(93 days)
Not Found
No
The device description and performance studies focus on the mechanical action of microneedles and clinical outcomes, with no mention of AI or ML technologies.
Yes
The device is described as a "treatment to improve the appearance of surgical or traumatic hypertrophic scars," directly indicating a therapeutic purpose to mitigate an existing condition or improve a physical aspect.
No
Explanation: The device is intended as a treatment to improve the appearance of scars, not to diagnose a condition.
No
The device description explicitly states it is a "handheld device that creates microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles." This describes a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The SkinStylus SteriLock® MicroSystem is a handheld device that creates microinjuries in the skin using microneedles. Its purpose is to improve the appearance of scars by stimulating the skin's natural healing process.
- Lack of Sample Analysis: The device does not analyze any samples taken from the body. It directly interacts with the skin tissue.
- Intended Use: The intended use is a treatment to improve the appearance of scars, not to diagnose or detect a condition through sample analysis.
Therefore, the SkinStylus SteriLock® MicroSystem falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Product codes
OAI
Device Description
The SkinStylus SteriLock® MicroSystem is a handheld device that creates microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdomen
Indicated Patient Age Range
adults aged 22 years or older.
Intended User / Care Setting
licensed and trained aestheticians (skin care specialists) who were supervised by a licensed dermatologist.
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
A total of 34 subjects completed the study. 30 of those subjects had a scar located on the abdomen. Subjects enrolled in the study included men (5.8%) and women (94.2%) over age 22. The study included 12/34 subjects with Fitzpatrick Skin Type (FST) IV - VI.
At each clinical visit, digital images were taken of each subject's scars, before and after treatment. After the first treatment, on each subsequent treatment, objective and subjective data were obtained from patients regarding the occurrence of any adverse event or other sequel. On day 15, and day 31 imaging was performed before and after treatment. 90 days after the last treatment (day 31), grading images were graded by the following blinded graders: a Board Certified Dermatologist and two Board Certified Plastic Surgeons after completion of the study using the following assessment tools [Table 2].
Each subject had a scar on the abdomen that had been photographed and divided into a treatment and an untreated/control segment, roughly equal in length to each other.
At 90 days after the last treatment, both sides of the scar (treated side and untreated/control side) were photographed. The photographs were not retouched and were arranged in pairs on Powerpoint@slides. Each slide contains two images from the same subject randomly arranged so that the grader did not know whether the slide with the two treated side images was presented before or after the slide with the two non-treated side images. Additionally, while both images on the slide came from the same subject, the grader did not know which image represented the before or after condition.
On each set of slides there was a horizontal, 100 mm line located under each image. This line represents a VAS scale where the far left end is marked as "0.0 mm" and represents "Normal Skin" and is marked at "100 mm" and represents a "Poor Scar".
Each of the three graders, comprised of a Board Certified Dermatologist and two Board Certified Plastic Surgeons were asked to view each slide and grade each image by using a mouse to grab the vertical line and place it on the horizontal VAS scale line in a position that indicated his/her professional opinion of the relative condition of the scar observed in the image.
Summary of Performance Studies
Study Type: Clinical Study
Sample Size: 34 subjects completed the study, 30 of those with a scar located on the abdomen.
Key Results:
Primary Effectiveness Endpoint: A 10 mm (Minimal Clinical Important Difference (MCID) for the validated Visual Analogue Scale) improvement in the treatment side of the scar using the 100 mm validated VAS scale observed by at least 2 out of 3 blinded graders compared to the non-treatment side 90 days after last of 3 treatments. The treatment site photos were also correlated to the graded non-treatment side control photos.
Out of the 30 abdomen subjects that completed the trial and had their abdomen treated, 22 subjects had at least a 10 mm improvement, compared to the non-treated side, according to at least 2 of the 3 blinded evaluators. This results in a responder rate of 73% with 95% CI from 58% to 89%.
Secondary Effectiveness Endpoint:
Self-assessed Scar Improvement Scale completed by subjects at 90 days after last of 3 treatments on the same side.
Out of the 30 subjects that completed the trial and had their abdomen treated, 28 had SASIS scores of 1 or greater indicating that they were satisfied with the treatment (93% with 95% Cl from 84% to 100%.)
Out of the 30 subjects that completed the trial and had their abdomen treated, 19 had SASIS scores of 3 or greater indicating the they had seen a scar improvement higher than 50% (63% with 95% Cl from 46% to 81%.)
Subject Global Aesthetic Improvement Scale completed by subjects at 90 days after last of 3 treatments on the same side.
Out of the 30 subjects that completed the trial and had their abdomen treated, 27 had SGALS of 3 or lower indicated that they were satisfied with the treatment (90% with 95% Cl from 79% to 100%.)
Safety Endpoint: Adverse event monitoring at each visit; treatment 2, treatment 3, 90 days after treatment 3, and 6 months after treatment 3.
There were 10 out of 30 subjects (33% with 95% CI from 17% to 50%) who completed the trial and had their abdomen treated that experienced common treatment responses.
Adverse Events: There were 2 out of 34 subjects who completed the trial and presented adverse events (hyperpigmentation - one subject Fitzpatrick Skin Type II and one subject Fitzpatrick Skin Type II). The incidence of adverse events (hyperpigmentation) was 6% with 95% CI from 0% to 14% in the 34 subjects that completed the trial. At the 180 day safety visit, both subjects reported that the hyperpigmentation had resolved.
Key Metrics
Responder rate: 73% (95% CI 58% to 89%) for primary endpoint.
SASIS scores of 1 or greater (satisfied with treatment): 93% (95% CI 84% to 100%).
SASIS scores of 3 or greater (scar improvement higher than 50%): 63% (95% CI 46% to 81%).
SGALS scores of 3 or lower (satisfied with treatment): 90% (95% CI 79% to 100%).
Incidence of adverse events (hyperpigmentation): 6% (95% CI 0% to 14%).
Predicate Device(s)
SkinPen Precision System (DEN160029)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4430 Microneedling device for aesthetic use.
(a)
Identification. A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. This classification does not include devices intended for transdermal delivery of topical products such as cosmetics, drugs, or biologics.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The technical specifications and needle characteristics must be identified, including needle length, geometry, maximum penetration depth, and puncture rate.
(2) Non-clinical performance data must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be tested:
(i) Accuracy of needle penetration depth and puncture rate;
(ii) Safety features built into the device to protect against cross-contamination, including fluid ingress protection; and
(iii) Identification of the maximum safe needle penetration depth for the device for the labeled indications for use.
(3) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(4) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life.
(5) Performance data must demonstrate the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device.
(6) Software verification, validation, and hazard analysis must be performed for all software components of the device.
(7) The patient-contacting components of the device must be demonstrated to be biocompatible.
(8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
(9) Labeling must include the following:
(i) Information on how to operate the device and its components and the typical course of treatment;
(ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
(iii) Validated methods and instructions for reprocessing of any reusable components;
(iv) Disposal instructions; and
(v) A shelf life.
(10) Patient labeling must be provided and must include:
(i) Information on how the device operates and the typical course of treatment;
(ii) The probable risks and benefits associated with use of the device; and
(iii) Postoperative care instructions.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 10, 2020
Esthetic Education LLC % Marc Sanchez Attorney & Regulatory Consultant Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty) 53516 Bickett Chapel Hill, North Carolina 27517
Re: K200044
Trade/Device Name: SkinStylus SteriLock MicroSystem Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling Device For Aesthetic Use Regulatory Class: Class II Product Code: OAI Dated: January 6, 2020 Received: January 8, 2020
Dear Marc Sanchez:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200044
Device Name SkinStylus SteriLock® MicroSystem
Indications for Use (Describe)
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Traditional 510(k) Submission SkinStylus SteriLock® MicroSystem K200044
510(k) Summary
The following information is provided as required by 21 CFR 807.92 for the SkinStylus SteriLock® MicroSystem 510(k) premarket notification.
| Sponsor: | Esthetic Education LLC
7950 E. Acoma Drive Suite 100
Scottsdale, AZ 85260
Establishment Registration: 3011338460 |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | GUANGZHOU CARAIN BEAUTY EQUIPMENT
103 & 601, No. 3 of Xin Liu Mu Road,
Zhong Cun Street
Guangzhou Guangdong, CHINA 511495
Establishment Registration: 3011568699 |
| Contact: | Marc C. Sanchez, Esq.
Contract In-House Counsel and Consultants, LLC (d/b/a FDA Atty)
53516 Bickett Chapel Hill NC 27517
Ph: 202.765.4491
E-mail: msanchez@fdaatty.com |
| Date Prepared: | April 7, 2020 |
| Proprietary Name: | SkinStylus SteriLock® MicroSystem |
| Common Name: | Powered Microneedle Device |
| Regulation Number: | 21 CFR 878.4430 |
| Regulatory Class: | Class II |
| Product Code: | QAI |
Predicate Device(s): SkinPen Precision System (DEN160029)
Device Description:
The SkinStylus SteriLock® MicroSystem is a handheld device that creates microinjuries into the skin, by virtue of a 1A DC motor that rapidly reciprocates an array of 32 gauge microneedles that are no longer than 2.5mm. The device consists of a power source, a motor body with depth adjustment, a removable nosecone interface, and a disposable, single use cartridge containing an array of microneedles.
4
The power source consists of two separate systems. One option is a rechargeable lithium-ion battery that delivers no more than 5 volts DC and 1 amp of current to power the motor. The other option consists of an AC wall adaptor that converts 110v AC into 5v DC. A power cord connects the wall adaptor to the device via a USB connector and a standard 1/8" headphone plug on the device side.
The motor body is comprised of anodized aluminum with a dial mechanism that controls the depth of penetration of the microneedles from 0.0 mm to a maximum of 2.5mm.
The removable nosecone provides the SkinStylus® with an interface between the motor and the cartridge to prevent any fluid from entering the motor body. The removable nosecone is autoclave sterilized or intermediate-level disinfected after every use.
The SkinStylus® disposable cartridge is designed in three configurations, a 12-needle array with all needles at 2.5mm, a 36-needle array with all needles at 2.5mm and a 36-needle array with 18 needles at 1.0mm and 18 needles at 2.5mm. The needle array is housed in a specially designed and patented cartridge housing that prevents liquids from entering the motor body via the inside lumen of the cartridge.
The SkinStylus SteriLock® microneedles are composed of 304 18/8 surgical steel.
Each lot of cartridges are individually packaged and then gamma ray sterilized.
5
| Device Name/Model | SkinStylus SteriLock®
MicroSystem | SkinPen Precision System | Needle Geometry | Array 1) 36 solid needles
all at 2.5mm.
Array 2) 18 solid needles at
2.5mm and 18 pins at
1.0mm alternating rows.
Array 3) 12 solid needles
all at 2.5mm
All needles 32 SWG
Radius 0.008mm (Max) | 14 solid needles (32
BWG; Radius 0.005mm
(Max)) |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| 510(k) Number | K200044 | DEN160029 | Speed | 6200- 8840 RPM | 6300RPM-7700 RPM |
| Indication for Use | Intended to be used as a
treatment to improve the
appearance of surgical or
traumatic hypertrophic
scars on the abdomen in
adults aged 22 years or
older. | Intended to be used as a
treatment to improve the
appearance of facial acne
scars in adults aged 22
years or older | Cross Contamination Safety
Feature | Cartridge design
and intermediate
disinfected
handpiece and
nosecone with
optional
reprocessed
(autoclave
sterilized) nosecone; | Cartridge
design and
BioSheath |
| Mode of Action | Microneedling (using one or
more needles to mechanically
puncture and injure skin tissue
for aesthetic use) | Same | Sterility and Cleaning | Disposable cartridge Gamma
Ray Sterilized prior to
packaging | Disposable cartridge
Ethylene Oxide
Sterilized prior to
packaging |
| Power Source 1 | 5 Volt DC/1 amp
rechargeable
lithium-ion battery | 5 Volt DC/1 amp
rechargeable
lithium-ion battery | Clinical Trial to
Support Intended
Use and Safety | YES | YES |
| Power Source 2 | 110 AC
converted to
5 Volt DC/1
amp | AC Adapter 5VC +/-,
1 A minimum | | | |
| Range of Needle Length | 0.25mm-2.5mm | 0.25mm-2.5mm | | | |
| Maximum Penetration | 2.5mm | 2.5mm | | | |
Table 2 Technological Characteristics
6
7
Intended Use:
The SkinStylus SteriLock® MicroSystem is intended to be used as a treatment to improve the appearance of surgical or traumatic hypertrophic scars on the abdomen in adults aged 22 years or older.
Summary of Clinical Test Reports
A clinical study was conducted to support the safety and effectiveness of the SkinStylus SteriLock® MicroSystem for the treatment of scars on the abdomen.
The study was conducted at a single center and included treatments on day 1, day 15, and day 31, with follow-up visits at 90 days from day 31 and 6 months after the final (day 31) treatment. Treatments were conducted by licensed and trained aestheticians (skin care specialists) who were supervised by a licensed dermatologist. The scar was photographed and then was divided into a treatment half and a control half. Both sides were cleaned and numbed prior to treatment. A thin layer of lubricant was applied to both sides prior to treatment to protect against abrasion and friction during the procedure. The aestheticians were instructed to start at a depth setting of 1.0 mm and increase the depth to 2.5mm on all patients until localized petechia and mild, localized capillary bleeding was observed on the treatment side of the scar structure. All three cartridge types were used on every patient and all patients received some portion of each treatment at a depth of 2.5mm. Following treatment, the area was cleaned with sterile saline and a sterile gauze dressing was applied.
A total of 34 subjects completed the study. 30 of those subjects had a scar located on the abdomen. Subjects enrolled in the study included men (5.8%) and women (94.2%) over age 22. The study included 12/34 subjects with Fitzpatrick Skin Type (FST) IV - VI.
| # | % | |||
|---|---|---|---|---|
| Total # of subjects applies | 38 | Sex | ||
| Total # of subjects approved after screening | 36 | Male | 2 | 5.88% |
| Total # of subjects completing trial | 34 | Female | 34 | 94.20% |
| Total # of subjects completing trial with scar | ||||
| on abdomen | 30 | Ethnicity | ||
| Mean Age (years) | 47.50 | Hispanic or Latino | 9 | 26.47% |
| Mean (standard deviation) | 1.52 | Non-Hispanic or Latino | 27 | 79.41% |
| Minimum | 26 | Race | ||
| Maximum | 60 | American Indian or | ||
| Alaskan Native | 1 | 2.94% | ||
| Asian | 2 | 5.88% | ||
| Black or African | ||||
| American | 2 | 5.88% | ||
| White | 31 | 91.18% |
Table 1: Summary of Demographic Information
8
| Fitzpatrick Skin Type | |||
|---|---|---|---|
| I | 1 | 2.94% | |
| II | 13 | 38.24% | |
| III | 12 | 35.29% | |
| IV | 7 | 20.59% | |
| V | 3 | 8.82% | |
| VI | 2 | 5.88% |
At each clinical visit, digital images were taken of each subject's scars, before and after treatment. After the first treatment, on each subsequent treatment, objective and subjective data were obtained from patients regarding the occurrence of any adverse event or other sequel. On day 15, and day 31 imaging was performed before and after treatment. 90 days after the last treatment (day 31), grading images were graded by the following blinded graders: a Board Certified Dermatologist and two Board Certified Plastic Surgeons after completion of the study using the following assessment tools [Table 2]. Details of each of these assessment tools are provided below in Tables 3 and 4. The results of the study are provided in Tables 5 and 6.
Table 2: Study Endpoints
| Primary
Effectiveness
Endpoint | The primary endpoint was established as a 10 mm (10mm is the Minimal Clinical
Important Difference (MCID) for the validated Visual Analogue Scale)
improvement in the treatment side of the scar using the 100 mm validated VAS
scale observed by at least 2 out of 3 blinded graders compared to the non-
treatment side 90 days after last of 3 treatments. The treatment site photos were
also correlated to the graded non-treatment side control photos. |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary
Effectiveness
Endpoint | Self-assessed Scar Improvement Scale completed by subjects at 90 days after last
of 3 treatments on the same side. |
| | Subject Global Aesthetic Improvement Scale completed by subjects at 90 days
after last of 3 treatments on the same side. |
| Safety
Endpoint | Adverse event monitoring at each visit; treatment 2, treatment 3, 90 days after
treatment 3, and 6 months after treatment 3. |
The photo grading included the following effectiveness assessments using a 100 mm VAS scale:
Visual Analogue Scale (VAS) scar scoring system
Image /page/8/Figure/7 description: The image shows a scale from normal skin to poor scar. The scale ranges from 0 mm to 100 mm. The left side of the scale is labeled "Normal Skin" and the right side is labeled "Poor Scar."
Each subject had a scar on the abdomen that had been photographed and divided into a treatment and an untreated/control segment, roughly equal in length to each other. The scar was treated with microneedling on three separate treatment appointments at least 14 each of the three treatment appointments, a different cartridge array type was used, but the order was randomized and each subject had to receive one treatment from each of the three cartridges.
9
At 90 days after the last treatment, both sides of the scar (treated side and untreated/control side) were photographed. The photographs were not retouched and were arranged in pairs on Powerpoint@slides. Each slide contains two images from the same subject randomly arranged so that the grader did not know whether the slide with the two treated side images was presented before or after the slide with the two non-treated side images. Additionally, while both images on the slide came from the same subject, the grader did not know which image represented the before or after condition.
On each set of slides there was a horizontal, 100 mm line located under each image. This line represents a VAS scale where the far left end is marked as "0.0 mm" and represents "Normal Skin" and is marked at "100 mm" and represents a "Poor Scar".
Each of the three graders, comprised of a Board Certified Dermatologist and two Board Certified Plastic Surgeons were asked to view each slide and grade each image by using a mouse to grab the vertical line and place it on the horizontal VAS scale line in a position that indicated his/her professional opinion of the relative condition of the scar observed in the image.
In addition to the clinician graded effectiveness measures, the following patient-reported measures were recorded throughout the study:
| Rating | Description |
|---|---|
| -1 | Exacerbation of scars |
| 0 | No change in appearance of scars |
| 1 | 1% - 25% improvement in appearance of scars |
| 2 | 25% - 50% improvement in appearance of scars |
| 3 | 50% - 75% improvement in appearance of scars |
| 4 | 75% - 99% improvement in appearance of scars |
Table 3: Self-assessed Scar Improvement Scale
Table 4: Subject Global Aesthetic Improvement Scale
| Rating | Description |
|---|---|
| 1 | Very Much Improved: Optimal cosmetic result. |
| 2 | Much Improved: Marked improvement in appearance from the |
| initial condition, but not completely optimal. | |
| 3 | Improved: Obvious improvement in appearance from initial |
| condition. | |
| 4 | No Change: The appearance is essentially the same as the |
| original condition. | |
| 5 | Worse: The appearance is worse than the original condition. |
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Primary Endpoint Results
From the evaluation of the patient data collected during the study, the mean difference in VAS scores on the treatment side was found to be greater than the mean difference in VAS scores on the control side. This result indicates that the SkinStylus SteriLock®McroSystem was found to improve the appearance of abdominal scars, measured using the VAS scar scoring system. The Mnimal Cinically Important Difference (MCD) has been established as an improvement of at least 10 mm out of 100 mm (the entire VAS length).
The primary end point was established as a 10 mm (10 mm is the VAS) improvement in the treatment side of the scar using the 100 mm validated VAS scale observed by at least 2 out of 3 blinded graders compared to the nontreatment side. Out of the 30 abdomen subjects that completed the trial and had their abdomen treated, 22 subjects had at least a 10 mm improvement, compared to the non-treated side, according to at least 2 of the 3 blinded evaluators. This results in a responder rate of 73% with 95% CIfrom 58% to 89%.
The visual improvements seen in the photo grading results after the last treatment, were considered to be clinically meaningful as the non-treatment side was also graded and compared against the treatment side results.
Table 5: Responder rates by Fitzpatrick Skin Type according to VAS improvement of 10mm Minimum Clinically Important Difference (MCID) by at least 2 out of 3 graders.
| Fitzpatrick Skin Type | # of subjects in Fitzpatrick Skin Type | # of responders | Percent responding | 95% CI for responder rate (%) |
|---|---|---|---|---|
| Skin Type I to III | 18 | 12 | 67% | (45, 88) |
| Skin Type IV to VI | 12 | 10 | 83% | (62,100) |
Table 6: Responder rates by age group according to VAS improvement of 10mm Minimal Clinically Important Difference (MCID) by at least 2 out of 3 graders.
| Age Group | # of subjects in age group | # of responders | Percent responding | 95% CI for responder rate (%) |
|---|---|---|---|---|
| 21 to 40 years old | 9 | 8 | 89% | (68, 100) |
| 41 to 50 years old | 10 | 7 | 70% | (42, 99) |
| 51 to 60 years old | 10 | 7 | 64% | (35, 92) |
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Table 7: Responder rates by age of scar group according to VAS improvement of 10mm Mnimal Clinically Important Difference (MCID) by at least 2 out of 3 graders.
| Age of scar | # of subjects
with scar in
age range | # of responders | Percent responding | 95% CI for
responder
rate (%) |
|--------------------------|--------------------------------------------|-----------------|--------------------|-------------------------------------|
| 0 to 105
months old | 22 | 17 | 77% | (60, 95) |
| 106 to 180
months old | 5 | 3 | 60% | (17,100) |
| 181 to 240
months old | 3 | 2 | 67% | (13,100) |
Secondary Endpoint Results
The patient survey results for the Self-Assessed Scar Improvement Scale (SASIS) survey and for the Subject Global Aesthetic Improvement Scale (SGAIS) survey are reported in Tables 8 and 9, respectively.
In the SASIS survey, scores of 1, 2, 3, and 4 indicate perceived improvement in the scar appearance (improvement between 1% and 100%), while a score of -1 means the scar appears worse and a score of 0 means the scar appears unchanged. In the SGAS survey, scores of 1, 2, and 3 indicate perceived improvement in the scar appearance (very much improved, much improved, and improved), while a score of 4 means the scar is unchanged and a score of 5 means the scar appears worse. Both surveys were evaluated as a measure of consistency in the patient results.
Out of the 30 subjects that completed the trial and had their abdomen treated, 28 had SASIS scores of 1 or greater indicating that they were satisfied with the treatment (93% with 95% Cl from 84% to 100%.)
Out of the 30 subjects that completed the trial and had their abdomen treated, 19 had SASIS scores of 3 or greater indicating the they had seen a scar improvement higher than 50% (63% with 95% Clfrom 46% to 81%.)
Out of the 30 subjects that completed the trial and had their abdomen treated, 27 had SGALS of 3 or lower indicated that they were satisfied with the treatment (90% with 95% Clfrom 79% to 100%.
Both surveys corroborated the results that patients were satisfied and saw improvement in the scar appearance after the three SkinStylus SteriLock®MicroSystem treatments.
| Rating | |||||||
|---|---|---|---|---|---|---|---|
| -1 | |||||||
| Exacerbation | |||||||
| of scars | 0 | ||||||
| No change | |||||||
| in | |||||||
| appearance | |||||||
| of scars | 1% - 25% | ||||||
| improvement | |||||||
| in | |||||||
| appearance | |||||||
| of scars | 26% - 50% | ||||||
| improvement | |||||||
| in | |||||||
| appearance | |||||||
| of scars | 51% - 75% | ||||||
| improvement | |||||||
| in | |||||||
| appearance | |||||||
| of scars | 76% - 100% | ||||||
| improvement | |||||||
| in | |||||||
| appearance | |||||||
| of scars | |||||||
| Number | |||||||
| of | |||||||
| subjects | 0 | 2 | 5 | 4 | 13 | 6 | |
| Percentage | |||||||
| of | |||||||
| subjects (%) | 0 | 6 | 17 | 13 | 43 | 20 |
Table 8. Self-assessed Scar Improvement Scale Results
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| Rating | |||||
|---|---|---|---|---|---|
| 1 | |||||
| Very Much | |||||
| Improved: | |||||
| Optimal | |||||
| cosmetic result. | 2 | ||||
| Much Improved: | |||||
| Marked | |||||
| improvement in | |||||
| appearance from | |||||
| the initial condition, | |||||
| but not completely | |||||
| optimal. | 3 | ||||
| Improved: | |||||
| Obvious | |||||
| improveme | |||||
| nt in | |||||
| appearance | |||||
| from initial | |||||
| condition. | 4 | ||||
| No Change: | |||||
| The | |||||
| appearance | |||||
| is essentially | |||||
| the same as | |||||
| the original | |||||
| condition. | 5 | ||||
| Worse: | |||||
| The appearance | |||||
| is worse than | |||||
| the original | |||||
| condition. | |||||
| Number of subjects | 6 | 8 | 13 | 3 | 0 |
| Percentage of | |||||
| subjects (%) | 20 | 27 | 43 | 10 | 0.00 |
Table 9. Subject Global Aesthetic Improvement Scale Results
Safety Information and Adverse Events Results
Safety information (including images taken before and after treatment) was collected throughout the study during each subsequent visit via patient interviews. Additionally, patients were contacted by a study team member within 6 hours after each treatment and asked about their treatment experience. Common treatment responses are side effects that result from treatment which resolve on the order of days. Common treatment responses that persist were defined and categorized as adverse events when assessed by the investigator at the next visit. Subjects were informed of the following potential common treatment responses in the informed consent process: skin will be red and flushed similar to a moderate sunburn, skin tightness and mild sensitivity to the ss, burning, tinging, itching, and/ or scaling/dryness, edema (swelling), tenderness/discomfort, a possibility of developing an infection (an increase in redness, warmth, itching, or pus formation). Adverse events were assessed by the investigator at each subsequent visit. At the 6-month post-treatment visit, no adverse events persisted.
Safety Endpoint: Common treatment responses (CTRs) reported during the study:
There were 10 out of 30 subjects (33% with 95% CI from 17% to 50%) who completed the trial and had their abdomen treated that experienced common treatment responses. Some subjects experienced more than one CTR. The following CTRs were reported:
Scabbing/peeling: There were 2 out of 30 (7%) subjects who completed the trial and had their abdomen treated who presented scabbing/peeling symptoms that lasted up to 6 days after treatment.
Dryness: There were 4 out of 30 (13%) subjects who completed the trial and had their abdomen treated that presented dryness symptoms that lasted up to 8 days after treatment.
Discomfort: There were 2 out of 30 (7%) subjects who completed the trial and had their abdomen treated that presented discomfort symptoms that lasted up to 2 hours after treatment.
Redness/Swelling: There were 6 out of 30 (20%) subjects who completed the trial and had their abdomen treated that presented redness/swelling symptoms that lasted up to 4 days after treatment.
13
Adverse Events: There were 2 out of 34 subjects who completed the trial and presented adverse events (hyperpigmentation - one subject Fitzpatrick Skin Type II and one subject Fitzpatrick Skin Type II). The incidence of adverse events (hyperpigmentation) was 6% with 95% CIfrom 0% to 14% in the 34 subjects that completed the trial. As stated above, at the 90 day after initial treatment visit, 2 subjects (2/34, 6%) reported hyperpigmentation in the area of the treated side of the scar that had persisted since treatment on day 31. However, at the 180 day safety visit, both subjects reported that the hyperpigmentation had resolved. This hyperpigmentation adverse event that resolved within the six month safety period was not unexpected, as similar reports of hyperpigmentation that resolves within six months has been reported in the literature5. No other patient reported any other adverse event and the investigators did not observe any other adverse event when examining the subject as well as the images taken before and after each treatment visit.
Non-Clinical Test Reports
The following tests were performed on the SkinStylus SteriLock® MicroSystem device.
| Test Completed | Standard |
|---|---|
| BiocompatibilityA | |
| Cytotoxicity - ISO 10993-5:2009 | |
| Sensitization - ISO 10993-10:2010 | |
| Irritation - Intracutaneous Injection Test GLP |
- ISO 10993-10:2010 |
| | Acute Systemic Toxicity – Systemic
Injection GLP - ISO 10993-11:2017 |
| | Material-Mediated Pyrogenicity ISO 10993 |
| | Metallurgical Analysis – GLP - ASTM E1019-
11(Method A)(C/S Analyzer) |
| Sterilization ValidationB | Sterilization of Health Care Products –
Moist heat ISO 17665-1:2006
Sterilization of Medical Devices ISO 11737-
1: 2006 Sterilization of Medical Devices
ISO 11737-2: 2009
Sterility and Bacteriostasis/Fungistasis
Tests ISO 11737-2: 2009 and USP 71 |
| Reprocessing ValidationB | ISO 11737-1: 2018 (AAMI TIR-30; 2011;
AAMI TIR-12:2004)
Cleaning Validation
Intermediate-Level Disinfection
Validation
Autoclave Sterilization Validation |
| Fluid Ingress ValidationB | SkinStylus Sterilock Microsystem
Leak Testing Report from
MicroChem Laboratories |
| Shelf-life TestingB | Standard Test Method for Seal Strength of Flexible
Barrier Materials ASTM F88/F88M-15
Standard Test Method for Detecting Seal Leaks in
Porous Medical Packaging by Dye Penetration
ASTM F1929-15 |
| | Standard Test Method for Microbial Ranking
of Porous Packaging Materials ASTM
F1608-16 |
| Electrical Safety and
Electromagnetic CompatibilityC | IEC 60601-1-2 and 60601-1 |
| Depth Penetration ValidationD | Internal Method - Depth Penetration Report |
| Needle Reciprocal Rate Validation | Internal Method - Needle Reciprocal Rate Report |
Table 1 Summary of Non-Clinical Performance Testing
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A Mitigation measure for adverse tissue reaction.
B Mitigation measure for cross-contamination and infection.
C Mitigation measure for electrical shock or electromagnetic interference with other devices. 9 Mitigation measure for Damage to underlying tissue including nerves and blood vessels, scarring, and hyper/hypopigmentation due to exceeding safe penetration depth or mechanical failure.**
**NOTE: The proposed device contains NO software
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Summary of Substantial Equivalence
The SkinStylus SteriLock® MicroSystem and the predicate are for similar uses and rely on the same mode of action. Both devices include disposable needle cartridges with design features to mitigate the likelihood of cross-contamination between patients and to prevent needle depth greater than 2.5mm. Both devices also include a redundant safety feature to ensure no fluid enters the motor or housing. The clinical trial conducted on the proposed device confirms that while there may be differences in technology and indications for use, the subject device is as safe and as effective as the predicate.