(97 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Amigo Remote Catheter System:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantifiable acceptance criteria and device performance metrics are not detailed. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
The "performance" described is in terms of meeting design specifications and customer requirements through various verification and validation tests:
| Acceptance Criteria Category | Reported Device Performance (as inferred) |
|---|---|
| Safety | Meets design specifications and customer requirements. Demonstrated through electrical/mechanical safety, biocompatibility, and risk analysis conforme to ISO 14971. Conforms to IEC 60601-1 and 60601-1-2 for electrical/mechanical safety and EMC. |
| Functionality | Meets design specifications and customer requirements. Demonstrated through functional performance tests. |
| Material/Sterility | Meets design specifications and customer requirements. Demonstrated through cleaning, sterilization, and biocompatibility studies conforming to ISO 10993-1. |
| Usability/Durability | Meets design specifications and customer requirements. Demonstrated through shelf life and transit studies. |
| Intended Use | Facilitates manipulation, positioning, and control of percutaneous diagnostic catheters for stimulating cardiac tissue and recording electrophysiological data in the right atrium and right ventricle. (No specific performance metrics like precision or speed are given). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. No clinical test set (human patient data) was used. The testing was non-clinical (benchtop, in-vitro, etc.).
- Data Provenance: Not applicable. The data comes from internal non-clinical laboratory testing (e.g., electrical, mechanical, biocompatibility labs).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- Number of Experts: Not applicable. Since no clinical test set was used, no experts were needed to establish ground truth for patient data. Expert judgment would have been involved in defining design specifications and interpreting non-clinical test results, but this is not a "ground truth" establishment in the typical sense for a clinical study.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. The document explicitly states: "No additional clinical evaluations of the Amigo for the intended use were performed." This means no human reader studies, with or without AI assistance, were conducted.
- Effect Size: Not applicable.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Was standalone performance done? Yes, in a non-clinical context. The "standalone performance" refers to the device itself (the Amigo system) performing its intended functions without human intervention acting as a variable in the performance metric. The non-clinical tests (electrical/mechanical safety, functional performance, cleaning, biocompatibility, sterilization, shelf life, transit studies) assess the device's inherent performance against specifications. However, this is not an "algorithm" in the typical sense of AI/ML.
7. Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical tests, the "ground truth" was established by engineering design specifications, industry standards (ISO 14971, IEC 60601-1, IEC 60601-1-2, ISO 10993-1), and customer requirements. The device's performance was compared against these pre-defined benchmarks.
8. Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device is a mechanical/electrical catheter control system, not an AI/ML algorithm that requires a training set. The "design verification and validation testing" serves as the assessment of the final product, not a "training set" in the machine learning context.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: Not applicable. No training set was used.
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NOV 2 0 2012
510(k) Summary (As required by section 21 CFR 807.92(c))
| Contact: | Catheter Robotics, Inc.Jennifer EnglundVice President, Clinical Affairs and RegulatoryTelephone: 973-691-2000 / Fax: 973-810-4887Email: 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 DriveMount 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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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.
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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
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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
§ 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).