SHARKCORE FINE NEEDLE BIOPSY SYSTEM

K141894 · Covidien, LLC( Formerly Beacon Endoscopic Corp.) · FCG · Oct 6, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K141894
• Device Name: SHARKCORE FINE NEEDLE BIOPSY SYSTEM
• Applicant: Covidien, LLC( Formerly Beacon Endoscopic Corp.)
• Product Code: FCG · Gastroenterology, Urology
• Decision Date: Oct 6, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1075
• Device Class: Class 2

Intended Use

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

Device Story

SharkCore™ Fine Needle Biopsy System is an echogenic biopsy needle used via ultrasound endoscope instrument channel. System comprises Beacon™ EUS Delivery System and exchangeable SharkCore™ FNB needle sub-assembly. Used by physicians to sample submucosal and extramural gastrointestinal lesions. Needle features passive, automatic safety shielding to prevent needle stick injuries. Device is single-use. Physician visualizes target via ultrasound endoscope, advances needle to sample tissue; output is tissue sample for diagnostic evaluation. Benefits include targeted biopsy of lesions within or adjacent to GI tract.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Echogenic biopsy needle; modular design (delivery system and exchangeable needle sub-assembly); passive automatic safety shielding; single-use; compatible with ultrasound endoscope instrument channels.

Indications for Use

Indicated for fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes, and intraperitoneal masses within or adjacent to the gastrointestinal tract using an ultrasound endoscope.

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 (K133008)
• EchoTip Ultra Ultrasound Needle (K083330)

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 6, 2014

Covidien, Ilc. Saket Bhatt Regulatory Affairs Manager 2000 Commonwealth Avenue, Suite 110 Auburndale, MA 02466-2008

Re: K141894

> Trade/Device Name: SharkCore™ Fine Needle Biopsy System Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-urology biopsy instrument Regulatory Class: II Product Code: FCG Dated: September 11, 2014 Received: September 12, 2014

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.

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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 (reporting of medical device-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 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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

# 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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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) To be determined K141894

Device Name

SharkCore™ Fine Needle Biopsy System

#### Indications for Use (Describe)

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

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)

#### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

#### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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#### 510(k) SUMMARY 5.0

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

### Submitter's Name, Address, Telephone Number and Contact Person

Covidien IIc (formerly Beacon Endoscopic Corp.) 2000 Commonwealth Ave. Suite 110 Auburndale, MA 02466-2008

Contact: Saket Bhatt, Regulatory Affairs Manager, Covidien IIc 540 Oakmead Parkway, Sunnyvale, CA, 94085

Phone: [phone] [phone] (same as phone#) Fax:

Date Prepared: July 10, 2014

#### Name of Medical Device:

SharkCore™ Fine Needle Biopsy System (includes Beacon™ EUS Delivery System and SharkCore™ FNB Needle) Device Regulation: 21 CFR 876.1075, Class II Product Code: FCG Common/Usual Name: Kit, Needle, Biopsy (FCG) Classification Panel: Gastroenterology-Urology Devices Panel

#### Establishment Registration Number, Owner/Operator Number:

Establishment Registration Number: 3009144059 Owner/Operator Number: 10037745

#### Predicate Devices

BNX Fine Needle Aspiration System (reference K133008, November 20, 2013) EchoTip Ultra Ultrasound Needle (reference K083330; Feb 06, 2009)

## Device Description

The SharkCore™ Fine Needle Biopsy (FNB) System is an echogenic biopsy needle used through the instrument channel of an ultrasound imaging endoscope. The system is used to sample targeted submucosal and extramural gastrointestinal lesions through the accessory channel of an ultrasound endoscope. The SharkCore™ Fine Needle Biopsy (FNB) System is modular in design consisting of two major components; i.e., a delivery system (Beacon™ EUS Delivery System) and a separate exchangeable needle sub-assembly (SharkCore™ FNB Needle).

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### Indications for Use

The SharkCore™ Fine Needle Biopsy System is used with an ultrasound endoscope for fine needle biopsy, (FNB), of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal 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 stick injury.

## Technological Characteristics Compared to Predicate Devices

The SharkCore™ Fine Needle Biopsy System is identical to the legally marketed BNX™ Fine Needle Aspiration System (reference K133008) in terms of 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. The SharkCore Fine Needle Biopsy System is substantially equivalent to the legally marketed EchoTip Ultra Ultrasound Needle (reference K083330; Feb 06, 2009) in terms of indications for use, anatomical location of use and labeling.

#### Performance Data

Bench testing demonstrates performance equivalence for the SharkCore FNB system when evaluated against its predicate devices.

#### Conclusion

Covidien IIc considers the SharkCore™ Fine Needle Biopsy System to be substantially equivalent to legally marketed predicate devices BNX Fine Needle Aspiration System (reference K133008, November 20, 2013), and EchoTip Ultra Ultrasound Needle (reference K08330; Feb 06, 2009). The test results and compliance with applicable standards provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its indications for use.