(264 days)
The HydroPearl Microspheres are intended for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids.
The HydroPearl Microspheres are a pre-formed, compressible, precisely calibrated, spherical embolic agent consisting of a biocompatible hydrogel. The HydroPearl Microspheres are offered in a variety of diameters ranging from 75-1100 um and are provided in a sterile syringe pre-filled with microspheres in phosphate buffered saline. The pre-filled syringe is packaged in a sealed sterile dispenser tray. The HydroPearl Microspheres are delivered to the treatment site through a delivery catheter.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the HydroPearl Microspheres:
This document is a 510(k) Summary for a medical device called HydroPearl Microspheres. It provides a summary of the pre-clinical testing performed to demonstrate substantial equivalence to a predicate device, rather than a clinical study establishing specific performance metrics against pre-defined acceptance criteria for diagnostic efficacy.
Therefore, the requested information elements related to diagnostic performance (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, and training set details) are not applicable in the context of this 510(k) submission. This submission focuses on pre-clinical equivalency, biocompatibility, and functional performance.
Acceptance Criteria and Reported Device Performance
The provided document details various pre-clinical tests and their outcomes, indicating a "Pass" or "Meet" result against internal criteria rather than specific numerical acceptance criteria for diagnostic accuracy.
| Category | Specific Test/Criteria | Reported Device Performance (Pass / Meet means acceptable) |
|---|---|---|
| Mechanical | Compression (Temporary deformation with smooth passage through catheter) | Pass |
| Robustness (Syringe to syringe transfer) | Pass | |
| Delivery force (Delivery through catheter within force specification) | Pass | |
| Dimensional (Maintains diameter) | Pass | |
| Resilience | Pass | |
| Time to suspension/time in suspension | Pass | |
| Chemical | Residual solvents testing (Meets criteria for residuals) | Meet |
| pH test of solution (Maintains pH) | Meet | |
| Syringe leachables testing (Syringe does not leach into microsphere/PBS) | Meet | |
| MR Compatibility | Tested to be MR Safe | Pass |
| Catheter Comp. | Microspheres can be delivered through a catheter of 0.017" - 0.041" ID | Pass |
| Contrast Agents | Microspheres are compatible with contrast agent per IFU | Pass |
| Shelf Life | After aging conditioning, the microspheres/packaging meet specifications | Pass |
| Animal Testing | Embolization effectiveness and histopathological evaluation (necrosis, inflammation, and off-target embolization) compared to predicate device (1, 7, 30 days) | Pass |
| Biocompatibility | Cytotoxicity (MEM elution, Agar diffusion) | Pass (Subjected to full battery of testing) |
| Sensitization/Irritation (Guinea pig maximization, Intracutaneous reactivity) | Pass (Subjected to full battery of testing) | |
| Hemocompatibility (Hemolysis, Complement Activation, UPTT) F | Pass (Subjected to full battery of testing) | |
| Systemic toxicity (Systemic toxicity, Rabbit pyrogen) | Pass (Subjected to full battery of testing) | |
| Implantation (2, 13, and 26 wk implantation) | Pass (Subjected to full battery of testing) | |
| Genotoxicity (Ames Test, Chromosomal aberration, Rodent Bone Marrow Micronucleus) | Pass (Subjected to full battery of testing) | |
| Packaging Valid. | Subjected to ISTA conditions - Packaging testing for adequacy | Pass |
| Sterilization Val. | Meets criteria for ISO 17665-1 | Pass |
Information Not Applicable/Provided for this 510(k) Summary:
As this is a 510(k) submission focused on substantial equivalence through pre-clinical testing, it does not include the detailed diagnostic study information typically associated with AI/software devices aiming to establish diagnostic performance.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" primarily refers to physical samples of the device components and animal models for pre-clinical evaluation, not a diagnostic data set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in a diagnostic sense, is not established for this type of submission. Animal testing involved histopathological evaluation, implicitly performed by qualified personnel, but not for establishing a "ground truth" for a diagnostic algorithm.
- Adjudication method for the test set: Not applicable.
- 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 is a physical embolic device, not an AI/software diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the animal study, histopathology was used to evaluate embolization effectiveness and tissue response (necrosis, inflammation, off-target embolization). This serves as a biological ground truth for the device's effect in vivo, not a diagnostic ground truth.
- The sample size for the training set: Not applicable. There is no algorithm training set for this device.
- How the ground truth for the training set was established: Not applicable.
Summary of the Study (Verification and Test Summary):
The study described is a series of pre-clinical bench tests and animal studies designed to evaluate the physical, chemical, and biological performance of the HydroPearl Microspheres and to demonstrate their substantial equivalence to a legally marketed predicate device (Biosphere Embosphere Microspheres).
- Mechanical Tests: Evaluated the microspheres' ability to deform, maintain their dimensions, transfer between syringes, and be delivered through catheters within specifications.
- Chemical Tests: Assessed residual solvents, pH stability, and leachables from the syringe.
- Safety Tests: Included MR safety, catheter compatibility, compatibility with contrast agents, shelf life, and extensive biocompatibility testing according to ISO 10993 standards (cytotoxicity, sensitization/irritation, hemocompatibility, systemic toxicity, implantation, and genotoxicity).
- Animal Testing: Compared the HydroPearl Microspheres to the predicate device in an animal model to assess embolization effectiveness and histopathological responses (necrosis, inflammation, and off-target embolization) at 1, 7, and 30 days post-embolization.
- Other Validations: Packaging and sterilization validations were also performed.
Conclusion: All tests passed or met the established criteria, leading to the conclusion that the HydroPearl Microspheres are as safe, effective, and perform as well as the predicate device. The submission leveraged existing published studies/literature for uterine fibroid embolization for additional clinical information, but did not present a new clinical study with specific acceptance criteria for diagnostic performance.
§ 870.3300 Vascular embolization device.
(a)
Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 870.1(e).