(63 days)
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.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Non-Clinical Performance Bench Testing | ||
| Design Verification | Meet all design and functional requirements. | PASSED |
| FEA (Safety Factor of Cannula) | Demonstrate comparable or improved safety factor compared to predicate/reference cannula to reduce tip shear. | PASSED |
| Hydrogel Verification (Hydration, Moisture) | Meet established in-house standards for hydrogel hydration and moisture content, based on and more stringent than predicate. | PASSED |
| Compatibility Verification (Deployment/Removal) | Successful deployment and removal of markers in each compatible probe, based on and more stringent than predicate. | PASSED |
| Mechanical Verification (Deployment, Self-Retraction, Bond Strength) | Meet established in-house standards for marker deployment, pushrod self-retraction, and bond strength, based on and more stringent than predicate. | PASSED |
| Human Factors/Usability Testing | ||
| Simulated Use Testing | Safe and effective interaction for intended users, uses, and environments per FDA recognized standards (IEC 62366-1, IEC 60601-1-6, FDA Guidance). | PASSED |
| Formative Studies | Findings support safe and effective use. | PASSED |
| Biocompatibility Testing | ||
| Cytotoxicity (MEM Elution) | No unacceptable adverse biological response. Comply with ISO 10993-1, 10993-5. | PASSED |
| Chemical Characterization Testing | ||
| Exhaustive Extractables | No unacceptable adverse biological response from leachable substances. Comply with ISO 10993-12, 10993-18. | PASSED |
| Toxicological Risk Assessment | No unacceptable toxicological risks. Comply with ISO 10993-1, 10993-18, 10993-17. | PASSED |
| Sterilization & Shelf-Life Testing | ||
| Bioburden Testing | Meet established bioburden limits. Comply with ANSI/AAMI/ISO 11737-1. | PASSED |
| Sterilization Testing | Effective sterilization. Comply with ANSI/AAMI/ISO 11737-1. | PASSED |
| Sterility Testing (Natural Product/BI) | Demonstrate product sterility. Comply with ANSI/AAMI/ISO 11737-1. | PASSED |
| Endotoxin Testing | Meet endotoxin limits. Comply with USP , ANSI/AAMI ST72. | PASSED |
| Residual Analysis Testing | Meet residual limits related to sterilization. Comply with USP , ANSI/AAMI ST72. | PASSED |
| Shelf-Life / Transit Verification (12-month) | Maintain integrity, sterility, and performance after 12 months simulated aging. Comply with ASTM F1980-16, F2095-11, F38/F88M-15. | PASSED |
| Shelf-Life / Transit Verification (18-month) | Maintain integrity, sterility, and performance after 18 months simulated aging. Comply with ASTM F1980-16, F2095-11, F38/F88M-15. | PASSED |
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.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.