(210 days)
The Pollogen Legend+™ System is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO).
It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3).
Pollogen Ltd's modified Legend*™ system delivers bipolar radiofrequency (RF) electrical current to the skin surface for dermatological procedures requiring ablation and resurfacing of the skin. The physician can control the parameters of the device through a user interface. The system consists of:
- Main Unit (includes the Controller); -
- Control Panel (User Interface); -
- RF Generator; -
- VO (VoluDerm) Treatment Applicator -
- Disposable tips; gen12, gen36 & gen36L -
- Treatment Applicators 1-3 (TriPollar); -
- Foot Switch; -
- Patient-Controlled Manual Switch. -
The device generates RF energy, which is applied to the skin. The VO (VoluDerm Energy) treatment applicator applies pulses of bipolar RF energy that flows between electrodes to create micro-ablation points on the skin via an array of multi-electrode pins.
The TriPollar treatment Applicators 1-3 apply bipolar RF energy that flows between electrodes on the skin. The three applicators differ in size and configuration and are indicated for treatment of various size facial areas. The operator can adjust treatment parameters, such as the power level and treatment time from the user interface on the Main Unit. The Applicator is applied with a little pressure and a rubbing/massaging technique (linear, circular, etc., depending on the area). The applicator should be moved continuously on the skin. No active cooling of the electrodes or the skin is required.
The provided text describes Pollogen Ltd.'s modified Legend+™ System, an electrosurgical cutting and coagulation device. The key focus of the submission for K173503 is to add a new disposable tip, gen36L, to the existing VO applicator.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria in terms of quantitative performance metrics for the device's efficacy in ablation, resurfacing, or wrinkle treatment. Instead, the acceptance criteria appear to be framed around demonstrating substantial equivalence to a predicate device (Pollogen Legend+™ System K171359) and establishing safety and effectiveness, particularly for the new gen36L tip.
The performance data primarily focuses on compliance with international standards and a pre-clinical animal study.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Safety and Effectiveness (for gen36L tip) | Animal Study: Tested on 3 pigs. No procedure-related complications or premature deaths. Macroscopic and histological evaluations demonstrated the device can safely perform ablation and resurfacing of the skin. |
| Compliance with Electrical Safety Standards | Performance Tests: Demonstrated compliance with: |
- IEC/EN 60601-1 Ed 3.1 (Medical Electrical Equipment Part 1: General requirements for safety)
- IEC/EN 60601-2-2 (Particular requirements for the basic safety and essential performance of high frequency surgical equipment and accessories, including emission & immunity)
- IEC 62304 (Medical device software Software life cycle processes) |
| Biocompatibility | Performance Test: All parts in contact with the patient comply with the requirements of ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing) and ISO 10993-7 (Ethylene oxide sterilization residuals). |
| Software Verification and Validation | Performance Test: Software verified and validated according to FDA guidance. |
| Substantial Equivalence (Intended Use) | The modified Legend+™ system has the same intended use and indications for use as the predicate device, including ablation and resurfacing of skin with VoluDerm Energy (VO applicator) and non-invasive treatment of mild to moderate facial wrinkles and rhytides with TriPollar RF Energy. |
| Substantial Equivalence (Technological Characteristics) | Similar technological characteristics to the predicate device. The only difference is the addition of the gen36L tip. The minor difference in electrode pin length of gen36L (1000 microns vs. 600 microns for gen12/gen36) is deemed not to raise new safety/effectiveness questions, supported by comparison to a reference device (INTRAcel Premium K153727) which has similar or longer pins. |
| Substantial Equivalence (Principles of Operation) | The principles of operation (bipolar RF energy delivery, fractional non-homogeneous delivery via multi-electrode pins for VO, and homogenous heating for TriPollar for collagen remodeling) are the same as the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Animal Study: 3 pigs.
- Data Provenance: Not explicitly stated, but implies a controlled laboratory setting given "animal study." The manufacturer is Pollogen Ltd. in Israel, suggesting the study was likely conducted or overseen in that region or a designated test facility. This is a prospective study for the purpose of demonstrating the safety and effectiveness of the new tip.
- For other performance tests (standards compliance, biocompatibility, software V&V): The document does not specify sample sizes, as these are typically validated through engineering tests, documentation reviews, and adherence to established protocols rather than case-based test sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Animal Study: The document states "macroscopic and histological evaluation of the tissue." This implies that veterinary pathologists or other qualified experts conducted these evaluations. However, the exact number of experts and their specific qualifications (e.g., years of experience, board certifications) are not specified in the provided text.
4. Adjudication Method for the Test Set
- Animal Study: The document does not explicitly state an adjudication method (like 2+1, 3+1, etc.) for the macroscopic and histological evaluations. It simply mentions that these evaluations were performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was NOT done. The study's purpose was to demonstrate the safety and effectiveness of a device modification (the gen36L tip) by showing substantial equivalence to an already cleared predicate, rather than to compare human reader performance with and without AI assistance. The device in question is a medical device for skin treatment, not an AI or imaging diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was Done
- Not applicable in the context of typical AI/diagnostic standalone studies. The Pollogen Legend+™ System is a hardware device delivering RF energy, operated by a human. Its performance is inherent to its physical operation, not an algorithm interpreted by itself. The software verification and validation are for the operational integrity of the device's control system, not for an AI diagnostic algorithm operating standalone.
7. The Type of Ground Truth Used
- Animal Study: The ground truth for the animal study was established through histological evaluation of tissue samples from the treated areas. This is a definitive biological assessment of tissue changes at a microscopic level. It also mentions "macroscopic evaluation," which represents visual assessment.
8. The Sample Size for the Training Set
- Not applicable. This device is a physical medical device, not an AI model that requires a training set of data. The "training" for the device would involve engineering design, component testing, and calibration.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As stated above, this is not an AI model requiring a training set with established ground truth.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.