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 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.

AI/ML Overview

This document is a 510(k) summary for the Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration Needle. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report for the device's performance.

Therefore, much of the requested information regarding acceptance criteria, specific study details, and AI-related aspects (like MRMC studies) is not present in the provided text. The document refers to "bench testing" but does not provide details about its acceptance criteria or results.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "additional performance criteria were introduced to evaluate the ability of the device design to support the proposed indications for use" and lists "Bench Testing" including "Simulated Use Test Method" and "Fluid Injection Capability." However, it does not provide the specific acceptance criteria for these tests or the quantitative results of the device's performance against those criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. The document mentions "Bench testing" but does not specify the sample sizes used for these tests, nor does it provide information on data provenance (country, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Cannot be provided. This device is an aspiration needle, not an interpretive AI system. The concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is relevant for diagnostic imaging AI studies, but not for the mechanical performance testing of an aspiration needle described here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Cannot be provided. Similar to point 3, adjudication methods (like 2+1, 3+1 consensus) are typically used in studies involving human interpretation or decision-making, especially in evaluating diagnostic AI. This is not mentioned or implied for the bench testing of an aspiration needle.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable / Cannot be provided. The device is an endoscopic ultrasound aspiration needle, not an AI system or an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is irrelevant to this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable / Cannot be provided. This device is a physical medical instrument, not an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Cannot be provided. For the bench testing of an aspiration needle, "ground truth" would likely refer to objective measurements of physical properties (e.g., needle tip sharpness, material strength, fluid flow rate, penetration force) against engineering specifications, rather than clinical "expert consensus, pathology, or outcomes data." The document does not specify these objective measurements or criteria.

8. The sample size for the training set

Not applicable / Cannot be provided. The concept of a "training set" specifically refers to data used to train machine learning models. This document describes a physical medical device, not an AI model, so a training set as typically understood in AI is not relevant.

9. How the ground truth for the training set was established

Not applicable / Cannot be provided. See point 8.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

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: Jennifer Edouard Regulatory Affairs Specialist Telephone: 508-683-6134 Fax: 508-683-5939

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:

5. Indications for Use:

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).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.