The Bard® Mission® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.

Device Description

The subject device BARD® MISSION® Disposable Core Biopsy Instrument is a single use core biopsy device. It is available in several needle gauge sizes and lengths. The plunger is color coded according to the various gauge sizes, e.g. yellow = 20 gauge, pink = 18 gauge, purple = 16 gauge, and green = 14 gauge.

AI/ML Overview

The provided text describes the 510(k) submission for the Bard® Mission® Disposable Core Biopsy Instrument. This document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and biocompatibility.

Crucially, this document does not contain information about a study involving AI assistance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by human experts for an algorithm's performance. The device in question is a physical medical instrument for obtaining biopsy samples, not a diagnostic imaging AI or similar software.

Therefore, many of the requested criteria regarding AI performance, human reader improvement, expert consensus, and ground truth establishment for a diagnostic algorithm are not applicable to this document.

However, I can extract information related to the device's acceptance criteria and performance based on the non-clinical (bench) testing described in the 510(k) summary.

Here's a breakdown of the available information:

1. Table of acceptance criteria and the reported device performance:

The document states: "The subject device, BARD® MISSION® Disposable Core Biopsy Instrument, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs."

While specific numerical acceptance criteria and their corresponding reported performance values are not explicitly detailed in a table, the document lists the in vitro tests performed and generally states that the device "performed as expected."

Acceptance Criteria Category (Derived from Tests Performed)	Reported Device Performance
Number of Samples (ability to collect samples)	Performed as expected
Penetration Depths (accuracy of needle penetration)	Performed as expected
Stylet / Cannula to Handle Tensile Strength (durability)	Performed as expected
Corresponding Working Needle Length and Cutting Cannula OD, and Stylet/Cannula Working Needle Lengths (dimensional accuracy)	Performed as expected
Integrity of the Sterile Barrier (sterility maintenance)	Performed as expected
Performance After Ship Testing (durability during transport)	Performed as expected
Needle Protection After Shipping and Storage (safety and integrity)	Performed as expected

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

Sample Size: The document does not specify exact numerical sample sizes for each in vitro test. It broadly refers to "the subject device BARD® MISSION®" being tested.
Data Provenance: The tests are described as "in vitro tests," meaning they were performed in a lab setting (bench testing) rather than on human or animal subjects. The provenance is internal testing performed by C.R. Bard. The document does not specify a country of origin for these specific tests, but the submission is to the US FDA. The testing is prospective in the sense of being performed for this submission.

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

Not Applicable. This document describes the performance of a physical biopsy instrument through bench testing, not a diagnostic algorithm requiring expert interpretation or ground truth establishment in a clinical context. The "ground truth" for these engineering tests would simply be the objective measurements and adherence to specifications.

4. Adjudication method for the test set:

Not Applicable. As above, this is about physical instrument performance tests, not diagnostic interpretations requiring adjudication.

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 is a physical core biopsy instrument, not an AI-assisted diagnostic tool.

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

Not Applicable. This is not an algorithm.

7. The type of ground truth used:

For the physical tests, the "ground truth" is based on engineering specifications, measurements, and established testing protocols (e.g., ISO 10993-1 for biocompatibility). There is no "expert consensus" or "pathology" in the sense of interpreting images for diagnosis.

8. The sample size for the training set:

Not Applicable. This is a physical device, not an AI model requiring a training set.

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

Not Applicable. As above, no training set for an AI model.

In summary, the provided document focuses on the substantial equivalence of a physical medical device (biopsy instrument) based on non-clinical (bench) performance testing and biocompatibility, as opposed to the performance of a diagnostic AI algorithm.

Summary

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Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other.

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

September 14, 2017

Bard Peripheral Vascular, Inc. % Mark Job Regulatory Technology Services. LLC 1394 25th Street, NW Buffalo, MN 55313

Re: K171953

Trade/Device Name: Bard® Mission® Disposable Core Biopsy Instrument Regulation Number: 21 CFR§ 876.1075 Regulation Name: Gastroenterology-Urology-Biopsy Instrument Regulatory Class: II Product Code: KNW Dated: September 5, 2017 Received: September 6, 2017

Dear Mark Job:

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 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.

Joyce M. Whang -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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Indications for Use

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

510(k) Number (if known) K171953

Device Name

Bard® Mission® Disposable Core Biopsy Instrument

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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."

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BARD® MISSION® Disposable Core Biopsy Instrument 510(k) Summary 21 CFR 807.92

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (I)(3)(A) of the Food, Drug and Cosmetic Act, a 510(k) summary upon which substantial equivalence determination is based is as follows:

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc
	1625 West 3rd Street
	Tempe, Arizona 85281

Phone:	480-350-6067
Fax:	480-449-2570
Contact:	Susan Sheffield, Regulatory Affairs Associate
Date:	15 May 2017

Subject Device Name:

Device Trade Name:	Bard® Mission® Disposable Core Biopsy Instrument
Common or Usual Name:	Core Biopsy Instrument
Classification:	Instrument, Biopsy (Product Code KNW); Class II
Review Panel:	Gastroenterology / Urology
Regulation Number:	21 CFR 876.1075

Predicate Devices:

M-Biopsy™ Semi-Automatic Biopsy Instrument by Mermaid ● Medical (K161409; cleared 2 August 2016)
. BARD® MONOPTY® and BARD® MAX-CORE® Disposable Core Biopsy Instruments (K133948/S001; cleared 21 February 2014)

Reference Devices:

POWERGLIDE® Midline Catheter (K121073; cleared 1 June 2012) .
ULTRACLIP® DUAL TRIGGER Breast Tissue Marker (K042341; 20 September . 2004)
ENCOR® Breast Biopsy System (K051158; 16 May 2005)
. SIDEKICK® and USHER® Support Catheters (K131493; cleared 2 August 2013)

The purpose of the secondary predicate device BARD® MAX-CORE®/MONOPTY® is to highlight similarities to the branding for BARD® disposable core biopsy devices. The reference

Image /page/3/Picture/17 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are a solid green color. The "A" in "BARD" is unique, as it is formed by two triangles that meet at the top, creating a sharp, angular shape. The letters are bold and evenly spaced, giving the word a strong and balanced appearance.

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devices are included to provide sufficient evidence for the safe usage of the materials found in BARD® MISSION®.

Device Description:

Indications for Use of Device:

The BARD® MISSION® Disposable Core Biopsy Instrument is intended for use in obtaining biopsy samples from soft tissues such as from the lung, liver, spleen, kidney, prostate, lymph nodes, breast, thyroid, and various soft tissue tumors.

Technological Comparison to Predicate Device:

The subject device BARD® MISSION® has the following similarities to the primary predicate device M-Biopsy™:

Same class and regulation number
Same Intended Use ●
Similar Indications for Use ●
0 Same Target Population/Conditions of Use (anatomical location of use, user interface, how device interacts with other devices, interaction with patient, etc.)
Same Fundamental Scientific Technology, including Design, Mechanism/Mode of Action, and Energy Used/Delivered)
. Same catalogue offerings, including Gauge Size, Needle Length, and Penetration Depth
. Similar design features, such as Centimeter Markings, Grip Design, Color Coding, and Echogenicity
. Same imaging capabilities

The subject device BARD® MISSION® Disposable Core Biopsy Instrument incorporates the following differences:

Slight alterations to the language used in the Indications for Use in order to maintain . consistency in branding for the BARD® Disposable Core Biopsy products
Different dimensions of the Specimen Notch used to collect the biopsy sample o
Differences in design, such as the Finger Grips and Fire Ready Indicator .
Unknown differences, such as: ●
- Color Coding o
- Echogenic Enhancement o
- Sterility Assurance o

Image /page/4/Picture/24 description: The image shows the word "BARD" in a stylized, sans-serif font. The letters are a solid green color. The letters are bold and have a uniform thickness. The overall impression is clean and modern.

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Performance Data:

To demonstrate that the subject device BARD® MISSION® is as safe and as effective as the predicate device M-Biopsy™, its technological characteristics and performance criteria were evaluated. Using FDA Guidance Documents on non-clinical testing of medical devices and internal Risk Assessment procedures, the following in vitro tests were performed on the subject device:

Number of Samples
· Penetration Depths
Stylet / Cannula to Handle Tensile Strength
Corresponding Working Needle Length and Cutting Cannula OD, and Stylet/Cannula Working Needle Lengths
Integrity of the Sterile Barrier
· Performance After Ship Testing
Needle Protection After Shipping and Storage

The results from bench testing demonstrate that the subject device BARD® MISSION® performed as expected according to the technological characteristics and performance requirements of C.R. Bard; and thus, can be concluded as comparable to other semiautomatic core biopsy devices on the market, demonstrating the subject device BARD® MISSION® to be as safe, as effective, and performs as well as the legally marketed device M-Biopsy™.

Biocompatibility:

Per ISO 10993-1:2009, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process." The following biocompatibility tests were successfully performed and/or adopted in accordance with GLP regulations:

Cytotoxicity
Sensitization
Intracutaneous Reactivity ●
o Material Mediated Pyrogenicity

The results of biocompatibility testing demonstrate that the subject device BARD® MISSION® is considered biocompatible for its intended use.

Conclusions:

The subject device, BARD® MISSION® Disposable Core Biopsy Instrument, met all predetermined acceptance criteria of design verification and validation as specified by applicable standards, guidance, test protocols and/or customer inputs. Likewise, the subject device BARD® MISSION® and the predicate device M-Biopsy™ share the same or similar characteristics: intended use, indications for use, target population / conditions for use, and fundamental scientific technology. Therefore, Bard concludes that the subject device BARD® MISSION® Disposable Core Biopsy Instrument is substantially equivalent to the legally marketed predicate device M-Biopsy™ Semi-Automatic Biopsy Instrument.

Image /page/5/Picture/20 description: The image shows the word "BARD" in a stylized, sans-serif font. The color of the text is a dark green. The letters are bold and have a slightly geometric appearance. The background is white.

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.