(87 days)
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.
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: ● 0 Carrying Case Instructions for Use.
The Philips BlueControl device is intended to treat mild psoriasis vulgaris. The provided text outlines the performance data, including clinical studies, that support the substantial equivalence determination for this device.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly present a table of acceptance criteria for its clinical performance. Instead, it describes clinical studies and their outcomes as evidence of effectiveness. The primary endpoint for effectiveness was a statistically significant improvement in Local Psoriasis Area and Severity Index (LPASI) scores.
| Acceptance Criteria Category | Specific Metric (Inferred) | Acceptance Threshold (Inferred) | Reported Device Performance |
|---|---|---|---|
| Clinical Effectiveness | Change from Baseline (CfB) of the LPASI at week 12 | Statistically significant improvement in treated plaques compared to control plaques. | - 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. |
| Safety | Incidence of serious adverse events (SAEs) related to treatment | No serious adverse events considered related to any of the studied treatment regimen. | - No serious adverse events were considered related to any of the studied treatment regimen. - 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. - Hyperpigmentation (tanning) was expected and reported, which reduced within a few days after treatment completion. No other device-related adverse effects were observed. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: N=23 enrolled subjects in the main clinical study, with each subject having treated and control plaques.
- Data Provenance: Prospective, clinical studies conducted in Europe per ISO 14155 (Clinical investigation of medical devices for human subjects -- Good clinical practice).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
The document does not explicitly state the number or qualifications of experts used to establish the ground truth for the test set (i.e., evaluate LPASI scores). It mentions that "psoriasis severity was evaluated using the Local Psoriasis Area and Severity Index (LPASI), a modified version of the validated PASI." This typically implies trained clinicians or dermatologists, but specific details are not provided.
4. Adjudication Method for the Test Set:
The document does not describe a specific adjudication method (e.g., 2+1, 3+1) for the LPASI evaluations in the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned. The study design involved comparing treated plaques to control plaques within the same subjects, rather than comparing human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance:
Not applicable. The Philips BlueControl is a light therapy device, not an AI algorithm, so a standalone algorithm-only performance assessment is not relevant in this context.
7. Type of Ground Truth Used:
The ground truth for effectiveness was based on clinical assessment using the Local Psoriasis Area and Severity Index (LPASI), performed by presumably clinical investigators or dermatologists as part of the clinical studies. For safety, it was adverse event reporting and evaluation.
8. Sample Size for the Training Set:
Not applicable. The Philips BlueControl is a medical device, not an AI/machine learning algorithm, so there is no "training set" in the conventional sense for algorithm development. The device's performance is based on its physical properties and clinical evaluation in humans.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI algorithm. The device's design and parameters are based on scientific understanding of blue light therapy for psoriasis and established medical device development standards, rather than AI model training.
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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
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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
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Indications for Use
510(k) Number (if known)
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)
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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 SurgicalInstrument |
| Regulatory Class: | II |
| Product Code, CFR: | ONE |
| Review Panel: | General and Plastic Surgery (79) |
PREDICATE DEVICE III.
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: ●
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- 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.
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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:Philips BlueControl | Primary Predicate:Omnilux Clear-UK081307 | Secondary Predicate:Omnilux BlueK030883 | Comparison |
|---|---|---|---|---|
| Energy Source | LED | LED | LED | Same |
| OutputWavelength(s)(nm) | 452+/-7 | Blue: 415 +/- 5Red: 633 +/- 6 | 415 +/- 5 | Similarwavelengths in theblue lightspectrum |
| DoseRate/Intensity(mW/cm²) | 40 +/- 5 | 40 | 40 | Same |
| Average Dose(J/ cm²) | 72 +/- 9 (maximum dose: 90) | 40 (blue)70 (red) | 48 (dosage range: 1-150) | The averagetreatment dose iswithin dose rangeof the predicates. |
| Method ofDelivery | Blue light treatmentadministrated through the lowerhousing. | Blue light treatmentadministrated throughtreatment head. | Blue light treatmentadministrated throughtreatment head. | Same |
| TreatmentRegimen | A full course of the treatmentconsists of 4 weeks of dailytreatment 5-7 times a weekfollowed by 8 weeks oftreatment 3 times a week. Asingle treatment takesapproximately 30 minutes withor without interruptions. | Alternate treatments of blueand red light twice a weekfor 20 minutes pertreatment for 4 weeks.Forearm test for 20 minutesbefore starting treatmentregime. | One treatment consists of20 minutes at standarddose. The full treatmentcourse consists of 8treatments. | Similar intreatment time perday. |
| Item | Subject Device:Philips BlueControl | Primary Predicate:Omnilux Clear-UK081307 | Secondary Predicate:Omnilux BlueK030883 | Comparison |
| TreatmentControl(s) | On/off button puts device instandby mode.Infrared sensor on the treatmentface measures the skintemperature. It senses thepresence of the skin andactivates LEDs. | Three position switch: Off-Blue- Red | The control unit consists ofan LCD and keyboardtogether with the controlelectronics. The userinterface software allowsthe operator to access andcontrol all device functions. | All devices haveon/off switches.The sensorprovidesequivalent orbetter safetyassurance. |
| TreatmentIndicator(s) | Visual signal:-flashing blue- waiting for skindetection-solid blue -treatment is inprogress;- flashing blue slowly afterrecovery from skin overheated(exceeds 43 °C) until the skincool off.-solid orange- device isoverheated: exceeds 51 °C(device switches off);-flashing green-charging-solid green-fully charged-flashing and solid red- batteryemptyAudio signal:-one (1) beep- connected topower supply- a two (2) tones beep- thetreatment starts- a two (2) tones beep- thetreatment ends | None | Unknown | The treatmentlight and audioindicators provideequivalent orbetter safetyassurancecomparing toOmnilux Clear-U. |
| Item | Subject Device:Philips BlueControl | Primary Predicate:Omnilux Clear-UK081307 | Secondary Predicate:Omnilux BlueK030883 | Comparison |
| -a long 3-second beep- deviceoverheated (device switchesoff)-three (3) beeps- battery empty | ||||
| TreatmentTimer | Yes- 30 minutes treatment perarea after which deviceautomatically switches off. | None | Unknown | The treatmenttimer providesequivalent orbetter safetyassurancecomparing toOmnilux Clear-U. |
| TreatmentSurface Area(cm²) | 38 | 28.7 | 525 (LED head activedimensions) | Comparable insize with OmniluxClear-U. |
| MaxTreatmentTemperature(°C) | 43 (skin)51 (device) | 39-43 | Unknown | Similar intemperature limitwith OmniluxClear-U |
| PatientContactingMaterials | Clear polycarbonate LED coverOEKO-TEX®-certified fabricdevice holder and straps | Rigid ABS | NA | Biocompatiblematerials used inboth theBlueControl andOmnilux Clear-U. |
| Power Supply | 3.7 V/rated capacity 6.1Whlithium-ion rechargeablebattery.AC charger:Input: 100-240V at 50-60 Hz | "A separate universal,power supply converts mainAC power to the DC powerrequired" | Wall power | The differences inpower supplyprovide equivalentor better safetyassurance. |
| Item | Subject Device:Philips BlueControl | Primary Predicate:Omnilux Clear-UK081307 | Secondary Predicate:Omnilux BlueK030883 | Comparison |
| Output: 5V DC and 1A/7W | ||||
| Dimensions(height xwidth x depthin cm) | 12.5 x 7.72 x 2.28 | 12 x 6 x 4 | 37 x 18 x 49 | Comparable insize with OmniluxClear-U |
| Weight | 5.9 oz. (without fixation strap)7.8 oz. (with fixation strap) | Less than 1 pound | 26.4 lb. | Similar in weightwith OmniluxClear-U |
| TreatmentHead Design | 40 Blue LEDs | 30 Blue LEDs | Number of LEDs notavailable | Similar in designwith OmniluxClear-U |
| Principles ofOperation | Wearable | Handheld | Desktop | All devices arepositioned overthe specific skintreatment area todeliver lightenergy. |
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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.
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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
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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
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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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.