(135 days)
Birtcher Model 625, R.A. Fischer CO UV-9 Therapy Lamp
Not Found
No
The summary describes a UV light therapy device with a timer and wand, with no mention of AI, ML, image processing, or data-driven decision making.
Yes
The device uses phototherapy and UV light to treat specific dermatologic disorders like psoriasis and vitiligo, which indicates a therapeutic purpose.
No
The device is indicated for treatment of dermatologic disorders using phototherapy, not for diagnosis.
No
The device description clearly outlines physical hardware components including a control housing, UV fluorescent lamps, a reflector assembly, and a plastic wand. This indicates it is a hardware device that emits UV radiation for therapeutic purposes, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device is a phototherapy device that applies ultraviolet light directly to the skin for treatment. It does not analyze any biological samples.
The description clearly states its function is to provide "photo-therapeutic ultraviolet light" for treating dermatologic disorders by directing the light to "selected wound areas." This is a therapeutic application, not an in vitro diagnostic one.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
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. 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. 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. 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Birtcher Model 625, R.A. Fischer CO UV-9 Therapy Lamp
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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