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 Description

The BNX FNA / SharkCore FNB Systems are sterile, single patient use endoscopic ultrasound aspiration needles. The devices consists of the Beacon 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 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.

AI/ML Overview

The provided document is a 510(k) summary for the BNX™ Fine Needle Aspiration System and the SharkCore™ Fine Needle Biopsy System. It describes the devices, their indications for use, and a summary of performance data. However, it does not contain the detailed information needed to construct a table of acceptance criteria and the study that proves the device meets those criteria, specifically regarding:

Specific acceptance criteria values: The document only states that the devices "met the required specifications for completed design verifications tests." It does not provide the actual numerical or qualitative acceptance criteria for these tests (e.g., "unlocking forces must be > X N," or "sheath extension must be Y mm").
Reported device performance values: Similarly, it states the devices "met the required specifications" but does not report the actual measured performance values (e.g., "unlocking forces measured Z N," or "sheath extension measured W mm").
Sample sizes for test or training sets: It mentions "bench testing" but does not specify the number of units tested.
Data provenance: No information on country of origin or retrospective/prospective nature.
Details about experts or ground truth: Not applicable for bench testing.
Adjudication method: Not applicable for bench testing.
MRMC comparative effectiveness study: Not applicable, as this is bench testing, not a clinical study involving human readers.
Standalone algorithm performance: Not applicable, as this is a physical medical device, not an AI algorithm.
Type of ground truth, training set size, and how training ground truth was established: Not applicable for bench testing.

Therefore, I can only provide the information that is available in the document, which primarily concerns the types of tests performed and a general statement about meeting specifications.

1. Table of Acceptance Criteria and Reported Device Performance

Test Performed	Acceptance Criteria (Not Explicitly Stated, Implied "Met Specified Requirements")	Reported Device Performance (General Statement, Specifics Not Provided)
Unlocking Forces	Must meet pre-defined force requirements (e.g., minimum force to unlock mechanism)	Met the required specifications
Retention Forces	Must meet pre-defined force requirements (e.g., force to retain components)	Met the required specifications
Sheath Extension Over Needle	Must meet pre-defined dimensional requirements (e.g., length of sheath coverage over needle tip)	Met the required specifications
Dimensional Specifications	All critical dimensions must fall within specified tolerances	Met the required specifications
Bond Strengths	Must meet pre-defined strength requirements for bonded components	Met the required specifications
Durability	Must withstand specified wear and tear or repeated use cycles	Met the required specifications

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

Sample Size: Not specified. The document only mentions "Bench testing has been performed."
Data Provenance: Not specified, but likely laboratory testing conducted by the manufacturer, Covidien, LLC. This is prospective testing of manufactured devices.

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

Not applicable. The described testing involves bench testing of physical device attributes (forces, dimensions, durability), not human expert evaluation of data or images.

4. Adjudication method for the test set:

Not applicable. The described testing involves bench testing of physical device attributes.

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 document pertains to the 510(k) clearance of physical aspiration/biopsy needles and does not involve AI or human image interpretation.

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

Not applicable. This document pertains to a physical medical device, not an algorithm.

7. The type of ground truth used:

For this bench testing, the "ground truth" would be the engineering specifications and design requirements that the device's performance characteristics (e.g., unlocking force, dimensions) were measured against.

8. The sample size for the training set:

Not applicable. This document describes verification testing for a physical device, not an algorithm that requires a training set.

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

Not applicable. No training set is involved in the context of this device's regulatory submission as described.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, overlapping each other to create a sense of depth and connection.

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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 Ilc15 Hampshire StreetMansfield, MA 02048
Contact Person:	Saket Bhatt,Regulatory Affairs ManagerCovidien IIc540 Oakmead ParkwaySunnyvale, CA, 94085Phone : 408-328-7357Fax : 408-328-7357 (same as phone #)
Date:	April 1, 2015
Name of Medical Device:	Device Regulation: 21 CFR 876.1075, Class IIProduct Code: FCG for SharkCore Fine Needle Biopsy SystemFCG and NEU for BNX Fine Needle Aspiration SystemCommon/Usual Name: Kit, Needle, BiopsyProprietary Name: BNX Fine Needle Aspiration System / SharkCore Fine Needle Biopsy SystemClassification 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).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.

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.