(216 days)
The Eclipse MicroPen EVO 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 Eclipse MicroPen EVO™ is a minimally invasive microneedling device that mechanically creates microscopic punctures in the epidermal and dermal layers of the skin by means of micro-needles in a reciprocating cartidge head. The MicroPen EVO is comprised of a reusable pen body, a sterile, single use microneedling cartridge, a rechargeable battery pack, a battery charger with power supply, and a disposible MicroSleeve sheath. 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 skin being treated. Charging is accomplished by placing the MicroPen EVO pen body or the battery pack on the Charger base.
The provided text describes the acceptance criteria and performance of the Eclipse MicroPen EVO, a microneedling device. However, it does not contain information related to a study that involves human expert adjudication, multi-reader multi-case (MRMC) studies, or detailed information about training data for an AI model. The document focuses on bench testing and engineering verification for the device's physical and mechanical performance, and its biological compatibility.
Therefore, many of the requested sections (2-9) are not applicable or cannot be answered from the provided text, as they pertain to studies typically done for AI/ML-driven medical devices analyzing images or other complex data. The Eclipse MicroPen EVO is a mechanical device, and its evaluation is based on engineering and materials testing, not AI performance on clinical data or human reader assessments.
Here's a breakdown of what can be extracted about the acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the tests performed and the statements that the device "met the established criteria" or "passed." The reported performance is the outcome of these tests.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Motor Speed: Puncture Rate | Consistent speed and puncture rate within 6300-7700 RPM (7000 +/- 10%) under worst-case skin conditions for 30 minutes. | All test articles met criteria; puncture rate ranged from 6513 to 7164 RPM, demonstrating consistent performance under worst-case load. |
| Needle Penetration Depth & Extension Accuracy | Within +/- 0.25 mm for depths up to 1.25 mm; within +0mm/-0.50 mm for depths 1.50 mm and above; no dislodgement or serious deformation; max extension not exceeding 2.0 mm. | All test articles passed; within +/- 0.25 mm for depths up to 1.25 mm; within +0.00/-0.50 mm for depths 1.5mm - 2.0mm; no articles exceeded 2.0 mm; no dislodged or deformed needles. |
| Needle Retention | Retention force >= 110 g (1.08 N). | All test needles (n=35) exceeded 110g (1.08 N) retention force, performing better than the predicate device. |
| Battery Life | >4 hours of operation (at least 8 cycles) on a single full charge; no degradation in battery longevity after multiple charges. | All test articles passed; average battery run times were 9.38 hours (trials 1&2) and 10.32 hours (trial 3), significantly exceeding the 4-hour requirement. |
| Use Life (Handpiece, Charger, Battery) | Function for 2000 hours without physical, mechanical, or visual degradation. | Handpieces, batteries, and chargers continued to function for the 2000-hour test with no observable degradation to finish, seals, mechanical function, or labels. Batteries operated beyond 4 hours for the test. |
| Cartridge Life/Reliability | Complete 60 minutes continuous use under load (worst-case scenario), no wear or damage to components, including needles. | All nine test articles completed 60 minutes continuous use under load and were still functional. No signs of unacceptable wear, burrs, hooks, bending, breakage, or loss of needles. This included aged cartridges (2-year equivalent). |
| Microbial Ingress Protection | Prevent ingress of worst-case microorganisms. | The MicroSleeve Protective Sheath and microneedling cartridge provided effective protection against fluid ingress and aided in mitigating cross-contamination for all tested microorganisms. |
| Suction Prevention | No visible signs of suction (e.g., red marks) on human skin after 1 minute at min/max piston extension limits. | No evidence of suction on the skin after 1 minute of simulated use at minimum (0.0mm) and maximum (2.0mm) extension limits with modified cartridges simulating potential suction without needle penetration. |
| Cleaning and Disinfection (Handpiece) | 6-log reduction of common vegetative microorganisms; 3-log reduction of mycobacterium. | Achieved a 6-log reduction of specified common vegetative microorganisms (Pseudomonas aeruginosa, Escherichia coli, Klebsiella pneumoniae, Staphylococcus aureus) and a 3-log reduction of Mycobacterium terrae. |
| Cleaning and Disinfection (Battery Pack/Charger) | 6-log reduction of common vegetative microorganisms. | Achieved a 6-log reduction of specified common vegetative microorganisms. |
| Biocompatibility | Devices meet ISO standards for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, and Material Mediated Pyrogenicity. | Device demonstrated biocompatibility with no evidence of material-mediated pyrogenicity according to ISO 10993 series and USP standards. |
| Electrical Safety and EMC | Complies with IEC 60601-1 and IEC 60601-1-2. | Adheres to IEC 60601-1:2005 + A1: 2012 and EN/JEC 60601-1-2: 2015 /IEC 60601-1-2: 2014 standards. |
| Software | Complies with ISO 62304:2006. | Adheres to ISO 62304:2006. |
2. Sample size used for the test set and data provenance:
- Puncture Rate Testing: Not explicitly stated, just "All test articles" and "The MicroPen EVO handpieces with attached needling cartridges and battery pack."
- Needle Penetration Depth and Extension Accuracy: Not explicitly stated, just "All MicroPen EVO test articles."
- Needle Retention: n=35 needles from nine cartridges.
- Battery Life Testing: Thirty trials were completed.
- Use Life Testing: Not explicitly stated, just "test articles."
- Cartridge Reliability Testing: Nine test articles.
- Microbial Ingress Testing: Not explicitly stated, just "Fully assembled MicroPen EVO test units."
- Suction Testing: Not explicitly stated, just "all nine test cartridges."
- Cleaning and Disinfection: Not explicitly stated.
- Data Provenance: All testing appears to be internal company testing ("Eclipse conducted testing/trials"). The testing used synthetic skin (SynDaver SynTissue) to simulate worst-case human skin conditions and, for suction prevention, human forearms. This is retrospective in the sense that the data was collected for this submission, not a prospective clinical trial. The country of origin for the data is implied to be where Eclipse MedCorp LLC conducts its testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is evaluated through engineering and materials testing, not through expert assessment of clinical data or images.
4. Adjudication method for the test set:
- None. As above, this is laboratory/engineering testing with predefined objective pass/fail criteria.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This type of study is for AI-powered diagnostic/interpretive devices, not mechanical microneedling devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no AI algorithm being evaluated for standalone performance.
7. The type of ground truth used:
- The "ground truth" for this device's performance is established through physical and mechanical measurements against defined engineering specifications and industry standards, and biological testing (biocompatibility, microbial ingress) against established limits. For example, RPMs are measured directly, needle depth is measured directly, and bacterial reduction is measured by CFU counts. For non-quantitative aspects like visual degradation, it's based on observable physical state.
8. The sample size for the training set:
- Not applicable. There is no AI model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.