(29 days)
Not Found
No
The summary describes a robotic catheter system with a master/slave control system and software enhancements, but there is no mention of AI or ML technologies being used for control, data analysis, or any other function.
No
The device facilitates manipulation and control of catheters for data collection. It does not directly treat a disease or medical condition.
No
The device is a robotic catheter system designed to facilitate the manipulation, positioning, and control of other catheters for data collection. It does not perform the diagnostic function itself but assists in the process.
No
The device description explicitly states it is a "Robotic Catheter System" and includes "a new E-Stop button," indicating significant hardware components beyond just software. The performance studies also include "E-Stop Button functional testing" and "System testing," further confirming the presence of hardware.
Based on the provided text, the Hansen Medical Sensei® X Robotic Catheter System and Accessories is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a robotic system intended to facilitate manipulation, positioning and control of catheters within the heart atria. It is used for collecting electrophysiological data in vivo (within the living body), not for testing samples in vitro (outside the body).
- Intended Use: The intended use is focused on guiding catheters for electrophysiological mapping within the heart, which is a procedure performed directly on the patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or performing any tests on specimens taken from the patient.
Therefore, the Hansen Medical Sensei® X Robotic Catheter System is a therapeutic or diagnostic device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Hansen Medical Sensei X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters 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
DXX
Device Description
The Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen Control Catheters, 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, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei X Robotic Catheter System include a series of software enhancements and a new E-Stop button.
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)
Design verification and validation testing was performed to verify that the performance of the Sensei X Robotic Catheter System remains substantially equivalent to the predicate device. Testing performed on the modified Sensei X System included the following: - Software Testing - . E-Stop Button functional testing - . System testing. All of the pre-determined acceptance criteria were met. No additional clinical evaluation of the Sensei X Robotic Catheter System is required as a result of these changes.
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
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 eagle or bird-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 5, 2014
Hansen Medical, Inc. Todd Milholland Senior Manager, Regulatory Affairs 800 East Middlefield Rd Mountain View, California 94043
Re: K141822
Trade/Device Name: Sensei X Robotic Catheter System Regulation Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: II Product Code: DXX Dated: July 3, 2014 Received: Julv 7, 2014
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
Linda J. Ricci -S
for 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): K141822
Hansen Medical Sensei® X Robotic Catheter System Device Name:
Indications for Use:
The Hansen Medical Sensei X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters 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)
Image /page/2/Picture/11 description: The image shows the name "Linda J. Ricci -S" in a bold, sans-serif font. The text is black against a white background. The letters are evenly spaced and the text is left-aligned.
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SECTION 7
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:
Address: | Hansen Medical, Inc.
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: | July 3, 2014 |
Device Information:
| Regulatory Class:
Trade/Device Name: | Class II
Hansen Medical Sensei® X Robotic Catheter
System |
|-----------------------------------------|-----------------------------------------------------------------|
| 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 Sensei X Robotic Catheter System is substantially equivalent in intended use and method of operation to the earlier Sensei System (Sensei X Robotic Catheter System) cleared under K102168.
4
Device Description:
The Hansen Medical Sensei X Robotic Catheter System and Accessories, when used in conjunction with compatible Hansen Control Catheters, 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, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Sensei X Robotic Catheter System include a series of software enhancements and a new E-Stop button.
Intended Use:
The Hansen Medical Sensei® X Robotic Catheter System and Accessories are intended to facilitate manipulation, positioning and control of Hansen Medical's robotically steerable catheters 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 X Catheter Control 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 Sensei X Robotic Catheter 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 Sensei X Robotic Catheter System remains substantially equivalent to the predicate device. Testing performed on the modified Sensei X System included the following:
- Software Testing ●
- . E-Stop Button functional testing
- . System testing
All of the pre-determined acceptance criteria were met.
5
Clinical Testing:
No additional clinical evaluation of the Sensei X Robotic Catheter System is required as a result of these changes.
Substantial Equivalence:
The modified Sensei X Robotic Catheter System has the following similarities to the predicate Sensei X Robotic Catheter System cleared under K102168:
- have the same indication for use,
- have the same fundamental scientific technology, ●
- . have the same technological characteristics, and
- . have the same operating principles.
Summary:
Based on the above similarities, the Sensei X Robotic Catheter System subject to this submission is substantially equivalent to the predicate device.