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510(k) Data Aggregation
(413 days)
The radiofrequency-energy only delivery components of the Youmagic FLM System are indicated for use in dermatologic surgical procedures for electrocoagulation and hemostasis.
The Youmagic FLM System is a prescription use device.
The Youmagic FLM System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. The Youmagic FLM System delivers energy from the disposable tip to the patient. The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances for delivery to the patient through single and multiple pass stamping motions of the tip.
The Youmagic FLM System is a monopolar, conductive radiofrequency System designed for use in non-invasive dermatological procedures.
The System consists of the following components: Console, including touchscreen, a Handpiece, Treatment Tip, and AC power cord. The System is used with the following WE Medical-supplied accessories: Cryogen Canister, Return Pad.
The System continuously monitors output power, output energy, treatment duration, and measured impedance.
The System also controls the coolant delivery through the Handpiece. The Handpiece delivers RF energy while cooling tissue by thermal conduction.
Based on the provided FDA 510(k) Clearance Letter for the Youmagic FLM System (YM5-U1), here's an analysis of the acceptance criteria and the study that proves the device meets them:
Important Note: The provided document is a 510(k) clearance letter, which means the device was determined to be "substantially equivalent" to a predicate device, not necessarily that it underwent a rigorous clinical trial demonstrating superiority. The "study" referenced in the prompt (and in this response) primarily refers to the non-clinical and comparative assessments performed for the 510(k) submission, as no clinical studies were included in this submission (refer to "8. Clinical Test Conclusion" on Page 7).
The acceptance criteria here are primarily based on demonstrating substantial equivalence to a predicate device, meaning the proposed device is as safe and effective as the legally marketed predicate device. The performance data presented are largely derived from non-clinical tests and comparisons to the predicate's specifications.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission relying on non-clinical data and comparison to a predicate, the "acceptance criteria" are implied by the predicate device's specifications and the non-clinical tests performed. The "reported device performance" are the proposed device's specifications and test results aligning with the predicate or demonstrating safety and effectiveness within similar ranges.
| Acceptance Criterion (Implied by Predicate) | Reported Device Performance (Youmagic FLM System) | Comment on Meeting Criteria |
|---|---|---|
| Indications for Use: Dermatologic surgical procedures for electrocoagulation and hemostasis. (Predicate has broader indications) | The radiofrequency-energy only delivery components of the Youmagic FLM System are indicated for use in dermatologic surgical procedures for electrocoagulation and hemostasis. The Youmagic FLM System is a prescription use device. | The proposed device's indications are within the range of the predicate's, specifically for electrocoagulation and hemostasis. Considered acceptable as it does not raise new safety/effectiveness issues. |
| Product Code: GEI | GEI | Met (SAME) |
| Regulation Number: 21 CFR 878.4400 | 21 CFR 878.4400 | Met (SAME) |
| Prescription or OTC: Prescription Use | Prescription Use | Met (SAME) |
| User Interface: LCD / Touchscreen Technology | LCD / Touchscreen Technology for user interaction and controls | Met (SAME) |
| Mode of Operation: Manual or Footswitch (Predicate) | Manual | Met (Difference is in physical specification and deemed not to affect safety/effectiveness based on compliance with IEC standards). |
| Frequency: 6.78 MHz | 6.78 MHz | Met (SAME) |
| Monitored parameters: Cooling system and temperature detection control | The product is equipped with a cooling system and a temperature detection control system | Met (SAME) |
| Monopolar operation | Monopolar | Met (SAME) |
| Temperature sensors: NTC Sensor | NTC Sensor | Met (SAME) |
| Impedance monitor | Impedance monitor | Met (SAME) |
| Continuity monitor | Continuity monitor | Met (SAME) |
| Output frequency: 6.78MHz | 6.78MHz | Met (SAME) |
| Waveform: sine wave | sine wave | Met (SAME) |
| Max Power output: 400W (Predicate full range), but 173W with Total Tip 4.0 cm² | 175W | Met (Minor difference; deemed equivalent as the proposed device's max power is within the relevant predicate tip's output range). |
| Voltage output: Max peak to peak voltage 770Vpp@400Ω (Predicate) | Max peak to peak voltage 750Vpp@400Ω | Met (Similar performance specifications and deemed not to affect safety/effectiveness based on compliance with IEC standards). |
| Crest factor: 2.007～4.123 (Predicate) | 2.02～4.134 | Met (Similar performance specifications and deemed not to affect safety/effectiveness based on compliance with IEC standards). |
| Pulse Number: 5 | 5 | Met (SAME) |
| Pulse Width: 200ms | 200ms | Met (SAME) |
| Pulse Interval: 50ms | 50ms | Met (SAME) |
| Duty cycle: 0.8 | 0.8 | Met (SAME) |
| Load resistor range: 75Ω～400Ω | 75Ω～400Ω | Met (SAME) |
| Treatment Area (Tip): Varied (3.0cm², 0.25cm², 16.0cm² for predicate) | Total Tip 4.0cm² | Met (Within the range of the predicate's tip sizes, deemed not to affect safety/effectiveness based on compliance with IEC standards). |
| Maximum Average Power: 144W±20% (Predicate, 4.0 cm² tip) | 146W (calculated: 175W * 0.833 ≈ 146W) | Met (Minor difference, calculated to be very close and within acceptable limits). A detailed calculation was provided in the submission (ESU Performance Testing Report). |
| Electrode Material: Cu | Cu | Met (SAME) |
| Insulation Material: Polyimide/ABS | Polyimide/ABS (Acrylonitrile Butadiene Styrene) | Met (SAME) |
| Return Pad - Conductive or capacitive: Conductive | Conductive | Met (SAME) |
| Return Pad - Physical specifications: 215mm(L) × 118mm(W) (Predicate) | 210mm(L) × 101mm(W) | Met (Deemed physically equivalent). |
| Return Pad - Materials: Anti-adhesive film, aluminum foil, conductive adhesive, tongue, sponge. | Anti-adhesive film, aluminum foil, conductive adhesive, tongue, sponge. | Met (SAME) |
| Return Pad - Technical specification: R＜50Ω@ (200KHz-5MHz) | R＜50Ω@ (200KHz-5MHz) | Met (SAME) |
| Biological Safety: Biocompatibility tests | ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (skin sensitization), ISO 10993-23 (irritation) compliant. | Met (Compliant with international standards for biocompatibility). |
| Electrical Safety & Performance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC/TR 60601-4-2 | Compliant with IEC 60601-1:2020 (General requirements for basic safety and essential performance), ISO 60601-1-2:2020 (Electromagnetic disturbances), IEC 60601-2-2:2017 (High frequency surgical equipment), IEC /TR 60601-4-2:2016 (Electromagnetic immunity). | Met (Compliant with relevant international standards for safety and essential performance). |
| Thermal Effects on Tissue | Thermal effects test on tissue per FDA Guidance - Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. | Met (Compliant with FDA guidance). |
Study Proving Device Meets Acceptance Criteria
The "study" in this context refers to the non-clinical testing and substantial equivalence comparison performed to support the 510(k) submission.
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not applicable in the context of human clinical data for this 510(k). The "test set" here refers to the actual device units and components subjected to engineering, performance, and biocompatibility testing. The sample size for these non-clinical tests would typically involve a predefined number of devices/components to ensure statistical significance for engineering parameters, but these specifics are not detailed in the clearance letter.
- Data Provenance: The testing was conducted by WE Medical Technology (Wuxi) Co., Ltd. in Wuxi, Jiangsu, PR China. The tests are non-clinical (bench testing, electrical safety, biocompatibility, thermal effects). The data is prospective in the sense that the device was manufactured and then subjected to these specific tests to demonstrate compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable for non-clinical testing for substantial equivalence. "Ground truth" in this context is established by engineering specifications, regulatory standards (e.g., ISO, IEC), and comparison to the predicate device's established performance. The "experts" would be the engineers, quality control specialists, and regulatory affairs personnel at WE Medical Technology responsible for conducting and verifying these tests against the established standards and predicate specifications. Their qualifications would be expertise in electrosurgical device design, testing, and regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- None. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for independent review of results (e.g., image interpretation). For non-clinical testing, the "adjudication" is inherent in the validation procedures, quality control checks, and regulatory review process that determines if the test results meet the predefined acceptance criteria (i.e., compliance with standards and equivalence to predicate specifications).
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. An MRMC comparative effectiveness study was not performed, as explicitly stated: "No clinical study is included in this submission" (Page 7). This device is an electrosurgical tool, not an AI-assisted diagnostic or therapeutic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware electrosurgical device, not a software algorithm or AI device. Its performance is evaluated through its physical and electrical characteristics as per relevant standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:
- International Consensus Standards: Compliance with recognized standards like ISO 10993 (biocompatibility) and IEC 60601 series (electrical safety and performance).
- FDA Guidance Documents: Compliance with relevant FDA guidelines, such as "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery" for thermal effects testing.
- Predicate Device Specifications: The established performance and safety profile of the legally marketed predicate device (Thermage FLX System, K170758) serves as the benchmark for equivalence.
- Engineer-defined specifications: Internal engineering design specifications and test protocols.
8. The sample size for the training set:
- Not applicable. There is no "training set" in the context of an electrosurgical device going through a 510(k) process based on substantial equivalence. This terminology is relevant for machine learning or AI models.
9. How the ground truth for the training set was established:
- Not applicable. As there is no training set for this type of device submission.
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