(30 days)
The CLEARSIGN II Amplifier is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.
The LabSystem Pro (LS PRO) EP Recording System (K141185) with CLEARSIGN/CLEARSIGN II Amplifier is an integrated system that acquires, displays, records, and measures physiological signals that originate from that heart. The CLEARSIGN II Amplifier is a reusable electromedical device containing hardware and software that acquires, conditions and presents the physiological signal to the LabSystem PRO EP Recording System such that the signals are available for clinical user selection, display and recording. The CLEARSIGN II Amplifier is used in conjunction with the compatible diagnostic electrophysiology (EP) catheters, surface ECG leads, intravascular pressure transducers, intracardiac stimulators, RF ablation generators and cardiac ablation catheters. The CLEARSIGN II Amplifier is intended for use during EP diagnostic and therapeutic procedures in an EP cath lab.
This document is a 510(k) premarket notification for the CLEARSIGN II Amplifier, which is a Transducer Signal Amplifier and Conditioner. The submission seeks to prove substantial equivalence to a previously cleared device, also named CLEARSIGN II Amplifier (K150235).
The device in question (CLEARSIGN II Amplifier) is intended to amplify and condition electrocardiographic signals of biologic origin and pressure transducer input, transmitting this information to a host computer (the LabSystem PRO EP Recording System) that can record and display the information.
Acceptance Criteria and Reported Device Performance
The document describes performance data through various verification tests to support a determination of substantial equivalence. While specific quantitative acceptance criteria are not explicitly detailed in a table format, the document states that "No new safety or performance issues were raised during the device testing" and that the testing assures "conformance to the requirements for its intended use."
Here's a breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Inferred from testing type) | Reported Device Performance (Inferred from Conclusion) |
|---|---|
| Accurate ECG Offset Measurement | Passed: "CLEARSIGN II ECG Offset Test" performed without new safety/performance issues. |
| Correct Firmware Functionality (v2.09) | Passed: "Firmware version 2.09 Verification Testing" performed without new safety/performance issues. |
| Software Functionality and Reliability | Passed: "Software Verification Testing" performed without new safety/performance issues. |
| Conformance to Intended Use | Passed: "The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing described is verification testing against design specifications, not a clinical study on patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The testing described is design verification (engineering tests), not a clinical study requiring expert ground truth for interpretation of medical data.
4. Adjudication Method for the Test Set:
Not applicable. This was design verification testing, not a clinical study with subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The submission focuses on substantial equivalence based on identical indications for use and fundamentally similar technological characteristics to a predicate device, with verification testing ensuring no new safety or performance issues. This is not a study comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Yes, in essence, the "Performance Data" section describes standalone testing of the device's hardware and software components. The "CLEARSIGN II ECG Offset Test," "Firmware version 2.09 Verification Testing," and "Software Verification Testing" evaluate the device's intrinsic functions without a human-in-the-loop performance assessment.
7. Type of Ground Truth Used:
The ground truth used for the verification testing would be the engineering specifications and expected output parameters for the device's functions (e.g., specific voltage levels for ECG amplification, correct processing logic for firmware, proper software operation). It does not involve expert consensus, pathology, or outcomes data in the medical sense, but rather conformance to defined technical requirements.
8. Sample Size for the Training Set:
Not applicable. This device is an amplifier and conditioner, not an AI or machine learning algorithm that requires a training set of data. The "firmware" and "software" mentioned are likely traditional programmed logic, not adaptive learning models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as no training set (for machine learning) is relevant to this device's development or regulatory submission.
§ 870.2060 Transducer signal amplifier and conditioner.
(a)
Identification. A transducer signal amplifier and conditioner is a device used to provide the excitation energy for the transducer and to amplify or condition the signal emitted by the transducer.(b)
Classification. Class II (performance standards).