(413 days)
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are biocompatible, flexible, radiopaque electrophysiology catheters that are available in a variety of diameters, lengths, curve shapes, and electrode number and spacing configurations, with a high-torque shaft with an array of platinum iridium alloy electrodes at the distal tip that can be used for recording electrical signals. The catheter is designed to facilitate the electrophysiological mapping of the heart.
The RithmID-SD Steerable Diagnostic Electrophysiology Catheter consist of a handle, a shaft and a steerable diagnostic tip. The catheter is introduced through the sheath and into the femoral vein, from the inferior vena cava into the heart and coronary sinus. The RithmID-SD Steerable Diagnostic Electrophysiology Catheter are available in 6F in various curves, including B, D, Y, and R curves.
The provided text is a 510(k) summary for a medical device called the "RithmID-SD Steerable Diagnostic Electrophysiology Catheter". This document focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility testing, and comparisons of technical characteristics.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list acceptance criteria for each test in a separate column. Instead, for most tests, it states "All test samples met the acceptance criteria," indicating that the criteria were satisfied. The performance results are qualitative; for a few tests, comparative statements are made relative to the reference device.
Here's a compilation of the tests and their reported performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Corrosion Resistance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Particulate Matter Evaluation | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria and is equivalent to the Reference Device. |
| Radiopacity Detectability | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Signal Acquisition | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Usability | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. The performance of the Subject Device is better or equivalent to the Reference Device. |
| Electrical Safety | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Visual Inspection (Bench Testing) | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Dimensional Verification | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Simulated Use | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Connection Plug Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Tip Fatigue Tolerance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Shaft Fatigue Tolerance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Flexural Fatigue Tolerance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Torsional Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Electrode Conductor Resistance | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. |
| Buckling Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. The buckling force of the Subject Device is less than or equal to the Reference Device. |
| Peak Tensile Force | Not explicitly stated, implied "met criteria" | All test samples met the acceptance criteria. The peak tensile force of the Subject Device was compared to the Reference Device. |
| Torque Strength | Data comparison, not a pass/fail criterion | The average number of 360° rotations when permanent mechanical deformation occurs was recorded for the Subject Device and Reference Device. The torque strength of the Subject device is compared to the Reference Device for reference only. |
| Packaging Integrity (Distribution Sim.) | ASTM D4169-16 | All test samples met the acceptance criteria per ASTM D4169-16. |
| Packaging Integrity (Visual Insp.) | ASTM F1886/F1886M-16 | All test samples met the acceptance criteria per ASTM F1886/F1886M-16. |
| Packaging Integrity (Bubble Leak) | ASTM F2096-11 | All test samples met the acceptance criteria per ASTM F2096-11. |
| Packaging Integrity (Tray Seal Strength) | F88/F88M-15 | All test samples met the acceptance criteria per F88/F88M-15. |
| Cytotoxicity | Non-cytotoxic (ISO 10993-5) | Non-cytotoxic |
| Sensitization | Non-sensitizer (ISO 10993-10) | Non-sensitizer |
| Intracutaneous Reactivity | Non-irritant (ISO 10993-10) | Non-irritant |
| Acute Systemic Toxicity | Non-Toxic (ISO 10993-11) | Non-Toxic |
| Systemic Toxicity (Pyrogenicity) | Non-Pyrogenic (ISO 10993-11) | Non-Pyrogenic |
| Hemocompatibility (Hemolysis) | Non-Hemolytic (ISO 10993-4) | Non-Hemolytic |
| Hemocompatibility (Thrombogenicity) | Passed (ISO 10993-4) | Passed |
| Hemocompatibility (Complement Act.) | Non-Activator (ISO 10993-4) | Non-Activator |
| Hemocompatibility (PTT) | Passed (ISO 10993-4) | Passed |
| Shelf Life (Accelerated Aging) | Meets design specification at 1 year | All acceptance criteria met; device performs as intended to Design Specification. |
| Sterilization (SAL) | SAL of 10^-6 | Achieved a SAL of 10^-6. |
| EO and ECH Residuals | Below limits specified in ISO 10993-7 | Below the limits specified in ISO 10993-7. |
| Bacterial Endotoxin Levels |
§ 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).