BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System

K150891 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · FCG · May 1, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150891
• Device Name: BNX Fine Needle Aspiration System and SharkCore LG Fine Needle Biopsy System
• Applicant: Covidien, LLC( Formerly Beacon Endoscopic Corp.)
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: May 1, 2015
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Indications for Use

BNX Fine Needle Aspiration System: The device is used to sample targeted sub-mucosal and extramural gastrontestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks. The 19Ga. and 22Ga. BNX™ ASPIRATION Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures. Shark Core Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adiacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shelding feature to aid in the prevention of needle sticks.

Device Story

Sterile, single-use endoscopic ultrasound (EUS) aspiration/biopsy needles; used with ultrasound endoscope accessory channel. System comprises Beacon delivery system and either BNX aspiration needle or SharkCore biopsy needle. Features integrated passive safety shield that automatically covers needle tip upon removal to prevent needle sticks. Operated by clinicians during endoscopic procedures to sample lesions or implant fiducial markers. Output is tissue sample or implanted marker. Benefits include reduced risk of accidental needle sticks for healthcare personnel and precise tissue acquisition/marking under EUS guidance.

Clinical Evidence

Bench testing only. Testing evaluated unlocking forces, retention forces, sheath extension, dimensional specifications, bond strengths, and durability to verify design modifications.

Technological Characteristics

Sterile, single-use endoscopic needles (19, 22, 25 gauge). Features passive automatic needle protection shield. Materials, sterilization, and shelf life consistent with predicate devices. Mechanical actuation for needle deployment and safety shield engagement.

Indications for Use

Indicated for patients requiring endoscopic ultrasound-guided sampling of submucosal, extramural, or intraperitoneal lesions, mediastinal masses, or lymph nodes within or adjacent to the GI tract. BNX needles also indicated for fiducial marker implantation in soft tissue.

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

• BNX Fine Needle Aspiration System (K142198)
• SharkCore™ EUS FNB (K141894)

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

May 1, 2015

Covidien, LLC Saket Bhatt Regulatory Affairs Manager 540 Oakmead Parkway Sunnyvale, CA 94085

Re: K150891

> Trade/Device Name: BNX™ Fine Needle Aspiration System Product Code: FCG, NEU Trade/Device Name: SharkCore™ Fine Needle Biopsy System Product Code: FCG

> Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Dated: April 1, 2015 Received: April 2, 2015

Dear Saket Bhatt,

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 [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,

# 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K150891

Device Name

BNX Fine Needle Aspiration System and the SharkCore Fine Needle Biopsy System

Indications for Use (Describe)

BNX Fine Needle Aspiration System: The device is used to sample targeted sub-mucosal and extramural gastrontestinal lesions through the accessory channel of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks. The 19Ga. and 22Ga. BNX™ ASPIRATION Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

Shark Core Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adiacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shelding feature to aid in the prevention of needle sticks.

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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FORM FDA 3881 (8/14)

Page 1 of 1

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# 510(k) Summary Page 1 of 2

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

| Submitter's Name and Address: | Covidien Ilc<br>15 Hampshire Street<br>Mansfield, MA 02048 |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Saket Bhatt,<br>Regulatory Affairs Manager<br>Covidien IIc<br>540 Oakmead Parkway<br>Sunnyvale, CA, 94085<br>Phone : [phone]<br>Fax : [phone] (same as phone #) |
| Date: | April 1, 2015 |
| Name of Medical Device: | Device Regulation: 21 CFR 876.1075, Class II<br>Product Code: FCG for SharkCore Fine Needle Biopsy System<br>FCG and NEU for BNX Fine Needle Aspiration System<br>Common/Usual Name: Kit, Needle, Biopsy<br>Proprietary Name: BNX Fine Needle Aspiration System / SharkCore Fine Needle Biopsy System<br>Classification Panel: Gastroenterology-Urology Devices Panel |
| Predicate Devices: | The modified BNX EUS FNA is substantially equivalent to the BNX Fine Needle Aspiration System cleared in K142198 (October 8, 2014).<br>The modified SharkCore EUS FNB is substantially equivalent to the SharkCore ^TM EUS FNB cleared in K141894 (October 6, 2014). |
| Device Description: | The BNX FNA / SharkCore FNB Systems are sterile, single patient use endoscopic ultrasound aspiration needles. The devices consists of the Beacon ^TM Endoscopic Ultrasound Delivery System and either the BNX Fine Needle Aspiration Needle or the SharkCore Fine Needle Biopsy Needle which are assembled before insertion through the accessory channel of an ultrasound endoscope. The devices are offered with needle sizes of 19, 22 and |

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## 510(k) SUMMARY Page 2 of 2

25 gauge. The BNX FNA / SharkCore FNB Systems have an integrated needle protection shield that automatically engages over the distal end of the needle during removal to cover the needle sharp. In this manner, the needle tip is covered to help protect against inadvertent needle sticks.

BNX Fine Needle Aspiration System: The device is used to sample targeted sub-Indications For mucosal and extramural gastrointestinal lesions through the accessory channel Use: of an ultrasound endoscope. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks. The 19Ga. And 22 GA. BNX™ Aspiration Needles are also intended to implant fiducial markers under endoscopic ultrasound to radiographically mark soft tissue for future therapeutic procedures.

> SharkCore Fine Needle Biopsy System: The device is used with an ultrasound endoscope for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses within or adjacent to the gastrointestinal tract. The needle is designed with a passive (i.e., automatic) safety shielding feature to aid in the prevention of needle sticks.

Technological The modified BNX FNA / SharkCore FNB Systems are similar to the legally marketed devices described in K142198 and K141894 respectively in terms of Characteristics: principle of operation, technological and performance characteristics (control mechanism, environmental specifications, dimensional specifications, ergonomics of patient-user interface, packaging, sterilization and shelf life), materials, anatomical site, operating instructions, and single-use disposition.

Performance Bench testing has been performed for those attributes that may be impacted by Data: the modifications made to the subject devices which demonstrates that the proposed modified BNX FNA / SharkCore FNB Systems met the required specifications for completed design verifications tests which included evaluation of unlocking forces, retention forces, sheath extension over the needle, dimensional specifications, bond strengths and durability.

- The results of the non-clinical testing and a comparison of similarities and Conclusion: differences between the modified devices and the respective predicate devices demonstrate that the proposed and predicate devices are substantially equivalent.