Search Results
Found 1 results
510(k) Data Aggregation
(258 days)
Dermaroller GmbH
The XCELLARISPRO TWIST microneedling device and accessories is 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 and for treatment of wrinkles in Fitzpatrick skin types I, II and/or III in the following facial areas: glabellar frown lines, periorbital lines and cheek folds in adults aged 22 years or older.
The XCELLARISPRO TWIST is a microneedling device and intended to create many, very tiny, microscopic punctures in the epidermal and dermal layers of the skin using sterile stainlesssteel needles. The XCELLARISPRO TWIST has 4 component parts and 2 consumables. Component parts: (1) handpiece, (2) control unit, (3) power supply and (4) foot switch. Consumables: (1) sterile, single-use needling module (Ethylene oxide sterilized) and (2) disposable barrier sleeves that cover the handpiece during each patient use.
The provided text describes the acceptance criteria and supporting studies for the XCELLARISPRO TWIST microneedling device.
It's important to note that this submission does not include clinical performance testing for the XCELLARISPRO TWIST device itself. Instead, it relies on non-clinical performance testing and substantial equivalence to predicate devices, which did undergo clinical studies.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the "Special Controls" for microneedling devices (21 C.F.R. § 878.4430(b)(1)-(10)) and the non-clinical performance data provided. The document primarily focuses on verifying technical specifications and safety aspects.
| Acceptance Criterion (Special Control) | Reported Device Performance |
|---|---|
| 1. Technical specifications and needle characteristics identified (needle length, geometry, puncture rate, maximum protrusion depth). | Needle Length: 2.5 mm (each of 6 stainless steel microneedles) |
| Needle Geometry: Not explicitly detailed beyond "6 stainless steel microneedles in squared arrangement." | |
| Puncture Rate: 50-150 per second (adjustable, ±10% variation) | |
| Maximum Protrusion Depth: 2.5 mm (recommended max 1.5 mm) | |
| 2. Non-clinical performance data demonstrate that the device performs as intended under anticipated conditions of use. | i. Accuracy of needle protrusion depth and puncture rate: Tested in pig skin with high-speed camera measurements. |
| ii. Safety features: Fluid ingress protection via bellows confirmed. | |
| iii. Maximum safe needle protrusion depth: Identified in pig skin with high-speed camera measurement. | |
| 3. Performance data demonstrates sterility of patient-contacting components (needling module) according to ISO 11737-2, ISO 11135. | Needling module provided sterile, Ethylene oxide sterilized. (Implicitly, performance data supports this claim.) |
| 4. Performance data supports shelf life (continued sterility, package integrity, device functionality) according to ISO 11607-1. | (Implicitly, performance data supports this claim as it is a required special control.) |
| 5. Performance data demonstrates electrical safety and EMC of all electrical components according to IEC 60601-1 and IEC 60601-1-2. | (Implicitly, performance data supports this claim as it is a required special control.) |
| 6. Software verification, validation, and hazard analysis. | (Implicitly, performed as it is a required special control.) |
| 7. Biocompatibility of patient-contacting components (cytotoxicity, irritation, sensitization, acute systemic toxicity, material-mediated pyrogenicity) per ISO 10993-1. | (Implicitly, tested and found biocompatible as it is a required special control.) |
| 8. Cleaning and disinfection validations performed for reusable components. | Surfaces of control unit and handpiece are made of materials which can be cleaned and disinfected (Implicitly, validations performed.) |
| 9. Labeling includes: device operation, typical course of treatment, technical parameters, validated reprocessing methods, disposal instructions, shelf life. | (Implicitly, confirmed that labeling includes these items as per special control.) |
| 10. Patient labeling includes: device operation, typical course of treatment, probable risks/benefits, post-operative care. | (Implicitly, confirmed that patient labeling includes these items as per special control.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size:
- For testing "Accuracy of needle protrusion depth and puncture rate" and "Maximum safe needle protrusion depth," pig skin was used. The specific number of pig skin samples or measurements is not provided in the document.
- For other non-clinical tests (sterility, shelf life, electrical safety, biocompatibility, cleaning/disinfection), the sample sizes are not specified in this summary.
- Data Provenance: The tests are stated as "non-clinical performance testing." The location or specific origin of the data/testing facility is not specified. It is retrospective in the sense that the tests were completed before the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The non-clinical tests described (e.g., high-speed camera measurements on pig skin, electrical safety, sterility) typically rely on standardized measurement techniques and validated protocols rather than expert consensus on a "ground truth" derived from human observation.
4. Adjudication method for the test set
- An adjudication method is typically relevant for studies involving human interpretation or subjective assessment. Since the described tests are non-clinical and objective measurements (e.g., physical parameters, microbiological tests, electrical tests), an adjudication method is not applicable and therefore not mentioned.
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 MRMC comparative effectiveness study was done. This device is a microneedling device, not an AI software or diagnostic tool that would involve human readers interpreting cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No standalone algorithm performance study was done. This device is a hardware microneedling device, not an algorithm.
7. The type of ground truth used
- For the non-clinical performance tests:
- Technical specifications: Measured physical parameters (e.g., needle length, protrusion depth, puncture rate) against engineering specifications.
- Sterility: Absence of microorganisms (based on microbiological testing).
- Biocompatibility: Response of biological systems to materials (based on standardized in-vitro/in-vivo tests).
- Electrical Safety/EMC: Compliance with international safety standards.
- Cleaning/Disinfection Validation: Reduction of microbial load after reprocessing.
- The "ground truth" for these tests is defined by established scientific principles, recognized standards, and specific pass/fail criteria outlined in those standards.
8. The sample size for the training set
- Not applicable. This device is a microneedling device and does not involve machine learning or a "training set" in the context of an AI/algorithm.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this device.
Ask a specific question about this device
Page 1 of 1