Search Results

The SkinPen® Precision system is a microneedling device and accessories intended to be used as a treatment to improve the appearance of wrinkles of the neck for Fitzpatrick skin types II - IV and to improve the appearance of facial acne scars in adults with all Fitzpatrick skin types aged 22 years and older.

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. (K202243, Class 2, Regulation 878.4430, Product Code: QAI.); 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. (Class I, 510(k) Exempt, Regulation 878.4022, Product code: NAE.); SkinPen® BioSheath: nonsterile, disposable cover for the microneedling pen handpiece to avoid contamination of the SkinPen® Precision.; Sani-Cloth AF3: Sanitizing cloth available for purchase along with device to sanitize between uses.

The provided FDA 510(k) clearance letter (K220506) for the SkinPen® Precision System does not contain information about acceptance criteria or a study proving the device meets acceptance criteria for its clinical indications (improving the appearance of wrinkles of the neck and facial acne scars).

The letter states, "No Clinical testing was conducted as part of this submission." This submission is a "Special 510(k)" for a modification to an already cleared device (K202243 SkinPen Precision System). The "acceptance criteria" and "study that proves the device meets the acceptance criteria" would have been part of the original 510(k) for the predicate device, K202243, or a prior submission that established the clinical effectiveness for the indications for use.

Instead, this submission focuses on a non-clinical performance testing related to a change in the disinfecting cloth used with the device.

Here's a breakdown of the information that is present, in relation to your request, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• No clinical acceptance criteria or performance data are provided in this document for the indications of use (wrinkles of the neck, facial acne scars).
• Non-clinical (cleaning validation) acceptance criteria and performance:
  • Acceptance Criteria for Cleaning Validation: The goal was to confirm that the Sani-Cloth AF3 is sufficient for bacterial removal from the device even under worst-case contamination scenarios. The implicit acceptance criterion is that the bacteria are effectively removed.
  • Reported Device Performance (Cleaning Validation): "it was confirmed that the bacteria were removed from the device when cleaned with Sani-Cloth AF3... The new Sani-Cloth AF3 shows the same or improved results than the previously used Sani-Cloth HB."

2. Sample Size Used for the Test Set and Data Provenance

• Clinical Test Set: Not applicable, as no clinical testing was performed for this submission.
• Non-clinical (Cleaning Validation) Test Set: The document describes "application of bacteria on the SkinPen device surface." The exact sample size (number of devices, number of wipes, etc.) is not explicitly stated, but it refers to "worst-case conditions."
• Data Provenance: Not explicitly stated, but likely conducted in a laboratory setting as part of the manufacturer's testing for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Clinical Test Set: Not applicable.
• Non-clinical (Cleaning Validation) Test Set: The "ground truth" here is the presence or absence of bacteria (before and after cleaning). This would be established by standard microbiological laboratory techniques, not by human experts in the context of clinical interpretation. The qualifications of the microbiologists or lab technicians are not provided.

4. Adjudication Method for the Test Set

• Clinical Test Set: Not applicable.
• Non-clinical (Cleaning Validation) Test Set: Not applicable in the sense of clinical adjudication. The result (bacteria removed or not) would be determined by laboratory assays.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Readers Improve with AI vs Without AI Assistance

• This device is a microneedling system, not an AI diagnostic or assistive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done

• This device is a microneedling system, not an algorithm. Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used

• Clinical Ground Truth: For the clinical indications (wrinkles and acne scars), the ground truth for the original predicate device clearance would likely have been based on clinician assessments (e.g., blinded expert photographic evaluations, severity scales) and/or patient-reported outcomes. This document does not provide that information.
• Non-clinical (Cleaning Validation) Ground Truth: The ground truth for the cleaning validation was the microbiological assessment of bacterial presence/absence on the device surface.

8. The Sample Size for the Training Set

• Clinical Training Set: Not applicable, as no clinical studies were performed for this submission, and it's not an AI/model development submission.
• Non-clinical (Cleaning Validation) Training Set: Not applicable. This was a validation study, not a model training process.

9. How the Ground Truth for the Training Set Was Established

• Not applicable for the reasons stated above.

In summary, this document primarily outlines the regulatory clearance (510(k)) for a minor modification (change in disinfecting wipe) to an already cleared microneedling device. It does not provide the details of clinical acceptance criteria or studies proving clinical effectiveness, as those would have been part of the original clearance for the predicate device (K202243). The only "study" mentioned is a non-clinical cleaning validation.

Ask a specific question about this device