Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

K160845 · Boston Scientific Corporation · ODG · May 3, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K160845
• Device Name: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
• Applicant: Boston Scientific Corporation
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: May 3, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

Device Story

Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) device; sterile, single-use aspiration needle. Used with curvilinear array (CLA) echoendoscope; inserted through accessory channel. Components include needle, syringe, and stopcock. Principle: needle penetrates lesion under ultrasound guidance; vacuum suction applied via syringe/stopcock to aspirate tissue sample. Used in clinical settings by gastroenterologists/endoscopists. Output: tissue sample for biopsy/pathological analysis. Facilitates diagnosis of gastrointestinal lesions; enables minimally invasive tissue acquisition.

Clinical Evidence

No clinical data provided. Bench testing only; verification activity confirmed the modified Franseen needle tip design met predefined product specifications.

Technological Characteristics

Sterile, single-use endoscopic ultrasound aspiration needle. Features Franseen (three-pronged) needle tip geometry. Connects to curvilinear array echoendoscope via standard luer connection. Includes syringe and stopcock for vacuum suction control. Mechanical device; no software or electronic components.

Indications for Use

Indicated for sampling targeted submucosal and extramural gastrointestinal lesions in patients undergoing endoscopic ultrasound procedures.

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 Endoscopic Ultrasound Aspiration Needle (K133312)

Submission Summary (Full Text)

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

May 3, 2016

Boston Scientific Corporation Yingying Gao Sr. RA Specialist 100 Boston Scientific Way Marlborough, MA 01752

Re: K160845

> Trade/Device Name: Acquire Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: ODG, FCG Dated: April 27, 2016 Received: April 28, 2016

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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.

for

Sincerely yours,

# Herbert P. Lerner -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)

K160845

#### Device Name

Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

Indications for Use (Describe)

The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

| 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: Yingying Gao Senior Regulatory Affairs Specialist Telephone: [phone] Fax: [phone]

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

Date Prepared: March 24, 2016

#### 2. Proposed Device:

Trade Name: Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device Classification Name: Endoscopic Ultrasound System, gastroenterology-urology Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II

#### 3. Predicate Device:

Trade Name: Expect™ Slimline Endoscopic Ultrasound Aspiration Needle Manufacturer and Clearance Number: Boston Scientific Corp, K133312 Classification Name: Endoscopic ultrasound system, gastroenterology-urology Regulation Number: 876.1500 & 876.1075 Product Code: ODG and FCG Classification: Class II

#### 4. Device Description:

Device Name: Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

The Acquire™ device is comprised of the following:

- One (1) Acquire™ needle ●
- One (1) Syringe ●
- One (1) Stopcock ●

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The Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is a sterile singleuse device. It 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.

Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample.

#### 5. Intended use/ Indications for Use:

The Acquire™ Fine Needle Biopsy Device is designed to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of a curvilinear echoendoscope.

#### 6. Technological Characteristics:

The proposed Acquire™ device is used to acquire samples in the digestive tract by coupling it with an ultrasound curvilinear endoscope. The proposed Acquire™ device is identical to the predicate Expect™ Slimline device, with the exception of the needle tip geometry. The proposed Acquire™ device will be offered with a Franseen needle tip (three-pronged tip). The proposed Acquire™ device shares the same technical characteristics as its predicate, the currently cleared Expect™ Slimline EUS-FNA needle (K133312).

#### 7. Performance Data:

No performance testing is required to evaluate the new needle tip design. Verification activity has been performed on the proposed Acquire™ device, which demonstrates that the modified needle tip design met the pre-defined product specification: "Franseen" Needle Grind Specification.

### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is substantially equivalent to the currently cleared Expect™ Slimline EUS-FNA needle (K133312).