(59 days)
Not Found
No
The summary describes a standard electrosurgical generator with different modes for cutting and coagulation, without any mention of AI or ML capabilities.
Yes
The device is used for the removal and destruction of skin lesions and coagulation of tissue, which are therapeutic actions.
No
The device is described as performing functions for the removal and destruction of skin lesions and the coagulation of tissue, which are therapeutic functions, not diagnostic ones.
No
The device description and performance studies clearly indicate this is a hardware device (electrosurgical generator) with various modes and functions for tissue treatment, not a software-only device. The testing includes electrical and mechanical verification, which are not applicable to software-only devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "removal and destruction of skin lesions and the coagulation of tissue" and "electrosurgical cutting, blending, coagulation, fulguration, and bipolar procedures." These are all procedures performed directly on the patient's body.
- Device Description: The description details various electrosurgical functions (Cut, Blend, Coagulation, Fulguration, Bipolar) which are methods of applying energy to tissue for therapeutic purposes.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a person's health. There is no mention of analyzing samples or providing diagnostic information based on such analysis.
The device is an electrosurgical generator used for surgical procedures on the skin.
N/A
Intended Use / Indications for Use
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.
Product codes
GEI
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.
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 (
§ 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.
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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
1
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 Registration | |
| Number: | 3007593903 |
| Submitter Address: | 5115 Ulmerton Road |
| Clearwater, Florida 33760-4004 | |
| United States of America | |
| Submitter Telephone Number: | (727) 803-8617 |
| Submitter FAX Number: | (727) 322-4465 |
| Contact Person: | Brian Kunst |
| Vice President, Regulatory Affairs and Quality Assurance | |
| Date Prepared: | June 15, 2016 |
| DEVICE IDENTIFICATION: | |
| Proprietary Names: | Bantam/PRO Electrosurgical Generator |
| DERM 942 Electrosurgical Generator | |
| DERM 941 Electrosurgical Generator | |
| Common Name: | Electrosurgical Generator |
| Classification Name: | 21CFR 878.4400; Class II; Product Code GEI |
| Electrosurgical Cutting and Coagulation Device and | |
| 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 (Accessories | | | |
| Monopolar Handle | Bovie-Medical A901 | Bovie-Medical A902 | Bovie-Medical A902 |
| Accessory Kit | A900, A950 - Yes | Yes | Yes |
| 2.4 Enclosure | | | |
| | A950
Image: [A950] | A952
Image: [A952] | DERM942
Image: [DERM942] |
| | A900
Image: [A900] | | DERM941
Image: [DERM941] |
| IEC Classification | Class I | Class I | Class I |
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Image /page/8/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".
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Image /page/9/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.
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.