(83 days)
Not Found
No
The summary describes a hardware device that emits UV light for phototherapy. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
Yes
The device is indicated for "phototherapeutic treatment of dermatologic conditions" and is designed to "deliver therapeutic ultraviolet-B light," which directly implies its purpose is to provide therapy.
No
The device description and intended use state it is for "phototherapeutic treatment" and "deliver therapeutic ultraviolet-B light," indicating a treatment function, not a diagnostic one.
No
The device description explicitly states it is comprised of two distinct hardware components: a patient attached unit and a medical grade power supply. It details the physical components within the patient attached unit, including UV-LEDs, circuitry, a fan, and a heat sink.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Resolve™ UVB Phototherapy System is a medical device that delivers ultraviolet light directly to the patient's skin for therapeutic treatment of dermatologic conditions. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "phototherapeutic treatment of dermatologic conditions," which is a direct treatment method, not a diagnostic test.
- Device Description: The description focuses on the physical components and how it delivers light to the skin surface. There is no mention of sample collection, analysis, or diagnostic results.
Therefore, the Resolve™ UVB Phototherapy System falls under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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).
Product codes (comma separated list FDA assigned to the subject device)
FTC
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin surface
Indicated Patient Age Range
Not Found
Intended User / Care Setting
outpatient setting such as a dermatologist's office under supervision of trained medical personnel.
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)
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).
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.
K020591, K022165, K022196, K070180
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
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 Incorporated
1430 O'Brien Drive, Suite F
Menlo Park, California 94025 |
|---------------------------|-------------------------------------------------------------------------------------------|
| | Contact Person: Lloyd H. Griese
Vice 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 |
| CLASSIFICATION
NAME: | Ultraviolet lamp for dermatologic disorders
(See 21 CFR 878.4630) |
| DEVICE
CLASSIFICATION: | Class II |
| PRODUCT CODE | FTC |
| PREDICATE
DEVICES: | 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.
1
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).
2
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.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement around the logo.
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
4
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
5
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 |
|---|---|
| Page | of |
ાર