The AURORA system 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.

Device Description

The Psoria-Shield AURORA system delivers UVA or UVB phototherapy to target skin areas through one of two handpieces. The handpieces are connected to a base unit which uses an air cooling system to maintain system temperature, and has a built-in touchscreen to operate the device.

AI/ML Overview

This document is a 510(k) summary for the Psoria-Shield AURORA system, a medical device for phototherapy. It asserts substantial equivalence to a predicate device (Psoria-Shield PS1000). The information provided focuses on the device's design, intended use, and safety compliance, rather than comprehensive performance studies with acceptance criteria in the context of clinical efficacy or diagnostic accuracy that would typically involve statistical metrics.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the format of predefined thresholds for clinical or diagnostic performance metrics. Instead, it describes compliance with safety and electrical standards and consistency of energy output.

Acceptance Criterion (Implicit)	Reported Device Performance
Energy Output Consistency	Performance testing using pre-production AURORA systems demonstrated that the energy levels output from each handpiece are consistent with user-defined energy levels.
Electrical Safety (IEC 60601-1:2005+A1:2012)	Successfully performed on production devices.
Electromagnetic Disturbances (IEC 60601-1-2:2014)	Successfully performed on production devices.
Basic Safety and Essential Performance (IEC 60601-2-57)	Successfully performed on production devices.
Photobiological Safety (IEC 62471:2009)	Successfully performed.
Software Development & Testing (IEC 62304)	Executed in compliance.
Risk Management (ISO 14971)	Executed in compliance.
Substantial Equivalence to Predicate	The AURORA system has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate PS1000 system. Performance data demonstrates that the AURORA system is as safe and effective as the predicate PS1000 system.
New Questions of Safety or Effectiveness (Design Changes)	Minor differences (air cooling, operating system, separate handpieces) do not raise any new questions of safety or effectiveness.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "pre-production AURORA systems" and "production devices" for performance and safety testing. However, it does not specify the sample size (e.g., number of devices or test cycles) used for these tests. There is no information regarding the data provenance (e.g., country of origin, retrospective/prospective). This device is a phototherapy device, not a diagnostic one, so traditional "test sets" for diagnostic accuracy are not applicable here.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable to this submission. The device is a phototherapy system, not an AI/diagnostic device that requires expert-established ground truth for performance evaluation in the context of a 510(k) submission. Its safety and operational characteristics are evaluated against engineering and medical device standards.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3. There is no "test set" in the diagnostic context requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

This information is not applicable. The AURORA system is a phototherapy device, not a diagnostic AI system where MRMC studies comparing human readers with and without AI assistance would be relevant. The submission focuses on device safety and operational equivalence to a predicate.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This information is not applicable. The AURORA is a physical phototherapy device, not an algorithm. Its operation involves a human user selecting settings and applying treatment.

7. The Type of Ground Truth Used

The concept of "ground truth" (expert consensus, pathology, outcomes data) typically applies to diagnostic or prognostic AI devices. For this phototherapy device, the "truth" is established by:

Compliance with recognized electrical and safety standards (IEC 60601 series, IEC 62471).
Measurement of physical outputs (energy levels) against defined specifications.
Substantial equivalence to a legally marketed predicate device, implying its safety and effectiveness have been previously established.

8. The Sample Size for the Training Set

This information is not applicable. The AURORA system is a hardware device; there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reasons as #8.

Summary

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July 2, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below it.

Psoria-Shield John Yorke General Manager 409 Mandeville St Utica, New York 13502

Re: K192411

Trade/Device Name: Psoria-Shield AURORA Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: June 1, 2020 Received: June 3, 2020

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/cfpmp/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 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

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,

Colin Kejing Chen 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 Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120
Indications for Use	Expiration Date: 06/30/2020See PRA Statement on last page

510(k) Number (if known)	K192411
Device Name	AURORA™
Indications for Use (Describe)	The AURORA system 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.
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

Psoria-Shield Inc's AURORA System

Manufacturer:	Psoria-Shield Inc.409 Mandeville StUtica, NY 13502, USA
Phone:	866 991 9547
Contact Person:	John Yorke
Date Prepared:	July 1, 2020
Trade Name:	Aurora
Common or Usual Name:	Ultraviolet lamp for dermatologic disorder

Classification Name: Light, Ultraviolet, Dermatological

Predicate Device

Psoria-Shield Inc's PS1000 (K103540, cleared 2011)

Purpose of the Special 510(k) Notice

The AURORA is a modification to Psoria-Shield's existing PS1000 system. Psoria-Shield has redesigned the unit to perform the same function.

Indications For Use

Device Description

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Technological Characteristics

The AURORA system is a modified version of the PS1000 predicate device, and has similar technological characteristics. It uses the same energy source to deliver a UVA or UVB phototherapy to a

2.88 cm² target surface area.

Changes in design from the PS1000 include the following:

An air-cooling system to prevent overheating of the system during use O
Separate handpieces to deliver UVA or UVB light O
An integrated touchscreen running on Linux operating system O
Removal of the built-in camera due to lack of customer interest O
A USB printer port has been added with software functionality allowing patient O treatment data to be printed out for record keeping.

Summary Of Performance Data

Performance testing using pre-production AURORA systems demonstrated that the energy levels output from each handpiece are consistent with user-defined energy levels.

Electrical Safety Testing was successfully performed on production devices to show compliance to the following standards:

IEC 60601-1:2005+A1:2012 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
IEC 60601-1-2:2014 General requirements for basic safety and essential performance --Collateral Standard: Electromagnetic disturbances - Requirements and tests
-IEC 60601-2-57 Medical Electrical Equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

UV Safety Testing was successfully performed to show compliance to IEC 62471:2009 Photobiological Safety of lamps and lamp systems.

Software Verification: The software development and testing were executed in compliance to IEC 62304 Medical device software - Software life cvcle processes and ISO 14971 Medical devices - Application of risk management to medical devices.

Substantial Equivalence

The AURORA system has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate PS1000 system. As shown in the table below, the minor differences in the air cooling, operating system, addition of separate handpieces to deliver UVA or UVB phototherapy do not raise any new questions of safety or effectiveness. Performance data demonstrates that the AURORA system is as safe and effective as the predicate PS1000 system. Thus, the AURORA system is substantially equivalent to its predicate device.

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	Psoria-Shield Modified Device(Aurora)	Psoria-Shield cleared PS1000
Intended Use	The AURORA is intended to be used for the treatment of dermatologic disorders.	The PS1000 is intended to be used for the treatment of dermatologic disorders.
Indications for Use	The Psoria-Light Model AURORA 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 Psoria-Light Model PS1000 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.
Components	Base stationTouchscreen/GUITwo handpieces	Base stationTouchscreen/GUIHandpiece
Operating System	Linux Ubuntu	Windows XP
Safety Features	Key lock to prevent accidental energy emission.	Key lock to prevent accidental energy emission.
Power Source	110V wall power	110V wall power
Dimensions	19" (W) x 14" (L) x 8" (H)	17.5" (W) x 22" (L) x 18" (H)
Weight	12lbs	60lbs
Accessories	USB-connected printer	None
Available Wavelengths	UVA (350 – 395nm)UVB (300 – 320nm)	UVA (350 – 395nm)UVB (300 – 320nm)
Minimum Power (UVA)	0.1 J/cm²	0.4 J/cm²
Maximum Power (UVA)	3.4 J/cm²	5.0 J/cm²
Minimum Power (UVB)	0.1 J/cm²	0.015 J/cm²
Maximum Power (UVB)	3.4 J/cm²	3.120 J/cm²
Treatment Area	2.88cm²	2.88cm²
Handpiece design	Two handpieces. One handpiece only emits UVA light; the other only emits UVB light. User selects which handpiece to use from the touchscreen.	One handpiece that can emit either UVA or UVB light. The user selects which type from the touchscreen.
Camera	No camera.	Camera integrated into handpiece and displayed on tablet.
Keylock feature	Any light emission requires keylock to be turned to an 'on' position.	Any light emission requires keylock to be turned to an 'on' position.

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Conclusions

Based on the test results, the similar indications for use, and the similar technological characteristics, the AURORA is considered to be substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.