ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O

K093195 · Cook Ireland, Ltd. · FCG · Jan 21, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K093195
• Device Name: ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O
• Applicant: Cook Ireland, Ltd.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Jan 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultra sound endoscope for Fine Needle Aspiration (FNA).

Device Story

EchoTip Ultra Endobronchial High Definition Ultrasound Needle is a biopsy instrument for fine needle aspiration (FNA). Device consists of a needle with a dimpled surface for enhanced ultrasonic visualization, an adjustable sheath, an adjustable needle length mechanism, a preloaded stylet, an adaptor for endoscope accessory channel connection, and a syringe for specimen aspiration. Used in conjunction with an endobronchial ultrasound (EBUS) endoscope. Physician advances needle into target lesion under ultrasound guidance; stylet removed; aspiration performed via syringe. Enables sampling of submucosal and extramural lesions in tracheobronchial tree or gastrointestinal tract. Benefits include improved visualization of needle tip during ultrasound-guided procedures, facilitating accurate tissue sampling.

Clinical Evidence

Bench testing only.

Technological Characteristics

Endoscopic ultrasound needle with dimpled surface for ultrasonic visualization. Includes adjustable sheath and needle length mechanisms, preloaded stylet, accessory channel adaptor, and aspiration syringe. Mechanical device; no software or electronic components.

Indications for Use

Indicated for patients requiring fine needle aspiration (FNA) of submucosal and extramural lesions located within or adjacent to the tracheobronchial tree or gastrointestinal tract.

Regulatory Classification

Identification

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Predicate Devices

• Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503)
• Cook Endoscopic Ultrasound Needle (K083330)

Submission Summary (Full Text)

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Cook Echo Tip® Ultra Endobronchial High Definition Ultrasound Needle Page 8 of 45

## Section 5.0 510(k) Summary

Name: Address:

Phone:

Contact Persons:

Fax:

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

JAN 2 1 2010

353 61 334440 353 61 334441 Emmett Devereux, Quality & Regulatory Manager Jacinta Kilmartin, Regulatory Affairs Specialist

353 61 334440 353-61-239293

October 7, 2009

EchoTip® Ultra Endobronchial High Definition Ultrasound Needle

Aspiration Needle

Kit, Needle, Biopsy (21 CFR 876.1075, Product Code: FCG)

Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503) Cook Endoscopic Ultrasound Needle (K083330)

The EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is an endoscopic ultrasound needle used for fine needle aspiration (FNA). The device is used in conjunction with an endobronchial ultrasound (EBUS) endoscope to gain access to the target site. The needle is dimpled for ultrasonic visualization. The needle is

Phone: Fax:

Date:

Trade Name:

Common Name:

Classification Name:

Predicate Devices:

Description of the Device:

K093195.

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advanced into the target site for aspiration. The device allows for the adjustment of the sheath length and the needle length to enable the user to adiust for the working length of the endoscope and to control needle insertion depth. It is preloaded with a stylet which is removed for aspiration. The device is supplied with an adaptor which allows the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to be connected to the endoscope's accessory channel. The device is also supplied with a syringe that is used to aspirate the specimen.

This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultra sound endoscope for Fine Needle Aspiration (FNA).

The EchoTip® Ultra Endobronchial High Definition Ultrasound Needle is substantially equivalent to the currently marketed predicate devices, the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503) and Cook Endoscopic Ultrasound Needle (K083330).

Non-clinical testing was carried out on the device to determine the equivalence of the EchoTip® Ultra Endobronchial High Definition Ultrasound Needle to the predicate devices to provide assurance of safety and effectiveness.

## Indications for use:

Comparison of Characteristics:

Performance Data:

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Image /page/2/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 a stylized image of a human figure with outstretched arms.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

JAN 2 1 2010

Ms. Jacinta Kilmartin Regulatory Affairs Specialist Cook Ireland Limited O'Hallorañ Road National Technology Park LIMERICK IRELAND

Re: K093195

Trade/Device Name: EchoTip® Ultra Endobronchial High Definition Ultrasound Needle Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology-urology biopsy instrument Regulatory Class: Class II Product Code: FCG Dated: December 22, 2009 Received: December 24, 2009

Dear Ms. Kilmartin:

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 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been deternined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 onay publish further announcements concerning your device in the Federal Register.

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## Page 2 - Ms. Jacinta Kilmartin

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

, Hebert Leven

Janine M. Morris, Director (Acting) Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Section 4.0 Indications for Use

093195 510(k) Number (if known): _

Device Name: EchoTip® Ultra Endobronchial High Definition Ultrasound Needle

Indications for Use:

. "

This device is used to sample targeted submucosal and extramural lesions within or adjacent to the tracheobronchial tree or gastrointestinal tract through the accessory channel of an ultra sound endoscope for Fine Needle Aspiration (FNA).

Prescription Use Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

| 510(k) Number | K093195 |
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