(272 days)
The Venus Freeze is a non-invasive device intended for use in Dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
The Venus Freeze is a noninvasive, non-ablative device consisting of:
- Main Unit (console)
- Touch Screen user interface
- RF Power module
- Controller unit
- Two treatment applicators:
(1) Octipolar M applicator - for large treatment areas, composed of 8 RF electrodes
(2) Diamondpolar™ applicator - for small treatment areas, composed of 4 RF electrodes.
The Touch Screen user interface allows the selection of treatment parameters (time and power) by pressing on the treatment buttons and displays the current treatments settings.
The Controller Unit provides the operational and safety function of the system.
Treatment applicators transmit Bi-Polar RF energy in a method that creates an organized Bi-Polar RF energy matrix which produces homogeneous heating in the entire treatment area for maximum safety and efficacy, eliminating the need for pre/post cooling mechanisms.
The RF power module provides RF energy to the selected applicator, producing a 1MHz signal.
The provided text states that for the Venus Freeze device, "Venus-Concept believes that animal and clinical studies are not required to determine the safety and efficacy of the device" due to previously published scientific research and clinical studies on similar radiofrequency devices. Therefore, a specific study proving the device meets acceptance criteria as typically outlined in an FDA submission with performance data, sample sizes, and ground truth establishment was not conducted for this 510(k) submission.
Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices and adherence to relevant performance standards for safety.
Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is explicitly stated as not required or not applicable:
Acceptance Criteria and Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Adherence to recognized safety standards for medical electrical equipment (e.g., ANSI AAMI 60601-2-2 for safety of high-frequency surgical equipment, EN 60601-1, IEC 60601-1-2). | The Venus Freeze complies with ANSI AAMI 60601-2-2, EN 60601-1, and IEC 60601-1-2. |
| Substantial equivalence to predicate devices for the non-invasive treatment of mild to moderate facial wrinkles and rhytides. | The Venus Freeze is found substantially equivalent to the EndyMed Imagine TC Skin Treatment System (K083461), Lumenis Aluma (K051214), and Syneron Polaris (K031671) based on its intended use, power, and frequency being within previously cleared values. |
| Safety and efficacy of radiofrequency devices emitting energy with a frequency of 1000 KHz and power of 37 to 150 W (as established in scientific research and clinical studies on similar systems). | The device operates within these parameters (1MHz signal, power not explicitly stated but implied to be within the 37-150W range of established devices). The submitter states that safety and efficacy are "well established in scientific research and clinical studies" for devices with these characteristics. The submitter cites "comprehensive animal and clinical study performed in scientific research and published in the literature" for similar devices. |
Study Details (As per the provided document, studies were not conducted for this specific device's 510(k) submission to establish safety and efficacy directly.)
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. No new test set data from a clinical or animal study was generated for this 510(k) submission. The safety and efficacy relied on existing literature for similar devices.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. No new ground truth was established for a test set specific to the Venus Freeze device in this submission.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No new test set requiring adjudication was used.
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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 a non-AI electrosurgical device for dermatologic procedures; therefore, an MRMC study related to readers and AI assistance is not relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware device, not an AI algorithm. Its performance is inherent in its operation and not separate from human-in-the-loop (operator) performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the purpose of this 510(k) submission, the "ground truth" for safety and efficacy for the device type (radiofrequency devices for wrinkle treatment) was established through "comprehensive animal and clinical study performed in scientific research and published in the literature" of similar devices, rather than new evidence for the Venus Freeze itself.
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The sample size for the training set:
- Not applicable. No training set for an algorithm was used or mentioned. The device's design implicitly relies on established engineering principles and prior research of similar devices.
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How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.