LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L

K091440 · Bovie Medical · GEI · Oct 9, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K091440
• Device Name: LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L
• Applicant: Bovie Medical
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 9, 2009
• 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 laparoscopic 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

Laparoscopic electrosurgical device; delivers RF current and gravity-fed sterile saline to soft tissue for cutting and coagulation. Components: insulated handle with saline flow control and RF activation button; 32cm shaft with sintered stainless steel electrode tip. Operated by physician in laparoscopic procedures; requires electrosurgical generator and IV saline bag. Device provides localized energy/saline delivery to target tissue; facilitates surgical resection/hemostasis. Single-use; sterile.

Clinical Evidence

Bench testing only.

Technological Characteristics

Sintered stainless steel electrode tip; RF energy source; 32cm shaft; 10ft tubing/power cord; sterile, single-use; ethylene oxide sterilization; conforms to IEC 60601-2-2.

Indications for Use

Indicated for laparoscopic cutting and coagulation of soft tissue using RF current and saline. Contraindicated for contraceptive tubal coagulation (permanent female sterilization).

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

• Bovie Medical Resection Device (K-082568)

Submission Summary (Full Text)

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KOSIYUO

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

#### GENERAL INFORMATION:

# OCT - 9 2009

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

May 12, 2009

# DEVICE DESCRIPTION:

Trade Name:

Common Name:

Classification Name:

Laparoscopic 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:

Bovie Medical Resection Device (K-082568)

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

#### INTENDED USE:

The Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic 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.

> The electrode shaft measures 32 centimeters (12.6 inches) in length and is intended to be placed through a cannula with a minimum diameter of 10 millimeters..

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

This device use technology substantially equivalent to the Bovie Medical Resection Device (K-082568). Both consist of a sintered stainless steel electrode tip that is used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy. The difference between the two devices is that the predicate device is used for open surgical procedures and the Laparoscopic Resection Device is used for laparoscopic procedures.

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

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

There are no significant differences in technology, intended use, or performance between the Laparoscopic 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 three stripes representing the department's mission. 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 Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Bovie Medica Inc. % Mr. Richard Kozloff 7100 30th Avenue North Saint Petersburg, Florida 33710

OCT - 9 2009

Re: K091440

Trade/Device Name: Laparoscopic Resection Device, model sr326L Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 21, 2009 Received: August 25, 2009

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.

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 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.

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### Page 2- Mr. Richard Kozloff

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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

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

Enclosure

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# Indications for Use

510(k) Number (if known):

Laparoscopic Resection Device Device Name:

Indications for Use:

The Laparoscopic Resection Device is a sterile, single use electrosurgical device intended to be used in conjunction with an electrosurgical generator for the laparoscopic 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 (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)

Division Sign Off

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

510(k) Number K091440