(318 days)
Not Found
No
The device description and performance studies focus on the mechanical action of microneedling and physician/subject assessment of results, with no mention of AI or ML in the device's operation or analysis. The image processing mentioned is for physician assessment, not automated analysis.
Yes
Explanation: The device is intended to improve the appearance of facial acne scars, which is a treatment for a medical condition.
No
The device is a microneedling device intended for treatment to improve the appearance of facial acne scars, not for diagnosis.
No
The device description clearly outlines multiple hardware components including a control unit, handpiece, needle cartridge, footswitch, and power supply. While digital photographs are used for assessment, the core device is a physical microneedling system.
Based on the provided text, the Exceed device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Exceed's Intended Use: The Exceed device is intended to be used as a treatment to improve the appearance of facial acne scars. It is a physical device that directly interacts with the skin.
- Mechanism of Action: The device works by creating microscopic punctures in the skin using needles. This is a mechanical action, not a diagnostic test performed on a sample.
- No Mention of Sample Analysis: The description focuses on the device's physical components and how it is used on the skin. There is no mention of collecting or analyzing biological samples.
- Image Processing is for Assessment, Not Diagnosis: While digital photographs are taken and analyzed, this is done to assess the effectiveness of the treatment after the fact, not to diagnose a condition using a biological sample.
In summary, the Exceed device is a therapeutic device used for a cosmetic/medical treatment, not a diagnostic device used to analyze biological samples for the purpose of diagnosis.
N/A
Intended Use / Indications for Use
The Exceed is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV in adults aged 22 years or older.
Product codes
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 needles. The Exceed micro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece, 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 stroke from 100-150Hz using a digital display and a keypad. 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 gauge that allows the user to control the depth of the needle protrusion from 0 - 1.9mm. 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 a maximum of 1.5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital photographs (VISIA)
Anatomical Site
Face / facial
Indicated Patient Age Range
adults aged 22 years or older
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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 at a single center. 56 otherwise healthy volunteers with facial acne scarring were recruited. Subjects were assessed at baseline and 12 weeks after the last treatment. At each visit digital photographs (VISIA) were taken of the subject's face. At the end of the study the digital images of the subject's face were randomized and analyzed independently by 3 physicians using the Acne Scar Assessment Scale (ASAS). The ASAS scale is a validated 5-point photo numeric descriptive grading scale used to grade acne scarring.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical performance testing.
Sample Size: 56 otherwise healthy volunteers with facial acne scarring were recruited. 47 subjects (83.9%, (47/56)) completed all treatment and follow up visits.
Key Results - Effectiveness (Physician measurement): Results of the photograding using the Acne Scar Assessment Scale (ASAS) demonstrated that at baseline the mean population score was 2.89. At final follow up (3 months after the last treatment) the mean grade was 2.27.
Key Results - Effectiveness (Subject measurement):
- Self-assessed Scar Improvement Scale (SASIS): 38/43 (88%) of subjects reported some improvement in their acne scarring. 5/43 (12%) reported no improvement. No subjects reported a worsening of their acne scars.
- Subject Global Aesthetic Improvement Scale (SGAIS): 33/43 (77%) of subjects reported some improvement in their acne scarring. 10/43 (23%) reported that the appearance of their acne scarring was essentially the same as the original condition. No subjects reported that the appearance of their acne scars worsened.
- Additional questions of subject's satisfaction: 37 (86%) of subjects noticed improvement. 18 (41.9%) were satisfied, and 7 (16.3%) were extremely satisfied. 38 (88%) would recommend the treatment to friends and family.
Key Results - Safety: No serious adverse events were reported. No adverse events persisted at the final follow up. In 18 out of 56 subjects (32%), 26 adverse events were reported during the study. 22 were anticipated/expected and 4 were unanticipated/unexpected. 25 of 26 events (96%) were attributable to the test device. 23 of 26 (88.5%) were mild, and 3 of 26 (11.5%) were moderate. No adverse event was directly linked or resulted in study discontinuation. Bruising (6 events in 5 subjects) and swollen lymph-nodes (6 events in 3 subjects) were the most common adverse events.
Subject reported pain: Mean pain score of 2.8 (mean of 4 treatments, (range 0-9)) on the evening of treatment. Mean pain scores receded to
§ 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 contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 19, 2019
Mt. Derm GmbH % Susan D'Arcy Director Ismart Marketing Svcs 129 Green Lanes, Wylde Green Birmingham, B735LT Gb
Re: K182407
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 7, 2019 Received: July 9, 2019
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
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,
Cynthia Chang, Ph.D. Assistant Director 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) K182407
Device Name Exceed Microneedling device
Indications for Use (Describe)
The Exceed is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, II, III and IV 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
This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c).
Date Prepared: August 22nd 2018
Date amended: July 01th 2019
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) |
2. 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 needles. The Exceed micro needling device consists of 7 component parts; Control Unit, Sterile single use Safety needle cartridge, Handpiece, 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 stroke from 100-150Hz using a digital display and a keypad. 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 gauge that allows the user to control the depth of the needle protrusion from 0 - 1.9mm. 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
4
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 a maximum of 1.5 mm .
Indications/Intended Use 3.
The Exceed is a microneedling device and accessories intended to be used as a treatment to improve the appearance of facial acne scars in Fitzpatrick skin types I, III and IV in adults aged 22 years or older."
The device is a prescription use device and complies with 21CFR 801.109.
Predicate Device 4.
DEN160029 SkinPen Precision Microneedling 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 microneedling system because both systems are microneedling devices containing one or more needles to mechanically puncture and injure the skin tissue for aesthetic use.
5
Image /page/5/Picture/0 description: The image shows the text "MT.DERM" in white letters against a red background. The letters are sans-serif and appear to be slightly blurred, giving them a soft, glowing effect. The text is centered in the image and takes up most of the space.
5. Technological Characteristics
| Property | Exceed Microneedling
device | DEN160029
SkinPen Precision
Microneedling 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 | K182407 | 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 | Prescription use | Prescription use | Identical |
| Intended Location
of Use | Face | Face | Identical |
| Intended use and
Indications | The Exceed is a microneedling
device and accessories intended
to be used as a treatment to
improve the appearance of
facial acne scars in Fitzpatrick
skin types I, II, III and IV 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. | Substantially Equivalent |
| Property | Exceed Microneedling
device | DEN160029
SkinPen Precision
Microneedling system | Significant differences |
| Geometry | 6 needles, squared arrangement | 14 needles, radial arrangement | Dissimiliar. Clinical and Non-clinical
performance testing demonstrates that the
Exceed microneedling device does not
pose any undue or additional risks. |
| Needle protrusion
setting | 0 - 1.9 mm | 0 - 2.5 mm | Dissimilar in general, but maximum
needle penetration within the face for
both devices is 1.5mm. Clinical and Non-
clinical performance testing demonstrates
that the Exceed microneedling device
does not pose any undue or additional
risks. |
| Maximum needle
penetration
(maximum needle
length) | 1.5mm | 1.5 mm | Substantially equivalent. Both devices
use a maximum needle penetration length
of 1.5mm for the indication of treating
acne scars (Skinpen references a
capability of extending from 1.5mm to a
maximum of 2.5mm however this has not
been demonstrated to be safe and
effective for this indication
[Manufacturers claim1]. |
| Frequency | 100-150 Hz (±10%) | 6300RPM to 7700 RPM1
(105 - 128.3 Hz) | Dissimilar. Clinical and Non-clinical
performance testing demonstrates that the
Exceed microneedling device does not
pose any undue or additional risks. |
6
1 Data obtained from marketing material and user guide
6. Substantial Equivalency and Comparison of Technological Similarities & Differences
6.1. Key Similarities.
- i. The device classification (generic description) and basic technologies are equivalent in that both devices are micro needling systems containing >1 needle that mechanically punctures or injures the skin for aesthetic use.
- ii. Identical intended use.
- iii. Intended for prescription use.
- iv. Location of use (Face)
- The depth of penetration of the needles (needle length) is equivalent 1.5mm v.
6.2. Differences.
Although the systems share the basic generic description and technologies they do differ in several areas.
- Geometry and needle count a.
- b. Needle protrusion setting
7
c. Frequency
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).
- Geometry and needle count the difference in needle count and geometry has been a. addressed in terms of safety through specific non-clinical performance testing demonstrating that the needle geometry of the proposed device is uniform and clinical performance testing to demonstrate substantial equivalence. The difference in geometry and needle count does not raise any new questions in relation to safety or effectiveness compared to the predicate device.
- Needle protrusion setting the needle protrusion setting of the proposed device is within b. the range of the predicate device. The predicate device used a maximum of 1.5mm in its reported clinical study and Instructions for Use and therefore is comparable to the proposed device that does not exceed 1.5mm. Non- Clinical performance testing demonstrates the needle protrusion setting of the proposed device is reproduceable within the technical specifications of the device. Clinical performance testing demonstrates safety and effectiveness in use.
- Frequency the frequency range (oscillation) of the Exceed microneedling device is c. greater than the predicate device. In terms of performance testing the upper range of 150 Hz was considered to be worst case scenario and therefore relevant non-clinical performance testing has been carried out at this maximum setting. Results from these range of tests provides evidence that this difference does not raise any new concerns regards safe use of the device in its intended use. Clinical performance testing demonstrates safety and effectiveness in use.
Although there are differences between the proposed device and predicate device DEN160029 SkinPen Precision System where there are differences, General controls of the FD&C Act and "Special controls" including non-clinical and clinical performance testing demonstrate that the Exceed microneedling device raises no new questions in relation to safety and effectiveness compared to the predicate device.
8
MT.DERM
7. General controls and mitigation measures
To demonstrate safe and effective performance and support substantial equivalence the eystem has undergone a number of non-clinical performance tests in line with rems of general requirements, biocompatibility, electrical safety and software. The following non-clinical performance data is provided in support of the substantial equivalence determination.
7.1. Summary of Risk and mitigation measures
| Identified Risk to Health | Mitigation Measures | Evidence |
|---|---|---|
| Adverse tissue reaction | Biocompatibility evaluation | ISO 10993 – 5,2009 10993-7:2008, 10993-10:2010 and ISO 10993-11:2017(E) and USP 40 |
| Pyrogen Test, 2017 and 10993-12:2012 | ||
| FDA - Blue Book Memorandum #G95-1 | ||
| Labeling | ISO 15223-1:2012 | |
| EN 1041:2008 | ||
| IEC 82079-1:2012 | ||
| IEC62366:2007 | ||
| Sterilization validation | ISO11135-1:2007 | |
| ISO/TS11135-2:2008 | ||
| ISO11737-1:2006 | ||
| Cross contamination and | ||
| infection | Reprocessing validation | A cleaning validation was performed for reusable components of the device. (Reprocessing |
| Medical Devices in Health Care Settings: Validation Methods and Labeling) | ||
| Non-clinical performance testing | 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 highspeed camera measurement. | ||
| Shelf life testing | 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 | ||
| Labeling | ISO 15223-1:2012 | |
| EN 1041:2008 | ||
| IEC 82079-1:2012 | ||
| IEC62366:2007 | ||
| Identified Risk to Health | Mitigation Measures | Evidence |
| Electrical shock or | ||
| Electromagnetic interference | ||
| with other devices | EMC testing and electrical | |
| safety testing | IEC60601-1:2005 | |
| IEC60601-1-2:2014 | ||
| IEC60601-1-6:2010 | ||
| Labeling | ISO 15223-1:2012 | |
| EN 1041:2008 | ||
| IEC 82079-1:2012 | ||
| IEC62366:2007 | ||
| Damage to underlying tissue | ||
| including nerves and blood | ||
| vessels, scarring and hyper | ||
| and hypopigmentation. | ||
| Exceeding safe penetration | ||
| depth | ||
| Mechanical failure | Non-clinical performance testing | 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 highspeed camera measurement. | ||
| Software malfunction | Technological characteristics | 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 highspeed camera measurement. | ||
| Shelf life testing | ISO 11607 1:2006 | |
| ISO11607 2:2006 | ||
| Labeling | ISO 15223-1:2012 | |
| EN 1041:2008 | ||
| IEC 82079-1:2012 | ||
| IEC62366:2007 | ||
| Software verification, validation | ||
| and hazard analysis | IEC62304:2006 |
9
MT.DERM
10
8. Special Controls - Non clinical performance testing
In addition to the general standards and risk mitigation measures identified above, the Exceed Microneedling device has been subjected to the special controls outlined in 21 CFR 878.4430.
9. Clinical performance testing
A clinical study was conducted to support the safe and effective performance of the Exceed Microneedling device for the treatment of acne scars on the face.
The study was conducted at a single center. 56 otherwise healthy volunteers with facial acne scarring were recruited. Subjects underwent 4 micro needling sessions 4 weeks apart. Treatments were conducted by a medical physician.
Subjects were assessed at baseline and 12 weeks after the last treatment.
The subjects face was cleansed using a skin disinfecting product and numbed using a topical anaesthetic prior to the treatment. A sterile gel was applied to the subject's face to prevent abrasion and friction during the treatment. The physician was instructed to start with a minimum needle protrusion of 0.5 mm and increase until pinpoint bleeding was achieved. During the treatment blood was with a sterile saline solution, to prevent encrustation.
Forty-seven subjects (83.9%, (47/56)) completed all treatment and follow up visits.
The mean age of the subjects was 35.8 years (range 18-62 years). The study population was comprised of 18 (32.1%) males and 38 (67.9%) females. Fitzpatrick phototypes ranged from I -IV. No subjects with Fitzpatrick skin type V or VI were included in the study.
A summary of the subject demographics is given in Table 1.
Table 1: Subject demographics at baseline.
| All Subjects | ||
|---|---|---|
| N | 56 | |
| Age (years) | ||
| Mean (SD) | 35.8 (9.9) | |
| Minimum | 18 | |
| Median | 32 | |
| Maximum | 62 | |
| N | (%) |
11
| Sex | ||
|---|---|---|
| Male | 18 | 32.1 |
| Female | 38 | 67.9 |
| Fitzpatrick Skin Type | ||
| I | 1 | 1.8 |
| II | 29 | 51.8 |
| III | 20 | 30.8 |
| IV | 6 | 10.7 |
| Acne Scar Assessment Scale | ||
| Very mild (1) | 5 | 9 |
| Mild (2) | 14 | 25 |
| Moderate (3) | 21 | 37 |
| Severe (4) | 16 | 29 |
Measurement of effectiveness
Physician measurement of effectiveness
At each visit digital photographs (VISIA) were taken of the subject's face. At the end of the study the digital images of the subject's face were randomized and analyzed independently by 3 physicians using the Acne Scar Assessment Scale (ASAS). The ASAS scale is a validated 5-point photo numeric descriptive grading scale used to grade acne scarring (table 2).
| Table 2. Acne Scar Assessment Scale | |
|---|---|
| ------------------------------------- | -- |
| Grade | Term | Description |
|---|---|---|
| 0 | Clear | No depressions are seen in the treatment area. Macular discoloration may be |
| seen. | ||
| 1 | Very Mild | A single depression is easily noticeable with direct lighting (deep). Most or all |
| of the depressions seen are only readily apparent with tangential lighting | ||
| (shallow). | ||
| 2 | Mild | A few to several, but less than half of all the depressions are easily noticeable |
| with direct lighting (deep). Most of the depressions seen are only readily | ||
| apparent with tangential lighting (shallow). |
12
| Grade | Term | Description |
|---|---|---|
| 3 | Moderate | More than half of the depressions are apparent with direct lighting (deep). |
| 4 | Severe | All or almost all the lesions can be seen with direct lighting (deep). |
Subject measurement of effectiveness
At the end of the study period subjects were asked to grade the effectiveness of the treatment using the following subject reported measures.
-
- Self-assessed Scar Improvement Scale (SASIS)
-
- Subject Global Aesthetic Improvement Scale (SGAIS)
-
- Subject Satisfaction of treatment.
Measurement of Safety
During the study the physician recorded adverse events.
Using a subject diary, subjects graded their pain, discomfort and redness/swelling on the day of the treatment and thereafter daily until day 7. Pain and discomfort were recorded using an 11-point visual analogue scale (0-10) where 0 was equivalent to "no pain" or "no discomfort" to 10, "most intense pain ever" and "most discomfort ever". A descriptive grading scale was used for subjects to evaluate their skin redness with the addition of photography depicting grades of skin redness in different phototypes (table 3).
Table 3 Redness grading scale
| Grade | Description |
|---|---|
| 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. |
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Results – Safety
No serious adverse events were reported. No adverse events persisted at the final follow up. In 18 out of 56 subjects (32%), 26 adverse events were reported during the study (Table 4).
There were 22 anticipated or expected adverse events and 4 unanticipated or unexpected adverse events. Three of the unexpected adverse events were attributable to the device (n=2) and bleeding of treatment area 2 days post intervention (n=1). One unexpected event (fever and rigors) was not attributable to the device.
Of the 26 reported events, 23 of 26 (88.5%) were recorded as mild, and 3 of 26 (11.5%) as moderate. All but one event (Fever and ague, 1 of 26 (3.8%)) was attributable to the test device. No adverse event was directly linked or resulted in study discontinuation.
Bruising (6 events in 5 subjects) and swollen lymph-nodes (6 events in 3 subjects) were the most common adverse events. Table 4 lists all adverse events.
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Table 4 – Adverse events
| Adverse Event (AE)
Category | Number of
Adverse
events | Number of
subjects | Adverse events in relation to the device | | Expected/
Unexpected | Fitzpatrick
skintype |
|-----------------------------------|--------------------------------|-----------------------|------------------------------------------|-------------|-------------------------|--------------------------------------|
| | | | Related | Non-Related | | |
| Bleeding 2 days post
treatment | 1 | 1 | 1 (100%) | 0 | Unexpected | FP III |
| Bruising | 6 | 5 | 6 (100%) | 0 | Expected | 4/5 FP II
1/5 FP III |
| Fever and ague | 1 | 1 | 0 | 1 (100%) | Unexpected | FP III |
| Flaking of the skin
surface | 3 | 1 | 3 (100%) | 0 | Expected | FP II |
| Headache | 2 | 2 | 2 (100%) | 0 | Unexpected | 1/2 FP II
1/2 FP III |
| Herpes simplex | 1 | 1 | 1 (100%) | 0 | Expected | FP III |
| Hyperpigmentation | 4 | 4 | 4 (100%) | 0 | Expected | 1/4 FP II
2/4 FP III
1/4 FP IV |
| Pustules and rash | 1 | 1 | 1 (100%) | 0 | Expected | FP III |
| Serous fluid leakage | 1 | 1 | 1 (100%) | 0 | Expected | FP II |
| Swollen lymph nodes | 6 | 3 | 6 (100%) | 0 | Expected | 1/3 FP II
2/3 FP III |
| All categories | 26 | 18 | 25 (96%) | 1 (4%) | | - |
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Subject reported outcomes - Pain and Discomfort
Subject evaluation of pain on the evening of the treatment showed a mean pain score of 2.8 (mean of 4 treatments, (range 0-9)). Mean pain scores receded to 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 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.