The EleVation Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for breast abnormalities. The 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 essue margins be examined for completeness of removal using standard surgical procedures.

Device Description

The ELEVATION™ Breast Biopsy System is a handheld, self-contained, single insertion, multiple sample vacuum-assisted biopsy device and is intended to be used with ultrasound guidance. The device can obtain and store multiple samples with a single insertion probe. The components of the system are designed to operate safely when used together for diagnostic sampling during a breast biopsy procedure. The device consists of a battery-powered, reusable driver and a disposable probe with a sample container.

AI/ML Overview

The provided text is a 510(k) summary for the "EleVation Breast Biopsy System". This document focuses on demonstrating substantial equivalence of a modified device to a previously cleared predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies in the typical sense of a novel AI/medical device.

Therefore, the information requested regarding acceptance criteria, extensive studies, sample sizes, expert ground truth, MRMC studies, standalone performance, and training data is not directly applicable or available in this document. The FDA 510(k) process for this type of device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through a comparison of technological characteristics and non-clinical performance testing.

Here's how to interpret the available information in the context of your questions:

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

The document doesn't present a table of specific clinical acceptance criteria (e.g., sensitivity, specificity, AUC) and corresponding reported performance values for diagnostic tasks. Instead, it refers to performance criteria for mechanical and functional aspects of the device.

Acceptance Criteria Category (Implied)	Reported Device Performance (Summary from text)
Functional/Mechanical Performance
Software Validation	Passed (demonstrates substantial equivalence)
Penetration Force	Performed comparable to predicate device
Tensile Strength	Performed comparable to predicate device
Prime/Pierce Testing	Performed comparable to predicate device
Reliability	Performed comparable to predicate device
Sample Mass	Performed comparable to predicate device
Safety and Effectiveness	Demonstrated to be as safe and effective as the legally marketed predicate device.

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

Not applicable for clinical diagnostic performance. The document describes non-clinical performance testing (e.g., mechanical tests), not a clinical study with a test set of patient data.
Data Provenance: The studies are non-clinical and relate to engineering and mechanical performance of the device components.

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

Not applicable. There is no "ground truth" in the diagnostic sense (e.g., pathology confirmed diagnosis) established by experts for this type of non-clinical device testing. The "ground truth" for the non-clinical tests would be the established engineering specifications and performance of the predicate device.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring expert 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 device is a biopsy system, not an AI diagnostic tool that assists human readers.

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

Non-clinical/Engineering Ground Truth: The "ground truth" for the tests performed (Software Validation, Penetration Force Testing, Tensile Testing, Prime/Pierce Testing, Reliability Testing, Sample Mass Testing) would be established engineering specifications and the performance characteristics of the predicate device (K192948), to which the modified device is compared for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device's non-clinical performance testing, as it's not an AI/machine learning device.

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

Not applicable. (See point 8)

Summary

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July 15, 2021

Bard Peripheral Vascular, Inc. Meghan Mckelvev Senior Regulatory Affairs Specialist 1625 W. 3rd Street Tempe, Arizona 85281

Re: K211933

Trade/Device Name: EleVation Breast Biopsy System Regulation Number: 21 CFR 876.1075 Regulation Name: Gastroenterology-Urology Biopsy Instrument Regulatory Class: Class II Product Code: KNW Dated: June 21, 2021 Received: June 22, 2021

Dear Meghan Mckelvey:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpm/pmn.cfm identifies.combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K211933

Device Name EleVation Breast Biopsy System

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary (K211933) 21 CFR 807.92

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

1. Submitter Information:

Applicant:	Bard Peripheral Vascular, Inc.1625 West 3rd StreetTempe, Arizona 85281
Phone:	602-830-5063
Fax:	312-949-0436
Contact:	Meghan McKelvey, Senior Regulatory Affairs Specialist
Date:	July 14, 2021

2. Subject Device:

Device Trade Name:	ELEVATIONTM Breast Biopsy System
Classification Name:	Instrument, Biopsy (Product Code KNW)
Review Panel:	Gastroenterology/Urology
Regulation Number:	21 CFR 876.1075

3. Predicate Device:

ELEVATION™ Breast Biopsy System (K192948; cleared November 7, 2019)

4. Device Description:

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5. Indications for Use of Device:

The ELEVATION™ Breast Biopsy System is indicated to obtain tissue samples from the breast or axillary lymph nodes for diagnostic analysis for 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.

6. Technological Comparison to Predicate Devices:

The technological characteristics of the subject device are substantially equivalent to those of the predicate device, in terms of following:

Intended Use
. Indications for Use
Performance Characteristics .
. Target Population
. Fundamental Scientific Technology
. Operating Principle (Mechanism of Action)
. Patient Contacting Materials
. Sterility Assurance Level and Method of Sterilization
. Shelf-Life
Packaging Configuration

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

. Software Modifications (Transportation Indicator and Enhanced Logging Capabilities)
. Needle Tip Modification (Needle Tip Dimensional Improvement and Venting Hole Change)
. Addition of Optional Accessories (Introducer Stylet, Half-Notch Support Cannula, Additional Sample Container)

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7. Performance Testing Summary:

To demonstrate substantial equivalence of the subject device to the predicate device, the technological characteristics and performance criteria were evaluated. Using the FDA Guidance document, "Design Control Guidance for Medical Device Manufacturers," dated March 11, 1997, and internal risk assessments procedures, the following non-clinical tests were performed:

. Software Validation
. Penetration Force Testing
. Tensile Testing
Prime/Pierce Testing
Reliability Testing
. Sample Mass Testing

The results demonstrate that the technological characteristics and performance criteria of the modified ELEVATION™ Breast Biopsy System is comparable to the predicate device and that it performs as safely and as effectively as the legally marketed predicate device.

8. Conclusion:

The modified ELEVATION™ Breast Biopsy System is substantially equivalent to the legally marketed predicate device, the ELEVATION™ Breast Biopsy System (K192948).

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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.