(169 days)
No
The 510(k) summary describes a robotic catheter system with mechanical components (pull wires, telescoping design) and focuses on changes to the indications for use. There is no mention of AI, ML, image processing, or any data-driven decision-making components. The description is purely mechanical and procedural.
No.
The device acts as a conduit for the placement of therapeutic devices, but it is not therapeutic itself.
No
Explanation: The device is described as a robotic catheter intended to facilitate navigation and provide a conduit for placing therapeutic devices, not to diagnose conditions. Its function is to assist in interventional procedures, not to identify diseases or conditions.
No
The device description clearly details physical components like catheters, pull wires, and marker bands, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a robotic catheter intended to facilitate navigation within the peripheral and neuro vasculature and provide a conduit for placing therapeutic devices. This is an invasive medical device used directly within the body for procedural purposes.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing performed outside the body.
Therefore, the Hansen Medical Magellan™ Robotic Catheter 9Fr falls under the category of a surgical or interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
DRA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design validation and verification activities were performed. The MRC 9Fr Long Length (80cm) with the expanded indication and the predicate MRC 9Fr device cleared under K132369 have the same technological characteristics. Compared to the MicroVention 6Fr Chaperon guide and inner catheters (the predicate device), the MRC 9Fr Long Length (8cm) has similar characteristics that determine its performance in accessing the neurovasculature. Minor differences in characteristics do not alter performance and do not present new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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.
1
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
2
Indications for Use
510(k) Number (if known) K160919
Device Name
Hansen Medical Magellan™ Robotic Catheter 9Fr
Indications for Use (Describe)
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.
| 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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 Road |
| Mountain View, CA. 94043 | |
| Office Phone: | 650-404-5800 |
| Establishment | |
| Registration 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).
4
Reference Device
The Hansen Medical Magellan Robotic Catheter 9Fr (K132369).
De vice De scription
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.
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
5
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. Table 5-1 below lists all sizes the MRC 9Fr is currently available in.
| Catalog
Number | 1. Guide
Effective
Length
(cm) | 2. Guide
Overall
Length
(cm) | 3. Leader
Overall
Length
(cm) | Total
Effective
Length
(cm) | Minimum
Guide Wire
Length for
Exchange (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
6
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
7
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 Catheter
System | Hansen Medical
Magellan Robotic Catheter 9Fr
w/ Expanded Indication |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Code | DQY (Percuraneous Catheter) | DRA (Steerable Catheter) |
| Class | Class II | Class II |
| 21CFR | 870.1250 | 870.1280 |
| K Number | K082385 | K160919 |
| Indications
for Use | Chaperon Guiding Catheter is
intended for general intravascular
use, including the neuro and
peripheral vasculature. Chaperon
Guiding Catheter can be used to
facilitate introduction of diagnostic
or therapeutic devices. Chaperon
Guiding Catheter is not intended for
use in coronary arteries. | 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 in the U.S. 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. |
8
| MRC 9Fr and the Microvention Chaperon 6Fr | |||||
|---|---|---|---|---|---|
| Performance | |||||
| Specification | MRC 9Fr | ||||
| Guide | |||||
| (Long) | Chaperon | ||||
| Guide | MRC 9Fr | ||||
| Leader | Chaperon | ||||
| Leader | Rationale | ||||
| Section | |||||
| OD | 9Fr | ||||
| 0.128 in | 6F | ||||
| 0.084 in | 6Fr | ||||
| 0.084 in | 5F | ||||
| 0.071 in | 12.3.3.1 | ||||
| ID | 6Fr | ||||
| 0.084 in | 5Fr | ||||
| 0.071 in | 3Fr | ||||
| 0.039 in | 3Fr | ||||
| 0.048 in | 12.3.3.2 | ||||
| Guidewire | |||||
| Compatibility | 0.035 in | ||||
| 0.018 in | |||||
| 0.014 in | 0.035 in | ||||
| 0.018 in | |||||
| 0.014 in | 0.035 in | ||||
| 0.018 in | |||||
| 0.014 in | 0.035 in | 12.3.3.3 | |||
| Total | |||||
| Insertion | |||||
| Length | 80 cm | 95 cm | 101 cm | 117 cm | 12.3.3.4 |
| Distal Flex | |||||
| Length | 2.7 cm | 7 cm | 3.0 cm | 7 cm | 12.3.3.5 |
| Hydrophilic | |||||
| Coating | |||||
| Length | 45 cm | N/A | 85 cm | 15 cm | 12.3.3.6 |
| Tip | |||||
| Configuration | Configurable | ||||
| bend to any | |||||
| angle up to | |||||
| 90° in all | |||||
| directions | STR, MP2, | ||||
| BUR | Configurable | ||||
| bend to any | |||||
| angle up to | |||||
| 180° in all | |||||
| directions | 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.
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 as the predicate device.