(89 days)
The M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatiis (eczema) under the direction of a physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.
The M Series Phototherapy Devices are intended to be used as a partial body therapeutic device. They are designed to be used under the direction of a physician for individuals who require phototherapy. Treatments are controlled through the ClearLink Software interface or the Smart Touch Software interface. Access to the interface and stored information is restricted to individuals who have been established by the physician as authorized operators. Authorized operators program treatments in joules or millijoules based on established treatment protocols governed by the patient's skin type, condition, minimum erythemal dose (M.E.D.), and treatment frequency.
This document is a 510(k) Premarket Notification from the FDA regarding the "M Series Phototherapy Equipment." It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance studies with acceptance criteria for a new, innovative device.
Therefore, the requested information regarding acceptance criteria, specific performance metrics, sample sizes, expert involvement, and ground truth establishment, which are typical for studies validating the performance of a novel diagnostic or AI-driven device, is not present in this document.
The document indicates that the M Series Phototherapy Equipment's performance data is "the same as or very similar to that of the claimed predicate device." It also states that the lamps and construction are the same, and the primary difference is an updated indication for use and intended use. This implies that the device is not being evaluated for new performance outcomes requiring extensive clinical studies with specific acceptance criteria that would typically be detailed in a submission for a novel technology. Instead, it relies on the established safety and effectiveness of its predicate devices.
Based on the provided text, the following information can be extracted/inferred:
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A table of acceptance criteria and the reported device performance:
- This document does not specify quantitative acceptance criteria or detailed performance metrics for the M Series Phototherapy Equipment itself. The basis for clearance is substantial equivalence to predicate devices.
- Implied "Performance": The document states: "The M Series phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The lamps and construction used in the production of the predicate devices and the M Series phototherapy equipment are the same." This implies that its performance is accepted as equivalent to the predicates (ClearLink Controlled Phototherapy Equipment K182215 & 1 Series Phototherapy Unit K100378).
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Sample size used for the test set and the data provenance:
- No specific "test set" or associated sample size is mentioned, as this is not a study validating a new performance claim. The submission relies on a comparison to predicate devices, not on new clinical data demonstrating specific performance numerically.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no new test set requiring expert ground truth establishment for a novel performance claim is described.
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Adjudication method for the test set:
- Not applicable.
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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 phototherapy equipment, not an AI or diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as new performance claims requiring ground truth establishment are not the basis of this submission. The "ground truth" for its safety and effectiveness is implicitly derived from the previously cleared predicate devices.
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The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
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How the ground truth for the training set was established:
- Not applicable.
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June 22, 2021
Daavlin Distributing Co. Michele Thiel Senior Regulatory Affairs Specialist 205 W. Bement Street Bryan, Ohio 43506
Re: K210881
Trade/Device Name: M Series Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp For Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: March 22, 2021 Received: March 25, 2021
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.
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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 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 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.
Purva Pandya 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)
K210881
Device Name
M Series Phototherapy Equipment
Indications for Use (Describe)
The M Series Phototherapy Devices are indicated for use to treat diagnosed skin disorders such, as but not limited to, psoriasis, vitiligo, and atopic dermatiis (eczema) under the direction of a physician will determine the light spectrum (ultraviolet to visible), the energy or duration of the treatment, as well as the treatment environment. The population may range from pediatric, when accompanied by a responsible adult to operate it, to geriatric.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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K210881 510(K) Summary:
| Date of Summary: | March 22, 2021 |
|---|---|
| 510(k) Submitter: | Daavlin Distributing Company |
| Contact Person: | Michele ThielSenior Regulatory Specialist/Management RepresentativeDaavlin Distributing Company205 West Bement StreetP.O. Box 626Bryan, Ohio 43506Phone: (419) 636-6304 Ext. 207Fax: (419) 636-1739Email: mthiel@daavlin.com |
| Trade Name: | M Series Phototherapy Equipment |
| Common Name: | Phototherapy Equipment |
| 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: | ClearLink Controlled Phototherapy Equipment & 1 SeriesPhototherapy Unit |
| 510(k) Numbers: | K182215 & K100378 |
| Product Code: | FTC |
| Company: | Daavlin Distributing Company |
| Device Description: | The M Series Phototherapy Devices are intended to be used as apartial body therapeutic device. They are designed to be usedunder the direction of a physician for individuals who requirephototherapy.Treatments are controlled through the ClearLink Softwareinterface or the Smart Touch Software interface. Access to theinterface and stored information is restricted to individuals whohave been established by the physician as authorized operators.Authorized operators program treatments in joules or millijoulesbased on established treatment protocols governed by thepatient's skin type, condition, minimum erythemal dose (M.E.D.),and treatment frequency. |
| Indications for Use: | The M Series Phototherapy Devices are indicated for use to treatdiagnosed skin disorders such, as but not limited to, psoriasis,vitiligo, and atopic dermatitis (eczema) under the direction of aphysician. The physician will determine the light spectrum(ultraviolet to visible), the energy or duration of the treatment, aswell as the treatment environment. The population may rangefrom pediatric, when accompanied by a responsible adult tooperate it, to geriatric. |
| Intended Use: | The M Series Phototherapy Devices are intended to be used as apartial body therapeutic device. They are designed to be usedunder the direction of a physician for individuals who requirephototherapy. |
| Predicate Comparison: | The M Series phototherapy equipment is constructed in the samedesign configuration as the predicate devices, utilizing identicalenergy sources and materials of identical or similar composition.The spectral output, mode of operation, labeling, treatment area,treatment modality, patient safety, and general operatingprincipals of the M Series phototherapy equipment are the sameor similar to those of the predicate devices. The only differencebetween the predicate devices and the M Series phototherapydevice is the updated indication for use and intended use. |
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| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Features | M SeriesPhototherapyEquipment | 1 Series PhototherapyUnit | ClearLinkPhototherapyEquipment |
| 510(k)Number | This Submission | K100378 | K182215 |
| Indications forUse | The M SeriesPhototherapy Devicesare indicated for use totreat diagnosed skindisorders such, as butnot limited to, psoriasis,vitiligo, and atopicdermatitis (eczema)under the direction of aphysician. Thephysician willdetermine the lightspectrum (ultraviolet tovisible), the energy orduration of thetreatment, as well as thetreatment environment.The population mayrange from pediatric,when accompanied by aresponsible adult tooperate it, to geriatric. | The 1 Series Unit is atherapeutic productdesigned forindividuals who requireultraviolet radiation fordiagnosed skindisorders. The 1 Series,equipped with PL-L36W/03 Blue lamps,is indicated for thetreatment of mild tomoderate acne vulgaris. | The ClearLinkControlledPhototherapyEquipment are medicalultraviolet devices,which are intended foruse, by or under thedirection of aphysician, fortherapeutic treatmentfor individuals whorequire ultravioletradiation for diagnosedskin disorders.When equipped withblue lamps theClearLink ControlledPhototherapyEquipment is intendedfor use for thetreatment of mild tomoderate acne vulgaris. |
| Prescriptive | Yes | Yes | Yes |
| PatientPopulation | Pediatric to Geriatric | Dermatology Patients | Pediatric to Geriatric |
| PatientContact | Patient comes in directcontact with the acrylicwhen placing hands orfeet inside fortreatment. | There is no directpatient contact requiredduring treatment, but ifprescribed patient canplace hands directly onthe acrylic. | There is no directpatient contact with thedevice during treatment– Areas of skin areexposed to controlledultraviolet and bluelamp radiation from adistance ofapproximately 9 inches(22.86 cm) away. |
| AnatomicalSites | Topical skin treatment | Topical skin treatment | Topical skin treatment |
| Subject Device | Predicate Device | Predicate Device | |
| Features | M SeriesPhototherapyEquipment | 1 Series PhototherapyUnit | ClearLinkPhototherapyEquipment |
| 510(k)Number | This Submission | K100378 | K182215 |
| ApplicationEnvironment | Hospital, Clinic,Medical Center, PrivateMedical Practice, orother environmentunder the direction of aphysician. | Medical Office orunder direction ofphysician | Hospital, Clinic,Medical Center, PrivateMedical Practice, orOther ProfessionalMedical Environmentsunder direction ofphysician |
| Materials | Assembled componentshoused in metal framewith reflective internalsurfaces and fluorescentlamps | Assembled componentshoused in plastic case | Assembled componentshoused in metal framewith reflective internalsurfaces andfluorescent lamps |
| ManufacturingMethods | Identical | Identical | Identical |
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| Performance Standards: | The M Series phototherapy equipment performance data is thesame as or very similar to that of the claimed predicate device.The lamps and construction used in the production of thepredicate devices and the M Series phototherapy equipment arethe same. The only difference between the predicate devices andthe M Series devices is the updated indication for use andintended use. The rest of the devices (materials, construction,treatment modality, patient safety, etc., remains exactly the sameor similar. |
|---|---|
| Conclusion: | On the basis of the information provided in this Summary, theDaavlin Distributing Company believes the M Seriesphototherapy equipment is substantially equivalent to the legallycommercialized predicate device. |
§ 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.