(78 days)
No
The summary describes a robotic catheter and its compatibility with a robotic system, but there is no mention of AI or ML in the device description, intended use, or performance studies. The focus is on mechanical and material properties and compatibility with existing robotic systems.
No
The device is described as facilitating navigation and providing a conduit for manual placement of therapeutic devices, but it is not itself a therapeutic device.
Yes
The device description explicitly states, "Both the MRC 6Fr v1.2 and the predicate may also be used for delivery of diagnostic contrast agents." This indicates a diagnostic function.
No
The device description explicitly states it is comprised of a Guide (Outer Catheter) and a Leader (Inner Catheter), which are physical hardware components. The performance studies also involve testing of physical properties like tensile strength and pressure burst.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices." This describes a device used within the body for navigation and delivery of other devices, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a catheter used for navigation and delivery of therapeutic devices within the peripheral vasculature. While it mentions the delivery of diagnostic contrast agents, this is a function of the catheter as a conduit, not a diagnostic test performed on a sample.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device is clearly intended for interventional procedures within the body, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Hansen Medical Magellan Robotic Catheter 6Fr 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 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.
Product codes
DRA
Device Description
The Magellan Robotic Catheter 6Fr v1.2 and accessories are a modification of the predicate Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories cleared under K133552. Both the predicate device and the modified Magellan Robotic Catheter 6Fr are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a nonarticulating Leader (Inner Catheter). The devices are provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr v1.2 is designed to be used with Hansen Medical Magellan Robotic System and is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. Both the MRC 6Fr v1.2 and the predicate may also be used for delivery of diagnostic contrast agents. The modified MRC 6Fr is compatible with power contrast injection systems up to a maximum of 600 psi. Whereas, the predicate device is rated for a maximum pressure of 100 psi. The device is provided sterile and is intended for single use only. The catheter is one of several compatible devices available for use with Hansen Medical's Magellan Robotic System cleared under K111004, K132369 and K141614.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral 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
Design verification testing was performed to verify that the performance of the Magellan Robotic Catheter 6Fr v1.2 remains substantially equivalent to the predicate device. Testing performed on the Magellan Robotic Catheter 6Fr v1.2 included the following:
- Tensile Strength Testing
- . Simulated Use Testing
- Pressure Burst Testing
- ISO MEM Elution Cytotoxicity Testing
- ASTM Hemolysis
- Chemical Characterization Testing
All of the pre-determined acceptance criteria were met.
Clinical evaluation is not required for this device.
Key Metrics
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 features a stylized representation of a human figure in profile, with three overlapping faces suggesting community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the department's role and national scope. The logo is simple, using a single color, and is designed to be easily recognizable.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 27, 2015
Hansen Medical, Inc. Elisa Aldridge Staff Regulatory Affairs Associate 800 East Middlefield Road Mountain View, CA 94043
Re: K151463
Trade/Device Name: Hansen Magellan Robotic Catheter 6Fr Regulation Number: 21 CFR 870.1280 Regulation Name: Steerable Catheter Regulatory Class: Class II Product Code: DRA Dated: July 22, 2015 Received: July 23, 2015
Dear Ms. Aldridge:
This letter corrects the 510(k) Summary associated with our substantially equivalent letter of August 18, 2015.
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
1
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 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" (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.
Mada Jellman
for
Bram D. Zuckerman Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 6
Indications for Use
510(k) Number (if known): To be determined
Device Name: Hansen Medical Magellan Robotic Catheter 6Fr
Indications for Use:
The Hansen Medical Magellan Robotic Catheter 6Fr 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 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.
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
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: K151463
Applicant Information:
| Owner Name: | Hansen Medical, Inc. |
|---|---|
| Address: | 800 East Middlefield Road |
| Mountain View, CA. 94043 | |
| Office: 650-404-5800 | |
| Establishment | |
| Registration Number: | 3006026430 |
| Contact Person: | Elisa Aldridge |
| Phone Number: | 650 404 2784 |
| Facsimile Number: | 650 404 2773 |
| Date Prepared: | May 29, 2015 |
Device Information:
| Regulatory Class: | Class II |
|---|---|
| Trade/Device Name: | Hansen Medical Magellan Robotic Catheter 6Fr |
| 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 6Fr v1.2 is substantially equivalent in intended use and method of operation to the Hansen Medical Magellan Robotic Catheter 6Fr (K133552).
4
Device Description:
The Magellan Robotic Catheter 6Fr v1.2 and accessories are a modification of the predicate Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories cleared under K133552. Both the predicate device and the modified Magellan Robotic Catheter 6Fr are comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a nonarticulating Leader (Inner Catheter). The devices are provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr v1.2 is designed to be used with Hansen Medical Magellan Robotic System and is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. Both the MRC 6Fr v1.2 and the predicate may also be used for delivery of diagnostic contrast agents. The modified MRC 6Fr is compatible with power contrast injection systems up to a maximum of 600 psi. Whereas, the predicate device is rated for a maximum pressure of 100 psi. The device is provided sterile and is intended for single use only. The catheter is one of several compatible devices available for use with Hansen Medical's Magellan Robotic System cleared under K111004, K132369 and K141614.
Indications for Use:
The Hansen Medical Magellan Robotic Catheter 6Fr 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 6Fr is intended to be used with the Hansen Medical Magellan Robotic Catheter System and accessories.
Comparison to Predicate Device(s):
The Magellan Robotic Catheter 6Fr v1.2 is a modification of the predicate device to allow for compatibility with power contrast injection systems of the Magellan Robotic Catheter 6Fr Guide to pressures up to a maximum of 600 psi. The catheter modifications involve replacement of the predicate device Guide flush line and stopcock with a high pressure braided flush line and female luer connector. The changes are limited to the flush line. The main body of the catheter and the splayer remain unchanged. The modifications described herein do not affect the intended use of the device or alter the fundamental scientific technology associated with the device. This modified catheter will also be marketed under the name Magellan Robotic Catheter 6Fr.
5
Technological Characteristics/Performance Data:
The Magellan Robotic Catheter 6Fr v1.2 is substantially equivalent to the predicate device in intended use, fundamental scientific technology, and performance specifications. Design verification testing was performed to verify that the performance of the Magellan Robotic Catheter 6Fr v1.2 remains substantially equivalent to the predicate device. Testing performed on the Magellan Robotic Catheter 6Fr v1.2 included the following:
- ●
- ●
- Tensile Strength Testing ●
- . Simulated Use Testing
- Pressure Burst Testing
-
ISO MEM Elution Cytotoxicity Testing
ASTM Hemolysis
-
- > Chemical Characterization Testing -
All of the pre-determined acceptance criteria were met.
Clinical Testing:
Clinical evaluation is not required for this device.
Substantial Equivalence:
The Magellan Robotic Catheter 6Fr v1.2 has the following similarities to the Magellan Robotic Catheter 6Fr predicate device cleared under K133552.
- has the same indication for use,
- has the same fundamental scientific technology, ●
- has the same technological characteristics,
- has the same principles of operation,
- incorporate the same basic catheter design ●
- has the same sterilization process, and
- has the same shelf life. ●
6
Summary:
In summary, the Magellan Robotic Catheter 6Fr v1.2 and accessory components subject to this submission are as safe and effective as the Magellan Robotic Catheter 6Fr and accessory components. It has the same indication for use, the same technological characteristics, and the same principles of operation as the Magellan Robotic Catheter 6Fr. The differences between the modified Magellan Robotic Catheter 6Fr and the Magellan Robotic Catheter 6Fr raise no new issues of safety or effectiveness. Performance data demonstrate that the modified Magellan Robotic Catheter 6Fr v1.2 and accessory components are as safe and effective as the Magellan Robotic Catheter 6Fr and accessory components and is therefore substantially equivalent to the predicate device.