HABIB ENDOHPB

K083292 · Emcision , Ltd. · KNS · Jun 10, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K083292
• Device Name: HABIB ENDOHPB
• Applicant: Emcision , Ltd.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Jun 10, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract.

Device Story

Habib EndoHPB is a single-use, sterile bipolar radiofrequency (RF) catheter; designed for endoscopic procedures. Device features two ring electrodes; introduced into the gastrointestinal tract via an endoscope biopsy channel. Connected to an external RF generator; delivers bipolar energy to target tissue. Operation performed by endoscopists; enables tissue cauterization and coagulation. Clinical benefit includes controlled tissue coagulation during endoscopic surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Bipolar RF catheter; two ring electrodes; single-use; sterile. Connects to external RF generator. Class II device per 21 CFR 876.4300.

Indications for Use

Indicated for use to assist in the coagulation of tissue during endoscopic surgical procedures in the gastrointestinal tract.

Regulatory Classification

Identification

An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.

Predicate Devices

• Habib Endoblate catheter (K072383)

Submission Summary (Full Text)

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# K083292

## SECTION 3

### Summary of Safety and Effectiveness

| Sponsor: | EMcision, Ltd. | JUN 10 2009 |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 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 | |
| Summary Prepared: | 2007-05-01 | |
| Trade Name: | Habib EndoHPB | |
| Common Name: | Endoscopic Electrosurgical Unit | |
| Classification: | Class II per 21 CFR 876.4300 | |
| Product Code: | Gastroenterology-Urology (GU)<br>KNS | |
| Predicate Device:<br>(K072383.) | Habib Endoblate catheter manufactured by EMcision Ltd | |

#### Intended Use:

The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract.

### Description:

The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy.

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## SECTION 3

#### Summary of Safety and Effectiveness

The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.

Technological Differences:

The Habib EndoHPB has the same basic technological characteristics as the Habib Endoblate. Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.

Performance Data:

Performance testing was undertaken to ensure that the Habib EndoHPB 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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2009

EMcision Ltd. % Mr. Morten Simon Christensen Staff Engineer & FDA Office Coordinator Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA. 95131

Re: K083292

Trade/Device Name: Habib EndoHPB

Regulation Number: 21 CFR 876.4300

Regulation Name: Endoscopic electrosurgical unit and accessories

Regulatory Class: II Product Code: KNS Dated: May 20, 2009 Received: May 26, 2009

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.

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 (OS) regulation (21 CFR Part 820); and if avplicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2

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 one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological 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)

Not yet Allocated

Device Name

Habib EndoHPB

The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ OR Over the Counter Use X

(per 21 CFR 878.4400)

Coles n Pollard

(Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Habib EndoHPB 510(k) Section 2, Indications for Use Statement Revision 2 2009-06-09 EMcision, Ltd. Page 2-1