(189 days)
The E-PEN 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 and older.
The E-PEN is a microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartridge head. The E-PEN is comprised of a reusable pen body, a sterile, single use microneedling cartridge, and a power adapter. The microneedling cartridge is attached to the pen body and activated with an On/Off button. The depth of needle penetration can be adjusted by the user depending on the condition of the skin being treated. Charging is accomplished by attaching the E-PEN pen body to the power adapter.
This document is a 510(k) clearance letter for the E-pen microneedling device. It contains regulatory information and a summary of performance data. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical effectiveness or performance as an AI/software device. This type of information is typically found in clinical study reports, scientific publications, or more detailed regulatory submissions for AI-powered devices, which are not present in this 510(k) clearance letter for a microneedling device.
The provided information focuses on:
- Regulatory Classification: The device is a Class II microneedling device for aesthetic use (21 CFR 878.4430).
- Intended Use: To improve the appearance of facial acne scars in adults aged 22 years and older.
- Technical Specifications: Comparison with a predicate device (SkinPen Precision System, DEN160029) showing similar design, materials, and operating parameters (e.g., number of needles, needle gauge, penetration depth, speed).
- Non-Clinical Performance Data: Biocompatibility, sterilization validation, sterility/shipping/shelf-life, EMC (Electromagnetic Compatibility), electrical safety, software validation (moderate level of concern), and bench testing (needle length, penetration depth, speed, prevention of re-use).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving clinical effectiveness or AI performance based on this document. The document primarily demonstrates substantial equivalence to a predicate device based on technical and safety specifications, not a new clinical performance study against specific acceptance criteria for a health outcome based on AI.
If this were a submission for an AI-powered device, the information requested (AI performance, ground truth, experts, etc.) would be crucial and would typically be provided in a different section or supplementary documentation.
§ 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.