AgeJet

{0}------------------------------------------------ July 7, 2022 Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Triworks Group SRL % Matthew Brulport President NEOconcepts LLC 2773 Alum Crossing Dr. Lewis Center, Ohio 43035 Re: K212472 Trade/Device Name: AgeJet Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: June 17, 2022 Received: June 21, 2022 Dear Matthew Brulport: 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 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 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 {1}------------------------------------------------ device reporting (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-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/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, for 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212472 Device Name AgeJet System Indications for Use (Describe) The Agelet system is an electrosurgical device and is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. 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. 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The name "TRIWORKS" is written in a sans-serif font, with a small green rectangle to the left and a red rectangle to the right, resembling the colors of the Italian flag. # K212472. 510(k) Summary This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92(c). | Submitter's Name: | Lorenzo Berchicci | |----------------------|---------------------------------------------------------------------------------------------------------------------------------------| | Company: | Triworks Group srl | | Submitter's Address: | via Leone Belpulsi, 3 - 86100 Campobasso (CB) Operational<br>Office: via Don Giuseppe Mucciardi, 5 86020 Campochiaro<br>(CB) - Italy. | | Phone: | +39 0874 1896435 | | Fax: | +39 0874 1896435 | | Email: | Lorenzo Berchicci 1.berchicci@triworks.it | | Date Prepared: | July 4th 2022 | | Device Trade Name: | AgeJet | Device Common name: Electrosurgical Device # Device Classification Information: | Regulation<br>Number | Device<br>Classification<br>name | Device<br>Class | Product<br>Code | Classification<br>Panel | Type | |----------------------|-------------------------------------------------------------------------|-----------------|-----------------|------------------------------|------------------------| | 21 CFR<br>878.4400 | Electrosurgical<br>cutting and<br>coagulation device<br>and accessories | Class 2 | GEI | General &<br>Plastic Surgery | Traditional<br>510 (k) | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the logo for TRIWORKS, a company that appears to be in the beauty industry. The logo features a stylized trident symbol in gray above the word "TRIWORKS" in black. Below "TRIWORKS" is a green and red line, and below that is the tagline "The Intelligent Beauty" in gray. ## Device Description The AgeJet system is an electro-surgical device intended for use in dermatological applications in hospital and clinics. The AgeJet system comprises of the following. ## AgeJet Generator The wheeled unit powered by120 VAC (available 110-240 VAC according to the market) with standard wall socket. ## Footswitch This is a single pedal type for activation of the output. # Handpiece/Cable Assembly The handpiece and the cable assembled can be easily plugged and unplugged from the AgeJet Generator as reported in the User Manual. The handpiece has an integral key that is used by the generator to ensure it is not used beyond its operational life. ## Handpiece holder The handpiece holder with the thermal sensor is connected to the generator according to the User Manual. ## Procedure Pack Comprising one or more disposable nozzles that is connected to the handpiece, and which have an integral key that is used by the generator to ensure it is not used beyond its operational life. # Nitrogen Gas Cylinder & Pressure regulator These are not supplied as a part of the AqeJet system. Only medical grade nitrogen (99.5% purity) should be used. The Nitrogen tank is specified as 534mm high by 106mm diameter, a capacity of 560 litres at 2200psiG. # Cylinder Holder Plate Kit This kit includes screws, plate, cable holder shaft and cable tray. Please refer to the User Manual for the installation procedures. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image features the logo for TRIWORKS, a brand associated with beauty products. Above the brand name is a stylized trident symbol in gray. Below the brand name, there is a green rectangle on the left and a red rectangle on the right, possibly representing the colors of the Italian flag. The tagline "The Intelligent Beauty" is written in a simple font below the rectangles. ## Intended Use The AgeJet system is an electrosurgical device used in dermatologic and general surgical for electro coagulation and hemostasis. Plasma energy is delivered to the tissue and energy is rapidly transferred to the tissue surface. As the plasma energy passes through the tissue it generates an electrothermal reaction which is capable of coagulating tissue. #### Indications for Use The AgeJet system is an electrosurgical device that can be used in the treatment of dermatological and general surgical conditions through electro coagulation and hemostasis. #### Predicate device(s) The AgeJet system is substantially equivalent to the PlaDuo system K201735.The AgeJet system is predicated against Pladuo as both devices are electrosurgical devices intended for the treatment of dermatological and general surgical conditions through electro coagulation and hemostasis. The key technological characteristics of the subject device and predicate device are summarized in the following table; {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for TRIWORKS. Above the company name is a gray trident-like symbol. Below the company name is the tagline "The Intelligent Beauty", with a green and red line above the tagline. | Characteristics | Proposed device<br>AgeJet Device<br>K212472 | PlaDuo System<br>K201735 | Degree of equivalence | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------| | Manufacturer name &<br>address. | Triworks SRL<br>Via S. Rocco, 58 Bis<br>86037<br>Palata CB<br>Italy | SheNB Co Ltd<br>Seongsui-ro,<br>148 Seongdong-gu<br>Seoul<br>South Korea | N/A | | Device Trade Name | AgeJet | PlaDuo | N/A | | Mode of Operation | Nitrogen Gas | Nitrogen Gas | Identical | | Intended use | An electrosurgical device used in<br>dermatologic and general surgical<br>for electro coagulation and<br>hemostasis. | An electrosurgical device used in<br>dermatologic and general surgical<br>for electro coagulation and<br>hemostasis. | Identical | | Principle of Operation | Plasma energy is delivered to the<br>skin and the energy is rapidly<br>transferred to the skin surface.<br>As the plasma energy passes<br>through the tissue it generates<br>an electrothermal reaction which<br>is capable of coagulating tissue. | Plasma energy is delivered to the<br>skin and the energy is rapidly<br>transferred to the skin surface. As<br>the plasma energy passes through<br>the tissue it generates an<br>electrothermal reaction which is<br>capable of coagulating tissue. | Identical | | Frequency | 2.45Ghz | 2.45Ghz | Identical | | Modulation | Pulsed Carrier wave | Pulsed Carrier Wave | Identical | | Max Power (w) overall | 260W<br>(260-160 = 100W) | 100W | Identical | | Cooling compressor<br>power (W) | 160W | Not Applicable | PlaDuo does not have patient<br>cooling system | | Maximum Magnetron<br>output | 900W<br>(AgeJet uses only 11% of total at<br>all energy levels) | Not known | - | | Output Energy (joule) | 0.5-41 | 4 | Identical | | Characteristics | Proposed device<br>AgeJet Device<br>K212472 | PlaDuo System<br>K201735 | Degree of equivalence | | Repetition rate | 1-3 Hz | 1-3Hz | Identical | | Pulse Width (single<br>pulse) | 4 to 15ms | 5 to 15ms | Equivalent | | Depth of Thermal<br>effect | Up to 350 microns | Up to 400 microns | Equivalent | | Gas requirement | Medical grade Nitrogen 99.9% | Medical grade Nitrogen 99.9% | Identical | | Electrical supply<br>Voltage | AC 110 - 240 Volts<br>50/60 Hz | AC 100 - 230 Volts<br>50/60 Hz | Equivalent | | Mains connection | Detachable Power Cord to IEC<br>type appliance inlet<br>Mains Switch controlled ON/OFF<br>Operation | Detachable Power Cord to IEC<br>type appliance inlet<br>Mains Switch controlled ON/OFF<br>Operation | Identical | | Device classification | Class II | Class II | Identical | | Regulation number | 21 CFR 878.4400 | 21 CFR 878.4400 | Identical | | Rx/OTC | RX | RX | Identical | | Device classification<br>name | Electrosurgical cutting and<br>coagulation device and<br>accessories | Electrosurgical cutting and<br>coagulation device and<br>accessories | Identical | | Device product code,<br>classification name | GEI | GEI | Identical | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for TRIWORKS, a company that is branded as "The Intelligent Beauty". The logo features a stylized trident above the company name. The trident is gray, and the company name is in black, with a green bar above the "TRI" and a red bar above the "WORKS". {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for TRIWORKS. The logo features a stylized trident symbol in gray above the word "TRIWORKS" in blue. Below "TRIWORKS" are two small rectangles, one green and one red, side by side. Underneath the rectangles is the tagline "The Intelligent Beauty" in gray. #### Similarities and Differences between the subject and predicate device: Key Similarities The AgeJet system is substantially equivalent to the PlaDuo System (K201735), as both are electrosurgical devices used in dermatologic and general surgical for electro coagulation and hemostasis. Both systems exact their effect on the tissue through the same mechanism. Plasma energy is delivered to the skin and the energy is rapidly transferred to the skin surface. As the plasma energy passes through the tissue it generates an electrothermal reaction which is capable of coagulating tissue. The AgeJet system and PlaDuo have the same principle of operation, mode of action and equivalent energy outputs to a maximum of 4Joule. Both devices have similar incremental precision settings of 0.25J and 0.1 Joule respectively. The AgeJet, and PlaDuo systems have identical treatment pulse repetition rates 1.0 to 3.0 Hz. The pulse of UHF required to generate a given energy level or single Pulse width are equivalent. The RF output frequency of the proposed device is identical to the predicate device 2.45Ghz. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for TRIWORKS, a company that specializes in beauty products. The logo features a stylized trident symbol in gray, with the word "TRIWORKS" written below it in a sans-serif font. Underneath the word "TRIWORKS" are two horizontal bars, one green and one red, which may represent the Italian flag. The tagline "The Intelligent Beauty" is written in a smaller font below the bars. #### Differences There are no significant differences in terms of the key device parameters that raise questions in terms of safety and efficacy. Where there are differences between the AgeJet system and the predicate device, these occur in terms of the devices services which do not alter efficacy parameters of the device and where necessary have been tested and conform to relevant standards. #### Electrical safety and safety standards To demonstrate safety and effectiveness of the AgeJet system and to demonstrate substantial equivalence to the predicate devices, Triworks Group srl has completed several non-clinical performance tests. The AgeJet meets established requirements for overall design, electrical safety, software validation and usability studies confirming that the design outputs meet design input requirements and established specifications. The AgeJet system successfully passed testing per internal verification/validation requirements and national/international standards illustrated below: EN 60601-1:2006 EN 60601-1-2:2015 EN 60601-2-2:2018 ## Other Non-Clinical Performance testing To demonstrate safety and effectiveness and substantial equivalence the AgeJet system has undergone several non-clinical performance tests in line with recognized standards in terms of general requirements, biocompatibility, and software. The following non-clinical performance data is provided in support of the substantial equivalence determination. #### Biocompatibility Materials used in the AgeJet system have been evaluated in respect to material composition, use and patient/user contact according to ISO 10993-1: 2018. #### Software verification and validation testing Software has been classified in accordance with EN 62304:2015 and Guidance for the Content of Premarket Submissions for Software Contained in Medical {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for TRIWORKS. The logo features a stylized trident symbol in gray, above the word "TRIWORKS" in a sans-serif font. Below the word, there are two horizontal bars in green and red, resembling the colors of the Italian flag. Underneath the bars, the tagline "The Intelligent Beauty" is written in a smaller, lighter gray font. Devices Guidance for Industry and FDA Staff May 2005. Verification and Validation in accordance with the software risk concern provides evidence that all design specifications were met. #### Performance testing Performance tests were conducted to assess the performance characteristics of AgeJet and ensure its functionality and stability when used in accordance with the manufacturer indications. The device was tested to verify that the output power value falls within the manufacturers specified range, thus ensuring the efficiency of the device. The results show that AgeJet works as expected, according to the manufacturers specifications. In vitro testing of the AgeJET nitrogen plasma device was performed on four different types of tissue as per Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery (DOC-FDA-2014-D-0217): liver, kidney, muscle, and skin. Treatment settings included the three power levels, low (1 J), medium (2 J) and maximum (4 J), at the minimum clinically relevant distance (5 mm) from the tissue surface and at temperature close to physiological 37°C. All test settings were triplicated and collected biopsy samples analyzed by H&E histology method. The testing demonstrated that the treatments produced clearly detectable thermal damage profiles in treated tissues with depths ranging from a few tens of microns up to a few hundred microns for a sinqle pulse treatment and several stacked pulses, respectively. The study demonstrated the ability of the AgeJet device to achieve consistent thermal damage profiles in line with the target treatment and comparable to the profiles produced by the predicate device. Thus, it can be concluded that treatment by such device at the appropriate testing settings will possess a desirable clinical treatment effect. #### Statement of Substantial Equivalence: 513(i) of the FD&C Act (21 U.S.C. 360c(i) states that for substantial equivalence a proposed device is required to have the same intended use and equivalent technological characteristics as the predicate device. Where there are differences in technological characteristics, these can be negated by appropriate clinical or non-clinical performance testing demonstrating that the proposed device is as safe and effective as the predicate device, and that the proposed device does not {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for TRIWORKS, a company that specializes in beauty products. The logo features a stylized trident above the word "TRIWORKS" in a sans-serif font. Below the word "TRIWORKS" are two horizontal bars, one green and one red, which may represent the Italian flag. The tagline "The Intelligent Beauty" is located below the bars. raise any different questions of safety and effectiveness than the predicate device for the same intended use. Triworks Group srl has demonstrated that the AgeJet device has the same intended use as the predicate device, employs equivalent technological characteristics, and has similar thermal effects in tissue. Where there are minor differences, these occur only in the basic services of the device. The sponsor demonstrates that the device does not pose any additional questions regarding safety and efficacy relative to the predicate. Therefore, the AgeJet system, as designed, and manufactured, has been demonstrated to be substantially equivalent to the referenced predicate, the PlaDuo System K201735.