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.

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).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the SharkCore™ Fine Needle Biopsy System. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a clinical trial summary.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness studies are not available in this document. This submission relies on bench testing and comparison to predicate devices, not human or clinical performance studies with specific metrics outlined in the request.

Here's a breakdown of what can be extracted and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Function: Fine needle biopsy (FNB) of submucosal lesions, mediastinal masses, lymph nodes and intaperitoneal masses within or adjacent to the gastrointestinal tract.	"Bench testing demonstrates performance equivalence for the SharkCore FNB system when evaluated against its predicate devices." No specific quantitative performance metrics (e.g., accuracy, sensitivity, specificity, yield) are provided or were likely required for this type of 510(k) submission based on substantial equivalence.
Safety: Passive (automatic) safety shielding feature to aid in the prevention of needle stick injury.	Integrated into the device design as described. No specific performance data (e.g., rate of successful deployment, reduction in needle sticks) is provided.
Equivalence to BNX™ Fine Needle Aspiration System (K133008) in:	"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."
Equivalence to EchoTip Ultra Ultrasound Needle (K083330) in:	"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."

2. Sample size used for the test set and the data provenance

Not Available. The document states "Bench testing demonstrates performance equivalence" but does not specify the sample size of devices tested or the data provenance (e.g., country of origin, retrospective/prospective). This is a pre-market notification using bench testing, not a clinical study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Available. No ground truth establishment by experts is described in this document, as it focuses on engineering and design equivalence through bench testing, not clinical performance requiring expert interpretation of results.

4. Adjudication method for the test set

Not Applicable / Not Available. There was no human "test set" requiring adjudication in this 510(k) submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. This device is a biopsy system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This device is a physical biopsy system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable / Not Available. As mentioned, the document focuses on bench testing for substantial equivalence, not clinical outcomes or diagnostic accuracy requiring a ground truth as defined in this question. The "ground truth" for the bench testing would have been engineering specifications and predicate device performance.

8. The sample size for the training set

Not Applicable / Not Available. There is no "training set" as this is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not Applicable / Not Available. As above, no training set or its ground truth is relevant or discussed.

Summary

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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 (800) 638-2041 or (301) 796-7100 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: (408) 328-7357 (408) 328-7357 (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

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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.

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
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.(b)
Classification. (1) Class II (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Herbert P. Lerner -S

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Indications for Use (Describe)

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FOR FDA USE ONLY

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510(k) SUMMARY 5.0

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

Name of Medical Device:

Establishment Registration Number, Owner/Operator Number:

Predicate Devices

Device Description

Indications for Use

Technological Characteristics Compared to Predicate Devices

Performance Data

Conclusion

§ 876.1075 Gastroenterology-urology biopsy instrument.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW