RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

K100712 · Boston Scientific Corporation · FCG · Mar 30, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K100712
• Device Name: RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
• Applicant: Boston Scientific Corporation
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Mar 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Resound EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

Device Story

Resound Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is a biopsy instrument used to acquire aspiration samples from lesions within or adjacent to the digestive tract. Device couples to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope via standard luer connection. Operation involves physician-guided penetration of targeted lesions under ultrasound visualization while applying suction to obtain tissue samples. Used in clinical settings by gastroenterologists or trained specialists. Output is a tissue sample for diagnostic evaluation. Benefits include minimally invasive access to submucosal and extramural lesions for pathological analysis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Endoscopic ultrasound aspiration needle; compatible with curvilinear array echoendoscopes; standard luer connection; manual suction-based aspiration mechanism.

Indications for Use

Indicated for sampling targeted submucosal and extramural gastrointestinal lesions in patients requiring endoscopic ultrasound-guided fine needle aspiration.

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

• Wilson-Cook EchoTip Ultrasound Needle (K934356)
• Olympus Single-Use Aspiration Needle (K023272)

Submission Summary (Full Text)

{0}------------------------------------------------

K1007/2

SECTION 6 510(k) SUMMARY

#### 1. Submitter

MAR 3 0 2010

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: [phone] Fax: [phone]

Contact: Ashley Pyle Sr. Regulatory Affairs Specialist Date Prepared: December 18, 2009

#### 2. Device

Trade Name: Resound Endoscopic Ultrasound Aspiration Needle Common Name: Kit, Needle, Biopsy Classification Name: Gastroenterology-Urology Biopsy Instruments Regulation Number: 876.1075 Product Code: FCG Classification: Class II

#### 3. Predicate Devices

Wilson-Cook EchoTip Ultrasound Needle (K934356) Olympus Single-Use Aspiration Needle (K023272)

## 4. Device Description

The Resound Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is an endoscopic ultrasound aspiration needle that can be coupled to the biopsy channel of a Curvilinear Array (CLA) Echoendoscope with a standard luer connection and delivered into the digestive tract. The needle is used to acquire aspiration samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. An aspiration sample is obtained by penetrating the lesion with the needle while applying suction.

### 5. Indication for Use:

The Resound EUS-FNA device is intended for sampling targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

{1}------------------------------------------------

K₁₀₀¹/₂
pg 2 of r

### 6. Technological Characteristics:

The proposed Resound EUS-FNA device has the same technological characteristics as the currently marketed Wilson-Cook EchoTip Ultrasound Needle and Olympus Aspiration Needle.

#### 7. Performance Data:

Bench Testing has been performed on the finished Resound EUS-FNA device to demonstrate that the proposed device is substantially equivalent to the predicate devices.

# 8. Conclusion:

Boston Scientific has demonstrated that the proposed Resound EUS-FNA device is substantially equivalent to the currently marketed Wilson-Cook EchoTip Ultrasound Needle and the Olympus Aspiration Needle.

{2}------------------------------------------------

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 stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

Boston Scientific Corporation % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

## MAR 3 0 2010

Re: K100712

Trade/Device Name: Resound™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: FCG and ODG Dated: March 11, 2010 Received: March 12, 2010

Dear Mr. Lehtonen:

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 note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 device-related

{3}------------------------------------------------

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

Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# SECTION 5 INDICATIONS FOR USE STATEMENT

Indications for Use:

510(k) Number (if known): 40 Be Determined

K100 1/2

Device Name: Resound™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA)

Indications for Use:

The Resound EUS-FNA device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

Prescription Use X (Part 21 CFR 801 Part D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number.

Premarket Notification, Resound™ EUS-FNA Proprietary and Confidential Information of Boston Scientific Corporation

000094