The Loktal Medical Electronics ind. E com. Ltda EPP - Wavetronic 5000 Digital HF Surgical Unit is intended for resection, ablation, excision of soft tissue, coagulation, and desiccation of soft tissue in patients requiring surgery.

Device Description

The Wavetronic 5000 Digital HF Surgical Unit is a non-sterile, reusable electrosurgical generator, which is designed to generate high frequencies (RF) of high voltage and low amperage current, operating at high frequency (4 MHz) to be employed by a variety of electrosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are effected through push buttons and dials, and lamps, which give the operator feedback of status.

The Wavetronic 5000 Digital HF Surgical Unit is an electrosurgical cutting and coagulation device intended to remove tissue and control bleeding by use of high-frequency electrical current.

The device has four modes of operation;

Cut a basic cutting mode that produces minimal heat.
Blend (cut and coagulation) surface coagulation takes place simultaneously with cutting, with wave ratio being approximately 50/50.
Coagulation a mode with high lateral heat emission.
Bipolar (bipolar coagulation mode) bipolar coagulation mode is intended to remove tissue and control bleeding by use of high-frequency, electrosurgical current.

The control unit of the device front panel control provides the user with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. The therapeutic parameters can be set or adjusted any time through surgery, and displays the therapeutic method, the set power, and other necessary data required throughout the treatment.

The Wavetronic 5000 Digital HF Surgical Unit consists of the following main components:

Wavetronic 5000 Digital high-frequency electromagnetic energy generator
Optional wave selection (cut, blend, coag, bipolar)
Footswitch
Power cable

AI/ML Overview

This document is a 510(k) Pre-market Notification for the Wavetronic 5000 Digital HF Surgical Unit. It aims to demonstrate substantial equivalence to legally marketed predicate devices.

Based on the provided text, the device itself (Wavetronic 5000 Digital HF Surgical Unit) is an electrosurgical cutting and coagulation device. The acceptance criteria and supporting studies outlined here refer to the performance of this hardware device, not to an AI/ML algorithm for diagnosis or prognosis.

Therefore, most of the requested AI/ML specific information (like AI-assisted human reader improvement, standalone AI performance, expert qualifications for AI ground truth, etc.) are not applicable to this submission.

Here's the information that can be extracted:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in the typical format of a clinical study for a diagnostic AI/ML device. Instead, it describes acceptance based on compliance with voluntary standards and successful completion of non-clinical tests. The "performance" is demonstrated by meeting these standards and passing tests.

Acceptance Criteria Category	Reported Device Performance
Overall Design	Meets all requirements as shown by acceptable results obtained in testing.
Biocompatibility	Complies with applicable voluntary standards; passed testing.
Electrical Safety	Meets all requirements; passed testing.
Output	Confirmed to meet design inputs and specifications; passed testing.
Applicability of Standards	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2.
Functional Equivalence (to predicates)	Demonstrated through comparative analysis of intended use, technological characteristics, and principles of operation, showing no new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable as this is a hardware device submission, not a study involving a test dataset of medical images or patient data in the context of an AI/ML device.

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)

This information is not applicable. Ground truth is not established by experts for a hardware electrosurgical unit in the way it would be for an AI/ML diagnostic device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. No adjudication method for a test set of data 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

This information is not applicable. This is a hardware device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. This device is a manual electrosurgical unit, not an AI algorithm. Its performance is inherent to its physical operation and energy delivery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable in the context of typical AI/ML ground truth. For this hardware device, the "ground truth" (or verification) is based on:

Compliance with recognized voluntary standards: Such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. These standards define safety and performance requirements.
Engineering specifications and design inputs: The device's output and functionality are verified against its own design specifications.
Biocompatibility testing: To ensure materials are safe for patient contact.
Electrical safety testing: To ensure the device operates safely electrically.

8. The sample size for the training set

This information is not applicable. There is no "training set" for this type of hardware device.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set" or corresponding ground truth establishment in the AI/ML sense for this device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

LOKTAL MEDICAL ELECTRONICS IND. COM.LTDA- EPP % Ms. Carrie Hetrick Emergo Group 816 Congress Avenue, Suite 1400 Austin. Texas 78701

October 8, 2015

Re: K134036

Trade/Device Name: Wavetronic 5000 Digital HF Surgical Unit Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 11, 2015 Received: September 14, 2015

Dear Ms. Hetrick:

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. 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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); medical device reporting (reporting of medical device-related adverse events) (21 CFR

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803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joshua C. Nipper -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director

For

Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K134036

Device Name

Wavetronic 5000 Digital HF Surgical Unit and Accessories

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

for

Wavetronic 5000 Digital HF Surgical Unit

1. Submission Sponsor

LOKTAL MEDICAL ELECTRONICS IND. COM.LTDA- EPP Rua Trona Constanzo, 156 São Paulo – SP - Brazil CEP: 05516-020 Phone Number: 55 11 3722-0345 Fax Number: 55 11 3721-9438 Luciano Rodrigues Grillo, International Sales Manager

2. Submission Correspondent

Emergo 816 Congress Avenue, Suite 1400 Austin, TX 78701 Cell Phone: (720) 838.4113 Office Phone: (512) 327.9997 Fax: (512) 327.9998 Contact: Carrie, Senior Consultant, RA Email: project.management@emergogroup.com

3. Date Prepared

October 6, 2015

4. Device Identification

Trade/Proprietary Name:	Wavetronic 5000 Digital HF Surgical Unit
Common/Usual Name:	Electrosurgical cutting and coagulation device and accessories
Classification Name:	Electrosurgical Cutting & Coagulation & Accessories
Classification Regulation:	878.4400
Product Code:	GEI
Device Class:	Class II
Classification Panel:	General and Plastic Surgery

5. Legally Marketed Predicate Device(s)

The Wavetronic 5000 Digital HF Surgical Unit is a state-of-the-art high-frequency energy device that is substantially equivalent to the current products that are already cleared for USA distribution under the following 510(k) Premarket Notification numbers:

K082834Ellman International, Inc. Surgitron IEC ●
. K051956Sometech, Inc. Dr. OPPEL ST-501

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6. Device Description

The Wavetronic 5000 Digital HF Surgical Unit is an electrosurgical cutting and coagulation device intended to remove tissue and control bleeding by use of high-frequency electrical current.

The device has four modes of operation;

1. Cut a basic cutting mode that produces minimal heat.
1. Blend (cut and coagulation) surface coagulation takes place simultaneously with cutting, with wave ratio being approximately 50/50.
1. Coagulation a mode with high lateral heat emission.
Bipolar (bipolar coagulation mode) bipolar coagulation mode is intended to 4. remove tissue and control bleeding by use of high-frequency, electrosurgical current.

The Wavetronic 5000 Digital HF Surgical Unit consists of the following main components:

Wavetronic 5000 Digital high-frequency electromagnetic energy generator
Optional wave selection (cut, blend, coag, bipolar)
Footswitch
Power cable

5. Indication for Use Statement

6. Substantial Equivalence Discussion

The following table compares the Wavetronic 5000 Digital HF Surgical Unit to the predicate device with respect to intended use, technological characteristics and principles of operation, providing more detailed information regarding the basis for the determination of substantial equivalence.

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Manufacturer	Loktal Medical Electronicsind. E com. Ltda EPP	Ellman International, Inc.	Sometech, Inc.
Trade Name	Wavetronic 5000 Digital HFSurgical Unit	Surgitron IEC	Dr. OPPEL ST-501
510(k)Number	K134036	K082834	K051956
	Image: Wavetronic	Image: Ellman	Image: Sometech
Product Code	GEI	GEI	GEI
RegulationNumber	21 CFR 878.4400	21 CFR 878.4400	21 CFR 878.4400
RegulationName	Electrosurgical Cutting andCoagulation Device andaccessories	Electrosurgical Cutting andCoagulation Device andaccessories	Electrosurgical Cutting andCoagulation Device andaccessories
Indications forUse	The Loktal MedicalElectronics ind. E com. LtdaEPP - Wavetronic 5000Digital HF Surgical Unit isintended for resection,ablation, excision of softtissue, coagulation, anddesiccation of soft tissue inpatients requiring surgery.	Non-ablative treatment ofmild to moderate facialwrinkles and rhytides forskin phototypes I-IV Thedevice is also indicated for:- Cutting, snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty IRAUP),myringotomy with effectivehemorrhage control,epistaxis treatment,turbinate shrinkage, skinincisions, biopsy, cysts,abscesses, tumors,cosmetic repairs,development of skin flaps,skin tags, andblepharoplasty.- Blended Cutting andCoagulation: snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy with effectivehemorrhage control,epistaxis treatment,turbinate shrinkage, skintags, papilloma keloids,keratosis, verrucae, basalcell carcinoma, nevi,fistulas, epithelioma,cosmetic repairs, cysts,	The Dr. OPPEL ST-501 isintended for the removaland destruction of skinlegions and the coagulationof tissue. Non-sterile andreusable electrodes areused in conjunction with anelectrosurgical handpieceand generator.

		Table 5A – Comparison of Characteristics
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Manufacturer	Loktal Medical Electronicsind. E com. Ltda EPP	Ellman International, Inc.	Sometech, Inc.
Trade Name	Wavetronic 5000 Digital HFSurgical Unit	Surgitron IEC	Dr. OPPEL ST-501
		development of skin flaps.• Hemostasis: control ofbleeding, epilation,telangiectasias.• Fulguration: basal cellcarcinoma, papilloma, cystdestruction, tumors,
		verrucae, hemostasis.• Bipolar: pinpointprecise coagulation,pinpoint hemostasis in anyfield (wet or dry), snoring,submucosal palatalshrinkage, traditionaluvulopalatoplasty (RAUP),myringotomy with effectivehemorrhage control,
		epistaxis treatment, andturbinate shrinkage.
Prescriptionor OTC	Prescription	Prescription	Prescription
DeviceTechnologies	Application of heat to thetissue w/ RF energy	Application of heat to thetissue w/ RF energy	Application of heat to thetissue w/ RF energy
Modes ofOperation	MonopolarBlendCoagulationBipolar	MonopolarBlendCoagulationFulgurationBipolar	MonopolarBlendCoagulationFulgurationBipolar
ElectricalProtection	Type BF, Class I	Type BF, Class I	Type BF, Class I
Energy Type	Radiofrequency	Radiofrequency	Radiofrequency
Modes ofOperation	MonopolarBipolar	Monopolar mode used forindications for use: (Non-ablative treatment of mildto moderate facial wrinklesand rhytides for skinprototypes I-IV.).Bipolar mode used forother indications for use.	MonopolarBipolar
NominalOperatingPower	60 to 100 Watts(Monopolar)24 Watts (Bipolar)	120 Watts (Monopolar)120 Watts (Bipolar)	125 Watts (Monopolar)
Output PeakPower	100 Watts	120 Watts	700 Watts
Power Supply	110/220Vac	110Vac	100/110/120/220/230/240VAC
OutputFrequency	4 MHz	4 MHz (monopolar)1.7 MHz (bipolar)	4.0 MHz partially rectified
Interface	Buttons and knobs on theunit; there is a hand-piece	Buttons and knobs on theunit; there is a hand-piece	Buttons and knobs on theunit; there is a hand-piece
Manufacturer	Loktal Medical Electronicsind. E com. Ltda EPP	Ellman International, Inc.	Sometech, Inc.
Trade Name	Wavetronic 5000 Digital HFSurgical Unit	Surgitron IEC	Dr. OPPEL ST-501
	utilized to deliver thetreatment.	utilized to deliver thetreatment.	utilized to deliver thetreatment.
Material ofthe GeneratorCase	Aluminum, Plastic, StainlessSteel	Plastic, Metal	Plastic, Metal
UnitConstruction	Constructed of materialsthat conform to safetystandards and requirement	Constructed of materialsthat conform to safetystandards and requirement	Constructed of materialsthat conform to safetystandards and requirement
Power DigitalDisplay	Yes	No	No
OperatingTemperature	5°C to 40°C	10°C to 40°C	10°C to 40°C
OperatingHumidity	30% - 75%	30% - 75%	30% - 75%
SkinTemperatureMonitoring	Based on Patient Feedback- Built-in IR thermometer	Based on Patient Feedback- Built-in IR thermometer	Based on Patient Feedback- Built-in IR thermometer
Power LevelAdjustable viaApplicator	NO	NO	NO
RF EnergyEmissionIndicator	YES	YES	YES
ApplicatorDimensions	16 cm x 2 cm x 2.1 cm	0.8" x 0.8" x 6.3"(2 cm x 2 cm x 16 cm)	225(W) x 300(L) x155(H)mm
Energy Source	110 - 220 VAC, max 3A, 50-60 Hz	100 - 240 VAC, max 4A, 50– 60 Hz	100/110/120/220/230/240VAC, 50/60Hz
SystemDimensions	6.2" x 7.9" x 8.3"(16 cm x 20 cm x 21 cm)	9.5" x 7.1" x 16.5 "(24 cm x 18 cm x 42 cm)	225(W)x300(L)x155(H)mm
SystemWeight	9.3 lbs (4.2 kg)	26 lbs (11.8 kg)	22 lbs (10 kg)
Waveform	Sinusoid	Sinusoid	Sinusoid partially rectified
TreatmentDuration	Treatment contingent - 5sec to 5 minutes	3 – 5 min. per area	Not known
DualDispersivePatchElectrodeGrounding	YES	YES	YES
PatchElectrodeContactQualityMonitoring	YES	YES	NO
RF EnergyEmissionIndicator	YES; Information displayedon the screen of theapplicator and on the mainscreen of the unit.	YES	YES
Manufacturer	Loktal Medical Electronicsind. E com. Ltda EPP	Ellman International, Inc.	Sometech, Inc.
Trade Name	Wavetronic 5000 Digital HFSurgical Unit	Surgitron IEC	Dr. OPPEL ST-501
ExchangeableFuse	239 V T 1AL, 250V
BlendFunction	Yes	Yes	No
Coag Function	Yes	Yes	Yes
BipolarFunction	Yes	Yes	Yes
Portable	Yes	Yes	Yes
IECCertification	IEC 60601-1IEC 60601-1-2IEC 60601-2-2	IEC 60601-1:2007EN 60601-1:2007EN 60601-2-2:2007IEC EN 60601-2-2:2009	IEC 60601-1IEC 60601-1-2IEC 60601-2-2 ANSI / AAMIHF18
OptionalTrolley Cart	Yes	Yes	Yes

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7. Non-Clinical Performance Data

The device has been tested for applicable safety requirements. TheWavetronic 5000 Digital HF Surgical Unit complies with the applicable voluntary standards for biocompatibility. As part of demonstrating safety and effectiveness ofWavetronic 5000 Digital HF Surgical Unit and in showing substantial equivalence to the predicate devices that are subject to this 510(k) submission, Loktal Medical Electronics Ind. e Com. Ltda completed a number of tests. The Wavetronic 5000 Digital HF Surgical Unit meets all the requirements for the overall design, biocompatibility, and electrical safety confirm that the output meets the design inputs and specifications. TheWavetronic 5000 Digital HF Surgical Unit passed all testing stated above as shown by the acceptable results obtained.

The following testing has been performed to support substantial equivalence:

8. Clinical Performance Data

There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. These types of devices, including the predicate devices, have been on the market for many years with a proven safety and efficacy for the use of the device. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

9. Statement of Substantial Equivalence

It has been shown in this 510(k) submission that the differences, between the Wavetronic 5000 Digital HF Surgical Unit and the predicate devices listed above, do not raise any questions regarding its safety and effectiveness. Further, the Wavetronic 5000 Digital HF Surgical Unit utilizes the same type of technology as the predicate device. The Wavetronic 500 Digital HF Surgical Unit, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

Regulation Number and Section

§ 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.