(107 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.
Heart rate, multi-lead ECG and BP waveforms from different heart sites are continuously presented on the Physiological Waveform Display. The hemodynamic data, waveform and numerical, 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 Horizon XVu system consists of a Front End unit (CFE) and a Central system. The CFE acquires, processes, and converts vital signs from the patient into digital signals and sends them to the central system for process and display. The central system contains a computer workstation, displays, printer, and other components. The system is capable of acquiring and displaying ECG/Heart Rate, ICECG, invasive blood pressures, pulse oximetry, respiration, cardiac output, and body temperature.
The provided text describes a 510(k) submission for a modification to the Mennen Medical Horizon XVu device, specifically adding an Intra-Cardiac ECG (ICECG) measurement option. The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving new clinical effectiveness. Therefore, some of the requested information, particularly related to clinical study design (sample size, expert ground truth, adjudication, MRMC studies) for new effectiveness claims, is not detailed in this type of regulatory document.
However, based on the provided text, we can extract information regarding acceptance criteria (implied by the comparison to a predicate device) and the verification/validation activities performed.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the modified Horizon XVu with ICECG (960-OPT-600) are implicitly defined by its substantial equivalence to two predicate devices:
- Horizon XVu (K081484): For the overall Cathlab system functionality, ensuring that the addition of ICECG does not negatively impact existing vital sign acquisition and display.
- Mennen Medical EMS-XL cardiac electrophysiology system (K071348): Specifically for the ICECG measurement capabilities, ensuring its performance is comparable to the ICECG functionality of the EMS-XL.
The device performance is reported by comparing its characteristics directly to these predicate devices.
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Horizon XVu with ICECG) |
|---|---|
| Overall System Functionality (vs. Horizon XVu K081484) | |
| Acquisition & Display of ECG/Heart Rate | Yes (Same as predicate) |
| Acquisition & Display of 4 Invasive BP channels | Same as predicate |
| Acquisition & Display of NIBP | Yes (Same as predicate) |
| Acquisition & Display of Respiration | Yes (Same as predicate) |
| Acquisition & Display of SpO2 | Yes (Same as predicate) |
| Acquisition & Display of EtCO2 | Yes (Same as predicate) |
| Acquisition & Display of Temperature | Yes (Same as predicate) |
| Operating Principle | No changes |
| Control Mechanism | No changes |
| Energy Type | No changes |
| Software Platform | Same as predicate |
| Hardware Platform | Same as predicate |
| ICECG Measurement Functionality (vs. EMS-XL K071348) | |
| Patient Isolation | Same as EMS-XL (Double isolation, meets/exceeds ANSI/AAMI) |
| Common Mode Rejection | Same as EMS-XL (100 dB minimum) |
| Input Impedance | Same as EMS-XL (2.5 megΩ) |
| ICECG Dynamic Range | Same as EMS-XL (+/- 5 mVolt) |
| ICECG Baseline Correction | Same as EMS-XL (+/- 300 mVolt) |
| ICECG Sampling Rate | Same as EMS-XL (1000 sample/sec, 16 bit) |
| ICECG Bandwidth | Same as EMS-XL (500 Hz) |
| Notch Filter (50 Hz, 60 Hz, None) | Same as EMS-XL |
| Saturation Recovery | Same as EMS-XL (Less than 1 sec) |
| Connection (Patient Connection Box) | Same as EMS-XL (965-030-020) |
| Difference: Number of ICECG channels | 6 Bipolar channels (vs. 20/50 Bipolar or Monopolar in EMS-XL) |
| Difference: Gain settings | 1/4, 1/2, 1, 2, 4, 8 (vs. 0 to 250 continues control in EMS-XL) |
| Difference: High Pass filter steps | 0.05, 0.5, 5, 10, 15, 20, 30, 40, 50 Hz (more steps than EMS-XL) |
| Difference: Low Pass filter steps | 200, 250, 300, 350, 400, 450, 500 Hz (more steps than EMS-XL) |
Study Details
The provided document describes verification and validation activities rather than a traditional clinical study with a test set of patient cases. This is typical for a 510(k) modification aiming to demonstrate substantial equivalence, especially when the modification is primarily technological (adding a new parameter that leverages existing technology).
-
Sample size used for the test set and data provenance:
- Test set: Not applicable in the sense of a clinical patient cohort. The testing described is system-level and software validation.
- Data provenance: Not specified other than "performance tests designed to ensure that the device meets all functional requirements and performance specifications". It is implied that this testing was internal to Mennen Medical or conducted by approved testing bodies. The document does not mention data from human subjects or a clinical test set for the ICECG functionality.
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- Not applicable/Not specified. Ground truth in this context would refer to the established performance requirements of the predicate devices and industry standards. No mention of human expert adjudication for a "test set" of cases.
-
Adjudication method for the test set:
- Not applicable.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC study was not done. The submission is for a device modification to add a measurement parameter, not a new diagnostic algorithm requiring comparative effectiveness against human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies that the performance tests were for the device's ability to acquire and display the ICECG signal correctly, which is a "standalone" or intrinsic performance evaluation of the hardware and software. The "stand-alone" performance criteria are tied to the specifications of the predicate EMS-XL system's ICECG measurement.
-
The type of ground truth used:
- The ground truth for this submission is based on engineering specifications and established performance characteristics of the predicate devices (Horizon XVu and EMS-XL), as well as compliance with electrical safety and EMC standards (e.g., IEC 60601 series). The claim is that the new ICECG functionality performs equivalently to an already cleared device, and the overall system still performs equivalently to the original cleared Horizon XVu.
-
The sample size for the training set:
- Not applicable. This is not a submission for an AI/ML algorithm that requires a training set of data. The "software" changes relate to displaying and controlling existing vital signs and the new ICECG, implying configuration and integration rather than learning.
-
How the ground truth for the training set was established:
- Not applicable (as there is no training set for an AI/ML algorithm).
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).