(52 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on a master/slave control system for robotic navigation.
No
The device is intended to facilitate navigation and provide a conduit for the placement of other therapeutic devices, rather than being a therapeutic device itself.
No
The device is described as facilitating navigation and providing a conduit for manual placement of therapeutic devices, rather than diagnosing a disease or condition.
No
The device description explicitly details a "master/slave control system" and a "mechanical joint," indicating significant hardware components beyond just software. The performance studies also include hardware-focused testing like "Visual and Dimensional Verification Testing," "IEC 606061-1 Testing," and "Life cycle Testing."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is used to "facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices." This describes a system used in vivo (within the body) for guiding procedures and delivering devices.
- Device Description: The description reinforces this by explaining its function in positioning a catheter tip "inside the vasculature."
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body. This device is designed to interact directly with the patient's anatomy during a medical procedure.
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 adds a mechanical joint between the Magellan Robotic System Rail and Adapter Plate to facilitate removal.
The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.
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 System remains substantially equivalent to the predicate device. Testing performed on the Magellan Robotic System included the following:
- Visual and Dimensional Verification Testing
- IEC 606061-1 Testing
- Table Compatibility
- Life cycle 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).
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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 features a stylized depiction of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The profiles are encircled by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2014
Hansen Medical Kate Whitin Sr. Director, Regulatory Affairs 800 East Middlefield Road Mountain View, California 94043
Re: K141614
Trade/Device Name: Magellan Robotic System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX Dated: June 12, 2014 Received: June 16, 2014
Dear Ms. Whitin:
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
1
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/Resourcesfor You/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.
Image /page/1/Picture/8 description: The image shows a logo with the letters "K" and "l" in a stylized, handwritten font. Below the letters, the text "Ken Skodacek for" is visible. The background features a faint, blurred image of the FDA logo, suggesting a connection to the Food and Drug Administration.
Bram D. Zuckerman, M.D. 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): K141614
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)
Image /page/2/Picture/12 description: The image shows a logo with the letters "K" and "I" in a stylized, handwritten font. Below the logo, the text "Ken Skodacek for" is printed in a smaller, sans-serif font. The logo is simple and modern, with a personal touch due to the handwritten style of the letters.
Bram Zuckerman
Special 510(k) Submission
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Image /page/3/Picture/0 description: The image shows the logo for Hansen Medical. The logo consists of a blue, stylized heart shape on the left, followed by the word "hansen" in black, sans-serif font. Below the word "hansen" is the word "MEDICAL" in smaller, sans-serif font. A registered trademark symbol is located to the right of the word "hansen".
SECTION 7
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92(c).
510(k) Number: K141614
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: | Kate Whitin Lee |
| Phone Number: | 650 404 5841 |
| Facsimile Number: | 650 404 2773 |
| Date Prepared: | August 5, 2014 |
Device Information:
| Regulatory Class: | Class II |
|---|---|
| Trade/Device Name: | Hansen Medical Magellan Robotic 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 modified Hansen Medical Magellan System (Magellan Robotic System), is substantially equivalent in intended use and method of operation to the cleared Magellan System (Magellan Robotic System) cleared under K132369.
Hansen Medical Magellan Robotic System Traditional 510(k) Submission
Page 7-1 of 4 510(k) Summary
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Image /page/4/Picture/0 description: The image shows the logo for Hansen Medical. The logo features a blue, stylized heart shape on the left, followed by the word "hansen" in black, lowercase letters. Below "hansen" are the words "MEDICAL" in smaller, black, uppercase letters. The logo is clean and modern, with a focus on the company name and its association with the medical field.
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 adds a mechanical joint between the Magellan Robotic System Rail and Adapter Plate to facilitate removal.
The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.
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 Magellan Robotic System and accessory components are 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. Both the proposed and predicate device facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices, while allowing the physician to perform the procedure from a position beyond the radiation field.
Technological Characteristics/Performance Data:
The Magellan Robotic System and accessory components are substantially equivalent to the predicate device in intended use, fundamental scientific technology, and performance specifications. Design verification testing was
Hansen Medical Magellan Robotic System Traditional 510(k) Submission
Page 7-2 of 4 510(k) Summary
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Image /page/5/Picture/0 description: The image shows the logo for Hansen Medical. The logo consists of a blue, stylized heart shape on the left, followed by the word "hansen" in black, sans-serif font. Below "hansen" is the word "MEDICAL" in smaller, sans-serif font, with a wider letter spacing.
performed to verify that the performance of the Magellan Robotic System remains substantially equivalent to the predicate device. Testing performed on the Magellan Robotic System included the following:
- Visual and Dimensional Verification Testing ●
- IEC 606061-1 Testing ●
- Table Compatibility
- Life cycle Testing ●
All of the pre-determined acceptance criteria were met.
Clinical Testing:
No additional clinical evaluation of the Magellan Robotic System is required as a result of these changes.
Substantial Equivalence:
The Magellan Robotic System has the following similarities to the predicate device cleared under K132369:
- . has the same intended use, although the indications for use are limited to the robotic system and accessory components,
- has the same fundamental scientific technology, ●
- has the same technological characteristics, and ●
- has the same principles of operation.
Traditional 510(k) Submission
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Image /page/6/Picture/0 description: The image shows the logo for Hansen Medical. The logo consists of a blue, stylized heart shape on the left, followed by the words "hansen" in black, with a registered trademark symbol. Below "hansen" is the word "MEDICAL" in smaller, black letters.
Summary:
In summary, the Magellan Robotic System and accessory components subject to this submission are as safe and effective as the predicate device. They have the same intended use, the same fundamental technological characteristics, and the same principles of operation as the predicate device. The differences between the Magellan Robotic System and the predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the Magellan Robotic System and accessory components are as safe and effective as the predicate device and are therefore substantially equivalent.
Hansen Medical Magellan Robotic System Traditional 510(k) Submission
Page 7-4 of 4 510(k) Summary
800 East Middlefield Road · Mountain View, CA 94043 · T 650.4040.5800 www.hansenmedical.com