BNX FINE NEEDLE ASPIRATION SYSTEM

K103668 · Boston Endoscopic Engineering · FCG · Dec 30, 2010 · Gastroenterology, Urology

Device Facts

• Record ID: K103668
• Device Name: BNX FINE NEEDLE ASPIRATION SYSTEM
• Applicant: Boston Endoscopic Engineering
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Dec 30, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The BNX™ Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.

Device Story

BNX Fine Needle Aspiration System is a sterile, single-patient-use endoscopic ultrasound (EUS) biopsy device. It comprises a modular delivery system (sheath and handle) and an aspiration needle/stylette assembly. Operated by a physician through an ultrasound endoscope accessory channel; the device targets submucosal and extramural gastrointestinal lesions. The needle tip is etched for ultrasonic visualization. During the procedure, the needle penetrates the lesion; suction is applied via a standard hypodermic syringe to acquire tissue samples into the needle lumen. The modular design allows needle size exchange (19, 22, or 25 gauge) without disconnecting the handle from the endoscope. The output is a tissue sample for diagnostic evaluation. The device benefits patients by enabling minimally invasive, image-guided biopsy of GI lesions.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including mechanical/integrity evaluations (tensile strength, torque resistance, bond strength, fracture testing) and performance evaluations (device function, locking forces, stylette withdrawal, perforation testing, needle echogenicity, and aspiration capability).

Technological Characteristics

Modular EUS-FNA biopsy needle system. Components: metallic needle, stylette, sheath, and handle assembly. Features etched needle tips for ultrasonic visualization. Needle sizes: 19, 22, 25 gauge. Connectivity: manual luer-lock connection to endoscope. Sterilization: sterile, single-patient use. No software or electronic components.

Indications for Use

Indicated for sampling targeted submucosal and extramural gastrointestinal lesions via ultrasound endoscope accessory channel.

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

• Cook Medical EchoTip Ultrasound Needle (K083330)
• Olympus Single-Use Aspiration Needle (K023272)

Submission Summary (Full Text)

{0}------------------------------------------------

K103668

# DEC 3 0 2010

# 510(k) SUMMARY

# Page 1 of 3

ィ

This 510(k) Summary for the BNX™ Fine Needle Aspiration System is being submitted in accordance with 21 CFR 807.92.

| Submitter's Name<br>and Address: | Boston Endoscopic Engineering (BEE) Corp.<br>18 Park Street<br>Danvers, MA USA 01923 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Annette Fagnant, Regulatory Affairs Consultant,<br>MedDRA Assistance Inc.<br>53 Kennedy Road<br>Foster, RI 02825<br>Phone: [phone]<br>Fax: [phone] |
| Date: | November 19, 2010 |
| Name of Medical<br>Device: | Device Regulation: 21 CFR 876.1075, Class II<br>Product Code: FCG<br>Common/Usual Name: Kit, Needle, Biopsy (FCG)<br>Proprietary Name: BNXTM Fine Needle Aspiration System<br>Classification Panel: Gastroenterology-Urology Devices Panel |
| Predicate Devices: | The subject device is substantially equivalent to the:<br>Cook Medical EchoTip Ultrasound Needle (K083330, cleared 2/6/2009) andOlympus Single-Use Aspiration Needle (K023272, cleared 12/23/2002). |
| Device<br>Description: | The BNXTM Fine Needle Aspiration System is a sterile, single patient use<br>endoscopic ultrasound aspiration needle. The device consists of the BNXTM<br>Aspiration Delivery System and BNXTM Fine Needle Aspiration Needle which<br>are assembled before insertion through the accessory channel of an<br>ultrasound endoscope. The needle is used to acquire aspiration samples<br>from lesions targeted using an ultrasound endoscope. An aspiration sample is<br>obtained by penetrating the lesions with the needle while applying suction.<br>The device will be offered with needle sizes of 19, 22 and 25 gauge. |

{1}------------------------------------------------

#### 510(k) SUMMARY Page 2 of 3

Indication For Use:

The BNX™ Fine Needle Aspiration System is used to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope.

Technological Characteristics:

The proposed BNX™ Fine Needle Aspiration System has similar intended use and similar technological characteristics compared with the predicate Cook Echo-Tip Ultrasound Needle and the Olympus Single-Use Aspiration Needle. All three devices are endoscopic ultrasound fine needle aspiration (EUS-FNA) biopsy needles designed to be compatible with the accessory channel of standard ultrasonographic endoscopes. A comparison of the intended use of the proposed BNX™ Fine Needle Aspiration System and the predicate devices is provided in the table below. Although the predicate Cook device was cleared for delivery of injectable materials into tissue during endoscopic procedures, similar to the predicate Olympus Single Use Aspiration Needle, the indication for use statement for the BNX™ Fine Needle Aspiration System is limited to use for sampling targeted submucosal and extramural lesions within the gastrointestinal tract. The application of an EUS-FNA device for delivery of injectable materials is a separate and distinct use from the procedure required to sample targeted sub-mucosal and extramural gastrointestinal lesions (i.e., no delivery of injectable materials is required for sample acquisition) and therefore exclusion of delivery of injectable materials as a component of the indication statement for the proposed BNX FNA device is not relevant to the safety and effectiveness of the device when used as labeled.

| Comparison of Indication for Use Statements | | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Proposed Device<br>BNX FNA System<br>(This Submission) | EchoTip Ultra<br>UltraSound Needle<br>(Cook Medical)<br>K083330 | Single Use Aspiration<br>Needle (Olympus<br>Medical)<br>K023272 |
| The BNX™ Fine<br>Needle Aspiration<br>System is used to<br>sample targeted sub-<br>mucosal and<br>extramural<br>gastrointestinal<br>lesions through the<br>accessory channel of<br>an ultrasound<br>endoscope. | This device is intended<br>to be used with an<br>ultrasound endoscope<br>for delivery of injectable<br>materials into tissues<br>during endoscopic<br>procedures and fine<br>needle aspirations (FNA)<br>of submucosal lesions,<br>mediastinal masses,<br>lymph nodes and<br>intraperitoneal masses<br>within or adjacent to the<br>GI tract. | This instrument has been<br>designed to be used with<br>the ultrasound endoscope<br>for ultrasonically guided<br>fine needle aspiration<br>(FNA) of submucosal and<br>extramural lesions within<br>the gastrointestinal tract<br>(i.e. pancreatic masses,<br>mediastinal masses,<br>perirectal masses and<br>lymph nodes). |

The referenced EUS-FNA devices incorporate a long stiff metallic needle with stylette housed in a sheath with handle assembly. The handle is screwed onto the luer-lock connection of the endoscope. The needle is manipulated by a handle piston which is locked and unlocked by means of

{2}------------------------------------------------

### 510(k) SUMMARY Page 3 of 3

a screw to avoid advancement of the needle during introduction and withdrawal of the biopsy assembly. The tips of these EUS-FNA needles are etched for enhanced ultrasonic needle visualization. Tissue samples are acquired into the lumen of the needle via applied suction using a standard hypodermic syringe. Whereas, the handle/ sheath/needle subassemblies of the predicate Cook and Olympus EUS-FNA are integrated in a single device, the BNX™ FNA System is modular in design, i.e., the sheath and handle assembly are incorporated in a Delivery System as a separate component from the aspiration needle/stylette assembly. The modular design facilitates exchange of any size aspiration needle as the needle can be removed from the scope without requiring that the handle be disconnected.

Performance Data:

Biocompatibility and bench testing was performed demonstrating that the subject device is substantially equivalent to the predicate devices for the proposed intended use. Specifically, verification tests were performed on the proposed BNX™ FNA System; including where applicable, a direct comparison with the predicate devices. Verification tests performed included: mechanical/integrity evaluations (i.e., handle tensile strength, handle resistance to torque, bond strengths and needle fracture) and performance evaluations (i.e., device function/durability, aspiration needle/handle locking force, needle and catheter sheath extension locking forces, stylette withdrawal force, perforation testing, needle echogenicity and aspiration capability) both before and following exposure to aging conditions. Additionally, testing has been performed that demonstrates packaging integrity for the labeled shelf-life. Results of performance testing have established that the BNX FNA System is adequately designed for its use having established conformance with pre-specified intended acceptance criteria. Furthermore, the BNX FNA System was determined to be functionally equivalent to the predicate Cook and/or Olympus device with respect to key performance criteria such as needle puncture force and echogenicity (i.e., acoustic reflection). Thus, the performance data verify that the proposed BNX FNA System is substantially equivalent to the currently marketed predicate Cook Medical EUS-FNA device. Based upon testing performed it can be established that BNX FNA System raises no new issues of safety or effectiveness compared with the predicate devices.

Clinical data are not necessary to demonstrate substantial equivalence.

Conclusion:

Boston Endoscopic Engineering Corp. has demonstrated that the proposed BNX™ Fine Needle Aspiration System is substantially equivalent to the predicate Cook Echo-Tip Ultrasound Needle and the Olympus Single Use Aspiration Needle.

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, with three lines forming a stylized bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

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

Boston Endoscopic Engineering Corp. c/o Paula Wilkerson, RAC Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 E. Aurora Road, Unit B7 TWINSBURG OH 44087

DEC 3 0 2010

Re: K103668

Trade/Device Name: BNX™ Fine Needle Aspiration System Regulation Number: 21 CFR §876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: December 15, 2010 Received: December 16, 2010

Dear Ms. Wilkerson:

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-related

{4}------------------------------------------------

Page 2

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR, 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hubert Lemmer MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

#### Indication for Use Statement 4.0

**510(k) Number (if known):**

K103668

DEC 3 0 2010

Device Name:

BNX™ Fine Needle Aspiration System

Indications for Use:

The BNX™ Fine Needle Aspiration System is used to sample targeted sub-mucosal and extramural lesions of the gastrointestinal tract through the accessory channel of an ultrasound endoscope.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


ductive.

Traditional 510(k) - BNX™ Fine Needle Aspiration System