(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.
§ 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.