(600 days)
The Hansen Medical Catheter Control System, Steerable Guide Catheter, Sheath, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-DxTM Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.
The Hansen Medical Catheter Control System and Accessories and Steerable Guide Catheter and Sheath are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. 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 heart, whilst enabling a physician to remain seated and away from the x-ray radiation source.
The provided text is a 510(k) summary for the Hansen Medical Catheter Control System (CCS) and Accessories, and Steerable Guide Catheter (SGC) and Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment relevant to an AI/diagnostic device.
The provided text details:
- Device Information: Trade Name, Common Name, Classification.
- Predicate Devices: The Stereotaxis Niobe Magnetic Navigation System (K021555) is identified as the predicate.
- Device Description: The system is a master/slave control system for manipulating steerable catheters within the heart atria, allowing a physician to operate away from X-ray radiation.
- Intended Use: To facilitate manipulation, positioning, and control for collecting electrophysiological data within the heart atria using specific percutaneous mapping catheters (Polaris-DxTM and LivewireTM).
- Substantial Equivalence: The document states that based on indications for use and engineering data, the device is substantially equivalent to the predicate.
- FDA Communication: The FDA's letter confirms substantial equivalence but adds a limitation regarding the device's unproven safety and effectiveness for use with cardiac ablation catheters in treating cardiac arrhythmias, including atrial fibrillation.
In summary, this regulatory submission for a medical device (a catheter control system) focuses on substantial equivalence, not on a performance study with acceptance criteria as typically found for diagnostic or AI-driven devices.
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510(k) SUMMARY
MAY -- 2 2007
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
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510(k) Number: K052480
Applicant Information:
| Owner Name: | Hansen Medical, Inc. |
|---|---|
| Address: | 380 N. Bernardo Ave.Mountain View, CA. 94043Office: 650-404-5800 |
| Contact Person: | Doug Worth, RAC |
| Phone Number: | 650 404 5800 |
| Facsimile Number: | 650 404 5901 |
| Date Prepared: | 04/27/2007 |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Hansen Medical Catheter Control System (CCS) and AccessoriesHansen Medical Steerable guide Catheter (SGC) and Sheath |
| Common name: | Steerable Catheter Control SystemSteerable Guide Catheter |
| Classification name: | System, Catheter Control, Steerable, (21 CFR 870.1290/DXX) |
Predicate Devices:
The Hansen Medical Catheter Control System and Accessories and Steerable Guide Catheter and Sheath are substantially equivalent in intended use and method of operation to:
Stereotaxis Niobe Magnetic Navigation System Stereotaxis, Inc. - K021555
Hansen Medical CCS and SGC
510(k) Submission
Section 6, Page 1 of 2 510K Summary
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Device Description:
The Hansen Medical Catheter Control System and Accessories and Steerable Guide Catheter and Sheath are designed to facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart. 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 heart, whilst enabling a physician to remain seated and away from the x-ray radiation source.
Intended Use:
The Hansen Medical Catheter Control System, Steerable Guide Catheter, Sheath, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-DxTM Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical,
Comparison to Predicate Device(s):
The Hansen Medical Catheter Control System and accessories and Steerable Guide Catheter and Sheath are substantially equivalent to the predicate device.
Substantial equivalence:
Based upon the indications for use and the design and engineering data provided in this premarket notification, the Hansen Medical Catheter Control System and accessories and Steerable Guide Catheter and Sheath have been shown to be substantially equivalent to a currently marketed predicate device.
Harsen Medical CCS and SGC 510(k) Submission
Section 6. Page 2 of 2 510K Summary
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES U.S.A." arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight. The symbol is rendered in a dark color, contrasting with the lighter background.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2007
Hansen Medical c/o Doug Worth, RAC Manager Regulatory Affairs 380 North Bernardo Ave. Mountain View, CA 94043
Re: K052480
Trade/Device Name: Hansen Medical Catheter Control System (CCS) and accessories, Steerable guide Catheter (SGC) and Sheath Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable catheter control system Regulatory Class: II Product Code: DXX and DRA Dated: February 8, 2007 Received: February 9, 2007
Dear Mr. Worth:
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). You may, therefore, market the device, subject to the general controls provisions of the Act and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device 's labeling, on the packaging for the Steerable Guide Catheter and Sheath, on the Remote Catheter Manipulator, and the Workstation:
The safety and effectiveness of this device for use with cardiac ablation catheters, in the treatment of cardiac arrhythmias including atrial fibrillation, have not been established.
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Page 2 - Doug Worth, RAC
Furthermore, this warning must be prominently displayed on the Remote Catheter Manipulator, Workstation, all labeling, including pouch box, and carton labels, instructions for use and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
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 Iimited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0295. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International,
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Page 3 - Doug Worth, RAC
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and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
:
Sincerely yours
Dana Dee Tillman, Ph.D., M.B.A.
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052480
Device Name: Hansen Medical Catheter Control System (CCS) and Accessories Hansen Medical Steerable guide Catheter (SGC) and Sheath
Indications for Use:
The Hansen Medical Catheter Control System, Steerable Guide Catheter, Sheath, and accessories are intended to facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, using the following percutaneous mapping catheters: the Polaris-Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation and the Livewire™ Electrophysiology catheters made by St. Jude Medical.
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)
R. Vaunes
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number K052480
§ 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).