SIM2, JB2	Configurable bend to any angle up to 90° in all directions	Configurable bend to any angle up to 180° in all directions
Intended Use (Neurovasculature)	Yes (inclusive of neurovasculature)	Yes (inclusive of neurovasculature)	Yes (expanded to neurovasculature for 80cm length)	Yes (expanded to neurovasculature for 80cm length)

Reported Device Performance (against the predicate): The document states: "The minor differences in the characteristics between the two products do not alter the performance and do not present any new issues of safety or effectiveness." It concludes that the device "is substantially equivalent with respect to intended use and technological characteristics as the predicate device, and is expected to perform equivalently in accessing the neuro vasculature." The "performance" is demonstrated through design validation and verification activities described in Section 18.0 Performance Testing (which is not included in the provided text but is referenced).

2. Sample size used for the test set and the data provenance

The document explicitly states: "Clinical evaluation is not required for this device." Therefore, there is no "test set" in the sense of patient data for clinical evaluation, nor is there information on sample size or data provenance for such a test. The evaluation relies on comparing technological characteristics and performance data from internal design validation and verification.

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

Not applicable, as no clinical test set was required or used.

4. Adjudication method for the test set

Not applicable, as no clinical test set was required or used.

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 is a robotic steerable catheter, not an AI-assisted diagnostic or interpretative device that augments human readers.

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

Not applicable. This is a physical robotic catheter, not a standalone algorithm.

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

The document does not detail specific "ground truth" as would be used in an AI or diagnostic imaging study. Instead, the "truth" for this device's performance relies on engineering and performance testing data (referenced as "design validation and verification activities described in Section 18.0 Performance Testing" on page 7) to ensure physical characteristics (dimensions, flexibility, guidewire compatibility, etc.) meet specifications and are comparable to the predicate device for the intended use in neurovasculature.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device that requires a training set.

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 consists of a stylized graphic of three human profiles facing right, layered on top of each other to create a sense of depth. The profiles are black and are positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the graphic.

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

September 20, 2016

Hansen Medical, Inc. Joy Sacmar VP. OA & RA 800 E Middlefield Road Mountain View, California 94043

Re: K160919

Trade/Device Name: Hansen Medical Magellan Robotic Catheter 9Fr Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: August 15, 2016 Received: August 16, 2016

Dear Joy Sacmar:

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 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.

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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 vours.

Mude Yellman
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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Indications for Use

510(k) Number (if known) K160919

Device Name

Hansen Medical Magellan™ Robotic Catheter 9Fr

Indications for Use (Describe)

The Magellan Robotic Catheter 9Fr Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature.

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

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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SECTION 5.0 510(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.

K160919 510(k) Number

Applicant Information

Owner Name:	Hansen Medical, Inc.
Address:	800 East Middlefield RoadMountain View, CA. 94043
Office Phone:	650-404-5800
EstablishmentRegistration Number:	3006026430
Contact Person:	Marysa Loustalot
Company Contact:	Joy M. Sacmar, Vice-President RA/QA
Phone Number:	650 404 2777
Facsimile Number:	650 404 5901
Date Prepared:	September 13, 2016

De vice Information

Regulatory Class:	Class II
Trade/Device Name:	Hansen Medical Magellan Robotic Catheter 9Fr
Common Name:	Robotic Control Catheter
Classification Name:	Steerable catheter
Regulation Number:	21 CFR 870.1280
Product Code:	DRA

Predicate Device

The Hansen Medical Magellan Robotic Catheter 9Fr is substantially equivalent in intended use and method of operation to the MicroVention Chaperon 6Fr Guiding Catheter (K082385).

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Reference Device

The Hansen Medical Magellan Robotic Catheter 9Fr (K132369).

De vice De scription

Figure 5-1 below is a diagram taken from the current commercially available MRC 9Fr Guide (80cm) Box Label providing additional details on tip dimensions.

Image /page/4/Figure/8 description: The image shows two diagrams of medical instruments with measurements. The first diagram on the left shows a blue instrument with an inner diameter (ID) of 0.039 inches (1.00 mm) and an outer diameter (OD) of 0.084 inches (2.13 mm). The instrument is shown bending 180 degrees over a length of 30 mm, with a height of 23 mm. The second diagram on the right shows a gray instrument with an ID.6 Fr of 0.084 inches (2.13 mm) and an OD.9 Fr of 0.128 inches (3.25 mm). This instrument is shown bending 90 degrees over a length of 27 mm, with a height of 23 mm.

Figure 5-1 MRC 9Fr diagram taken from label PN 20995 Rev. C

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CatalogNumber	1. GuideEffectiveLength(cm)	2. GuideOverallLength(cm)	3. LeaderOverallLength(cm)	TotalEffectiveLength(cm)	MinimumGuide WireLength forExchange (cm)
MC9F50(11142)	50	74	125	71	260
MC9F65(11141)	65	90	141	86	260
MC9F80(11140)	80	107	158	101	300

Table 5-1 Magellan™ Robotic Catheter 9Fr - Lengths

Image /page/5/Figure/3 description: The image shows a diagram with three measurements labeled 1, 2, and 3. Measurement 1 spans from the second square block to the start of the filtration system. Measurement 2 spans from the second square block to the end of the second filtration unit. Measurement 3 spans from the first square block to the end of the second filtration unit.

Figure 5-2 Magellan™ Robotic Catheter 9Fr

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Intended Use

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 Long Length (80 cm) is also indicated for use as a conduit for manual placement of therapeutic devices in the neuro vasculature.

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

Comparison to Predicate Device(s)

The Hansen Medical Magellan Robotic (MRC) 9Fr Long Length (80cm) Guide and Leader is substantially equivalent to the MicroVention 6Fr Chaperon Guiding Catheter System.

The MRC 9Fr remains as a telescoping design, comprised of a steerable Leader within a steerable Guide and is designed to be used with the Hansen Medical Magellan™ Robotic System (Magellan System). The distal sections of each Hansen Catheter component articulate individually, and the distal end of the Leader can extend up to 21 cm beyond the distal end of the Guide. The MRC 9Fr Long Length is the only size available in the MRC 9Fr family that can access the neurovasculature at a total insertion length (Guide and Leader Catheter) of 101 cm.

Technological Characteristics/Performance Data

The MicroVention 6Fr Chaperon Guide catheter was chosen as the predicate device as it has a similar intended use and target anatomy as the MRC 9Fr Long Length (80cm) expanded indication. The Chaperon and Magellan catheters are both access catheters intended to provide a conduit for manual delivery of therapy. Diameters, lengths, and tip shape are the critical characteristics that determine the performance ability of an access catheter.

The MRC 9Fr Long Length (80cm) with the expanded indication and the predicate MRC 9Fr device cleared under K132369 have the same technological characteristics. In comparison to the MicroVention 6Fr Chaperon guide and inner catheters (the predicate device), the MRC 9Fr Long Length (8cm) has similar characteristics that determine the performance of accessing the neuro vasculature. The minor differences in the characteristics between the two products do not alter the performance and do not present any new issues of safety or effectiveness. Performance of the MRC 9Fr

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Long Length (80cm) to access the neuro vasculature was further demonstrated in the design validation and verification activities described in Section 18.0 Performance Testing.

Therefore, the Hansen Medical Magellan Robotic 9Fr Long Length (80cm) is substantially equivalent with respect to intended use and technological characteristics as the predicate device, and is expected to perform equivalently in accessing the neuro vasculature.

Clinical Testing

Clinical evaluation is not required for this device.

Substantial Equivalence

Product	Micro Vention Inc.6 Fr Chaperon Guiding CatheterSystem	Hansen MedicalMagellan Robotic Catheter 9Frw/ Expanded Indication
Code	DQY (Percuraneous Catheter)	DRA (Steerable Catheter)
Class	Class II	Class II
21CFR	870.1250	870.1280
K Number	K082385	K160919
Indicationsfor Use	Chaperon Guiding Catheter isintended for general intravascularuse, including the neuro andperipheral vasculature. ChaperonGuiding Catheter can be used tofacilitate introduction of diagnosticor therapeutic devices. ChaperonGuiding Catheter is not intended foruse in coronary arteries.	The Hansen Medical Magellan™Robotic Catheter 9Fr is intended tobe used to facilitate navigation toanatomical targets in the peripheralvasculature and subsequentlyprovide a conduit for manualplacement of therapeutic devices.The Magellan Robotic Catheter 9FrLong Length (80 cm) is alsoindicated for use in the U.S. as aconduit for manual placement oftherapeutic devices in the neurovasculature.The Magellan™ Robotic Catheter9Fr is intended to be used with theHansen Medical Magellan™Robotic System and accessories.

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MRC 9Fr and the Microvention Chaperon 6Fr
PerformanceSpecification	MRC 9FrGuide(Long)	ChaperonGuide	MRC 9FrLeader	ChaperonLeader	RationaleSection
OD	9Fr0.128 in	6F0.084 in	6Fr0.084 in	5F0.071 in	12.3.3.1
ID	6Fr0.084 in	5Fr0.071 in	3Fr0.039 in	3Fr0.048 in	12.3.3.2
GuidewireCompatibility	0.035 in0.018 in0.014 in	0.035 in0.018 in0.014 in	0.035 in0.018 in0.014 in	0.035 in	12.3.3.3
TotalInsertionLength	80 cm	95 cm	101 cm	117 cm	12.3.3.4
Distal FlexLength	2.7 cm	7 cm	3.0 cm	7 cm	12.3.3.5
HydrophilicCoatingLength	45 cm	N/A	85 cm	15 cm	12.3.3.6
TipConfiguration	Configurablebend to anyangle up to90° in alldirections	STR, MP2,BUR	Configurablebend to anyangle up to180° in alldirections	VTR,SIM2, JB2	12.3.3.7

Performance Attribute and Characteristic Comparison of the Hansen Medical MRC 9Fr and the MicroVention Chaperon 6Fr

Conclusion

In comparison to the MicroVention 6Fr Chaperon guide and inner catheters (the predicate device), the MRC 9Fr Long Length (8cm) has similar characteristics that determine the performance of accessing the neuro vasculature. The minor differences in the characteristics between the two products do not alter the performance and do not present any new issues of safety or effectiveness.

Regulation Number and Section

§ 870.1280 Steerable catheter.

(a)
Identification. A steerable catheter is a catheter used for diagnostic and monitoring purposes whose movements are directed by a steering control unit.(b)
Classification. Class II (performance standards).