(83 days)
The Resolve™ UVB Phototherapy System is an ultraviolet light emitting medical device indicated for phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The Allux Medical Resolve™ UVB Phototherapy System is intended to be used with all Skin Types (I - VI).
The Resolve™ UVB Phototherapy System is designed to deliver therapeutic ultraviolet-B light to a localized area onto a patient's skin surface. This system is designed to be easy to operate and is intended to be used in an outpatient setting such as a dermatologist's office under supervision of trained medical personnel. The device is comprised of two distinct components. The first is a patient attached unit and the second is a medical grade power supply. The patient attached unit is small and lightweight and is intended to be held in place or affixed to a patient at the desired treatment site. A portion of one side of the patient attached unit is composed of a fused silica transparent window out of which ultraviolet light is emitted; this window surface is intended to make contact with and lay flush to the skin thus enabling a localized treatment. The patient attached unit houses an array of ultraviolet light emitting diodes (UV-LEDs) that serve as the therapeutic light source. Additionally, the drive and control circuitry necessary to operate the UV-LEDs, as well as a fan and heat sink to dissipate waste thermal energy, are located inside the patient attached unit's protective housing. Operator interface features include on-off switch and both visual and audible status indicators.
The Allux Medical Resolve™ UVB Phototherapy System is an ultraviolet light emitting medical device indicated for phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. It is intended for use with all Skin Types (I - VI).
Here's an analysis of the provided text regarding acceptance criteria and performance studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state specific quantitative acceptance criteria for the Resolve™ UVB Phototherapy System in terms of efficacy for treating dermatological conditions. Instead, the submission relies on demonstrating substantial equivalence to existing predicate devices.
However, the text mentions general performance aspects:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| UVB Emissions within Specification (for the device itself) | Performance data are included with the 510(k) to demonstrate that UVB emissions are within specification for the device. |
| UVB Spectra Similarity to Predicate Devices | Performance data demonstrate that UVB emissions "are the same or very similar to the spectra emitted by the predicate UVB devices." |
| Electrical Safety | Information to support electrical safety was included with the 510(k). |
| Electromagnetic Compatibility (EMC) | Information to support electromagnetic compatibility was included with the 510(k). |
| Biocompatibility | Information to support biocompatibility was included with the 510(k). |
| Functionality | Information to support functionality was included with the 510(k). |
| Safety and Effectiveness (comparable to predicate devices, no new questions raised) | The device "is judged to pose no new questions of safety and effectiveness when compared with devices that have been cleared." "This technological feature [LEDs] is not considered by Allux Medical to raise new questions of safety or efficacy." |
| Intended Use Equivalence (same as predicate devices) | The Resolve UVB Phototherapy System "has the same indications for use as those cleared for the claimed UVB predicate devices." |
| Technological Equivalence (similar technologies, despite LED light source) | "The Resolve device uses LEDs as a UVB light source. LEDs are used in other medical devices to provide light at spectra other than UVB. Since the Resolve UVB System... employs similar technologies..." |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not describe a clinical study with a "test set" in the context of dermatological efficacy for the Resolve™ UVB Phototherapy System. The submission relies on performance data related to the device itself (UVB emissions, electrical safety, etc.) and a claim of substantial equivalence to predicate devices.
There is no mention of a patient-based test set or data provenance (e.g., country of origin, retrospective/prospective). The "performance data" mentioned refers to engineering and technical evaluations of the device's physical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since there is no described clinical study with a "test set" for diagnostic accuracy or treatment efficacy, there is no information about experts used to establish ground truth.
4. Adjudication Method
Not applicable, as no clinical study with a "test set" and ground truth establishment is described for the Resolve™ UVB Phototherapy System.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done comparing human readers with and without AI assistance. The device is a phototherapy system that directly treats patients, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study
The text describes a standalone performance evaluation in terms of the device's inherent characteristics. The "performance data" included with the 510(k) are:
- Demonstration that UVB emissions are within specification for the device.
- Confirmation that the UVB spectra are the same or very similar to predicate UVB devices.
- Information supporting electrical safety, electromagnetic compatibility, biocompatibility, and functionality.
This represents a standalone evaluation of the device's physical and operational attributes, not a clinical efficacy study.
7. Type of Ground Truth Used
For the "standalone" performance evaluations mentioned (UVB emissions, electrical safety, etc.), the "ground truth" would be established by technical specifications, industry standards, and measurements against those standards. For example, a spectroradiometer would be used to measure the UVB spectrum, and electrical safety would be tested according to relevant safety standards.
For the claim of substantial equivalence regarding the intended use and efficacy, the "ground truth" is based on the established clinical effectiveness of the predicate UVB phototherapy devices for the stated dermatological conditions.
8. Sample Size for the Training Set
Not applicable. The device is a phototherapy system; it does not involve machine learning or a "training set" in the context of an AI algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI algorithm.
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SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
K072035
5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
907 1 6 2007
This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT | Allux Medical Incorporated1430 O'Brien Drive, Suite FMenlo Park, California 94025 |
|---|---|
| Contact Person: Lloyd H. GrieseVice President, Quality Assurance | |
| Telephone No: (650) 473-9407 x113 | |
| Fax No: (650) 473-9809 | |
| E-mail: lgriese@alluxmedical.com | |
| TRADE NAME: | Resolve™ UVB Phototherapy System |
| COMMON NAME: | UV Phototherapy Device |
| CLASSIFICATIONNAME: | Ultraviolet lamp for dermatologic disorders(See 21 CFR 878.4630) |
| DEVICECLASSIFICATION: | Class II |
| PRODUCT CODE | FTC |
| PREDICATEDEVICES: | Lumenis, Ltd. Bclear™ UVB Phototherapy System(K020591) |
| TheraLight, Inc. UV120-2 UVA / UVB Phototherapy System(K022165) | |
| Natus Medical, Inc. Natus® Blue Light Phototherapy Unit(K022196) | |
| Respironics Inc. Bili-Tx Neonatal Phototherapy Device(K070180) |
Description of Device:
The Resolve™ UVB Phototherapy System is designed to deliver therapeutic ultraviolet-B light to a localized area onto a patient's skin surface. This system is designed to be easy to operate and is intended to be used in an outpatient setting such as a dermatologist's office under supervision of trained medical personnel.
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510(K) S OF SAFETY AND EFFECTIVENESS SECTION 5.
The device is comprised of two distinct components. The first is a patient attached unit and the second is a medical grade power supply. The patient attached unit is small and lightweight and is intended to be held in place or affixed to a patient at the desired treatment site. A portion of one side of the patient attached unit is composed of a fused silica transparent window out of which ultraviolet light is emitted; this window surface is intended to make contact with and lay flush to the skin thus enabling a localized treatment.
The patient attached unit houses an array of ultraviolet light emitting diodes (UV-LEDs) that serve as the therapeutic light source. Additionally, the drive and control circuitry necessary to operate the UV-LEDs, as well as a fan and heat sink to dissipate waste thermal energy, are located inside the patient attached unit's protective housing. Operator interface features include on-off switch and both visual and audible status indicators.
Indications for Use:
The Resolve™ UVB Phototherapy System is an ultraviolet light emitting medical device indicated for phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The Allux Medical Resolve™ UVB Phototherapy System is intended to be used with all Skin Types (I - VI).
Description of Substantial Equivalence:
Currently published clinical data support UVB phototherapy treatment for a variety of dermatologic conditions. The intended use of the Resolve UVB Phototherapy System is considered by Allux Medical to be within the scope of the predicate devices that emit UVB light for dermatologic phototherapy. The Resolve UVB Phototherapy System employs light emitting diodes (LEDs) as a light source. This technological feature is not considered by Allux Medical to raise new questions of safety or efficacy. Use of LEDs as a therapeutic light source in medical devices is within the scope of predicate devices that are used in phototherapeutic applications such as the treatment of neonatal hyperbilirubinemia.
Performance Data:
The Resolve UVB Phototherapy System has the same indications for use as those cleared for the claimed UVB predicate devices. Performance data are included with the 510(k) to demonstrate that UVB emissions are within specification for the device and are the same or very similar to the spectra emitted by the predicate UVB devices. Additionally, information to support electrical safety, electromagnetic compatibility, biocompatibility, and functionality were included with the 510(k).
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SECTION 5. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
Conclusion:
The Resolve UVB Phototherapy System is similar to other UVB emitting devices for localized treatment of dermatologic disease with the main difference being the source of the UV light. The Resolve device uses LEDs as a UVB light source. LEDs are used in other medical devices to provide light at spectra other than UVB. Since the Resolve UVB System has the same intended use, employs similar technologies, and is judged to pose no new questions of safety and effectiveness when compared with devices that have been cleared, Allux Medical considers it to be substantially equivalent to the legally marketed claimed predicate devices for the purpose of this 510(k) submission.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 6 2007
Allux Medical, Inc. % Mr. Lloyd H. Griese VP. Quality Assurance 1430 O'Brien Drive, Suite F Menlo Park, California 94025
Re: K072035
Trade/Device Name: Resolve™ UVB Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet lamp for dermatologic disorders Regulatory Class: II Product Code: FTC Dated: September 14, 2007 Received: September 18, 2007
Dear Mr. Griese:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA 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 that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 - Mr. Lloyd H. Griese
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): KO 720 3/
Device Name: Resolve™ UVB Phototherapy System
Indications for Use:
The Resolve™ UVB Phototherapy System is an ultraviolet light emitting medical device for localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), and seborrheic dermatitis. The Resolve™ UVB Phototherapy System is intended to be used with all Skin Types (I – VI).
Prescription Use __x (21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) |
|---|
| Division of General, Restorative, and Neurological Devices |
| 510(k) Number | 4072035 |
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ાર
§ 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.