SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE

K082568 · Bovie Medical · GEI · Nov 17, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082568
• Device Name: SALINE ENHANCED ELECTROSURGICAL RESECTION (SEER) DEVICE
• Applicant: Bovie Medical
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Nov 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Device Story

Resection Device is a sterile, single-use electrosurgical instrument for soft tissue cutting and coagulation. Device consists of an insulated handle with a push-button RF activation switch and a saline flow control mechanism; a 10-foot power cord with a 3-prong plug; and a shaft with an electrode tip. Saline is gravity-fed from an IV bag through the handle to the electrode tip. During surgery, the clinician uses the device to deliver RF energy and saline simultaneously to the target tissue. The saline-enhanced RF delivery facilitates tissue cutting and coagulation. The device is intended for use by clinicians in a sterile surgical environment.

Clinical Evidence

Bench testing only. The device conforms to safety standard IEC 60601-2-2.

Technological Characteristics

Electrosurgical cutting and coagulation device. Components: insulated handle, saline flow control, electrode tip. Energy source: high-frequency radiofrequency (RF) current from an external electrosurgical generator. Connectivity: wired (10-foot power cord). Sterilization: ethylene oxide gas. Single-use. Conforms to IEC 60601-2-2.

Indications for Use

Indicated for cutting and coagulating soft tissue using RF current and saline in conjunction with an electrosurgical generator. 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 Solid Cylinder Monopolar Device (K014260)

Submission Summary (Full Text)

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Page 1 of 3

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

082 5568

### GENERAL INFORMATION:

# NOV 1 7 2008

510k Owner's Name Address

Bovie Medical 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs Telephone #: [phone] FAX Number: [phone]

Date Prepared:

Contact Person

September 2, 2008

# DEVICE DESCRIPTION:

Trade Name:

Common Name:

Classification Name:

Saline Enhanced Electrosurgical Resection (SEER) Device

Resection (Cutting and Coagulation) Device

Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878.4400; Class II; Product Code: GEI)

Predicate Device:

TissueLink Solid Cylinder Monopolar Device (K-01260)

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Page 2 of 3

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

#### DEVICE DESCRIPTION:

Predicate Devices:

TissueLink: Solid Cylinder Monopolar Device

K014260

#### INTENDED USE:

The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue.

#### DEVICE COMPONENTS AND OPERATION:

- 1) Insulated Handle:
The Insulated Handle encases the controlling mechanism for the flow of saline, and activation of the RF current for the device.

The activation of RF current is accomplished by a single push button on the top of the handle.

The Handle has a flow control mechanism so the flow of saline can be regulated by the user within the sterile field. The tubing length 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 of the Insulated Handle and Power Cord meets the requirements for Dielectric Withstands of Accessories.

- 2) Shaft and Electrode Tip:
The electrode tip delivers RF energy for cutting and coagulation and delivers saline which is gravity-fed from an Intravenous bag to the tip.

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# KO82568

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

Page 3 of 3

These devices use technology substantially equivalent to the TissueLink Solid Cylinder Monopolar Device (K014260). Both consist of an electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.

Resection Devices are provided sterile, sterilized using ethylene oxide gas, and are for single use only.

The Resection Device conforms to the requirements of safety standard IEC 60601-2-2.

There are no significant differences in technology, performance, or intended use between the Resection Device and the given predicate device. 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 U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The logo is black and white.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 7 2008

Bovic Medical % Mr. Richard Kozloff VP, Quality Assurance/Regulatory Affairs 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Re: K082568

Trade/Device Name: Resection Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 6, 2008 Received: November 7, 2008

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Richard Kozloff

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Prosmarket Surveillance at [phone]. For questions regarding the reporting of device adverse vents (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely yours.

Mark M. Millman

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

Enclosure

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Indications for Use

510(k) Number (if known): K082568

Device Name: Resection Device

Indications for Use:

The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the delivery of radiofrequency ("RF") current and sterile saline for cutting and coagulating soft tissue. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Prescription Use V (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)

Neil ReOphm formxm

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

**510(k) Number** K082568