CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)

K121441 · Bovie Medical Corporation · HQP · Jul 20, 2012 · Ophthalmic

Device Facts

• Record ID: K121441
• Device Name: CAUTERY; LOW TEMPERATURE (FINEADJUSTABLE FINE TIP, ELONGATED FINE TIP, MICRO FINE TIP)
• Applicant: Bovie Medical Corporation
• Product Code: HQP · Ophthalmic
• Decision Date: Jul 20, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4115
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

Device Story

Single-use, battery-operated cautery device; used for hemostasis by stopping small bleeders. Operation: user presses green button to complete internal circuit; power from 1.5V alkaline batteries heats cautery tip; heated tip vaporizes water in blood/tissue to induce clotting. Used in clinical settings; operated by healthcare professionals. Safety features: recessed activation button prevents accidental activation; removable battery pack allows for battery recycling and prevents post-disposal activation. Device eliminates separate cautery head component by embedding tip tubes directly into ABS handle. Benefits: provides effective hemostasis with improved safety features for disposal and handling.

Clinical Evidence

Bench testing only. No clinical data provided. Substantial equivalence is based on design, material, and functional comparisons to legally marketed predicate devices.

Technological Characteristics

Single-use, battery-operated thermal cautery. Materials: Nichrome 80 and Kanthal A-1 (tips), Acrylonitrile Butadiene Styrene (ABS) (handle). Energy: 1.5V alkaline batteries. Sterilization: Ethylene Oxide (SAL 10^-6). Design: Recessed activation button, removable battery pack, integrated tip tubes.

Indications for Use

Indicated for stopping small bleeders in hemostasis and other similar uses in patients requiring cauterization.

Regulatory Classification

Identification

A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.

Predicate Devices

• Various Hand Held, Battery Operated Cautery Devices (K945757, K945765, K945492, K945764, K810909, K810017, K945760, K945759, K945493, K945762, K945763)

Submission Summary (Full Text)

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JUL 20 2012

K 121441

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## 510(k) SUMMARY

## (As Required per 21 CFR 807.92(c))

Bovie Medical Corporation

#### GENERAL INFORMATION:

510k Owner's Name

Address

Telephone Number: FAX Number:

Contact Person

5115 Ulmerton Road Clearwater, Florida 33760-4004 [phone] [phone]

Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs

Date Prepared:

May 9, 2012

### DEVICE DESCRIPTION:

| Trade Name: | Bovie® Cautery Device |
|----------------------|------------------------------------------------------------------------------------------------------|
| Common Name: | Battery Operated Cautery; Cauterizer |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and<br>Accessories |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed | |
| Predicate Device(s): | Various Hand Held, Battery Operated Cautery Devices<br>(K945757, K945765, K945492, K945764, K810909) |

K810017, K945760, K945759, K945493, K945762, K945763)

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### 510(k) SUMMARY

. Pge 2 of 3

(As Required per 21 CFR 807.92(c))

### DEVICE FUNCTION, TECHNOLOGY, AND INTENDED USE:

Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.

Cautery device technology remains mostly unchanged from those manufactured and sold over the last 30 years. These devices incorporate one or two 1.5 volt batteries as a power source and an internal conductor strip to direct power to the tip. The devices that are the subject of this submission have been designed with additional safety enhancements, including a recessed activation button (to prevent inadvertent activation if the device is placed on a surface without the protective cap in place) and easily removable batteries that prevents activation of the device after its disposal. The batteries may also be recycled rather than discarded in the user facility biohazard waste stream. Safety enhancements were made to prevent inadvertent device activation in the event that the user does not comply with the recommended disposal instructions after use.

Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared. The patient contacting tip component and the cautery handle materials remain the same. Cautery tip configurations (shapes) are also unchanged from those previously cleared. A change to improve manufacturability was made to eliminate the cautery head component and to install cautery tip tubes directly into the cautery handle. The previous cautery head design was not patient contacting. Warnings and Cautionary labeling are carried through to the new design. Device packaging is also unchanged.

#### INTENDED USE:

Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

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## 510(k) SUMMARY

Page 3 of 3

# (As Required per 21 CFR 807.92(c))

| Characteristics | Bovie® Cauteries | Battery Operated Cauteries |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | (This Submission) | (Various Submissions) |
| Indications for<br>Use | Bovie® Cautery Devices are<br>used for stopping small<br>bleeders in hemostasis and<br>other similar uses. | Used for stopping small<br>bleeders in hemostasis and<br>other similar uses. |
| Disposal<br>Instructions | Cut tip or remove tip using<br>hemostats. Replace the cover<br>cap to prevent button<br>activation.<br><br>Twist the battery<br>compartment to remove and<br>separate batteries. | Cut tip or remove tip using<br>hemostats. Replace the cover<br>cap to prevent button<br>activation. |
| Sterility | Single Use; Sterilized by<br>Ethylene Oxide; Sterility<br>Assurance Level of 10-6. | Single Use; Sterilized by<br>Ethylene Oxide; Sterility<br>Assurance Level of 10-6. |
| Design for<br>Safety | Easily removal battery pack<br>and recessed activation<br>button. | Non-removable batteries and<br>non-recessed activation<br>button. |
| Materials | Patient contacting tips<br>constructed of Nichrome 80<br>and Kanthal A-1. Cautery<br>handles constructed of<br>Acrylonitrile Butadiene<br>Styrene (ABS). | Patient contacting tips<br>constructed of Nichrome 80<br>and Kanthal A-1. Cautery<br>handles constructed of<br>Acrylonitrile Butadiene<br>Styrene (ABS). |
| | Cautery tip tubes are<br>embedded in the handle. | Cautery tip tubes are<br>embedded in a Delrin®<br>cautery head that is placed<br>into the handle. |
| Energy Source | Device is powered by one or<br>two 1.5 volt alkaline<br>batteries. | Device is powered by one or<br>two 1.5 volt alkaline batteries. |

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

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

Bovie Medical Corporation % Mr. Richard Kozloff Vice President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760

JUL 2 0 2012

Re: K121441

Trade/Device Name: Bovie® Cautery Device Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal cautery unit Regulatory Class: Class II Product Code: HQP Dated: July 05, 2012 Received: July 06, 2012

Dear Mr. Kozloff:

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 (reporting of medical

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#### Page 2- Mr. Richard Kozloff

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/icm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sincerely, yours,

Erich Keith

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K121441

Device Name: Bovie® Cautery Device

Indications for Use:

Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.

Neil R.P. Ogle Forman

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number j<12144(

Prescription Use く (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)