HABIB LAPAROSCOPIC HEXABLATE

K073687 · Emcision , Ltd. · GEI · Jan 9, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K073687
• Device Name: HABIB LAPAROSCOPIC HEXABLATE
• Applicant: Emcision , Ltd.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 9, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The Habib Laparoscopic Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures.

Device Story

Habib Laparoscopic Hexablate is a bipolar radiofrequency (RF) electrosurgical device for tissue coagulation during laparoscopic surgery. Device comprises a handle, laparoscopic shaft, introducer, and an array of seven parallel electrodes (six in a ring, one central). Device connects to an RF generator via a switch unit. During surgery, electrodes are inserted into tissue; RF power is applied to coagulate the target area. Central electrode provides aspiration to remove fluids and gases from the coagulation zone. Introducer allows passage through standard 12mm laparoscopic ports. Device is single-use. Physician operates device during laparoscopic procedures to achieve hemostasis or tissue coagulation, potentially reducing intraoperative bleeding and improving surgical outcomes.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bipolar RF electrosurgical device. Seven-electrode array (6 outer, 1 central) deploying to 20mm diameter. Includes laparoscopic shaft, handle, and introducer for 12mm port compatibility. Features integrated aspiration through the central electrode. Single-use. Energy source: external RF generator.

Indications for Use

Indicated for use in laparoscopic intraoperative surgical procedures to assist in tissue coagulation. Prescription use only.

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

• Habib Hexablate (K071103)
• Habib 4X Laparoscopic (K062935)

Submission Summary (Full Text)

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SECTION 3 Summary of Safety and Effectiveness

| Sponsor: | EMcision, Ltd. | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact Person: | Nagy Habib, MD<br>Chief Executive Officer<br>Liver Surgery Section, Hammersmith Hospital<br>Du Cane Road<br>London, W12 0NN<br>United Kingdom | JAN - 9 2008 |
| Summary Prepared: | August 20, 2007 | |
| Trade Name: | Habib Laparoscopic Hexablate | |
| Common Name: | Electrosurgical cutting and coagulation device and accessories | |
| Classification: | Class II per 21 CFR 878.4400 | |
| Product Code: | GEI | |
| Predicate Devices: | Habib Hexablate (K071103) - EMcision<br>Habib 4X Laparoscopic (K062935) RITA Medical | |

Intended Use:

The Habib Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures.

# Description:

The Habib Laparoscopic Hexablate is a bipolar radiofrequency (RF) device that consists of a handle, laparoscopic shaft and introducer and an array of seven parallel electrodes which extend out from the laparoscopic shaft. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Laparoscopic Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Laparoscopic Hexablate is designed for use in laparoscopic surgery and is a single use device.

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#### Technological Differences:

The Habib Laparoscopic Hexablate has the same basic technological characteristics as the Habib Hexablate (K071103). Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue. The primary difference is that the Habib Laparoscopic Hexablate is used via a laparoscopic port. The size and shape of the coagulation zone created by each device is similar. Both devices uses aspiration through the center electrode to remove fluids and gases from the center of the coagulation zone.

The Laparoscopic Hexablate is fitted with an introducer which allows the electrodes to pass through a standard Ø12mm laparoscopic port without damaging the seals.

The Habib 4X Laparoscopic (K062935) has the same basic technological characteristics as the Habib Laparoscopic Hexablate. Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue during laparoscopic procedures. The primary difference is that the Habib 4X Laparoscopic and the Habib Laparoscopic Hexablate is the number of electrodes. The Habib 4X Laparoscopic has 4 electrodes on a fixed 10mm diameter, whilst the Habib Laparoscopic has 7 electrodes (six outer array and 1 centre) which deploy upon exit of the introducer port to 20mm diameter.

## Performance Data:

Performance testing was done to ensure that the Habib Laparoscope Hexablate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol to the right, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular fashion around the bird. The bird symbol is composed of three curved lines that suggest the shape of a bird in flight. The logo is in black and white.

Public Health Service

JAN - 9 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EMcision, Ltd % Underwriters Laboratories, Inc. Mr. Morten Simon Christensen 455 East Trimble Road San Jose, California 95131

Re: K073687

Trade/Device Name: Habib Laparoscopic Hexablate Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 27, 2007 Received: December 28, 2007

Dear Mr. Christensen:

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 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. Morten Simon Christensen

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 Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (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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# SECTION 2 Indications for Use Statement

Indications For Use Statement

510(K) Number (if known) *K073687*

Device Name

Habib Laparoscopic Hexablate

The Habib Laparoscopic Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures

Prescription Use ﻬﺎ OR Over the Counter Use __ (per 21 CFR 801.109)

PLEASE DO NO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

MD, MPH
Division of General, Restorative,
and Neurological Devices

510(k) Number

1<073687

Habib Laparoscopic Hexablate 510(k) Section 2, Indications for Use Statement

Revision 1