ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A

K092359 · Cook Ireland, Ltd. · FCG · Nov 2, 2009 · Gastroenterology, Urology

Device Facts

• Record ID: K092359
• Device Name: ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A
• Applicant: Cook Ireland, Ltd.
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Nov 2, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This device is used to access or sample submucosal and extramural lesions of the gastrointestinal tract, access of the following: the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.

Device Story

19-gauge endoscopic ultrasound needle with stylet; needle features dimpled surface for enhanced ultrasonic visualization. Device advanced through accessory channel of ultrasound endoscope to target site. Stylet used to puncture target and assist insertion; withdrawn post-insertion. Enables fine needle injection (FNI), fine needle aspiration (FNA), or site access. Used by physicians in clinical settings. Output is physical access to target tissue or delivery of injectables; visualization provided by external ultrasound imaging system. Benefits include improved needle visibility during endoscopic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

19-gauge needle with stylet; dimpled surface for ultrasonic visualization. Manual operation via ultrasound endoscope accessory channel. No electronic components, software, or energy source.

Indications for Use

Indicated for patients requiring access or sampling of submucosal and extramural gastrointestinal lesions, or access to bile ducts, pancreatic ducts, cystic duct, or gallbladder, and for delivery of injectable materials into tissues via ultrasound endoscope.

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

• EchoTip® Ultra Ultrasound Needle (K083330)
• Wilson-Cook Cystotome™ Needle Knife (K022595)

Submission Summary (Full Text)

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Cook Ireland EchoTip Ultra High Definition Ultrasound Access Needle Company Confidential

09235

## Section 5.0 510(k) Summary

Name:

Address:

Phone: Fax: Contact Persons:

Phone:

Fax:

Date: .

Trade Name:

Common Name:

Classification Name:

Legally Marketed Devices:

Description of the Device:

Indications for use:

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

മ 2009

353 61 334440 353 61 239293 Emmett Devereux, Quality & Regulatory Manager Tracy Moriarty, Regulatory Affairs Specialist

353 61 334440 353 61 239293 31st July 2009

EchoTip® Ultra High Definition Ultrasound Access Needle Endoscopic Ultrasound Needle

Kit, needle, biopsy (21 CFR 876.1075, Product Code: FCG) EchoTip® Ultra Ultrasound Needle (K083330) Wilson-Cook Cystotome™ Needle Knife (K022595)

The EchoTip® Ultra High Definition Ultrasound Access Needle is a 19 gauge endoscopic ultrasound needle with a stylet and a needle. The needle is dimpled for improved ultrasonic visualization and is advanced through the accessory channel of an ultrasound endoscope to the target site. The preloaded stylet is used to puncture the target site and aid in inserting the needle. The stylet is withdrawn from the needle. Fine needle injection (FNI), fine needle aspiration (FNA) or access to the target site can then be performed.

This device is used to access or sample submucosal and extramural lesions of the gastrointestinal tract, access of the following:

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Cook Ireland EchoTip Ultra High Definition Ultrasound Access Needle

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Company Confidential 092359

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Comparison of Characteristics:

the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope. The EchoTip® Ultra High Definition Ultrasound Access Needle is substantially equivalent to the currently marketed predicate devices: the EchoTip® Ultra Ultrasound Needle (K083330) and the Wilson-Cook Cystotome™ Needle Knife (K022595)

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

Performance Data:

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Tracy Moriarty Regulatory Affairs Specialist Cook Ireland Ltd. O'Halloran Road National Technology Park LIMERICK IRELAND

### NOV - 2 2009

Re: K092359

Trade/Device Name: EchoTip® Ultra High Definition Ultrasound Access Needle Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated; July 31, 2009 Received: August 4, 2009

Dear Ms. Moriarty:

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 of medical

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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,

Janine M. Morris

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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Cook Ireland EchoTip Ultra High Definition Ultrasound Access Needle

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Company Confidential

# Section 4.0 Indications for Use

510(k) Number (if known): 八 0923359

Device Name: EchoTip® Ultra High Definition Ultrasound Access Needle

Indications for Use:

This device is used to access or sample submucosal and extramural lesions of the gastrointestinal tract, access of the following: the intra- or extra-hepatic bile ducts, pancreatic ducts, cystic duct, gallbladder or for delivery of injectable materials into tissues through the accessory channel of an ultrasound endoscope.

Prescription Use.
(Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use
(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/K092359
510(k) Number***_*****_**