(95 days)
The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).
The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device. It is indicated for use in localized phototherapeutic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories:
- Handheld UV light Emission device that delivers the UVB light
- Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
- Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.
The provided text describes a 510(k) premarket notification for the "Skylit Phototherapy System" (later referred to as "Clarify Medical Phototherapy System"). This device is a handheld UV light treatment system for dermatologic conditions. The submission aims to demonstrate substantial equivalence to previously marketed devices.
Based on the provided document, the device in question is a phototherapy system, not an AI/algorithm-based device. Therefore, the questions related to AI acceptance criteria, sample size for AI test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and training set information are not applicable to this medical device submission.
The acceptance criteria provided focus on the electrical, optical, software, and biocompatibility safety and performance of the phototherapy device. The study proving these criteria are met consists of various performance tests and validations.
Here's a breakdown of the applicable information:
1. A table of acceptance criteria and the reported device performance:
| Element of Comparison | Method for Safety Assessment | Test Result Meet Design Input Specifications and Demonstrate Equivalence | Notes |
|---|---|---|---|
| UBV light Source, Max Power Output | Performance Testing (optical emissions spectrum measured at the treatment surface, biologically weighted emissions curve computed using the International Commission on Illumination accepted erythema curve, optical power at treatment surface measured). Evaluated in accordance with IEC 60601-2-57. | Yes | Verification testing demonstrated weighted peak of emissions within established therapeutic range (300-320nm) and optical power at treatment surface met specified requirements. |
| Power Source | Electrical Safety Testing, Battery Performance Testing. Evaluated in accordance with IEC 60601-1 and IEC 60601-1-4. | Yes | Not explicitly detailed in the provided text beyond "Yes." |
| Prescription Stored on the device | System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | This refers to prescriptions being stored on a cloud server for the subject device, a feature that distinguishes it from some predicate devices. |
| Treatment Reminders | Software Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | This feature is built into the mobile software application. |
| Auto Calculation of treatment adjustment | System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | This capability is built into the software in accordance with the prescribed protocol. |
| Skin Contact Materials | Performance testing. Evaluated for biocompatibility in accordance with ISO 10993-1 (cytotoxicity, sensitization, irritation) as a "surface device" with limited contact duration (< 24 hours). | Yes | The distal end material has been tested to ISO-10993. |
| Wireless communications between handheld and console | System Validation. Compliance with relevant FDA guidance documents for Mobile Medical Applications and Radio Frequency Wireless Technology in Medical Devices. Also, electromagnetic compatibility (EMC) assessed according to IEC 60601-1-2. | Yes | The device uses Bluetooth wireless communication between the handheld unit and the mobile phone software application. |
| Records Retention | System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | Treatment data is stored and uploaded to a server. |
| Remote Physician Review of the results | System Validation. Compliance with relevant FDA guidance documents for software (e.g., Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices) and IEC 62304. | Yes | This feature is enabled by the cloud-based Physician Portal Software. |
| Electrical Safety | Testing to applicable sections of IEC 60601-1 and IEC 60601-1-4. | Not explicitly stated as a row in Table 2, but mentioned in "Standards and Guidance Documents" section. | Not explicitly detailed beyond "Yes." |
| Software and Wireless Safety | Review and compliance with FDA guidance documents: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Mobile Medical Applications, Radio Frequency Wireless Technology in Medical Devices. Consideration of IEC 62304. | Covered by System Validation | Not explicitly detailed beyond "Yes." |
| Electromagnetic Compatibility (EMC) | Assessed according to IEC 60601-1-2. | Covered by Wireless Communications validation | Not explicitly detailed beyond "Yes." |
| Human Factors/Usability | Formative studies and software validation. Compliance with IEC 62366 to be verified by an independent third party prior to marketing. | Will be confirmed | The document states: "Clarify medical will not market the device until compliance with IEC 62366: Medical devices – Application of usability engineering to medical devices is verified by an independent third party." This is a pre-market condition. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on performance testing and comparison to predicate devices, not a clinical study with a test set of patient data as might be used for an AI/algorithm-based device.
- Data Provenance: Not applicable. The "data" here refers to engineering test results and compliance with medical device standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as understood in the context of AI (e.g., expert labels on medical images) is not relevant for this device's testing. Safety and performance are established through engineering and systems validation against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no external "test set" requiring adjudication.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI or algorithm-only device. It's a hardware device with associated software to manage its function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Ground Truth: For this type of device, "ground truth" relates to compliance with engineering and safety standards. Examples include:
- Optical Emissions: Measured values against specified therapeutic ranges (300-320nm).
- Electrical Safety: Compliance with IEC 60601-1 standards.
- Software Functionality: Validation against design input specifications and recognized software lifecycle processes (IEC 62304) and FDA guidance for medical device software.
- Biocompatibility: Results of cytotoxicity, sensitization, and irritation tests against ISO 10993 standards.
- These are objective, measurable criteria, not subjective interpretations requiring expert consensus as in AI image analysis.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W O66-G609 Silver Spring, MD 20993-0002
May 23, 2017
Skylit Medical Don Canal Vice President 401 North A Street Suite 775 San Diego, California 92101
Re: K170489
Trade/Device Name: Skylit Phototherapy System Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: February 22, 2017 Received: February 23, 2017
Dear Don Canal:
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 Actinclude 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
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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely, Jennifer R. Stevenson -S
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K170489
Device Name Clarify Medical Phototherapy System
Indications for Use (Describe)
The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical Device. It is intended for use in localized phototheraputic treatment of dermatologic conditions such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and lenkoderma on all skintypes (I-VI).
| 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" as required by section 807.92(c)
| Date Prepared: | May 22, 2017 |
|---|---|
| Manufacturer Name | Clarify Medical, Inc.401 N. A Street, Suite 775San Diego, CA 92101, USATelephone: (972) 955-7644 |
| Official Contact | Don CanalRegulatory Affairs401 N. A StreetSan Diego, CA 92101, USATelephone:(972) 955-7644Email: don@clarifymed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Clarify Phototherapy System |
|---|---|
| Common Name | Light, Ultraviolet, Dermatological |
| Classification NameClassification Regulations | Ultraviolet lamp for dermatologic disorders21 CFR878.4630Class II |
| Product Code | FTC |
| Submission Type | 510(k) |
| Classification PanelPremarket Review | General & Plastic SurgeryODE/DSD/General Surgery Devices Branch One(GSDB1) |
Predicate Devices
The Clarify System is substantially equivalent to the other legally marketed phototherapy, UVB treatment devices. Specifically, the Clarify Phototherapy System is substantially equivalent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097), Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035).
Device Description
The Clarify Phototherapy System is a handheld medical device that produces UVB light for the purpose of phototherapy. It was developed and will be marketed by Skylit Medical, Inc. DBA Clarify Medical, Inc. and is referred to herein as "Clarify Medical" or "Clarify". The Clarify Medical Phototherapy System is an Ultraviolet Light Emitting Medical device.
It is indicated for use in localized phototherapeutic treatment of dermatologic conditions
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such as psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis and leukoderma on all skin types (I-VI). The system consists of the following components and accessories:
- Handheld UV light Emission device that delivers the UVB light 1.
-
- Mobile Software Application that runs on smartphone (Android and iOS) platforms. This Application is the primary user interface, and provides patient guidance when phototherapy is delivered and treatment reminders
-
- Physician Portal Software is a cloud based software application that links the patient to the prescribing physician during home therapy.
Federal (U.S.) law restricts this device to sale by or on the order of a physician.
The Clarify System delivers UV light between the wavelengths of 300 and 320 nm using Light Emitting Diodes (LEDs). The handheld device is powered by a rechargeable battery and is connected to a smartphone software application that enables the device and provides feedback during treatment. The smartphone also provides reminders on treatment days and provides a means for patient feedback and dose adjustment. The smartphone application also provides the means for the patient to take photographs for comparison purposes.
Indications for Use Statement
The system is indicated for the treatment of psoriasis, vitiligo, atopic dermatitis (eczema). seborrheic dermatitis and leucoderma on all skin types (I-VI). The device can be used in the comfort of a patient's home or in a physician's office.
Comparison to Predicate Devices
The Clarify System is substantially equivalent to the other legally marketed phototherapy, UVB treatment devices. Specifically, the Clarify Phototherapy System is substantially equivalent to the Lerner Medical Inc. Levia Phototherapy System (K040062/K090097). Daavlin Distributing Co. DermaPal (K073587) and Allux, Inc. Resolve UVB Phototherapy System (K072035). The detailed comparison between the Subject Device and the Predicate devices is provided in Table 1 below.
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| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
|---|---|---|---|---|
| Clarify MedicalPhototherapy System(Subject Device) | Lerner MedicalDevices, Inc.Levia PhototherapySystem / LH-75TPhototherapySystemK040062 / K090097 | Daavlin DistributingCo.DermaPal K073587 | AlluxResolveUVBPhototherapy SystemK072035 | |
| Image: Clarify Medical Phototherapy System | Image: Levia Phototherapy System | Image: DermaPal K073587 | Image unavailable | |
| Indicationsfor Use | The Clarify MedicalPhototherapy System isan Ultraviolet LightEmitting Medicaldevice. It is intendedfor use in localizedphototherapeutictreatment ofdermatologicconditions such aspsoriasis, vitiligo,atopic dermatitis(eczema), seborrheicdermatitis andleukoderma on all skintypes (I-VI). | K040062: The LeviaPhototherapy System isintended for use inUVB phototherapy forthe treatment ofpsoriasis, vitiligo,atopic dermatitis(eczema), seborrheicdermatitis andleucoderma. The LeviaPhototherapy System isintended for use on allskin types (I-VI).K090097: The LH-75TPhototherapy System isintended for use, by orunder the direction of aphysician, in UVBphototherapy for thetreatment of psoriasis,vitiligo, atopicdermatitis (eczema),seborrheic dermatitisand leucoderma. TheLH-75T PhototherapySystem is intended foruse on all skin types (I-VI). | The DermaPal® is ahandheld ultravioletlight emittingfluorescent lamp. It isintended for use, by orunder the direction of aphysician, for thetreatment of psoriasis,vitiligo, and atopicdermatitis (eczema) onall skin types (I - VI). | The Resolve™ UVBPhototherapy System isan ultraviolet lightemitting medical devicefor localizedphototherapeutictreatment ofdermatologic conditionssuch as psoriasis,vitiligo, atopicdermatitis (eczema),and seborrheicdermatitis. TheResolve™ UVBPhototherapy System isintended to be usedwith all Skin Types (I -VI). |
| Product Codes/ RegulationNumber | FTC / 21 CFR878.4630 | FTC / 21 CFR878.4630 | FTC / 21 CFR878.4630 | FTC / 21 CFR878.4630 |
| Treatmentarea | $4.5 cm^2$ | $3 cm^2$ | 11.4 x 2.54 cm | 12.8 x 9.0 cm |
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
| Clarify MedicalPhototherapy System(Subject Device) | Lerner MedicalDevices, Inc.Levia PhototherapySystem / LH-75TPhototherapySystemK040062 / K090097 | Daavlin DistributingCo.DermaPal K073587 | AlluxResolveUVBPhototherapy SystemK072035 | |
| UVB lightsource | LED UV lamps | Arc Lamp | Fluorescent UV lamps | LED UV lamps |
| UserInterface | Touch screen onMobile Device andStart button on | Control Box withcables to handhelddevice | Control Box withcables to handhelddevice | Control Box withcables to handhelddevice |
| Max PowerOutput | 3-15 mW/cm2 | 90-100 mW/ cm2 | 3.9-6.8 mW/ cm2 | 1 mW/cm2 |
| UV lightWavelength | 300-320 nm | 300-320 nm | 300-320 nm | 300-320nm |
| Mode ofoperation | Hand piece used withwireless connectionto mobile phone | Hand piececonnected to consolewith touch screencontrol panel tocontrol treatment | Hand piece used instandalone treatmentmode | Patient attachedunit connectedto a powersupply used instandalonetreatment mode |
| Physicianprovides dosinginstructions andphysician canadjust time/dosebased on | Physician providesdosing instructionsand patient canadjust time/dosebased on treatmentoutcome | Physician providesdosing instructionsand patient canadjust time/dosebased on treatmentoutcome | Unknown | |
| Increase UVBtreatment Doseafter eachtreatment | Yes, thiscapability is builtinto the SW inaccordance withthe prescribedprotocol. | Yes, this capabilityis built into the SWin accordance withthe prescribedprotocol. | Instructions areprovided in theDFU. Not built intothe the SW, thepatient mustmanually calculateand enter the dose. | Unknown |
| Deliverymethod | Spot treatment window | Spot treatment attachment(LiteSpot™), Quartz fiber-optic brush attachment(LiteBrush™) | Spot treatment wand withintegrated comb | Spot treatment window |
| PowerSource | Rechargeable battery | AC outlet | AC outlet | AC outlet |
| Prescriptionstored onDevice | Yes - Cloud server | Yes - USB | No | No |
| ScalpAttachment | No | Yes | Yes | No |
| UseEnvironme | Home / Physician'soffice | Home / Physician'soffice | Home / Physician'soffice | Home / Physician'soffice |
| Subject Device | Predicate Device | Predicate Device | Predicate Device | |
| Clarify MedicalPhototherapy System(Subject Device) | Lerner MedicalDevices, Inc.Levia PhototherapySystem / LH-75TPhototherapySystemK040062 / K090097 | Daavlin DistributingCo.DermaPal K073587 | AlluxResolveUVBPhototherapy SystemK072035 | |
| IPX -Rating/waterResistance | Not water resistant | Not water resistant | Not water resistant | Not water resistant |
| Communicationsbetween | Bluetooth wireless | Wired connection | Wired connection | Wired connection |
| Recordsretentionand remotephysicianreview ofresults. | Yes. Treatment data isstored and uploaded toServer for remotereview | Yes. Treatment data isstored locally on thedevice. no remotereview of data ispossible | No record retentioncapability | No record retentioncapability |
| Treatmentday/Timereminderset by User | Yes | No | No | No |
| Timer tocontroltreatmentduration | Yes - stored in theSoftware, based onPrescription | Yes - entered by theuser for each treatment | Yes - entered by theuser for each treatment | Yes - entered by theuser for each treatment |
| TargetPopulation | Patients and clinicians | Patients andclinicians | Patients andclinicians | Patients andclinicians |
Table 1 – Predicate Comparison Table
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Summary of Performance Data – Bench
The determination of substantial equivalence is based on an assessment of non-clinical performance data. Table 2 below contains a summary of the performance testing that was submitted, referenced, or relied on in the premarket notification submission to determine substantial equivalence and how their results support a determination of substantial equivalence.
| Element of Comparison | Method for SafetyAssessment | Test Result MeetDesign InputSpecifications andDemonstrateEquivalence |
|---|---|---|
| UBV light Source, Max PowerOutput | Performance Testing | Yes |
Table 2 – Performance Test Summary
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| Element of Comparison | Method for SafetyAssessment | Test Result MeetDesign InputSpecifications andDemonstrateEquivalence |
|---|---|---|
| Power Source | Electrical Safety Testing,Battery PerformanceTesting | Yes |
| Prescription Stored on the device | System Validation | Yes |
| Treatment Reminders | Software Validation | Yes |
| Auto Calculation of treatmentadjustment | System Validation | Yes |
| Skin Contact Materials | Performance testing | Yes |
| Wireless communications betweenhandheld and console | System Validation | Yes |
| Records Retention | System Validation | Yes |
| Remote Physician Review of theresults | System Validation | Yes |
Performance Test Conclusion
Based on technical comparison, the Subject device has been shown to be equivalent to the predicate devices.
Standards and Guidance Documents
Optical emissions testing:
Clarify has verified that optical emissions within the 300-320nm range is equivalent to that of the predicate devices. With the LEDs switched on, the optical emissions spectrum is measured at the treatment surface. The biologically weighted emissions curve is then computed using the International Commission on Illumination accepted erythema curve. Clarify has completed verification testing to demonstrate that the weighted peak of emissions is within the established therapeutic range (300-320nm). The optical power at the treatment surface is also measured to ensure it meets the specified requirements. The device has been evaluated for safety and performance in accordance with IEC 60601-2-57 Medical electrical equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use.
Electrical safety:
Clarify has completed testing to the applicable sections of IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, and IEC 60601-1-4 Medical electrical equipment – Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems.
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Software and wireless safety:
Due to the software component and wireless functionality of the device. Clarify will review and comply with the following FDA guidance documents: Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Issued 5/11/2005), Guidance for Industry and FDA Staff: Mobile Medical Applications (Issued 9/25/2013), and Guidance for Industry and FDA Staff: Radio Frequency Wireless Technology in Medical Devices (Issued 8/13/2013). The following standard has been considered when evaluating the software: IEC 62304: Medical device software - Software life cycle processes.
Electromagnetic compatibility (EMC):
Since the system includes electronics, EMC has been assessed according to IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances.
Biocompatibility:
The distal end of the Clarify Phototherapy System will have limited contact duration (< 24 hours) with skin and is therefore considered a "surface device" according to Annex A of ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process. Based on the device type and contact duration, FDA Blue Book Memorandum #G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," recommends the following biocompatibility tests be performed: cytotoxicity, sensitization, and irritation. The Clarify Device distal end material has been tested to ISO-10993.
Human factors:
Clarify medical has completed numerous formative studies and software validation of the Clarify System. Clarify medical will not market the device until compliance with IEC 62366: Medical devices – Application of usability engineering to medical devices is verified by an independent third party.
§ 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.