(202 days)
The Smart Touch Multiple Machine Phototherapy System can be connected to the following Daavlin models:
3 Series Models 311-48, 311-24, 311/350-24/24, 350-48, 350-24
M Series Models 311-10, 350-10, 311/350-04/06
The Smart Touch Multiple Machine Phototherapy System is a medical ultraviolet light source system, which is intended for use by or under the direction of a licensed physician for the treatment of psoriasis, vitiligo and atopic dermatitis (eczema) on all skin types (I-VI).
The Smart Touch Multi Machine Software is used to control multi phototherapy devices from a custom built computer containing a UV3001 interface board supplied by Daavlin (schematics located in Device Specification of this 510(k) submission), with spectral output at peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA). An "off the shelf" replacement is not possible. Replacement can ONLY be obtained by Daavlin. It is intended for use by or under the direction of a physician, for the treatment of diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema).
The provided text describes a 510(k) submission for the "Smart Touch Multi-Machine Software" by The Daavlin Distributing Company. This submission aims to demonstrate substantial equivalence to a predicate device, the "Spectra 3 Series PC & SP Ultraviolet Phototherapy Cabinet (K063621)".
Here's an analysis of the acceptance criteria and the study (or lack thereof) based on the provided information:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (from submission or inferred) | Reported Device Performance |
|---|---|---|
| Intended Use | Same as predicate device (treatment of psoriasis, vitiligo, and atopic dermatitis on all skin types (I-VI)). | "The intended use... of the Smart Touch Multi Machine Software are the same as those of the predicate device." |
| Spectral Output | Peak wavelengths of 311 nm (Narrow Band UVB) and 350 nm (UVA), same as predicate. | "utilizing identical energy sources (UV lamps)...spectral output...are the same as those of the predicate device." |
| Mode of Operation | Same as predicate device. | "Mode of operation...are the same as those of the predicate device." |
| Labeling | Same as predicate device. | "labeling...are the same as those of the predicate device." |
| Treatment Area | Same as predicate device. | "treatment area...are the same as those of the predicate device." |
| General Operating Principles | Same as predicate device. | "general operating principals...are the same as those of the predicate device." |
| Control System Functionality | Updated to utilize current technology and control multiple units, while maintaining safety and effectiveness equivalent to the predicate. | "the control system hardware and software has been updated to utilize current technology and control multiple units." |
| Device Configuration | Constructed in the same design configuration as the predicate. | "The Smart Touch Multi Machine Software is constructed in the same design configuration as the predicate device." |
| Energy Sources/Materials | Identical energy sources (UV lamps) and materials of identical composition. | "utilizing identical energy sources (UV lamps) and materials of identical composition." |
Study Information
Based on the provided document, the "study" conducted for this 510(k) submission is a comparison to a predicate device rather than a new performance study with a dedicated test set, training set, or expert ground truth adjudication as one would expect for an AI/ML device.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document does not describe a performance study with a test set that generates specific performance metrics like sensitivity, specificity, or accuracy. The submission relies on claiming substantial equivalence based on the device's fundamental design, intended use, and technological characteristics being very similar to a legally marketed predicate device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No ground truth establishment by experts is described, as no specific performance study requiring such assessment was conducted for this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication method is mentioned, as there is no test set in the context of an AI/ML performance evaluation.
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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:
- No. An MRMC study was not done. This device is software for controlling phototherapy devices, not an AI/ML diagnostic or assistive tool that would typically involve human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML algorithm in the context of typical standalone performance evaluation. The "software" is a control system for hardware. The document states: "The Smart Touch Multi Machine Software performance data is the same as or very similar to that of the claimed predicate device. The control system hardware used is the same." This implies that the performance is derived from the established safety and effectiveness of the predicate device's hardware and the similar control system.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No new ground truth data was generated or used. The "ground truth" for this submission is effectively the established safety and effectiveness of the predicate device, which the new device is claimed to be substantially equivalent to due to identical or very similar operating principles and components.
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The sample size for the training set:
- N/A. There is no mention of a training set, as this is not an AI/ML device that undergoes machine learning training.
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How the ground truth for the training set was established:
- N/A. As there is no training set, there is no ground truth establishment for it.
Summary of Device Evaluation Method
The submission for the Daavlin Smart Touch Multi-Machine Software relies on demonstrating substantial equivalence to an existing predicate device (Daavlin Spectra 3 Series PC & SP Ultraviolet Phototherapy Cabinet K063621). The core argument is that the new software is an update to the control system of a device that is already deemed safe and effective, and that its fundamental characteristics, intended use, and operational principles remain unchanged. Therefore, a separate, extensive clinical or performance study with new data, test sets, or expert ground truths was not deemed necessary by the submitter (and implicitly accepted by the FDA for clearance). The performance data cited is comparative, referencing the predicate device's established performance rather than new empirical data for the software itself.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.