(263 days)
The Horizon XVu is a state-of-the-art computerized laboratory, capable of acquiring and displaying essential patient data such as ECG/Heart Rate, Intra Cardiac ECG (ICECG), invasive blood pressures, pulse oximetry, respiration, cardiac output, body temperatures, and EtCO2.
BP waveforms from different heart and vascular sites, are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform, gradients and FFR, can be stored, recorded, analyzed and presented in a variety of report formats.
The prime function of the Horizon XVu (Cathlab) is to acquire and display vital-sign data and waveforms in real time during the catheterization process, creating a fully documented case history. The system has a computer that utilizes powerful, real-time, software to control the system operation and to process the vital patient sign data measurements acquired from the CFE or entered manually at the keyboard. The Horizon XVu system consists of: (A) a Front End unit and (B) a Central system. The "Cathlab Patient Front End" (CFE) acquires, processes, and converts vital signs from the patient into digital signals. The CFE then sends the digitized signals and data, via a network connection, to the central system of the Horizon XVu for process and display. The Central System contains the following main devices: Computer, Two local LCD displays, Video line driver, AC Power Unit, Laser printer, Hub, Modem. FFR is a mode that uses two invasive pressure inputs. Pa - Proximal pressure measured with external pressure transducer at the artery or aorta. and Pd - Distal pressure measured with a pressure wire sensor in the coronary arteries across lesion. Mean pressures are calculated and the ratio between the means Pd/Pa is calculated and displayed.
The provided document describes the Mennen Medical Horizon XVu with the addition of Fractional Flow Reserve (FFR) measurement, submitted as a traditional 510(k) for device modification (K123792).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document provides a comparison table between the predicate device (Volcano ComboMap) and the modified Horizon XVu with FFR, particularly focusing on input circuit parameters and measurement capabilities. While it doesn't explicitly state "acceptance criteria" as a pass/fail threshold, it presents a comparison of specifications.
| Feature / Parameter | Predicate Device (Volcano ComboMap) | Reported Device Performance (Horizon XVu with FFR) |
|---|---|---|
| FDA 510(k) | K041134 | K091165 (prior to change) |
| Features | FFR + Flow velocity | FFR |
| Pressure wire | Volcano | Volcano or Radi |
| Transducer input | 5μV/V/mmHg | 5μV/V/mmHg |
| Pressure range | -30 to +330 mmHg | -50 to +300 mmHg |
| Pressure bandwidth | DC to 25 Hz | DC to 6 Hz, DC to 12 Hz, DC to 24 Hz, DC to 40 Hz |
| Measurement accuracy | ± 3 mmHg (-30 to +100 mmHg), ± 3% (> 100 mmHg) | +/- 2 mmHg, or +/- 2%, whichever is greater, exclusive of transducer |
| # pressure channels | 2 | 4 (2 used for FFR) |
| Analog Pressure output | 1V/100 mmHg | Same |
| Pa (Proximal Pressure) | Mean Arterial Pressure | Same |
| Pd (Distal Pressure) | Mean Distal Pressure at the tip of the pressure wire | Same |
| FFR = Pd/Pa | Ratio | Same |
| Tracing | ECG, Pa dynamic, Pa mean, Pd dynamic, Pd mean, FFR | Same |
Note: The document emphasizes that "the basic amplifier specifications are the same for the Horizon XVu (FDA approved) and the Horizon XVu with FFR." The key "reported device performance" is that the Horizon XVu with FFR can successfully display the FFR waveform and value, and its FFR measurement capabilities are comparable to the predicate. The provided table details the technical specifications that are meant to show this comparability and thus meet the implicit acceptance criteria of substantial equivalence.
2. Sample Size for the Test Set and Data Provenance
The document states: "At the system level, SW Validation of the performance of the Horizon XVu with 9600PT580/585 as compared to the Horizon XVu Cathlab system, was carried out in accordance with the test plan described in the Mennen Medical Validation Test Procedure for the Horizon XVu."
It also mentions: "Final testing for the Horizon XVu system included performance tests designed to ensure that the device meets all functional requirements and performance specifications, in accordance with the requirements of the Final Test Procedure for the Horizon XVu system."
- Sample Size for Test Set: The document does not specify a sample size for the test set. It refers generally to "system level, SW Validation" and "Final Testing" without providing numbers of test cases, patients, or data points.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective. The validation and testing appear to be internal to Mennen Medical, conducted as part of their software and system validation process.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications to establish ground truth. The testing mentioned appears to be focused on technical performance and comparison to specifications rather than clinical ground truth established by external experts.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method for the test set. The validation seems to rely on internal test plans and procedures, likely against predefined technical specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No MRMC comparative effectiveness study is mentioned. The submission is for a device modification (addition of FFR measurement capability) and focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and functionality, not on human-in-the-loop performance metrics or improvements with AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The testing described appears to be standalone in nature, focusing on the system's ability to acquire, process, calculate, and display FFR and other vital signs according to its specifications, without explicitly evaluating human interaction or diagnostic decisions. The FFR calculation itself is an algorithm. However, no specific "algorithm only" performance metrics (e.g., sensitivity, specificity, AUC) are provided for the FFR calculation; rather, it focuses on the accuracy of the underlying pressure measurements. The "Measurement accuracy" for FFR is specified for the pressure measurements: "+/- 2 mmHg, or +/- 2%, whichever is greater, exclusive of transducer." This is a standalone performance metric for the pressure measurement component of the FFR calculation.
7. The Type of Ground Truth Used
The ground truth used for the device's FFR capability is based on the accuracy of pressure measurements and the ratio calculation (Pd/Pa) as compared to predefined technical specifications. The document states a measurement accuracy of "+/- 2 mmHg, or +/- 2%, whichever is greater, exclusive of transducer." This implies that the ground truth for evaluation is derived from calibrated pressure inputs and the expected mathematical outcome of the FFR ratio. It is a technical ground truth rather than a clinical one established by pathology or patient outcomes.
8. The Sample Size for the Training Set
The document does not specify a training set sample size. This device is a "programmable diagnostic computer" with added FFR measurement, not an AI/ML-based device that typically undergoes a training phase with a distinct training set. The FFR calculation is based on established physiological principles and algorithms, not learned from data in the way AI models are trained.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set for an AI/ML model, there is no discussion of how ground truth for a training set was established. The FFR calculation is a deterministic algorithm based on real-time pressure measurements.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.