(75 days)
No
The summary describes a phototherapy device with software control for treatment parameters, but there is no mention of AI or ML being used for diagnosis, treatment planning, or any other function. The treatment parameters are programmed by authorized operators based on established protocols.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended for use... for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders."
No
The device is described as therapeutic equipment for skin disorders, not for diagnosing them. Its purpose is to deliver ultraviolet radiation treatment, not to identify or characterize medical conditions.
No
The device description explicitly states "The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices" and describes delivering treatment with "Narrow Band UVB, Broad Band UVB and/or UVA ultraviolet light," indicating it is a hardware device that emits light, controlled by software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders." This is a treatment modality, not a diagnostic one.
- Device Description: The description reinforces the therapeutic nature, explaining how it delivers UV light for treatment based on established protocols.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (blood, tissue, etc.) or to provide information for the diagnosis of a condition. IVDs are designed to perform tests on samples to aid in diagnosis.
Therefore, the ClearLink Controlled Phototherapy Equipment is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.
Product codes
FTC
Device Description
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. The ClearLink Phototherapy Equipment delivers treatment, with Narrow Band UVB, Broad Band UVB and/or UVA ultraviolet light.
Treatments are controlled through the ClearLink Software interface. Access to this interface and stored information is restricted to individuals who have been established by the physician as authorized operators. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Topical skin treatment
Indicated Patient Age Range
Pediatric to Geriatric
Intended User / Care Setting
Hospital, Clinic, Medical Center, Private Medical Practice, or Other Professional Medical Environments under direction of physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The ClearLink controlled phototherapy equipment performance data is the same as or very similar to that of the claimed predicate device. The ultraviolet light tubes and cabinet construction used in the production of the predicate device and the ClearLink controlled phototherapy equipment are the same. The only difference between the predicate flex devices and the link devices is the substitution of the link controller for the flex controller for actual entry of doses. The rest of the devices (materials, construction, treatment modality, patient safety, etc., remains exactly the same.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Daavlin Distributing Company Michele Thiel Management Representative 205 West Bement Street P.O. Box 626 Bryan, Ohio 43506
October 29, 2018
Re: K182215
Trade/Device Name: ClearLink Controlled Phototherapy Equipment Regulation Number: 21 CFR 878.4630 Regulation Name: Ultraviolet Lamp for Dermatologic Disorders Regulatory Class: Class II Product Code: FTC Dated: August 13, 2018 Received: August 15, 2018
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 mav, 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 avare 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
1
requirements, including, but not limited to: registration and listing (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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Neil R Ogden -S 2018.10.29 09:04:00 -04'00'
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) K182215
Device Name
ClearLink Controlled Phototherapy Equipment
Indications for Use (Describe)
The ClearLink Controlled Phototherapy Equipment are medical ultraviolet devices, which are intended for use, by or under the direction of a physician, for therapeutic treatment for individuals who require ultraviolet radiation for diagnosed skin disorders. When equipped with blue lamps the ClearLink Controlled Phototherapy Equipment is intended for use for the treatment of mild to moderate acne vulgaris.
| 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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E. 510(K) Summary:
| Date of Summary: | October 26, 2018 |
|---|---|
| 510(k) Submitter: | Daavlin Distributing Company |
| Contact Person: | Michele Thiel |
| Management Representative | |
| Daavlin Distributing Company | |
| 205 West Bement Street | |
| P.O. Box 626 | |
| Bryan, Ohio 43506 | |
| Phone: (419) 636-6304 Ext. 207 | |
| Fax: | |
| (419) 636-1739 | |
| Email: mthiel@daavlin.com | |
| Trade Name: | ClearLink Controlled Phototherapy Equipment |
| 510(K) Number: | K182215 |
| Common Name | Ultraviolet 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: | Flex Controlled Phototherapy Equipment & 1 Series |
| 510(k) Numbers: | K050695 & K100378 |
| Product Code: | FTC |
| Company: | Daavlin Distributing Company |
| Device Description: | The ClearLink Controlled Phototherapy Equipment are medical |
| ultraviolet devices, which are intended for use, by or under the | |
| direction of a physician, for therapeutic treatment for individuals who | |
| require ultraviolet radiation for diagnosed skin disorders. The ClearLink | |
| Phototherapy Equipment delivers treatment, with Narrow Band UVB, | |
| Broad Band UVB and/or UVA ultraviolet light. |
Treatments are controlled through the ClearLink Software interface.
Access to this interface and stored information is restricted to
individuals who have been established by the physician as authorized
operators. 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. |
| Indications for Use: | The ClearLink Controlled Phototherapy Equipment are medical
ultraviolet devices, which are intended for use, by or under the
direction of a physician, for therapeutic treatment for individuals who
require ultraviolet radiation for diagnosed skin disorders. When
equipped with blue lamps the ClearLink Controlled Phototherapy
Equipment is intended for use for the treatment of mild to moderate
acne vulgaris. |
| Predicate Comparison: | The ClearLink controlled phototherapy equipment is constructed in the
same design configuration as the predicate device, utilizing identical
energy sources (UV lamps) and materials of identical composition. The
ClearLink controlled devices vary from the predicate device, in that the
control system hardware and software of the ClearLink control has been
updated to utilize current technology. The intended use, general and
specific indications for use, spectral output, mode of operation,
labeling, treatment area, and general operating principals of the
ClearLink controlled equipment are the same or similar to those of the
predicate device. The only difference between the predicate flex
devices and the link devices is the substitution of the link controller for
the flex controller for actual entry of doses. The rest of the devices
(materials, construction, treatment modality, patient safety, etc.,
remains exactly the same. |
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| Features | Subject Device | Predicate Device |
|---|---|---|
| ClearLink Phototherapy Equipment | Flex Controlled Phototherapy | |
| Equipment | ||
| 510(k) Number | This Submission | K050695 & K100378 |
| Indications for | ||
| Use | The ClearLink Controlled | |
| Phototherapy Equipment are | ||
| medical ultraviolet devices, which | ||
| are intended for use, by or under | ||
| the direction of a physician, for | ||
| therapeutic treatment for | ||
| individuals who require ultraviolet | ||
| radiation for diagnosed skin | ||
| disorders. | ||
| When equipped with blue lamps | ||
| the ClearLink Controlled | ||
| Phototherapy Equipment is | ||
| intended for use for the | ||
| treatment of mild to moderate | ||
| acne vulgaris. | The Flex Controlled Phototherapy | |
| Equipment are ultraviolet emitting | ||
| medical light sources, which are | ||
| intended for use by or under the | ||
| direction of a licensed physician for the | ||
| treatment of psoriasis, vitiligo, and | ||
| atopic dermatitis (eczema) on all skin | ||
| types (I-VI). | ||
| When equipped with blue lamps the | ||
| Series-1 Phototherapy Equipment is | ||
| intended for use for the treatment of | ||
| mild to moderate acne vulgaris. | ||
| Prescriptive | Yes | Yes |
| Patient | ||
| Population | Pediatric to Geriatric | Pediatric to Geriatric |
| Patient Contact | There is no direct patient contact | |
| with the device during treatment | ||
| – Areas of skin are exposed to | ||
| controlled ultraviolet and blue | ||
| lamp radiation from a distance of | ||
| approximately 9 inches (22.86 | ||
| cm) away. | There is no direct patient contact with | |
| the device during treatment - Areas of | ||
| skin are exposed to controlled | ||
| ultraviolet radiation from a distance of | ||
| approximately 9 inches (22.86 cm) | ||
| away. | ||
| Anatomical Sites | Topical skin treatment | Topical skin treatment |
| Application | ||
| Environment | Hospital, Clinic, Medical Center, | |
| Private Medical Practice, or Other | ||
| Professional Medical | ||
| Environments under direction of | ||
| physician | Hospital, Clinic, Medical Center, Private | |
| Medical Practice, or Other Professional | ||
| Medical Environments under direction | ||
| of physician | ||
| Materials | Assembled components housed | |
| in metal frame with reflective | ||
| internal surfaces and fluorescent | ||
| lamps | Assembled components housed in | |
| metal frame with reflective internal | ||
| surfaces and fluorescent lamps | ||
| Manufacturing | ||
| Methods | Identical | Identical |
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| Performance Standards: | The ClearLink controlled phototherapy equipment performance data is
the same as or very similar to that of the claimed predicate device. The
ultraviolet light tubes and cabinet construction used in the production
of the predicate device and the ClearLink controlled phototherapy
equipment are the same. The only difference between the predicate
flex devices and the link devices is the substitution of the link controller
for the flex controller for actual entry of doses. The rest of the devices
(materials, construction, treatment modality, patient safety, etc.,
remains exactly the same. |
| ------------------------ | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
On the basis of the information provided in this Summary, the Daavlin Conclusion: Distributing Company believes the ClearLink controlled phototherapy equipment is substantially equivalent to the legally commercialized predicate device.