CAPENERGY - C100, C200, C300, C400, C50

K191202 · Capenergy Medical S.L. · PBX · Feb 11, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K191202
• Device Name: CAPENERGY - C100, C200, C300, C400, C50
• Applicant: Capenergy Medical S.L.
• Product Code: PBX · General, Plastic Surgery
• Decision Date: Feb 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The CAPENERGY C Devices - C100, C200, C300, C400, C50 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.

Device Story

Capenergy C-series devices provide therapeutic diathermy via radiofrequency (RF) alternating electrical currents. System consists of a console with 1-4 independent channels, electrodes/plates, and user interface. RF current is delivered in monopolar mode, forming an electric circuit between an active electrode and a passive return plate. User manages frequency, power, and timer via screen/keyboard. Device elevates tissue temperature to 40-45°C (max 47°C) to treat pain, muscle spasms, and improve circulation; also includes massage functionality for temporary cellulite reduction. Operated by clinicians in a professional setting. Output provides controlled thermal energy to patient tissue; healthcare providers monitor temperature and power levels via device interface to guide treatment.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing only. Bench testing confirmed ability to reach and maintain therapeutic temperatures (40-45°C) for at least 10 minutes, electrical safety, electromagnetic compatibility, and biocompatibility of patient-contacting materials.

Technological Characteristics

RF diathermy device; monopolar application; sinusoidal waveform. Frequencies: 0.8, 1.0, 1.2 MHz (±25%). Power: 45W ±10%. Class I, Type BF. Materials biocompatible per ISO 10993-1. Software validated per IEC 62304. Standards: IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2015, IEC 60601-1-6:2010.

Indications for Use

Indicated for patients requiring topical heating for pain relief, muscle spasms, or increased local circulation, and for temporary reduction in cellulite appearance. Contraindicated for patients with active implants (pacemakers, cochlear implants, insulin pumps), implanted cables, angina, epilepsy, nervous diseases, pregnancy, lactation, cardiovascular dysfunction, neoplasms, insensibility to temperature, decompensated arteriopathies, active infectious bacterial processes, or coagulation problems.

Regulatory Classification

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.

Predicate Devices

• Indiba Diathermia Radiofrequency Device (K161458)
• Winback Back 3SE (K162828)

Submission Summary (Full Text)

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February 11, 2020

Capenergy Medical S.L. Pilar Sanchez General Manager Avinguda Mare de Deu de Montserrat, 41 Sant Joan Despi, Barcelona, Spain 08970

Re: K191202

Trade/Device Name: Capenergy - C100, C200, C300, C400, C50 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: PBX Dated: October 31, 2019 Received: November 14, 2019

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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191202

Device Name

CAPENERGY C Devices - C100, C200, C300, C400, C50

Indications for Use (Describe)

The CAPENERGY C Devices - C100, C200, C300, C50 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

] Over-The-Counter Use (21 CFR 801 Subpart C)

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FORM FDA 3881 (7/17)

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Image /page/3/Picture/2 description: The image features the logo for Capenergy. The logo consists of the word "CAPENERGY" in a bold, light blue sans-serif font. Above the text is an abstract graphic that includes a solid orange circle, which is partially obscured by a light blue abstract shape that resembles a stylized depiction of a ship or energy wave. The background is white, and a thin gray line is present at the bottom of the image.

# Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50

## SECTION 05 - 510(k) Summary

- 510 (k) Submitter: Capenergy Medical S.L. Pol. Ind. Fontsanta Av. Mare de Deu de Montserrat, 41 bis Pje 1º derecha 08970 Sant Joan Despí Barcelona - España
#### Establishment Registration Number: Not Established

| Contact person: | Pilar Sánchez<br>General Manager |
|-----------------|----------------------------------|
| Phone: | [phone] |
| e-mail: | [e-mail] |

| DATE OF SUBMISSION: | 2020-02-10 |
|---------------------|-----------------------------------------------------------------------------------------------------|
| SUBMITTER NAME: | Capenergy Medical S.L. |
| SUBMITTER ADDRESS: | Av. Mare de Deu de Montserrat, 41 bis Pje 1º derecha<br>08970 Sant Joan Despí<br>Barcelona - España |

| CONTACT: | Pilar Sánchez |
|------------|------------------|
| TELEPHONE: | [phone] |

e-mail:

[e-mail]

DEVICE TRADE NAME: CAPENERGY - C 100, C 200, C 300, C 400, C 50 COMMON NAME: Massager, Vacuum, Radio Frequency Induced Heat CLASSIFICATION NAME: Massager, Vacuum, Radio Frequency Induced Heat REGULATION NUMBER: 21 CFR 878.4400 PRODUCT CODE: PBX Indiba Diathermia Radiofrequency Device - K161458 PREDICATE DEVICE(S): Winback Back 3SE - K162828

### DEVICE DESCRIPTION:

The proposed device is an equipment for diathermy by energy transfer using radio frequency alternating electrical currents applied to the patient by using electrodes or plates.

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K191202

## 510(k) Premarket Notification

# Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50

## SECTION 05 - 510(k) Summary

The RF current is coupled to the human body by means of an insulated or non-insulated electrode -the active accessory-, which together with the body and the return electrode -the passive plate- forms an electric circuit, which allows the passage of RF current through the body areas situated between the two electrodes.

The number of available channels on the different models of the CAPENERGY product range varies from one to four. When a model has several channels, these operate independently. Each channel has a keyboard that lets you manage the parameters of frequency and channel power. It also has two light columns that report the selected power level and a qualitative indication of the power delivered by the channel.

The user interface has a screen and a keyboard that allows you to manage several functions: timer, connected accessories management, state management, energy and temperature measurements and alarms. The user interface is organized in a menu system that makes it possible to choose between the different features available on the equipment.

### SUMMARY OF COMPARISON WITH PREDICATE DEVICE:

In the establishment of substantial equivalence, the CAPENERGY devices is compared with the following previously cleared devices:

- -Indiba Diathermia Radiofrequency Device (K161458)
- Winback Back 3SE (K162828) -

Comparison of the proposed devices with the predicate devices is summarized in the following table:

| ELEMENT OF<br>COMPARISON | Primary Predicate<br>Indiba Diathermia<br>Radiofrequency Device<br>(Indiba USA Inc.) | Reference predicate<br>device<br>Winback Back 3SE<br>(Winback USA Corp) | Subject Device<br>CAPENERGY - C100, C200, C300,<br>C400, C50<br>(Capenergy Medical S.L) |
|--------------------------|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| REGULATORY DATA | | | |
| Regulatory Class | Class II | Class II | Class II |
| Classification name | Electrosurgical, cutting and<br>coagulation and accessories | Electrosurgical, cutting<br>and coagulation and<br>accessories | Electrosurgical, cutting and<br>coagulation and accessories |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21CFR 878.4400 |
| Product code | PBX | PBX | PBX |
| FDA clearance | 510(k) Cleared: K161458 | 510(k) Cleared:<br>K162828 | - |
| USE | | | |

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Image /page/5/Picture/2 description: The image contains the logo for CAPENERGY. The logo features the word "CAPENERGY" in a bold, blue sans-serif font. Above the text is an abstract graphic consisting of a solid orange circle and a light blue, stylized shape that resembles a lightning bolt or a stylized plant.

# Document: CAPENERGY - C 100, C 200, C 300,

### C 400, C 50

| ELEMENT OF<br>COMPARISON | Primary Predicate<br>Indiba Diathermia<br>Radiofrequency Device<br>(Indiba USA Inc.) | Reference predicate<br>device<br>Winback Back 3SE<br>(Winback USA Corp) | Subject Device<br>CAPENERGY - C100, C200, C300,<br>C400, C50<br>(Capenergy Medical S.L) |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use<br>(from the Instructions for<br>Use sheet) | The Indiba Diathermia<br>Radiofrequency Devices are<br>intended to provide topical<br>heating for the purpose of<br>elevating tissue temperature for<br>treatment of selected medical<br>conditions such as: relief of<br>pain, muscle spasms, increase<br>in local circulation.<br><br>The massage device provided<br>is intended to provide a<br>temporary reduction in the<br>appearance of cellulite. | The Winback Back<br>3SE device is intended<br>to provide topical<br>heating for the purpose<br>of elevating tissue<br>temperature for<br>treatment of selected<br>medical conditions<br>such as: relief of pain,<br>muscle spasms,<br>increase in local<br>circulation.<br><br>The Winback Back<br>3SE massage device<br>provided is intended to<br>provide a temporary<br>reduction in the<br>appearance of cellulite. | The CAPENERGY C Devices -<br>C100, C200, C300, C400, C50,<br>C500 are intended to provide topical<br>heating for the purpose of elevating<br>tissue temperature for treatment of<br>selected medical conditions such as:<br>relief of pain, muscle spasms,<br>increase in local circulation.<br><br>The massage device provided is<br>intended to provide a temporary<br>reduction in the appearance of<br>cellulite |
| ELEMENT OF<br>COMPARISON | Primary Predicate<br>Indiba Diathermia<br>Radiofrequency Device<br>(Indiba USA Inc.) | Reference predicate<br>device<br>Winback Back 3SE<br>(Winback USA Corp) | Subject Device<br>CAPENERGY - C100, C200, C300,<br>C400, C50<br>(Capenergy Medical S.L) |
| Contraindications<br>(from the Instructions for<br>Use sheet) | Pacemakers or other<br>electronical implants<br>Pregnancy<br>Skin disorders (open wounds or<br>recent burnts)<br>Thrombophlebitis<br>External use. Do not use on<br>endocavity ways (oral, vaginal,<br>rectal)<br>Persons suffering from lack of<br>sensibility (congenital<br>insensibility to pain, paraplegia<br>or pharmacological treatments<br>reducing sensibility to pain and<br>heat) | The practitioner must<br>avoid using the<br>equipment on<br>patients with:<br>Pace maker<br>Insulin pump<br>Neurostimulators.<br>Pregnancy<br>High blood pressure<br>or hypotension<br>Cartilage growth<br>Cancer<br>Bleeding disorders<br>Infectious diseases<br>where heat is<br>proscribed<br>Phlebitis<br>Tuberculosis.<br><br>he practitioner must<br>seek medical advice<br>on the following:<br>insensitivity to pain<br>insensitivity to heat<br>Burns<br>Cancerous lesion in<br>the treatment area. | Presence of pacemakers or other<br>active implants, as cochlear<br>implants, insuline pump, etc.<br>Implanted cables<br>Angina<br>Epilepsy<br>Nervous diseases<br>Pregnancy<br>Lactation<br>Cardiovascular dysfunction<br>Neoplasm<br>Insensibility to temperature ,even if<br>only temporary<br>Decompensated arteriopathies<br>Active infectious bacterial<br>processes<br>Coagulation problems<br>Presence of metal implants<br>(consult with specialist) |
| PRINCIPLE OF<br>OPERATION | | | |
| Operating principle | Radio frequency diathermy | Radio frequency<br>diathermy | Radio frequency diathermy |
| TECHNOLOGICAL<br>CHARACTERISTICS | | | |
| General description | The Indiba Diathermia<br>Radiofrequency Device is a<br>therapeutic device for deep,<br>non-invasive diathermy. The<br>device consists of a console<br>which generates a<br>radiofrequency current which is<br>delivered to the patient, in<br>monopolar form, through two<br>different types of electrodes:<br>stainless steel conductive | The Winback Back<br>3SE generates a high<br>frequency sinusoidal<br>current with a<br>monopolar mode of<br>application using two<br>electrodes. A fixed<br>electrode is placed in<br>contact with the patient<br>and a handheld<br>electrode is | The CAPENERGY - C100, C200,<br>C300, C400, C50 are devices for<br>diathermy by energy transfer using<br>radio frequency alternating electrical<br>currents applied to the patient by<br>using electrodes or plates.<br>Its particular emission of<br>frequencies, the ability to regulate<br>and control the increase of the<br>desired temperature allows to<br>operate with a maximum |
| ELEMENT OF | Primary Predicate<br>Indiba Diathermia | Reference predicate<br>device | Subject Device<br>CAPENERGY - C100, C200, C300, |
| COMPARISON | Radiofrequency Device | Winback Back 3SE | C400, C50 |
| | (Indiba USA Inc.)<br>resistive electrodes, and thin-<br>layer insulated capacitive<br>electrodes. The electrodes are<br>inserted into a<br>handle/handpiece, one handle<br>for each kind of electrode, and<br>the handle is connected to the<br>console by means of a 2-metre<br>cable.<br>In resistive mode the system<br>delivers a high-frequency<br>current of 448 kHz directly to<br>the patient's skin surface. In<br>capacitive mode, the electrode<br>coating creates a layer<br>between the electrode and the<br>human tissue, forming a<br>capacitor that allows a high-<br>frequency current to pass. | (Winback USA Corp)<br>manipulated by a<br>therapist. When both<br>electrodes are in<br>contact with a patient<br>the electrical circuit is<br>closed and RF therapy<br>can be provided.<br>The device can be<br>operated in a capacitor<br>resistive monopolar<br>mode and a multipolar<br>mode.<br>The product consists of<br>a power console on a<br>moveable trolley, LCD<br>monitor, and<br>accessories including<br>capacitive resistive<br>electrodes and<br>multipolar electrodes.<br>The unit can be<br>adjusted to provide<br>various levels of<br>treatment frequency<br>ranging from 300 KHz | (Capenergy Medical S.L)<br>temperature of 45 °C, and never<br>exceed 47 °C (for safety). |
| RF frequency | Frequency emission is limited<br>to the following value:<br>0,40 MHz - 0,449 MHz | to 1 MHz.<br>300kHz – 1 MHz | Fixed values are established for the<br>treatment time, percentage of power<br>output and working frequency. There |
| | | | are three available options:<br>0,8MHz +/-25%<br>1,0 MHz +/-25%<br>1,2 MHz +/-25% |
| Supply voltage and<br>frequency | (100 – 240) V ~ 50/60 Hz | (100 - 240) V ~ 50/60<br>Hz | 100-120/200-240V ± 10%, 50/60 Hz |
| Output power | 100-200 W | 300 W | 45 W +/-10% for a charge of 06-j530<br>ohms to 1 MHz |
| ELEMENT OF<br>COMPARISON | Primary Predicate<br>Indiba Diathermia<br>Radiofrequency Device<br>(Indiba USA Inc.) | Reference predicate<br>device<br>Winback Back 3SE<br>(Winback USA Corp) | Subject Device<br>CAPENERGY - C100, C200, C300,<br>C400, C50<br>(Capenergy Medical S.L) |
| Dimensions | 400 mm x 530 mm x 150 mm | 1000 x 370 x 450 mm | 562 mm x 211 mm x 420 mm<br>220 mm x 211 mm x 420 mm |
| Weight | 8,6 kg (CT9); 8,4 kg (CT8) | 18 Kg | 10,7 Kg - 22,5 kg |
| Safety Class /<br>Protection | Class I - Type BF | Class I - Type BF | Class I - Type BF |
| Waveform | Sinusoidal | Sinusoidal | Sinusoidal |
| Compliance with<br>voluntary standards /<br>LAB tests performed | IEC 60601-1:2005<br>IEC 60601-1-2:2007<br>IEC 62304:2006<br>ISO10993-1:2009 | IEC 60601-1:2005<br>IEC 60601-1-2:2007<br>ISO10993-1:2009 | IEC 60601-1:2005 + /A1:2012<br>IEC 60601-1-2:2015<br>IEC 60601-1-6:2010<br>IEC 62304:2006<br>ISO10993-1:2009 |
| Environmental<br>Conditions (Use) | Temperature: 10° to 40°C<br>Relative Humidity: 30-75% | Temperature: 15° to 40°C<br>Relative Humidity: 30-<br>60% | Temperature: 10° to 40°C (+/- 2°C)<br>Relative humidity: less than 80%. |

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# Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50

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# Document:

CAPENERGY - C 100, C 200, C 300, C 400, C 50

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# Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50

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# Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50

## SECTION 05 - 510(k) Summary

### INTENDED USE:

As established in the Indications for Use Statement:

The CAPENERGY C Devices - C100, C200, C300, C400, C50 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.

### SUMMARY DISCUSSION OF NON-CLINICAL DATA:

The proposed device has been subject to bench testing to determine 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℃) 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 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 testing, and confirmed to be biocompatible for their intended use.

### SUMMARY DISCUSSION OF CLINICAL DATA:

Non-clinical test data are submitted to support this premarket notification and to establish substantial equivalence. No clinical studies are submitted.

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# Document: CAPENERGY - C 100, C 200, C 300, C 400, C 50

## SECTION 05 - 510(k) Summary

### CONCLUSIONS:

The subject device CAPENERGY – C 100, C 200, C 300, C 50 – is similar to the predicate devices in principles of operation and technological characteristics. Testing was conducted to evaluate the performance of the subject device and to compare results to the performance of the predicate devices. Results of validation and verification activities in design control that included testing / certification to the designated standards and performance testing of the devices has demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use.

We conclude that the subject device CAPENERGY - C 100, C 300, C 400, C 50 is substantially equivalent to the predicate devices in terms of safety and effectiveness for the requested intended use.