EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE

K133312 · Boston Scientific Corporation · ODG · Jan 3, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K133312
• Device Name: EXPECT SLIMLINE ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
• Applicant: Boston Scientific Corporation
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Jan 3, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

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

Device Story

Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle; used for sampling submucosal and extramural gastrointestinal lesions. Device couples to biopsy channel of curvilinear array (CLA) echoendoscope via standard luer connection. Physician operates device during endoscopic procedure; needle penetrates lesion while suction is applied to acquire aspiration samples. Output is physical tissue/fluid sample for diagnostic analysis. Device features slim handle design, low-profile locking knobs with retention, and modified internal handle components compared to predicate. Benefits include improved ergonomics and handling during ultrasound-guided procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included device durability, needle and sheath adjustment locking force, handle actuation force, handle tensile test, locking knob retention, smooth actuation, needle extension length, and handle resistance to torque.

Technological Characteristics

Endoscopic ultrasound aspiration needle. Features slim handle design, low-profile locking knobs with retention, and modified internal handle components. Connects to curvilinear array echoendoscope via standard luer connection. Mechanical device; no energy source or software.

Indications for Use

Indicated for sampling targeted submucosal and extramural gastrointestinal lesions in patients requiring endoscopic ultrasound-guided fine needle aspiration via 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 Aspiration Needle (K110030)
• Expect™ Endoscopic Aspiration Needle (K112198)

Submission Summary (Full Text)

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JAN - 3 2014

SECTION 6. 510(K) SUMMARY

#### 510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Yingying Gao: Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]

Secondary Contact: Ashley Santos Regulatory Affairs Manager Telephone: [phone] Fax: [phone]

Date Prepared: October 25th, 2013

2. Proposed Device:

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

### 3. Predicate Device:

Trade Name: Expect™ Endoscopic Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K110030 Classification Name: Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II

And

Trade Name: Expect" Endoscopic Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K112198 Classification Name: Endoscope and Accessories & Endoscopic Ultrasound System Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II

Special 510(k) Premarket Notification, Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle SECTION 6

. IQ

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# 4. Device Description:

The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle 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. Indications for Use:

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

## 6. Technological Characteristics:

The proposed Expect™ Slimline device is a new configuration, including slim handle design, low profile locking knobs with retention feature and modified handle internal components. The currently cleared Expect™ EUS-FNA needle is composed of an ergonomic handle with bigger outer diameter (K110030 & K112198).

#### 7. Performance Data:

Bench Testing has been performed on the proposed Expect" Slimline device, which demonstrates that the modified handle design met the required specifications for completed design verification tests. Bench Testing includes:

- . Device Durability
- Needle and Sheath Adjustment Locking Force .
- . Handle (Needle) Actuation Force
- . Device Handle Tensile Test
- . Locking Knob Retention
- Smooth Actuation of Handle .
- . Needle Extension Length
- Device (Handle) Resistance to Torque

## 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Expect™ Slimline Endoscopic Aspiration Needle is substantially equivalent to the currently cleared Expect EUS-FNA devices (K110030 & K112198).

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

January 3, 2014

Boston Scientific Corporation Yingying Gao Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752

- Re: K133312
Trade/Device Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FCG Dated: December 5, 2013 Received: December 6, 2013

Dear Yingying Gao,

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

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Page 2 - Yingying Gao

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

Benjamin Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# SECTION 4. INDICATIONS FOR USE STATEMENT

K133312 510(k) Number (if known): Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Device Name: Needle The Expect™ Slimline (SL) Needle is designed to sample Indications for Use: . targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

Prescription Use AND/OR X (Part 21 CFR 801 Subpert D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IP NEBORD)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin Risher -S 2014.01.03 12 12 12 2017 -05 00

Special 510(k) Premistici Notification, Experile Slimline (SL) Enicscopic Ultrassund Aspiration Newlo 88CHON 5

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