EXPECT ENDOSCOPIC ASPIRATION NEEDLE

K110030 · Boston Scientific Corp · ODG · Jan 12, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K110030
• Device Name: EXPECT ENDOSCOPIC ASPIRATION NEEDLE
• Applicant: Boston Scientific Corp
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Jan 12, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The Expect™ Needle is designed to sample targeted submucosal and extramural lesions through the accessory channel of a curvilinear echoendoscope.

Device Story

Expect™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is a manual surgical instrument used to acquire tissue samples from submucosal and extramural gastrointestinal lesions. The device is designed for use through the accessory channel of a curvilinear array (CLA) echoendoscope. It is operated by a physician during endoscopic ultrasound procedures. The device features a modified handle design compared to the predicate. The physician uses the echoendoscope to identify and target lesions within or adjacent to the digestive tract, then advances the needle to perform aspiration. The collected samples are used for diagnostic purposes to inform clinical decision-making. The device is a mechanical tool; it does not involve electronic processing, software, or automated analysis.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual endoscopic aspiration needle. Features a modified handle design compared to the predicate. Designed for compatibility with standard curvilinear array (CLA) echoendoscope accessory channels. No electronic components, software, or energy sources.

Indications for Use

Indicated for sampling targeted submucosal and extramural gastrointestinal lesions via the accessory channel of a curvilinear echoendoscope.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Expect - Endoscopic Ultrasound Aspiration Needle (K100712)

Submission Summary (Full Text)

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

KI10030 SECTION 6 510(k) SUMMARY

## 510(k) SUMMARY

### 1. Submitter:

JAN 1 2 2011

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

Contact: Ashley Pyle Sr. Regulatory Affairs Specialist Date Prepared: December 23, 2010

## 2. Proposed Device:

Trade Name: Expect™ Endoscopic Aspiration Needle Trade Name: Expect - Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: FCG and ODG Classification: Class II

#### 3. Predicate Device:

Trade Device: Trade Name: Expect - Endosoopio Fiophean Scientific Corporation, K100712
Manufacturer and Clearance Number: Boston Services Endanceria Ultrassund System Manufacturer and Clearance Nambol : Doctories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: FCG and ODG Classification: Class II

## 4. Device Description:

The Expect™ Endoscopic Ultrasound Aspiration Needle (EUS-FNA) is an endossopics
) is and the final started as any locasy channel of a Curvilinear a The Expect™ Endoscopic Utrasound Aspiration Neculo (1905) chamel of a Curvilianea Array
ultrasound aspiration needle that can be coupled to the digestive tract. ultrasound aspiration needle mail be coupled to the bropsy with the digestive tract.
(CLA) Echoendoscope with a standard her connection and adjacent to the (CLA) Echoendoscope with a sialloau neer comecions within and adjacent to the The needle is used to acqure aspiratori samples from was and want the echoendoscope.
digestive system's major lumens that can be identified and targeted using the echoendoseo digestive system's major lumens that can oc licitimed and argues and arguined on suction.

## 5. Indications for Use:

The Expect™ EUS-FNA device is intended for sampling targeted submucosal and extramural
and the counter the commens chappel of a currilinear echoendoscope. The Expect™ EUS-FNA device is intended for sumpling any and of a curvilinear echoendoscope.
gastrointestinal lesions through the accessory channel of a curvilinear echoendosc

Special 510(k) Premarket Notification, Expect Endoscopic Ultrasound Aspiration Needle

## 0000015

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

#### 6. Technological Characteristics:

The proposed Expect™ EUS-FNA device has a modified handle design as compared to the
currently cleared Expect™ EUS-FNA device K100712.

#### 7. Performance Data:

Bench Testing has been performed on the Expect™ EUS-FNA device to demonstrate that the modified handle design met the required specifications for the completed tests.

#### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Expect™ Endoscopic Aspiration Needle substantially equivalent to the currently cleared Expect™ EUS-FNA device K100712.

# 000016

Special 510(k) Premarket Notification, Expect Endoscopic Ultrasound Aspiration Needle

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Boston Scientific Corporation c/o Ms. Paula Wilkerson Sr. Staff Engineer - Medical Devices Intertek Testing Services NA, Inc. 2307 East Aurora Road, Unit B7 TWINSBURG OF 44087

JAN 1 2 2011

Re: K110030

Trade/Device Name: Expect™ Endoscopic Aspiration Needle Regulation Number: 21 CFR \$876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: ODG Dated: December 29, 2010 Received: January 5. 2011

Dear Ms. Wilkerson:

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}------------------------------------------------

Page 2

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.html 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Herbert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

#### Enclosure

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

# SECTION 5 INDICATIONS FOR USE STATEMENT

| JAN 12 2011 | |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number (if known): | To Be Determined K110030 |
| Device Name: | Expect™ Endoscopic Aspiration Needle |
| Indications for Use: | The Expect™ Needle is designed to sample targeted submucosal and extramural lesions through the accessory channel of a curvilinear echoendoscope. |

tom Wh

(Division Sign-Off) (Division of Reproductive, Gastro-Renal, and Urological Devices 10030 510(k) Number -

Prescription Use X 1 reseription 201 Subpart 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)

Special 510(k) Premarket Notification, Expect Endoscopic Ultrasound Aspiration Needle

000014