(281 days)
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.
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. 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.
The provided text is a 510(k) Premarket Notification for the CAPENERGY C Devices (C100, C200, C300, C400, C50). This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study for the device itself. Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets them, particularly in the context of AI/ML performance, is not present in this document.
However, based on the non-clinical data section, we can infer some information about performance testing.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Ability to reach and maintain therapeutic tissue temperature (40-45°C) on the surface of human skin for at least 10 minutes | "demonstrated ability to reach and maintain therapeutic temperature (40-45℃) on the surface of human skin for at least 10 minutes." |
| Correct operation according to intended use (general) | "Functional laboratory testing performed in foreseeable operating conditions showed correct operation of the device as per its intended use" |
| Electrical Safety (IEC 60601-1:2005 + A1:2012) | Compliance met (implied by non-clinical summary) |
| Electromagnetic Compatibility (IEC 60601-1-2:2015) | Compliance met (implied by non-clinical summary) |
| Software Validation (IEC 62304:2006, FDA guidance) | "results of this testing conclude the software has met these requirements." |
| Biocompatibility of patient-contacting materials (ISO 10993-1:2009) | "confirmed to be biocompatible for their intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "bench testing" and "functional laboratory testing," which typically refers to testing of the device itself rather than human or image data. No patient or image test set is mentioned.
- Data Provenance: Not applicable, as no human or image data test set is described. The testing appears to be primarily laboratory-based device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No ground truth based on expert review of patient data is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring adjudication (e.g., image review) is described.
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
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device description and intended use (diathermy device) do not involve human readers interpreting images or data with or without AI assistance.
- Effect Size of AI Improvement: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This document describes a physical medical device (diathermy) and its performance, not an AI algorithm. The software validation mentioned is for the device's operational software, not an AI component making diagnostic or treatment recommendations.
7. The type of ground truth used
- Type of Ground Truth: For the performance tests mentioned (temperature maintenance, electrical safety, EMC, software validation, biocompatibility), the "ground truth" would be established by engineering specifications, relevant international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 10993-1), and internal performance targets.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This document does not describe the development or testing of an AI/ML algorithm that would require a training set.
9. How the ground truth for the training set was established
- How Ground Truth was Established: Not applicable, as no training set for an AI/ML algorithm is mentioned.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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)
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."
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 SánchezGeneral Manager |
|---|---|
| Phone: | +34 93 477 43 48 |
| e-mail: | pilar@capenergy.com |
| DATE OF SUBMISSION: | 2020-02-10 |
|---|---|
| SUBMITTER NAME: | Capenergy Medical S.L. |
| SUBMITTER ADDRESS: | Av. Mare de Deu de Montserrat, 41 bis Pje 1º derecha08970 Sant Joan DespíBarcelona - España |
| CONTACT: | Pilar Sánchez |
|---|---|
| TELEPHONE: | +34 93 477 43 48 |
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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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:
Comparison of the proposed devices with the predicate devices is summarized in the following table:
| ELEMENT OFCOMPARISON | Primary PredicateIndiba DiathermiaRadiofrequency Device(Indiba USA Inc.) | Reference predicatedeviceWinback Back 3SE(Winback USA Corp) | Subject DeviceCAPENERGY - C100, C200, C300,C400, C50(Capenergy Medical S.L) |
|---|---|---|---|
| REGULATORY DATA | |||
| Regulatory Class | Class II | Class II | Class II |
| Classification name | Electrosurgical, cutting andcoagulation and accessories | Electrosurgical, cuttingand coagulation andaccessories | Electrosurgical, cutting andcoagulation 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: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 OFCOMPARISON | Primary PredicateIndiba DiathermiaRadiofrequency Device(Indiba USA Inc.) | Reference predicatedeviceWinback Back 3SE(Winback USA Corp) | Subject DeviceCAPENERGY - C100, C200, C300,C400, C50(Capenergy Medical S.L) |
|---|---|---|---|
| Indications for use(from the Instructions forUse sheet) | The Indiba DiathermiaRadiofrequency Devices areintended to provide topicalheating for the purpose ofelevating tissue temperature fortreatment of selected medicalconditions such as: relief ofpain, muscle spasms, increasein local circulation.The massage device providedis intended to provide atemporary reduction in theappearance of cellulite. | The Winback Back3SE device is intendedto provide topicalheating for the purposeof elevating tissuetemperature fortreatment of selectedmedical conditionssuch as: relief of pain,muscle spasms,increase in localcirculation.The Winback Back3SE massage deviceprovided is intended toprovide a temporaryreduction in theappearance of cellulite. | The CAPENERGY C Devices -C100, C200, C300, C400, C50,C500 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 isintended to provide a temporaryreduction in the appearance ofcellulite |
| ELEMENT OFCOMPARISON | Primary PredicateIndiba DiathermiaRadiofrequency Device(Indiba USA Inc.) | Reference predicatedeviceWinback Back 3SE(Winback USA Corp) | Subject DeviceCAPENERGY - C100, C200, C300,C400, C50(Capenergy Medical S.L) |
| Contraindications(from the Instructions forUse sheet) | Pacemakers or otherelectronical implantsPregnancySkin disorders (open wounds orrecent burnts)ThrombophlebitisExternal use. Do not use onendocavity ways (oral, vaginal,rectal)Persons suffering from lack ofsensibility (congenitalinsensibility to pain, paraplegiaor pharmacological treatmentsreducing sensibility to pain andheat) | The practitioner mustavoid using theequipment onpatients with:Pace makerInsulin pumpNeurostimulators.PregnancyHigh blood pressureor hypotensionCartilage growthCancerBleeding disordersInfectious diseaseswhere heat isproscribedPhlebitisTuberculosis.he practitioner mustseek medical adviceon the following:insensitivity to paininsensitivity to heatBurnsCancerous lesion inthe treatment area. | Presence of pacemakers or otheractive implants, as cochlearimplants, insuline pump, etc.Implanted cablesAnginaEpilepsyNervous diseasesPregnancyLactationCardiovascular dysfunctionNeoplasmInsensibility to temperature ,even ifonly temporaryDecompensated arteriopathiesActive infectious bacterialprocessesCoagulation problemsPresence of metal implants(consult with specialist) |
| PRINCIPLE OFOPERATION | |||
| Operating principle | Radio frequency diathermy | Radio frequencydiathermy | Radio frequency diathermy |
| TECHNOLOGICALCHARACTERISTICS | |||
| General description | The Indiba DiathermiaRadiofrequency Device is atherapeutic device for deep,non-invasive diathermy. Thedevice consists of a consolewhich generates aradiofrequency current which isdelivered to the patient, inmonopolar form, through twodifferent types of electrodes:stainless steel conductive | The Winback Back3SE generates a highfrequency sinusoidalcurrent with amonopolar mode ofapplication using twoelectrodes. A fixedelectrode is placed incontact with the patientand a handheldelectrode is | The CAPENERGY - C100, C200,C300, C400, C50 are devices fordiathermy by energy transfer usingradio frequency alternating electricalcurrents applied to the patient byusing electrodes or plates.Its particular emission offrequencies, the ability to regulateand control the increase of thedesired temperature allows tooperate with a maximum |
| ELEMENT OF | Primary PredicateIndiba Diathermia | Reference predicatedevice | Subject DeviceCAPENERGY - C100, C200, C300, |
| COMPARISON | Radiofrequency Device | Winback Back 3SE | C400, C50 |
| (Indiba USA Inc.)resistive electrodes, and thin-layer insulated capacitiveelectrodes. The electrodes areinserted into ahandle/handpiece, one handlefor each kind of electrode, andthe handle is connected to theconsole by means of a 2-metrecable.In resistive mode the systemdelivers a high-frequencycurrent of 448 kHz directly tothe patient's skin surface. Incapacitive mode, the electrodecoating creates a layerbetween the electrode and thehuman tissue, forming acapacitor that allows a high-frequency current to pass. | (Winback USA Corp)manipulated by atherapist. When bothelectrodes are incontact with a patientthe electrical circuit isclosed and RF therapycan be provided.The device can beoperated in a capacitorresistive monopolarmode and a multipolarmode.The product consists ofa power console on amoveable trolley, LCDmonitor, andaccessories includingcapacitive resistiveelectrodes andmultipolar electrodes.The unit can beadjusted to providevarious levels oftreatment frequencyranging from 300 KHz | (Capenergy Medical S.L)temperature of 45 °C, and neverexceed 47 °C (for safety). | |
| RF frequency | Frequency emission is limitedto the following value:0,40 MHz - 0,449 MHz | to 1 MHz.300kHz – 1 MHz | Fixed values are established for thetreatment time, percentage of poweroutput and working frequency. There |
| are three available options:0,8MHz +/-25%1,0 MHz +/-25%1,2 MHz +/-25% | |||
| Supply voltage andfrequency | (100 – 240) V ~ 50/60 Hz | (100 - 240) V ~ 50/60Hz | 100-120/200-240V ± 10%, 50/60 Hz |
| Output power | 100-200 W | 300 W | 45 W +/-10% for a charge of 06-j530ohms to 1 MHz |
| ELEMENT OFCOMPARISON | Primary PredicateIndiba DiathermiaRadiofrequency Device(Indiba USA Inc.) | Reference predicatedeviceWinback Back 3SE(Winback USA Corp) | Subject DeviceCAPENERGY - C100, C200, C300,C400, C50(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 mm220 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 /Protection | Class I - Type BF | Class I - Type BF | Class I - Type BF |
| Waveform | Sinusoidal | Sinusoidal | Sinusoidal |
| Compliance withvoluntary standards /LAB tests performed | IEC 60601-1:2005IEC 60601-1-2:2007IEC 62304:2006ISO10993-1:2009 | IEC 60601-1:2005IEC 60601-1-2:2007ISO10993-1:2009 | IEC 60601-1:2005 + /A1:2012IEC 60601-1-2:2015IEC 60601-1-6:2010IEC 62304:2006ISO10993-1:2009 |
| EnvironmentalConditions (Use) | Temperature: 10° to 40°CRelative Humidity: 30-75% | Temperature: 15° to 40°CRelative Humidity: 30-60% | Temperature: 10° to 40°C (+/- 2°C)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.
§ 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.