(228 days)
Not Found
No
The description focuses on a master/slave robotic control system for catheter manipulation and visualization of 3D maps, with no mention of AI or ML algorithms for analysis, decision-making, or image processing.
No.
The device is intended to facilitate manipulation, positioning, and control of mapping catheters for collecting electrophysiological data, not for treating a disease or condition.
Yes
Explanation: The device is described as facilitating the collection of electrophysiological data within the heart atria with electro-anatomic mapping and recording systems, which are used to diagnose heart conditions.
No
The device description explicitly mentions a "Catheter Control System" and "Artisan Catheter and accessories," indicating hardware components are part of the system, not just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "facilitate manipulation, positioning and control, for collecting electrophysiological data within the heart atria". This describes a device used in vivo (within a living organism) to assist in a medical procedure and data collection, not a test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description reinforces the in vivo nature by stating it's designed to "facilitate manipulation, positioning and control of mapping percutaneous catheters within the atria of the heart". It also mentions a "master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the heart".
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis. The focus is on controlling a catheter for data collection within the body.
Therefore, the Sensei Robotic Catheter System, Artisan Catheter, and accessories, as described, fall under the category of a medical device used for a procedure and data acquisition in vivo, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Sensei Robotic Catheter System, Artisan Catheter, 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.
Product codes (comma separated list FDA assigned to the subject device)
DXX, DRA
Device Description
The Hansen Medical Sensei Catheter Control, Artisan Catheter and accessories and 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 Catheter Control System has been modified to display 3D electroanotomic maps from a 30 party mapping system in the center screen of the Sensei system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
heart atria
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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: | 380 N. Bernardo Ave. |
| Mountain View, CA. 94043 | |
| Office: 650-404-5800 | |
| Contact Person: | Doug Worth, RAC |
| Phone Number: | 650 404 5800 |
| Facsimile Number: | 650 404 5901 |
| Date Prepared: | 11/14/2007 (revised 1/7/08) |
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Sensei Catheter Control System |
| Common name: | Steerable Catheter Control System |
| Classification name: | System, Catheter Control, Steerable, (21 CFR 870.1290/DXX) |
Predicate Devices:
The modified Hansen Medical Sensei Catheter Control system is substantially equivalent in intended use and method of operation to the earlier Sensei system (K052480).
Device Description:
The Hansen Medical Sensei Catheter Control, Artisan Catheter and accessories and 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
K073225 Hansen Medical
Attachment 2, Page 2 of 3 Indication for Use and 510(k) Summary
1
from the x-ray radiation source The Catheter Control System has been modified to display 3D electroanotomic maps from a 30 party mapping system in the center screen of the Sensei system.
Intended Use:
The Sensei Robotic Catheter System, Artisan Catheter, 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.
Comparison to Predicate Device(s):
The modified Hansen Medical Sensei Catheter Control System is substantially equivalent to the predicate device.
Substantial equivalence:
Based upon the indications for use and the design and engineering data provided in this pre-market notification, the Hansen Medical Sensei Robotic Catheter System, Artisan Catheter and have been shown to be substantially equivalent to a currently marketed predicate device.
K073225 Hansen Medical
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines above a wavy base.
Public Health Service
JUN 3 0 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Hansen Medical, Inc. c/o Doug Worth, RAC Manager, Regulatory Affairs 380 N. Bernardo Ave. Mountain View, CA 94043
Re: K073225
Trade/Device Name: Sensei Catheter Control System, Model 02057 Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II Product Code: DXX and DRA Dated: May 29, 2008 Received: May 30, 2008
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 Artisan 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.
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
3
Page 2 -- Mr. Doug Worth, RAC
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 limited 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) 276-0120. 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, 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.
NOCETIN
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): Ko13225
- Hansen Medical Sensei Catheter Control System Device Name: Hansen Medical Artisan Steerable guide Catheter
Indications for Use:
The Sensei Robotic Catheter System, Artisan Catheter, 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)
Deeth
K073225 Hansen Medical
Attachment 2, Page 1 of 3 Indication for Use and 510(k) Summary