(84 days)
Not Found
No
The summary describes a robotic catheter system with master-slave control and the ability to import 3D maps, but there is no mention of AI or ML algorithms for decision-making, image analysis, or other functions.
No. The device is intended to facilitate manipulation, positioning and control of catheters for data collection within the heart atria, not to directly treat a condition. While it aids in a medical procedure, its primary function is not therapeutic.
No
The device is used to facilitate the manipulation, positioning, and control of catheters for collecting electro-anatomic mapping and recording data within the heart atria. While it assists in the data collection process, it is not described as directly performing a diagnostic function itself, but rather as a robotic system to control other diagnostic catheters.
No
The device description explicitly states it is a "Robotic Catheter System and Accessories" and describes a "master-slave control system" for manipulating catheters, indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states the device is a robotic catheter system used to manipulate and position catheters within the heart atria for collecting electro-anatomic mapping and recording data. This is an in vivo (within the body) procedure.
- Intended Use: The intended use is to facilitate catheter manipulation and data collection inside the heart, not to analyze samples taken from the body.
Therefore, the Hansen Medical Sensei® Robotic Catheter System is a medical device used for an in vivo procedure, not an IVD.
N/A
Intended Use / Indications for Use
The Hansen Medical Sensei® Robotic Catheter System and Accessories are Intended to facilitate manipulation, positioning and control of Hansen Medical’s robotically Steerable electrophysiological mapping and recording catheters for collecting electro-anatomic mapping and recording data within the heart’s atria with existing mapping catheters: the Polarissystems, using the following persultanosals made by Boston Scientific Corporation DX™ Steerable Diagnostic catheters made by St. Jude Medical.
Product codes
DXX
Device Description
The Hansen Medical Sensei Robotic Catheter System and Accessories, when rne franson modioawith compatible Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous icatheters within the atria of the heart. The fundamental concept of the system catherers within the atha of there control system that enables and visualizes ls based on a masterrolave catherer tip at a desired point inside the heart, while enabling a physician to remain seated and away from the x-ray radiation enabiling a prysidian to tomain esaesei Robotic Catheter System include source. The modified to the Delectroanotomic maps from a 30 party mapping system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atria of the heart
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)
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
Ko91808
SECTION 7
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in This summary of 510(K) Sulety and Sheet, and 21 CFR 807.92.
510(k) Number:
Applicant Information:
| Owner Name: | |
|---|---|
| Address: |
Hansen Medical, Inc. 800 East Middlefield Road Mountain View, CA. 94043 Office: 650-404-5800
| Contact Person: | Kate Whitin |
|---|---|
| Phone Number: | 650 404 5800 |
| Facsimile Number: | 650 404 2773 |
Date Prepared: 8/7/2009
Device Information:
| Classification: | Class II |
|---|---|
| Trade Name: | Hansen Medical Sensei® Robotic Catheter 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 Robotic Catheter System is The mounted hamon modical over and method of operation to the earlier Sensei System (K090365).
Device Description:
The Hansen Medical Sensei Robotic Catheter System and Accessories, when rne franson modioawith compatible Control Catheters, are designed to facilitate manipulation, positioning and control of mapping percutaneous icatheters within the atria of the heart. The fundamental concept of the system catherers within the atha of there control system that enables and visualizes ls based on a masterrolave catherer tip at a desired point inside the heart, while
Hansen Medical Sensei Robotic Catheter System Special 510(k) Submission
Section 7, Page 1 of 2 510(k) Summary
1
enabling a physician to remain seated and away from the x-ray radiation enabiling a prysidian to tomain esaesei Robotic Catheter System include source. The modified to the Delectroanotomic maps from a 30 party mapping system.
Intended Use:
The Hansen Medical Sensei® Robotic Catheter System and Accessories are The Hansen Medical Ochocle Robers of Robers of Control of Hansen Intended to facilitate mampulation, positioning electrophysiological Medically Stoblically Stochable electro-anatomic mapping and recording data within the field athla with oreating mapping catherers: the Polarissystems, using the following persultanosals mapped on Scientific Corporation
Dx™ Steerable Diagnostic catheters made by Boston Scientific Corporation DX "" Steerable Diagnostio Gatholoro matte by St. Jude Medical.
Comparison to Predicate Device(s):
The modified Hansen Medical Sensei Catheter Control System is The modified Harisen Medical Oonoor Outholer. The modifications described substantially equivalient to the production of the device or alter the fundamental scientific technology associated with the device.
Substantial equivalence:
Based upon the indications for use and the design and engineering data Based upon the Indications for aconomic the Hansen Medical Sensei Robotic provided in this pre-market notinousen, and hanswilly equivalent to a currently marketed predicate device.
Special 510(k) Submission
Section 7, Page 2 of 2 510(k) Summary
2
Image /page/2/Picture/0 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 a stylized symbol that resembles an abstract eagle or bird-like figure with three wing-like shapes.
DEPARTMENT OF HEALTH & HUMAN SERVICES :
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP 1 0 2009
Hansen Medical, Inc. c/o Ms. Kate Whitin Director, Regulatory Affairs 800 E. Middlefield Road Mountain View, CA 94043
Re: K091808
Trade/Device Name: Hansen Medical Sensei Robotic Catheter System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (two) Product Code: DXX Dated: August 7, 2009 Received: August 10, 2009
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). 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 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.
3
Page 2 - Ms. Kate Whitin
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 Scction 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); medical device reporting (reporting of medical device-related 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
4
Page 3 – Ms. Kate Whitin
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.
Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SECTION 6
Indications for Use
510(k) Number (if known): K091808
Hansen Medical Sensei® Robotic Catheter System Device Name:
Indications for Use:
The Hansen Medical Sensei® Robotic Catheter System and Accessories are The Hansen Mculear Ochool October Roll control of Hansen Interioed to faoilitato manipulations for collecting electrophysiological Medical s robotically Stobrable carrers anatomic mapping and recording data within the fleart athle with oleoting catheters: the Polarissystems, using the following portutions made by Boston Scientific Corporation DX - Steerable Diagnootio Saviology 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)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K091808
Hansen Medical
Sensei Robotic Catheter System
Special 510(k) Submission
Section 6, Page 1 of 1
Indication for Use