BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215

K092149 · Bovie Medical · GEI · Mar 18, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092149
• Device Name: BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215
• Applicant: Bovie Medical
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Mar 18, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are sterile. single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

Device Story

Sterile, single-use bipolar electrosurgical device; delivers RF energy and gravity-fed saline to operative site for tissue/bone coagulation. Components: insulated handle, shaft, electrode tip. Saline flow regulated via handle mechanism and roller clamp; RF activation via footswitch. Used in OR by surgeons for orthopedic, spine, endoscopic, abdominal, and thoracic procedures. Device connects to external RF generator and IV saline bag. Coagulation effect achieved through combined RF energy and saline delivery; benefits include controlled hemostasis during surgery.

Clinical Evidence

No clinical data provided. Substantial equivalence based on technological characteristics and performance comparisons to predicate devices.

Technological Characteristics

Bipolar electrosurgical device; sintered steel electrode tip; insulated handle/shaft. Energy source: RF generator. Connectivity: 3-prong electrical plug, IV tubing for gravity-fed saline. Sterilization: Ethylene oxide gas. Configurations: straight, angled, and laparoscopic shafts. Conforms to IEC 60601-2-2.

Indications for Use

Indicated for coagulation of soft tissue and bone in orthopedic, spine, endoscopic, abdominal, and thoracic surgical procedures. Contraindicated for contraceptive tubal coagulation.

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

• TissueLink: Aquamantys 2.3 Bipolar Sealer (K-052859)
• TissueLink: Aquamantys 6.0 Bipolar Sealer (K-052859)
• Aquamantys SS4.0 Bipolar Sealer (K-063639)

Submission Summary (Full Text)

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# 510(k) SUMMARY (per CFR21 807.92(c))

## GENERAL INFORMATION:

# MAR 1 8 2010

| 510k Owner's Name | Bovie Medical |
|-------------------|------------------------------------------------------|
| Address | 5115 Ulmerton Road |
| | Clearwater, Florida 33760-4004 |
| Contact Person | Richard A. Kozloff |
| | Vice-President; Quality Assurance/Regulatory Affairs |
| | Telephone #: [phone] |
| | FAX Number: [phone] |
| Date Prepared: | March 9, 2010 |

DEVICE DESCRIPTION:

| Trade Name: | BOSS Bipolar Operative Saline-Enhanced Sintered Steel<br>Coagulation Device |
|----------------------|---------------------------------------------------------------------------------------------------------------------|
| Common Name: | Resection (Cutting and Coagulation) Device |
| Classification Name: | Electrosurgical Cutting and Coagulation Devices and<br>Accessories (21CFR 878.4400; Class II;<br>Product Code: GEI) |

## DEVICE DESCRIPTION:

Predicate Devices:

TissueLink: Aquamantys 2.3 Bipolar Sealer

K-052859

TissueLink: Aquamantys 6.0 Bipolar Sealer K-052859

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#### 510(k) SUMMARY (per CFR21 807.92(c))

#### INTENDED USE:

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are sterile. single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

#### DEVICE COMPONENTS AND OPERATION:

- 1) Insulated Handle:
The Insulated Handle encases the shaft and tip and one of the controlling mechanisms for the flow of saline. The activation of RF current is accomplished by footswitch.

There are two flow control mechanisms so the flow of saline (one directly on the handle and a roller clamp just proximal to the handle). Saline flow can be regulated by the user within the sterile field. The saline delivery tubing is approximately ten (10) feet in length and incorporates an I.V. spike on the end to attach directly to a hanging IV (saline) bag.

The Handle power cord is approximately ten (10) feet in length and incorporates a 3-prong electrical plug.

The insulation on the Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

- 2) Shaft and Electrode Tip:
The electrode tip delivers RF energy for coagulation and delivers saline which is gravity-fed from an intravenous bag to the tip. There are three handle shape configurations: straight shaft, angled shaft, and laparoscopic shaft. Each is constructed of the same materials.

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## 510(k) SUMMARY (per CFR21 807.92(c))

These devices use technology substantially equivalent to the Aquamantys SS4.0 Bipolar Sealer (K-063639) and the Aquamantys 6.0 Bipolar Sealer (K-052859). Both consist of an electrode tip that is used to coagulate tissue through the utilization of high frequency radiofrequency energy and saline.

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

These devices conform to the requirements of safety standard IEC 60601-2-2. There are no significant differences in technology, performance, or intended use between BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation devices and predicate devices. There are no new questions raised regarding safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

# MAR 1 8 2010

Bovie Medical % Mr. Richard A. Kozloff Vice - President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004

Re: K092149

Trade Name: BOSS Bipolar Operative Saline-Enhanced Sintered Steel) Coagulation Device

Regulation Number: 21 CFR 878.4400

Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: March 9, 2010 Received: March 10, 2010

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

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### Page 2 - Mr. Richard A. Kozloff

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical 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/ucm115809.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,

Mark N. Melkerson

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

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#### Indications for Use

510(k) Number (if known):

Device Name: BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Device

Indications for Use:

BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Devices are sterile, single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopedic, spine, endoscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Prescription Use イ (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

FOR M. MELKERSON

Sien Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092149