(59 days)
None
No
The description focuses on a master/slave robotic control system for navigation and device placement, with no mention of AI or ML capabilities for image analysis, decision support, or autonomous functions. The performance studies are standard verification and validation tests for a robotic system.
No.
The text states that the device is intended to "provide a conduit for manual placement of therapeutic devices," indicating that it facilitates the use of other therapeutic devices rather than being one itself.
No
Explanation: The device is described as facilitating navigation and providing a conduit for placement of therapeutic devices, which are interventional rather than diagnostic functions.
No
The device description explicitly mentions a "Magellan Robotic System" and "Magellan Robotic Catheter 9Fr," which are hardware components. The summary also details hardware-related testing like "Electrical Safety Test" and "System Set Up Test."
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the system is for "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 reinforces this by explaining it's a "master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature." This is a description of an interventional medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Magellan Robotic System does not fit this description.
N/A
Intended Use / Indications for Use
Magellan Robotic System: 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.
Magellan Robotic Catheter 9Fr: 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 is intended to be used with the Hansen Medical Magellan Robotic System and accessories.
Product codes
DXX, DRA
Device Description
The Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr 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 modifications to the Magellan System were made to expand system-quide wire compatibility, provide alternate quide wire navigation using the Master Input Device in addition to the existing Workstation and Bedside Controllers and to provide support for future compatible Hansen vascular catheters.
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
physician
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 verification and validation testing was performed to ensure that the Magellan System met design specifications and customer requirements. Testing activities included software and catheter verification and validation tests. Verification and Validation testing includes the following:
- System Set Up Test .
- Catheter Installation Test .
- . System -Guide Wire Compatibility Test
- Procedure Simulation (Catheter and . Guide Wire navigation) Test
- Magellan Catheters Drive Modes .
- User Interface Test .
- . 3D Controller Test
- System Status and Error Message . Test
- · System Power Cycle Test
- . Emergency and Configuration Tests
- . Electrical Safety Test
Risk analysis activities were completed based on ISO 14971.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
KI32369
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:
Applicant Information:
| Owner Name: | Hansen Medical, Inc. |
|---|---|
| Address: | 800 East Middlefield Road |
| Mountain View, CA. 94043 | |
| Office: 650-404-5800 |
Contact Person: Hassan Labay Phone Number: 650 404 5888 Facsimile Number: 650 404 2773
P 2 7 2013
Date Prepared: 9/26/2013
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Hansen Medical Magellan™ Robotic System; |
| Magellan ™ Robotic Catheter 9Fr ( Formerly known as | |
| NorthStar™ Robotic Catheter ) | |
| Common name: | Steerable Catheter Control System; |
| Steerable catheter | |
| Classification name: | System, Catheter Control, Steerable (21 CFR 870.1290/DXX); |
| Catheter, Steerable (21 CFR 870.1280/DRA) |
Predicate Devices:
The modified Hansen Medical Magellan System (Magellan Robotic System and the Magellan Robotic Catheter 9Fr), is substantially equivalent in intended use and method of operation to the cleared Magellan System (Magellan Robotic System and Magellan Robotic Catheter 9Fr) cleared under K111004.
Special 510(k) Submission
1
Device Description:
The Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr 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 modifications to the Magellan System were made to expand system-quide wire compatibility, provide alternate quide wire navigation using the Master Input Device in addition to the existing Workstation and Bedside Controllers and to provide support for future compatible Hansen vascular catheters.
Intended Use:
Maqellan Robotic System: 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.
Magellan Robotic Catheter 9Fr: 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 is intended to be used with the Hansen Medical Magellan Robotic System and accessories.
Summary of Technological Characteristics in Comparison to Predicate Device:
The Magellan System is substantially equivalent to the predicate device. The Magellan Robotic System software modifications to expand system-quide wire compatibility, to enhance user interface and clinical procedural workflow and to expand system support for an additional Hansen Medical vascular control catheter 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
Hansen Medical Magellan ™ System Special 510(k) Submission
2
placement of therapeutic devices, while allowing the physician to perform the procedure from a position beyond the radiation filed.
Substantial equivalence:
Based upon the indications for use and the design and engineering data provided in this pre-market notification, the Hansen Medical Magellan System has been shown to be substantially equivalent to a currently marketed predicate device.
Summary of Non-Clinical Testing:
Design verification and validation testing was performed to ensure that the Magellan System met design specifications and customer requirements. Testing activities included software and catheter verification and validation tests. Verification and Validation testing includes the following:
- System Set Up Test .
- Catheter Installation Test .
- . System -Guide Wire Compatibility Test
- Procedure Simulation (Catheter and . Guide Wire navigation) Test
- Magellan Catheters Drive Modes .
- User Interface Test .
- . 3D Controller Test
- System Status and Error Message . Test
- · System Power Cycle Test
- . Emergency and Configuration Tests
- . Electrical Safety Test
Risk analysis activities were completed based on ISO 14971.
Summary of Clinical Testing:
No additional clinical evaluation of the Magellan System is required as a result of these changes.
Hansen Medical Magellan™ System Special 510(k) Submission
Section 7, Page 3 of 4 510(k) Summary
3
Substantial equivalence:
4
The modified Magellan Robotic System and Magellan Robotic Catheter 9Fr have the following similarities to the predicate devices which previously received clearance under K111004.
- have the same indication for use, .
- . have the same fundamental scientific technology,
- . incorporate the same catheter design,
- . catheter incorporate the same materials, and
- . catheter uses the same sterilization processes.
In summary, the Magellan System (Magellan Robotic System and the Magellan Robotic Catheter 9Fr) subject to this submission is substantially equivalent to the predicate device.
Hansen Medical Magellan ™ System Special 510(k) Submission
Section 7, Page 4 of 4 510(k) Summary
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of a human figure embracing a bird, which is meant to represent the department's mission of protecting the health of all Americans and providing essential human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2013
Hansen Medical, Inc. Hassan Labay 800 East Middlefield Road Mountain View, CA 94043 US
Re: K132369
Trade/Device Name: Magellan Robotic System, Magellan Robotic Catheter 9Fr Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System, Steerable Catheter Regulatory Class: Class II Product Code: DXX, DRA Dated: August 28, 2013 Received: August 29, 2013
Dear Hassan Labay:
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
5
Page 2 - Hassan Labay
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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
SECTION 6
Indications for Use
510(k) Number: K132369
Device Name: Hansen Medical Magellan Robotic System, Magellan Robotic Catheter 9Fr (Formerly known as NorthStar Robotic Catheter)
Indications for Use:
Magellan Robotic System: 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.
Magellan Robotic Catheter 9Fr. 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 is intended to be used with the Hansen Medical Magellan Robotic System and accessories.
Prescription Use x (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Digitally signed by
Owen P. Faris -5
Date: 2013.09.27
12:59-31-04'00'
Special 510(k) Submission
Hansen Medical Magellan™ System Section 6. Page 1 o! 1 Indication for Use