WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT

• K Number: K134036
• Device Name: WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
• Manufacturer: LOKTAL MEDICAL ELECTRONICS IND. COM. LTDA- EPP
• Date Cleared: 2015-10-08 ( 646 days)
• Product Code: GEI
• Regulation Number: 878.4400

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 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. 4. 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

Predicate Devices

K082834, K051956

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on standard electrosurgical generator technology with manual controls and pre-set modes. There is no mention of AI, ML, or any adaptive or learning capabilities.

Therapeutic

Yes
The device is described as an electrosurgical unit intended for resection, ablation, excision of soft tissue, coagulation, and desiccation, which are all therapeutic actions. Additionally, the control unit allows for setting and adjusting "therapeutic parameters" during "therapy" or "treatment."

Diagnostic

No

The device is an electrosurgical unit intended for surgical procedures like resection, ablation, excision, coagulation, and desiccation of soft tissue, which are therapeutic actions, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an electrosurgical generator and lists hardware components like the generator itself, footswitch, and power cable. It is a physical device that generates high-frequency electrical current for surgical procedures.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use is for surgical procedures on soft tissue in patients. This involves direct interaction with the patient's body for therapeutic purposes (resection, ablation, excision, coagulation, desiccation).
• Device Description: The device is an electrosurgical generator that uses high-frequency electrical current to cut and coagulate tissue during surgery.
• Lack of IVD Characteristics: An IVD device is intended for use in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.

Therefore, the Wavetronic 5000 Digital HF Surgical Unit is a surgical device used directly on a patient, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

GEI

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

The device has been tested for applicable safety requirements. The Wavetronic 5000 Digital HF Surgical Unit complies with the applicable voluntary standards for biocompatibility. As part of demonstrating safety and effectiveness of Wavetronic 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. The Wavetronic 5000 Digital HF Surgical Unit passed all testing stated above as shown by the acceptable results obtained.

Key Metrics

Not Found

Predicate Device(s)

K082834, K051956

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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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

1

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

2

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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3

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.

5

| Manufacturer | Loktal Medical Electronics
ind. E com. Ltda EPP | Ellman International, Inc. | Sometech, Inc. |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | Wavetronic 5000 Digital HF
Surgical Unit | Surgitron IEC | Dr. OPPEL ST-501 |
| 510(k)
Number | K134036 | K082834 | K051956 |
| | Image: Wavetronic | Image: Ellman | Image: Sometech |
| Product Code | GEI | GEI | GEI |
| Regulation
Number | 21 CFR 878.4400 | 21 CFR 878.4400 | 21 CFR 878.4400 |
| Regulation
Name | Electrosurgical Cutting and
Coagulation Device and
accessories | Electrosurgical Cutting and
Coagulation Device and
accessories | Electrosurgical Cutting and
Coagulation Device and
accessories |
| Indications for
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. | Non-ablative treatment of
mild to moderate facial
wrinkles and rhytides for
skin phototypes I-IV The
device is also indicated for:

• Cutting, snoring,
  submucosal palatal
  shrinkage, traditional
  uvulopalatoplasty IRAUP),
  myringotomy with effective
  hemorrhage control,
  epistaxis treatment,
  turbinate shrinkage, skin
  incisions, biopsy, cysts,
  abscesses, tumors,
  cosmetic repairs,
  development of skin flaps,
  skin tags, and
  blepharoplasty.
• Blended Cutting and
  Coagulation: snoring,
  submucosal palatal
  shrinkage, traditional
  uvulopalatoplasty (RAUP),
  myringotomy with effective
  hemorrhage control,
  epistaxis treatment,
  turbinate shrinkage, skin
  tags, papilloma keloids,
  keratosis, verrucae, basal
  cell carcinoma, nevi,
  fistulas, epithelioma,
  cosmetic repairs, cysts, | The Dr. OPPEL ST-501 is
  intended for the removal
  and destruction of skin
  legions and the coagulation
  of tissue. Non-sterile and
  reusable electrodes are
  used in conjunction with an
  electrosurgical handpiece
  and generator. |

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

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