(39 days)
The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
The 3 Series NeoLux device is a full body medical ultraviolet device, which is intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet or visible radiation for diagnosed skin disorders. The 3 Series NeoLux device delivers a 360-degree full body treatment, with spectral output from UV through visible, through an array of 24-48 fluorescent lamps (Either F72 or F79 length). Treatments are controlled through the Smart Touch Controller Software interface, Flex Controller or ClearLink Controller interface. The Smart Touch Software interface is installed remotely on a custom-built computer. An "off the shelf" replacement is not possible. Replacement can only be obtained through Daavlin. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Furthermore, the physician can restrict the amount and type of access that is granted to each authorized operator. Each authorized operator is assigned an initial default pin number. The system requires each operator to select a new individual pin and change the default pin upon initial logon. Authorized operators program treatments in joules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency. The Smart Touch equipped computer will interface with the 3 Series NeoLux device through a closed wired Ethernet connection and a Daavlin Distributing Company UV4001. While the Flex Controller is controlled by an integrated digital timer with an LCD segmented display and four membrane buttons as the interface, and ClearLink Controller is controlled by a microprocessor controlled with an LCD touch screen display. When the operator sets the treatment time or the desired dose using the operator interface located on the control panel, the treatment begins by illuminating the lamps which emit the prescribed light.
This document is a 510(k) summary for the Daavlin 3 Series NeoLux phototherapy equipment, seeking clearance from the FDA. It details the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
Based on the provided information, the 3 Series NeoLux device is a phototherapy equipment indicated for treating diagnosed skin disorders such as psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. This is not an AI/ML powered device, therefore the request for information on acceptance criteria and a study that proves the device meets the acceptance criteria is not applicable in the context of AI/ML performance.
The document primarily focuses on establishing substantial equivalence to legally marketed predicate devices, meaning it has the same intended use and technological characteristics as a predicate device, or has different technological characteristics but does not raise different questions of safety and effectiveness and is as safe and effective as a legally marketed device.
Here's an analysis of the provided information, structured as requested, with "N/A" for sections not applicable to this type of device or not explicitly mentioned in the provided text:
Acceptance Criteria and Device Performance Study for 3 Series NeoLux (Non-AI/ML Device)
The 3 Series NeoLux is a phototherapy device, not an AI/ML powered medical device. Therefore, the concept of "acceptance criteria" and "device performance" in the context of metrics like sensitivity, specificity, or image analysis accuracy typically associated with AI/ML studies is not applicable here.
Instead, the device's "performance" is demonstrated through its fulfillment of its intended use (delivering specific light spectrums for dermatologic treatment) and its substantial equivalence to previously cleared predicate devices. The "study" mentioned for phototherapy devices typically involves engineering and safety testing to ensure the device operates as intended and meets relevant safety standards (e.g., electrical safety, electromagnetic compatibility, radiation emission controls).
1. Table of Acceptance Criteria and Reported Device Performance
Note: For non-AI/ML devices like this phototherapy unit, the "acceptance criteria" are generally derived from recognized standards, predicate device characteristics, and safety/performance specifications rather than diagnostic performance metrics. The "reported device performance" is descriptive of its features and operational parameters, demonstrating its equivalence to predicate devices.
| Feature / Criterion Type | Acceptance Criterion (Based on Predicate/Standards) | Reported Device Performance (3 Series NeoLux) |
|---|---|---|
| Intended Use | Treat diagnosed skin disorders (psoriasis, vitiligo, atopic dermatitis) under physician direction. | Treats diagnosed skin disorders (psoriasis, vitiligo, atopic dermatitis) under physician direction. |
| Patient Population | Pediatric to Geriatric | Pediatric to Geriatric |
| Treatment Modality | Delivers UV through visible light for dermatologic therapy. | Delivers UV through visible light for dermatologic therapy. |
| Spectral Output | UV through Visible | UV through Visible |
| Number of Lamps | 24 - 48 (similar to predicate K153749) | 24 - 48 |
| Power Output (mW/cm²) | 5 - 255 (similar to predicate K153749 at 9") | 5 - 254 (at 9", dependent on number of lamps) |
| Application Environment | Hospital, Clinic, Medical Center, Private Medical Practice, or other Professional Medical environments under physician direction. | Hospital, Clinic, Medical Center, Private Medical Practice, or other Professional Medical environments under physician direction. |
| Construction Materials | Metal frame, reflective internal surfaces, fluorescent lamps, protective acrylic (similar to predicate K153749). | Metal frame, reflective internal surfaces, fluorescent lamps, protective acrylic. |
| Manufacturing Methods | Identical to predicate devices | Identical |
| Patient Cooling | Fan (similar to predicate K153749) | Fan |
| Controller Type | Flex Controller, SmartTouch Controller, ClearLink Controller | ClearLink Controller, Flex Controller, SmartTouch Controller |
| General Operating Principles | Same or similar to predicate devices. | Same or similar to predicate devices. |
| Labeling | Same or similar to predicate devices. | Same or similar to predicate devices. |
| Patient Safety | Same or similar to predicate devices. | Same or similar to predicate devices. |
| Electrical Safety | Adherence to recognized electrical safety standards (e.g., IEC 60601 series). | Not explicitly detailed in summary, but assumed to meet standards for 510(k) clearance. |
| EMC | Adherence to recognized EMC standards. | Not explicitly detailed in summary, but assumed to meet standards for 510(k) clearance. |
| Performance from Applicable Standards | Device performance data is the same as or very similar to predicate devices. | Device performance data is the same as or very similar to predicate devices. |
Proof of Meeting Acceptance Criteria:
The "study" demonstrating the device meets these criteria is the submission of technical documentation to the FDA as part of the 510(k) process. This typically includes:
- Engineering drawings and specifications.
- Risk analysis.
- Verification and validation testing results (e.g., electrical safety according to IEC 60601, electromagnetic compatibility (EMC), photobiological safety, power output measurements, controller function tests).
- Materials compatibility and biocompatibility if applicable.
- Software validation if software is involved in safety-critical functions (which it appears to be for the Smart Touch Controller).
The 510(k) summary explicitly states: "The 3 Series NeoLux device performance data is the same as or very similar to that of the claimed predicate devices. The lamps and construction used in the production of the predicate devices and the 3 Series NeoLux are the same. The devices materials, construction, treatment modality, patient safety, etc., is exactly the same or similar." This statement, backed by the detailed comparison table, is the core of how the device demonstrates it meets the "acceptance criteria" by being substantially equivalent to already cleared devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: N/A. This is not an AI/ML device that uses a "test set" in the context of machine learning model evaluation. The "testing" involves engineering and functional validation of the physical device.
- Data Provenance: N/A. This information is not relevant for a phototherapy device's 510(k) clearance in the way it would be for an AI/ML diagnostic or prognostic tool.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: N/A. Ground truth establishment is not relevant for this type of device clearance. The device treats conditions diagnosed by a physician, but the device itself does not make a diagnosis or prediction that requires "ground truth" to evaluate its performance.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. Not relevant for this type of device clearance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is not an AI/ML diagnostic or interpretive device, so an MRMC study is not applicable.
- Effect Size of Human Readers Improvement with AI vs. Without AI Assistance: N/A. As this is not an AI-assisted device, this metric is irrelevant.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Study: No. This device does not have an "algorithm" in the context of AI/ML; it is a physical medical device.
7. The Type of Ground Truth Used
- Type of Ground Truth: N/A. Not relevant for this type of device clearance.
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. This is not an AI/ML device that uses a "training set."
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: N/A.
Summary Conclusion:
The Daavlin 3 Series NeoLux phototherapy device obtained 510(k) clearance (K230382) by demonstrating substantial equivalence to its predicate devices (3 Series Phototherapy Unit K153749 and M Series Phototherapy Equipment K210881). The "acceptance criteria" and "performance study" for such a device primarily revolve around its technical specifications, safety, and functionality matching or being very similar to the predicate devices, ensuring it is as safe and effective. The provided document details these similarities across various features like intended use, patient population, technical characteristics (number of lamps, spectral output, power output, materials), and operational environment. It does not involve AI/ML performance metrics or studies.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 24, 2023
Daavlin Distributing Co. Michele Thiel Regulatory Manager 205 West Bement Street Bryan, Ohio 43506
Re: K230382
Trade/Device Name: 3 Series NeoLux Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: March 16, 2023 Received: March 16, 2023
Dear Michele Thiel:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Carr -S
for Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230382
Device Name 3 Series NeoLux
Indications for Use (Describe)
The 3 Series Neolux devices are indicated for use to treat diagnosed skin disorders such as, but not limited to, psoriasis, vitiligo, and atopic dermatitis (eczema) under the direction of a physician. The population may range from pediatric to geriatric.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K230382 510(k) Summary
| 510(K) Summary: | ||
|---|---|---|
| ----------------- | -- | -- |
| Date of Summary: | March 23, 2023 |
|---|---|
| 510(k) Submitter: | Daavlin Distributing Company |
| Contact Person: | Michele Thiel |
| Regulatory Manager | |
| Daavlin Distributing Company | |
| 205 West Bement Street | |
| Bryan, Ohio 43506 | |
| Phone: (419) 636-6304 Ext. 207 | |
| Fax: (419) 636-1739 | |
| Email: mthiel@daavlin.com | |
| Trade Name: | 3 Series NeoLux |
| Common Name: | Phototherapy Equipment |
| 510(k) Number: | K230382 |
| Regulation Number: | 21 CFR 878.4630 |
| Classification Name: | Ultraviolet lamp for dermatologic disorders |
| Device Class: | Class II |
| Product Code: | FTC |
| Panel: | General and Plastic Surgery |
| Predicate Devices: | 3 Series Phototherapy Unit (K153749) |
| M Series Phototherapy Equipment (K210881) | |
| 510(k) Numbers: | K153749, K210881 |
| Company: | Daavlin Distributing Company |
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| Device Description: | The 3 Series NeoLux device is a full body medical ultraviolet device,which is intended for use, by or under the direction of a physician, fortherapeutic treatment for individuals who require ultraviolet or visibleradiation for diagnosed skin disorders.The 3 Series NeoLux device delivers a 360-degree full bodytreatment, with spectral output from UV through visible, through anarray of 24-48 fluorescent lamps (Either F72 or F79 length).Treatments are controlled through the Smart Touch ControllerSoftware interface, Flex Controller or ClearLink Controller interface.The Smart Touch Software interface is installed remotely on acustom-built computer. An "off the shelf" replacement is not possible.Replacement can only be obtained through Daavlin. Access to theinterface and stored information is restricted to individuals who havebeen established by the physician as authorized operators.Furthermore, the physician can restrict the amount and type of accessthat is granted to each authorized operator. Each authorized operator isassigned an initial default pin number. The system requires eachoperator to select a new individual pin and change the default pinupon initial logon. Authorized operators program treatments in joulesbased on established treatment protocols governed by the patient'sskin type, condition, minimum erythemal dose (M.E.D.), andtreatment frequency. The Smart Touch equipped computer willinterface with the 3 Series NeoLux device through a closed wiredEthernet connection and a Daavlin Distributing Company UV4001.While the Flex Controller is controlled by an integrated digital timerwith an LCD segmented display and four membrane buttons as theinterface, and ClearLink Controller is controlled by a microprocessorcontrolled with an LCD touch screen display. When the operator setsthe treatment time or the desired dose using the operator interfacelocated on the control panel, the treatment begins by illuminating thelamps which emit the prescribed light. |
|---|---|
| Indications for Use: | The 3 Series Neolux devices are indicated for use to treat diagnosedskin disorders such as, but not limited to, psoriasis, vitiligo, and atopicdermatitis (eczema) under the direction of a physician. Thepopulation may range from pediatric to geriatric. |
| Intended Use: | The 3 Series Neolux devices are intended to be used as full bodytherapeutic devices. They are designed to be used under the directionof a physician for individuals who require phototherapy. |
| PredicateComparison: | The 3 Series NeoLux device is constructed in the same designconfiguration as the predicate devices, utilizing identical energysources and materials of identical or similar composition. The spectraloutput, mode of operation, labeling, treatment area, treatmentmodality, patient safety, and general operating principals of the 3Series NeoLux device is the same or similar to those of the predicatedevices. |
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| Features | Subject Device | Predicate Device | Predicate Device |
|---|---|---|---|
| 3 Series NeoLuxPhototherapyEquipment | 3 Series NeoLuxPhototherapy Unit | M SeriesPhototherapyEquipment | |
| 510(k) Number | This SubmissionK230382 | K153749 | K210881 |
| Picture | Image: 3 Series NeoLux Phototherapy Equipment | Image: 3 Series NeoLux Phototherapy Unit | Image: M Series Phototherapy Equipment |
| Features | Subject Device3 Series NeoLuxPhototherapyEquipment | Predicate Device3 Series NeoLuxPhototherapy Unit | Predicate DeviceM SeriesPhototherapyEquipment |
| 510(k) Number | This SubmissionK230382 | K153749 | K210881 |
| Indications forUse | The 3 Series Neoluxdevices are indicatedfor use to treatdiagnosed skindisorders such as, butnot limited to,psoriasis, vitiligo, andatopic dermatitis(eczema) under thedirection of aphysician. Thepopulation may rangefrom pediatric togeriatric. | The 3 Series NeoLux isa full body ultravioletemitting medical lightsource, which isintended for use by orunder the direction of alicensed physician forthe treatment ofpsoriasis, vitiligo, andatopic dermatitis(eczema) on all skintypes (I-VI). | The M SeriesPhototherapyDevices are indicatedfor use to treatdiagnosed skindisorders such, as butnot limited to,psoriasis, vitiligo,and atopic dermatitis(eczema) under thedirection of aphysician. Thephysician willdetermine the lightspectrum (ultravioletto visible), theenergy or duration ofthe treatment, as wellas the treatmentenvironment.The population mayrange from pediatric,when accompanied by aresponsible adult tooperate it, to geriatric. |
| Prescriptive | Yes | Yes | Yes |
| PatientPopulation | Pediatric to Geriatric | Pediatric to Geriatric | Pediatric to Geriatric |
| PatientContact | There is no directpatient contact with thedevice during treatment– Areas of skin areexposed to controlledultraviolet radiationfrom a distance ofapproximately 9 inches(22.86 cm) away. | There is no directpatient contact with thedevice during treatment- Areas of skin areexposed to controlledultraviolet radiationfrom a distance ofapproximately 9 inches(22.86 cm) away. | Patient comes in directcontact with the acrylicwhen placing hands orfeet inside fortreatment. |
| AnatomicalSites | Topical skin treatment | Topical skin treatment | Topical skin treatment |
| Features | Subject Device | Predicate Device | Predicate Device |
| 3 Series NeoLux | 3 Series NeoLux | M Series | |
| PhototherapyEquipment | Phototherapy Unit | PhototherapyEquipment | |
| 510(k) Number | This SubmissionK230382 | K153749 | K210881 |
| ApplicationEnvironment | Hospital, Clinic,Medical Center, PrivateMedical Practice, orother ProfessionalMedical environmentsunder the direction of aphysician. | Hospital, Clinic,Medical Center, PrivateMedical Practice, orOther ProfessionalMedical Environmentsunder direction ofphysician | Hospital, Clinic,Medical Center, PrivateMedical Practice, orother environmentunder the direction of aphysician. |
| Materials | Interior: Assemblescomponents, ballasts,electronics housed in ametal frame withreflective internalsurfaces, fluorescentlamps, and protectiveacrylic. | Interior: Assemblescomponents, ballasts,electronics housed in ametal frame withreflective internalsurfaces, fluorescentlamps, and protectiveacrylic. | Assembled componentshoused in metal framewith reflective internalsurfaces andfluorescent lamps |
| ManufacturingMethods | Identical | Identical | Identical |
| Number ofLamps | 24 - 48 | 24 - 48 | 8 |
| LampSpectrums | UV through Visible | UV through Visible | UV through Visible |
| TreatmentArea | Full Body | Full Body | Partial Body |
| PatientCooling | Fan | Fan | Ambient |
| Power Output(mW/cm2) | 5 – 254 | 5 – 255 | 2.9- 17.46 |
| Controller | ClearLink ControllerFlex ControllerSmartTouch Controller | Flex ControllerSmartTouch Controller | ClearLink ControllerSmartTouch Controller |
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4 Power output is dependent on number of lamps at 9".
Power output is dependent on number of lamps at 9".
« Power output is dependent on number of lamps at 0".
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| Performance Standards: | The 3 Series NeoLux device performance data is the same as orvery similar to that of the claimed predicate devices. The lamps andconstruction used in the production of the predicate devices and the3 Series NeoLux are the same. The devices materials, construction,treatment modality, patient safety, etc., is exactly the same orsimilar. |
|---|---|
| Conclusion: | On the basis of the information provided in this Summary, theDaavlin Distributing Company believes the 3 Series NeoLux deviceis substantially equivalent to the legally commercialized predicatedevices. |
§ 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.