WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT

K134036 · Loktal Medical Electronics Ind. Com. Ltda- Epp · GEI · Oct 8, 2015 · General, Plastic Surgery

Device Facts

• Record ID: K134036
• Device Name: WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
• Applicant: Loktal Medical Electronics Ind. Com. Ltda- Epp
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 8, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Wavetronic 5000 Digital HF Surgical Unit is a reusable electrosurgical generator; delivers high-frequency (4 MHz) RF energy to soft tissue. Operates in four modes: Cut, Blend, Coagulation, and Bipolar. User interface includes push buttons, dials, and digital display for parameter monitoring. Used in clinical settings by physicians to remove tissue and control bleeding. Device transforms electrical input into RF output via handpiece; provides feedback on status via lamps and display. Benefits include precise tissue management and hemostasis. System includes generator, footswitch, and power cable.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility and electrical safety verification against voluntary standards.

Technological Characteristics

RF electrosurgical generator; 4 MHz output frequency. Materials: Aluminum, plastic, stainless steel. Modes: Monopolar (Cut, Blend, Coagulation) and Bipolar. Power: 60-100W (Monopolar), 24W (Bipolar). Connectivity: Standalone unit with footswitch. Electrical safety: Type BF, Class I. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2. Features: Digital power display, dispersive patch electrode monitoring.

Indications for Use

Indicated for patients requiring surgery for resection, ablation, excision, coagulation, and desiccation of soft tissue.

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

• Surgitron IEC (K082834)
• Dr. OPPEL ST-501 (K051956)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are connected to a wing-like shape on the left side. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| 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)

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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: [phone] Office Phone: [phone] Fax: [phone] Contact: Carrie, Senior Consultant, RA Email: [e-mail]

### 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 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;

- 1. Cut a basic cutting mode that produces minimal heat.
- 2. Blend (cut and coagulation) surface coagulation takes place simultaneously with cutting, with wave ratio being approximately 50/50.
- 3. 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 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

### 5. Indication for Use Statement

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.

### 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 Electronics<br>ind. E com. Ltda EPP | Ellman International, Inc. | Sometech, Inc. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Wavetronic 5000 Digital HF<br>Surgical Unit | Surgitron IEC | Dr. OPPEL ST-501 |
| 510(k)<br>Number | K134036 | K082834 | K051956 |
| | Image: Wavetronic | Image: Ellman | Image: Sometech |
| Product Code | GEI | GEI | GEI |
| Regulation<br>Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Regulation<br>Name | Electrosurgical Cutting and<br>Coagulation Device and<br>accessories | Electrosurgical Cutting and<br>Coagulation Device and<br>accessories | Electrosurgical Cutting and<br>Coagulation Device and<br>accessories |
| Indications for<br>Use | The Loktal Medical<br>Electronics ind. E com. Ltda<br>EPP - Wavetronic 5000<br>Digital HF Surgical Unit is<br>intended for resection,<br>ablation, excision of soft<br>tissue, coagulation, and<br>desiccation of soft tissue in<br>patients requiring surgery. | Non-ablative treatment of<br>mild to moderate facial<br>wrinkles and rhytides for<br>skin phototypes I-IV The<br>device is also indicated for:<br>- Cutting, snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty IRAUP),<br>myringotomy with effective<br>hemorrhage control,<br>epistaxis treatment,<br>turbinate shrinkage, skin<br>incisions, biopsy, cysts,<br>abscesses, tumors,<br>cosmetic repairs,<br>development of skin flaps,<br>skin tags, and<br>blepharoplasty.<br>- Blended Cutting and<br>Coagulation: snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective<br>hemorrhage control,<br>epistaxis treatment,<br>turbinate shrinkage, skin<br>tags, papilloma keloids,<br>keratosis, verrucae, basal<br>cell carcinoma, nevi,<br>fistulas, epithelioma,<br>cosmetic repairs, cysts, | The Dr. OPPEL ST-501 is<br>intended for the removal<br>and destruction of skin<br>legions and the coagulation<br>of tissue. Non-sterile and<br>reusable electrodes are<br>used in conjunction with an<br>electrosurgical handpiece<br>and generator. |

| | | Table 5A – Comparison of Characteristics |
|--|--|------------------------------------------|
|--|--|------------------------------------------|

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| Manufacturer | Loktal Medical Electronics<br>ind. E com. Ltda EPP | Ellman International, Inc. | Sometech, Inc. |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Trade Name | Wavetronic 5000 Digital HF<br>Surgical Unit | Surgitron IEC | Dr. OPPEL ST-501 |
| | | development of skin flaps.<br>• Hemostasis: control of<br>bleeding, epilation,<br>telangiectasias.<br>• Fulguration: basal cell<br>carcinoma, papilloma, cyst<br>destruction, tumors, | |
| | | verrucae, hemostasis.<br>• Bipolar: pinpoint<br>precise coagulation,<br>pinpoint hemostasis in any<br>field (wet or dry), snoring,<br>submucosal palatal<br>shrinkage, traditional<br>uvulopalatoplasty (RAUP),<br>myringotomy with effective<br>hemorrhage control, | |
| | | epistaxis treatment, and<br>turbinate shrinkage. | |
| Prescription<br>or OTC | Prescription | Prescription | Prescription |
| Device<br>Technologies | Application of heat to the<br>tissue w/ RF energy | Application of heat to the<br>tissue w/ RF energy | Application of heat to the<br>tissue w/ RF energy |
| Modes of<br>Operation | Monopolar<br>Blend<br>Coagulation<br>Bipolar | Monopolar<br>Blend<br>Coagulation<br>Fulguration<br>Bipolar | Monopolar<br>Blend<br>Coagulation<br>Fulguration<br>Bipolar |
| Electrical<br>Protection | Type BF, Class I | Type BF, Class I | Type BF, Class I |
| Energy Type | Radiofrequency | Radiofrequency | Radiofrequency |
| Modes of<br>Operation | Monopolar<br>Bipolar | Monopolar mode used for<br>indications for use: (Non-<br>ablative treatment of mild<br>to moderate facial wrinkles<br>and rhytides for skin<br>prototypes I-IV.).<br>Bipolar mode used for<br>other indications for use. | Monopolar<br>Bipolar |
| Nominal<br>Operating<br>Power | 60 to 100 Watts<br>(Monopolar)<br>24 Watts (Bipolar) | 120 Watts (Monopolar)<br>120 Watts (Bipolar) | 125 Watts (Monopolar) |
| Output Peak<br>Power | 100 Watts | 120 Watts | 700 Watts |
| Power Supply | 110/220Vac | 110Vac | 100/110/120/220/230/240<br>VAC |
| Output<br>Frequency | 4 MHz | 4 MHz (monopolar)<br>1.7 MHz (bipolar) | 4.0 MHz partially rectified |
| Interface | Buttons and knobs on the<br>unit; there is a hand-piece | Buttons and knobs on the<br>unit; there is a hand-piece | Buttons and knobs on the<br>unit; there is a hand-piece |
| Manufacturer | Loktal Medical Electronics<br>ind. E com. Ltda EPP | Ellman International, Inc. | Sometech, Inc. |
| Trade Name | Wavetronic 5000 Digital HF<br>Surgical Unit | Surgitron IEC | Dr. OPPEL ST-501 |
| | utilized to deliver the<br>treatment. | utilized to deliver the<br>treatment. | utilized to deliver the<br>treatment. |
| Material of<br>the Generator<br>Case | Aluminum, Plastic, Stainless<br>Steel | Plastic, Metal | Plastic, Metal |
| Unit<br>Construction | Constructed of materials<br>that conform to safety<br>standards and requirement | Constructed of materials<br>that conform to safety<br>standards and requirement | Constructed of materials<br>that conform to safety<br>standards and requirement |
| Power Digital<br>Display | Yes | No | No |
| Operating<br>Temperature | 5°C to 40°C | 10°C to 40°C | 10°C to 40°C |
| Operating<br>Humidity | 30% - 75% | 30% - 75% | 30% - 75% |
| Skin<br>Temperature<br>Monitoring | Based on Patient Feedback<br>- Built-in IR thermometer | Based on Patient Feedback<br>- Built-in IR thermometer | Based on Patient Feedback<br>- Built-in IR thermometer |
| Power Level<br>Adjustable via<br>Applicator | NO | NO | NO |
| RF Energy<br>Emission<br>Indicator | YES | YES | YES |
| Applicator<br>Dimensions | 16 cm x 2 cm x 2.1 cm | 0.8" x 0.8" x 6.3"<br>(2 cm x 2 cm x 16 cm) | 225(W) x 300(L) x<br>155(H)mm |
| Energy Source | 110 - 220 VAC, max 3A, 50-<br>60 Hz | 100 - 240 VAC, max 4A, 50<br>– 60 Hz | 100/110/120/220/230/240<br>VAC, 50/60Hz |
| System<br>Dimensions | 6.2" x 7.9" x 8.3"<br>(16 cm x 20 cm x 21 cm) | 9.5" x 7.1" x 16.5 "<br>(24 cm x 18 cm x 42 cm) | 225(W)x300(L)x155(H)mm |
| System<br>Weight | 9.3 lbs (4.2 kg) | 26 lbs (11.8 kg) | 22 lbs (10 kg) |
| Waveform | Sinusoid | Sinusoid | Sinusoid partially rectified |
| Treatment<br>Duration | Treatment contingent - 5<br>sec to 5 minutes | 3 – 5 min. per area | Not known |
| Dual<br>Dispersive<br>Patch<br>Electrode<br>Grounding | YES | YES | YES |
| Patch<br>Electrode<br>Contact<br>Quality<br>Monitoring | YES | YES | NO |
| RF Energy<br>Emission<br>Indicator | YES; Information displayed<br>on the screen of the<br>applicator and on the main<br>screen of the unit. | YES | YES |
| Manufacturer | Loktal Medical Electronics<br>ind. E com. Ltda EPP | Ellman International, Inc. | Sometech, Inc. |
| Trade Name | Wavetronic 5000 Digital HF<br>Surgical Unit | Surgitron IEC | Dr. OPPEL ST-501 |
| Exchangeable<br>Fuse | 239 V T 1AL, 250V | | |
| Blend<br>Function | Yes | Yes | No |
| Coag Function | Yes | Yes | Yes |
| Bipolar<br>Function | Yes | Yes | Yes |
| Portable | Yes | Yes | Yes |
| IEC<br>Certification | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 | IEC 60601-1:2007<br>EN 60601-1:2007<br>EN 60601-2-2:2007<br>IEC EN 60601-2-2:2009 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-2 ANSI / AAMI<br>HF18 |
| Optional<br>Trolley 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.