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510(k) Data Aggregation
(240 days)
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
LiPPS™ Intravascular Pressure Sensing System is intended to be used in an environment like cathlab and for use in blood vessels, including coronary and peripheral vessels, to measure intravascular pressure during angiography and/or interventional procedures. Pressurements are obtained to provide hemodynamic information, such as fractional flow reserve, for the diagnosis and treatment of blood vessel diseases.
The subject device LiPPSTM Intravascular Pressure Sensing System contains H2000 LiPPS™ Analyzer and LiPPS™ Wire Pressure Guide Wire.
The LiPPS™ Wire Pressure Guide Wire is used together with the H2000 LiPPS™ Analyzer in order to measure intravascular pressure. The LiPPS™ Wire contains an optical sensor and an optical fiber to induce the blood pressure and transmit signal. The LiPPS™ Wire can be connected to the analyzer through the companied handle (with an optical cable and an optical connector). The LiPPS™ Analyzer is an electronic signal processing and display units which can process signals received from the LiPPSTM Wire to display intravascular blood pressure and fractional flow reserve (FFR) values, and various connection cables. LiPPS™ Wire and companied handle (with an optical cable and an optical connector) are sterile, single-use devices. The LiPPS™ Analyzer and its accessories are reusable.
The provided text is a 510(k) Summary for the LiPPS™ Intravascular Pressure Sensing System, which details the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence. This document does not describe acceptance criteria for an AI/ML-driven device or a study involving human readers and AI assistance. It focuses on the non-clinical performance and substantial equivalence of a physical medical device (an intravascular pressure sensing system) to existing predicate devices.
Therefore, many of the requested items regarding AI/ML device performance, MRMC studies, ground truth establishment, sample sizes for AI training/testing, and expert adjudication are not applicable to the information provided in this document.
However, I can extract information related to the device's non-clinical performance that is analogous to "acceptance criteria" and "device performance" for a medical device that measures physical parameters.
Based on the provided text, here's what can be extracted and what cannot:
LiPPS™ Intravascular Pressure Sensing System Acceptance Criteria and Performance (Non-Clinical)
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance characteristics of the LiPPS™ Intravascular Pressure Sensing System and compares them to predicate devices to demonstrate substantial equivalence. For a device like this, the "acceptance criteria" are implied by the specifications listed and the successful completion of standard-based testing.
| Acceptance Criteria (Implied/Standard-Based) | Reported Device Performance (LiPPS™ Intravascular Pressure Sensing System) |
|---|---|
| For H2000 LiPPS™ Analyzer: | |
| Compliance with IEC 60601-1:2005+AMD1:2012 (Basic Safety & Essential Performance) | "The test results demonstrated that the proposed device comply with the standard requirements." |
| Compliance with IEC 60601-1-2:2014 (EMC) | "The test results demonstrated that the proposed device comply with the standard requirements." |
| Compliance with IEC 60601-2-34:2011 (Invasive Blood Pressure Monitoring Equipment) | "The test results demonstrated that the proposed device comply with the standard requirements." |
| Software Development and Validation (IEC 62304, FDA Guidance) | "The software embedded in H2000 LiPPS™ Analyzer has been developed, documented and validated in accordance with industry standards and FDA guidance." |
| Pressure Range (Analyzer) | -30 to 300mmHg |
| For LiPPS™ Wire Pressure Guide Wire: | |
| Sterilization (EO process) | Validated to 10⁻⁶ SAL in accordance with ISO 11135. |
| Compliance with ISO 11070:2014 (Sterile single-use intravascular introducers, dilators and guidewires) | "The test results demonstrated that the proposed device comply with the standard requirements." |
| Pressure Range (Guide Wire) | -300 to 300mmHg |
| Accuracy | ± 1mmHg plus ± 1% of reading (over -30 to 50mmHg) or ± 1mmHg plus ± 3% of reading (over 50 to 300 mmHg) |
| Zero Thermal Effect |
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