(243 days)
No
The description mentions an "integral temperature and impedance feedback mechanism" that "automatically adjusting energy delivery," which is a form of automated control based on sensor data, but it does not explicitly mention or imply the use of AI or ML algorithms for this adjustment. The performance studies focus on standard electrical safety, EMC, and software validation according to IEC 62304, without any mention of AI/ML specific validation or performance metrics.
Yes
The device's intended use explicitly states "treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation" and "electrocoagulation and hemostasis", which are therapeutic purposes.
No
Explanation: The device is intended for therapeutic purposes such as topical heating for pain relief, muscle spasm treatment, increasing local circulation, and electrocoagulation/hemostasis, not for diagnosing conditions. It applies energy to treat, rather than to identify or classify disease states.
No
The device description explicitly mentions hardware components such as an AC/DC power supply unit, RF generator, controller, user interface, hand piece, cable, and switch. It also describes the hand piece as being comprised of conductive and capacitive electrodes. The performance studies include bench testing and functional laboratory testing related to electrical safety and electromagnetic compatibility, which are hardware-related aspects. While software verification and validation were performed, the device is clearly a system with significant hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described are for topical heating, pain relief, muscle spasms, increased local circulation, temporary reduction of cellulite appearance, electrocoagulation, and hemostasis. These are all therapeutic or surgical procedures performed on the patient's body.
- Device Description: The device generates RF energy and applies it to tissue. It monitors temperature and impedance of the tissue.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide diagnostic information. This device's function is to apply energy to the body for therapeutic or surgical purposes.
N/A
Intended Use / Indications for Use
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.
Product codes
PBX, GEI
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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) |
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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 derecha |
| 08970 Sant Joan Despí | |
| Barcelona | |
| Spain | |
| 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
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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
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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 RF | |||
| System - C25, C50, C100, C200, | |||
| C300, C400, C500 |
including Set of Capenergy
Reusable Non-invasive RF
monopolar Electrodes | The Capenergy C Devices -
C50, C100, C200, C300, C400
K191202 | Thermi Reusable Non-invasive RF
Electrode K171094 |
| FDA clearance | K222260 | K191202 | K171094 |
| Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Product Code,
Class | PBX
Class II | PBX
Class II | GEI
Class II |
| IFU | 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 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 | Thermi Temperature Controlled
Radiofrequency (RF) System
are indicated for use in dermatological and
general surgical procedures for
electrocoagulation and hemostasis. |
| 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. | intended to provide a temporary
reduction in the appearance of
cellulite | | |
| Device Description | Capenergy RF generator produces
an oscillating electric field in the
antenna (electrode). The oscillating
electrical field is transmitted to the
surrounding soft tissue, causing
heating of the tissue. A
thermocouple in the electrode
measures this increase in
temperature and maintains a
feedback loop to ensure a set point
temperature in the tissue. | Capenergy RF generator produces an
oscillating electric field in the
antenna (electrode). The oscillating
electrical field is transmitted to the
surrounding soft tissue, causing
heating of the tissue. A thermocouple
in the electrode measures this
increase in temperature and
maintains a feedback loop to ensure a
set point temperature in the tissue. | Thermi RF generator produces an
oscillating electric field in the antenna
(electrode). The oscillating electrical field
is transmitted to the surrounding soft
tissue, causing heating of the tissue. A
thermocouple in the electrode measures
this increase in temperature and maintains
a feedback loop to ensure a set point
temperature 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-j530
ohms 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 mm
345x 420 mm x 220 mm
562 mm x 420 mm x 220 mm | 345x 420 mm x 220 mm
562 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 |
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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
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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
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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 with
voluntary 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 | ||
| Environmental | |||
| conditions | 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
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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
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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).