KLS MARTIN ELECTROSURGICAL INSTRUMENTS

K082505 · Kl Martin L.P. · GEI · Jun 12, 2009 · General, Plastic Surgery

Device Facts

• Record ID: K082505
• Device Name: KLS MARTIN ELECTROSURGICAL INSTRUMENTS
• Applicant: Kl Martin L.P.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 12, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures. KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures. KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures. KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue. KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.

Device Story

Electrosurgical instruments (forceps, scissors, cables) used in general, gynecological, and laparoscopic surgery; operated by surgeons. Devices receive electrical power from external bipolar electrosurgical generators; transmit current to tissue via insulated instruments to perform cauterization, coagulation, cutting, or dissection. Instruments feature various shapes/sizes for surgical efficiency. Output is thermal effect on tissue; aids in hemostasis and tissue separation. Benefits include precise tissue manipulation and coagulation during procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Bipolar electrosurgical instruments including forceps, scissors, and cables. Insulated construction to isolate user from electrical current. Designed for use with bipolar electrosurgical generators. Variety of shapes and sizes available.

Indications for Use

Indicated for patients undergoing general, gynecological, or laparoscopic surgical procedures requiring tissue grasping, dissection, cutting, or bipolar coagulation. Contraindicated for tubal sterilization or tubal coagulation for sterilization procedures.

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

• Claris Non-Stick Bipolar Forceps (K051429)
• BiTech Bipolar Scissors (K042077)
• POWERGRIP Bipolar Coagulation Forceps (K033177)
• Bissinger Cables (K981919)
• Detachable Bipolar Coagulation Bissinger Forceps (K970968)

Submission Summary (Full Text)

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JUN 1 2 2009

## 510(K) SUMMARY

Submitter:

.

Contact Person:

Date of Summary:

Device Name:

Trade Name:

Common Name:

Classification Name and Number:

Regulatory Class:

Predicate Devices:

Intended Use:

KLS-Martin, L.P. 11239-1 St. Johns Industrial Parkway South Jacksonville, FL 32246 Phone: [phone] Fax: [phone]

Tom Faucett Product Marketing Liaison

18 May 2009

Electrosurgical Instruments

KLS Martin Electrosurgical Instruments

Electrosurgical, Cutting & Coagulation & Accessories

Electrosurgical, Cutting & Coagulation & Accessories (CFR 878.4400)

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Claris Non-Stick Bipolar Forceps (K051429)

BiTech Bipolar Scissors (K042077)

POWERGRIP Bipolar Coagulation Forceps (K033177)

Bissinger Cables (K981919)

Detachable Bipolar Coaqulation Bissinger Forceps (K970968)

KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.

KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar

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Kof.ros

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coagulation of tissue during general, gynecology and laparoscopic surgical procedures.

KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.

KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.

KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures

KLS Martin Electrosurqical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurqical generator to a bipolar instrument.

The KLS Martin Electrosurgical Instruments are surgical instruments that allow the surgeon to cauterize and coagulate tissue by passing a electrical current that is provided by a electrosurgical generator. The instruments are insulated to isolate the user from the current. The KLS Martin Electrosurgical Instruments are manufactured in a variety of shapes and sizes to allow the operating surgeon choices for optimum efficiency.

## Technological Characteristics:

#### Similarities to Predicate:

The KLS Martin Electrosurgical Instruments are identical in design, manufacturing, material and operation to the Claris Non-Stick Bipolar Forceps (K051429), BiTech Bipolar Scissors (K042077), POWERGRIP Bipolar Coagulation Forceps (K033177), Bissinger Cables

Device Description:

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(K981919) and Bissinger Detachable Bipolar Coagulation Forceps (K970968).

### Substantial Equivalence:

5.3

Due to identical operating aspects, the design, the ability to be utilized with multiple generators and the same manufacturing facility as the Claris Non-Stick Bipolar Forceps (K051429), BiTech Bipolar Scissors (K042077), POWERGRIP Bipolar Coagulation Forceps (K033177), Bissinger Cables (K981919) and Bissinger Detachable Bipolar Coagulation Forceps (K970968) and have the same indications for use leads to the decision that the KLS Martin Electrosurgical Instruments are substantially equivalent to the predicate devices.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized shapes resembling birds in flight, arranged in a descending order of size.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 2 2009

KLS Martin L.P. % Mr. Tom Faucett Product Marketing Liaison 11239-1 St. Johns Industrial Parkway South Jacksonville, Florida 32246

Re: K082505

Trade/Device Name: KLS Martin Electrosurgical Instruments Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: April 28, 2009 Received: May 21, 2009

Dear Mr. Faucett:

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

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Page 2-Mr. Faucett

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

F.A. Dalla

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

Enclosure

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082505

# Indications for Use

#### K082505 510(k) Number (if known):

Device Name:

#### KLS Martin Electrosurgical Instruments

Indications For Use:

Indications For Use: KLS Martin Bipolar Scissors are intended for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.

> KLS Martin Bipolar Instruments with Handles and Exchangeable Electrodes are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gyneoology and laparoscopic surgical procedures.

> KLS Martin marLap Bipolar Coagulation instruments are intended for grasping, dissecting, cutting and bipolar coagulation of tissue during general, gynecology and laparoscopic surgical procedures.

> KLS Martin Bipolar Forceps/Non-Stick are design to grasp, manipulate and coagulate selected tissue.

KLS Martin Electrosurgical Instruments have not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures

KLS Martin Electrosurgical cables are intended for use in electrosurgical procedures to provide transmission of electrical power from the bipolar electrosurgical generator to a bipolar instrument.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

urrence of CDRH, Office of Device Evaluation (ODE)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082505

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