(373 days)
HydroMARK™ Plus Breast Biopsy Site Marker is intended to mark tissue during a percutaneous breast biopsy procedure, including axillary lymph nodes, be visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and MRI
The HydroMARK™ Plus Breast Biopsy Site Marker contains a two-component implantable marker that provides permanent marking of a breast biopsy or axillary lymph node biopsy site following a breast biopsy procedure. The implantable marker is made of a highly expandable solid cylinder of polymerized and desiccated hydrogel that has the permanent titanium marker embedded. Upon fluid contact (e.g., water, blood, etc.), the hydrogel material expands to an equilibrium point. Once the material hydrates, it is visible under ultrasound. Over time, the hydrogel is resorbed by the patient's body. The titanium wire is permanently visible under x-ray and MRI even after the hydrogel is resorbed. The implantable component of the HydroMARK™ Plus Biopsy Site Marker is supplied preloaded in a sterile, disposable applicator that is designed to fit into specified commercially available breast biopsy devices. During a breast biopsy procedure, the marker is deployed through a compatible introducer or by direct puncture into the biopsy cavity created by the breast biopsy device.
The provided text is a 510(k) Summary for the HydroMARK™ Plus Breast Biopsy Site Marker, seeking to establish substantial equivalence to a predicate device (HydroMARK™ Breast Biopsy Site Marker). It details various performance and biocompatibility tests conducted to demonstrate this equivalence, rather than providing the kind of robust clinical study data typically associated with an AI/ML device approval that would include information on expert reader performance, ground truth establishment, and training/test set details as requested in the prompt.
Therefore, much of the requested information regarding AI/ML-specific study design (such as number of experts, adjudication methods, MRMC studies, standalone performance of an algorithm, and training/test set details for AI models) is not applicable to this submission, as it describes a physical medical device (a biopsy site marker) and its performance, not an AI/ML diagnostic or assistive tool.
However, I can extract the relevant acceptance criteria and reported device performance from the provided document, relating to the physical device itself.
Here's the breakdown based on the provided text, focusing on the device's performance characteristics as a physical marker:
1. A table of acceptance criteria and the reported device performance:
Since this is a physical device and not an AI/ML algorithm, the "acceptance criteria" are derived from the "Indications for Use" and various performance tests aiming to demonstrate substantial equivalence to the predicate device. The performance is reported as meeting these criteria, often by demonstrating equivalence or acceptable results compared to the predicate or relevant standards.
| Acceptance Criteria (Derived from Indications for Use / Bench Testing) | Reported Device Performance |
|---|---|
| Visibility under ultrasound for at least 6 weeks (from Indications for Use) | Verified. "Both immediate post-deployment testing and long-term migration performance of HydroMARK Plus Breast Biopsy Site Markers were confirmed." (While the specific "6 weeks" is not explicitly re-stated as a test result, the overall confirmation of long-term visibility supports this claim of equivalence to the predicate, which also states this.) Testing included "Time to Equilibrium" where "Testing proved both subject and predicate devices achieved hydrogel equilibrium within 24 hours, demonstrating substantial equivalence." |
| Permanently visible by x-ray and MRI (from Indications for Use) | Verified. The predicate device claims this, and the subject device uses the same titanium marker for permanent visibility, with "MRI Status (Marker)" being "Conditional" for both predicate and subject. "Both immediate post-deployment testing and long-term migration performance of HydroMARK Plus Breast Biopsy Site Markers were confirmed." (Again, specific "permanently visible" not numeric, but implied by equivalence and material.) |
| Safety and Effectiveness of Implantation | "Literature analysis was provided demonstrating product is safe and effective in both breast and lymph node." "HydroMARK™ Implantation Data: PASSED. All tests passed and no local tissue side effects were observed at both lymph node and intramuscular sites at 8 and 26 weeks. Applies only to implant portion of the device." "HydroMARK™ Plus Implantation Data: PASSED. All animals survived, and no abnormalities or adverse reactions were observed at necroscopy. Overall, the test article scored a relative score of '0' with a reactivity grade of 'minimal or no reaction' per Table E.3. of ISO 10993-6:2016 and met the requirements of the study." |
| Residual Moisture (Substantial Equivalence to Predicate) | "RESULTS: Testing provided no statistical difference with 95% confidence comparing predicate and subject devices, proving substantial equivalence." |
| Hydrogel Degradation (Substantial Equivalence to Predicate) | "RESULTS: Testing and existing clinical evidence of HydroMARK™ hydrogel was provided demonstrating substantial equivalence between predicate and subject devices." |
| Biocompatibility (Meeting ISO 10993-1:2020 and other specific ISO standards) | "All the biocompatibility testing conducted on the HydroMARK™ device is applicable to HydroMARK™ Plus devices as well since it is an extension of the existing HydroMARK™ product family... The materials utilized in the HydroMARK™ and HydroMARK™ Plus Biopsy Site Marker devices have been evaluated against all applicable biological endpoints and are considered biocompatible in accordance with EN ISO 10993-1:2020..." Specific tests: Acute Systemic Toxicity (PASSED), Cytotoxicity (PASSED), Irritation (PASSED), Sensitization (PASSED), Pyrogenicity (PASSED). |
| Sterilization (Meeting ISO 11135:2014) | "Sterilization: PASSED. Meets standard for ISO 11135:2014 Sterilization of Health Care Products; Ethylene Oxide Requirements for Development, Validation and Routine control of a sterilization process for medical devices." |
| Shelf Life (Device: 18 months; Packaging: 36 months) | "Shelf Life [Device]: The shelf life for the HydroMARK™ Plus Breast Biopsy Site Marker [subject device] is 1.5 years/18 months." "Shelf Life [Packaging]: HydroMARK™ Plus Breast Biopsy Site Marker [subject device] has been assessed and passed for up to 36 months." |
| Risk Management (Acceptable per ISO 14971:2019 and company policies) | "All risks have been reduced as far as possible through allowed controls. The product risk is acceptable in view of the benefits of the device." "Based on the clinical steps and failure modes tested on HydroMARK™ Plus vs. HydroMARK™, risks have been determined to be acceptable to risk management policies." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not directly specified in terms of "cases" like in an AI/ML study, but performance and biocompatibility tests were conducted. For instance:
- Implantation Data: Refers to "All animals survived" and "no abnormalities or adverse reactions were observed at necroscopy" for the HydroMARK Plus Implantation Data. The specific number of animals is not provided in this summary. It mentions "standard muscle implantation and lymph node sites" for HydroMARK device data and "additional implantation study" for HydroMARK Plus.
- Residual Moisture, Time to Equilibrium, Toxicity, Pyrogenicity, Irritation, Sensitization: These are laboratory bench tests and animal studies. Specific sample sizes (e.g., number of test articles or animals per test) are not detailed in this summary document, but results are reported as "PASSED."
- Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "Non-Clinical Bench Performance Data" and "Biological Evaluation Testing," which are typically laboratory or animal studies, not human clinical trials. They would be prospective in the sense of being planned tests on the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. This is a physical device submission, not an AI/ML diagnostic. "Ground truth" for this device relates to physical and biological properties (e.g., material composition, sterility, biocompatibility, physical expansion, visibility under imaging modalities) established through engineering specifications, laboratory tests, and animal studies, not human expert reader consensus on images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Adjudication methods are relevant for human reader studies, typically in AI/ML performance evaluations. The presented data is from bench and animal testing.
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. No MRMC study was done, as this is not an AI/ML device for diagnostic assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This refers to a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this medical device is established through:
- Physical and Chemical Benchmarking: Direct measurements of material properties, expansion rates, and stability.
- Biological/Toxicological Standards: Compliance with ISO 10993 series for biocompatibility, using laboratory assays and animal studies to assess absence of toxicity, irritation, sensitization, and pyrogenicity, and demonstration of acceptable local tissue effects upon implantation over time.
- Imaging Visibility: Demonstration of visibility under ultrasound (acute and long-term), x-ray, and MRI, likely through phantom studies or animal imaging.
- Engineering Specifications: Adherence to design requirements, manufacturing processes, and sterilization validation.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI/ML system requiring a training set. The device was developed through traditional engineering and material science principles.
9. How the ground truth for the training set was established
- Not Applicable. No training set for an AI model. "Ground truth" for manufacturing and design would be established through material specifications, quality control, and adherence to established engineering principles and medical device standards.
§ 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.