Who is the manufacturer of Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

Deltronix Equipamentos Ltda filed the 510(k) submission for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 (K223784).

What is the FDA product code for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200

K223784 · Deltronix Equipamentos Ltda · GEI · Apr 18, 2023 · General, Plastic Surgery

Device Facts

Record ID	K223784
Device Name	Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200
Applicant	Deltronix Equipamentos Ltda
Product Code	GEI · General, Plastic Surgery
Decision Date	Apr 18, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.

Device Story

High-frequency electrosurgical generators (Precision TC2/3/4, SEG 100/150/200) provide power for cutting and coagulating tissue; used in surgical settings by trained medical professionals. Devices utilize monopolar and bipolar techniques; include impedance and continuity monitoring. Output is delivered via accessories to human tissue. Healthcare providers operate the device to achieve desired surgical outcomes; output affects tissue state directly through high-frequency energy application. Benefits include precise tissue management during surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

High-frequency electrosurgical generator; monopolar and bipolar output; sinusoidal waveform; 400KHz output frequency; power output 100W-400W; voltage output 4185V; crest factor 1.7-8.2; impedance and continuity monitoring; 1 or 2 channels depending on model.

Indications for Use

Indicated for use with monopolar and bipolar accessories for cutting and coagulating living human tissue by qualified and trained medical professionals.

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

VALLEYLAB FORCE FX (K944692)

Reference Devices

Valleylab FX8 (K172757)

Related Devices

K230194 — HF Surgery Generator 400KHZ · Richard Wolf Medical Instruments Corporation · Mar 22, 2023
K162656 — ESU-1 Electrosurgical Generator · Tva Medical, Inc. · Nov 10, 2016
K172757 — Valleylab FX8 Electrosurgical Platform · Covidien, LLC · Nov 2, 2017
K210488 — Ultrasonic Surgical & Electrosurgical Generator · Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · Oct 25, 2021
K201221 — Electrosurgical Generator · New Deantronics Taiwan , Ltd. · Sep 28, 2020

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 18, 2023 Deltronix Equipamentos Ltda % Mr. Bruno Milhoci Regulatory Affairs Specialist Passarini Regulatory Affairs PR Serviços Regulatórios Administrativos Ltda Rua Alice Aem Saadi, 855/ 2404 Ribeirao Pret, SP 14096-570 Brazil Re: K223784 Trade/Device Name: Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG 200 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: March 16, 2023 Received: March 23, 2023 Dear Mr. Milhoci: 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. {1}------------------------------------------------ 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 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. | Mark Trumbore -S | Digitally signed by Mark Trumbore -S Date: 2023.04.18 11:55:59 -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) K223784 Device Name Precision TC2, Precision TC3, Precision TC4, SEG 100, SEG 150, SEG200 Indications for Use (Describe) The Deltronix Precision and SEG are a high frequency electrosurgical generators intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | ☐ 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 Approved: OMB No. 0910-0120 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Deltronix. The logo features the letters "DTX" in white, set against a blue hexagon. Below the hexagon, the word "DELTRONIX" is written in blue, with a trademark symbol next to it. The logo has a clean and professional design. ### 510(k) Summary ## ADMINISTRATIVE INFORMATION | Sponsor/Manufacturer Name | Deltronix | |-----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person and Preparer | Bruno Milhoci. Regulatory Affairs Specialist Passarini Regulatory Affairs PR Servi\u00e7os Regulat\u00f3rios Administrativos Ltda E-Mail: bruno@rapassarini.com.br Telephone +55 (16) 3421 8488 | | Date Prepared | DEC - 16 2022 | #### DEVICE NAME AND CLASSIFICATION | Trade/ Proprietary Name | Precision TC2, Precision TC3, Precision TC4, SEG 100 SEG 150, SEG200 | |-------------------------|-------------------------------------------------------------------------| | Common Name | Electrosurgical Generator | | Regulation Number | 21 CFR 878.4400 | | Classification Name | Electrosurgical, Cutting & Coagulation & Accessories | | Regulatory Class | Class II | | Product Code | GEI | # IDENTIFICATION PREDICATE DEVICE | Trade/ Proprietary Name | VALLEYLAB FORCE FX | |-------------------------|------------------------------------------------------| | Common Name | Electrosurgical Generator | | Regulation Number | 21 CFR 878.4400 | | Classification Name | Electrosurgical, Cutting & Coagulation & Accessories | | Regulatory Class | Class II | | Product Code | GEI | | 510(k) Number | K944692 | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for Deltronix. The logo features the letters "DTX" in white, set against a blue hexagon. Below the hexagon, the word "DELTRONIX" is written in blue, with a trademark symbol to the right. ## IDENTIFICATION OF REFERENCE DEVICE PREDICATE Trade/ Proprietary Name Common Name Regulation Number Classification Name Regulatory Class Product Code 510(k) Number Valleylab FX8 Electrosurgical Generator 21 CFR 878.4400 Electrosurgical, Cutting & Coagulation & Accessories Class II GEI K172757 ## INDICATIONS FOR USE The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. # SUBJECT DEVICE DESCRIPTION The electrosurgical generators of Precision and SEG lines are intended to cut and electrosurgical coagulation of living human tissues. This objective is achieved through the power supply at high frequency. The electrosurgical generator of the Precision line may coagulate by using both monopolar technique and bipolar technique. Electrosurgical generators of the Precision and SEG lines and accessories should be used only by qualified and trained medical professionals in the use of electrosurgical equipment and surgical technique to be held. #### TECHNOLOGICAL CHARACTERISTICS The subject device and the predicate devices have intended use and technological characteristics. Differences in the design features between the subject devices and the primary predicate devices K944602, and the reference predicate device K172757 are addressed by comparison to the reference devices as listed in the table below: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Deltronix. The logo features the letters "DTX" in a stylized, bold, sans-serif font, enclosed within a blue hexagon. Below the hexagon, the word "DELTRONIX" is written in a similar blue font, with a trademark symbol to the right. # Table 5.1: Substantial Equivalence comparison | Description | Deltronix Precision TC4 | Deltronix Precision TC3 | Deltronix Precision TC2 | Deltronix SEG100 | Deltronix SEG150 | Deltronix SEG200 | Valleylab FX / K944602 | Valleylab FX8 / K172757 | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | The Deltronix Precision and SEG are a high frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | The Valleylab Force FX-C Electrosurgical Generator is an isolated output electrosurgical generator that provides power for cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery. | The Valleylab FX8 FX Series Energy Platform is a high- frequency electrosurgical generator intended for use with monopolar and bipolar accessories for cutting and coagulating tissue. | | Prescription or OTC | Prescription only | Prescription only | Prescription only | Prescription only | Prescription only | Prescription only | Prescription only | Prescription only | | ESU | | | | | | | | | | Major Functions | Bipolar Monopolar Impedance monitor Continuity monitor | Bipolar Monopolar Impedance monitor Continuity monitor | Bipolar Monopolar Impedance monitor Continuity monitor | Bipolar Monopolar Impedance monitor Continuity monitor | Bipolar Monopolar Impedance monitor Continuity monitor | Bipolar Monopolar Impedance monitor Continuity monitor | Bipolar Monopolar Impedance monitor Continuity monitor | Bipolar Monopolar Impedance monitor Continuity monitor | | Performance | | | | | | | | | | Output frequency | Bipolar precise 400KHz | Bipolar precise 400KHz | Bipolar precise 400KHz | Bipolar precise 400KHz | Bipolar precise 400KHz | Bipolar precise 400KHz | Bipolar precise 470KHz | Bipolar precise 470KHz | | | Bipolar standard 400KHz | Bipolar standard 400KHz | Bipolar standard 400KHz | Bipolar standard 400KHz | Bipolar standard 400KHz | Bipolar standard 400KHz | Bipolar Standard 470KHz | Bipolar Standard 470KHz | | | Bipolar Macro 400KHz | Bipolar Macro 400KHz | Bipolar Macro 400KHz | Bipolar Macro 400KHz | Bipolar Macro 400KHz | Bipolar Macro 400KHz | Bipolar Macro 470KHz | Bipolar Macro 470KHz | | | Monopolar Cut Pure Hi 400KHz | Monopolar Cut Pure Hi 400KHz | Monopolar Cut Pure Hi 400KHz | Monopolar Cut Pure Hi 400KHz | Monopolar Cut Pure Hi 400KHz | Monopolar Cut Pure Hi 400KHz | Monopolar Cut Low 390KHz | Monopolar Cut Low 390KHz | | | Monopolar Cut Pure Low 400KHz | Monopolar Cut Pure Low 400KHz | Monopolar Cut Pure Low 400KHz | Monopolar Cut Pure Low 400KHz | Monopolar Cut Pure Low 400KHz | Monopolar Cut Pure Low 400KHz | Monopolar Cut Pure 390KHz | Monopolar Cut Pure 390KHz | | | Monopolar Blend1 400KHz | Monopolar Blend1 400KHz | Monopolar Blend1 400KHz | Monopolar Blend1 400KHz | Monopolar Blend1 400KHz | Monopolar Blend1 400KHz | Monopolar Cut Blend 390KHz | Monopolar Cut Blend 390KHz | | | Monopolar Blend2 400KHz | Monopolar Blend2 400KHz | Monopolar Blend2 400KHz | Monopolar Blend2 400KHz | Monopolar Blend2 400KHz | Monopolar Blend2 400KHz | Monopolar Coag Disiccate 390KHz | Monopolar Coag Disiccate 390KHz | | | Monopolar Blend3 400KHz | Monopolar Blend3 400KHz | Monopolar Blend3 400KHz | Monopolar Blend3 400KHz | Monopolar Blend3 400KHz | Monopolar Blend3 400KHz | Monopolar Coag Fulgurate 390KHz | Monopolar Coag Fulgurate 390KHz | | | Monopolar Coag Disiccate 400KHz | Monopolar Coag Disiccate 400KHz | Monopolar Coag Disiccate 400KHz | Monopolar Coag Disiccate 400KHz | Monopolar Coag Disiccate 400KHz | Monopolar Coag Disiccate 400KHz | Monopolar Coag LCF Fulgurate 240KHz | Monopolar Coag LCF Fulgurate 240KHz | | | Monopolar Coag Spray 400KHz | Monopolar Coag Spray 400KHz | Monopolar Coag Spray 400KHz | Monopolar Coag Spray 400KHz | Monopolar Coag Spray 400KHz | Monopolar Coag Spray 400KHz | Monopolar Coag Spray 390KHz | Monopolar Coag Spray 390KHz | | | Monopolar Coag Fulgurate 400KHz | Monopolar Coag Fulgurate 400KHz | Monopolar Coag Fulgurate 400KHz | Monopolar Coag Fulgurate 400KHz | Monopolar Coag Fulgurate 400KHz | Monopolar Coag Fulgurate 400KHz | | | | Waveform | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | | Channels | 2 | 2 | 2 | 1 | 1 | 1 | 2 | 2 | | Power output | 400W | 300W | 200W | 100W | 150W | 200W | 300W | 300W | | Voltage output | 4185 Volts | 4185 Volts | 4185 Volts | 4185 Volts | 4185 Volts | 4185 Volts | 4853 Volts | 4853 Volts | | Crest Factor | 1.7 to 8.2 | 1.7 to 8.2 | 1.7 to 8.2 | 1.7 to 8.2 | 1.7 to 8.2 | 1.7 to 8.2 | 1.4 to 7.7 | 1.4 to 7.7 | | Input power (VA) | 1253 VA Max | 1253 VA Max | 1253 VA Max | 1253 VA Max | 1253 VA Max | 1253 VA Max | 924 VA Max | 924 VA Max | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for DTX Deltronix. The logo features the letters "DTX" in a bold, sans-serif font, stacked on top of the word "DELTRONIX" which is also in a sans-serif font. Both the letters and the word are in a blue color. The letters "DTX" are enclosed in a blue hexagon. # K223784 – 510(k) Summary - Deltronix The subject device Deltronix Precision and SEG are substantially equivalent to the primary predicate device K944602, and reference device K172757, in designs functionalities. The reference device is K172757. #### CONCLUSION The documentation submitted in this premarket notification demonstrates that the subject devices have comparable features and performance and, therefore, are substantially equivalent to the identified predicate devices.