The FINESSE™ Ultra Breast Biopsy System Driver is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of a histologic abnormality (e.g., malignancy). When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedures.

Device Description

The subject device, the modified FINESSE™ Ultra Breast Biopsy System Driver, is a non-sterile, self-contained, handheld, reuseable, electro-mechanical vacuum-assisted breast biopsy device that utilizes a rechargeable lithium-ion battery. The driver is designed to operate safely when used with the FINESSE™ Ultra Breast Biopsy System probe for diagnostic sampling of tissue during a breast biopsy procedure.

AI/ML Overview

The provided text describes a 510(k) summary for a modified medical device, the FINESSE™ Ultra Breast Biopsy System Driver. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a standalone clinical study. As such, much of the requested information regarding acceptance criteria and study details (like sample size, number of experts, ground truth, MRMC study, training data) is not present in this type of submission.

Here's a breakdown of the available information based on your request:

1. A table of acceptance criteria and the reported device performance

The document states: "The Modified FINESSE™ Ultra Breast Biopsy System Driver met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs."

However, the specific acceptance criteria and the quantitative or qualitative device performance results are not detailed in this 510(k) summary. The summary indicates that performance was evaluated via "data collected from bench testing," but the details of this testing are not provided.

Acceptance Criteria	Reported Device Performance
Not specified in this document. The document states that the device "met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs."	Not specified in this document. The document states that performance data was collected from "bench testing" and demonstrate substantial equivalence, but no specific performance metrics or results are provided.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not specified. The performance evaluation was conducted through "bench testing," which doesn't typically involve human subjects or patient data in the same way a clinical trial would.
Data Provenance: Not applicable in the context of human data. The testing was "bench testing," meaning it was conducted in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this was bench testing for an electromechanical device, there isn't a "ground truth" established by medical experts in the way that would apply to an AI diagnostic device. The "ground truth" for functions like software recovery from errors or current IR port functionality would be determined by engineering specifications and verification tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there's no diagnostic test set requiring human 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

No. This document describes a physical medical device (biopsy system driver), not an AI-assisted diagnostic tool. Therefore, an MRMC study related to human reader performance with AI assistance is not relevant and was not conducted.

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

Not applicable. This is a physical electromechanical device, not a software algorithm.

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

Not applicable in the conventional sense of clinical ground truth. The "ground truth" for this device's performance is likely defined by engineering specifications, successful completion of design verification and validation tests (e.g., successful recovery from errors, proper functioning of the IR port for software updates), and demonstration that it performs identically to the predicate device.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning model, so there is no training set.

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

Not applicable, as there is no training set.

Summary

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Modified FINESSE™ Ultra Breast Biopsy System Driver

510(k) Summary of Safety and Effectiveness 21 CFR 807.92

DEC 2 7 2010

As required by the Safe Medical Devices Act of 1990, coded under Section 513, Part (1)(3)(A) of the Food, Drug and Cosmetic Act, a summary of the safety and effectiveness information upon which substantial equivalence determination is based as follows:

Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc1415 West 3rd StreetP.O. Box 1740Tempe, Arizona 85281
Phone:	480-379-2836
Fax:	480-449-2546
Contact:	Cindy Moss, Project Manager, Regulatory Affairs
Date	November 15, 2010

Subject Device Name:

Device Trade Name:	Modified FINESSE™ Ultra Breast BiopsySystem Driver
Common or Usual Name:	Biopsy Instrument (21 CFR 876.1075, ProductCode KNW)
Classification:	Class II
Classification Panel:	Gastroenterology/Urology

Predicate Device:

· FINESSE™ Ultra Breast Biopsy System (K093068, cleared November 10, 2009), manufactured by Bard Peripheral Vascular, Inc.
$\frac{1}{3}$

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Device Description:

Intended Use of Device:

The modified FINESSE™ Ultra Breast Biopsy System Driver is intended to obtain soft tissue samples for diagnostic and histological analysis of breast abnormalities.

Indications for Use of Device:

The FINESSE™ Ultra Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

Technological Comparison to Predicate Devices:

The modified FINESSE™ Ultra Breast Biopsy System Driver is identical to the predicate devices in the following ways:

. Intended Use
. Indications for Use
Target Population .
Fundamental Scientific Technology .
. Operating Principle
Driver Mechanical Design .
Performance Characteristics .

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The subject device and the predicate device are different in the following way:

. Software
- o Modifications to address errors resulting from out of alignment issues between driver and probe components. The software updates will allow the device to recover from non-clinically relevant errors and make the device easier to use.
- o Modification to allow use of the current IR port to update software

Performance Data:

The Modified FINESSE™ Ultra Breast Biopsy System Driver was evaluated via data collected from bench testing, and the data demonstrate that the Modified FINESSE™ Ultra Breast Biopsy System Driver is substantially equivalent to the predicate device. The testing performed was that which was identified during the Risk Assessment and Design Failure Modes and Effects Analysis.

Conclusions:

The Modified FINESSE™ Ultra Breast Biopsy System Driver met all acceptance criteria for design verification and validation, as specified by applicable standards, guidance, test protocols and/or customer inputs. The modified FINESSE™ Ultra Breast Biopsy System Driver is substantially equivalent to the legally marketed predicate device, the driver of the FINESSE™ Ultra Breast Biopsy System.

Image /page/2/Picture/12 description: The image shows the word "BARD" in a bold, sans-serif font. The letters are outlined in black, with a white fill. The letters are evenly spaced and of uniform size, creating a balanced and legible wordmark.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

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

C. R. Bard. Inc. Bard Peripheral Vascular, Inc. % Ms. Cindy Moss Regulatory Affairs Project Manager 1415 West Third Street Tempe, Arizona 85281

DEC 2 7 20:0

Re: K103359

Trade/Device Name: FINESSE™ Ultra Breast Biopsy System Driver Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-urology-biopsy instrument Regulatory Class: Class II Product Code: KNW Dated: December 15, 2010 Received: December 16, 2010

Dear Ms. Moss:

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. Iisting 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.

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Page 2 - Ms. Cindy Moss

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 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.fdagov/AboutFDA/CentersOffices/CDRH/CDRHQffices/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Chaloff

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

DEC 2 7 2010

510(k) Number (if known): 16 10 3359

Device Name: FINESSE™ Ultra Breast Biopsy System Driver

Indications for Use: The FINESSE™ Ultra Breast Biopsy System Driver is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis of breast abnormalities. The instrument is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

Prescription Use_X (Part21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) 11.2 1.0. 892 far Mxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K103359

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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.