(32 days)
The Flex controlled phototherapy equipment is a medical ultraviolet device, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
The Flex controlled phototherapy equipment is a microprocessor controlled fluorescent uitraviolet light source, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB), 305 m (Broad Band UVB) and 350 nm (UVA). It is intended for use by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The Flex controlled devices deliver full body phototherapy, whereby fluorescent tubes deliver the specified dose of UVA and/or UVB light.
Unfortunately, I cannot fulfill your request to describe the acceptance criteria and study proving device performance based on the provided text. Here's why:
The provided text is a 510(k) summary for a medical device called "Flex Controlled Phototherapy Equipment." This document primarily focuses on establishing substantial equivalence to a predicate device, not on proving that the device meets specific acceptance criteria through a performance study.
Here's a breakdown of what's missing and why I can't extract the requested information:
- Acceptance Criteria and Reported Device Performance (Table): The document does not define specific acceptance criteria (e.g., accuracy thresholds, failure rates, etc.) nor does it present detailed performance data of the "Flex controlled phototherapy equipment." It states its performance "is the same as or very similar to that of the claimed predicate device." This is a claim of equivalence, not a direct measurement against defined criteria for the new device.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth Type, Training Set Size, Training Set Ground Truth: All these points relate to a detailed performance study with a test set, expert evaluation, and ground truth establishment. The 510(k) summary explicitly states: "The Flex controlled phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the Flex controlled phototherapy equipment are the same." This indicates a reliance on the predicate device's established performance rather than a new, independent performance study for the specific device being submitted. The only "performance data" mentioned is the shared components and similar operational principles.
In essence, the document you provided is a regulatory filing for substantial equivalence, which is a different type of submission than a detailed clinical or technical performance study. To answer your questions, I would need a different type of document, such as a full clinical study report, a technical validation report, or a comprehensive premarket approval (PMA) application that typically includes such performance data.
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APR 1 9 2005
Image /page/0/Picture/1 description: The image shows a sequence of numbers and letters, "K050695". The characters are written in a handwritten style, with varying stroke thicknesses. The numbers are clearly distinguishable, and the letter "K" is at the beginning of the sequence.
510(k) Summary
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | The Daavlin Distributing Company |
|---|---|
| Registration Number: | 1526255 |
| Address: | 205 West Bement Street |
| Bryan, Ohio 43506 | |
| Telephone: | 419.636.6304 |
| Contact: | David W. Swanson |
| Date Prepared: | March 4, 2005 |
| Device Trade Name: | Flex Controlled Phototherapy Equipment |
| Device Common Name: | Ultraviolet Phototherapy Lamp |
| Device Classification: | Class II |
| Product Code: | FTC |
| Regulation Number: | CFR 878.4630 |
| Regulation Name: | Ultraviolet lamp for dermatologic/skin disorders |
| Predicate Device: | Daavlin Distributing Company |
| Spectra 300 Series, Ultraviolet Phototherapy Device, K828654 | |
| Spectra 724 Series, Ultraviolet Phototherapy Device, K854498 | |
| Spectra Mini Series, Ultraviolet Phototherapy Device, K820690 |
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Device Description:
The Flex controlled phototherapy equipment is a microprocessor controlled fluorescent uitraviolet light source, with spectral output at peak wavelengths of 311 nm (Narrow Band UVB), 305 m (Broad Band UVB) and 350 nm (UVA). It is intended for use by or under the direction of a physician, for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema). The desired dose is selected using the operator interface located on the front panel of the device. The Flex controlled devices deliver full body phototherapy, whereby fluorescent tubes deliver the specified dose of UVA and/or UVB light.
Predicate Device Comparison:
The Flex controlled phototherapy equipment is constructed in the same design configuration as the predicate device, utilizing identical energy sources (UV lamps) and materials of identical composition. The Flex controlled devices vary from the predicate device, in that the control system hardware and software of the Flex control has been updated to utilize current technology. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the Flex controlled equipment are the same or similar to those of the predicate device.
Intended Use:
The Daavlin Flex controlled phototherapy equipment is a medical ultraviolet light source, which is intended for use for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (I - VI).
Performance Data:
The Daavlin Flex controlled phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the Flex controlled phototherapy equipment are the same.
Conclusion:
On the basis of the information provided in this Summary, the Daavlin Distributing Company believes the Flex controlled phototherapy equipment is substantially equivalent to the legally commercialized predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the snake and a base representing the staff.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 9 2005
Mr. David W. Swanson Daavlin Distributing Co. 205 West Bement Street Bryan, Ohio 43506
Re: K050695
K050075
Trade/Device Name: Flex Controlled Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: March 4, 2005 Received: March 18, 2005
Dear Mr. Swanson:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your Section 910(x) premaince is substantially equivalent (for the indications referenced and nave determined the arrest and as a research and the sinces marketed in interstate for use stated in the encrosury mansted promotive promise (Device Amendments, or 10
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1970, the charteries and the Federal Food. Drug. devices that have been reculted in acconcire approval of a proval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that to not require approval of the general controls provisions of the Act. The
You may, therefore, market the device, subject to the general contro You may, inerefore, market the devreet, saojoet to the egeneral controls provisions of the Act merelies of the supply bitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Scc above) nno enter regulations affecting your device
it may be subject to such additional controls. Existing major regulations EDA it may be subject to such additional controls: "Bhoting also to 898. In addition. FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to Salesa can be found in the Code of Federal regarations,
may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s Issuance of a sudomine with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decemmanon alla Jour and Jour and agencies. You must or any lederal statules and regulations administred or registration and listing (21
comply with all the Act's requirements, including, but not more anguraments as set comply with all the Act s requirements, menualism practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the aloctronic CFR Part 807), labeling (21 CFR Part 801), government 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (Q5) regalation (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000
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Page 2 – Mr. David W. Swanson
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the same of the support of the privalence of your device to a leg This letter will allow you to begin maketing your active of your device of your device to a legally
premarket notification. The FDA finding of substantial enames of this pe premarket notification. The FDA Inding of Subscandar of the more of the marketed premits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rs the real and the many of any 12, 276, 0130 - Alancelares not the regulat If you desire specific advice for your ac vice on our lacemes note the regulation entitled,
contact the Office of Compliance at (240) 276-0120 . Also, please note the regulat contact the Office of Collipilalicc at (240) 270 - 1 (2107R Part 807.97). You may obtain
"Misbranding by reference to premarket notification its of from the Division of Smal "Misbranding by reference to prematic nothication (cr. 02 Act from the Division of Small other general information on your responsionities and its toll-free number (800) 638-2041 or Manufacturers, International and Colisuner Assistance at no over in of the more of the more in the support/index.html.
Sincerely yours,
Signature
- Miriam C. Provost, Ph.D. Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number K032667
Device Name Flex Controlled Phototherapy Equipment
Indications for Use
The Flex controlled phototherapy equipment is a medical ultraviolet device, which is intended for the treatment of psoriasis, vitiligo, and atopic dermatitis (eczema) on all skin types (1 - VI).
Prescription Use X_
OR (per 21 CFR 801.109) Over-the-Counter Use ___
(Please do not write below this line - Continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
I'm Native
050695
§ 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.