(104 days)
The SkinPen® Precision Elite 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 vears and older.
The SkinPen® Precision Elite System consists of a microneedling pen handpiece (SkinPen® Precision Elite) and a sterile needle cartridge (SkinPen® Precision Elite Cartridge). The accessories are a charging base with power adaptor and a BioSheath to cover the handpiece.
The provided text is a 510(k) summary for the SkinPen® Precision Elite System. It details the device, its intended use, and comparison to a predicate device. However, it explicitly states "No Clinical testing was conducted as part of this submission" (Section 12, page 6).
Therefore, there is no information within this document to address the requested points regarding acceptance criteria and a study proving the device meets those criteria, as no clinical study was performed for this submission. The device's substantial equivalence was based on non-clinical performance testing (reciprocating rate, puncture depth), electrical safety, risk management, sterility, software verification and validation, and biocompatibility, along with a direct comparison to a predicate device.
To answer your request, if a clinical study had been performed and described in the document, here's what the response would look like if the information were present:
Based on the provided 510(k) summary, no clinical performance study was conducted to demonstrate the device meets specific acceptance criteria based on human subject data. The submission relies on substantial equivalence to a predicate device and non-clinical testing.
Therefore, I cannot provide the detailed information requested in points 1 through 9.
Explanation from the document:
- Section 12 "Clinical Testing Summary" (Page 6): "No Clinical testing was conducted as part of this submission."
The acceptance criteria and study detailed in your request typically refer to clinical performance studies, which were not performed for this device's submission as stated. The changes made to the device (user interface, cartridge connection points, NFC chip for verification) were supported by:
- Non-clinical performance testing (reciprocating rate, puncture depth).
- Software verification and validation.
- Electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6).
- Biocompatibility testing (ISO 10993-1).
- Sterility standards (ISO 11135).
- Risk Management (IEC 62304).
The submission argues that these changes "do not impact the device effectiveness, and safety is increased with the use of the NFC chip," and that "There are no changes to the general technology, mechanism of action, or indications for use." This forms the basis for demonstrating substantial equivalence without a new clinical study.
§ 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.