Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle

K151895 · Boston Scientific Corporation · FCG · Oct 22, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K151895
• Device Name: Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle
• Applicant: Boston Scientific Corporation
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Oct 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended 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 gastrointestinal tract. Do no use this instrument for any purpose other than its intended use.

Device Story

Device is a single-use aspiration needle system for fine needle aspiration (FNA) of submucosal and extramural lesions. Components include a sheath-covered needle, handle, adaptor, syringe, and stopcock. Operated by a physician during endoscopic procedures; device passes through the accessory channel of an endobronchial ultrasound (EBUS) endoscope. The adaptor secures the device to the bronchoscope biopsy port. The handle actuates the needle; syringe and stopcock provide vacuum suction for sample aspiration. Stylet protects the sheath during passage and assists in sample expulsion. Device enables tissue sampling under ultrasound guidance, aiding in diagnostic decision-making for lesions.

Clinical Evidence

Bench testing only. No clinical data provided. Performance testing included biocompatibility (ISO 10993-1:2009) and mechanical bench tests (flexibility, passability, durability, locking forces, tensile strength, and aspiration capability) to confirm equivalence to predicate devices.

Technological Characteristics

Components: needle, adaptor, syringe, stopcock. Features: adjustable sheath/needle length, locking mechanisms, echogenic needle, kink-resistant stylet. Materials: same as Expect™ Slimline. Connectivity: mechanical coupling to endoscope biopsy port via luer connection. Sterilization: not specified. Software: none.

Indications for Use

Indicated for ultrasound-guided fine needle aspiration (FNA) of submucosal and extramural lesions of the gastrointestinal tract using endobronchial ultrasound endoscopes.

Regulatory Classification

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.

Predicate Devices

• Expect™ Slimline (SL) Endoscopic Ultrasound Aspiration needle (K133312)
• Single Use Aspiration Needle NA-201SX-4022 (K050503)

Reference Devices

• Vizishot device

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

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 [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.

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)

| <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|--------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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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: [phone] Fax: [phone]

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

Date Prepared: July 9, 2015

### 2. Device:

| Trade Name: | Expect TM Pulmonary Endobronchial Ultrasound<br>Transbronchial Aspiration Needle |
|----------------------|----------------------------------------------------------------------------------------------|
| Device Common Name: | Endobronchial Ultrasound Transbronchial Aspiration<br>Needle/ 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 Ultrasound<br>Aspiration needle |
|-------------|------------------------------------------------------------------|
|-------------|------------------------------------------------------------------|

Premarket Notification, Expect™ Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle SECTION 6

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| Device Common Name: | Endoscopic Ultrasound Aspiration needle /<br>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 Aspiration<br>Needle/ 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:

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.

# 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
- 2. Device Passability
- 3. Device Durability (Robustness)
- 4. Needle and Sheath Adjustment Locking Force
- 5. Handle actuation force (Needle extension)
- 6. Needle Sharpness
- 7. Stylet Removal Force
- 8. Handle Home Position
- 9. Needle Extension Length
- 10. Adjustable Working Length (Sheath Extension length)
- 11. Needle to Luer Tensile Strength
- 12. Sheath to Sheath Hub (Actuation Guide)
- 13. Tensile strength; Adaptor to scope tensile
- 14. Device Luer to Adaptor Luer to Scope Tensile
- 15. Adaptor Lock & Unlock Force
- 16. Adaptor Suction

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- 17. Needle Extension Length Marking
- 18. Sheath Length Adjustment Markings
- 19. Handle Rotation
- 20. 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).