Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device

K223616 · Boston Scientific Corporation · ODG · Dec 30, 2022 · Gastroenterology, Urology

Device Facts

• Record ID: K223616
• Device Name: Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device
• Applicant: Boston Scientific Corporation
• Product Code: ODG · Gastroenterology, Urology
• Decision Date: Dec 30, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Indications for Use

The Acquire™ S 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™ S is an endoscopic ultrasound fine needle biopsy (FNB) device used to sample gastrointestinal lesions. The device consists of a needle, vacuum syringe, and one-way stopcock. It is inserted through the accessory channel of a curvilinear array echoendoscope. The physician adjusts sheath and needle length using locking knobs on the handle. Under real-time ultrasound visualization, the needle penetrates the target lesion; suction is applied via the syringe to aspirate tissue samples. The device features an echogenic distal tip for ultrasound visibility. It is used in clinical settings by physicians to obtain tissue samples for diagnostic purposes, potentially benefiting patients by enabling minimally invasive biopsy of lesions within or adjacent to the digestive tract.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical performance bench testing, including device durability, stylet removal force, needle extension length, adjustable catheter length, and stylet cap tensile testing. Biocompatibility was evaluated per ISO 10993 and sterilization validation per ISO 11135.

Technological Characteristics

139cm long needle device for use with curvilinear echoendoscopes. Features include adjustable sheath/needle length, locking handle mechanisms, and echogenic distal tip for ultrasound visualization. Includes vacuum syringe and stopcock for suction. Biocompatibility per ISO 10993; sterilization per ISO 11135. Mechanical device; no software or electronic components.

Indications for Use

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

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.

In combination with the general controls of the FD&C Act, the integrated operating table-electromechanical surgical system is subject to the following special controls: 1. (1) Premarket clinical performance testing, or a combination of premarket clinical performance testing and postmarket surveillance (in accordance with special control (2)), must include the following: 1. (i) Objective performance measures (e.g., rate and number of conversions to other surgical modalities, rate of device related adverse events (including tissue injury, hematoma, and increased blood loss), and their severity, cause, and outcomes) must be reported with relevant descriptive comparator performance measures. 2. (ii) The data must demonstrate the performance of the device for providing accurate and precise control of attached surgical instruments in range of clinical conditions relevant to the device's intended use. 3. (iii) The test dataset must include data collected from a patient population representative of the intended patient population under anticipated conditions of use. 2. (2) Data obtained from postmarket surveillance must demonstrate, in consideration of the premarket data obtained in accordance with special control (1), that the device performs in accordance with special control (1), unless FDA determines, based on the totality of the premarket data, that data from postmarket surveillance is not required to demonstrate that the device performs as intended. Such postmarket surveillance must be conducted per a protocol determined appropriate by FDA to demonstrate that the device performs as intended (in consideration of the premarket data obtained in accordance with special control (1)), and must include initiation, enrollment, and reporting requirements to ensure timely periodic updates to FDA on post-market surveillance progress and outcomes. 3. (3) Animal performance testing must evaluate the extent of port site trauma due to repositioning of table during surgical procedures when utilizing robotic minimally invasive and laparoscopic approaches 4. (4) The device manufacturer must develop, and update as necessary, a device-specific use training program that ensures proper device setup/use/shutdown, accurate control of instruments to perform the intended surgical procedures, troubleshooting and handling during unexpected events or emergencies, and safe practices to mitigate use error. 5. (5) The device manufacturer may only distribute the device to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program. (6) Human factors assessment must demonstrate that the user can correctly use the device system across all intended use environments with the provided instructions and training materials, including patient access during normal operating conditions and emergency situations, and effects arising from the integrated nature of the operating table and robotic surgical arms. (7) Labeling must include: (i) A detailed summary of clinical performance testing conducted with the device, including study population, results, adverse events, and comparisons to any comparator groups identified; (ii) A statement in the labeling that the safety and effectiveness for the representative specific procedures was based on evaluation of the device as a surgical tool and did not include evaluation of outcomes related to the treatment of the patient's underlying disease or condition, unless FDA determines that it can be removed or modified based on clinical performance data submitted to FDA; (iii) Identification of compatible devices; (iv) The list of surgical procedures for which the device has been determined to be safe with clinical justification; (v) Reprocessing instructions for reusable components; (vi) A shelf life for any sterile components; (vii) A description of the device-specific use training program; (viii) A statement that the device is only for distribution to facilities that implement and maintain the device-specific use training program and ensure that users of the device have completed the device-specific use training program; and (ix) A summary of any completed postmarket surveillance data collected as required by special control (2), including updated labeling to accurately reflect outcomes observed in postmarket surveillance. (8) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use and must include: (i) Device motion accuracy and repeatability; (ii) System testing; (iii) Instrument reliability; (iv) Crosstalk; (v) Table motion control; (vi) Thermal effects on tissue; (vii) User-device interface performance; (viii) Workspace access testing; and (ix) Performance testing with compatible devices. (9) Software verification, validation, and hazard analysis must be performed. (10) Electromagnetic compatibility and electrical, thermal, and mechanical safety testing must be performed. (11) Performance data must demonstrate the sterility of all patient-contacting device components. (12) Performance data must support the shelf life of the device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life. (13) Performance data must validate the reprocessing instructions for the reusable components of the device. (14) Performance data must demonstrate that all patient-contacting components of the device are biocompatible. (15) Performance data must demonstrate that all patient-contacting components of the device are non-pyrogenic. (16) The device manufacturer must submit a report to the FDA annually on the anniversary of initial marketing authorization for the device, until such time as FDA may terminate such reporting, which comprises the following information: (i) Cumulative summary, by year, of complaints and adverse events since date of initial marketing authorization; and (ii) Identification and rationale for changes made to the device, labeling, or device specific use training program, which did not require submission of a premarket notification during the reporting period.

Predicate Devices

• Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845)

Submission Summary (Full Text)

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December 30, 2022

Boston Scientific Corporation Kyra Mcnamara Regulatory Affairs Specialist II 100 Boston Scientific Wav Marlborough, MA 01752

Re: K223616

> Trade/Device Name: Acquire™ S 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: December 2, 2022 Received: December 5, 2022

Dear Kyra Mcnamara:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Sivakami Venkatachalam -S

# for

Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K223616

Device Name

Acquire S endoscopic ultrasound fine needle biopsy (fib) device

Indications for Use (Describe)

The Acquire S 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

Primary Contact: Kyra McNamara Regulatory Affairs Specialist II Telephone: [phone] Date Prepared: December 2, 2022

# 2. Proposed Device:

| Trade Name: | Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy<br>(FNB) Device |
|----------------------|---------------------------------------------------------------------|
| Classification Name: | Endoscopic ultrasound system, gastroenterology-urology |
| Regulation Number: | 21 CFR 876.1500 & 876.1075 |
| Product Code: | ODG and FCG |
| Regulatory Class: | Class II |

# 3. Predicate Device:

| Trade Name: | Acquire TM Endoscopic Ultrasound Fine Needle Biopsy<br>(FNB) Device |
|----------------------|---------------------------------------------------------------------|
| Manufacturer: | Boston Scientific |
| 510(k) Number: | K160845 |
| Classification Name: | Endoscopic ultrasound system, gastroenterology-urology |
| Regulation Number: | 21 CFR 876.1500 & 876.1075 |
| Product Code: | ODG and FCG |
| Regulatory Class: | Class II |

# 4. Device Description:

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

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K223616 Page 2 of 3

The Acquire™ S device is comprised of the following:

- One (1) Acquire STM needle ●
- One (1) Vacuum Syringe .
- One (1) One-Way Stopcock ●

The Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is an endoscopic ultrasound biopsy 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 device sheath length can be adjusted to accommodate different model echoendoscopes. The need to acquire samples from lesions within and adjacent to the digestive system's major lumens that can be identified and targeted using the echoendoscope. Both the sheath and needle length can be adjusted based on distance to the target lesion. The sheath and needle length adjustments are set and locked by the physician by using the locking knob mechanisms on the handle of the device. A sample is obtained by penetrating the lesion with the needle while applying suction and manipulating the needle in a back and forth motion to acquire a sample. The sample can be prepared per normal institutional protocol. The Acquire™ Needle has echogenic (visible under ultrasound) features at the distal end to facilitate real time visualization of the device under ultrasound.

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

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

The Acquire™ S 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™ S device is a 139cm long needle used to acquire samples in the digestive tract by coupling it with an ultrasound curvilinear endoscope. The proposed Acquire™ S device is identical to the predicate Acquire™ device, with the exception of the stylet tip geometry. The proposed Acquire™ S device will have a taper point stylet, compared to the currently cleared Acquire™, which has a ball point stylet tip. The proposed Acquire™ S device shares the same technical characteristics as its predicate, the currently cleared Acquire ™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845).

#### 7. Performance Data:

Non-clinical performance bench testing, simulated use testing, biocompatibility per the requirements of ISO 10993, and sterilization validation per the requirements of ISO 11135 were completed to evaluate the design of the Acquire™ S device for the change in stylet tip geometry.

Bench Testing included:

- Device Durability ●
- . Stylet Removal Force
- Needle Extension Length ●
- Adjustable Catheter Length ●
- Stylet Cap Tensile

All testing was passing and demonstrates the device's ability to fulfill non-clinical performance bench testing, biocompatibility, and sterilization requirements.

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### 8. Conclusion:

Boston Scientific Corporation has demonstrated that the proposed Acquire™ S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device is substantially equivalent to the currently cleared Acquire™ Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device (K160845).