(25 days)
The SofMave System is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue; which can also affect the appearance of lax tissue in the submental and neck regions for subjects aged 22 and older. The SofWave System is also intended for short-term improvement in the appearance of cellulite.
The SofWave System is an ultrasound system intended for aesthetic purposes. The system generates high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage. The SofMave System consists of two main functional components: 1) the console and 2) the applicator. The console includes the power sources, cooling unit, electrical components, the loT and the user interface. The applicator is comprised of an array of ultrasonic transducers that emit continuous acoustic waves at 10-12 MHz and an active cooling element that is used to cool the skin area in contact with the applicator. The applicator is connected by a flexible cable to the console.
The provided FDA 510(k) summary for the SofWave System (K230820) states that this device is a modification of a previously cleared device (K230019). The modifications are described as minor hardware and software changes, specifically the addition of Internet of Things (IoT) capability via Wi-Fi. It explicitly states that these changes do not alter the fundamental scientific technology of the modified device, and specifically the energy parameters for the console or the applicators are not changed.
Therefore, this 510(k) relies on the substantial equivalence to the predicate device the original SofWave System (K230019) and does not present new clinical performance data to establish acceptance criteria or device performance related to its indications for use. Instead, it focuses on verifying that the changes made to K230820 do not negatively impact safety or effectiveness.
Based on the provided document, the following points can be inferred:
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Acceptance Criteria and Reported Device Performance: No new performance criteria or clinical performance data are reported for the K230820 device in this document, as the changes are considered minor and not affecting the fundamental technology or energy parameters. The established performance of the predicate device (K230019) is implicitly relied upon.
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Sample Size for Test Set and Data Provenance: Not applicable. The document does not describe a new clinical study with a test set for K230820.
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Number of Experts and Qualifications: Not applicable.
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Adjudication Method: Not applicable.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable.
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Standalone Performance: Not applicable as no new clinical performance data is presented for K230820 related to its intended use. However, the document does state that "Verification testing demonstrates that the modified device functions as specified and is as safe and effective as the cleared predicate device," and mentions "Software verification and validation testing was performed. The results were found acceptable for the software changes and demonstrated that the software performs as intended." This refers to internal engineering verification for the specific changes, not clinical performance for the indications for use.
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Type of Ground Truth Used: Not applicable for K230820 in this document.
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Sample Size for Training Set: Not applicable.
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How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document does not contain the specific information requested regarding new acceptance criteria or a study that proves the [K230820](https://510k.innolitics.com/search/K230820) device meets acceptance criteria related to its clinical indications. This is because K230820 is presented as a modification of an already cleared device, and the submission argues that the modifications do not require new clinical performance testing. The "Performance Data" section focuses on verification and validation of the minor changes:
- Risk analysis to assess the impact of modifications.
- Verification testing to show the modified device functions as specified and is as safe and effective as the predicate.
- Electrical safety and EMC testing (repeated for the modified device).
- Biocompatibility (established based on the predicate device, as no new patient-contacting materials were introduced).
- Software verification and validation testing for the specific software changes.
To find the acceptance criteria and clinical study details for the original SofWave System (K230019), one would need to consult the 510(k) submission for that predicate device.
§ 878.4590 Focused ultrasound stimulator system for aesthetic use.
(a)
Identification. A Focused Ultrasound Stimulator System for Aesthetic Use is a device using focused ultrasound to produce localized, mechanical motion within tissues and cells for the purpose of producing either localized heating for tissue coagulation or for mechanical cellular membrane disruption intended for noninvasive aesthetic use.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Focused Ultrasound Stimulator System for Aesthetic Use.” See § 878.1(e) for the availability of this guidance document.