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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.

Here's a breakdown of the requested information based on the provided text:

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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The Panosol II Tru-Blu UBL-417 is generally indicated to treat dermatological indications. The Panosol II Tru-Blu UBL-417 is specifically indicated to treat moderate inflammatory Acne Vulgaris

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I'm sorry, I cannot answer your request with the provided information. The text is a 510(k) clearance letter from the FDA for a phototherapy system. It confirms that the device is substantially equivalent to a predicate device and can be marketed. It does not contain any details about acceptance criteria or a study proving the device meets those criteria, as it is a regulatory document and not a clinical study report.

Therefore, I cannot provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, qualifications of experts, adjudication methods for a test set.
3. Information about MRMC comparative effectiveness studies or standalone algorithm performance.
4. Details about the type of ground truth used or the training set size and ground truth establishment.

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The HOUVA 3 Phototherapy system with PhotoSense II™ Exposure Control is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

Not Found

This FDA document is a 510(k) clearance letter for a phototherapy system. It confirms that the device is substantially equivalent to legally marketed predicate devices. However, it does not contain any information regarding specific acceptance criteria, performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence, not on a detailed scientific study demonstrating the device meets performance metrics.

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The National Biological Corporation Derma-Wand provides photo-therapeutic ultraviolet light. The UVB wand is indicated for dermatologic disorders such as psoriasis and vitiligo. While the UVC wand is indicated for dermatologic disorder in which bactericidal management is desired.

The grounded sheet metal control housing contains the timer and high voltage components. The UV fluorescent lamps and reflector assembly are enclosed in a light-weight plastic wand designed to allow the user to direct the UV radiation to selected wound areas. There is no physical body contact for treatment.

The Derma-Wand (K982082) is a UV radiator device. The provided text indicates that its acceptance was based on demonstrating substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, Sample size for test set, Number of experts for ground truth, Adjudication method, MRMC study, Standalone performance study, Type of ground truth, Training set size, How ground truth for training set was established) are not applicable or cannot be extracted from the provided documentation.

Here's what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance
Not applicable. The device was cleared based on substantial equivalence to predicate devices, not specific performance criteria demonstrated by the device in a clinical or analytical study. The comparison focused on similar technological characteristics.

2. Sample size used for the test set and the data provenance
Not applicable. No test set or associated data provenance is mentioned as part of the submission for substantial equivalence. The comparison was based on technical characteristics and existing predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment by experts is described for this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a UV radiator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a UV radiator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The clearance was based on substantial equivalence to predicate devices, not a ground truth study of the Derma-Wand's performance.

8. The sample size for the training set
Not applicable. There is no mention of a training set as the device is not an AI algorithm.

9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or ground truth establishment for a training set.

Summary of the Study/Comparison for Substantial Equivalence (K982082):

The submission for the Derma-Wand (K982082) established substantial equivalence to predicate devices – Birtcher Model 625 and R.A. Fischer CO UV-9 Therapy Lamp. The "study" or comparison approach involved demonstrating that the proposed device has the same intended use and similar technological characteristics, and does not raise different questions regarding safety and effectiveness.

The areas of comparison were:

• Electrical Rating: Voltage, current, power ratings, high voltage breakdown, and current leakage were comparable to predicate devices and met industry standards.
• Digital Timer: The proposed device utilized an integral digital timer (+/- 3 seconds accuracy) to control UV lamp activation, which was considered a state-of-the-art design compared to the pre-1976 predicate's external manual timer. The R.A. Fischer CO device also utilized an integral digital timer.
• UV Lamps: The lamps, ballasts, and circuitry were identical to existing production devices. Energy levels and spectral responses were comparable to predicate devices and those in current medical/commercial applications.
• Operating Temperatures: The specified range (65 to 105 degrees F) was identical, with no exposed high-temperature areas.
• Key-switch Safety: The proposed device featured a key-operated power switch for safety and unauthorized use prevention, a feature not present in the predicate's ON/OFF toggle switch.
• Control and UV Wand: The proposed device featured a grounded sheet metal control housing and a light-weight plastic wand for directed UV radiation without physical body contact. This was compared to the Birtcher Model 625 (integral molded housing, cold cathode quartz lamp, body contact) and the Fischer UV-9 (molded housing with three plug-in germicidal bulbs).
• Regulatory Requirements: The proposed devices would be manufactured under FDA Current Good Manufacturing Practices (CGMP), unlike the pre-1976 predicate.
• Product Safety: Submission for third-party evaluation by Electronic Testing Laboratories (ETL) and the Canadian Standards Association (CSA) was planned.

The FDA determined that the device was substantially equivalent for the Indications for Use of photo-therapeutic ultraviolet light for dermatologic disorders (UVB wand for psoriasis and vitiligo, UVC wand for bactericidal management) to devices marketed prior to May 28, 1976.

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