(59 days)
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.
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.
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.
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).
This document is a 510(k) premarket notification for electrosurgical generators and does not describe a study involving an AI device or its acceptance criteria. Therefore, most of the requested information regarding AI device performance, sample sizes, ground truth establishment, or expert evaluation methods is not applicable.
The document focuses on demonstrating substantial equivalence of the new Bovie Bantam/PRO, Bovie Derm 941, and Bovie Derm 942 Electrosurgical Generators to legally marketed predicate devices.
Here's the information that is available from the provided text, adapted to the closest relevant categories:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Purpose | Verification Performed |
|---|---|---|
| Electrical Verification | To verify electrical product and performance specification requirements where the test method is other than inspection or proof by design evidence. | Perform testing required to verify the electrical functionality of the generator. |
| FPGA Validation for Main Board | To specify the FPGA validation procedure for the logic design used in the generator. | Validate the operation of the programmable systems on the main board of the generator to ensure FPGA design meets functional and timing requirements. |
| Mechanical Verification | To verify mechanical product and performance specification requirements. | Perform testing required to verify the mechanical functionality of the generator and to ensure generator has adequate mechanical strength and resistance to heat. |
| Usability Validation | Validate the user interface of the Electrosurgical Generator. | Validate that the device fulfills the user needs and intended uses. |
No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc., for an AI device) are reported in this document beyond verification that the devices pass these tests and meet relevant standards. The conclusion states that "Performance testing demonstrates equivalence between the proposed and predicate devices," implying successful completion of these tests.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is not a study assessing an AI device on a test set of data. The "test set" here refers to the physical devices being tested.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth in the context of an AI device is not relevant here. The "ground truth" for these electrosurgical generators would be their functional specifications and safety standards.
4. Adjudication Method for the Test Set
Not applicable, as this is not a study with expert adjudication of data.
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. This document does not describe an AI device or an MRMC study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance is established by adherence to recognized international standards and specifications for electrosurgical equipment. The document explicitly lists:
- IEC-60601-1, Edition 3.1: Medical Electrical Equipment - Part 1: General Requirements For Safety
- IEC 60601-1-2:2007: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- IEC-60601-2-2 : 2009: Particular requirements for the safety of high frequency surgical equipment
8. The Sample Size for the Training Set
Not applicable. This is not an AI device trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a serpent entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
| 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 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 RegistrationNumber: | 3007593903 |
| Submitter Address: | 5115 Ulmerton RoadClearwater, Florida 33760-4004United States of America |
| Submitter Telephone Number: | (727) 803-8617 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Brian KunstVice President, Regulatory Affairs and Quality Assurance |
| Date Prepared: | June 15, 2016 |
| DEVICE IDENTIFICATION: | |
| Proprietary Names: | Bantam/PRO Electrosurgical GeneratorDERM 942 Electrosurgical GeneratorDERM 941 Electrosurgical Generator |
| Common Name: | Electrosurgical Generator |
| Classification Name: | 21CFR 878.4400; Class II; Product Code GEIElectrosurgical Cutting and Coagulation Device andAccessories |
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 /Protocol Number | Purpose | Verification Performed |
|---|---|---|
| ElectricalVerification | To verify electrical product and performancespecification requirements where the testmethod is other than inspection or proof bydesign evidence. | Perform testing required to verify the electricalfunctionality of the generator. |
| FPGA Validation forMain Board | To specify the FPGA validation procedure forthe logic design used in the generator. | Validate the operation of theprogrammable systems on the mainboard of the generator to ensure FPGAdesign meets functional and timingrequirements. |
| MechanicalVerification | To verify mechanical product andperformance specificationrequirements | Perform testing required to verify themechanical functionality of the generator andto ensure generator has adequate mechanicalstrength and resistance to heat |
| Usability Validation | Validate the user interface of theElectrosurgical Generator. | Validate that the device fulfills theuser needs and intended uses |
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Image /page/6/Picture/0 description: The image shows the word "Bovie" in a stylized, cursive font. The word is rendered in a light blue color. A registered trademark symbol is located to the right of the word.
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 ForSafety |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General requirements forbasic safety and essential performance - Collateral Standard:Electromagnetic disturbances - Requirements and tests |
| IEC-60601-2-2 : 2009 | Particular requirements for the safety of high frequency surgicalequipment |
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SUBSTANTIAL EQUIVALENCE SUMMARY
| Bovie-Medical A900Bovie Medical A950Bovie-Medical IDS-310 | A952Electrosurgical Unit | DERM 942 Electrosurgical UnitDERM 941 Electrosurgical Unit | |
|---|---|---|---|
| Clinical | |||
| Intended Use | A950- intended to be usedfor cutting and coagulation,fulguration, and bipolarprocedures.A900: Intended for the removaland destruction of skin lesionsand coagulation of tissue | Intended for cutting andcoagulation of soft tissue andremoval and destruction of skinlesions | Intended for the removal anddestruction of skin lesions andcoagulation 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,COAGULATIONGround-referencedFULGURATION | Isolated, floating - CUT, BLEND,COAGULATIONGround-referencedFULGURATION | Ground-referencedFULGURATION |
| Power Regulation | Dial Knob and handle up/dnbuttons | Dial Knob and handle up/dnbuttons | Dial Knob and handle up/dnbuttons |
| Maximum Output | A950 | Cut, Blend, Coagulation Modesnot available | |
| Power and Modes | 60W Monopolar Mode- Cut,Blend, Coagulation | 50W Monopolar Mode- Cut,Blend, Coagulation | |
| A95035W FulgurationA90030W Fulguration | 40W Fulguration | 40W Fulguration | |
| A95030W Bipolar modeA90030W Bipolar mode | 40W Bipolar mode | DERM94240W Bipolar mode | |
| IDS-31050W Micro Bipolar mode | 40W Micro Bipolar Mode | Micro Bipolar mode notavailable | |
| Bovie-Medical A900Bovie Medical A950Bovie-Medical IDS-310 | A952Electrosurgical Unit | DERM 942 Electrosurgical UnitDERM 941 Electrosurgical Unit | |
| Neutral ElectrodeMonitoring ofGround Pad | A950 – NoIDS-310 - Yes | Yes | No |
| Ground Pad Type | A950 – SolidIDS-310 – Solid or Split | Solid or Split | Solid |
| Accessories | |||
| Monopolar Handle | Bovie-Medical A901 | Bovie-Medical A902 | Bovie-Medical A902 |
| Accessory Kit | A900, A950 - Yes | Yes | Yes |
| 2.4 Enclosure | |||
| A950Image: [A950] | A952Image: [A952] | DERM942Image: [DERM942] | |
| A900Image: [A900] | DERM941Image: [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.
§ 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.