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510(k) Data Aggregation
(170 days)
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/or other any interventional procedures. Blood pressure measurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
The proposed OptoWire III is a new version of the OptoWire Deux that includes changes to strengthen the robustness of the product. Additional changes have been made to improve manufacturability. Changes include a reduction in tip length and coil gap, changes in the tube inner and outer configuration, and a minor material change in the PTFE coating.
The Opsens OptoWire III is used in conjunction with the Opsens OptoMonitor and Accessories, the "OptoMonitor System" consisting of an electronic signal processing and display units (OptoMonitor) that process signals received from the OptoWire to display intravascular blood pressure and hemodynamic information, such as fractional flow reserve (FFR) values, and various connection cables.
The OptoWire III consists of the following items:
- OptoWire assembly (quidewire) including the pressure sensor sub-assembly
- Fiber Optic Interface Cable (FOIC)
- Packaging including tray, Torque Device, pouch and box
- Labelling including labels and printed IFU
The provided text describes a 510(k) premarket notification for the OptoWire III. This document focuses on demonstrating substantial equivalence to a predicate device (OptoWire Deux) rather than proving the device meets acceptance criteria from a clinical study with specific performance metrics like sensitivity, specificity, or accuracy compared to a ground truth.
Therefore, much of the requested information regarding acceptance criteria for a diagnostic study, sample sizes for training/test sets, expert qualifications, and adjudication methods is not present in this regulatory submission. The document emphasizes engineering and bench testing to demonstrate that changes made to the OptoWire III do not raise new questions of safety or effectiveness compared to its predicate.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria (e.g., target sensitivity, specificity) with corresponding reported device performance for a diagnostic task. Instead, it compares the technological characteristics and performance of the proposed device (OptoWire III) to its predicate device (OptoWire Deux) to demonstrate substantial equivalence.
The "Performance Data" section describes various design verification tests, biocompatibility tests, and animal studies to ensure the OptoWire III functions as intended and is safe. Key performance aspects like Pressure Accuracy and Thermal Zero Shift for the pressure sensor are explicitly stated and are identical to the predicate:
| Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) |
|---|---|
| +/- 1 mmHg plus +/-1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg) | +/- 1 mmHg plus +/-1% of reading (pressure range -30 to 50 mmHg) or +/- 3% of reading (pressure range 50 to 300 mmHg) |
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(121 days)
To measure pressure in blood vessels including both coronary and peripheral vessels, during diagnostic angiography and/ or other any interventional procedures. Blood pressurements provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel disease.
The OptoWire Deux is a hybrid Nitinol/Stainless Steel pressure sensing guidewire that is a steerable guidewire with an optical pressure sensor mounted proximal to the 3.5 cm long radio opaque tip. The OptoWire Deux is for use in combination with Opsens' OptoMonitor system for blood pressure measurement. The OptoWire Deux has a diameter of 0.014" (0.36 mm) and an effective length of 175 cm. The OptoWire Deux is supplied preconnected to the OptoWire cable along with a torque device. The OptoWire cable is unique to each OptoWire and it must be used conjunctionally with the OptoWire supplied in the same tray. OptoWire Deux is supplied sterile, non-pyrogenic and is intended for single use only. The changes described in this special 510k device modification only affect the OptoWire. There are no change to the OptoMonitor device included in the cleared systems K142598.
The Opsens OptoWire Deux pressure guidewire is designed to measure blood pressure in coronary and peripheral vessels during diagnostic angiography and interventional procedures, providing hemodynamic information such as fractional flow reserve (FFR). The device is a hybrid Nitinol/Stainless Steel steerable guidewire with an optical pressure sensor.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device (OptoWire One, K142598) through verification and validation tests rather than explicitly stating acceptance criteria and numerical performance for all aspects. However, some key performance specifications are listed and implicitly serve as acceptance criteria for functionality.
| Characteristic | Acceptance Criteria (from predicate device spec) | Reported Device Performance (OptoWire Deux) |
|---|---|---|
| Pressure Range | -30 to 300 mmHg | -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) | +/- 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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