(74 days)
The Venus Legacy BX Device is a non-invasive device intended for use in dermatologic and general surgical procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV
The Venus Legacy BX device is a non-invasive, non-ablative medical aesthetic device. It is designed to deliver RF (Radio Frequency, 1MHz) energy and PMF (Pulsed Magnetic Field, 15Hz) energy to the skin. RF energy heats the tissue to trigger cellular changes for the intended use. The RF treatment is supplemented with an adjunct magnetic energy for the reduction of the downtime healing process.
The device consists of an RF Power Module, a Pulsed Magnetic Field (PMF) module, two hand piece applicators, and a console with control electronics and an LCD touch screen.
The document provided is a 510(k) premarket notification for the Venus Legacy BX Device, which seeks to demonstrate substantial equivalence to a previously cleared predicate device. It is not a study that proves a device meets specific acceptance criteria through clinical performance data. Therefore, many of the requested details about acceptance criteria derived from clinical studies, sample sizes, expert involvement, and ground truth establishment are not applicable to this type of submission.
The document primarily focuses on demonstrating that the new device has "substantially equivalent" technological characteristics and performance to its predicate.
Here's a breakdown based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on non-clinical testing and comparison to a predicate, formal "acceptance criteria" for clinical performance are not explicitly stated or demonstrated with clinical data. Instead, the "acceptance criteria" are implied as matching the specifications and performance of the predicate device.
| Acceptance Criterion (Implied) | Reported Device Performance (Venus Legacy BX) |
|---|---|
| Functional Equivalence to Predicate Device: | |
| RF Output Parameters match Predicate Venus Freeze (MP)2 | Bench test demonstrated same RF output specifications as predicate. |
| PMF Output Parameters match Predicate Venus Freeze (MP)2 | Bench test demonstrated same PMF output specifications as predicate. |
| Temperature Stability match Predicate Venus Freeze (MP)2 | Bench test demonstrated same temperature stability profile as predicate. |
| Safety (Electrical, Mechanical) and EMC | Complies with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. Similar safety features and compliance to predicate. |
| Biocompatibility of Patient Contact Materials | Complies with ISO10993 Standard; similar materials to predicate. |
| Device Specifications Match Predicate Capabilities: | |
| Maximal RF Output Power (150W) | Matches specification. |
| RF Output Frequency (1MHz) | Matches specification. |
| Magnetic Frequency (Pulse, 15Hz) | Matches specification. |
| Maximal Magnetic Field (15 Gauss) | Matches specification. |
| Inner Design and Components | Similar to the predicate device (console with power supply, RF generator, controller, display panel, and handpiece applicators). |
| Methods and Parameters of Treatment (energy levels, treatment area, duration) | Similar to the respective methods and parameters in the predicate device. |
| Software Validation | Software validation testing (provided in Section 12, though Section 12 is not included in the provided text). |
| Intended Use/Indications for Use | Non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV (for females), which is substantially equivalent to predicate. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable. No clinical test set data is provided or referenced in the document for the Venus Legacy BX device. The evaluation was based on non-clinical bench testing comparing the device to its predicate.
- Data Provenance: Not applicable. The "data" presented comes from internal bench testing (RF output, PMF output, temperature stability, safety standards compliance) of the Venus Legacy BX device, compared against the specifications of the predicate device (Venus Freeze (MP)2).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical test set requiring expert-established ground truth. The comparison was to the technical specifications and proven performance of a predicate device.
4. Adjudication method for the test set
- Not applicable. No clinical test set was conducted that would require an adjudication method.
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
- Not applicable. This device is an aesthetic medical device (RF and PMF energy delivery), not an AI-powered diagnostic or interpretive device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI system. Its performance relates to its physical parameters and energy delivery capabilities.
7. The type of ground truth used
- For the "performance" verification: The "ground truth" was effectively the established technical specifications, safety standards compliance, and proven performance of the predicate device (Venus Freeze (MP)2), which the Venus Legacy BX device aimed to match or demonstrate equivalence to through bench testing.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
Summary of the Study (as described in the document):
The "study" conducted for the Venus Legacy BX Device was a non-clinical bench test to demonstrate substantial equivalence to the predicate Venus Freeze (MP)2 device (K111670).
- Objective: To show that the Venus Legacy BX device has the same RF and PMF output specifications and temperature stability profile as the predicate device, despite minor design modifications (outer design only).
- Methodology:
- Bench testing was performed on the Venus Legacy BX device to measure its RF output parameters, PMF output parameters, and temperature stability.
- These measurements were then compared to the reported (or known) RF output measurements, PMF output parameters, and temperature stability of the predicate Venus Freeze (MP)2 device.
- Compliance with voluntary recognized safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2) was also assessed.
- Biocompatibility of patient contact materials was confirmed against ISO10993.
- Software validation testing was mentioned as being performed but results not detailed in the provided text.
- Findings: The bench tests demonstrated that the Venus Legacy BX device has the same RF and PMF output specifications and temperature stability profile as the predicate device. The inner design and components, safety features, compliance with safety standards, and intended use/indications for use were found to be similar or substantially equivalent to the predicate.
- Conclusion: Based on the performance testing comparing the Venus Legacy BX device to the predicate device, it was concluded that the Venus Legacy BX device is substantially equivalent for the stated intended use. This means the device met the "acceptance criteria" of being functionally and safely equivalent to the established predicate.
§ 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.