Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle

K163058 · Boston Scientific · ODG · Jan 30, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K163058
• Device Name: Expect Slimline (SL) Endoscopic Ultrasound Aspiration Needle
• Applicant: Boston Scientific
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Jan 30, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: Therapeutic

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. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.

Device Story

Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle; manual biopsy/aspiration device. Used with curvilinear array echoendoscope; inserted through accessory channel into digestive tract. Penetrates submucosal/extramural lesions; applies suction to acquire tissue samples. Also facilitates delivery of injectable fluids or fiducials into tissue; allows passage of accessory devices. Operated by physicians in clinical settings. Output is tissue sample for diagnostic evaluation or therapeutic delivery. Benefits include minimally invasive access to gastrointestinal lesions for biopsy or targeted therapy.

Clinical Evidence

Bench testing only. Testing included simulated use and fluid injection capability to validate the device's ability to support the expanded indications for use.

Technological Characteristics

Manual endoscopic aspiration needle; standard luer connection for coupling to echoendoscope biopsy channel. No changes to physical design or materials from predicate K133312. Non-powered, mechanical device.

Indications for Use

Indicated for sampling targeted submucosal and extramural gastrointestinal lesions via curvilinear echoendoscope accessory channel; also indicated for delivery of injectable fluids or fiducials into tissue and passage of accessory devices.

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™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K133312)
• ECHO Tip Ultra High Definition Ultrasound Access Needle (K092359)
• BNX Fine Needle Aspiration System (K150891)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing to the right, stacked one behind the other, with flowing lines beneath them.

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

January 30, 2017

Boston Scientific Jennifer Edouard Regulatory Specialist, Regulatory Affairs 100 Boston Scientific Way Marlborough, Massachusetts 01752

Re: K163058

> 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: October 31, 2016 Received: November 1, 2016

Dear Jennifer Edouard:

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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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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

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

Sincerely.

Benjamin R. 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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# Indications for Use

510(k) Number (if known) Unknown - K163058

Device Name

Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle

Indications for Use (Describe)

The Expect™ Slimline (SL) Needle is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.

Type of Use (Select one or both, as applicable)

| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# 510(k) SUMMARY

#### 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Jennifer Edouard Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]

Date Prepared: October 31, 2016

### 2. Proposed Device:

Trade Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle Classification Name: Endoscopic Ultrasound System, Gastroenetrology-Urology and Biopsy Needle Regulation Number: 876.1500 & 876.1075 Product Code: ODG & FCG Classification: Class II

### 3. Predicate Device:

Trade Name: Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle 510(k) Number: K133312 Classification Name: Endoscopic Ultrasound System, Gastroenetrology-Urology and Biopsy Needle Regulation Number: 876.1500 & 876.1075 Product Code: ODG & FCG Classification: Class II

Trade Name: ECHO Tip Ultra High Definition Ultrasound Access Needle 510(k) Number: K092359 Classification Name: Biopsy Needle Regulation Number: 876.1075 Product Code: FCG Classification: Class II

Trade Name: BNX Fine Needle Aspiration System 510(k) Number: K150891 Classification Name: Biopsy Needle and Marker, Radiographic, Implantable Regulation Number: 876.1075 & 878.4300 Product Code: FCG & NEU Classification: Class II

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# 4. Proposed Device Description:

The Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle is and 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 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. Per manufacturer's instructions, the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.

# 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. It can also be used for delivery of injectable materials (fluids) or fiducials into tissue or for passage of accessory devices.

# 6. Technological Characteristics:

There are no differences in the technological characteristics between the proposed device and the predicate Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K133312). The physical device will remain unchanged from the predicate K133312, but the expanded indications require changes to the product DFU. The original design specifications remain unchanged; however, additional performance criteria were introduced to evaluate the ability of the device design to support the proposed indications for use.

### 7. Performance Data:

Bench testing has been performed on the proposed Expect™ Slimline (SL) device. Bench Testing includes:

- Simulated Use Test Method .
- · Fluid Injection Capability

# 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Expect™ Slimline (SL) is substantially equivalent to the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle (K133312), the ECHO Tip Ultra High Definition Ultrasound Access Needle (K092359) and the BNX Fine Needle Aspiration System (K150891).