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The Houva-NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis and vitiligo.

The Houva V with Houva -NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

The Houva V with Houva-NET Control System is simply the integration of the new Houva-NET Control System software, into the predicate device, the Houva III Phototherapy System with PhotoSense II™. The Houva -NET Control System software is utilized to monitor multiple phototherapy devices from a single computer, the Houva-NET Central Computer. The central computer may be used to monitor mulitiple phototherapy devices from one central location. A custom built interface board. 5PCB-040, supplied by National Biological Corporation is installed in each phototherapy device. An "off-the shelf" replacement is not possible and a replacement may only be obtained from National Biological Corporation. Schematics are located in the Device Description of this 510(k) submission, Section 11.

The integration of the new Houva-NET Control System software into the predicate device, the Houva III Phototherapy System with PhotoSense II™, results in the modified system or the Houva V with Houva-NET Control System. The modification, as compared to the predicate, is limited to the replacement of the PhotoSense II Controller with the new Houva-NET Control. The Houva V with Houva-NET Control System software is designed to provide Ultraviolet A (UVA) and/or Ultraviolet B (UVB) radiation treatments in the same manner as the predicate device.

The Houva-NET Control System may be retrofitted into any Houva Phototherapy Systems, constructed in the same design configuration as the predicate device. Houva III Phototherapy System with PhotoSense II™ (K041212) and utilizing identical energy source (UV Lamps) and materials of identical composition. The Houva V with Houva-NET Control System's only variation from the predicate device is that the control system hardware and software have been updated to control multiple phototherapy units. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the Houva V with Houva-NET Control System are the same as those of the predicate. Additionally, the use of control system software and interface board to manage multiple phototherapy devices have already received FDA market clearance under K110912 integrated into the Daavlin Smart Touch Multi-Machine Software.

This document describes the Houva-NET Control System, a therapeutic product designed for ultraviolet radiation therapy for psoriasis and vitiligo. It is a control system that can be integrated into existing phototherapy devices to monitor multiple devices from a central computer.

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1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a specific diagnostic performance metric (like sensitivity, specificity, or AUC). Instead, it focuses on demonstrating substantial equivalence to a predicate device. The "performance data" refers to showing that the modified device performs as well as the predicate, particularly in terms of safety and technical functionality.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document does not specify a "test set" in terms of patient data or a specific number of devices tested. The testing involved "bench tests" focused on system verification and software validation, not clinical trials with patient samples.
• Data Provenance: Not applicable, as no human or clinical data was used. The focus was on engineering and software validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Experts and Qualifications: Not applicable. The "ground truth" for this device's evaluation was based on compliance with engineering standards (IEC 60601-1 Ed.2) and functional verification against design specifications of the predicate device. This typically involves engineers and quality assurance personnel, not medical experts establishing a diagnostic ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Since no clinical data or expert review of outputs was performed, there's no need for an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The device is a control system for phototherapy, not a diagnostic imaging device typically evaluated with MRMC studies. The document explicitly states: "Clinical testing was not required to establish equivalency of the device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Standalone Study: The evaluation performed was effectively "standalone" in the sense that the system (Houva-NET Control System) was tested for its functional capabilities and compliance with safety standards without evaluating its interaction or impact on human clinical decision-making. The "performance" assessment was of the system's technical operation, not its diagnostic or therapeutic efficacy in a human-in-the-loop context.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used was based on:
  • Engineering Specifications and Design Documentation: The device's performance was compared against its own design specifications and the known, approved specifications of the predicate device.
  • Compliance with International Standards: Specifically, IEC 60601-1 Ed.2 for electrical safety.
  • Functional Verification: Ensuring the software and hardware performed as intended (e.g., controlling multiple phototherapy units, maintaining wavelength output, timer accuracy).

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a control system, not an AI/ML algorithm that requires a "training set" of data. Its development involved traditional software engineering and hardware design, not machine learning model training.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there was no training set for an AI/ML algorithm.

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