(87 days)
No reference devices were used in this submission.
No
The summary describes a light therapy device and its clinical performance, with no mention of AI or ML capabilities.
Yes
The device is intended to treat a medical condition (mild psoriasis vulgaris) by emitting blue light, and clinical studies have shown it reduces the severity of this condition, indicating a therapeutic purpose.
No
The device is described as a treatment device that emits blue light to treat mild psoriasis vulgaris, and its performance studies measure the reduction in psoriasis severity after treatment. It does not mention any diagnostic capabilities.
No
The device description explicitly states it is a "rechargeable battery-operated, wearable device" and lists hardware components like the device itself, fixation strap, and power supply.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat mild psoriasis vulgaris" by emitting blue light. This is a therapeutic treatment applied directly to the patient's skin.
- Device Description: The device is a "wearable device for delivery of blue light to treat mild psoriasis vulgaris." It's a physical device that delivers energy to the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a therapeutic device used to treat a condition directly on the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ONE
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: ●
- o Carrying Case
- o Instructions for Use
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Adult patients.
Intended User / Care Setting
Home use.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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.
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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 Surgical |
| Instrument | |
| 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: ●
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.
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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-U
K081307 | Secondary Predicate:
Omnilux Blue
K030883 | Comparison |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| Energy Source | LED | LED | LED | Same |
| Output
Wavelength(s)
(nm) | 452+/-7 | Blue: 415 +/- 5
Red: 633 +/- 6 | 415 +/- 5 | Similar
wavelengths in the
blue light
spectrum |
| Dose
Rate/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 average
treatment dose is
within dose range
of the predicates. |
| Method of
Delivery | Blue light treatment
administrated through the lower
housing. | Blue light treatment
administrated through
treatment head. | Blue light treatment
administrated through
treatment head. | Same |
| Treatment
Regimen | A full course of the treatment
consists of 4 weeks of daily
treatment 5-7 times a week
followed by 8 weeks of
treatment 3 times a week. A
single treatment takes
approximately 30 minutes with
or without interruptions. | Alternate treatments of blue
and red light twice a week
for 20 minutes per
treatment for 4 weeks.
Forearm test for 20 minutes
before starting treatment
regime. | One treatment consists of
20 minutes at standard
dose. The full treatment
course consists of 8
treatments. | Similar in
treatment time per
day. |
| Item | Subject Device:
Philips BlueControl | Primary Predicate:
Omnilux Clear-U
K081307 | Secondary Predicate:
Omnilux Blue
K030883 | Comparison |
| Treatment
Control(s) | On/off button puts device in
standby mode.
Infrared sensor on the treatment
face measures the skin
temperature. It senses the
presence of the skin and
activates LEDs. | Three position switch: Off-
Blue- Red | The control unit consists of
an LCD and keyboard
together with the control
electronics. The user
interface software allows
the operator to access and
control all device functions. | All devices have
on/off switches.
The sensor
provides
equivalent or
better safety
assurance. |
| Treatment
Indicator(s) | Visual signal:
-flashing blue- waiting for skin
detection
-solid blue -treatment is in
progress;
- flashing blue slowly after
recovery from skin overheated
(exceeds 43 °C) until the skin
cool off.
-solid orange- device is
overheated: exceeds 51 °C
(device switches off);
-flashing green-charging
-solid green-fully charged
-flashing and solid red- battery
empty
Audio signal:
-one (1) beep- connected to
power supply - a two (2) tones beep- the
treatment starts - a two (2) tones beep- the
treatment ends | None | Unknown | The treatment
light and audio
indicators provide
equivalent or
better safety
assurance
comparing to
Omnilux Clear-U. |
| Item | Subject Device:
Philips BlueControl | Primary Predicate:
Omnilux Clear-U
K081307 | Secondary Predicate:
Omnilux Blue
K030883 | Comparison |
| | -a long 3-second beep- device
overheated (device switches
off)
-three (3) beeps- battery empty | | | |
| Treatment
Timer | Yes- 30 minutes treatment per
area after which device
automatically switches off. | None | Unknown | The treatment
timer provides
equivalent or
better safety
assurance
comparing to
Omnilux Clear-U. |
| Treatment
Surface Area
(cm²) | 38 | 28.7 | 525 (LED head active
dimensions) | Comparable in
size with Omnilux
Clear-U. |
| Max
Treatment
Temperature
(°C) | 43 (skin)
51 (device) | 39-43 | Unknown | Similar in
temperature limit
with Omnilux
Clear-U |
| Patient
Contacting
Materials | Clear polycarbonate LED cover
OEKO-TEX®-certified fabric
device holder and straps | Rigid ABS | NA | Biocompatible
materials used in
both the
BlueControl and
Omnilux Clear-U. |
| Power Supply | 3.7 V/rated capacity 6.1Wh
lithium-ion rechargeable
battery.
AC charger:
Input: 100-240V at 50-60 Hz | "A separate universal,
power supply converts main
AC power to the DC power
required" | Wall power | The differences in
power supply
provide equivalent
or better safety
assurance. |
| Item | Subject Device:
Philips BlueControl | Primary Predicate:
Omnilux Clear-U
K081307 | Secondary Predicate:
Omnilux Blue
K030883 | Comparison |
| | Output: 5V DC and 1A/7W | | | |
| Dimensions
(height x
width x depth
in cm) | 12.5 x 7.72 x 2.28 | 12 x 6 x 4 | 37 x 18 x 49 | Comparable in
size with Omnilux
Clear-U |
| Weight | 5.9 oz. (without fixation strap)
7.8 oz. (with fixation strap) | Less than 1 pound | 26.4 lb. | Similar in weight
with Omnilux
Clear-U |
| Treatment
Head Design | 40 Blue LEDs | 30 Blue LEDs | Number of LEDs not
available | Similar in design
with Omnilux
Clear-U |
| Principles of
Operation | Wearable | Handheld | Desktop | All devices are
positioned over
the specific skin
treatment area to
deliver light
energy. |
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7
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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.