(57 days)
The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatitis, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
The Enhanced AURORA™ Medical Diode system and related accessories is designed to allow a clinician to easily apply UVA or UVB light to the patient's affected skin. The clinician selects the desired treatment type (UVA or UVB light) and applies the light through the appropriate handpiece by pointing the exit aperture towards the affected skin area.
The device is comprised of four main components:
- A base station
- A touchscreen where the user can enter system commands
- Two handpieces connected to the base by power cables. One handpiece contains diode emitters that, when activated, emit UVA light. The other handpiece emits UVB light. Either handpiece will only operate if the appropriate wavelength is selected, so a user cannot accidentally activate the incorrect handpiece. Activation of energy occurs on depression of a trigger in the handpiece.
- A printer accessory that can print out verification of treatment parameters for hard copy records.
The document describes the acceptance criteria and study for the Enhanced AURORA™ Medical Diode system.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| UVA energy dosage output within 10% of user-selected power settings | Confirmed within 10% of user-selected power settings |
| UVB energy dosage output within 10% of user-selected power settings | Confirmed within 10% of user-selected power settings |
2. Sample size used for the test set and the data provenance
The document does not explicitly state a 'test set' in the context of clinical data or patient samples. The performance data is based on bench testing only. Therefore, there is no sample size for a test set of patient data, nor is there information about data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The performance data is derived from bench testing of the device's output, not from expert interpretation of medical images or patient data requiring ground truth establishment by experts.
4. Adjudication method for the test set
Not applicable, as a test set requiring adjudication by experts (e.g., for diagnostic accuracy) was not conducted. The assessment was based on physical measurements during bench testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a phototherapy system, not an AI-powered diagnostic tool, and therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a medical phototherapy system, not an algorithm. Its performance is assessed by its physical output characteristics during bench testing, not by an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was the user-selected power settings, against which the actual UVA and UVB energy dosage output was measured. This is a technical performance measurement, not a clinical ground truth.
8. The sample size for the training set
Not applicable. This document describes a medical device for phototherapy, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, for the same reason as above.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 8, 2023
Psoria-Shield, Inc. John Yorke General Manager 409 Mandeville St Utica, New York 13502
Re: K230076
Trade/Device Name: Enhanced AURORA™ system, and related accessories Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC, GEX Dated: January 9, 2023 Received: January 10, 2023
Dear John Yorke:
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,
Jianting Wang -S
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) K230076
Device Name
Enhanced AURORA TM Medical Diode system, and related accessories
Indications for Use (Describe)
The Enhanced AURORA™ Medical Diode system and related accessories is indicated for use in targeted PUVA photochemistry and UVB phototherapy for the treatment of skin conditions including psoriasis, vitiligo, atopic dermatius, eczema, and seborrheic dermatitis. In addition, the system UVB channel is indicated for the treatment of leukoderma.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY K230076
Psoria-Shield Inc's Enhanced AURORA™Medical Diode System, and related accessories
The following information is provided as required by 21 C.F.R. § 807.87 (2003) for Psoria-Shield Inc's AURORA system Traditional 510(k) premarket notification:
Document Control Clerk,
Pursuant to 21 CFR 807.87, this is to notify you of the intention of Psoria-Shield, Inc. to introduce the Enhanced AURORA™ Medical Diode system and related accessories into commerce.
GENERAL INFORMATION:
| Premarket Application | |
|---|---|
| Submitter: | Psoria-Shield, Inc.409 Mandeville StUtica, NY 13502, USAPhone: 315 864 3465Email: jy@psoriashield.com |
| Contact: | John YorkeGeneral ManagerPsoria-Shield, Inc.409 Mandeville StUtica, NY 13502, USAPhone: 315 864 3465Email: jy@psoriashield.com |
| Manufacturer: | Psoria-Shield, Inc.409 Mandeville StUtica, NY 13502, USAPhone: 315 864 3465Email: jy@psoriashield.com |
| Date Prepared: | January 9, 2023 |
| Classification Name: | Ultraviolet Lamp For Dermatologic DisordersLaser surgical instrument for use in general and plastic surgery and indermatology |
| CFR Citation Number: | 21 CFR 878.463021 CFR 878.4810 |
| Product Code: | FTC, GEX |
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| Classification: | Class II |
|---|---|
| Review Panel: | General & Plastic Surgery |
| Trade Name: | Enhanced AURORA™ Medical Diode system and relatedaccessories |
| Common Name: | The Enhanced AURORA™ Medical Diode system and relatedaccessories is a Diode medical device for dermatological disorders. |
| Generic Name: | AURORA™ system, and related accessories |
| EstablishmentRegistrationNumber: | 3008872264 |
| Predicate Devices: | The Psoria-Shield, Inc. AURORA™ (K192411 July 2, 2020)The PhotoMedex, Inc. XTRAC Ultra2 Excimer Laser System, ModelAL10000 (K073659 January 2, 2008). |
| Purpose of thisSubmission: | Psoria-Shield is seeking to introduce the Enhanced AURORA™Medical Diode system and related accessories into commerceclaiming substantial equivalence to the Psoria-Shield AURORA™(K192411) and the PhotoMedex XTRAC Ultra2 Excimer LaserSystem, Model AL10000 (K073659). |
| Indications for Use: | The Enhanced AURORA™ Medical Diode system and relatedaccessories is indicated for use in targeted PUVA photochemistryand UVB phototherapy for the treatment of skin conditions includingpsoriasis, vitiligo, atopic dermatitis, eczema, and seborrheicdermatitis. In addition, the system UVB channel is indicated for thetreatment of leukoderma. |
| Device Description: | The Enhanced AURORA™ Medical Diode system and relatedaccessories is designed to allow a clinician to easily apply UVA orUVB light to the patient's affected skin. The clinician selects thedesired treatment type (UVA or UVB light) and applies the lightthrough the appropriate handpiece by pointing the exit aperturetowards the affected skin area. |
| The device is comprised of four main components: | |
| - A base station- A touchscreen where the user can enter system commands- Two handpieces connected to the base by power cables. One- handpiece contains diode emitters that, when activated, emit UVAlight. The other handpiece emits UVB light. Either handpiece will onlyoperate if the appropriate wavelength is selected, so a user cannot |
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| - | accidentally activate the incorrect handpiece. Activation of energyoccurs on depression of a trigger in the handpiece.A printer accessory that can print out verification of treatmentparameters for hard copy records.The technical specifications for the AURORA are as follows: | ||
|---|---|---|---|
| ●●●●●●● | Weight:Size:Min/Max power output (UVA):Min/Max power output (UVB):Power Increase IncrementsSize of beam:Dosage Accuracy: | 20 lbs19" (W) x 14" (L) x 8" (H)100 mJ/cm² / 3400 J/cm²100 mJ/cm² / 3400 mJ/cm²20mJ/100mJ2.88 cm²10% | |
| Technical Characteristics: | The Enhanced AURORA™ Medical Diode system and relatedaccessories has the exact technological characteristics as thepreviously cleared AURORA™ (K192411 July 2,2020). Additionally,Psoria Shield is claiming substantial equivalence to the PhotoMedexXTRACT (K073659 January 2,2008).The Enhanced AURORA™ Medical Diode system and relatedaccessories emits either UVA or UVB light, depending on which hasbeen selected by the clinician. The power output is the same betweenUVA or UVB. The treatment area is the same between UVA or UVB.Treatment instructions are the same between both the UVA and UVB.Thus, the modified AURORA is the same device as the clearedAURORA™ (K192411 July 2,2020) except for the modifications listedin table below, and for which Psoria-Shield is seeking clearance: |
| Modification | Detailed description of modification |
|---|---|
| A modification wasimplemented to improvethe communicationbetween the EnhancedAURORA and thethermal printer. Minorchanges were made tothe code of theEnhanced AURORA.These modifiedchanges areincorporated in the newversion of the code1.2.4. | The update consisted of updating the USB Printer to improve thecommunication of the USB thermal printer address. The updatewas done to ensure that the firmware/software connection wasfixed to allow the Enhanced AURORA™ Medical Diode system toproperly function for the user. This was done to allow the clinicianto utilize the thermal printer function while additionally preventingthem from overriding the Patient ID function while utilizing thedevice. A software change to the code was made in order for theclinician to read results before printing and to include an addedtreatment area to the results screen on the Enhanced AURORA ™Medical Diode system. |
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| Performance Data: | Psoria-Shield has performed bench testing consistent with designverification activities required under 21 CFR 820 to confirm thedesign modifications have no effect on the safety or effectiveness ofthe modified device. This was confirmed through verifying that UVAand UVB energy dosage output are within 10% of user-selectedpower settings.Testing was performed using a production-equivalent EnhancedAURORA™ Medical Diode system and related accessories, withenergy dosage measured using a Coherent PowerMax PC thermopilesensor array. Testing was performed to confirm the joule output of thedevice in a cm² area in the center of both the thermopile and usingthe center of the chipset arrays for the most accurate readingpossible. Screenshots of the AURORA device were taken at thesame time to demonstrate the dosage that the device was calibratedto deliver in the pulse. |
|---|---|
| Substantial Equivalence: | The Enhanced AURORA™ Medical Diode system and relatedaccessories has the exact same use as the previously clearedAURORA™ (K192411 July 2, 2020). In addition, the EnhancedAURORA™ Medical Diode system and related accessories has theexact indications and principles of operation as the predicate devices,the exact technological characteristics to the AURORA™ (K192411July 2,2020) and very similar technical characteristics to thePhotoMedex XTRACT (K073659 January 2, 2008).Although there are minor differences between the EnhancedAURORA™ Medical Diode system and related accessories and itspredicate devices. Note that the indications for use (IFU's) are notbeing changed, modified, or altered in any fashion from the predicatedevices. Thus, the Enhanced AURORA™ Medical Diode system andrelated accessories is substantially equivalent to the predicatedevices. |
| Conclusion: | In summary, the company's Enhanced AURORA™ Medical Diodesystem and related accessories has the exact same use as thepreviously cleared AURORA™ (K192411 July 2,2020). In addition,the Enhanced AURORA™ Medical Diode system and relatedaccessories has the exact indications and principles of operation asthe predicate devices, and the exact technological characteristics tothe AURORA™ (K192411 July 2,2020) and very similar technicalcharacteristics to the PhotoMedex XTRACT (K073659 January 2,2008). Although there are minor differences between the EnhancedAURORA™ Medical Diode system and related accessories and itspredicate devices as summarized in table below. Note that theindications for use (IFU's) are not being changed, modified, or alteredin any fashion from the predicate devices. Thus, the Enhanced |
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AURORA™ Medical Diode system and related accessories is substantially equivalent to the predicate devices.
| Psoria ShieldEnhancedAURORA™ MedicalDiode system andrelated accessories(K230076) | Psoria ShieldAURORA™(K192411) | PhotoMedexXTRAC Ultra²Excimer LaserSystem, ModelAL10000(K073659) | |
|---|---|---|---|
| Intended Use | The EnhancedAURORA™ andrelated accessoriesis intended to beused for thetreatment ofdermatologicdisorders. | The AURORA isintended to be usedfor the treatment ofdermatologicdisorders. | The intended use istargeted UVBphototherapy fortreatment of theskin conditionsincludingpsoriasis, vitiligo,atopic dermatitis,and leukoderma. |
| Indications for Use | The EnhancedAURORA™ MedicalDiode system andrelated accessoriesis indicated for usein targeted PUVAphotochemistry andUVB phototherapyfor the treatment ofskin conditionsincluding psoriasis,vitiligo, atopicdermatitis, eczema,and seborrheicdermatitis. Inaddition, the systemUVB channel isindicated for thetreatment ofleukoderma. | The AURORAsystem is indicatedfor use in targetedPUVAphotochemistry andUVB phototherapyfor the treatment ofskin conditionsincluding psoriasis,vitiligo, atopicdermatitis (eczema),and seborrheicdermatitis. Inaddition, the systemUVB channel isindicated for thetreatment ofleukoderma. | UVB phototherapyfor psoriasis,vitiligo, atopicdermatitis, andleukoderma. |
| Wavelength | UVA:350-395nmUVB:300-320nm | UVA: 350-395nmUVB:320-320nm | 308nm |
Substantial Equivalence Table Comparing Subject and Predicate Device
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| Maximum Fluenceto Tissue: | Up to 3,400mJ/cm² | Up to 3,400mJ/cm² | 2-3.8 mJ/cm2 |
|---|---|---|---|
| Pulse Duration: | C/W | C/W | Quasi continuousoutput |
| Beam Delivery: | Flexible Fiber Opticand TherapeuticHandpieces | Flexible Fiber Opticand TherapeuticHandpieces | Flexible Fiber Opticand TherapeuticHandpieces |
| Aiming Beam | YES | YES | YES |
| Power Source | 110V wall power | 110V wall power | 110V wall power |
| Dimensions | H: 19 | H:19 | H: 34 |
| D: 14 | D:14 | D: 39 | |
| W: 8 | W: 8 | W:18 | |
| Safety Features | Key lock to preventaccidental energyemission andEmergency stopbutton | Key lock to preventaccidental energyemission andEmergency stopbutton | Key lock to preventaccidental energyemission andemergency stopbutton |
| Weight | 20lbs | 20lbs | 220lbs |
| Accessories | USB-connectedprinter | USB-connectedprinter | NA |
§ 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.