(97 days)
K/DEN: Not Found
No
The summary describes a remote-controlled mechanical system for manipulating catheters, with no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is intended to facilitate manipulation, positioning, and control of percutaneous diagnostic catheters for stimulating cardiac tissue and recording electrophysiological data, not for direct therapeutic treatment itself. While diagnostic information can lead to therapeutic interventions, the device's function is diagnostic support.
Yes
The Amigo Remote Catheter System is intended to facilitate manipulation, positioning and control of percutaneous diagnostic catheters for stimulating cardiac tissue and for recording electrophysiological data. It explicitly states that its safety and effectiveness for cardiac mapping is established when used with specific diagnostic catheters, indicating its role in a diagnostic process.
No
The device description explicitly states the system includes "several disposable components" and mentions electrical/mechanical safety tests, biocompatibility studies, and sterilization, indicating the presence of 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 Diagnostic devices are 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 performed outside of the body.
- Amigo's Function: The Amigo Remote Catheter System is used to manipulate and position catheters inside the body (in the right atrium and right ventricle) for diagnostic purposes (stimulating cardiac tissue and recording electrophysiological data). This is an in vivo procedure, not in vitro.
- Intended Use: The intended use clearly describes a procedure performed directly on the patient's heart, not on a sample taken from the patient.
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 (Amigo) 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 CATHETERS OTHER THAN the Boston Scientific Blazer® Dx-20 and Biosense Webster EZ STEER" diagnostic catheters has not been established.
Product codes
DXX
Device Description
The Amigo Remote Catheter System (Amigo) 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 xray radiation field. The Amigo 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
Not Found
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)
No additional clinical evaluations of the Amigo for the intended use were performed.
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
NOV 2 0 2012
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: | August 14, 2012 |
| Product Trade Name: | Amigo Remote Catheter System & 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: | Amigo Remote Catheter System & Accessories
(Blazer), Catheter Robotics, Inc. (K113628) |
| Manufacturer: | Catheter Robotics, Inc.
500 International Drive
Mount Olive, NJ 07828 |
| Establishment Registration: | 3008365050 |
Device Description:
The Amigo Remote Catheter System (Amigo) 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 xray radiation field. The Amigo system includes several disposable components which help to maintain the sterile field.
1
Statement of Intended Use:
The Amigo 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 and Biosense Webster EZ STEER™ diagnostic catheters has not been established.
Summary of Technological Characteristics in Comparison to the Predicate Device:
The Amigo is substantially equivalent to the predicated device. 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 and accessories have been shown to be substantially equivalent to currently marketed predicate device.
Summary of Non-Clinical Testing:
Design verification and validation testing was performed to ensure that the Amigo 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:
No additional clinical evaluations of the Amigo for the intended use were performed.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, depicted with stylized lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
NOV 2 0 2012
Catheter Robotics, Inc. c/o: Jennifer Englund Vice President, Clinical Affairs / Regulatory 500 International Drive Mount Olive, NJ 07828
Re: K122488
Trade/Device Name: Amigo Remote Catheter System (Model 1012) with Biosense Webster EZ STEER and Boston Scientific Blazer Diagnostic Catheters Regulatory Number: 21 CFR 870.1290 Regulation Name: Steerable catheter control system Regulatory Class: II (two) Product Code: DXX Dated: October 29, 2012 Received: November 1, 2012
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.
3
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 (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,
Owen P. Faris -S
for 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
K122488 510(k) Number (if known):
Device Name:
Catheter Robotics, Inc. Amigo Remote Catheter System & Accessories, Model 1012
Indications for Use:
The Amigo Remote Catheter System (Amigo) 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 CATHETERS OTHER THAN the Boston Scientific Blazer® Dx-20 and Biosense Webster EZ STEER" diagnostic catheters has not been established.
Prescription Use X
(Part 21 CFR 801 Subpart D) and/or
(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 K122488