(165 days)
Not Found
No
The device description and performance studies focus on the mechanical action of microneedling and physician-based assessment of results, with no mention of AI or ML in the device's operation or analysis. The use of digital photographs and physician grading is a standard clinical assessment method, not indicative of AI/ML.
Yes
The device is intended for the treatment of wrinkles, which is a medical condition or symptom, thus making it a therapeutic device.
No
Explanation: The device description and intended use clearly state that the Exceed is a microneedling device intended for the treatment of wrinkles, not for diagnosing them. While photographs are taken to assess the results of the treatment, the device itself does not perform any diagnostic function.
No
The device description clearly outlines multiple hardware components including a control unit, handpiece, needle cartridge, footswitch, and power supply. While digital image analysis is mentioned in the performance studies, the core device is a physical microneedling system.
Based on the provided information, the Exceed microneedling device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for the treatment of wrinkles in specific facial areas and skin types. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device description details a mechanical microneedling system designed to create physical punctures in the skin. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is characteristic of IVDs.
- Function: The device's function is to physically stimulate the skin for therapeutic effect. It does not perform tests or provide information about a patient's health status based on in vitro analysis.
While the study mentions the use of digital photographs (VISIA) and physician assessments using a grading scale, these are methods for evaluating the effectiveness of the treatment (a therapeutic outcome), not for diagnosing a condition using in vitro methods. The image processing is used to assess the physical changes in the skin after treatment, not to analyze biological markers.
N/A
Intended Use / Indications for Use
The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
Product codes (comma separated list FDA assigned to the subject device)
QAI
Device Description
The Exceed micro needling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless-steel nicro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece holder, Handpiece cover, Footswitch, Power supply. The control unit switches the device on and off and contains the power source (5.5-12 V, DC (150mA)). The control unit adjusts the frequency of the needle strom 100-150Hz using a digital display and a kevpad. The control unit receives power via a coaxial connector from a standard 100-240V, 50-60Hz, 1.2A wall socket transformer with an output of 15V. The handpiece contains a motor that moves the needles and a needle protrusion dial that allows the user to control the depth of the needle protrusion. The handpiece contains a scale that allows for the needle protrusion depth to be adjusted by the operator. The scale has a tolerance of £0.15 mm. The standard safety needle cartridge is a 6-stainless steel micro needle plate of 1.5 mm length. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use only. This standard safety needle cartridge is used for microneedling only. The length of needles is 1.5 mm. In combination with the handpiece needle protrusion can be adjusted between 0.0 mm (min) and 1.5 mm (max).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Facial areas: glabellar frown lines, periorbital lines and cheek folds.
Indicated Patient Age Range
adults aged 22 years or older.
Intended User / Care Setting
Prescriptive Use. Treatments were conducted by medically trained healthcare professionals.
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 clinical study was conducted to support the safety and effectiveness of the Exceed Micro needling device for the treatment of facial wrinkles. The objective of the study was to assess the effectiveness of the Exceed micro needling device in reducing the signs of skin aging as measured by the improvement in wrinkles, after 4 standardized treatment sessions and to assess the safety of the device as measured by the number of adverse events. The study was conducted at a single center. Forty-eight subjects were recruited for the study and 48 subjects completed the study. The average age of the subjects was 51.1 years (age range 39-67). Predominantly the population was female (1/48 (2%) subjects were male). The study included subjects with Fitzpatrick skin types I to III and V. None of the subjects were smokers. No subjects with Fitzpatrick skin type IV or VI were included in the study. No subject dropped out during the treatment phase of the study or during the follow-up. All subjects who were enrolled into the study and completed all treatment visits were included in the assessment and analysis.
At each visit digital photographs (VISIA) were taken of the subject's face and the principal investigator assessed facial photodamage (including wrinkles) using a validated scale (Lemperle (2001)*. At the end of the study the digital images of the subject's face were randomized and analyzed independently by 3 physicians using the same grading scale (Lemperle (2001). The Lemperle grading scale divides the face into 9 regions and scores each facial area for the signs of aging using a photonumeric scale (0-5) reference pictures where 0 indicates no wrinkles at rest and 5 being deep wrinkles at rest.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Clinical performance testing.
Sample Size: 48 subjects recruited and completed the study.
Key Results - Safety:
- In 13 out of 48 subjects (27%) adverse events were reported during the study. Nine (9) adverse events were related to the treatment (8 herpes simplex labialis (HSL) outbreaks and 1 dry skin).
- Following treatment, 48/48 (100%) of subjects experienced erythema. Physician grading of erythema immediately after the treatment was recorded as minor in 70% (34/48) of subjects. The remainder of subjects were graded as moderate by the physician.
- Subjects indicated that although the treatment appeared to be moderately painful (average pain score 5.2/10) it was not particularly uncomfortable (average discomfort score 1.3/10).
- Erythema, pain, and discomfort lasted up to 8 days, with percentages of subjects still reporting issues decreasing significantly by day 8. Skin peeling was experienced by 100% of subjects from day 3, reaching a maximum on day 4, and still reported by 65% of subjects by the evening of day 8.
Key Results - Effectiveness:
- A blinded assessment by three blinded evaluators was performed using the Lemperle grading scale for wrinkles.
- Of the six facial areas evaluated (horizontal forehead lines, glabella frown lines, periorbital lines, cheek folds, nasolabial folds and upper lip lines), three areas achieved a clinically meaningful result.
- For glabella frown lines, periorbital lines and cheek folds, the mean value of change was > 1 grade improvement in the grading scale, which was statistically significant.
- Glabella Frown Lines: 41/48 (85.4%) subjects graded as having a ≥1 grade improvement.
- Periorbital Lines: 42/48 (87.5%) subjects graded as having a ≥1 grade improvement.
- Cheek Folds: 43/48 (89.6%) subjects graded as having a ≥1 grade improvement.
- For horizontal forehead lines, nasolabial folds, and upper lip lines, the results did not demonstrate a clinically meaningful improvement at day 150.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Safety (Adverse Events):
- Related Adverse Events: 9 out of 48 subjects (18.75%).
- Incidence of Erythema: 100% of subjects.
- Physician-graded minor erythema: 70%.
- Physician-graded moderate erythema: 30%.
- Subject-graded moderate erythema: 40%.
- Subject-graded severe erythema: 60%.
- Average Pain Score (0-10 scale): 5.2 (range 3.8 to 6.1) during treatment.
- Average Discomfort Score (0-10 scale): 1.3 (range
§ 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.
September 7, 2018
MT. DERM GmbH % Susan D'Arcy Director Ismart Marketing Svcs 129 Green Lanes, Wylde Green Birmingham, B735LT Gb
Re: K180778
Trade/Device Name: Exceed Microneedling Device Regulation Number: 21 CFR 878.4430 Regulation Name: Microneedling device for aesthetic use Regulatory Class: Class II Product Code: QAI Dated: July 26, 2018 Received: August 6, 2018
Dear Susan D'Arcy:
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 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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
David Krause -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
2
Indications for Use
510(k) Number (if known) K180778
Device Name Exceed Microneedling device
Indications for Use (Describe)
The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skintypes I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds 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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3
510k Summary
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
Date Prepared: March 21st, 2018
Date Amended: September 6th 2018
Submitter's Name: MT.DERM GmbH
Submitter's Address: Gustav-Krone-Str. 3, 14167 Berlin, Germany Submitter's telephone number: +49 30 845 885 171 Contact person: Andreas Pachten, DIRECTOR QM and Regulatory Affairs
Device Trade Name: Exceed Microneedling device
1. Device Classification Information:
| Regulation
Number | Device
Classification
name | Device
Class | Product
Code | Generic description | Classification
Panel | Type |
|----------------------|----------------------------------------------|-----------------|-----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|------------------------|
| 21 CFR
878.4430 | Microneedling
device for
aesthetic use | Class 2 | QAI | 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. | General & Plastic
Surgery | Traditional
510 (k) |
Device Description 2.
The Exceed micro needling device is intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainless-steel nicro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece holder, Handpiece cover, Footswitch, Power supply
The control unit switches the device on and off and contains the power source (5.5-12 V, DC (150mA)). The control unit adjusts the frequency of the needle strom 100-150Hz using a digital display and a kevpad. The control unit receives power via a coaxial connector from a standard 100-240V, 50-60Hz, 1.2A wall socket transformer with an output of 15V. The handpiece contains a motor that moves the needles and a needle protrusion dial that allows the user to control the depth of the needle protrusion. The handpiece contains a scale that allows for the needle protrusion depth to be adjusted by the operator. The scale has a tolerance of £0.15 mm. The standard safety needle cartridge is a 6-stainless steel micro needle plate of 1.5 mm length. The safety needle cartridge is screwed into the handpiece. The safety needle cartridge is sterile and for single use only. This standard
4
safety needle cartridge is used for microneedling only. The length of needles is 1.5 mm. In combination with the handpiece needle protrusion can be adjusted between 0.0 mm (min) and 1.5 mm (max).
3. Indications/Intended Use
The Exceed is a microneedling device and accessories is intended for the treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
Caution: Federal law restricts this device to sale by or on the order of a physician.
4. Predicate Device
DEN160029 SkinPen Precision System
SkinPen Precision System DEN160029 is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in adults aged 22 years or older.
The Exceed Micro needling device is predicated against the SkinPen Precision System because both devices are microneedling devices containing one or more needles to mechanically puncture and injure the skin tissue for aesthetic use.
5
MT.DERM
K180778
5. Technological Characteristics
| Property | Exceed Microneedling device | DEN160029
SkinPen Precision System | Significant differences |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Manufacturer | MT.DERM GmbH
Gustav-Krone-Str. 3,
14167 Berlin, Germany | Bellus Medical, LLC, 4505
Excel Parkway, Suite 100,
Addison, TX 75001 | Not applicable |
| Device Trade Name | Exceed Microneedling device | SkinPen Precision System | Not applicable |
| 510(K) Number | K180778 | DEN160029 | Not applicable |
| Device Classification name | Microneedling device for
aesthetic use | Microneedling device for
aesthetic use | Identical |
| Device Product Code | QAI | QAI | Identical |
| Device Classification | Class II | Class II | Identical |
| Regulation number | 21 CFR 878.4430 | 21 CFR 878.4430 | Identical |
| Use | Prescriptive | Prescriptive | Identical |
| Intended Location of Use | Face | Face | Identical |
| Property | Exceed Microneedling
device | DEN160029
SkinPen Precision
System | Significant differences |
| Intended use and
Indications | The Exceed is a
microneedling device and
accessories is intended for
the treatment of wrinkles in
Fitzpatrick skin types I, II
and/or III in the following
facial areas: glabellar frown
lines, periorbital lines and
cheek folds in adults aged 22
years or older. | SkinPen® Precision System is
a microneedling device and
accessories intended to be used
as a treatment to improve the
appearance of facial acne scars
in adults aged 22 years or
older. | Dissimilar – Clinical performance
data provided demonstrates that the
Exceed Microneedling device is safe
and effective in the treatment of
facial wrinkles in Fitzpatrick skin
types I, II and/or III and raises no
new issues in terms of safety and
effectiveness. |
| Geometry | 6 needles, squared
arrangement | 14 needles, radial arrangement | Dissimilar. Clinical and non-clinical
performance testing demonstrates
that the Exceed microneedling
device does not pose any undue or
additional risks and is effective. |
| Needle protrusion
setting | 0 - 1.9 mm | 0 - 2.5 mm | Dissimilar. Clinical and non-clinical
performance testing demonstrates
that the Exceed microneedling
device does not pose any undue or
additional risks and is effective. |
| Needle protrusion
setting | 0 - 1.9 mm | 0 - 1 needle that mechanically punctures and injures the skin for aesthetic use.
- Both devices are intended for prescriptive use. ii.
- iii. The depth of penetration of the needles in clinical studies were equivalent 1.5mm
6.2. Differences.
- iv. Although the devices share the basic generic description and technologies they do differ in several areas.
- Intended use and indication a.
- b. Geometry and needle count
- Needle protrusion setting c.
- Maximum needle length d.
- e. Maximum needle penetration
- Frequency f.
- Treatment protocol g.
These differences have been addressed by the manufacturer through the applicable safety standards (General controls and mitigation measures) and through clinical and non-clinical performance testing (Special controls).
7. Non-clinical performance testing
To demonstrate safety and effectiveness and support substantial equivalence the Exceed Microneedling device has undergone non-clinical performance testing in line with recognized standards in terms of general requirements, biocompatibility, electrical safety and software.
8
In combination with the general controls of the FD&C Act, the microneedling device for aesthetic use is subject to the following special controls:
- The technical specifications and needle characteristics are identified, including needle length, geometry, 1. maximum penetration depth, and puncture rate.
-
- Non-clinical performance data demonstrates that the device performs as intended under anticipated conditions of use.
The following performance characteristics are tested:
- i. Accuracy of needle penetration depth and puncture rate in pig skin with high-speed camera measurement;
- ii. Safety features built into the device to protect against cross-contamination, including fluid ingress protection due to a safety membrane: and
- iii. Identification of the maximum safe needle penetration depth for the device in pig skin with high-speed camera measurement.
-
- Performance data demonstrates the sterility of the patient-contacting components of the device according to ISO 11135-1:2007, ISO/TS 11135-2:2008 and ISO 11737-1:2006.
-
- Performance data supports the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the intended shelf life according to ISO 11607-1:2006+A1:2014 and ISO11607-2:2006+A1:2014.
-
- Performance data demonstrates the electrical safety and electromagnetic compatibility (EMC) of all electrical components of the device according to ISO 60601-1:2012 and ISO 60601-1-2:2014 (ed 4.0).
-
- Software verification, validation, and hazard analysis werre performed for all software components of the device according to ISO 62304:2006 (ed 1.0).
-
- The patient-contacting components of the device were demonstrated to be biocompatible including evaluation of cytotoxicity, irritation, and sensitization, acute systemic toxicity and material-mediated pyrogenicity per the FDA guidance document "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.
-
- A cleaning validation was performed for reusable components of the device. (Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.)
-
- Labeling included 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
- Shelf life. v.
-
- Patient labeling included:
-
- 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. Post-operative care instructions.
8. Clinical performance testing
A clinical study was conducted to support the safety and effectiveness of the Exceed Micro needling device for the treatment of facial wrinkles.
The objective of the study was to assess the effectiveness of the Exceed micro needling device in reducing the signs of skin aging as measured by the improvement in wrinkles, after 4 standardized treatment sessions and to assess the safety of the device as measured by the number of adverse events.
9
The study was conducted at a single center. Subjects were treated 4 times, 30 days apart (Day 0, 30, 60 and 90) with final assessment 60 days after the last treatment at 150 days.
Treatments were conducted by medically trained healthcare professionals.
The face was cleansed and a numbing cream containing a local anesthetic was applied to the skin for 30 minutes. After 30 minutes the numbing cream was removed from the patient's face and a small quantity of hydrogel was applied prior to the treatment to protect the skin against abrasion and friction during the procedure. The operator was instructed to start at the lowest needle depth setting and gradually increase the depth until pin point bleeding was observed with a maximum needle depth of 1.5 mm. Following the treatment, the skin was cleansed with warm water and sterile gauze. A physical sunblock (SPF≥ 40) was applied to the skin.
Demographics:
Forty-eight subjects were recruited for the study and 48 subjects completed the study. The average age of the subjects was 51.1 years (age range 39-67). Predominantly the population was female (1/48 (2%) subjects were male). The study included subjects with Fitzpatrick skin types I to III and V. None of the subjects were smokers (table i). No subjects with Fitzpatrick skin type IV or VI were included in the study.
No subject dropped out during the treatment phase of the study or during the follow-up. All subjects who were enrolled into the study and completed all treatment visits were included in the assessment and analysis.
| Analysis | Age | M:F | Smoke | Fitzpatrick Skin type | ||||
|---|---|---|---|---|---|---|---|---|
| Mean | Range | I | II | III | V | |||
| N = 48 | 55.1 | 39 - 67 | 1:47 | 0 | 3 | 36 | 8 | 1 |
Table i - Demographic characteristics
10
Measurement of effectiveness
At each visit digital photographs (VISIA) were taken of the subject's face and the principal investigator assessed facial photodamage (including wrinkles) using a validated scale (Lemperle (2001)*. At the end of the study the digital images of the subject's face were randomized and analyzed independently by 3 physicians using the same grading scale (Lemperle (2001). The Lemperle grading scale divides the face into 9 regions and scores each facial area for the signs of aging using a photonumeric scale (0-5) reference pictures where 0 indicates no wrinkles at rest and 5 being deep wrinkles at rest.
"Lemperle G, Holmes RE, Lemperle SS. A Classification of Facial Wrinkles. Plastic and reconstructive surgery. 2001 Nov 1;108(6):1735-50
Measurement of safety
Immediately after each micro needling procedure the principal investigator was asked to grade the amount of visible erythema in the treatment area. Grading was carried out using a 5-point grading scale;
- None: No erythema or redness. Skin is normal color.
- Minor: very faint erythema or redness. Skin has a slight redness to it.
- . Mild: blotchy, visible redness that does not cover the entire face. Skin has a noticeable inconsistent redness to it.
- . Moderate: dull red color to the skin. Skin has a very definite redness to it.
- . Severe: Bright or dark red color to the skin. Skin is severely red.
Subjects also graded their erythema immediately after each micro needling procedure and in addition graded pain and discomfort experienced during the treatment procedure. A descriptive grading scale was used for subjects to evaluate their erythema with the addition of photography depicting grades of erythema in different phototypes.
This photonumeric scale was also used for subjects to record their erythema at home.
Pain and discomfort were recorded using an 11-point visual analogue scale (0-10) where 0 was equivalent to "ho pain" or "no discomfort" to 10, "most intense pain ever" and "most discomfort ever". This grading structure was also used to record changes to pain and discomfort from the evening of the treatment to Day 8 (7 days after the treatment). In addition, skin peeling was assessed by the patient from day 3 to day 8 using a visual analogue scale where 0 represented "no skin peeling or flakiness" to 10 "heavy skin peeling over the whole face." During all times any potential adverse events were recorded by the research staff.
Results - Safety - Physician reported outcomes
In 13 out of 48 subjects (27%) adverse events were reported during the study (table ii).
Nine (9) adverse events were related to the treatment. Eight (8) were herpes simplex labialis (HSL) outbreaks and 1 adverse event was dry skin. Of the 8 HSL outbreaks, 5 occurred in subjects with Fitzpatrick skin type 2, 2 occurred in skin type 3 and 1 occurred in skin type V. One subject (skin type 2) reported extremely dry skin which was selflimiting and not reported again by the subject.
Note: Thirteen (13) out of 48 subjects (27%) reported a predisposition to HSL at the beginning of the study. Of this predisposed population, an HSL outbreak was observed in 8 subjects were treated for their HSL using conventional antiviral thereafter were given prophylactic antiviral therapy prior to the micro needling procedure. There were no further reported outbreaks.
11
| Severity of adverse event | |||||||
|---|---|---|---|---|---|---|---|
| Event | Mild | Moderate | Severe | Total | |||
| Related to | Not-related to | Related | Non- | Related | Non- | Related | |
| the device | the device | related | related | + | |||
| (R) | (NR) | Non- | |||||
| related | |||||||
| Herpes Labialis n=8 | 8 (100%) | 0 | 0 | 0 | 0 | 0 | 8 |
| Dry skin n=1 | 1 | ||||||
| (100%) | 0 | 0 | 0 | 0 | 0 | 1 | |
| Cold/Flu n=2 | 0 | 2 | |||||
| (100%) | 0 | 0 | 0 | 0 | 2 | ||
| Surgery n=2 | 0 | 2 | |||||
| (100%) | 0 | 0 | 0 | 0 | 2 | ||
| Total | 9 | 4 | 0 | 0 | 0 | 0 | 13 |
Table ii. Adverse event - summary of observations and rate
Following treatment, 48/48 (100%) of subjects experienced erythema. Physician grading of erythema immediately after the treatment was recorded as minor in 70% (34/48) of subjects. The remainder of subjects were graded as moderate by the physician.
Results - Safety - Patient reported outcomes
Subjects were also asked to grade their erythema immediately at the treatment. Nineteen out of 48 (40%) subjects graded their skin redness as moderate and 29/48 (60%) subjects as severe (table iii).
| Table iii. Erythema assessment by physician and subject immediately after treatment | |||
|---|---|---|---|
| Grading of erythema | |||
| immediately after | |||
| treatment | Grading | ||
| Minor | Moderate | Severe | |
| Physician | 34/48 (70%) | 14/48 (30%) | 0 |
| Subject | 0 | 19/48 (40%) | 29/48 (60%) |
Subjects indicated that although the treatment appeared to be moderately painful it was not particularly uncomfortable (table iv).
Table iv. Pain and discomfort experienced during the treatment
| Subject assessment of pain and discomfort during the treatment
(average over 4 treatments) | Pain score¹
(range) |
|-----------------------------------------------------------------------------------------------|------------------------|
| Pain during treatment | 5.2 (3.8 to 6.1) |
| Discomfort during treatment | 1.3 ( 1 grade improvement in the grading scale (see Table v). This change was statistically significant. For horizontal
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forehead lines, nasolabial folds, and upper lip lines, the results did not demonstrate a clinically meaningful improvement at day 150.
| | Glabella Frown Lines
n (%) | Periorbital Lines
n (%) | Cheek Folds
n (%) |
|--------------------------------------------------------|-------------------------------|----------------------------|----------------------|
| Subjects graded as
having a ≥1 grade
improvement | 41/48 (85.4%) | 42/48 (87.5%) | 43/48 (89.6%) |
| Subjects graded as
unchanged
(Change = 0) | 7/48 (14.6%) | 6/48 (12.5%) | 5/48 (10.4%) |
| Subjects graded as
worsened | 0/48 (0%) | 0/48 (0%) | 0/48 (0%) |
Table v Comparison of Grade on the Lemperle Scale at Baseline and Day 150 by Three Blinded Assessors (primary endpoint)
For glabella frown lines, periorbital lines and cheek folds an improvement of >1 grade was shown for 18/48 (37.5%), 20/48 (41.7%) and 17/48 (35.4%) subjects (see Table v).
9. Statement of Substantial Equivalence:
MT.DERM GmbH has demonstrated that the Exceed Microneedling device has the same generic classification (generic description) and basic technologies as the predicate device DEN160029. Both devices are micro needling devices containing >1 needle that mechanically punctures or injures the skin for aesthetic use. Both devices have used needle depths of up to 1.5mm in clinical investigations.
Where there are differences between the Exceed micro needling device and the predicate (DEN160029) MT.DERM GmbH has conducted substantial clinical and non-clinical performance testing applicable to those general and special controls deemed necessary by the agency for this product classification and has determined that the Exceed microneedling device raises no new questions relating to safety or effectiveness and therefore has demonstrated that the Exceed microneedling device is substantially equivalent to the referenced predicate DEN160029.