(311 days)
The Sectum control unit is a high frequency generator intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such and muscle spasms, increase in local circulation and provide a temporary reduction in the appearance of cellulite. The Sectum control unit utilizes a BODY and PRECISION applicator for delivering high frequency electrotherapy to tissue.
The Sectum control unit is a radiofrequency energy generator employed for a variety of aesthetic applications. The control unit output is set and monitored via touchscreen and controlled by foot switch. The control unit can be used with corded bipolar Precision and Body applicators.
The Neauvia Sectum System's acceptance criteria and the study proving it meets these criteria are described below. The device in question is a high-frequency electrosurgical generator intended for topical heating to elevate tissue temperature for conditions such as pain and muscle spasms, increased local circulation, and temporary reduction of cellulite.
1. Table of Acceptance Criteria and the Reported Device Performance:
The provided document focuses on substantial equivalence to a predicate device (Venus Legacy CX) through non-clinical evidence and compliance with electrical safety and EMC standards. Therefore, the "acceptance criteria" can be inferred from these compliance requirements and the performance aspects compared to the predicate.
| Acceptance Criteria (Inferred from Non-Clinical Evidence) | Reported Device Performance |
|---|---|
| Compliance with Electrical Safety Standards (IEC 60601-1, IEC 60601-2-2) | Passed: Verified and validated through testing. |
| Compliance with Electromagnetic Compatibility (EMC) Standards (IEC 60601-1-2) | Passed: Verified and validated through testing. |
| Compliance with Usability Standards (IEC 60601-1-6) | Passed: Verified and validated through testing. |
| Compliance with Alarm Systems Standards (IEC 60601-1-8) | Passed: Verified and validated through testing. |
| Software Verification and Validation | Completed: Conducted and documented in accordance with FDA guidance for software in medical devices. |
| Ability to maintain tissue temperatures within therapy-specific limits (Skin surface temperature) | Proven: Skin surface temperature testing completed successfully, demonstrating the device's ability to maintain tissue temperatures within specified therapeutic ranges. |
| Biocompatibility of Patient-Contacting Materials (ISO 10993-1, ISO 10993-5, ISO 10993-10) | Compliant: Cytotoxicity and irritation testing showed components in patient contact are not cytotoxic (per ISO 10993-5) or irritating (per ISO 10993-10). |
| Substantial Equivalence to Predicate Device (Venus Legacy CX) in Performance, Options, and Size | Confirmed: The document states, "The subject devices included in The Neauvia Sectum System are substantially equivalent to predicate device in performance, options, and size. The system emits RF current to heat body and face tissues." The comparison table on page 4 details similar intended use, technological characteristics (e.g., RF energy, footswitch activation, touchscreen interface, bipolar mode, temperature sensors) despite some differences in specific parameters (e.g., Max Power Output, additional energy delivered features in predicate like PMF, Vacuum). The conclusion explicitly states, "The similar technological characteristics, indications for use and results of performance testing support the substantial equivalence of the Neauvia Sectum to the predicate device." |
2. Sample size used for the test set and the data provenance:
The document does not specify a "test set" in the context of human subjects or patient data. The provided evidence is based on non-clinical testing (e.g., electrical safety, EMC, software validation, skin surface temperature testing, and biocompatibility). Therefore, sample size and data provenance in terms of country of origin or retrospective/prospective nature are not applicable for these types of engineering and laboratory tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since the evidence is non-clinical testing and not based on human-read interpretations of medical images or diagnoses, the concept of "experts establishing ground truth for a test set" is not applicable in the traditional sense for this submission. The "ground truth" for these tests refers to the established standards and accepted scientific methodologies for proving compliance (e.g., passing electrical safety tests according to IEC standards). These tests would be conducted by qualified engineers and technicians in certified testing laboratories.
4. Adjudication method for the test set:
Not applicable, as there is no test set involving human interpretation requiring 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. The device is a high-frequency electrosurgical generator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical instrument and not an algorithm. Its performance is demonstrated through its functional capabilities, safety, and biocompatibility, as evaluated through non-clinical tests.
7. The type of ground truth used:
The "ground truth" for the non-clinical tests were established technical standards and validated testing protocols. For example:
- Electrical Safety, EMC, Usability, Alarm Systems: Compliance with specific IEC 60601 series standards.
- Software Validation: Adherence to FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Skin Surface Temperature Testing: Defined therapeutic temperature limits.
- Biocompatibility: Adherence to ISO 10993 series standards (ISO 10993-1, -5, -10).
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, as there is no training set for this device.
§ 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.