(90 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 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:
| Acceptance Criteria Category | Specific Criteria / Test Description | Reported Device Performance (New Device) |
|---|---|---|
| Material Equivalence | Polymer Raw Material: | |
| - Gel Permeation Chromatography (GPC): Equivalent molecular weight distribution (Number Average (Mn) and Weight Average (Mw)) and polydispersity between old and new polymer sources. No evidence of changed polymer composition. | "Results show the number (Mn) and weight averaged (Mw) molecular weights obtained from both sources are comparable. The polymer molecular weight distributions for both manufacturers are equivalent. There is no evidence of changed polymer composition..." | |
| - Nuclear Magnetic Resonance (NMR): Equivalent ratios of chemicals from first and second reaction steps, indicating no new chemical entities. | "Ratios of chemicals from the first reaction step demonstrate equivalency. NMR was also used to determine molar ratios of the secondary reaction step and also showed equivalency. ...No different or new chemical entities are identified." | |
| - Degradation Profiles: Hydrolysis products of both old and new polymers contain the same components in the same proportions. | "Finally, hydrolysis of both predicate and new polymers contained the same components, in the same proportions. Both raw material polymers are chemically equivalent." | |
| Finished Product Quality | Physical Characteristics: | |
| - Visual Inspection: Free of visual defects. | "met all original finished product specifications including visual inspection..." | |
| - Critical Dimensions: Outer diameter and length (0.070 inches and 0.20 inches for marker, 0.035-0.0625 inches for coil length, 0.039 inches for coil width). | "met all original finished product specifications including... dimensions..." (Implied to match the predicate device dimensions listed in the comparison table: 0.070 inches OD, 0.20 inches length, 0.035-0.0625 inches coil length, 0.039 inches coil width). | |
| - % Moisture: Within specified range pre- and post-sterilization. | "met all original finished product specifications including... % moisture..." | |
| - Functional Deployment: Deploys as intended. | "met all original finished product specifications including... functional deployment..." | |
| - Hydration Rate: Within specified range. | "met all original finished product specifications including... hydration rate..." | |
| Imaging Visibility | - Visibility under Ultrasound: Visible for at least 6 weeks. | "met all original finished product specifications including... visibility by ultrasound..." (The Indications for Use state "be visible under ultrasound for at least 6 weeks"). |
| - Visibility under X-ray: Permanently visible. | "met all original finished product specifications including... visibility by... x-ray..." (The Indications for Use state "be permanently visible by x-ray"). | |
| - Visibility under MRI: Permanently visible and safe in an MRI environment (no significant radio frequency induced heating, image artifacts, magnetically induced torque, or displacement force). | "met all original finished product specifications including... visibility by... MRI..." (The Indications for Use state "be permanently visible by... MRI." This implies compliance with ASTM F2182-11a, ASTM F2119-07, ASTM F2213-06, ASTM F2503-13, ASTM F2052-15). The document states the "Finished devices performed as intended according to the specifications established for the original device." concerning these tests. | |
| Biocompatibility | - Sterility: Sterile, meeting ISO 11135 requirements. | "met all original finished product specifications including... sterility..." |
| - Bioburden: Within acceptable limits. | "met all original finished product specifications including... bioburden..." | |
| - Pyrogens: Apyrogenic. | "met all original finished product specifications including... pyrogens..." | |
| - EO Residuals: Within acceptable limits (if Ethylene Oxide sterilized). | "met all original finished product specifications including... ethylene oxide residuals." | |
| - Biological Evaluation: Meeting ISO 10993 requirements (Cytotoxicity, Systemic Toxicity, Chemical Characterization). | The document lists the ISO 10993 standards and states that the "Finished devices performed as intended according to the specifications established for the original device," implying that these criteria were met. |
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.
§ 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.