(57 days)
The Venus BlissMAX device is a diode laser system intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals with a Body Mass Index (BMI) of 30 or less.
In addition, the Venus BlissMAX device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses:
- · Relief of minor muscle aches and pain, relief of muscle spasm
- Temporary improvement of local blood circulation
- · Temporary reduction in the appearance of cellulite
In addition, The Venus BlissMAX device using the FlexMAX applicators is intended for muscle conditioning to stimulate healthy muscles.
The Venus BlissMAX device using the FlexMAX applicators is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
The Venus BlissMAX device using the FlexMAX applicators is intended to be operated by a trained professional.
The Venus BlissMAX device is a computerized system comprised of a system console (main unit), four (4) Diode Laser applicators, one (1) MP2 (RF+ PEMF+ Vacuum) applicator and four (4) FlexMAX (EMS) applicators. The system delivers laser, bipolar RF and biphasic electrical energies, vacuum pressure, and pulsed electromagnetic fields (PEMF) to the skin and the underlying tissues of the treatment area. The device provides individual adjustment of laser power, EMS intensity level, and RF power, in addition to vacuum levels, for each patient.
The console of the Venus BlissMAX device contains a power supply unit, Laser, RF, and EMS controllers, (power modules, on main board), a suction module (vacuum), a controller unit (on main board), Laser water cooling system (power module, on main board), a touch- screen user interface and display panel.
The applicators are connected to the console via a cable. The RF applicator is comprised of various combinations of RF electrodes, magnetic coils, and vacuum conduits.
The Laser applicators are comprised of a light guide, touch sensors and light-emitting diodes.
The EMS applicator is comprised of two electrodes and a light indicator.
This document is a 510(k) summary for the Venus BlissMAX device, a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. Critically, there is no acceptance criteria table or formal study data presented in the provided text in the manner one might see for an AI/ML medical device where specific performance metrics (e.g., sensitivity, specificity) are tested against predefined thresholds.
Instead, this submission leverages the concept of "substantial equivalence" to predicate devices already cleared by the FDA. The "study" proving the device meets its acceptance criteria is primarily a comparison of its technological characteristics and safety testing to these predicate devices. The acceptance criteria are implicit in demonstrating that the new device is as safe and effective as the predicate devices, and that any differences do not raise new questions of safety or effectiveness.
Here's an analysis based on the provided text, addressing your questions where possible:
1. A table of acceptance criteria and the reported device performance
As mentioned, a formal acceptance criteria table with quantifiable performance metrics (like sensitivity, specificity, accuracy) akin to an AI/ML device is not present in this document. The device's performance is "accepted" if it is determined to be substantially equivalent to the predicate devices. The "reported device performance" is the demonstration through non-clinical testing that the device functions according to specifications and conforms to applicable safety standards, which are shared with the predicates.
Implicit Acceptance Criteria (based on Substantial Equivalence):
| Acceptance Criteria Category | Device Performance (How Criterion is Met) |
|---|---|
| Intended Use | Identical or highly similar to predicate devices. |
| Indications for Use | Identical or highly similar to predicate devices, with broader coverage for some areas (e.g., "back" for lipolysis) aligning with other predicate devices. |
| Technological Characteristics | Similar principles of operation (Diode Laser, RF, PEMF, Vacuum, EMS). Differences do not raise new safety/effectiveness concerns. |
| Safety (Electrical & EMC) | Conformance to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, EN 60601-2-22, IEC 60601-2-10, IEC 60825-1, IEC 60601-1-6. |
| Software Performance | Software verification testing conducted, results acceptable, in accordance with FDA guidance. |
| Biocompatibility | Patient-contacting components demonstrated biocompatibility per ISO 10993-1 guidance. |
| Clinical Performance | No clinical testing was deemed necessary as the device is substantially equivalent to predicates for which clinical data already existed or was not required for initial clearance. Bench testing for MP2 applicator (up to 150W) demonstrated safety, aligning with previous predicate data. |
2. Sample sizes 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" primarily refers to individual devices or components undergoing engineering and safety testing.
- Data Provenance: The data provenance for the safety and engineering tests (Electrical, EMC, Biocompatibility) would be internal lab testing or testing conducted by independent third-party laboratories. No specific country of origin for this testing data is provided, but it's typically performed in a controlled, accredited environment. The document states these are "non-clinical performance testing" and "Verification and Validation tests." There is no patient data involved in this submission for the Venus BlissMAX.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This type of expert evaluation for establishing ground truth (e.g., for image interpretation in AI/ML) is not applicable to this device's 510(k) submission. The ground truth for device safety and performance here comes from engineering and quality system standards (e.g., IEC standards, ISO 10993-1).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies, particularly for diagnostic devices where human expert consensus is needed to establish ground truth for patient outcomes or interpretations. This 510(k) relies on non-clinical engineering and safety performance testing against established standards.
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 study was NOT done or reported. This device is not an AI-assisted diagnostic tool for which an MRMC study would be relevant. Its clearance is based on substantial equivalence for physical therapeutic/aesthetic functionalities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable in the context of an "algorithm only" performance study. The device contains software and firmware (page 9), but these are for controlling the hardware functionality (e.g., power levels, timers, safety shutdowns), not for performing analytical tasks or diagnoses independently. The software testing mentioned is for verification of its control functions.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission is established by international and national consensus standards for medical device safety and performance (e.g., IEC standards, ISO standards for biocompatibility), as well as internal engineering specifications and functional requirements. For example, the "ground truth" that the device is electrically safe is compliance with IEC 60601-1.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML-based device that undergoes a "training set" for an algorithm. Its functionality is based on established physical principles (laser, RF, EMS, vacuum).
9. How the ground truth for the training set was established
- Not applicable. As there is no AI/ML training set, there is no ground truth establishment process for a training set.
Summary of the "Study" Proving Compliance:
The "study" proving the Venus BlissMAX meets its acceptance criteria (i.e., is safe and effective and substantially equivalent) is a comprehensive set of non-clinical tests and comparisons:
- Direct Comparison to Predicate Devices: The core of the submission is a detailed comparison of the Venus BlissMAX to its primary predicate (Venus BlissMAX K213308) and co-secondary predicates (Cynosure SculpSure K182741, Venus Legacy Pro K191528) across various technical specifications (wavelength, power density, components, indications for use, energy type, etc.). The acceptance criterion here is that the new device's characteristics are either identical, very similar, or that any differences do not introduce new safety or effectiveness concerns compared to the already cleared predicate devices.
- Safety Testing Conformity: The device underwent rigorous testing to ensure compliance with a multitude of international safety and performance standards relevant to medical electrical equipment, lasers, high-frequency surgical equipment, and muscle stimulators. These include:
- IEC 60601-1 (General requirements for basic safety and essential performance)
- IEC 60601-1-2 (EMC – Requirements and Tests)
- IEC 60601-2-2 (High frequency surgical equipment)
- EN 60601-2-22 (Laser equipment)
- IEC 60601-2-10 (Nerve and muscle stimulator)
- IEC 60825-1 (Safety of laser products)
- IEC 60601-1-6 (Usability)
- Software verification testing per FDA guidance.
- Biocompatibility testing per ISO 10993-1 guidance.
The acceptance of the device is based on the satisfactory results of these non-clinical tests and the successful demonstration of substantial equivalence without raising new safety or effectiveness questions.
§ 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.