(23 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 reabsorbable 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 HydroMARK® Breast Biopsy Site Marker is deployed by the delivery system and is left in the track created during the biopsy procedure.
This Special 510(k) is being submitted for modifications to two models of the cleared device, HydroMARK® Breast Biopsy Site Marker. The fundamental scientific technology of the two models of the modified HydroMARK® Breast Biopsy Site Markers has not changed. This submission contains information to support:
- Modifications to the rigid delivery system of two models of the HydroMARK® Breast Biopsy Site Marker;
- Compatibility for use of those two models with the Mammotome revolve® biopsy system; and
- IFU updates related to the modifications noted for those two models.
There are no changes to the supplier of the hydrogel material, or other materials of construction. There are no changes to the finished product manufacturing site. There are no changes to the sterilization location and method, no changes to packaging, no changes to shelf-life, and no changes to indications for use or intended use.
Changes to labeling include rebranding and legal manufacturer name and address, as well as updates to the IFU to incorporate instructions for use related to the added compatibility with the Mammotome revolve® Biopsy System.
The provided document is a 510(k) summary for the HydroMARK® Breast Biopsy Site Marker, specifically for modifications to an already cleared device. As such, it does not detail a full study establishing device acceptance criteria from scratch but rather demonstrates that the modifications do not alter the existing performance and safety profile, maintaining substantial equivalence to the predicate device.
However, based on the information provided, we can extrapolate and structure the details as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mark tissue during a percutaneous breast biopsy procedure | Device performs as intended, accurately marking the biopsy site |
| Visible under ultrasound for at least 6 weeks | No change from predicate; predicate is visible for at least 6 weeks |
| Permanently visible by X-ray and MRI | No change from predicate; predicate is permanently visible by X-ray and MRI |
| Functions with specified commercially available biopsy devices | Modifications tested for compatibility with Mammotome revolve® biopsy system |
| Meets biocompatibility (ISO 10993-1) | Device continues to meet ISO 10993-1 requirements |
| Maintains original shelf-life (3 years/36 months) | Shelf-life remains 3 years/36 months |
| Maintains sterilization method (ETO) | Sterilization method remains ETO |
| Deployment as intended | Deployment testing conducted, devices performed as intended |
| Ease of insertion and deployment (Usability) | Usability testing conducted, devices performed as intended |
| Visual and dimensional conformity to specifications | Visual and dimensional testing conducted, performed as intended |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in the traditional sense for a new device evaluation. Instead, it describes non-clinical performance data and comparison testing for the modified device against its predicate.
- Sample Size for Non-Clinical Testing: Not explicitly stated for each test (Visual, Dimensional, Deployment, Usability).
- Data Provenance: Not explicitly stated, but given it's a 510(k) submission by a US company, the testing is assumed to be conducted in a controlled lab/test environment, likely in the US. The tests are non-clinical (i.e., not performed on human subjects).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This submission concerns non-clinical performance and substantial equivalence based on material and design changes, not clinical outcomes requiring expert interpretation of human data.
4. Adjudication Method for the Test Set
Not applicable for this non-clinical testing. Performance was assessed against established specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The device is a physical marker, not an AI or imaging diagnostic tool that would typically involve a MRMC study.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is not an algorithm. Performance tests related to deployment, visibility, and biocompatibility are reported.
7. Type of Ground Truth Used
For the non-clinical performance data:
- Instrumental measurements/visual inspection for conformity: For visual and dimensional testing.
- Engineering specifications/functional performance criteria: For deployment and usability testing.
- ISO standards: For biocompatibility (ISO 10993-1).
- Predicate device's established performance: For visibility (ultrasound, X-ray, MRI, and duration) as the modifications did not impact these characteristics.
8. Sample Size for the Training Set
Not applicable. This device does not involve machine learning or an algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable as there is no training set for this 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.