(466 days)
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of benign superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, and benign pigmented lesions such as solar lentigo, age spots, or freckles.
The Rogers Sciences Inc.'s Lumina 24 is a light-emitting diode therapy system used to treat superficial and pigmented skin lesions. It consists of a battery-powered light source (Illuminator), optical fibers, and an optical pad (Light Patch). The Light Patch and its adhesive are made from hypoallergenic materials designed to be safe for Fitzpatrick Skin Types II and III. The Lumina 24 system applies Red Light (RL) therapy directly to the treatment area of the skin. To begin treatment, the patient applies the Light Patch to the treatment area and turns on the Illuminator. Light travels from the Illuminator through the optical connector to the Light Patch and to the skin. The Illuminator turns off automatically after 1 hour but treatment may be stopped at any time by turning it off manually. Because Lumina 24 is portable and batterypowered, treatment can take place while the patient is doing other activities.
Here's an analysis of the provided document to extract the acceptance criteria and study details:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Lumina 24 device appear to be primarily based on demonstrating substantial equivalence to the predicate device (EVIS MD Platinum Red Light Therapy) in terms of clinical effectiveness and safety. The key metric for clinical effectiveness is the "percent clearance of lesions" evaluated by a panel of experts. The safety criteria include the absence of adverse events and maintenance of device specifications (uniformity and repeatability) after use.
The study aimed to demonstrate that the Lumina 24 system is "substantially equivalent in clearance of lesions related to photo aging" and that there is "no statistically significant difference between the two devices" (Lumina 24 and EVIS MD Platinum).
| Acceptance Criteria | Reported Device Performance (Lumina 24 vs. EVIS MD Platinum) |
|---|---|
| Clinical Efficacy | |
| Percent clearance of benign superficial and pigmented lesions in Fitzpatrick Skin Types II and III (Primary Endpoint) | The 2x4 matrix of quartile clearance results for Lumina 24 and EVIS MD Platinum was analyzed by a Chi-Square test, yielding p=0.78. The study claimed >80% probability of detecting a 15% or greater difference in lesion clearance between Lumina 24 and EVIS MD at p=0.05. Conclusion: "Devices are substantially equivalent in clearance of lesions related to photo aging." Observed Quartile Clearance for Lumina 24 (N=17): - Q1 (76-100%): 1 patient - Q2 (51-75%): 0 patients - Q3 (26-50%): 6 patients - Q4 (0-25%): 10 patients |
| Safety | |
| Absence of adverse events (Secondary Endpoint) | Reported Performance: "No Adverse Events were reported by any subjects during their treatments with either the Lumina24 or EVIS MD Platinum system devices." (Evis AE = 0, Lumina24 = 0). |
| Subject satisfaction with skin appearance (Secondary Endpoint) | Reported Performance: "The week to week response variation per subject was not significant for both the Lumina24 and EVIS MD Platinum systems. The variation in satisfaction across all subjects for all weeks was not significant. The variation in satisfaction between devices for all weeks and all subjects was not significant." Mean VAS (10 pt Scale) for Lumina 24 (Weekly Avg): 4.8946 Mean VAS (10 pt Scale) for EVIS (Weekly Avg): 5.0911 |
| Device uniformity (irradiance at each measurement point within +/-20% of the mean irradiance value) (Secondary Endpoint) | Reported Performance: For Lumina 24 Light Patches, the uniformity on a given LP and across all LPs given to subjects was less than 10% before and after the study. The uniformity between the devices (referring to Lumina 24 units) before and after the study for each subject was less than +/-20%. All subjects' Lumina 24 systems "held up to the specifications of uniformity." |
| Device repeatability (irradiance at each measurement point within +/-20% of the median over 3 distinct measurements) (Secondary Endpoint) | Reported Performance: For Lumina 24 devices, "The repeatability of these devices shows that there was less than a 3% difference in light output before and after the study for each subject." All subjects' Lumina 24 systems "held up to the specifications of... repeatability." |
Here's the breakdown of the study details:
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): 17 subjects completed the study.
- Data Provenance: The study was a "prospective, randomized, controlled, masked study." The location or country of origin of the data is not explicitly stated in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: A panel of four (4) independent dermatology providers.
- Qualifications of Experts: They are described as "independent dermatology providers" and members of a "qualified review panel." Further specific qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication method for the test set
- The panel of four independent dermatology providers "reviewed the 1 month visit photos of the treated sites from all enrolled subjects and evaluated the number of lesions for a given anatomical site before (pre) or after (post) treatment."
- They were "blinded as to treatment used and whether the site was pre or post-intervention."
- The document implies a consensus-based adjudication, or at least a collective evaluation leading to the "percent clearance" calculation, but does not explicitly state a specific adjudication rule like 2+1 or 3+1. It seems their collective evaluation contributed to the overall percentage clearance calculation for each subject's treated area.
5. 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
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was NOT done in the context of human readers improving with or without AI assistance.
- This study was a comparative effectiveness study between two medical devices (Lumina 24 and EVIS MD Platinum), both of which are light-emitting diode therapy systems. There is no mention of AI or artificial intelligence facilitating human reader performance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This study is comparing two medical devices, not an AI algorithm. There is no AI algorithm being evaluated for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for lesion clearance was established based on expert visual assessment of high-resolution digital images. The "percent clearance of lesions" was calculated from the exact number of lesions counted by the panel of four independent dermatology providers (expert consensus).
8. The sample size for the training set
- Not applicable. This study is not evaluating an AI model that requires a training set. It is a clinical study comparing two physical medical devices.
9. How the ground truth for the training set was established
- Not applicable. As this is not an AI model evaluation, there is no training set and therefore no ground truth establishment for a training set.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are rendered in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 26, 2015
Rogers Sciences Incorporated % Mr. Raymond Kelly Licensale Incorporated 1801 Wedemeyer Street San Francisco, California 94129
Re: K140386 Trade Name: Lumina 24 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: GEX Dated: May 14, 2015 Received: May 18, 2015
Dear Mr. Kelly:
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 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
{1}------------------------------------------------
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,
Jennifer R. Stevenson -S
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) K140386
Device Name Rogers Sciences Inc (RSI) Lumina 24
Indications for Use (Describe)
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of benign superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, and benign pigmented lesions such as solar lentigo, age spots, or freckles.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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ROGERS SCIENCES, INC.
Address: 79 Golf Street, Southbridge, MA 01550 USA Phone: 888-691-2321 Web: www.rogerssciencesinc.com
510(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.(c)
Date Prepared: May 26, 2015
Applicant Rogers Science Inc. 79 Golf Street, Southbridge, MA 01550 USA Phone: 617-435-5152 Web: www.rogerssciencesinc.com
Contact Person Raymond Kelly Licensale Inc. 57 Lazy Brook Rd Monroe, CT 06468 USA Phone: (203) 880-4091
| Device Information | |
|---|---|
| Trade/Proprietary Name: | Lumina 24 |
| Common Name: | Powered Laser Surgical Instrument |
| Classification Name: | Laser Surgical Instrument |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Review Panel: | General & Plastic Surgery |
| Product Code: | GEX |
| Device Class: | 2 |
| Regulation Number: | 878.4810 |
Predicate Device Information K082247 "Evis MD Platinum Red Light Therapy" cleared by FDA on October 10, 2008
Indications for Use
Intended to provide light to the body. Generally indicated to dermatology use for the treatment of benign superficial and pigmented lesions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, and benign pigmented lesions such as solar lentigo, age spots, or freckles.
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Device Description
The Rogers Sciences Inc.'s Lumina 24 is a light-emitting diode therapy system used to treat superficial and pigmented skin lesions. It consists of a battery-powered light source (Illuminator), optical fibers, and an optical pad (Light Patch). The Light Patch and its adhesive are made from hypoallergenic materials designed to be safe for Fitzpatrick Skin Types II and III.
The Lumina 24 system applies Red Light (RL) therapy directly to the treatment area of the skin. To begin treatment, the patient applies the Light Patch to the treatment area and turns on the Illuminator. Light travels from the Illuminator through the optical connector to the Light Patch and to the skin. The Illuminator turns off automatically after 1 hour but treatment may be stopped at any time by turning it off manually. Because Lumina 24 is portable and batterypowered, treatment can take place while the patient is doing other activities.
Substantial Equivalence
Equivalence was determined using a side by side tabular comparison between the predicate and proposed devices which included: Features, Intended Use, Labeling, Materials, Specifications, Performance Data, and Technological Aspects.
| Basic UnitCharacteristics | Lumina 24 | K082247EVIS MD Platinum Red LightTherapy |
|---|---|---|
| Indications | Intended to provide light to the body.Generally indicated to dermatology usefor the treatment of superficial andpigmented lesions in patients withFitzpatrick Skin Types II and IIIexcluding vascular lesions such ashemangiomas, telangiectasia, or otherbenign pigmented lesions such as solarlentigo, age spots, or freckles. | Intended to provide light to the body.Generally indicated to dermatologyuse for the treatment of superficial,benign vascular and pigmentedlesions "such as but not limited tosolar lentigines, sun spots, liver spotsand age spots. |
| Power (mW) | $0.417 \pm 20%$ | 80.00 |
| Increments of PowerAvailable (mW) | $0.417 \pm 20%$$0.834 \pm 20%$ | 80.00 |
| Irradiance (mW/cm²) | $0.580 \pm 20%$ | 80.00 |
| Fluence (J/cm²) | 2.088 | 192.00 |
| Duration (min) | 60 | 20 |
| Beam Diameter (mm) | 7.5 | 7.5 |
| Pulse Rate (Hz) | Continuous | Continuous |
| Pulse Duration (ms) | 0 | 0 |
| Spot Size at Target (cm²) | 79 | 79 |
| Wavelength (nm) | $630 \pm 5$ | $630 \pm 5$ |
| Beam Mode | LED, 42 mil square | LED, 42 mil square |
| Beam Divergence Angle(Deg.) | 0.5" aperature (Theta = 30) | 0.5" aperature (Theta = 30) |
| Aiming Beam Type(Wavelength) | $630 \pm 5$ | $630 \pm 5$ |
| Controls(Power, Readouts) | Display, control buttons | Display, control buttons |
| Laser Medium | Light Emitting Diode | Light Emitting Diode |
| Basic UnitCharacteristics | Lumina 24 | K082247EVIS MD Platinum Red LightTherapy |
| Energy Source | Red Light | Red Light |
| Cooling Method | Air | Air |
| Display (Control Panel,Printouts) | display; control buttons | display; control buttons |
| Power Calibration | NA | NA |
| Clean/Disinfect | Wipe with alcohol between use | Wipe with alcohol between use |
| Software | None | None |
| Timer | Begins counting at the time the PowerSwitch is tuned On and the Light Patchestablishes contact with theIllumination Device. After 1-hour thepower is turned off | Begins counting at the time tuned on;20 Minutes per target area, 2treatments per week. Audible beepevery 3 minutes for 20 minutes,Timer to turn off the power after 1-hour |
| Treatment Length | 4 weeks first phase, maintenance longterm | 4-8 weeks first phase, maintenancelong term |
| Treatment Area | Torso below neck | Torso below neck |
| Handpiece Shape | Rectangular shaped | Rectangular shaped |
| Handpiece Material | Biocompatible polymer with adhesivestrip | Biocompatible polymer withadhesive strip |
| Handpiece Thickness | ≤ 8 mm | ≤ 8 mm |
| Handpiece Weight | ≤ 50 grams | ≤ 50 grams |
| Voltage Current | Set by potentiometer | Set by potentiometer |
| On-Off Button | External On/Off push-button | External On/Off push-button |
| Power Safeguard | If current from the battery increasesbeyond a threshold, the PowerSafeguard shuts off power | If current from the battery increasesbeyond a threshold, the PowerSafeguard shuts off power |
| Status IndicatorConditions | On-Off status, self-test, failures,disconnect during treatment, faultcondition, therapy completion | On-Off status, self-test, failures,disconnect during treatment, faultcondition, therapy completion |
| Therapy Thermal cut-out | When the LED approaches 50°Cjunction temperature, the internalthermistor allows system to shut off | When the LED approaches 50°Cjunction temperature, the internalthermistor allows system to shut off |
| Surface Temperature | Surface temperature≤ 43°C and meets IEC 60601-1 | Surface temperature≤ 43°C and meets IEC 60601-1 |
| Surface TemperatureDissipation | Temperature does not exceed 43°C | Temperature does not exceed 43°C |
| Positioning On Subject | Able to be placed on the target locationby the user | Able to be placed on the targetlocation by the user |
| Storage conditions | 10-27°C and 40-60%RH | 10-27°C and 40-60%RH |
| Electrical Safety | Compliant to safety requirements forelectrical equipment IEC60601-1 | Compliant to safety requirements forelectrical equipment IEC60601-1 |
| Cabling/CouplingElectrical Safety | Compliant to requirements for patient-applied parts with a Type BF rating.This is the requirement for electricalisolation in terms of high-potentialdielectric withstand and currentleakage | Compliant to requirements forpatient-applied parts with a Type BFrating. This is the requirement forelectrical isolation in terms of high-potential dielectric withstand andcurrent leakage |
| Shelf Life | 12 months shelf and 12 months UsefulLife | 12 months shelf and 12 monthsUseful Life |
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Clinical Summary:
Study Objective
This study compared the Light Emitting Diode therapy of the Lumina 24™ system and the EVIS MD Platinum system. Both of these systems use Red Light (630mm) technology. Both of these systems were compared for the treatment of superficial and pigmented lessions in patients with Fitzpatrick Skin Types II and III excluding vascular lesions such as hemangiomas, telangiectasia, or other benign pigmented lesions such as solar lentigo, age spots, or feckles.
Primary Endpoint
- Evaluated % clearance of lesions based on a quartile scale (ex. 01: >75%). Clearance . was determined by the exact number of lesions counted at an anatomical site before (pre) or after (post) treatment with one of the study devices (Lumina24 or EVIS MD). Posttreatment evaluation occurred one-month after completing treatment. Evaluation was performed by a panel of four independent dermatology providers who were blinded as to treatment used and whether the site was pre or post-intervention. The evaluators based the lesion counts on high-resolution digital images taken by the Principal Investigator.
The percent clearance was calculated by the following formula:
((BT - PT) / BT) x 100 = percent reduction in lesions, where
BT = before treatment lesion number in the anatomic area treated PT = post treatment lesion number in the anatomic area treated
The subjects were then grouped into four Quartiles, where:
- Q1 = greater than 75% clearance of lesions
- Q2 = 50% 75% clearance of lesions
- O3 = 25% -50% clearance of lesions
- Q4 = less than 25% clearance of lesions
Secondary Endpoints
- Mean score on subject satisfaction with skin appearance scale at 1 week, 2 weeks, 3 . weeks and at 1 month follow-up visit using the 100mm Visual-Analog-Scale (VAS), with 0 being very dissatisfied and 10 being very satisfied.
- Self-reported adverse events as documented on subject log ●
- Evaluate safety of the Lumina 24™ Light Patch (LP). Rogers Sciences (manufacturer of ● the Lumina 24™ system) measured pre- and post- uniformity and repeatability of each LP used in the study. 'Uniform' is specified as irradiance at each measurement point within +/-20% of the mean irradiance value. 'Repeatable' is specified as irradiance at each measurement point within +/-20% of the median over 3 distinct measurements. Measurements to be taken with a calibrated photometer.
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Study Methodology
This was a prospective, randomized, controlled, masked study. Subjects meeting all inclusion/exclusion criteria and consenting to participation were enrolled and given both the Lumina 24™ system and the EVIS MD Platinum for use at home to be applied to designated treatment areas chosen by the study clinician. The clinician picked a treatment location on the arms, legs, back, chest, and/or torso. The clinician selected a part of the body which had damaged skin on an area that is equal on both sides (symmetrical) of the body. Only one treatment area. for each side of the body was identified by the clinician for treatment. Randomization using standard randomization number table determined which device was used on the right and left side of the body. The treatment locations and how to apply a device to a given location were described and shown by the Principal Investigator to the subject. The subject used each device twice a week; both devices were applied on a Monday and Wednesday. Each device was applied on the same day but at separate times (the devices were not be applied and used simultaneously on a given treatment day). The Lumina 24™ system was applied for a 1-hr time period and the EVIS MD Platinum was applied for 18 minutes. Self-assessments were documented weekly (weeks 1, 2. and 3) and at 1 month (30 days +/- 7 days) for satisfaction with skin appearance. Adverse events were self-assessed as applicable. Photographs of each treatment site for each device were taken pre- and post- treatment.
STUDY RESULTS
A total of 17 subjects completed the study. Of the 17 subjects, four (4) had lesions on both sides of their legs. Two (2) of these subjects had lesions on the lower leg, and the other two (2) subjects had lesions on the upper leg. Five (5) subjects had lesions on both sides of their upper chest. The remaining eight (8) subjects had lesions on both sides of their arms/biceps.
| Eight (8) subjects had a Fitzpatrick Skin Type of 2 and the remaining nine (9) subjects had a | |
|---|---|
| Fitzpatrick Skin Type of 3. |
| Patient | Anatomical | Fitzpatrick | Side of Body | Side of Body |
|---|---|---|---|---|
| Number | Location | Skin Type | EVIS Applied | Lumina24 Applied |
| 1 | Upper Leg | 2 | Left | Right |
| 2 | Chest | 3 | Right | Left |
| 3 | Chest | 3 | Right | Left |
| 4 | Upper Leg | 3 | Right | Left |
| 5 | Lower Leg | 2 | Left | Right |
| 6 | Lower Leg | 3 | Left | Right |
| 7 | Chest | 2 | Left | Right |
| 8 | Chest | 2 | Left | Right |
| 9 | Arm | 2 | Left | Right |
| 10 | Chest | 3 | Right | Left |
| 11 | Arm | 2 | Left | Right |
| 12 | Arm | 2 | Left | Right |
| 13 | Arm | 3 | Left | Right |
| 14 | Arm | 3 | Right | Left |
| 16 | Arm | 3 | Left | Right |
| 17 | Arm | 2 | Left | Right |
| 19 | Arm | 3 | Right | Left |
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Patient Response
On a weekly basis subjects filled out a study log for both the Lumina24 and EVIS MD Platinum system. As part of the log, each subject marked their satisfaction with their skin appearance after treatment at 1 week, 2 weeks, 3 weeks, and at 1-month follow up visit using the 100mm VAS. The week to week response variation per subject was not significant for both the Lumina24 and EVIS MD Platinum systems. The variation in satisfaction across all subjects for all weeks was not significant. The variation in satisfaction between devices for all weeks and all subjects was not significant.
No Adverse Events were reported by any subjects during their treatments with either the Lumina24 or EVIS MD Platinum system devices.
| Mean VAS (10 pt Scale) for All Subjects (Based on Device) | |||||
|---|---|---|---|---|---|
| Week 1 | Week 2 | Week 3 | Week 4 | Weekly Avg. | |
| Lumina24 | 3.9000 | 4.6857 | 5.2500 | 5.7429 | 4.8946 |
| EVIS | 4.2964 | 4.7250 | 5.4214 | 5.9214 | 5.0911 |
| BEFORE | AFTER | ||||||
|---|---|---|---|---|---|---|---|
| Lumina24IlluminationDevice | Light Patch | EVISDevice | Lumina24IlluminationDevice | Light Patch | EVISDevice | ||
| Subject | mW/cm2 | mW/cm2 | mW/cm2 | Subject | mW/cm2 | mW/cm2 | mW/cm2 |
| 1 | 1.15 | 0.5946 | 12.15 | 1 | 1.16 | 0.5947 | 12.22 |
| 2 | 1.19 | 0.5524 | 10.85 | 2 | 1.19 | 0.5434 | 10.82 |
| 3 | 1.22 | 0.5532 | 11.02 | 3 | 1.22 | 0.5424 | 11.00 |
| 4 | 1.14 | 0.5501 | 10.99 | 4 | 1.12 | 0.5650 | 10.94 |
| 5 | 1.16 | 0.5843 | 11.03 | 5 | 1.15 | 0.5796 | 11.01 |
| 6 | 1.15 | 0.5409 | 12.09 | 6 | 1.15 | 0.5374 | 12.11 |
| 7 | 1.15 | 0.6119 | 12.08 | 7 | 1.16 | 0.6087 | 12.10 |
| 8 | 1.18 | 0.5459 | 10.87 | 8 | 1.18 | 0.5452 | 10.88 |
| 9 | 1.19 | 0.5932 | 12.14 | 9 | 1.20 | 0.5914 | 12.13 |
| 10 | 1.19 | 0.5281 | 10.85 | 10 | 1.18 | 0.5263 | 10.85 |
| 11 | 1.23 | 0.5329 | 11.00 | 11 | 1.23 | 0.5333 | 11.01 |
| 12 | 1.21 | 0.6020 | 11.01 | 12 | 1.20 | 0.6018 | 11.00 |
| 13 | 1.15 | 0.5949 | 10.85 | 13 | 1.17 | 0.5902 | 10.84 |
| 14 | 1.16 | 0.5688 | 12.07 | 14 | 1.17 | 0.5671 | 12.07 |
| 16 | 1.16 | 0.5737 | 12.05 | 16 | 1.17 | 0.5741 | 12.06 |
| 17 | 1.14 | 0.5767 | 11.07 | 17 | 1.15 | 0.5707 | 11.08 |
| 19 | 1.18 | 0.5683 | 10.85 | 19 | 1.17 | 0.5677 | 10.89 |
Before and after test measurements of the Study Devices. Measurements are of irradiance (mW/cm²).
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Lumina24 Device Testing
Device testing on the light output of the Lumina24 Illumination Device and Light Patches (LP) as well as on the EVIS MD Platinum System were undertaken before and after subjects used the devices during their study treatment. For the LPs, each one was measured before and after treatment for uniformity and repeatability.
There was little change in irradiance output across the devices from before and after the study took place for a given subject. The repeatability of these devices shows that there was less than a 3% difference in light output before and after the study for each subject.
The uniformity on a given LP and across all the LPs given to subject was less than 10% before and after the study. The uniformity between the devices before and after the study for each subject was less than +/-20%.
The Lumina24 system for each subject held up to the specifications of uniformity and repeatability outlined as secondary endpoints of the clinical study.
| AVERAGE UNIFORMITY | |||
|---|---|---|---|
| Lumina24 | |||
| Light PatchBefore | Light PatchAfter | DifferenceBefore andAfter | |
| Subject | mW/cm2 | mW/cm2 | mW/cm2 |
| 1 | -2.51% | -2.53% | -0.23% |
| 2 | 4.75% | 6.30% | -1.83% |
| 3 | 4.62% | 6.48% | -1.78% |
| 4 | 5.15% | 2.59% | 2.40% |
| 5 | -0.75% | 0.08% | -0.92% |
| 6 | 6.74% | 7.34% | -0.68% |
| 7 | -5.50% | -4.94% | -0.45% |
| 8 | 5.88% | 6.00% | -0.08% |
| 9 | -2.28% | -1.97% | -0.26% |
| 10 | 8.95% | 9.25% | -0.32% |
| 11 | 8.12% | 8.05% | 0.10% |
| 12 | -3.79% | -3.75% | -0.02% |
| 13 | -2.57% | -1.76% | -0.79% |
| 14 | 1.93% | 2.22% | -0.29% |
| 16 | 1.09% | 1.02% | 0.09% |
| 17 | 0.57% | 1.61% | -1.00% |
| 19 | 2.01% | 2.13% | -0.12% |
Uniformity test measurements of the Study Devices. Measurements are of irradiance (mW/cm2) difference from before and after the study on a given device used by a subject.
| REPEATABILITY DIFFERENCE | |||
|---|---|---|---|
| Lumina24 | EVIS | ||
| IlluminationDevice | Light Patch | Device | |
| Subject | mW/cm2 | mW/cm2 | mW/cm2 |
| 1 | 0.86% | 0.02% | 0.57% |
| 2 | 0.00% | -1.66% | -0.28% |
| 3 | 0.00% | -1.99% | -0.18% |
| 4 | -1.79% | 2.64% | -0.46% |
| 5 | -0.87% | -0.82% | -0.18% |
| 6 | 0.00% | -0.64% | 0.17% |
| 7 | 0.86% | -0.53% | 0.17% |
| 8 | 0.00% | -0.12% | 0.09% |
| 9 | 0.83% | -0.30% | -0.08% |
| 10 | -0.85% | -0.34% | 0.00% |
| 11 | 0.00% | 0.08% | 0.09% |
| 12 | -0.83% | -0.04% | -0.09% |
| 13 | 1.71% | -0.79% | -0.09% |
| 14 | 0.85% | -0.29% | 0.00% |
| 16 | 0.85% | 0.08% | 0.08% |
| 17 | 0.87% | -1.05% | 0.09% |
| 19 | -0.85% | -0.12% | 0.37% |
Repeatability test measurements of the Study Devices. Measurements are of irradiance (mW/cm2) difference from before and after the study on a given device used by a subject.
{10}------------------------------------------------
Percent Clearance
Within 30 days of last subject completing 1 month visit, a panel of 4 experts, in a blinded manner, reviewed the 1 month visit photos of the treated sites from all enrolled subjects and evaluated the number of lesions for a given anatomical site before (pre) or after (post) treatment using one of the treatment devices. The following are the quartile scale of percent lesions clearance before and after treatment with the Lumina24 and EVIS MD Platinum systems.
| ALL PATIENTS | N=17 | |
|---|---|---|
| QuartileClearanceLumina24 | QuartileClearanceEVIS | |
| Q1: 76-100% | 1 | 1 |
| Q2: 51-75% | 0 | 1 |
| Q3: 26-50% | 6 | 5 |
| Q4: 0-25% | 10 | 10 |
Percent lesions clearance based on quartile scale for each device across all patients (N=17).
The 2 x 4 matrix was evaluated for statistical significance by a Chi Square analysis of the Quartile results with the following outcome:
- . Chi Square of the Quartile analysis: p=0.78
- . Study has >80% probability detecting a 15% or greater difference in lesion clearance between Lumina and Evis at p=0.05
- . Conclusion: Devices are substantially equivalent in clearance of lesions related to photo aging.
Conclusion
Based on the results of the 4-member review panel of the pre- and post- images of the 17 subjects who were treated with the Lumina24 system and the EVIS Platinum MD system, there was no statistically significant difference between the two devices. Significant difference being defined as an 80% confidence that there is less than 20% difference between the Lumina24 system and the EVIS Platinum MD system. Furthermore none of the 17 subjects enrolled had an AE (Evis AE =0, Lumina24=0).
Due to the lack of difference in clinical response to the two devices as determined by an independent and qualified review panel. RSI has determined and demonstrated that the Lumina24 system and the EVIS MD Platinum system are clinically Substantially Equivalent (SE).
§ 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.