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510(k) Data Aggregation
(125 days)
The 4- Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
The 4 Series Unit is a partial-body phototherapy panel ultraviolet light source controlled by an integrated digital timer or a microprocessor controller. The operator interface consists of two main components: a LCD, and a Membrane with 4 buttons. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit ultraviolet light. The spectral output at peak wavelengths of 305nm,311nm,350nm,or 365nm depending on lamp. The 4 Series Unit is a therapeutic product designed for individuals who require ultraviolet radiation for diagnosed skin disorders.
This document describes a 510(k) premarket notification for the Daavlin Distributing Company's 4 Series Phototherapy Unit. The primary argument for substantial equivalence relies on the device being nearly identical to a previously cleared predicate device, the Daavlin 1 Series Phototherapy Unit (K100378).
Here's an analysis of the provided information regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Design Configuration | Same as predicate device (1 Series Phototherapy Unit) | "constructed in the same design configuration as the predicate device" |
| Energy Sources (UV lamps) | Identical to predicate device | "utilizing identical energy sources (UV lamps)" |
| Material Composition | Identical to predicate device | "materials of identical composition" |
| Intended Use | Same as predicate device | "The intended use... are the same of the predicate device." |
| Indications for Use | Same as predicate device | "general and specific indications for use... are the same of the predicate device." |
| Spectral Output | Same as predicate device | "spectral output... are the same of the predicate device." (Explicitly mentioned: "The spectral output at peak wavelengths of 305nm, 311nm, 350nm, or 365nm depending on lamp.") |
| Mode of Operation | Same as predicate device | "mode of operation... are the same of the predicate device." |
| Labeling | Same as predicate device | "labeling... are the same of the predicate device." |
| Accessories | Same as predicate device | "accessories... are the same of the predicate device." |
| General Operating Principles | Same as predicate device | "general operating principals... are the same of the predicate device." |
| Treatment Area | Similar to predicate device, but larger | "The treatment area, while still partial body, is similar, but larger on the 4 Series unit than on the predicate device." |
| Overall Performance Equivalence | Equivalent spectral/power outputs compared to predicate | "The 4 Series Phototherapy Unit performance data is the same as that of the claimed predicate devices. The Controller, UV lamps and cabinet construction used in the production of the predicate device and the 4 Series Phototherapy Unit are identical, giving equivalent spectral/power outputs." |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not describe a test set or clinical study in the traditional sense (e.g., patient data, prospective/retrospective studies). The claim of equivalence is based on the technical and design similarities to a predicate device. Therefore, information about sample size and data provenance for a test set is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No test set requiring expert ground truth establishment is described.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission focuses on device equivalence through design and technical specifications, not human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This device is a phototherapy unit (medical equipment for light therapy), not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this submission is the established performance and safety of the predicate device, the Daavlin 1 Series Phototherapy Unit (K100378). The entire argument revolves around demonstrating that the new device is fundamentally the same and performs identically or equivalently to this predicate.
8. The Sample Size for the Training Set
Not applicable. This device is a physical phototherapy unit; it does not involve machine learning algorithms or a "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted above, there is no training set for this type of device. The ground truth for the predicate device would have been established through its own regulatory clearance process, likely involving engineering testing and demonstrating safety and effectiveness for its intended use.
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