(187 days)
Not Found
No
The summary describes a remote catheter control system focused on mechanical manipulation and positioning, with no mention of AI/ML terms, image processing for analysis, or data-driven decision-making.
No
The device aids in the manipulation and control of diagnostic catheters for stimulating and recording cardiac data, but it is explicitly stated that its safety and effectiveness for ablation (a therapeutic treatment) has not been established.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended for "recording electrophysiological data," which is a diagnostic activity.
No
The device description explicitly mentions "disposable components" and describes a system that physically manipulates a catheter, indicating it includes hardware components beyond just software.
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 device is for "facilitat[ing] manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle." This describes a device used in vivo (within the body) for a diagnostic procedure, not a device used in vitro (outside the body) to examine specimens like blood, urine, or tissue.
- Device Description: The description details how the device interacts with catheters inserted into the body and how it is used under imaging guidance. This further supports its in vivo application.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Amigo Remote Catheter System is a medical device used for in vivo diagnostic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The Amigo Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.
The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established.
The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.
Product codes (comma separated list FDA assigned to the subject device)
DXX
Device Description
The Amigo RCS is designed to create a simple interface with commercially available catheters allowing the physician to insert, withdraw and rotate the catheter, and deflect the catheter tip via the remote controller. Catheter placement and positioning is performed under direct visualization using standard imaging equipment, while enabling the physician to remain seated and away from the X-ray radiation field. The Amigo RCS system includes several disposable components which help to maintain the sterile field.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
standard imaging equipment
Anatomical Site
right atrium and right ventricle
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 ensure that the Amiqo RCS and accessories met design specifications and customer requirements. Testing activities included electrical/mechanical safety tests and functional performance tests as well as cleaning, biocompatibility, sterilization, shelf life and transit studies.
Risk analysis activities were completed based on ISO 14971. Electrical/mechanical device safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1 and 60601-1-2, respectively. Supporting biocompatibility studies were performed in accordance with ISO 10993-1.
The clinical evaluation confirmed that Amigo RCS is safe and effective and operates as designed for its intended use and as described in its proposed labeling.
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 (As required by section 21 CFR 807.92(c))
| Contact: | Catheter Robotics, Inc.
Jennifer Englund
Vice President, Clinical Affairs and Regulatory
Telephone: 973-691-2000 / Fax: 973-810-4887
Email: jenglund@catheterrobotics.com |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 6, 2011 |
| Product Trade Name: | Amigo Remote Catheter System (RCS) & Accessories,
Model 1012 |
| Common/Usual Name: | Steerable Catheter Control System |
| Classification Name: | System, Catheter Control, Steerable, Class II
(21 CFR 870.1290, Product Code DXX) |
| Predicate Devices: | Hansen Medical Catheter Control System (CCS)
& Accessories, Hansen Medical, Inc. (K052480) |
| | Stereotaxis Niobe MNS Catheter Control System &
Accessories, Stereotaxis, Inc. (K021555) |
| Manufacturer: | Catheter Robotics, Inc.
500 International Drive
Mount Olive, NJ 07828 |
3008365050 Establishment Registration:
Device Description:
તે જે
ે જેવાં છે.
વર્ષના વિશ્વ
The Amigo RCS is designed to create a simple interface with commercially available catheters allowing the physician to insert, withdraw and rotate the catheter, and deflect the catheter tip via the remote controller. Catheter placement and positioning is performed under direct visualization using standard imaging equipment, while enabling the physician to remain seated and away from the x-ray radiation field. The Amigo RCS system includes several disposable components which help to maintain the sterile field.
1
Statement of Intended Use:
The Amigo Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.
The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established.
The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.
Summary of Technological Characteristics in Comparison to the Predicate Device:
The Amigo RCS is substantially equivalent to the predicated devices. Both the proposed and predicate devices provide stability for positioning of EP catheters, while allowing the physician to perform the procedure from a position beyond the radiation field.
Substantial Equivalence:
Based upon the intended use and technical information provided in this pre-market notification, the Amigo RCS and accessories have been shown to be substantially equivalent to currently marketed predicate devices.
Summary of Non-Clinical Testing:
Design verification and validation testing was performed to ensure that the Amiqo RCS and accessories met design specifications and customer requirements. Testing activities included electrical/mechanical safety tests and functional performance tests as well as cleaning, biocompatibility, sterilization, shelf life and transit studies.
Risk analysis activities were completed based on ISO 14971. Electrical/mechanical device safety and electromagnetic compatibility testing were conducted in accordance with IEC 60601-1 and 60601-1-2, respectively. Supporting biocompatibility studies were performed in accordance with ISO 10993-1.
Summary of Clinical Testing:
The clinical evaluation confirmed that Amigo RCS is safe and effective and operates as designed for its intended use and as described in its proposed labeling.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a graphic representation of an eagle or bird-like figure, with three curved lines forming its body and wings.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 2 2012
Catheter Robotics Inc. c/o Ms. Jennifer Englund Vice President-Clinical and Regulatory Affairs 500 International Drive, Suite 120 Mount Olive, NJ 07828
Re: K113628
Trade Name: Amigo Remote Catheter System & Accessories, Model 1012 Regulatory Number: 21 CFR 870.1290 Regulation Name: Steerable Catheter Control System Regulatory Class: Class II (Two) Product Code: DXX Dated: May 31, 2011 Received: June 4. 2011
Dear Ms. Englund:
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 Gontrols) or class-III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
3
Page 2 - Ms. Jennifer Englund
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours,
fo. Bram D. Zuckerman, M.D.
Director
Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _ K113628
Device Name:
Catheter Robotics, Inc. Amigo Remote Catheter System (RCS) & Accessories, Model 1012
Indications for Use:
The Amigo Remote Catheter System (RCS) is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data in the right atrium and right ventricle.
The safety and effectiveness of this device for ablation in the treatment of cardiac arrhythmias including atrial fibrillation, has not been established.
The safety and effectiveness of this device for cardiac mapping when used with any catheter other than the Boston Scientific Blazer™ Dx-20 has not been established.
Prescription Use X Over-The-Counter Use Prescription Ose ____________________________________________________________________________________________________________________________________________________________ (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 K113628