(25 days)
ONCOZENE™ Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
ONCOZENE™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.
ONCOZENE™ Microspheres are precise dimensioned, soft, deformable microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). ONCOZENE™ Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The fully polymerized microspheres are compressible to enable smooth delivery through the indicated delivery catheter. ONCOZENE™ Microspheres contain no added dyes and are visually opaque. ONCOZENE™ Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Available as 40μm, 75μm and 100μm microsphere diameter sizes, the ONCOZENE™ syringes are available with 2ml or 3ml microsphere volume per syringe.
The provided text describes a 510(k) premarket notification for a medical device called ONCOZENE™ Microspheres. This submission is for demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a clinical study with an aim to assess algorithm performance. Therefore, many of the requested categories, such as "reported device performance," "sample size for the test set," "number of experts," "adjudication method," "MRMC study," "standalone algorithm performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established," are not directly applicable or available in this type of submission.
Instead, the submission focuses on demonstrating equivalence based on similar design, specifications, fundamental scientific technology, and performance established through in-vitro testing, literature review, and post-market surveillance of the predicate device.
Here's the information that can be extracted or inferred based on the nature of a 510(k) submission for this type of device:
Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)
Since this is a 510(k) submission establishing substantial equivalence for a medical device that physically occludes vasculature, the "acceptance criteria" are not performance metrics of an AI algorithm, but rather a demonstration that the new device (ONCOZENE™ Microspheres) is as safe and effective as the predicate device (Embozene Microspheres). The "reported device performance" is essentially showing that ONCOZENE™ Microspheres meet or fall within the established specifications and safety profile demonstrated by the predicate.
| Acceptance Criteria Category | Reported ONCOZENE™ Device Performance (vs. Predicate) |
|---|---|
| Intended Use | Equivalent (embolization of hypervascular tumors and arteriovenous malformations). |
| Design | Same. |
| Specifications | Same for key characteristics like chemical composition, osmolarity, sterility, total fill volume, and shelf life. |
| pH of transport solution is tighter for ONCOZENE™ but within existing specification cleared for the predicate. | |
| Available diameter sizes (40μm, 75μm, 100μm) are a subset of the predicate's sizes. | |
| Fundamental Scientific Technology | Same (precise dimensioned, soft, deformable microspheres made from sodium polymethacrylate and coated with Polyzene®-F, intended to occlude vasculature). |
| Packaging | Similar (supplied sterile and packaged in polycycloolefin syringes). |
| Microsphere volume per syringe is 2ml or 3ml for ONCOZENE™ compared to 1ml or 2ml for predicate. | |
| Safety and Effectiveness | Concluded to be safe and effective based on: |
- Equivalence to predicate.
- Extensive review of scientific literature (1029 abstracts) on Transarterial Embolization (TAE) with various embolic agents, including the predicate.
- Review of CeloNova's adverse event data from >70,000 units of predicate distributed worldwide. |
1. A table of acceptance criteria and the reported device performance:
See table above. The "acceptance criteria" here refers to the parameters for demonstrating substantial equivalence. The "reported device performance" refers to how ONCOZENE™ Microspheres compare to these parameters and to the predicate device.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a traditional "test set" for an AI algorithm. The evaluation relies on in-vitro testing of the ONCOZENE™ Microspheres and a broad review of clinical experience with the predicate device and similar embolic agents.
- Data Provenance: The "clinical experience" review involved:
- 1029 abstracts from a PubMed search.
- CeloNova's adverse event data resulting from over 70,000 units of the predicate device distributed worldwide.
- This data is retrospective, covering experience over the last ten years with Transarterial Embolization (TAE) using various embolic agents. The countries of origin for the PubMed abstracts and worldwide distribution would be global.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is a medical device submission based on substantial equivalence, not an AI algorithm performance study requiring expert ground truthing. The "ground truth" concerning the safety and effectiveness of embolization with these types of microspheres is established through decades of medical practice, clinical trials (for the predicate and similar devices), and post-market surveillance summarized in the literature review.
4. Adjudication method for the test set:
Not applicable. No "test set" in the sense of a set of cases requiring adjudication for ground truth.
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 device is a physical embolization microsphere, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is not an AI algorithm. The device itself is "standalone" in that it performs its physical function (occlusion) without human-in-the-loop interaction during its mechanism of action, but its performance evaluation in this submission is not in the context of an algorithm.
7. The type of ground truth used:
For the conclusion of safety and effectiveness, the "ground truth" is based on:
- Expert Consensus/Clinical Evidence: Derived from a comprehensive literature review of Transarterial Embolization (TAE) using various embolic agents, including the predicate device, performed over the last ten years.
- Outcomes Data/Post-Market Surveillance: Adverse event data from over 70,000 units of the predicate device distributed worldwide.
- In-vitro Testing: Summary of in-vitro data for ONCOZENE™ Microspheres showing that minor manufacturing changes (for tighter pH control) did not necessitate additional testing.
8. The sample size for the training set:
Not applicable. There is no AI training set involved in this submission.
9. How the ground truth for the training set was established:
Not applicable. There is no AI training set involved in this submission.
§ 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).