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 tracheobronchial tree. Do no use this instrument for any purpose other than its intended use.

Device Description

The ExpectTM Pulmonary device is comprised of the following:

Expect™ Pulmonary needle
Expect™ Pulmonary adaptor
Syringe
Stopcock

The Expect™ Pulmonary device is an Endobronchial Ultrasound guided Transbronchial Aspiration Needle used for fine needle aspiration (FNA) of submucosal and extramural lesions of the tracheobronchial tree. 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 document is a 510(k) summary for the Boston Scientific Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria for a new AI/software device.

Therefore, the information required to populate a table of acceptance criteria and reported device performance related to AI/software functionality, as well as details about sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not present in this document.

This submission focuses on the physical and functional aspects of a medical device (a needle) and its accessories, not on a diagnostic algorithm or AI.

Here's why the requested information cannot be extracted from this document:

Nature of the Device: The device is a "Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle." This is a physical medical instrument used for tissue sampling. It is not an AI or software device.
Type of Submission: A 510(k) submission primarily aims to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This is done through comparing technological characteristics and performance data (often bench testing, biocompatibility, sterilization) to show that the new device is as safe and effective as the predicate. It does not typically involve clinical efficacy trials or AI performance evaluations as would be required for a novel diagnostic algorithm.
Performance Data Section: The "Performance Data" section (Section 7) describes:
- Biocompatibility Testing: Ensuring the materials are safe for human contact.
- Sterilization Testing: Ensuring the device can be properly sterilized.
- Performance Testing Summary: A list of 21 "bench tests" (e.g., Device Flexibility, Needle Sharpness, Handle actuation force, Tensile strength). These are engineering/mechanical tests on the physical device, not evaluations of diagnostic accuracy or AI performance.

In summary, this document does not contain the information required to address your specific questions about acceptance criteria for an AI/software device and the study proving it, because the device in question is a physical medical instrument, not an AI/software product.

Summary

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

November 10, 2015

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

Re: K151315

Trade/Device Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle Regulation Number: 21 CFR 874.4680 Regulation Name: Bronchoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOO Dated: October 1, 2015 Received: October 2, 2015

Dear Ms. 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

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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 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,

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K151315

Device Name

Expect™ Pulmonary Endobronchial Ultrasound Transbronchial 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: 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: October 29, 2015

2. Device:

Trade Name:	Expect TM Pulmonary Endobronchial UltrasoundTransbronchial Aspiration Needle
Device Common Name:	Endobronchial Ultrasound Transbronchial AspirationNeedle/ EBUS-TBNA needle
Classification Name:	Bronchoscope (flexible or rigid) and accessories
Regulation Number:	874.4680
Product Code:	EOQ
Classification:	Class II

3. Predicate Device:

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

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Regulation Number:	876.1075
Product Code:	FCG
Classification:	Class II
And
Reference device:
Trade Name:	Expect™ Slimline (SL) Endoscopic UltrasoundAspiration needle
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

4. Device Description:

Device Name: Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

The ExpectTM Pulmonary device is comprised of the following:

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

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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/Indications for Use:

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 tracheobronchial tree. Do not use this instrument for any purpose other than its intended use.

6. Technological Characteristics:

The proposed Expect™ Pulmonary device is designed to acquire sample in the Airway 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

Comparison to Predicate:

The proposed Expect Pulmonary device is substantially equivalent to the current marketed predicate, the Olympus Single Use Aspiration Needle NA-201SX-4022 (K050503). The Expect Pulmonary device has similar technological characteristics as the predicate, that is, they operate in the same manner to obtain a tissue biopsy using an ultrasound endoscope. The indication for use of the proposed Expect Pulmonary device is nearly identical to the predicate device.

The comparison of the proposed Expect Pulmonary device and the Olympus Vizishot device is provided in the following Table 6-1.

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Device Characteristics	Predicate Olympus Vizishot deviceK050503	Proposed Device BSC Expect™Pulmonary Device
Indications for Use	This instrument has been designed tobe used with ultrasonic endoscopesfor ultrasonically guided fine needleaspiration (FNA) of submucosal andextramural lesions of thetracheobronchial tree and thegastrointestinal tract.Do not use this instrument for anypurpose other than its intended use.	The Expect™ Pulmonary EndobronchialUltrasound Transbronchial AspirationNeedle is designed to be used withendobronchial ultrasound endoscopes forultrasound guided fine needle aspiration(FNA) of the submucosal and extramurallesions of the tracheobronchial tree.Do not use this instrument for anypurpose other than its intended use.
Single-Use	Single Use	Identical
Sterile	EO	Identical
Mechanism of Actionfor NeedleAdvancement	Manual	Identical
Mechanism for TissueSampling	Aspiration	Identical
Number of DevicePasses during aprocedure	Multiple Passes	Identical
Needle Gauge Size	21ga & 22ga	22ga & 25ga
Ability to Visualizewith EndoscopicUltrasound	Echogenic signature on distal end ofdevice	Identical
Sheath Length	Adjustable	Identical.
Minimum WorkingChannelCompatibility	2.0mm (for both 22ga and 21ga)	Identical. 2.0mm (for both 22ga and25ga)
Device to scopeattachment	Adaptor biopsy valves Attachment forOlympus ultrasound bronchoscopes.	Adaptor Attachment compatible withOlympus and Fujinon ultrasoundbronchoscopes.

Table 6-1 . Comparison of Key Characteristics

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The primary difference between the proposed Expect™ Pulmonary device and its predicate devices is the gauge size, patient contact materials and adjustable needle length. With the fully completed biocompatibility and performance bench testing, BSC considers these differences do not raise questions about the safety or effectiveness of the device. Based on the comparison above BSC considers the proposed Expect™ Pulmonary device substantially equivalent to the predicate devices.

The currently cleared Boston Scientific device Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration needle (K133312) is used as a reference device based on its design similarity to the Expect™ Pulmonary device.

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.

Sterilization Testing summary:

The proposed Boston Scientific Expect™ Pulmonary devices meet the requirements of ISO 11135-1:2007 "Sterilization of health care products - Ethylene oxide -- Part 1: Medical devices requirements for development, validation and routine control of a sterilization process for medical devices". This product's Ethylene oxide (EO) sterilization cycle is validated to achieve a minimum sterility assurance level (SAL) of 10 °. And the product Ethylene oxide residual levels conform to ISO 10993-7:2008 (R: 2012) "Biological Evaluation of Medical Devices- Part 7: Ethylene Oxide Sterilization Residuals".

Performance Testing Summary:

Non-clinical performance testing was conducted on the Expect™ Pulmonary device which demonstrates the device met the required specifications. The proposed Boston Scientific Expect™ Pulmonary device and packaging were successfully verified after nominal and accelerated age tests, showing the Expect™ Pulmonary device met its shelf life requirements.

The following bench tests were performed:

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

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

8. Conclusion:

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

Regulation Number and Section

§ 874.4680 Bronchoscope (flexible or rigid) and accessories.

(a)
Identification. A bronchoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the bronchoscope and is intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the rigid ventilating bronchoscope, rigid nonventilating bronchoscope, nonrigid bronchoscope, laryngeal-bronchial telescope, flexible foreign body claw, bronchoscope tubing, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps, flexible biopsy curette, and rigid bronchoscope aspirating tube, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.