(604 days)
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Not Found
No
The summary describes a mechanical microneedling device and its accessories. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The clinical study involves image grading by dermatologists, which is a human-driven process, not an automated AI/ML analysis.
Yes.
The device is intended to be used as a treatment to improve the appearance of facial acne scars, indicating a therapeutic purpose.
No.
The SkinPen Precision System is a microneedling device intended for treatment to improve the appearance of facial acne scars, not for diagnosis.
No
The device description clearly outlines hardware components including a microneedling pen handpiece, sterile needle cartridge, charging base, and BioSheath. While there might be software controlling the device, the core functionality and components are hardware-based.
Based on the provided information, the SkinPen® Precision System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "improve the appearance of facial acne scars." This is a therapeutic or aesthetic purpose, not a diagnostic one.
- Device Description: The device is a microneedling system that physically interacts with the skin. IVDs typically involve testing samples (like blood, urine, or tissue) outside the body to diagnose or monitor a condition.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples or providing diagnostic information about a patient's health status.
- Clinical Study Focus: The clinical study evaluates the improvement in appearance of acne scars, which is a measure of treatment effectiveness, not diagnostic accuracy.
Therefore, the SkinPen® Precision System falls under the category of a therapeutic or aesthetic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
QAI
Device Description
The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen Precision) and a sterile needle cartridge (SkinPen Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen Precision System treatment kit is provided separately and contains the following:
- SkinPen Precision Cartridge: sterile, disposable needle cartridge. Not to be . resterilized or reused.
- . SkinPen BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen Precision
- . Lift HG: hydrogel wound dressing (without drugs and/or biologics) to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Facial
Indicated Patient Age Range
adults aged 22 years or older.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Digital images were taken of each subject's facial acne scars at each clinical visit (baseline, day 30, day 60 prior to treatment, and 1 month and 6 months follow-up). These images were graded by 2 separate Board Certified Dermatologists after completion of the study using the Acne Scar Assessment Scale and Clinician's Global Aesthetic Improvement Assessment (CGAIS).
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A clinical study was conducted at a single center to support the safety and effectiveness of the SkinPen Precision System for the treatment of acne scars on the face.
Sample size: 20 subjects for effectiveness evaluation, 41 subjects for safety evaluation.
Study type: Clinical study with efficacy determined by blinded dermatologists evaluating photographs and patient-reported outcomes.
Key results:
- Safety: No adverse events persisted at the 6-month post-treatment visit. One subject experienced skin striae possibly related to the device, which resolved. Common treatment responses (dryness, rough skin, tightness, redness, itching, peeling, discomfort, tenderness, burning) were reported and resolved.
- Effectiveness (Acne Scar Assessment Scale): At 6-months post-treatment, 7/20 (35%) subjects had a 1-grade reduction in the Acne Scar Assessment Scale. 11/20 (55%) subjects showed improvement (reduction greater than 0) at 6-months post-treatment. The mean population score improved from 2.80 at baseline to 2.35 at 6-months post-treatment.
- Effectiveness (Self-assessed Scar Improvement Scale): At 6-months post-treatment, 18/20 (90%) subjects reported some percentage of improvement in the appearance of their acne scars. Mean value was 1.70 (1%-25% improvement).
- Effectiveness (Subject Global Aesthetic Improvement Scale): At 6-months post-treatment, 2/20 (10%) subjects reported very much improved, 8/20 (40%) reported much improved, and 8/20 (40%) reported improved. Mean value was 2.50 (improved).
- Patient Satisfaction Questionnaire: At 6-months post-treatment, 18/20 (90%) subjects noticed improvement in their acne scars, 17/20 (85%) subjects were satisfied (Extremely Satisfied, Satisfied, or Slightly Satisfied) with the treatment, and 18/20 (90%) subjects would recommend the treatment to friends and family.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Acne Scar Assessment Scale:
- 1-grade reduction from baseline: 7/20 (35%) at 6-months post-treatment.
- Improvement greater than 0: 11/20 (55%) at 6-months post-treatment.
- Mean change at 6-months post-treatment: -0.45.
- Self-assessed Scar Improvement Scale:
- Subjects reporting some percentage of improvement: 90% (18/20) at 6-months post-treatment.
- Mean value at 6-months post-treatment: 1.70 (indicating 1%-25% improvement).
- Subject Global Aesthetic Improvement Scale:
- Very Much Improved, Much Improved, or Improved: 90% (18/20) at 6-months post-treatment.
- Mean value at 6-months post-treatment: 2.50 (indicating improved).
- Patient Satisfaction Questionnaire:
- Notice improvement in acne scars: 90.0% (18/20) at 6-months post-treatment.
- Satisfied with treatment (Extremely, Satisfied, Slightly): 85.0% (17/20) at 6-months post-treatment.
- Would recommend to friends and family: 90.0% (18/20) at 6-months post-treatment.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4430 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
DE NOVO CLASSIFICATION REQUEST FOR SKINPEN PRECISION SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Microneedling device for aesthetic use. 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.
NEW REGULATION NUMBER: 21 CFR 878.4430
CLASSIFICATION: II
PRODUCT CODE: QAI
BACKGROUND
DEVICE NAME: SkinPen Precision System
SUBMISSION NUMBER: DEN160029
DATE DE NOVO RECEIVED: July 5, 2016
| CONTACT: | Bellus Medical, LLC
4505 Excel Parkway
Suite 100
Addison, Texas 75001 |
| ---------- | -------------------------------------------------------------------------------- |
|---|
INDICATIONS FOR USE
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.
LIMITATIONS
The sale, distribution, and use of the SkinPen Precision System is restricted to prescription use in accordance with 21 CFR 801.109.
This product is not intended for transdermal (under the skin) delivery of topical products such as cosmetics, drugs, or biologics.
Safety and effectiveness for needle depth settings greater than 1.5 mm has not been evaluated.
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The SkinPen Precision System allows for incremental increase in settings of up to 2.5 mm to allow for the variability in thickness of healthy skin and acne scar tissue. However, the device has not been clinically evaluated at cartridge settings of greater than 1.5 mm. As there are fine structures (i.e., nerve branches and accompanying blood vessels) that run under the skin and are essential to proper tissue function, it is not recommended to treat at needle depths greater than 1.5mm. It is essential that the thickness of the patient's skin in each anatomical area to be treated is assessed by a qualified clinician to address any potential risk of injuring these structures. Such structures include (but are not limited to) the supraorbital nerve (the terminal branch of the frontal nerve that provides the sensory innervations for the forehead, mucosa of frontal sinus, and the skin of the upper eyelid) and the temporal, buccal and marginal mandibular branches of the facial nerve (motor nerve that controls facial muscle movement). No adverse events were observed relating to such structures in the SkinPen Precision System clinical study when treating at needle depth of up to 1.5 mm. Please refer to Bellus provided training module on superficial nerve and vessel facial anatomy for additional information.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The SkinPen® Precision System consists of a microneedling pen handpiece (SkinPen Precision) and a sterile needle cartridge (SkinPen Precision Cartridge). The accessories are a charging base and a BioSheath. A SkinPen Precision System treatment kit is provided separately and contains the following:
- SkinPen Precision Cartridge: sterile, disposable needle cartridge. Not to be . resterilized or reused.
- . SkinPen BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen Precision
- . Lift HG: hydrogel wound dressing (without drugs and/or biologics) to protect against abrasion and friction during the microneedling procedure. May be applied to prevent skin from drying out post procedure
| Device Trade/Proprietary Name | SkinFuse Lift HG |
|---|---|
| Device Common Name | Hydrogel wound dressing without drugs and/or a biologic |
| Device Class | Class I, 510(k) Exempt |
| Classification Regulation | 878.4022 |
| Product Code | NAE |
Table 1 : SkinFuse Lift HG Regulatory Information
2
Image /page/2/Picture/0 description: The image shows two SkinPen Precision microneedling devices. The device on the left is a pen-shaped device with a blue body and a clear tip. The device on the right is a similar pen-shaped device, but it is resting in a white charging base. The SkinPen logo is visible on both devices.
Table 2: Device Characteristics:
| Table 2: Device Characteristics: | Microprocessor - Embedded Software Controlled | |
|---|---|---|
| Control mechanism | Microprocessor - Embedded Software Controlled | |
| Operating principle | Rotary | |
| Energy type | Charging base: AC powered | |
| SkinPen Precision microneedling pen handpiece: rechargeable Li+ batteries | ||
| Materials | BioSheath: (b) (4) | |
| SkinPen Precision cartridge (needle): stainless steel (b) (4) | ||
| SkinPen Precision cartridge (cartridge): (b) (4) | ||
| Performance Specifications | ||
| Motor | Designed to operate continuously at constant speed | |
| Motor speed | 1 speed: 7000 RPMs (6300-7700 RPMs) | |
| Needle penetration depth | 11 depth settings from 0 mm to 2.5 mm in 0.25 mm increments. Safety and effectiveness for settings greater than 1.5 mm has not been evaluated. | |
| Number of needles | 14 | |
| Shelf-life/reliability | SkinPen Precision microneedling pen handpiece: ≥ 2000 hours of use | |
| SkinPen Precision cartridge: (b) (4) | ||
| Reprocessing/Cross-Contamination | ||
| Re-Use Protection | The SkinPen Precision cartridge has a lock-out feature that prevents the installation of a used disposable cartridge for the second time | |
| Fluid Ingress Protection | Sealed SkinPen Precision cartridge to prevent fluid intake from patient to the device | |
| Sterility | SkinPen Precision cartridge: provided sterile (EO) | |
| SkinPen Precision System: not sterile | ||
| Packaging | Sterile, disposable SkinPen Precision cartridge packaged and labeled individually. Proprietary SkinPen Precision cartridge. | |
| Handpiece cover | During use, the SkinPen Precision microneedling pen handpiece is covered with a single use barrier sleeve (BioSheath). The sleeve is not sterile. | |
| Non-sterile reprocessing | The SkinPen Precision microneedling pen handpiece is reusable and is provided non-sterile. For reprocessing, use with BioSheath and clean/disinfect with a Sani-Cloth HB® germicidal disposable wipe. |
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SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The patient contacting components of the device are the needle cartridge and the SkinFuse Lift HG hydrogel. Both components have contact with breached/compromised skin for a limited duration ( 110-gram force. The acceptance criteria were met if the inner and outer needles within the cartridge could withstand this minimum force. Results demonstrate that the needles can withstand forces greater than those encountered during normal use.
- . Device use-life reliability: The device was evaluated over 2000 hours of use. This was representative of a use scenario of 4 hours a day, 5 days a week. The device motor and battery as well as the ability of the device to turn on and off were evaluated. The results confirm a use life of at least 2000 hours.
- . Needle cartridge reliability: To further evaluate the needle cartridge, the needle cartridge was subjected to worst case use testing with a duration of testing more than double the typical clinical duration of use. In addition, an axial load was applied to the needle cartridge throughout the test. At the end of testing the cartridge showed no visual evidence of discoloration or damage to the inside of the cartridge. The test demonstrated the ability of the device to perform consistently under conditions of use.
LITERATURE REVIEW AND TRAINING MATERIALS
The SkinPen Precision System can achieve a maximum depth setting of 2.5 mm. As noted in the clinical section below, a maximum depth setting of 1.5 mm was evaluated in the clinical study to support the safety and effectiveness of the device for the treatment for acne scars on the face. To mitigate the risks associated with the parameters that were not evaluated clinically, a literature review was provided, including the results of three anatomical studies which assessed the depths and locations of superficial nerves and facial blood vessels1.2-3. The results of these studies demonstrated that the depth of motor and sensory nerves that could cause impairment were as deep as 26 mm and no shallower
1 Rudolph R. "Depth of the facial nerve in face lift dissections." Plastic and Reconstructive Surgery. 1990:85(4):537-544.
2 Christensen KN, Lachman N, Pawlina W, Baum CL. "Cutaneous depth of the supraorbital nerve: a
cadaveric anatomic study with clinical applications to dermatology." Dermatol Surg. 2014;40(12):1342-1348. 3 Lee J-G, Yang H-M, Choi Y-J, et al. "Facial arterial depth and relationship with the facial musculature layer." Plastic and Reconstructive Surgery. 2015;135(2):437-444.
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than 2 mm3.2. The most superficial nerves, with depths around 2 mm were located in the periorbital area2. As noted in the section describing labeling below, the SkinPen Precision System contains a warning against treatment within the orbital rim and limits the depth for treatment of acne scars around the orbital rim to a maximum depth setting of 0.5 mm. For major facial blood vessels. the findings demonstrate that arteries are no shallower than 3-5 mm² from the skin surface. Therefore, a maximum penetration depth of 2.5 mm represents minimal risk, although the effectiveness for acne scar treatment at this depth is unknown. Included in the literature review was a retrospective analysis of over 550 patients treated with a similar device for a total of 3300 procedures5. The average depth of these treatments was 2-2.5 mm. Over 60% of the reported treatments were conducted on the face. There were no reports of adverse events that involved nerves or major vessels.
To further mitigate the risk of the unevaluated device parameters, a statement has been added to the labeling advising that depth settings greater than 1.5 mm have not been evaluated. In addition, training materials informing users of the locations of critical nerves and blood vessels and of the depth settings which have been determined to be safe is provided to each new device user.
SUMMARY OF CLINICAL INFORMATION
A clinical study was conducted to support the safety and effectiveness of the SkinPen Precision System for the treatment of acne scars on the face.
The study was conducted at a single center and included treatments on day 1, day 30, and day 60, with follow-up visits at 1 months after the final (day 60) treatment. Treatments were conducted by a trained aesthetician (skin care specialist). The face was cleaned and numbed prior to treatment. A thin laver of Skinfuse Lift HG was applied prior to treatment to protect against abrasion and friction during the procedure. The aestheticians were instructed to start at the lowest depth setting and gradually increase the depth until erythema was observed, with a maximum depth of 1.5mm. The instructions included a precaution that microneedling could be used around but not within the orbital rim. The face was divided into quadrants for treatment to ensure that all acne scars were treated. Following treatment, Skinfuse Lift HG was applied to prevent the skin from drving out post procedure.
A total of 41 subjects completed the study. Only 20 of these subjects were treated with the SkinPen Precision System. The other 21 subjects were treated with a prototype device. There are technological differences between the SkinPen Precision System and the prototype device. including a greater number of needles in the SkinPen Precision cartridge and faster motor speed in the SkinPen Precision device, which may affect the device effectiveness results. Therefore, the safety assessments collected for both treatment groups are included in the summary below.
4 Lee S., Gil Y. C., Choi Y. J., Tansati T., Kim H. J., Hu K. S. "Topographic anatomy of the superior labial artery for dermal filler injection." Plastic and Reconstructive Surgery, 2015; 135(2), 445-450.
5 Sasaki GH. "Micro-Needling Depth Penetration, Presence of Pigment Particles, and Fluorescein-Stained Platelets: Clinical Usage for Aesthetic Concerns." Aesthetic Surgery Journal. 2017;37(1):71-83.
8
However, for the effectiveness results, only the data for the SkinPen Precision group was considered.
Subjects enrolled in the study included both men (31.7%) and women (68.3%) over the age of 21. The study included 11/41 subjects with Fitzpatrick Skin Type (FST) V and VI.
| SkinPen Precision System | All Subjects | |||
|---|---|---|---|---|
| N | 20 | 41 | ||
| Age (years) | ||||
| Mean (standard deviation) | 43.8 (12.7) | 44 (11.9) | ||
| Minimum, Median, Maximum | 23, 48, 60 | 21, 46, 60 | ||
| N | (%) | N | (%) | |
| Sex | ||||
| Male | 7 | 35 | 13 | 31.7 |
| Female | 13 | 65 | 28 | 68.3 |
| Ethnicity | ||||
| Hispanic or Latino | 6 | 30 | 13 | 31.7 |
| Not Hispanic or Latino | 14 | 70 | 28 | 68.3 |
| Race | ||||
| American Indian or Alaska Native | 1 | 5 | 2 | 4.9 |
| Asian | 3 | 15 | 9 | 22.0 |
| Black or African American | 6 | 30 | 10 | 24.4 |
| White | 10 | 50 | 20 | 48.8 |
| Fitzpatrick Skin Type | ||||
| II | 2 | 10 | 3 | 7.3 |
| III | 4 | 20 | 10 | 24.4 |
| IV | 7 | 35 | 17 | 41.5 |
| V | 4 | 20 | 7 | 17.1 |
| VI | 3 | 15 | 4 | 9.8 |
Table 3: Summary of Demographic Information
The following is a summary of the important inclusion and exclusion criteria: Inclusion Criteria:
To be eligible for study enrollment, a subject was required to satisfy each of the following criteria:
-
- Men and women 18 to 60 years of age having general good health, with a maximum of 10% of subjects who were 18-30 years of age.
-
- At least 20% of the subjects will have Fitzpatrick skin types IV-VI.
-
- Individuals who have approximately 5 to 10 atrophic acne scars of mixed types (boxcar and/or rolling scars with some icepick scars allowed) on the face that are moderate to severe (grades 3 and 4 on Goodman and Baron's qualitative acne scar scale).
9
-
- Individuals willing to withhold aesthetic therapies to the areas of the face being treated or judged to potentially impact results by the Investigator (e g. soft tissue fillers and/or any resurfacing procedures, botulinum toxin, injectable fillers, microdermabrasion, IPL (intense pulsed light), peels, facials, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but not facial laser hair removal.
Exclusion Criteria:
A subject was not eligible to participate if they met any of the following exclusion criteria:
-
- Individuals who have presence of an active systemic or local skin disease that may affect wound healing.
- Individuals who have severe solar elastosis. 2.
-
- Individuals with sensitivity to topical lidocaine.
-
- Individuals who have a recent history or significant trauma to the face ( 5 active inflammatory acne lesions (including acne conglobate, nodules, or cysts) in either the right or left treatment area.
-
- Individuals who have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed treatment areas. Individuals who have a history of systemic granulomatous diseases, active or inactive, (e.g. Sarcoid. Wegeners, tuberculosis, etc.) or connective tissue disease (e.g. lupus, dermatomyositis, etc.)
-
- Individuals who currently have, or have a history of hypertrophic scars or keloid scars.
-
- Individuals who have had microdermabrasion or glycolic acid treatment to the treatment area(s) within 1 month prior to study participation or who will have this treatment during the study.
-
- Individuals who have a history of the following cosmetic treatments in the area(s) to be treated:
- Skin tightening procedure within the past year;
- . Injectable filler of anv tvpe within the past:
- o 12 months for hyaluronic acid fillers (e.g. Restylane)
- 0 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
- 24-months for Poly-L-Lactic acid fillers (e.g. Sculptra) o
- o Ever for permanent fillers (e.g. Silicone, ArteFill)
- . Neurotoxins within the past 3 months;
- . Ablative resurfacing laser treatment:
- Non-ablative, rejuvenative laser or light treatment within the past 6 months; ●
- . Surgical dermabrasion or deep facial peels:
- . Had a chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of the face and neck within 4 weeks.
-
- Individuals with a history of using any of the following prescription medications:
- Accutane or other systemic retinoids within the past 6 months: .
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- . Topical Retinoids within the past 2 weeks;
- . Prescription strength skin lightening devices (e.g. hydroquinone, tretinoin, alpha hydroxy acids (AHA), beta hydroxy acids (BHA) and polyhydroxy acids, 4hydroxyanisole alone or in combination with tretinoin, etc.) within 4 months;
- . Any anti-wrinkle, skin lightening devices, or any other device or topical or systemic medication know to affect skin aging or dyschromia (devices containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within 2 weeks;
- . Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, chronic Non-Steroidal Anti-Inflammatory Drug (NSAID) use);
- . Psychiatric drugs that in the Investigator's opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
The study was initially designed to include primary endpoint assessment by the treating investigator using the Goodman and Baron's qualitative grading system for acne scar severity. However, this scale has not been validated for this outcome measure. A scale is validated if there is evidence that the instrument accurately measures what it is intended to measure. To utilize a validated scale and reduce investigator bias, the study design was revised during the study, such that 2 blinded evaluators would evaluate images after completion of the clinical study using the following assessment tools and timepoints [Table 4]. Details of each of these assessment tools are provided below in Tables 6-9. The results of the study are provided in Tables 10-14.
| Table 4. Study Endpoints | |
|---|---|
| Primary effectiveness | |
| endpoints | Acne Scar Assessment Scale graded by two blinded dermatologists using |
| photographs taken at baseline, day 30, day 60, 1-month post-treatment, and | |
| 6-months post-treatment | |
| Clinician's Global Aesthetic Improvement Assessment graded by two | |
| blinded dermatologists using photographs taken at 1-month post-treatment, | |
| and 6-months post-treatment | |
| Secondary effectiveness | |
| endpoints | Self-assessed Scar Improvement Scale completed by subjects at baseline, 1- |
| month post-treatment, and 6-months post-treatment | |
| Subject Global Aesthetic Improvement Scale completed by subjects at | |
| baseline, 1-month post-treatment, and 6-months post-treatment | |
| Patient Satisfaction Questionnaire completed by subjects at 1-month post- | |
| treatment and 6-months post-treatment | |
| Safety Endpoint | Subject safety diaries provided to the subject at each treatment visit (day 1, |
| 30, and 60) and completed for 30 days to record treatment responses | |
| Adverse event monitoring at each visit; baseline, day 30, day 60, 1-month | |
| post-treatment, and 6-months post-treatment |
Table 4: Study Endnoints
At each clinical visit, digital images were taken of each subject's facial acne scars. On day 1, day 30, and day 60, imaging was performed prior to treatment. A total of 3 full-face images were collected. Images were also collected at the 1 month and 6-month follow-up visit. These images were graded by 2 separate Board Certified Dermatologists after completion of the study.
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Table 5: Subject Accountability
| All Subjects | SkinPen Precision System | |
|---|---|---|
| N = 65 | N = 33 | |
| Enrolled subjects | ||
| Completed subjects (PP population) | 41 | 20 |
| Discontinued subjects | 24 | 13 |
| Reason for discontinuation | ||
| Subject requested withdrawal | 10 | 7 |
| Lost to follow-up | 3 | 1 |
| Sponsor requested discontinuationa | 11 | 5 |
4Sponsor requested for these subjects to be discontinued from the study for not having severe acne scars based on the images reviewed.
Of the 13 subjects who were discontinued from SkinPen Precision group of the study 12/13 discontinued prior to treatment. One subject received two treatments prior to discontinuation. This subject was appropriately followed after discontinuation. None of the discontinued subjects in the prototype group received treatment prior to discontinuation.
The photo grading included the following effectiveness assessments:
- . Acne Scar Assessment Scale6
| 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). |
| 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). |
Table 6: Acne Scar Assessment Scale
This scale was validated in a published study [1]. In the referenced study, live blinded evaluation was completed at 6-months post treatment. In the current study, this scale was used for photo grading by blinded evaluators at all timepoints.
6 Jwala Karnik, Leslie Baumann, Suzanne Bruce, Valerie Callender, Steven Cohen, Pearl Grimes, John Joseph, Ava Shamban, James Spencer, Ruth Tedaldi, William Philip Werschler, Stacy R. Smith, "A double-blind, randomized, multicenter, controlled trial of suspended polymethylmethacrylate microspheres for the correction of atrophic facial acne scars." Journal of the American Academy of Dermatology. 2014;71(1):77-83.
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- . Clinician's Global Aesthetic Improvement Assessment (CGAIS)
| Rating | Description |
|---|---|
| 1 | Very Much Improved: Optimal cosmetic result in this subject. |
| 2 | Much Improved: Marked improvement in appearance from the initial |
| condition, but not completely optimal for this subject. | |
| 3 | Improved: Obvious improvement in appearance from initial condition, but a |
| re-treatment is indicated. | |
| 4 | No Change: The appearance is essentially the same as the original condition. |
| 5 | Worse: The appearance is worse than the original condition. |
Table 7: Clinician's Global Aesthetic Improvement Assessment (CGAIS)
In addition to the clinician graded effectiveness measures, the following patient-reported measures were recorded throughout the study:
- . Self-assessed Scar Improvement Scale
Table 8: Self-assessed Scar Improvement Scale
| Rating | Description |
|---|---|
| -1 | Exacerbation of Acne Scars |
| 0 | No change in appearance of acne scars |
| 1 | 1% - 25% improvement in appearance of acne scars |
| 2 | 25% - 50% improvement in appearance of acne scars |
| 3 | 50% - 75% improvement in appearance of acne scars |
| 4 | 75% - 99% improvement in appearance of acne scars |
- Subject Global Aesthetic Improvement Scale .
Table 9: 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. |
Patient Satisfaction Questionnaire Three questions were asked to the subjects in the study regarding their level of satisfaction with the treatment. It was included as a secondary endpoint in the study. See individual questions and results in the section below.
Safety information was collected throughout the study using subject safety diaries. Safety diaries were provided to the subject at each treatment visit (day 1, 30, and 60). The subject was
.
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instructed to record any observations related to treatment including common treatment responses. Common treatment responses are side effects that result from treatment which resolve on the order of days. Common treatment responses that persist may be 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 touch, redness, burning, tingling, itching, and/or scaling/dryness, edema (swelling), tenderness/discomfort, a possibility of developing an infection (an increase in redness, warmth, itching, or pus formation). The diaries included space for daily recording of observations for the 30 days in between treatment visits. Adverse events were assessed by the investigator at each subsequent visit.
Results:
Safety:
At the 6-month post-treatment visit, no adverse events persisted.
The following common treatment responses were reported in the subject safety diaries which were sent home with the subject:
- Dryness in 5/41 (12%) subjects lasting from 1-6 days .
- These responses were reported by 3 subjects with FST III, 1 subject with FST VI, O and 1 subject with FST V
- . Rough Skin in 3/41 (7%) of subjects lasting from 1-2 days
- These responses were reported by 1 subject with FST III, and 2 subjects with FST O V
- . Tightness in 2/41 (4%) of subjects lasting from 1-2 days
- These responses were reported by 2 subjects with FST VI O
- . Redness, Itching, Peeling Discomfort and Tenderness in 13/41 (31%) of subjects lasting 1-3 days
- These responses were reported by 6 subjects with FST III, 2 subjects with FST O VI, 3 subjects with FST V, and 2 subjects with FST V
- . Burning in 4/41 (9%) of subjects lasting 1-3 days
- o These responses were reported by 1 subject with FST III, 1 subjects with FST VI, and 2 subjects with FST V
Over the course of the study, 1 subject reported an arthropod bite on the inner right thigh that was determined to be moderate and unlikely related to SkinPen prototype device. One (1) subject (1/41, 2.4%) experienced an AE (skin striae [linear marks, ridges, or grooves] on the forehead and both sides of the face) that was determined to be mild and possibly related to use of the SkinPen Precision System. This AE was thought to be due to subject exposure to excess sunlight soon after treatment which was against study instructions, yet resolved without any additional complications.
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Effectiveness:
Acne Scar Assessment Scale:
Results of photo grading using the Acne Scar Assessment Scale demonstrated that at baseline the mean population score was mild at 2.80. Following the three treatments and 6 months of followup, the mean population score was reported as mild at 2.35.
The evaluation by the blinded assessors indicated that seven subjects (7/20, 35%) had a 1-grade reduction in the Acne Scar Assessment Scale at 6-months post-treatment compared to baseline. The seven subjects reporting a 1-grade reduction included 1 subject with FST II, 2 subjects with FST III, 1 subject with FST IV, 2 subjects with FST V, and 1 subject with FST VI.
In addition, 4 subjects (20%) showed an improvement greater than 0 but less than 1 on the Acne Scar Assessment Scale, giving a total of 55% (11/20) of subjects showing improvement at 6months post-treatment when compared with baseline. At 6-months post-treatment, the remaining 9 subjects (45%) reported no change in score when compared to baseline. The visual improvements seen in the photo grading results were considered to be clinically meaningful.
| System | ||||||
|---|---|---|---|---|---|---|
| Time Point | N | Mean | Standard Deviation | Minimum | Median | Maximum |
| Baseline | 20 | 2.80 | 0.52 | 2.00 | 3.00 | 4.00 |
| Day 30 | 20 | 2.78 | 0.57 | 2.00 | 2.75 | 4.00 |
| Day 60 | 20 | 2.70 | 0.55 | 2.00 | 2.50 | 3.50 |
| 1-Month Post-Treatment | 20 | 2.68 | 0.49 | 2.00 | 2.50 | 3.50 |
| 6-Months Post-Treatment | 20 | 2.35 | 0.69 | 1.50 | 2.50 | 3.50 |
Table 10: Results of Photo Grading of Acne Scar Assessment Scale for SkinPen Precision
| Table 11: Change from Baseline for Photo Grading of Acne Scar Assessment Scale for SkinPen | |||
|---|---|---|---|
| Precision System |
| Time Point | N | Subject
Improved
(%) | Subject
Worsened
(%) | Mean
Change | Standard
Deviation
for Change | Mean
Change (%) |
|-------------------------|----|----------------------------|----------------------------|----------------|-------------------------------------|--------------------|
| Day 30 | 20 | 30.0 | 20.0 | -0.03 | 0.50 | -0.9 |
| Day 60 | 20 | 35.0 | 20.0 | -0.10 | 0.50 | -3.6 |
| 1-Month Post-Treatment | 20 | 40.0 | 20.0 | -0.13 | 0.58 | -4.5 |
| 6-Months Post-Treatment | 20 | 55.0 | 0.0 | -0.45 | 0.46 | -16.1 |
Clinician Global Aesthetic Improvement Assessment:
Analysis using the CGAIS was conducted by comparing the best and worst images of each subject as graded by the blinded dermatologists on the Acne Scar Assessment Scale. However, the best and worst were not chosen based on timepoint and therefore this endpoint was not considered to be clinically meaningful.
Self-assessed Scar Improvement Scale:
Treatment with SkinPen Precision produced an improvement in SASIS scores at 1 month posttreatment and 6-months post-treatment. At 1-month post-treatment, 17 (85%) subjects reported some percentage of improvement in the appearance of their acne scars, with 3 (15%) subjects
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reporting no change. At 6-months post-treatment, 18 (90%) subjects reported some percentage of improvement in the appearance of their acne scars, with 2 (10%) subjects reporting no change. The mean values for the population were = 1.65 and 1.70, at 1-month post-treatment and 6months post-treatment respectively (1%-25% improvement in appearance of acne scars) when compared with a score of 0 (no change in appearance of acne scars). No subjects reported a negative score (i.e., exacerbation of acne scars) at either post-treatment timepoint.
Subject Global Aesthetic Improvement Scale:
Treatment with SkinPen Precision produced an improvement in SGAIS scores at 1 month posttreatment and 6-months post-treatment. At 1-month post-treatment, 7 (35%) subjects reported much improved, 9 (45%) subjects reported improved, and 4 (20%) subjects reported no change. At 6-months post-treatment, 2 (10%) subjects reported very much improved, 8 (40%) subjects reported much improved, 8 (40%) subjects reported improved, and 2 (10%) subjects reported no change. The mean values for the population were = 2.85 and 2.50, at 1-month post-treatment and 6-months post-treatment respectively (improved) when compared with a score of 4 (no change). No subjects reported a score of 5 (worse) at either post treatment timepoint.
Patient Satisfaction Questionnaire:
The results of the patient satisfaction questionnaire for all subjects indicated that a greater proportion of subjects selected favorable responses regarding treatments at 1 month and 6months post-treatment for the following inquiries:
- . Ouestion 1: Do you notice any improvement in how your acne scars look in the treated area?
| Time Point | Yes [N (%)] | No [N (%)] |
|---|---|---|
| 1-Month Post-Treatment | 16 (80.0) | 4 (20.0) |
| 6-Months Post-Treatment | 18 (90.0) | 2 (10.0) |
Table 12: Results of Patient Satisfaction Questionnaire - Question 1
- Question 2: How would you characterize your satisfaction with the treatment? ●
| Time Point | Extremely
Satisfied
[N (%)] | Satisfied
[N (%)] | Slightly
Satisfied
[N (%)] | Neither
Satisfied nor
Dissatisfied
[N (%)] | Slightly
Dissatisfied
[N (%)] | Dissatisfied
[N (%)] | Very
Dissatisfied
[N (%)] |
|-----------------------------|-----------------------------------|----------------------|----------------------------------|-----------------------------------------------------|-------------------------------------|-------------------------|---------------------------------|
| 1-Month Post-
Treatment | 3 (15.0) | 9 (45.0) | 5 (25.0) | 3 (15.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| 6-Months Post-
Treatment | 3 (15.0) | 9 (45.0) | 5 (25.0) | 1 (5.0) | 1 (5.0) | 1 (5.0) | 0 (0.0) |
Table 13: Results of Patient Satisfaction Questionnaire - Question 2
Question 3: Would you recommend this treatment to your friends and family members? ●
| Table 14: Results of Patient Satisfaction Ouestionnaire - Question 3 | |
|---|---|
| ---------------------------------------------------------------------- | -- |
| Time Point | Yes [N (%)] | No [N, (%)] |
|---|---|---|
| 1-Month Post-Treatment | 18 (90.0) | 2 (10.0) |
| 6-Months Post-Treatment | 18 (90.0) | 2 (10.0) |
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Pediatric Extrapolation
In this De Novo request, existing clinical data were not leveraged to support the use of the device in a pediatric patient population.
LABELING
Labeling has been included which consists of a user manual, instructions for use, box labeling, and patient labeling. The user manual and instructions for use include a description of the device technical parameters, relevant findings from the clinical study including common treatment responses. These documents summarize the main steps for using the device as well as the necessary measures to properly dispose of any single use items and clean the reusable components of the device.
The patient labeling includes information regarding how the treatment works, what to expect, and summarizes the findings of the clinical study in plain language.
The user manual, instructions for use, and box labeling include a precaution stating that the safety and effectiveness of the device has not been established at needle depths greater than 1.5 mm.
The following needle depths are recommended for treatment:
Table 15: Recommended Procedure Depths
| Acne Scar Procedure Depth (Suggested Guidelines) | |
|---|---|
| Forehead (0.25 – 1.0 mm) | Nose (0.25 – 0.75 mm) |
| Around the Orbital Rim* (0.25 – 0.5 mm) | Facial Acne Scars (up to 1.5 mm) |
*Note: Treatment can be performed around but not within the orbital rim.
RISKS TO HEALTH
The table below identifies the risks to health that may be associated with use of a microneedling device for aesthetic use and the measures necessary to mitigate these risks.
Table 16: Identified Risks to Health and Mitigation Measures
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Adverse tissue reaction | Biocompatibility evaluation |
| Labeling | |
| Cross-contamination and infection | Sterilization validation |
| Reprocessing validation | |
| Non-clinical performance testing | |
| Shelf life testing | |
| Labeling | |
| Electrical shock or electromagnetic interference | |
| with other devices | |
| Electrical safety testing | |
| Labeling |
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| Identified Risks to Health | Mitigation Measures |
|---|---|
| Damage to underlying tissue including nerves | |
| and blood vessels, scarring, and | |
| hyper/hypopigmentation due to | |
| • Exceeding safe penetration depth • Mechanical failure • Software malfunction | Non-clinical performance testing |
| Technological characteristics | |
| Shelf life testing | |
| Labeling | |
| Software verification, validation, and | |
| hazard analysis |
SPECIAL CONTROLS
- (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.
- Performance data must support the shelf life of the device by demonstrating (4) continued sterility, package integrity, and device functionality over the intended shelf life.
- Performance data must demonstrate the electrical safety and electromagnetic (ર) 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.
- The patient-contacting components of the device must be demonstrated to be (7) biocompatible.
- (8) Performance data must validate the cleaning and disinfection instructions for reusable components of the device.
- (9) Labeling must include the following:
- Information on how to operate the device and its components and the typical (i) course of treatment;
- (ii) A summary of the device technical parameters, including needle length, needle geometry, maximum penetration depth, and puncture rate;
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- (iii) Validated methods and instructions for reprocessing of any reusable components:
- (iv) Disposal instructions; and
- (v) Shelf life.
- (10) Patient labeling must be provided and must include:
- Information on how the device operates and the typical course of treatment; (i)
- (ii) The probable risks and benefits associated with use of the device; and
- Post-operative care instructions. (iii)
BENEFIT-RISK DETERMINATION
The risks of the device are based on nonclinical laboratory studies as well as data collected in a clinical study described above.
Adverse events (AEs) seen in the study included two subjects (3.1%) with a total of five nonserious AEs. One subject reported an arthropod bite on the inner right thigh that was determined to be moderate and unlikely related to SkinPen prototype device. One subject (1/41, 1.5%) experienced erythema, edema, and pruritus on the face that were determined to be mild and unlikely related to SkinPen Precision System and skin striae on the forehead and both sides of the face that was determined to be mild and possibly related to use of the SkinPen Precision System. This AE was thought to be due to subject exposure to excess sunlight soon after treatment which was against study instructions and resolved. The common treatment responses were dryness in 12% of subjects lasting from 1-6 days, rough skin in 7% of subjects lasting from 1-2 days, tightness in 4% of subjects lasting from 1-2 days, redness, itching, peeling, discomfort, and tenderness in 31% of subjects lasting 1-3 days, and burning in 9% of subjects lasting 1-3 days. These conditions all resolved. There were no serious AEs or reports of nerve and tissue damage. Although not seen in the clinical study, based on the literature, patients may experience reactivation of herpes simplex virus (cold sore), pigment changes that include lighter or darker skin in the area treatment that resolves over time, or no change in their acne scars. These adverse events and common treatment responses are included in the labeling.
The probable benefits of the device are based on nonclinical laboratory studies as well as data collected in a clinical study described above.
The indication for use to improve the appearance of facial acne scars is supported by the clinical study. There are many treatment modalities for the improvement of the appearance of acne scars: permanent treatments include laser, surgery (punch excisions), subcision, chemical peels, radiofrequency, and low energy light. Dermal fillers provide transient improvement. Lasers and chemical peel treatments have much higher risk profiles and patient recovery time but may provide more substantial improvement in the appearance of acne scars. These procedures are not typically performed on higher Fitzpatrick skin types due to the risks of pigment change. There are many treatments for improving the appearance of acne scars, because no single treatment works for evervone and some are much more invasive than others.
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The SkinPen Precision System has a lower risk profile than some of the alternative treatments and as demonstrated in the clinical study can be used on Fitzpatrick Skin Type II-VI. Fitzpatrick Skin Type I was not assessed in the study; however, this is acceptable because patients with lower Fitzpatrick Skin Types are not at an increased risk of adverse events. The safety concern for this device is in the higher Fitzpatrick Skin Types who are at higher risk of transient and permanent pigment changes and scarring. The higher Fitzpatrick Skin Types were studied appropriately in the clinical study.
In this study. using the Acne Scar Assessment Scale, the two blinded assessors saw an improvement in 55% of patients at 6 months with the SkinPen Precision System with the mean scores improving from 2.8 at baseline to 2.35 at the 6 month follow up. No subjects had scars which were graded as worse at the 6 month follow up compared to baseline.
Patient reported outcomes demonstrated improvement in scar appearance and patient satisfaction.
Patient Perspectives
Patient perspectives considered for the SkinPen Precision System during the review included the following patient reported outcomes which were collected during the study:
- . SASIS (self-assessed scar improvement) demonstrated an improvement in scores at 6months post-treatment (mean value of 1.70 which is a 1-25% improvement in scars) when compared with a score of 0 (no change).
- . Treatment with SkinPen Precision System produced an improvement in SGAIS scores at 6-months post-treatment (mean value 2.50 improved) when compared with a score of 4 (no change).
- . The patient satisfaction questionnaire demonstrated improvement in acne scars (90% satisfaction or 18/20 patients), satisfaction with treatment (85% or 17/20 patients), and recommendation to family and friends (90% or 18/20 subjects) at 6-months posttreatment.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
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.
The probable benefits outweigh the probable risks for the SkinPen Precision System. The device provides benefits and the risks can be mitigated using general controls and the identified special controls.
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CONCLUSION
The De Novo request for the SkinPen Precision System is granted and the device is classified as follows:
Product Code: QAI Device Type: Microneedling device for aesthetic use Regulation Number: 21 CFR 878.4430 Class: II