(27 days)
Not Found
No
The document describes a robotic system for navigation and placement of devices in the peripheral vasculature. It mentions a master/slave control system and a software update, but there is no mention of AI, ML, image processing, or any related concepts in the provided text.
No.
The device is intended to facilitate navigation and provide a conduit for the placement of therapeutic devices, but it is not a therapeutic device itself.
No
The device is described as a robotic system intended to facilitate navigation and placement of therapeutic devices within the peripheral vasculature. Its purpose is interventional (providing a conduit for placement of therapeutic devices) and navigational, not to diagnose a condition.
No
The device description explicitly states it is a "Robotic System" and includes "accessory components," indicating hardware is involved. The software update (Magellan v1.9.1) is a modification to an existing hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for facilitating navigation and providing a conduit for manual placement of therapeutic devices within the peripheral vasculature. This is an in-vivo (within a living organism) application, not an in-vitro (outside of a living organism, typically in a lab) diagnostic test.
- Device Description: The description reinforces the in-vivo nature by describing a system that enables and visualizes positioning of a catheter tip inside the vasculature.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Hansen Medical Magellan Robotic System is a medical device used for interventional procedures within the body, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
DXX
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.
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 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.
No additional clinical evaluation of the Magellan Robotic System is required as a result of these changes.
Key Metrics
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
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
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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 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.
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 Road |
| Mountain View, CA. 94043 | |
| Office: 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 Catheter |
| System 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.
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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.
Intended Use:
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.
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.