(245 days)
The Rejuvapen NXT is a microneedling device and accessories intended to be used as a treatment to improve the appearance of periorbital wrinkles in Fitzpatrick skin types I-IV. The Rejuvapen NXT is intended for use on adults at least 22 years of age.
The Rejuvapen is a handheld instrument that contains a Single Use micro needle cartridge containing 12 stainless steel microneedles in a circular arrangement with an adjustable microneedle depth of up to 2.5 mm. The needles create very small punctures in the epidermal and dermal layers of the skin. The device is powered by a medical grade wall plug-in supply. An adjustment is provided for a variable speed motor that controls the frequency of the puncture process with a
Here's an analysis of the acceptance criteria and study findings based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with quantitative thresholds for effectiveness as a primary endpoint. Instead, the effectiveness is demonstrated through a clinical study where improvement in periorbital wrinkles is observed. The acceptance criteria for safety are primarily qualitative observations and adherence to international standards.
| Acceptance Criteria Category | Specific Criteria/Standard Adhered To | Reported Device Performance |
|---|---|---|
| Safety - Biocompatibility | ISO 10993-5, ISO 10993-7, ISO 10993-10, ISO 10993-11, USP 40 part 151, ISO 10993-12 | Biocompatibility evaluation performed, indicating compliance with standards. (Implied successful given broader conclusion of substantial equivalence). |
| Safety - Sterilization | ISO11135-1:2007, ISO/TS11135-2:2008, ISO11737-1:2006 | Shelf life (2 years) verified; sterilization validation reports in accordance with standards. |
| Safety - Reprocessing | Cleaning and low-level disinfection validation, use of protective sleeve required. | Cleaning and low-level disinfection validations performed. |
| Safety - Electrical | IEC / ES60601-1, IEC60601-1-2, IEC60601-1-6 | EMC testing and electrical safety testing performed, complying with standards. |
| Performance - Needle Protrusion Accuracy | Maximum needle protrusion setting of 2.5 + 0.25 mm. | Bench testing demonstrated accuracy of needle penetration depth and maximum permissible depth within set tolerance (± 0.25mm) at depths of 0.5mm and 2.5mm. Device maintained functional integrity with aged cartridges and devices. |
| Performance - Puncture Frequency Accuracy | Maximum puncture frequency of 110 Hz + 2%. | Bench testing demonstrated accuracy of puncture rate within set tolerance (± 2%) at frequencies of 80 Hz and 110 Hz. Device maintained functional integrity with aged cartridges and devices. |
| Performance - Cross-Contamination | Safety features to protect against cross-contamination (e.g., fluid ingress protection, safety membrane). | Testing of the safety membrane/seal under worst-case scenario (maximum puncture rate and needle penetration depth) did not result in penetration of viral particles, protein, or hemoglobin markers. |
| Effectiveness (Periorbital Wrinkles) | Not explicitly stated as a quantitative threshold in the provided text, but implied as significant improvement. | Physician Assessment: For 37 subjects with consistent grading, mean improvement in Lemperle scale was 0.57. 19 out of 45 subjects (42%) had at least a one-grade improvement according to both assessors. |
| Subject Assessment: 37/46 (80%) of subjects graded their treatment response as "slight to somewhat noticeable improvement in periorbital wrinkles." | ||
| Adverse Events | Not explicitly stated as a quantitative threshold or maximum allowed percentage, but events should be mild and self-limiting. | 20 adverse events in 12/52 subjects (23%), all judged mild, self-limiting, and requiring no intervention. 14/20 (70%) were bruising, 2/20 (10%) swelling, 1/20 (5%) blotchy skin/bruising, 1/20 (5%) 'watery eyes'/allergic response. |
| Erythema (Physician) | Not explicitly stated as a quantitative threshold; generally expected to be mild/moderate and transient. | Immediately post-treatment: predominantly minor or mild (83-93% across treatments), with 2-10% moderate. No severe erythema was observed. |
| Erythema (Subject) | Not explicitly stated as a quantitative threshold; generally expected to be transient. | Immediately post-treatment: 26% severe, 52% moderate, 22% mild/minor. |
| One day post-treatment: 11% severe. | ||
| By evening Day 3: 96% mild, minor, or absent. | ||
| By Day 8: 96% none, 4% minor, 2% mild. | ||
| Pain/Discomfort (Subject) | Not explicitly stated as a quantitative threshold; generally expected to be low and transient. | Mean pain score during treatment: 2.1 (range 0-7) on a 0-10 scale. |
| Mean discomfort score during treatment: |
§ 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.