(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.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 28, 2023
Capenergy Medical S.L. Pilar Sanchez General Manager Avinguda Mare de Déu de Montserrat, 41 Sant Joan Despi, Barcelona, Catalonia 08970 Spain
Re: K222260
Trade/Device Name: Capenergy C Equipment RF System - C25, C50, C100, C200, C300, C400, C500 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: PBX, GEI Dated: January 29, 2023 Received: February 27, 2023
Dear Pilar Sanchez:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
{1}------------------------------------------------
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Mark Mark Trumbore -S Trumbore -S Date: 2023.03.28 12:52:43 -04'00'
Mark Trumbore, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K22260
Device Name
Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500
Indications for Use (Describe)
Capenergy C equipments RF System - C25, C50, C100, C200, C300 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, and dermatological procedures.
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Image /page/3/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is a stylized graphic that includes an orange circle and blue lines. The overall design is clean and modern.
CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
| DATE OF SUBMISSION: | 2023-03-28 |
|---|---|
| SUBMITTER NAME: | Capenergy Medical S.L. |
| SUBMITTER ADDRESS: | Av. Mare de Deu de Montserrat, 41 bis Pje 1º derecha08970 Sant Joan DespíBarcelonaSpain |
| CONTACT: | Pilar Sánchez General Manager |
| TELEPHONE: | +34 93 477 43 48 |
| e-mail: | pilar@capenergy.com |
| DEVICE TRADE NAME: | Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 |
| COMMON NAME: | Massager, Vacuum, Radio Frequency Induced Heat |
| REGULATION DESCRIPTION: | General & Plastic Surgery |
| CLASS: | Class II |
| REGULATION NUMBER: | 21 CFR 878.4400 |
| PRODUCT CODE: | PBX |
| SUBSEQUENT PRODUCT CODE: | GEI |
PREDICATE DEVICE Primary Predicate: Capenergy - C50, C100, C200, C300, C400 K191202
Reference Predicate(s): K171094 Thermi Reusable Non-invasive RF Electrode
DEVICE DESCRIPTION:
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
{4}------------------------------------------------
Image /page/4/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is an orange circle with light blue lines emanating from it, resembling a stylized sun or energy source.
CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
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.
SUMMARY OF COMPARISON WITH PREDICATE DEVICE:
In the establishment of substantial equivalence, Capenergy C Equipments RF Systems are compared with the following previously cleared devices:
| Primary Predicate:K191202 | Capenergy - C50, C100, C200, C300, C400 |
|---|---|
| Reference Predicate(s):K171094 | Thermi Reusable Non-invasive RF Electrode |
The comparison of the subject device with the primary predicate device is summarized in the following table
{5}------------------------------------------------
Image /page/5/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is a graphic element consisting of an orange circle with blue lines radiating outward, resembling a stylized sun or energy source.
CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
| Device Characteristic | Subject Device | Primary predicate Device | Secondary Predicate Device |
|---|---|---|---|
| Capenergy C equipments RFSystem - C25, C50, C100, C200,C300, C400, C500including Set of CapenergyReusable Non-invasive RFmonopolar Electrodes | The Capenergy C Devices -C50, C100, C200, C300, C400K191202 | Thermi Reusable Non-invasive RFElectrode K171094 | |
| FDA clearance | K222260 | K191202 | K171094 |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Product Code,Class | PBXClass II | PBXClass II | GEIClass II |
| IFU | Capenergy C equipments RFSystem - C25, C50, C100, C200,C300, C400, C500 are intended toprovide topical heating for thepurpose of elevating tissuetemperature for treatment ofselected medical conditions such as:relief of pain, muscle spasms,increase in local circulation | The Capenergy C Devices -C100, C200, C300, C400, C50,are intended to provide topicalheating for the purpose of elevatingtissue temperature for treatment ofselected medical conditions such as:relief of pain, muscle spasms,increase in local circulation.The massage device provided is | Thermi Temperature ControlledRadiofrequency (RF) Systemare indicated for use in dermatological andgeneral surgical procedures forelectrocoagulation and hemostasis. |
| The massage device provided isintended to provide a temporaryreduction in the appearance ofCelluliteCapenergy C equipments RF System- C25, C50, C100, C200, C300,C400, C500 are indicated for use indermatological and general surgicalprocedures for electrocoagulationand hemostasis. | intended to provide a temporaryreduction in the appearance ofcellulite | ||
| Device Description | Capenergy RF generator producesan oscillating electric field in theantenna (electrode). The oscillatingelectrical field is transmitted to thesurrounding soft tissue, causingheating of the tissue. Athermocouple in the electrodemeasures this increase intemperature and maintains afeedback loop to ensure a set pointtemperature in the tissue. | Capenergy RF generator produces anoscillating electric field in theantenna (electrode). The oscillatingelectrical field is transmitted to thesurrounding soft tissue, causingheating of the tissue. A thermocouplein the electrode measures thisincrease in temperature andmaintains a feedback loop to ensure aset point temperature in the tissue. | Thermi RF generator produces anoscillating electric field in the antenna(electrode). The oscillating electrical fieldis transmitted to the surrounding softtissue, causing heating of the tissue. Athermocouple in the electrode measuresthis increase in temperature and maintainsa feedback loop to ensure a set pointtemperature in the tissue. |
| RF Power | 45 W +/-10% for a charge of 06-j530 ohms to 1 MHz | 45 W +/-10% for a charge of 06-j530ohms to 1 MHz | Up to 20 W |
| Internal Cut-Off | 40-45°C | 40-45°C | 35-45°C |
| Treatment Time | 15-660 sec | 15-660 sec | 15-120 sec |
| RF Frequency | Fixed values are established for the treatment time, percentage of power output and working frequency. There are four available options:0.448 MHz +/-25%0,8MHz +/-25%1,0 MHz +/-25%1,2 MHz +/-25% | Fixed values are established for the treatment time, percentage of power output and working frequency. There are three available options:0,8MHz +/-25%1,0 MHz +/-25%1,2 MHz +/-25% | 0.46 MHz |
| Waveform | Sinusoidal | Sinusoidal | Sinusoidal |
| Safety Class Protection | Class I – Type BF | Class I - Type BF | Class I – Type BF |
| Supply voltage and frequency | 100-120/200-240V ± 10%, 50/60 Hz | 100-120/200-240V ± 10%, 50/60 Hz | 100-120/200-240V ± 10%, 50/60 Hz |
| Tissue impedance | 50 -300 Ohm | 50 -300 Ohm | 50 -300 Ohm |
| Dimensions | 170 x 220 mm x 250 mm345x 420 mm x 220 mm562 mm x 420 mm x 220 mm | 345x 420 mm x 220 mm562 mm x 420 mm x 220 mm | 149x 327x322mm(5,9 " x 12,9 " x 12,7 ") |
| Weight | 3.5 - 22.5Kg | 3.5 - 22.5Kg | 15.8 lbs |
{6}------------------------------------------------
Image /page/6/Picture/2 description: The image shows the logo for Capenergy. The text "CAPENERGY" is in a light blue sans-serif font. To the right of the text is an orange circle with blue lines emanating from it, resembling a stylized sun or energy symbol.
CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
{7}------------------------------------------------
Image /page/7/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is an orange circle with light blue lines radiating outward, resembling a stylized sun or energy burst. The overall design is clean and modern, suggesting a company involved in energy or technology.
CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
{8}------------------------------------------------
Image /page/8/Picture/2 description: The image shows the logo for Capenergy. The logo consists of the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is a stylized graphic of an orange circle with blue lines radiating outward, resembling a sun or energy burst. The overall design is clean and modern.
CAPENERGY C EQUIPMENTS RF SYSTEMS
510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
| Compliance withvoluntary standards /LAB tests performed | IEC 60601-1:2005 +/A1:2012 | IEC 60601-1:2005 +/A1:2012 | IEC 60601-1 |
|---|---|---|---|
| IEC 60601-1-2:2015 | IEC 60601-1-2:2015 | IEC 60601-1-2 | |
| IEC 60601-1-6:2010 | IEC 60601-1-6:2010 | IEC 60601-1-6 | |
| IEC 60601-2-2: 2017 | IEC 60601-2-2: 2017 | IEC 60601-2-2 | |
| IEC 62304:2006 | IEC 62304:2006 | ISO10993-1:2009 | |
| ISO10993-1:2009 | ISO10993-1:2009 | ||
| Environmentalconditions | Temperature: 10° to 40°C (+/- 20C)Relative humidity: less than 80%. | Temperature: 10° to 40°C (+/- 20C)Relative humidity: less than 80%. | Temperature: 10° to 40°C (+/- 20C)Relative humidity: less than 80%. |
Table 1 Comparison with predicate and reference Device
{9}------------------------------------------------
Image /page/9/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue sans-serif font. To the right of the text is an orange circle with light blue lines extending from it, creating a stylized design.
CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
INTENDED USE / INDICATIONS FOR USE:
As established in the Indications for Use Statement:
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.
SUMMARY DISCUSSION OF NON-CLINICAL DATA:
The proposed device has been subject to bench testing to determine conformance to performance specifications and requirements taking account of its intended use as diathermia radiofrequency device. Based on the bench tests conducted, the device demonstrated ability to reach and maintain therapeutic temperature (40-45°C) on the surface of human skin for at least 10 minutes.
Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use, specifically including:
- -Electrical safety -
- Electromagnetic compatibility
In addition to the electrical safety testing performed, software verification and validation was conducted to IEC 62304: 2006 - Medical device software - Software Life-Cycle Processes, and FDA guidance on software validation. The results of this testing conclude the software has met these requirements. 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.
CONCLUSIONS:
Based on the performance testing and comparison to predicate device, the Capenergy C equipments RF System - C25, C50, C100, C200, C300, C400, C500 with their set of Capenergy Reusable Noninvasive RF monopolar Electrodes are substantially equivalent in terms of technology, function and
{10}------------------------------------------------
Image /page/10/Picture/2 description: The image shows the logo for Capenergy. The logo features the word "CAPENERGY" in a light blue, sans-serif font. To the right of the text is an orange circle with blue lines emanating from it, possibly representing energy or movement. The overall design is clean and modern.
CAPENERGY C EQUIPMENTS RF SYSTEMS 510(k) Premarket Notification Submission
SECTION 05 - 510(k) SUMMARY
intended use, to the devices in predicate Capenergy C Devices - C50, C100, C200, C300, C400, and the device in predicate Thermi Reusable Non-Invasive RF Electrode (monopolar).
§ 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.