The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the gastrointestinal tract. Do not use this instrument for any purpose other than its intended use.

Device Description

The Expect™ Pulmonary device is comprised of the following: Expect™ Pulmonary needle, Expect™ Pulmonary adaptor, Syringe, Stopcock. The Expect™ Pulmonary needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage through the scope. The stylet may also be used to expel the sample after the procedure. Expect™ Pulmonary adaptor is an accessory to be attached and locked onto the biopsy port of the bronchoscope. It allows Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection. Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. They also can be used to expel the samples after the procedure.

AI/ML Overview

The provided text is a 510(k) summary for the Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria based on clinical outcomes or a standalone algorithm performance.

Therefore, many of the requested categories for describing acceptance criteria and a study to prove device performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth types for test and training sets) are not applicable or not present in this type of submission.

This document describes a pre-market notification for a medical device that functions as a tool for obtaining tissue samples. The "acceptance criteria" here are related to the device's physical and functional properties, primarily demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.

Here's the information extracted and formatted, with "N/A" for criteria not applicable or not found in the text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the successful completion of the performance tests, demonstrating that the device functions as intended and is comparable to predicate devices. The reported device performance is that all tests were successfully completed. No specific numerical performance metrics (e.g., "flexibility must be < X N") are provided, only that the tests were completed with acceptable results.

Acceptance Criteria Category	Specific Test Performed	Reported Device Performance
Mechanical Performance	Device Flexibility	Successfully completed
	Device Passability	Successfully completed
	Device Durability (Robustness)	Successfully completed
	Needle and Sheath Adjustment Locking Force	Successfully completed
	Handle Actuation Force (Needle Extension)	Successfully completed
	Needle Sharpness	Successfully completed
	Stylet Removal Force	Successfully completed
	Handle Home Position	Successfully completed
	Needle Extension Length	Successfully completed
	Adjustable Working Length (Sheath Extension length)	Successfully completed
	Needle to Luer Tensile Strength	Successfully completed
	Sheath to Sheath Hub (Actuation Guide) Tensile Strength	Successfully completed
	Device Luer to Adaptor Luer to Scope Tensile	Successfully completed
	Adaptor Lock & Unlock Force	Successfully completed
	Adaptor Suction	Successfully completed
	Needle Extension Length Marking	Successfully completed
	Sheath Length Adjustment Markings	Successfully completed
	Handle Rotation	Successfully completed
	Smooth Actuation	Successfully completed
Biocompatibility	Cytotoxicity	Acceptable results
	Sensitization	Acceptable results
	Irritation	Acceptable results
	Systemic Toxicity	Acceptable results

2. Sample Size Used for the Test Set and Data Provenance

This document describes non-clinical comparative performance bench testing. It does not involve a "test set" in the context of patient data or algorithm evaluation. The testing was conducted on manufactured devices.

Sample Size: Not specified. Standard practice for bench testing would involve a statistically relevant number of devices, but the exact number is not provided in this summary.
Data Provenance: N/A (bench testing, not patient data).
Retrospective or Prospective: N/A (bench testing).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

N/A. This is a medical device's physical and functional performance test, not a diagnostic algorithm. Ground truth, in this context, refers to engineering specifications and performance standards met by the device itself, not interpretation by experts.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically used in clinical studies or expert reviews of data, not for bench testing of device mechanics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

N/A. This is a physical medical device (needle), not an AI algorithm. Therefore, no MRMC study comparing human readers with or without AI assistance was performed.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

N/A. This is a physical medical device (needle), not an AI algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance testing is based on engineering specifications and established performance standards for medical devices of this type, as demonstrated by the predicate devices. For biocompatibility, it's based on ISO 10993-1:2009.

8. Sample Size for the Training Set

N/A. This is a physical medical device. There is no "training set" in the context of machine learning. The device design and manufacturing processes are developed based on engineering principles and previous device designs.

9. How the Ground Truth for the Training Set Was Established

N/A. No training set as per machine learning definition. Design ground truth is established through engineering design principles, material science, and regulatory requirements, often benchmarked against existing devices (predicates).

Summary

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

October 22, 2015

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

Re: K151895

Trade/Device Name: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: FCG Dated: September 24, 2015 Received: September 25, 2015

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 of medical device

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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 yours,

Herbert P. Lerner -S

for 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) To Be Determined - K151895

Device Name

Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

Indications for Use (Describe)

The Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is designed to be used with endobronchial ultrasound endoscopes for ultrasound guided fine needle aspiration (FNA) of the submucosal and extramural lesions of the gastrointestinal tract. Do no use this instrument for any purpose other than its intended use.

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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SECTION 6. 510(K) SUMMARY

510(k) SUMMARY

1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Contact: Yingying Gao Sr. Regulatory Affairs Specialist Telephone: 508-683-4356 Fax: 508-683-5939

Secondary Contact: Ashley Santos Regulatory Affairs Manager Telephone: 508-683-4359 Fax: 508-683-5939

Date Prepared: July 9, 2015

2. Device:

Trade Name:	Expect TM Pulmonary Endobronchial UltrasoundTransbronchial Aspiration Needle
Device Common Name:	Endobronchial Ultrasound Transbronchial AspirationNeedle/ EBUS-TBNA needle
Classification Name:	Gastroenterology-urology biopsy instrument
Regulation Number:	876.1075
Product Code:	FCG
Classification:	Class II

3. Predicate Device:

Primary Predicate device:

Trade Name:	Expect™ Slimline (SL) Endoscopic UltrasoundAspiration needle
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Premarket Notification, Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle SECTION 6

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Device Common Name:	Endoscopic Ultrasound Aspiration needle /EUS-FNA needle
Manufacturer:	Boston Scientific Corporation
Clearance Number:	K133312
Classification Name:	Endoscope and accessories
Regulation Number:	876.1500
Product Code:	ODG and FCG
Classification:	Class II

And

Secondary Predicate device:

Trade Name:	Single Use Aspiration Needle NA-201SX-4022
Device Common Name:	Endobronchial Ultrasound Transbronchial AspirationNeedle/ EBUS-TBNA needle
Manufacturer:	Olympus Medical Systems Corporation
Clearance Number:	K050503
Classification Name:	Gastroenterology-urology biopsy instrument
Regulation Number:	876.1075
Product Code:	FCG
Classification:	Class II

4. Device Description:

Device Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

The Expect™ Pulmonary device is comprised of the following:

Expect™ Pulmonary needle ●
Expect™ Pulmonary adaptor .
Syringe ●
. Stopcock

The Expect™ Pulmonary needle is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract. The device consists of a sheath covered needle which extends into the accessory channel of an endobronchial ultrasound (EBUS) endoscope and is locked into place. A handle on the proximal end of the device is used to actuate the needle in order gather samples. Both the sheath and needle length are adjustable while in the scope. A stylet is in place in order to provide protection to the inside of the sheath during device passage

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through the scope. The stylet may also be used to expel the sample after the procedure.

Expect™ Pulmonary adaptor is an accessory to be attached and locked onto the biopsy port of the bronchoscope. It allows Expect™ Pulmonary needle to pass through it and to be secured in place with a luer connection.

Syringe and stopcock are accessories to provide and control the vacuum suction to aspirate the sample. They also can be used to expel the samples after the procedure.

5. Intended use and Indications for Use:

Intended use:

Expect™ Pulmonary device is intended to be used with ultrasound endoscope for fine needle aspiration of the submucosal and extramural lesions of the accessible organ svstems.

Indications for Use:

6. Technological Characteristics:

The proposed Expect™ Pulmonary device is designed to acquire sample in the Esophagus by coupling with an ultrasound bronchoscope. It has the following technological characteristics:

. Adjustable sheath length and sheath locking mechanism
Adjustable needle length and needle locking mechanism ●
. Needle sharpness
Needle echogenicity in ultrasound image ●
Stylet with kink resistance
Smooth actuation ●
Aspiration capability ●
Passage of device through the scope to the target position
Secure scope attachment .

The Expect™ Pulmonary device shares similar design characteristics with its primary predicate device Expect™ Slimline device. Both of them have the adjustable lengths of sheath and needle with similar sheath and needle locking mechanism. These two devices have the same sharp echogenic needle and kink resistant stylet with the exact same materials and designs. The only differences are Expect™ Pulmonary device has a shorter sheath length and a shorter adjustable needle length. In additional, the same

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sheath material is shared between these two devices. The Expect™ Pulmonary sheath has a smaller outer and inner diameter and a shorter length. Based on the similarity of the needle, sheath, and the stylet, Expect™ Slimline and Expect™ Pulmonary devices have a similar actuation mechanism. The same syringe and stopcock are also shared between these two devices. As a result, their aspiration capabilities are identical.

The proposed Expect™ Pulmonary device has an adaptor that is attached and locked onto the biopsy port of the bronchoscope. The Expect™ Pulmonary device can pass through the adaptor and be secured in place with a luer connection. This Adaptor is similar to the adaptor biopsy valve of the Vizishot device.

The proposed device has the same intended use and similar technical characteristics as the currently marketed Boston Scientific Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration needle (K133312) and the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503).

7. Performance Data:

Biocompatibility Testing Summary:

The proposed Boston Scientific Expect™ Pulmonary devices were evaluated biocompatibility in accordance with ISO 10993-1:2009 Evaluation and Testing. The following tests were performed with acceptable results on the patient contacting portions of the Expect™ Pulmonary device: Cytotoxicity, Sensitization, Irritation, and Systemic Toxicity.

Performance Testing Summary:

Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence between the proposed Expect™ Pulmonary devices and its primary predicate device Expect™ Slimline device. The following tests were conducted on the Expect™ Pulmonary devices:

1. Device Flexibility
1. Device Passability
1. Device Durability (Robustness)
1. Needle and Sheath Adjustment Locking Force
1. Handle actuation force (Needle extension)
1. Needle Sharpness
1. Stylet Removal Force
1. Handle Home Position
1. Needle Extension Length
1. Adjustable Working Length (Sheath Extension length)
1. Needle to Luer Tensile Strength
1. Sheath to Sheath Hub (Actuation Guide)
1. Tensile strength; Adaptor to scope tensile
1. Device Luer to Adaptor Luer to Scope Tensile
1. Adaptor Lock & Unlock Force
1. Adaptor Suction

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1. Needle Extension Length Marking
1. Sheath Length Adjustment Markings
1. Handle Rotation
1. Smooth Actuation

8. Conclusion:

Boston Scientific has demonstrated that the proposed Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle is substantially equivalent to the currently marketed Boston Scientific Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration needle (K133312) and the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503).

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.