`
`510(K)_SUMMARY KFe2082.
`
`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.
`
`timer
`Digital Timer. The pre-1976 predicate device utilized an external manual
`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.
`
`to those used in
`UV Lamps. The UV lamps, ballasts, and circuitry are identical
`current production devices. The predicate UV source and the proposed devices rad-
`late energy levels and spectral responses which are comparable to each other and
`to devices currently in use for medical and commercial 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 housingwith three plug-in germicidal bulbs.
`
`Regulatory Requirements. The proposed devices will be manufactured and released
`within the established FDA Current Good Manufacturing Practices (CGMP) 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 finish-
`ed devices to third-party evaluation by Electronic Testing Laboratories (ETL) and
`the Canadian Standards Association (CSA).
`
`510k/Handisol /9-22-98/summary
`
`1
`
`EXHIBIT 1025
`
`1
`
`EXHIBIT 1025
`
`

`

`DEPARTMENTOF HEALTH & HUMAN SERVICES
`
`Public Health Service
`
`we SEANCES
`%,
`
`aotBALIg Co
`
`“ega:
`Food and Drug Administration
`
`9200 Corporate Boulevard
`Rockville MD 20850
`
`OCT 28 098
`
`Ms. Tracie Capozzio
`Director, RA and QA
`National Biological Corporation
`1532 Enterprise Pkwy.
`Twinsburg, Ohio 44087
`
`Re: K982082
`Trade Name: Derma-Wand
`Regulatory 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
`of the Act.
`The general controls provisions of the Act
`include requirements for annual registration,
`listing of
`devices, good manufacturing practice,
`labeling, and
`prohibitions against misbranding and adulteration.
`
`into either class II
`If your device is classified (see above)
`(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.
`A
`substantially equivalent determination assumes compliance with
`the current Good Manufacturing Practice requirement, as set
`forth in the Quality System Regulation (QS)
`for Medical
`Devices: General regulation (21 CFR Part 820) and that,
`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
`action.
`In addition, FDA may publish further announcements
`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
`regulations.
`
`laws or-
`
`2
`
`

`

`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
`regulation (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,
`
`f- 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
`
`3
`
`

`

`Premarket 510(k) No. K982082
`
`Device Name: Dennma-Wand
`
`INDICATIONS FOR USE
`
`IC9820872
`
`photo-therapeutic
`The National Biological Corporation Derma-Wand provides
`ultraviolet light. The UVB wand is indicated for dermatologic disorders such as
`psoriasis and vitiligo. While the UVC wand is indicated for dermtologic disorder
`in which bactericidal management is desired.
`
`Prescription Use
`(Per 21 CFR 801.109)
`
`CO
`
`(Divi
`
`Division of General RestorativeDeviowsi 3 8208 7
`
`5 1Q(k) Number
`
`510k/Handisol /9-22-98/ IFU
`
`4
`
`