(695 days)
EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies.
The EasyFinder™ Fixed Curve Diagnostic Catheter is a sterile, single-use diagnostic catheter with multiple electrodes and a fixed distal curve. It has been designed to facilitate electrophysiological mapping of cardiac structures in 28 models and 6 kinds of curves.
The catheter has a high-torque shaft with a fixed curve section containing an array of platinum electrodes. The high-torque shaft allows the plane of the curved tip to be rotated to facilitate accurate positioning of the catheter tip at the desired site.
The catheter is connected to separately cleared diagnostic electrophysiology equipment via an accessory, the FORLNK™ Cable for Mapping Catheter.
The provided document, a 510(k) summary for the EasyFinder™ Fixed Curve Diagnostic Catheter, indicates that no clinical study was included in the submission. Therefore, information regarding acceptance criteria derived from a clinical study, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as requested, is not available from this document.
The substantial equivalence determination for this device is based on non-clinical performance testing and comparison to a predicate device.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly define "acceptance criteria" in a quantitative sense as might be seen for a new AI/software device. Instead, it states that the device complies with specific industry standards and regulatory guidance, which serve as the "acceptance criteria" for demonstrating safety and effectiveness. The "reported device performance" is its compliance with these standards.
| Acceptance Criterion (Standard/Guidance) | Reported Device Performance |
|---|---|
| Biocompatibility Verification: ISO 10993-1:2018 and FDA's modified ISO guidelines | The biological safety of the catheter was verified as per the requirements. |
| Mechanical Verification: ISO 10555-1:2013 | Mechanical testing was performed to verify compliance of the catheter with the standard. |
| Electrical Verification: IEC 60601-1:2005, IEC 60601-1-2:2014, and IEC 60601-2-27:2011 | Electrical testing was performed to verify compliance of the catheter and accessory cable with applicable standards. |
| Bench Validation: Radiopacity of catheter; design and function of accessory cable | Validation testing was performed for radiopacity and to evaluate the design and function of the cable. |
| Cleaning and Sterilization Validation: ISO 11135:2014, AAMI TIR 28:2009, and FDA guidance document | Validation testing was performed to demonstrate that the catheter and accessory cable could be cleaned and sterilized in accordance with the standards. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Shelf Life Validation: Demonstrate shelf life | Validation testing was performed to demonstrate a shelf life of three years. |
| Indications for Use Equivalence: Same as predicate device | EasyFinder™ Fixed Curve Diagnostic Catheter is used for electrogram recording and cardiac stimulation during diagnostic electrophysiology studies (SE to predicate). |
| Configuration Equivalence: Cable connector, Tip electrode, Ring electrode, High-torque shaft (Same as predicate device) | The device has a cable connector, tip electrode, ring electrode, and high-torque shaft (SE to predicate). |
| Dimensional Comparison: Catheter effective length, Length of color code, Electrode length, Electrode diameter, Electrode spacing | Catheter effective length (Similar to predicate), Length of color code (SE to predicate), Electrode length (Similar to predicate), Electrode diameter (SE to predicate), Electrode spacing (SE to predicate). |
| Outside diameter of catheter shaft: Equivalent to predicate device | Outside diameter of catheter shaft (SE to predicate). |
| Curve shape: Similar to predicate device | Curve shape (Similar to predicate). |
| Functional Performance: Comply with ISO 10555-1 | Comply with ISO 10555-1 (SE to predicate). |
| Biological Characteristics: Comply with ISO 10993-1 | Comply with ISO 10993-1 (Similar to predicate). |
| Intended Healthcare Environment: Professional healthcare environment | Professional healthcare environment (SE to predicate). |
| Sterilization Method: EO sterilized | EO sterilized (SE to predicate). |
| Single Use: Yes | Yes (SE to predicate). |
| Shelf Life: 3 years | 3 years (SE to predicate). |
2. Sample size used for the test set and the data provenance:
- Not Applicable. No clinical study or separate test set in the context of an AI/software device performance evaluation was conducted or reported. Performance was based on non-clinical (bench) testing against established standards and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No clinical study or expert-adjudicated test set in the context of an AI/software device performance evaluation was conducted or reported.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No expert adjudication was conducted or reported.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a hardware medical device (diagnostic catheter), not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. For the non-clinical tests, the "ground truth" was established by the specifications defined in the referenced international standards (e.g., ISO, IEC). For equivalence to the predicate, the characteristics of the predicate device served as the reference.
8. The sample size for the training set:
- Not Applicable. No training set, in the context of an AI/software device, was used or reported.
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
Identification. An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.(b)
Classification. Class II (performance standards).