Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator

K161134 · Bovie Medical Corporation · GEI · Jun 20, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K161134
• Device Name: Bovie Bantam/PRO Electrosurgical Generator, Bovie DERM 941 Electrosurgical Generator, Bovie DERM 942 Electrosurgical Generator
• Applicant: Bovie Medical Corporation
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use for the DERM 941 and DERM 942 is for removal and destruction of skin lesions and the coagulation of tissue. The intended use for the Bantam/PRO is for removal and destruction of skin lesions and for electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures.

Device Story

Bovie Bantam/PRO, DERM 942, and DERM 941 are low-wattage (<50W) electrosurgical generators. Devices use RF energy to perform tissue cutting, blending, coagulation, fulguration, and bipolar procedures. Bantam/PRO supports all modes; DERM 942 supports fulguration and bipolar; DERM 941 supports fulguration only. Operated by clinicians in clinical settings. Devices transform electrical input into RF output delivered via monopolar handles or bipolar forceps. Output allows physicians to vaporize, cut, or coagulate tissue for lesion removal. Bantam/PRO includes return electrode monitoring for safety. Devices are modernized versions of existing Bovie product lines.

Clinical Evidence

Bench testing only. Verification and validation included electrical functionality testing, FPGA logic validation, mechanical strength/heat resistance testing, and usability validation to ensure user needs and intended uses are met.

Technological Characteristics

Low-wattage (<50W) RF electrosurgical generators. Power input: 100-240V AC 50/60Hz. Output modes: Cut, Blend, Coagulation, Fulguration, Bipolar. Features isolated/floating or ground-referenced outputs. Designed to IEC 60601-1 (safety), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (HF surgical equipment) standards. Includes FPGA-based logic control.

Indications for Use

Indicated for removal and destruction of skin lesions and coagulation of tissue in patients requiring electrosurgical cutting, blending, coagulation, fulguration, or bipolar procedures.

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

• Aaron A950 Electrosurgical Generator (K021817)
• Aaron A900 Electrosurgical Generator (K000961)
• Bovie IDS-310 Electrosurgical Generator (K134054)

Submission Summary (Full Text)

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

June 20, 2016

Bovie Medical Corporation Mr. Brian Kunst VP, Regulatory Affairs and Quality Assurance 5115 Ulmerton Road Clearwater, Florida 33760

Re: K161134

Trade/Device Name: Bovie Bantam/Pro, Bovie Derm 941, Bovie Derm 942 Electrosurgical Generators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: April 15, 2016 Received: April 22, 2016

Dear Mr. Kunst:

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 Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) 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/ResourcesforYou/Industry/default.htm. 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

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,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director 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) K161134

#### Device Name

Bovie Bantam/PRO Electrosurgical Generator, DERM 942 Electrosurgical Generator, DERM 941Electrosurgical Generator

#### Indications for Use (Describe)

The intended use for the DERM 942 is for removal and destruction of skin lesions and the coagulation of tissue.

The intended use for the Bantam/PRO is for removal and destruction of skin lesions and for electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures.

Type of Use (Select one or both, as applicable)

| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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Image /page/3/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is a light blue color, and there is a line underlining the word. To the right of the word, there is a small "R" in a circle, indicating a registered trademark.

## GENERAL INFORMATION:

| Submitter Name: | Bovie Medical Corporation |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Establishment Registration<br>Number: | 3007593903 |
| Submitter Address: | 5115 Ulmerton Road<br>Clearwater, Florida 33760-4004<br>United States of America |
| Submitter Telephone Number: | [phone] |
| Submitter FAX Number: | [phone] |
| Contact Person: | Brian Kunst<br>Vice President, Regulatory Affairs and Quality Assurance |
| Date Prepared: | June 15, 2016 |
| DEVICE IDENTIFICATION: | |
| Proprietary Names: | Bantam/PRO Electrosurgical Generator<br>DERM 942 Electrosurgical Generator<br>DERM 941 Electrosurgical Generator |
| Common Name: | Electrosurgical Generator |
| Classification Name: | 21CFR 878.4400; Class II; Product Code GEI<br>Electrosurgical Cutting and Coagulation Device and<br>Accessories |

### Model Numbers:

| Catalog # | Description |
|-----------|--------------------------------------|
| A952 | Bantam/PRO Electrosurgical Generator |
| A942 | DERM 942 Electrosurgical Generator |
| A941 | DERM 941 Electrosurgical Generator |

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Image /page/4/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is a light blue color, and there is a line extending from the bottom of the "B" that underlines the rest of the word. There is a registered trademark symbol to the right of the "e".

Legally Marketed Predicate Device(s): K021817: Aaron A950 Electrosurgical Generator Manufacturer: Bovie Medical Corporation K000961: Aaron A900 Electrosurgical Generator Manufacturer: Bovie Medical Corporation K134054: Bovie IDS-310 Electrosurgical Generator Manufacturer: Bovie Medical Corporation

#### INTENDED USE/INDICATIONS

The intended use for the DERM 941 and DERM 942 is for removal and destruction of skin lesions and the coagulation of tissue.

The intended use for the Bantam/PRO is for removal and destruction of skin lesions and for electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures.

#### DEVICE DESCRIPTION

The Bantam/PRO performs the following functions:

Cut mode: Allows the user to utilize electrosurgical current to vaporize or cut tissue.

Blend mode: Combines cutting with hemostasis, which achieves a bloodless cut.

Coagulation mode: Is used for the destruction of tissue and hemostasis.

Fulguration mode: Allows the user to coagulate over a broad area with less tissue penetration.

Bipolar mode: Allows coagulation of tissue using forceps.

The DERM 942 has the following functions shared with the Bantam/PRO: Fulguration mode: Allows the user to coagulate over a broad area with less tissue penetration.

Bipolar mode: Allows coagulation of tissue using forceps.

The DERM 941 has only the basic Fulguration mode function.

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Image /page/5/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is a light blue color, and there is a registered trademark symbol to the right of the "e". A line extends from under the "B" to under the "e".

The DERM 942 and 941 are termed High Frequency Dessicators since they perform treatment of skin lesions. The fulguration and bipolar are termed the dessication modes. The Bantam/PRO performs treatment of skin lesions but also has the basic cut and coagulation functions of a typical electrosurgical generator. All these units are considered low wattage (<50W).

#### PERFORMANCE TESTING

Performance testing was completed to demonstrate substantial equivalence of the subject device to the predicate (K120791). The devices were subjected to the following verification and validation tests, as applicable:

| Test Category /<br>Protocol Number | Purpose | Verification Performed |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electrical<br>Verification | To verify electrical product and performance<br>specification requirements where the test<br>method is other than inspection or proof by<br>design evidence. | Perform testing required to verify the electrical<br>functionality of the generator. |
| FPGA Validation for<br>Main Board | To specify the FPGA validation procedure for<br>the logic design used in the generator. | Validate the operation of the<br>programmable systems on the main<br>board of the generator to ensure FPGA<br>design meets functional and timing<br>requirements. |
| Mechanical<br>Verification | To verify mechanical product and<br>performance specification<br>requirements | Perform testing required to verify the<br>mechanical functionality of the generator and<br>to ensure generator has adequate mechanical<br>strength and resistance to heat |
| Usability Validation | Validate the user interface of the<br>Electrosurgical Generator. | Validate that the device fulfills the<br>user needs and intended uses |

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The Bovie Bantam/PRO, DERM 942, and DERM 941 were designed in accordance with the following standards:

| International Standard | Description |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC-60601-1, Edition 3.1 | Medical Electrical Equipment - Part 1: General Requirements For<br>Safety |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements for<br>basic safety and essential performance - Collateral Standard:<br>Electromagnetic disturbances - Requirements and tests |
| IEC-60601-2-2 : 2009 | Particular requirements for the safety of high frequency surgical<br>equipment |

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## SUBSTANTIAL EQUIVALENCE SUMMARY

| | Bovie-Medical A900<br>Bovie Medical A950<br>Bovie-Medical IDS-310 | A952<br>Electrosurgical Unit | DERM 942 Electrosurgical Unit<br>DERM 941 Electrosurgical Unit |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Clinical | | | |
| Intended Use | A950- intended to be used<br>for cutting and coagulation,<br>fulguration, and bipolar<br>procedures.<br>A900: Intended for the removal<br>and destruction of skin lesions<br>and coagulation of tissue | Intended for cutting and<br>coagulation of soft tissue and<br>removal and destruction of skin<br>lesions | Intended for the removal and<br>destruction of skin lesions and<br>coagulation of tissue |
| Technical | | | |
| Source of Power | 100-240V AC 50/60Hz | 100-240V AC 50/60Hz | 100-240V AC 50/60Hz |
| Operating Principle | RF energy | RF energy | RF energy |
| Monopolar Output | A950: | A952: | DERM942/941 |
| Type | Isolated, floating - CUT, BLEND,<br>COAGULATION<br>Ground-referenced<br>FULGURATION | Isolated, floating - CUT, BLEND,<br>COAGULATION<br>Ground-referenced<br>FULGURATION | Ground-referenced<br>FULGURATION |
| Power Regulation | Dial Knob and handle up/dn<br>buttons | Dial Knob and handle up/dn<br>buttons | Dial Knob and handle up/dn<br>buttons |
| Maximum Output | A950 | | Cut, Blend, Coagulation Modes<br>not available |
| Power and Modes | 60W Monopolar Mode- Cut,<br>Blend, Coagulation | 50W Monopolar Mode- Cut,<br>Blend, Coagulation | |
| | A950<br>35W Fulguration<br>A900<br>30W Fulguration | 40W Fulguration | 40W Fulguration |
| | A950<br>30W Bipolar mode<br>A900<br>30W Bipolar mode | 40W Bipolar mode | DERM942<br>40W Bipolar mode |
| | IDS-310<br>50W Micro Bipolar mode | 40W Micro Bipolar Mode | Micro Bipolar mode not<br>available |
| | Bovie-Medical A900<br>Bovie Medical A950<br>Bovie-Medical IDS-310 | A952<br>Electrosurgical Unit | DERM 942 Electrosurgical Unit<br>DERM 941 Electrosurgical Unit |
| Neutral Electrode<br>Monitoring of<br>Ground Pad | A950 – No<br>IDS-310 - Yes | Yes | No |
| Ground Pad Type | A950 – Solid<br>IDS-310 – Solid or Split | Solid or Split | Solid |
| <b>Accessories</b> | | | |
| Monopolar Handle | Bovie-Medical A901 | Bovie-Medical A902 | Bovie-Medical A902 |
| Accessory Kit | A900, A950 - Yes | Yes | Yes |
| 2.4 Enclosure | | | |
| | A950<br>Image: [A950] | A952<br>Image: [A952] | DERM942<br>Image: [DERM942] |
| | A900<br>Image: [A900] | | DERM941<br>Image: [DERM941] |
| IEC Classification | Class I | Class I | Class I |

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## CONCLUSION

These generators are essentially a facelift and modernization of low powered generators that have been in Bovie's line for years. There is no difference between the new and the predicate devices in terms of intended use, technology, and features. All the features of the Bantam/PRO, DERM 942, and DERM 941 are present on the predicate devices. The Bantam/PRO incorporates the safety feature of return electrode monitoring which is a feature not available in the Aaron 950. There is no new technology and no difference that would raise new or different questions of safety or efficacy. Performance testing demonstrates equivalence between the proposed and predicate devices.