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The HydroMARK® Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMARK® Breast Biopsy Site Marker [subject device] is a two-component marker that provides permanent marking of a breast biopsy site; a resorbable hydrogel component and a metallic component and is not intended to be removed unless the marked tissue is determined to require surgical removal. The marker is supplied pre-loaded in applicator devices designed to fit into the following:

• 8G Flexible Applicator System fits into:
  • O Mammotome revolve® 8G Probe (9cm with and without Specimen Management System and 12cm without Specimen Management System)
  • EnCor 7G Directional Vacuum-Assisted Biopsy Devices o
• . 10G Flexible Applicator System fits into:
  • Mammotome revolve® 10G Probe (9cm with and without Specimen Management O System and 12cm without Specimen Management System)
  • EnCor 10G Directional Vacuum-Assisted Biopsy Devices o
  • ATEC 9G Biopsy Handpiece Introducers O

The HydroMARK® Breast Biopsy Site Marker is a resorbable component that is a highly expandable solid cylinder of polymerized and desiccated hydrogel. The hydrogel has features that are unique and highly desirable for breast tissue marking. The hydrogels absorb fluid, they are readily visible by ultrasound imaging. During a breast biopsy procedure, the marker is deployed through a delivery tool into the cored-out space created by a breast biopsy device. Upon expansion, the hydrogel fills the space and conforms to the site of biopsy. Embedded in the hydrogel is a coiled metallic wire made of Titanium. The wire is coiled into loops to provide a unique identifier under ultrasound, x-ray and MRI imaging. The embedded metallic wire coil is visible under ultrasound for up to 6 weeks and is permanently visible under X-ray and MRI. The wire coil is available in (3) three shapes:

• Barrel Shape
• Open Coil Shape
• Butterfly Shape

The provided document is a 510(k) summary for the HydroMARK® Breast Biopsy Site Marker. It details the device's substantial equivalence to predicate devices and the non-clinical performance data supporting this claim.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for each test in a table format. Instead, it describes general "In-House Testing Standards" and states that all tests "PASSED," concluding that the device is "as safe, as effective, and performs as well as, the legally marketed predicate device."

However, based on the descriptions of the tests, we can infer the performance criteria. The device aims to demonstrate substantial equivalence to its predicate for various aspects, including safety, effectiveness, and performance characteristics.

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

The document provides a summary of non-clinical bench testing. It does not specify sample sizes for individual tests. The data provenance is "In-House Testing Standards as established by Devicor Medical Products, Inc." which indicates retrospective testing performed by the manufacturer, relying on internal procedures and industry best practices. There is no mention of country of origin for the data beyond the manufacturer being in Cincinnati, OH, U.S.A.

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

The document focuses on non-clinical (bench, human factors, biocompatibility, sterilization) tests, not clinical studies. Therefore, there is no mention of experts establishing ground truth for a test set in the context of clinical outcomes or imaging interpretation. The "ground truth" for these engineering and safety tests is defined by the established testing standards and internal design requirements.

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

This document describes non-clinical testing for substantial equivalence, not a clinical study involving human readers or interpretation of medical images. Hence, there is no adjudication method described for the test set. The results are reported as "PASSED" against established testing standards.

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 MRMC comparative effectiveness study was done or mentioned. This document is for a medical device (breast biopsy site marker), not an AI-powered diagnostic tool. Therefore, there's no discussion of human readers improving with or without AI assistance.

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

This point is not applicable as the device is a physical breast biopsy site marker, not an algorithm or AI.

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

For the non-clinical tests described:

• Design Verification, FEA, Hydrogel, Mechanical, Compatibility Testing: The "ground truth" is defined by the device's design requirements and the manufacturer's internal testing standards, often based on industry best practices for physical properties, functionality, and performance.
• Human Factors/Usability Testing: The "ground truth" relates to compliance with recognized standards (IEC 62366-1, IEC 60601-1-6, FDA Guidance) for user safety and effectiveness through simulated use and formative studies.
• Biocompatibility, Chemical Characterization, Bioburden, Sterilization, Endotoxin, Residual Analysis, Shelf-Life Testing: The "ground truth" is adherence to recognized international and national standards (e.g., ISO 10993 series, ANSI/AAMI, ASTM, USP) which define acceptable biological response, chemical safety, sterility, and material stability.

8. The sample size for the training set

This document describes the testing for a physical medical device (breast biopsy site marker), not an AI algorithm. Therefore, there is no concept of a "training set" in this context.

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

As there is no training set mentioned, this question is not applicable.

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The HydroMARK® Breast Biopsy Site Marker is indicated to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI.

The HydroMARK® Breast Biopsy Site Marker contains a resorbable hydrogel component and a metallic component for permanent marking. The hydrogel has features that are unique and highly desirable for breast tissue marking. The HydroMARK® Breast Biopsy Site Marker is provided pre-loaded in a sterile, disposable applicator that is compatible with specified commercially available biopsy devices. The marker is deployed by the delivery system and is left in the tract created during the biopsy procedure. This Traditional 510(k) addresses the qualification and validation of a new source of raw material polymer of the same original formulation, produced in a new facility and in smaller batch sizes, to be used by the manufacturer of the hydrogel component of the HydroMARK® Breast Biopsy Site Marker. The hydrogel component is manufactured by Coldstream Laboratories, Inc. The new source of polymer for the hydrogel is Corden Pharma, replacing Genzyme polymer.

The provided text describes a 510(k) premarket notification for a medical device called the HydroMARK® Breast Biopsy Site Marker. The notification aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily due to a change in the raw material polymer supplier for the hydrogel component.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner for specific benchmarks (e.g., "Visibility under ultrasound: >95% detected"). Instead, it lists various tests performed and states that the device "met all original finished product specifications" or "performed as intended according to the specifications established for the original device."

However, we can infer the acceptance criteria from the tests conducted and the statements of equivalence:

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

• Test Set Sample Size: For the polymer equivalence testing, "Three samples each of the predicate polymer and the new polymer" were tested by GPC. The same number seems implied for NMR and degradation profiles. For finished product testing, "The three manufacturing batches [of the new polymer] were combined and used to prepare HydroMARK® Breast Biopsy Site Markers which met all original finished product specifications". The exact number of finished devices tested is not specified, but it was enough to represent these combined batches.
• Data Provenance:
  • Polymer Raw Material: The new polymer batches were from the Corden Pharma Liestal, Switzerland facility. The predicate polymer was from Genzyme (original supplier/process).
  • Finished Product: The finished devices were manufactured using the new Corden Pharma polymer. The testing protocols were "identical to the tests used in the original 510(k)". The study is retrospective in the sense that it aims to demonstrate equivalence to previously established specifications and predicate devices.

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

This type of information (number of experts, their qualifications, and their role in establishing ground truth) is not applicable to this submission. This 510(k) is not for a diagnostic algorithm or a device requiring expert interpretation for performance evaluation. It's a submission for a physical medical device (breast biopsy site marker) that primarily relies on objective chemical, physical, and imaging characteristic tests, not human interpretive performance.

4. Adjudication method for the test set

Not applicable for the same reasons as #3. There was no "ground truth" established by expert consensus or adjudication in the context of human interpretation. The "ground truth" here is adherence to objective engineering, material science, and biological specifications.

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 submission is for a physical medical device (a biopsy site marker), not an AI/CAD system or a device that directly assists human readers in interpreting images. Therefore, an MRMC study or evaluation of human reader improvement with AI assistance is irrelevant to this submission.

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

Not applicable. As stated above, this is a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" in this context refers to the established specifications and performance characteristics of the predicate device and relevant industry standards (e.g., ISO, ASTM). Specifically:

• Chemical Equivalence: Established by comparing molecular weight distribution, NMR spectra, and degradation profiles to the known composition and characteristics of the original Genzyme polymer.
• Physical/Functional Performance: Established by existing specifications for visual inspection, critical dimensions, moisture content, functional deployment, hydration rate, invisibility under various imaging modalities, and biological safety (sterility, biocompatibility).
• Imaging Visibility/Safety: Established by adherence to specific ASTM standards for MRI compatibility.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The "training" in this context refers to the qualification and validation of the manufacturing process for the new polymer source, which involved testing "3 consecutive test batches" from the new facility.

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

Not applicable in the AI/ML sense. However, if interpreting "training set" as the batches used to qualify the new polymer manufacturing process:
The "ground truth" for qualifying these batches was established by comparison to the "original specifications" designed for the predicate device's polymer. This means the acceptable parameters (e.g., molecular weight range, chemical ratios) were already defined based on the performance of the previously approved device.

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