Philips BlueControl

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 6, 2017 Philips Electronics Nederland B.V. Ms. Gaozhen Hang Senior Regulatory Affairs Specialist High Tech Campus 5 Eindhoven, 5656 AE The Netherlands Re: K171055 Trade/Device Name: Philips BlueControl Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology Regulatory Class: Class II Product Code: ONE Dated: April 7, 2017 Received: April 10, 2017 Dear Ms. Hang: 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 comples with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. {1}------------------------------------------------ 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 (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 -S3 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K171055 Device Name Philips BlueControl Indications for Use (Describe) The Philips BlueControl is intended to emit energy in the spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat mild psoriasis vulgaris. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary The summary of safety and effectiveness information is included in this submission in accordance with the Safe Medical Device Act of 1990 and 21 CFR §807.92. ### I. SUBMITTER | Philips Electronics Nederland B.V. | |--------------------------------------| | High Tech Campus 5 | | Eindhoven 5656 AE | | The Netherlands | | Gaozhen Hang | | Senior Regulatory Affairs Specialist | | (302) 358-7026 | | gaozhen.hang@philips.com | | | Date Prepared:April 7, 2017 ### II. DEVICE | Trade Name: | Philips BlueControl | |-----------------------------|------------------------------------------------------| | Common/Classification Name: | Powered Light Based Non-Laser Surgical<br>Instrument | | Regulatory Class: | II | | Product Code, CFR: | ONE | | Review Panel: | General and Plastic Surgery (79) | ### PREDICATE DEVICE III. - 1. Omnilux Clear-U, K081307 - 2. Omnilux Blue, K030883 The predicates have not been subject to a design-related recall. No reference devices were used in this submission. #### IV. DEVICE DESCRIPTION The Philips BlueControl is a rechargeable battery-operated, wearable device for delivery of blue light to treat mild psoriasis vulgaris. It is a prescription device designed for home use. The Philips BlueControl is sold as a kit, which contains the following items: - Components: - o BlueControl Device - o Fixation Strap (Device Holder and Slings) - o Power Supply (USB Cable, Adapter and Charger) - Accessory: ● {4}------------------------------------------------ - 0 Carrying Case - Instructions for Use . ### INDICATIONS FOR USE V. The Philips BlueControl is intended to emit energy in the blue region of the spectrum, is generally indicated to treat dermatological conditions and specifically indicated to treat mild psoriasis vulgaris. {5}------------------------------------------------ ### COMPARISON OF TECHNOLOGICAL CHARACTERISCS WITH THE PREDICATE VI. Information for predicate devices was obtained from publicly available sources, including the 510(k) Summaries and device instruction manuals. | Item | Subject Device:<br>Philips BlueControl | Primary Predicate:<br>Omnilux Clear-U<br>K081307 | Secondary Predicate:<br>Omnilux Blue<br>K030883 | Comparison | |----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------| | Energy Source | LED | LED | LED | Same | | Output<br>Wavelength(s)<br>(nm) | 452+/-7 | Blue: 415 +/- 5<br>Red: 633 +/- 6 | 415 +/- 5 | Similar<br>wavelengths in the<br>blue light<br>spectrum | | Dose<br>Rate/Intensity<br>(mW/cm²) | 40 +/- 5 | 40 | 40 | Same | | Average Dose<br>(J/ cm²) | 72 +/- 9 (maximum dose: 90) | 40 (blue)<br>70 (red) | 48 (dosage range: 1-150) | The average<br>treatment dose is<br>within dose range<br>of the predicates. | | Method of<br>Delivery | Blue light treatment<br>administrated through the lower<br>housing. | Blue light treatment<br>administrated through<br>treatment head. | Blue light treatment<br>administrated through<br>treatment head. | Same | | Treatment<br>Regimen | A full course of the treatment<br>consists of 4 weeks of daily<br>treatment 5-7 times a week<br>followed by 8 weeks of<br>treatment 3 times a week. A<br>single treatment takes<br>approximately 30 minutes with<br>or without interruptions. | Alternate treatments of blue<br>and red light twice a week<br>for 20 minutes per<br>treatment for 4 weeks.<br>Forearm test for 20 minutes<br>before starting treatment<br>regime. | One treatment consists of<br>20 minutes at standard<br>dose. The full treatment<br>course consists of 8<br>treatments. | Similar in<br>treatment time per<br>day. | | Item | Subject Device:<br>Philips BlueControl | Primary Predicate:<br>Omnilux Clear-U<br>K081307 | Secondary Predicate:<br>Omnilux Blue<br>K030883 | Comparison | | Treatment<br>Control(s) | On/off button puts device in<br>standby mode.<br>Infrared sensor on the treatment<br>face measures the skin<br>temperature. It senses the<br>presence of the skin and<br>activates LEDs. | Three position switch: Off-<br>Blue- Red | The control unit consists of<br>an LCD and keyboard<br>together with the control<br>electronics. The user<br>interface software allows<br>the operator to access and<br>control all device functions. | All devices have<br>on/off switches.<br>The sensor<br>provides<br>equivalent or<br>better safety<br>assurance. | | Treatment<br>Indicator(s) | Visual signal:<br>-flashing blue- waiting for skin<br>detection<br>-solid blue -treatment is in<br>progress;<br>- flashing blue slowly after<br>recovery from skin overheated<br>(exceeds 43 °C) until the skin<br>cool off.<br>-solid orange- device is<br>overheated: exceeds 51 °C<br>(device switches off);<br>-flashing green-charging<br>-solid green-fully charged<br>-flashing and solid red- battery<br>empty<br>Audio signal:<br>-one (1) beep- connected to<br>power supply<br>- a two (2) tones beep- the<br>treatment starts<br>- a two (2) tones beep- the<br>treatment ends | None | Unknown | The treatment<br>light and audio<br>indicators provide<br>equivalent or<br>better safety<br>assurance<br>comparing to<br>Omnilux Clear-U. | | Item | Subject Device:<br>Philips BlueControl | Primary Predicate:<br>Omnilux Clear-U<br>K081307 | Secondary Predicate:<br>Omnilux Blue<br>K030883 | Comparison | | | -a long 3-second beep- device<br>overheated (device switches<br>off)<br>-three (3) beeps- battery empty | | | | | Treatment<br>Timer | Yes- 30 minutes treatment per<br>area after which device<br>automatically switches off. | None | Unknown | The treatment<br>timer provides<br>equivalent or<br>better safety<br>assurance<br>comparing to<br>Omnilux Clear-U. | | Treatment<br>Surface Area<br>(cm²) | 38 | 28.7 | 525 (LED head active<br>dimensions) | Comparable in<br>size with Omnilux<br>Clear-U. | | Max<br>Treatment<br>Temperature<br>(°C) | 43 (skin)<br>51 (device) | 39-43 | Unknown | Similar in<br>temperature limit<br>with Omnilux<br>Clear-U | | Patient<br>Contacting<br>Materials | Clear polycarbonate LED cover<br>OEKO-TEX®-certified fabric<br>device holder and straps | Rigid ABS | NA | Biocompatible<br>materials used in<br>both the<br>BlueControl and<br>Omnilux Clear-U. | | Power Supply | 3.7 V/rated capacity 6.1Wh<br>lithium-ion rechargeable<br>battery.<br>AC charger:<br>Input: 100-240V at 50-60 Hz | "A separate universal,<br>power supply converts main<br>AC power to the DC power<br>required" | Wall power | The differences in<br>power supply<br>provide equivalent<br>or better safety<br>assurance. | | Item | Subject Device:<br>Philips BlueControl | Primary Predicate:<br>Omnilux Clear-U<br>K081307 | Secondary Predicate:<br>Omnilux Blue<br>K030883 | Comparison | | | Output: 5V DC and 1A/7W | | | | | Dimensions<br>(height x<br>width x depth<br>in cm) | 12.5 x 7.72 x 2.28 | 12 x 6 x 4 | 37 x 18 x 49 | Comparable in<br>size with Omnilux<br>Clear-U | | Weight | 5.9 oz. (without fixation strap)<br>7.8 oz. (with fixation strap) | Less than 1 pound | 26.4 lb. | Similar in weight<br>with Omnilux<br>Clear-U | | Treatment<br>Head Design | 40 Blue LEDs | 30 Blue LEDs | Number of LEDs not<br>available | Similar in design<br>with Omnilux<br>Clear-U | | Principles of<br>Operation | Wearable | Handheld | Desktop | All devices are<br>positioned over<br>the specific skin<br>treatment area to<br>deliver light<br>energy. | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ The indications for use statement for the Philips BlueControl is not identical to the predicate devices; however the differences in the disease treated do not alter the intended therapeutic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. The technical of the Philips BlueControl device are either same or substantially equivalent as compared to the predicate devices. There are no technological differences that raise new or different questions of safety or effectiveness. {9}------------------------------------------------ ### VII. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility Testing The skin contacting materials of the device (lower housing, device holder and strap) were evaluated for biocompatibility per ISO 10993-1 (2009): Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing," for devices in contact with intact skin, including cytotoxicity, dermal sensitization, and dermal irritation. # Electric Safety and Electromagnetic Compatibility Testing The Philips BlueControl has been tested and complies with the applicable requirements of the following standards for medical devices used in the home environment: - . IEC 60601-1:2006 Medical Electrical Equipment - Part 1: General Requirements for Safety, 3rd edition - . IEC 60601-1-11: 2010 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance -- Collateral standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment - IEC 60601-2-57: 2011 Medical electrical equipment: Particular requirements for ● the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use - IEC 60601-1-2: 2007 General requirements for basic safety and essential . performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests # Photobiological Safety Testing The Philips BlueControl has been tested and complies with IEC 60601-2-57 (2011): 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, 1* edition and IEC 62471 (2006-07): Photobiological safety of lamps and lamp systems, 1st edition. Those IEC standards incorporate the measurement techniques of the following ANSI IESNA recommended practices: - RP 27.1:2005 Recommended practice for photobiological safety for lamps and . lamp systems - General requirements - RP 27.2:2000 Recommended practice for photobiological safety for lamps and . lamp systems - Measurement techniques - . RP-27.3:2007 Recommended practice for photobiological safety for lamps and lamp systems - Risk group classification and labeling {10}------------------------------------------------ ### Other Bench Testing Thermal safety and reliability testing has also been conducted to verify the risk controls implemented for the Philips BlueControl are effective to mitigate the hazards identified. ## Software Verification and Validation Testing Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. # Clinical Studies To support the proposed indication for use, two clinical studies of N=50 have been performed in Europe per ISO 14155: Clinical investigation of medical devices for human subjects -- Good clinical practice. In both studies, psoriasis severity was evaluated using the Local Psoriasis Area and Severity Index (LPASI), a modified version of the validated PASI. No serious adverse events were considered related to any of the studied treatment regimen. One clinical study was conducted on 23 enrolled subjects who received blue light treatment at 200 mW/cm2 setting for their mild plaque psoriasis. The patients were treated with blue light for 30 minutes per plague per treatment for 12 weeks followed by a 4-week follow up period without treatment. During the full course of 12-week treatment, the 30-minute blue light treatment was performed daily (5 to 7 treatments per week) for the first 4 weeks, followed by 8 weeks with 3 treatments per week. The plaque severity was evaluated using the LPASI. The primary endpoint, change from baseline (CfB) of the LPASI at week 12, revealed a significant improvement of the treated compared to the control plaques (△CfB: -0.92 ± 1.10, p = 0.0005, t test; p = 0.0006, Wilcoxon signed-rank test; mean 95% CI –1.38, –0.45). The mean change from baseline to week 12 was -2.38 (-3.02 to -1.73) in the treated plaque and -1.46 (-2.13 to -0.79) in the control plaque. All 16 adverse events observed during the study were evaluated. No serious adverse events were reported. None of the adverse events were device-related or treatment-related. The hyperpigmentation (tanning) of the treated skin was expected and reported by some of the study participants. The tanning effect reduced within a few days after completion of the treatment cvcle. No other device-related adverse effects of the device are observed. The results of these studies demonstrate the 12-week treatment cycle of BlueControl reduces the severity of mild psoriasis vulgaris. # VIII. CONCLUSIONS The Philips BlueControl and its predicates emit energy in the blue region of the light spectrum to treat dermatological conditions. The performance achieved by these devices uses nearly identical power intensities and wavelengths. Both the Philips BlueControl and the primary predicate are intended to be placed directly on the skin to provide the light energy. The primary predicate device is cleared for over-the- counter home use, and the {11}------------------------------------------------ Philips BlueControl is a prescription home use device. The intended patient population for the Philips BlueControl fall within the intended use of the secondary predicate device, which is generally indicated to treat dermatological conditions for prescription use. To support the specific indication for use, the clinical testing performed using Philips BlueControl demonstrates its effectiveness for treatment of mild psoriasis vulgaris in adult patients.