(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.
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Trade Name: Derma-Wand
OCT 28 1998 Common Name: UV Radiator
Classification Name: Light, Ultraviolet Dermatological
National Biological Corporation declares through it's official correspondent Tracie Capozzio that to the best of it's knowledge, the proposed device family has the same intended use and similar technological characteristics as predicate devices (Birtcher Model 625 and R.A. Fischer CO UV-9 Therapy Lamp). It can be demonstrated that the proposed device is as safe and effective as the legally marketed devices and does not raise different questions regarding safety and effectiveness than the predicate device. This is based on the following areas of comparison between the proposed device and (referenced) predicate device:
Electrical Rating. The voltage, current, and power ratings and characteristics are comparable. High voltage breakdown and current leakage specifications meet current industry and medical device standards.
Digital Timer. The pre-1976 predicate device utilized an external manual timer which did not control exposure time. The proposed NBC and the previously cleared R.A. Fischer CO device utilizes an integral digital timer which is a current state of the art design used in other NBC medical devices to control UV lamp activation. Stated timer accuracy is +/- 3 seconds.
UV Lamps. The UV lamps, ballasts, and circuitry are identical to those used in current production devices. The predicate UV source and the proposed devices radiate energy levels and spectral responses which are comparable to each other and to devices currently in use for medical and conmercial applications.
Operating Temperatures. The specified operating range (65 to 105 degrees F) is identical. There are no exposed, readily accessible high temperature areas which could pose a risk to the user or patient.
Key-switch safety. A key-operated power switch with removable key is standard on NBC products, to lock out timer/unit operation and prevent unauthorized device use. The predicate devices utilized an ON/OFF toggle switch.
Control and UV Wand. 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. Birtcher Model 625 device utilized an integral molded housing with a cold cathode quartz lamp, and did contact the body parts to be treated. The Fischer UV-9 utilized a molded housing with three plug-in germicidal bulbs.
Regulatory Requirements. The proposed devices will be manufactured and released within the established FDA Current Good Manufacturing Practices (CCMP) environment. The predicate device was distributed prior to 1976 and did not come under FDA/GMPs.
Product Safety. The Device Program Plan includes submission of the proposed finished devices to third-party evaluation by Electronic Testing Laboratories (ETL) and the Canadian Standards Association (CSA).
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines forming the wings and head. The eagle is facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 1998
Ms. Tracie Capozzio Director, RA and QA National Biological Corporation 1532 Enterprise Pkwy. Twinsburg, Ohio 44087
Re: K982082 Derma-Wand Trade Name: Requlatory Class: II Product Code: FTC Dated: August 19, 1998 Received: August 24, 1998
Dear Ms. Capozzio:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Tracie Capozzio
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket 510(k) No. K982082
K9820082
Device Name: Derma-Wand
INDICATIONS FOR USE
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.
Prescription Use
(Per 21 CFR 801.109) X
Acotte
(Divisio Division of Genera 510(k) Number
§ 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.