(243 days)
The Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 are indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500, including the hand piece, is a system generating RF energy with integral temperature and impedance feedback mechanism for procedures that require elevating tissue temperature. The Capenergy System constantly monitors the temperature and impedance of the target treatment tissue, automatically adjusting energy delivery to maintain effective and safe tissue heating.
Capenergy C equipment's RF System - C25, C50, C100, C200, C300, C400, C500 consists of an AC/DC power supply unit, RF generator, controller and user interface. The RF hand piece is connected to the console via a cable and a switch activates the energy delivery to the hand piece. The hand piece is comprised of conductive and capacitive electrodes.
The provided document, a 510(k) Premarket Notification Submission for the Capenergy C Equipment RF System, does not describe the acceptance criteria and a study proving the device meets those criteria in the typical format of a clinical study assessing diagnostic accuracy or comparative effectiveness.
Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on non-clinical performance testing and conformance to voluntary standards. The "acceptance criteria" here are primarily functional specifications and regulatory compliance rather than statistical performance metrics from a human-in-the-loop or standalone study.
Here's a breakdown of the information that can be extracted, and where the requested information is not applicable or not provided in this specific document:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion / Performance Aspect | Acceptance Criteria (or Standard) | Reported Device Performance |
|---|---|---|
| Functional Performance: | ||
| Ability to Reach Therapeutic Temperature | Not explicitly stated as an AC, but implied by intended use and predicate comparison (40-45°C) | "The device demonstrated ability to reach and maintain therapeutic temperature (40-45°C) on the surface of human skin for at least 10 minutes." |
| RF Power Output | 45 W +/-10% for a charge of 06-j530 ohms to 1 MHz (from predicate) | Subject device matched predicate: 45 W +/-10% for a charge of 06-j530 ohms to 1 MHz |
| Internal Cut-Off Temperature | 40-45°C (from predicate) | Subject device matched predicate: 40-45°C |
| Treatment Time | 15-660 sec (from predicate) | Subject device matched predicate: 15-660 sec |
| RF Frequency | Fixed values, 0.8MHz, 1.0 MHz, 1.2 MHz +/-25% (from predicate) | Subject device offered additional frequency: Fixed values are established for the treatment time, percentage of power output and working frequency. Four available options: 0.448 MHz +/-25%, 0,8MHz +/-25%, 1,0 MHz +/-25%, 1,2 MHz +/-25% |
| Waveform | Sinusoidal (from predicate) | Subject device matched predicate: Sinusoidal |
| Safety and Compliance: | ||
| Electrical Safety | Conformance to IEC 60601-1:2005 +/A1:2012, IEC 60601-2-2:2017 | "Functional laboratory testing... showed correct operation of the device," and "Electrical safety" testing performed. (Specific test results not detailed, but conformance is asserted) |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2015 | "Functional laboratory testing... showed correct operation of the device," and "Electromagnetic compatibility" testing performed. (Specific test results not detailed, but conformance is asserted) |
| Software Verification & Validation | Conformance to IEC 62304:2006 and FDA guidance | "Software verification and validation was conducted to IEC 62304: 2006... and FDA guidance... The results of this testing conclude the software has met these requirements." |
| Biocompatibility (Patient-Contacting) | Conformance to ISO 10993-1:2009 | "Patient contacting materials have been evaluated according to the requirements of ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and confirmed to be biocompatible for their intended use." |
| Safety Class Protection | Class I – Type BF (from predicate) | Subject device matched predicate: Class I – Type BF |
2. Sample Size Used for the Test Set and the Data Provenance
This document primarily describes non-clinical, bench testing, and compliance with standards. There is no mention of a clinical "test set" in the context of patient data or clinical images for evaluating diagnostic performance. The "test set" implicitly refers to the physical devices themselves and their components undergoing various performance and safety assessments.
- Sample Size: Not applicable in the context of clinical data. For bench testing, typically multiple units or components are tested, but the exact count is not specified.
- Data Provenance: Not applicable in the context of clinical data. The testing is reported as "Functional laboratory testing performed in foreseeable operating conditions." This suggests internal laboratory testing rather than external clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable to this type of submission. Ground truth, in the context of diagnostic or AI-based devices, refers to a definitive diagnosis or finding against which the device's performance is measured (e.g., pathology report, expert consensus on images). This submission pertains to an energy-based therapeutic device and its safety/functional performance, not a diagnostic AI system requiring expert-adjudicated ground truth.
4. Adjudication Method for the Test Set
This is not applicable for the same reasons as point 3. There is no diagnostic "test set" of cases requiring adjudication.
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
This is not applicable. The Capenergy C equipment RF System is a therapeutic device intended for "topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions" and "electrocoagulation and hemostasis." It is not an AI-assisted diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance would be relevant or performed for this product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As a therapeutic RF energy system, the device's primary function is to deliver energy for heating and coagulation. It's not an "algorithm-only" or "standalone" diagnostic system. Its performance relates to its physical outputs (RF power, temperature control, etc.), which were evaluated through bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the sense of clinical ground truth for diagnostic purposes. The "ground truth" for this device's performance relies on:
- Engineering specifications and standards: Conformance to electrical safety, EMC, software, and biocompatibility standards (e.g., IEC 60601 series, IEC 62304, ISO 10993-1).
- Physical measurements: The ability to achieve and maintain specific temperatures (40-45°C) and power outputs.
- Comparison to predicate devices: Establishing substantial equivalence by showing that the subject device operates safely and effectively within similar parameters as legally marketed devices.
8. The sample size for the training set
This is not applicable. This device is a hardware-based therapeutic system, not an AI/machine learning model that undergoes "training." Its "software" (evaluated to IEC 62304) controls the device's functions, but this is a traditional software development and validation process, not machine learning.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
§ 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.