COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE

K050578 · Cook Ireland, Ltd. · KNS · Apr 22, 2005 · Gastroenterology, Urology

Device Facts

• Record ID: K050578
• Device Name: COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE
• Applicant: Cook Ireland, Ltd.
• Product Code: KNS · Gastroenterology, Urology
• Decision Date: Apr 22, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Duette™ Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.

Device Story

Duette™ Multi-Band Mucosectomy Device is an endoscopic accessory used for mucosal resection in the upper gastrointestinal tract. The device consists of a ligation component featuring a barrel with latex bands and a ligator handle. The barrel attaches to the distal end of an endoscope; the operator actuates the handle to deploy bands for tissue ligation. The barrel design accommodates the introduction of an electrosurgical snare to perform endoscopic mucosal resection. The device is used by clinicians in a clinical setting to facilitate the removal of mucosal tissue.

Clinical Evidence

Non-clinical testing was performed on characteristics and operational functions to verify safety and performance. No clinical data provided.

Technological Characteristics

Device consists of a ligation barrel with latex bands and a ligator handle. Designed for attachment to the distal end of an endoscope. Accommodates electrosurgical snares. Mechanical operation.

Indications for Use

Indicated for endoscopic mucosal resection in the upper 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

• Olympus Distal Attachment (MH and MAJ models) for Endoscopic Mucosal Resection (K984358)

Submission Summary (Full Text)

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# COOK®

K050578
nd Ltd. Page 1 of 2

Cook Ireland L O'Halloran Road National Technological Park Limerick, IRELAND Phone: [phone] Fax: [phone] www.cookgroup.com

## 510(k) Summary

### SPONSOR:

Cook Ireland Ltd. O'Halloran Road, National Technology Park, Limerick, Ireland

## Contact Submitter:

Emmett Devereux QA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick, Ireland Phone: [phone] Fax: [phone] Email: [e-mail]

March 4, 2005 Date of Submission: Duette™M Device: Cook Ireland Duette TM Multi-Band Trade Name: Mucosectomy Device Common/Usual Name: Mucosectomy Device/EMR Device Endoscope and Accessories. 21 CFR§ 876.1500, Class: 78 KOG Predicate Device: Olympus Distal Attachment (MH and MAJ models) for Endoscopic Mucosal Resection, K984358 The Duette™ Multi-Band Mucosectomy Device Intended Use: is intended for endoscopic mucosal resection in

the upper gastrointestinal tract.

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# COOK

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### Device Description:

The Duette TM Multi-Band Mucosectomy Device has a ligation component consisting of a barrel with latex bands and a Ligator handle. This barrel is attached to the distal end of an endoscope and bands are deployed by actuating the handle. The barrel allows introduction of an electrosurgical snare for endoscopic therapies.

#### Comparison of Characteristics:

The subject device is similar with respect to intended use and/or design features to the predicate devices in terms of section 510(k) substantial equivalence.

### Test Data:

Non-Clinical testing was performed on characteristics and operational functions of the Duette™ Multi-Band Mucosectomy Device deemed necessary to verify safety and performance.

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Image /page/2/Picture/2 description: The image shows a circular logo with a stylized bird design in the center. The bird is depicted with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged around the upper half of the circle, following its curvature. The logo appears to be a simplified representation of the U.S. Department of Health and Human Services seal.

APR 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Emmett Devereux QA/RA Manager Cook Ireland Limited O'Halloran Road National Technology Park Limerick IRELAND

Re: K050578

R050578
Trade/Device Name: Duette™ Multi-Band Mucosectomy Device Regulation Number: 21 CFR® 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: KOG Dated: March 4, 2005 Received: March 7, 2005

Dear Mr. Devereux:

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 the enorosate) to 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 do not require apperal controls provisions of the Act. The general controls provisions of the Act device, subjoct to 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 (Premarket n your de rise is chase to such additional controls. Existing major regulations affecting your Apploral), It the 700 book 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 I Rase be actison that your device complies with other requirements of the Act or any FOA has made a decemination alla your crederal agencies. You must comply with all the I caral stares and regulating, but not limited to registration and listing (21 CFR Part 807); labeling Act 3 requirements, moduler on and in the practice requirements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you'lo begin mancung your avence of your device to a legally premarket notification. The PDA mainly of backamal 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 If you desire specific advice for your device on our laboring numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxxx<br>21 CFR 884.xxxx | (Gastroenterology/Renal/Urology)<br>(Obstetrics/Gynecology)<br>ﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ<br>(Radiology) | 240-276-0115<br>240-276-0115<br>240-276-0120 |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| 21 CFR 892.xxxx<br>Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premaket notification the Also, please note the regulation entimed, "Thisoration on your responsibilities under the Act from the 807.97). You may outlain other general missistance at its toll-free number (800)
Division of Small Manufacturers, International and Consumer Assistance at Manufacturers and Division of Small Manufactures, International and Collection://www.fda.gov/cdrh/dsmadsmamain.html

Sincerely yours,

Nancy C. brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _KQ50578

Device Name: Duette™ Multi-Band Mucosectomy Device

Indications for Use:

The Duette™ Multi-Band Mucosectomy Device is intended for endoscopic mucosal resection in the upper gastrointestinal tract.

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE-IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use Only Counter_ (Per 21 CFR § 801.109

OR

Daniel A. Lipton

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

Over-the-