(135 days)
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.
§ 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.