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510(k) Data Aggregation
(278 days)
The SavvyWire™ is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures, while measuring the pressure within the heart allowing calculation of hemodynamic parameters. Additionally, the Savvy Wire™ can be used for temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.
The OptoMonitor 3 is intended to measure cardiovascular blood pressure, including in heart chambers, coronary vessels and peripheral vessels, during interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve for the diagnosis and treatment of blood vessels and such as valve gradients during structural heart procedures.
The proposed SavvyWire™ is a new Catheter guidewire that includes functions for a structural wire, a pressure wire, and a pacing wire (temporary intracardiac pacing by transmitting an electrical signal from an external pulse generator to the heart.). Throughout the submission this will be referred to as either SavvyWire™ or Opsens Structural Wire (OSW). These two names are interchangeable and represent branding name vs. internal descriptive name. SavvyWire™ is intended to be used with the OptoMonitor 3 (K202943), and ideally with the OpM3-DU TAVI, which is based on the approved OptoMonitor 3 (K202943), with a fully integrated TAVI software update.
The provided text describes the performance data and substantial equivalence arguments for the SavvyWire™ and OptoMonitor 3 with TAVI, rather than detailing specific acceptance criteria and the results of a study designed to prove the device meets those criteria in a quantitative table. The document focuses on demonstrating substantial equivalence to existing predicate devices through various tests and studies.
Based on the provided text, a direct table of acceptance criteria and reported device performance with specific quantitative thresholds and met/not met status cannot be fully constructed as this information is not presented in that format. However, I can infer the general nature of the acceptance criteria from the tests conducted and the stated conclusions.
Here's a breakdown of the requested information based on the document, with inferred acceptance criteria where explicit quantitative values are not given:
Inferred Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Test Goals) | Reported Device Performance (as stated in the document) |
|---|---|
| Functional Equivalence (Overall System) | The SavvyWire™ and OptoMonitor 3 with TAVI are shown to perform in a manner equivalent to the predicate devices with the same intended use. All substantial equivalence requirements were met. |
| Safety and Effectiveness (Risk Management) | "All acceptance criteria were met regarding risks and device functionality." "No new questions of safety and effectiveness were identified during review of Risk Management documentation or execution of Verification and Validation activities." "The risks related to all applicable hazards which were identified for the SavvyWire™ have been reduced to the acceptable level by mitigation...all residual risks post-mitigation have been deemed acceptable for this design." The device is shown to be at least as safe and effective as the predicate device. |
| Sterilization, Packaging, Shelf-life | Equivalence to specified ISO and ASTM standards (ISO 11135-1, ISO 11607-1, ASTM F1980-07) was utilized. Devices subjected to accelerated aging equivalent to 2 years ("TO" = no aging) were tested. (Specific results are not detailed, but adherence to standards implies meeting criteria). |
| Biocompatibility | Evaluation conducted in accordance with FDA guidance Use of International Standard ISO 10993-1. All listed tests (Cytotoxicity, Sensitization, Intracutaneous reactivity, Systemic toxicity (acute), Hemocompatibility, Pyrogenicity, SC5b-9 complement) were completed. (Specific results are not detailed, but completion implies meeting criteria for classification as "External communicating device – circulating blood" with "limited exposure"). |
| Electrical Safety & EMC | The OptoMonitor 3 with TAVI Software complies with applicable requirements of IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-34 when used with SavvyWire™. Certain applicable portions of ISO 14708 are also applied. (Compliance implies meeting criteria). |
| Mechanical Performance (e.g., Guide Wire Properties) | Design Verification was conducted based on FDA Guidance Coronary, Peripheral, and Neurovascular Guidewires - Performance Tests and Recommended Labeling. All Design Requirements were verified. "Verification testing includes: Rapid Pacing Testing, Mechanical Testing, Functional Testing, FOIC Testing." "Design Specification Verification and ISO 11070 Compliance were completed by documentation check." (Meeting design requirements and compliance implies success). |
| Pacing Functionality (Equivalence to Bipolar Pacing Catheters) | The pacing of the SavvyWire™ (unipolar) was "tested to be equivalent to that of the reference device, Pacel™ Bipolar Pacing Catheters in an animal study comparing the two devices and clinical performance is also confirmed via a clinical study." (Successful equivalence demonstration). Animal performance testing "validated device functionality and to provide comparison data to the predicate devices." Clinical study demonstrated "use of the SavvyWire™ guidewire in the LV for rapid ventricular pacing...is substantially equivalent to other marketed devices." |
| Pressure Measurement Performance (Accuracy, Range, Drift, etc. for OptoMonitor 3) | Pressure Range: -30 to 300 mmHg. Pressure Accuracy: +/- 1 mmHg plus +/- 1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg). Thermal Zero Shift: |
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