(123 days)
The Deltronix Precision and SEG are a high frequency electrosurgical generators intended for use with monopolar and bipolar accessories for cutting and coagulating tissue.
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.
This is an electrosurgical generator device, not an AI/ML device. Therefore, the questions related to AI/ML device performance are not applicable.
Here's the relevant information extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance, rather than defining explicit acceptance criteria or presenting a standalone performance study with specific metrics. The "Performance" section in Table 5.1 compares output frequencies, waveform, channels, power output, voltage output, and crest factor between the subject devices and predicate devices.
| Description | Deltronix Precision TC4/TC3/TC2/SEG100/SEG150/SEG200 (Subject Devices) | Valleylab FX / K944602 (Predicate) | Valleylab FX8 / K172757 (Reference Predicate) |
|---|---|---|---|
| Indications for Use | For cutting and coagulating tissue using monopolar and bipolar accessories | For cutting, desiccating, and fulgurating tissue during bipolar and monopolar surgery | For cutting and coagulating tissue using monopolar and bipolar accessories |
| Prescription or OTC | Prescription only | Prescription only | Prescription only |
| Major Functions | 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 standard: 400KHz; Bipolar Macro: 400KHz; Monopolar Cut Pure Hi/Low: 400KHz; Monopolar Blend1/2/3: 400KHz; Monopolar Coag Disiccate/Spray/Fulgurate: 400KHz | Bipolar precise: 470KHz; Bipolar Standard: 470KHz; Bipolar Macro: 470KHz; Monopolar Cut Low/Pure/Blend: 390KHz; Monopolar Coag Disiccate/Fulgurate/Spray: 390KHz; Monopolar Coag LCF Fulgurate: 240KHz | Bipolar precise: 470KHz; Bipolar Standard: 470KHz; Bipolar Macro: 470KHz; Monopolar Cut Low/Pure/Blend: 390KHz; Monopolar Coag Disiccate/Fulgurate/Spray: 390KHz; Monopolar Coag LCF Fulgurate: 240KHz |
| Waveform | Sinusoidal | Sinusoidal | Sinusoidal |
| Channels | 2 (Precision TC2, TC3, TC4); 1 (SEG 100, SEG 150, SEG 200) | 2 | 2 |
| Power output | 400W (Precision TC4); 300W (Precision TC3); 200W (Precision TC2/SEG200); 150W (SEG150); 100W (SEG100) | 300W | 300W |
| Voltage output | 4185 Volts | 4853 Volts | 4853 Volts |
| Crest Factor | 1.7 to 8.2 | 1.4 to 7.7 | 1.4 to 7.7 |
| Input power (VA) | 1253 VA Max | 924 VA Max | 924 VA Max |
The "acceptance criteria" here implicitly refer to the demonstration of comparable performance within a range considered safe and effective for electrosurgical generators, as evidenced by comparison to predicate devices. The document states: "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."
2. Sample size used for the test set and the data provenance:
Not applicable, as this is demonstrating substantial equivalence for an electrosurgical generator, not an AI/ML device that requires a test set of data. The evaluation is based on technical specifications and comparison to existing cleared devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
Not applicable, as this is an electrosurgical generator, not an AI/ML device relying on expert-established ground truth from a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable, as this is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is an electrosurgical generator, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" for this type of device lies in adherence to established performance standards for electrosurgical generators and demonstrating equivalence to legally marketed predicate devices through engineering and functional comparisons.
8. The sample size for the training set:
Not applicable, as this is an electrosurgical generator, not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established:
Not applicable.
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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.
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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.
| MarkTrumbore -S | Digitally signed byMark Trumbore -SDate: 2023.04.1811:55:59 -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
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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) | |
|---|---|
| ☑ 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/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 SpecialistPassarini Regulatory AffairsPR Servi\u00e7os Regulat\u00f3rios Administrativos LtdaE-Mail: bruno@rapassarini.com.brTelephone +55 (16) 3421 8488 |
| Date Prepared | DEC - 16 2022 |
DEVICE NAME AND CLASSIFICATION
| Trade/ Proprietary Name | Precision TC2, Precision TC3, Precision TC4, SEG 100SEG 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 |
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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:
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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 | DeltronixPrecision TC4 | DeltronixPrecision TC3 | DeltronixPrecision TC2 | DeltronixSEG100 | DeltronixSEG150 | DeltronixSEG200 | Valleylab FX /K944602 | Valleylab FX8/ K172757 |
|---|---|---|---|---|---|---|---|---|
| Indicationsfor Use | The DeltronixPrecision andSEG are a highfrequencyelectrosurgicalgeneratorintended foruse withmonopolarand bipolaraccessories forcutting andcoagulatingtissue. | The DeltronixPrecision andSEG are a highfrequencyelectrosurgicalgeneratorintended foruse withmonopolarand bipolaraccessories forcutting andcoagulatingtissue. | The DeltronixPrecision andSEG are a highfrequencyelectrosurgicalgeneratorintended foruse withmonopolarand bipolaraccessories forcutting andcoagulatingtissue. | The DeltronixPrecision andSEG are a highfrequencyelectrosurgicalgeneratorintended foruse withmonopolarand bipolaraccessories forcutting andcoagulatingtissue. | The DeltronixPrecision andSEG are a highfrequencyelectrosurgicalgeneratorintended foruse withmonopolarand bipolaraccessories forcutting andcoagulatingtissue. | The DeltronixPrecision andSEG are a highfrequencyelectrosurgicalgeneratorintended foruse withmonopolarand bipolaraccessories forcutting andcoagulatingtissue. | The ValleylabForce FX-CElectrosurgicalGenerator isan isolatedoutputelectrosurgicalgenerator thatprovidespower forcutting,desiccating,andfulguratingtissue duringbipolar andmonopolarsurgery. | The ValleylabFX8 FX SeriesEnergyPlatform is ahigh-frequencyelectrosurgicalgeneratorintended foruse withmonopolarand bipolaraccessories forcutting andcoagulatingtissue. |
| Prescriptionor OTC | Prescriptiononly | Prescriptiononly | Prescriptiononly | Prescriptiononly | Prescriptiononly | Prescriptiononly | Prescriptiononly | Prescriptiononly |
| ESU | ||||||||
| MajorFunctions | BipolarMonopolarImpedancemonitorContinuitymonitor | BipolarMonopolarImpedancemonitorContinuitymonitor | BipolarMonopolarImpedancemonitorContinuitymonitor | BipolarMonopolarImpedancemonitorContinuitymonitor | BipolarMonopolarImpedancemonitorContinuitymonitor | BipolarMonopolarImpedancemonitorContinuitymonitor | BipolarMonopolarImpedancemonitorContinuitymonitor | BipolarMonopolarImpedancemonitorContinuitymonitor |
| Performance | ||||||||
| Outputfrequency | Bipolarprecise400KHz | Bipolarprecise400KHz | Bipolarprecise400KHz | Bipolarprecise400KHz | Bipolarprecise400KHz | Bipolarprecise400KHz | Bipolarprecise470KHz | Bipolarprecise470KHz |
| Bipolarstandard400KHz | Bipolarstandard400KHz | Bipolarstandard400KHz | Bipolarstandard400KHz | Bipolarstandard400KHz | Bipolarstandard400KHz | BipolarStandard470KHz | BipolarStandard470KHz | |
| Bipolar Macro400KHz | Bipolar Macro400KHz | Bipolar Macro400KHz | Bipolar Macro400KHz | Bipolar Macro400KHz | Bipolar Macro400KHz | Bipolar Macro470KHz | Bipolar Macro470KHz | |
| MonopolarCut Pure Hi400KHz | MonopolarCut Pure Hi400KHz | MonopolarCut Pure Hi400KHz | MonopolarCut Pure Hi400KHz | MonopolarCut Pure Hi400KHz | MonopolarCut Pure Hi400KHz | MonopolarCut Low390KHz | MonopolarCut Low390KHz | |
| MonopolarCut Pure Low400KHz | MonopolarCut Pure Low400KHz | MonopolarCut Pure Low400KHz | MonopolarCut Pure Low400KHz | MonopolarCut Pure Low400KHz | MonopolarCut Pure Low400KHz | MonopolarCut Pure390KHz | MonopolarCut Pure390KHz | |
| MonopolarBlend1400KHz | MonopolarBlend1400KHz | MonopolarBlend1400KHz | MonopolarBlend1400KHz | MonopolarBlend1400KHz | MonopolarBlend1400KHz | MonopolarCut Blend390KHz | MonopolarCut Blend390KHz | |
| MonopolarBlend2400KHz | MonopolarBlend2400KHz | MonopolarBlend2400KHz | MonopolarBlend2400KHz | MonopolarBlend2400KHz | MonopolarBlend2400KHz | MonopolarCoagDisiccate390KHz | MonopolarCoagDisiccate390KHz | |
| MonopolarBlend3400KHz | MonopolarBlend3400KHz | MonopolarBlend3400KHz | MonopolarBlend3400KHz | MonopolarBlend3400KHz | MonopolarBlend3400KHz | MonopolarCoagFulgurate390KHz | MonopolarCoagFulgurate390KHz | |
| MonopolarCoag Disiccate400KHz | MonopolarCoag Disiccate400KHz | MonopolarCoag Disiccate400KHz | MonopolarCoag Disiccate400KHz | MonopolarCoag Disiccate400KHz | MonopolarCoag Disiccate400KHz | MonopolarCoagLCF Fulgurate240KHz | MonopolarCoagLCF Fulgurate240KHz | |
| MonopolarCoag Spray400KHz | MonopolarCoag Spray400KHz | MonopolarCoag Spray400KHz | MonopolarCoag Spray400KHz | MonopolarCoag Spray400KHz | MonopolarCoag Spray400KHz | MonopolarCoag Spray390KHz | MonopolarCoag Spray390KHz | |
| MonopolarCoagFulgurate400KHz | MonopolarCoagFulgurate400KHz | MonopolarCoagFulgurate400KHz | MonopolarCoagFulgurate400KHz | MonopolarCoagFulgurate400KHz | MonopolarCoagFulgurate400KHz | |||
| Waveform | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal | Sinusoidal |
| Channels | 2 | 2 | 2 | 1 | 1 | 1 | 2 | 2 |
| Poweroutput | 400W | 300W | 200W | 100W | 150W | 200W | 300W | 300W |
| Voltageoutput | 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 |
| Inputpower (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 |
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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.
§ 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.