Search Results
Found 1 results
510(k) Data Aggregation
(318 days)
Mt. Derm GmbH
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.
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.
This document describes the safety and effectiveness study for the Exceed Microneedling device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the study's focus on demonstrating improvement in facial acne scars and safety outcomes. While no explicit percentage or threshold for "improvement" is stated as an acceptance criterion in an absolute sense, the study aims to show statistically significant or clinically meaningful improvement, and acceptable safety profiles compatible with similar aesthetic devices.
| Acceptance Criterion (Implied) | Reported Device Performance (Effectiveness) | Reported Device Performance (Safety) |
|---|---|---|
| Improvement in appearance of facial acne scars (Physician-assessed) | Mean ASAS score reduction from 2.89 at baseline to 2.27 at final follow-up. |
- 59% of subjects improved by 1 grade (as agreed by 2 of 3 blinded physicians).
- 83% of subjects showed some improvement (improvement > 0 but
Ask a specific question about this device
Page 1 of 1