(64 days)
GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
GelSpheres™ and BeadBlock™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). GelSpheres™ and BeadBlock Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ and BeadBlock Compressible Microspheres is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
GelSpheres™ Compressible Microspheres is supplied sterile and packaged in sealed glass vials. BeadBlock ™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /BeadBlock™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL., and (2) 2.0mL GelSpheres™/BeadBlock™ Compressible Microspheres in sterile PBS to a volume of 8 mL.
GelSpheres™ and BeadBlock Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200μm diameter. At the time of use, GelSpheres™/BeadBlock™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
Biocompatibles UK Ltd.'s submission for GelSpheres™ Compressible Microspheres and BeadBlock™ Compressible Microspheres is a 510(k) pre-market notification, which largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a new clinical study to establish performance from scratch.
Therefore, the document explicitly states: "The Intended Use of GelSpheres™/BeadBlock™ Compressible Microspheres and the predicate device are the same and unchanged other than product names. This pre-market notification addresses the change of the final packager from Biocure, inc to Biocompatibles UK LTD." and "There are more similarities than differences when comparing Biocompatibles, GelSpheres ™/BeadBlock™ to the predicate devices."
This means the submission does not contain a new, comprehensive clinical study with specific acceptance criteria directly assessing the device's clinical performance in the way a de novo device or a device with new indications would. Instead, the acceptance criteria are largely met by demonstrating adherence to established performance standards and equivalence to a device (K023089) that has already proven its safety and effectiveness.
Here's an breakdown based on the provided text, noting where specific information requested is not present in a 510(k) of this nature:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| Guidance For Industry; 2000: FDA Guidance for Neurological Embolization Products | Meets Guidance |
| ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, Part I: Evaluation and Testing | Meets Standard (Likely through biocompatibility testing) |
| ISO/EN 10993-3; 1993 Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity. | Meets Standard |
| ISO/EN 10993-4; 1993 Biological Evaluation of Medical Devices. Part 4: Selection of tests for interaction with blood. | Meets Standard |
| ISO/EN 10993-6; 1995 Biological Evaluation of Medical Devices, Part 6: Test for local effects after implantation. | Meets Standard |
| ISO/EN 10993-10; 1995 Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization. | Meets Standard |
| ISO/EN 10993-11; 1993 Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity. | Meets Standard |
| ISO/EN 10993-13; 1995 Biological Evaluation of Medical Devices, Part 13: Identification and Quantification of potential degradation products from polymers. | Meets Standard |
| ISO/EN 11607; 1997 Packaging for terminally sterilized products. | Meets Standard |
| AAMI TIR 22;1998 Guidance for application of EN 11607, Packaging for terminally sterilized products | Meets Guidance |
| AAMI 11134; 1993 Sterilization of Health Care Products - Requirements for validation and routine control - Industrial moist heat sterilization 200 edition. | Meets Standard |
| ANSI/AAMI/ISO 14937; 2000 Sterilization of Health Care Products - Characterization of a Sterilizing Agent and the Development, Validation and Routine Control of a Sterilization Process for Medical Devices. | Meets Standard |
| EN 554: Sterilization of Medical Devices validation and Routine Control of Sterilization by Moist Heat | Meets Standard |
| Equivalence to predicate device K023089 (Biocure, Inc, GelSpheres™ Microspheres): Same intended use, warnings, contraindications, and identical design and product/primary packaging. | Demonstrated through comparison of device characteristics |
2. Sample size used for the test set and the data provenance
Not applicable for a 510(k) focused on a packaging change and substantial equivalence. There is no specific "test set" of patient data presented or analyzed for clinical performance in this submission. The demonstration of safety and effectiveness relies on the predicate device's existing data and the new device's adherence to relevant standards for physical and biological properties.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No new clinical test set requiring expert ground truth establishment is presented in this 510(k). The clinical efficacy is leveraged from the predicate device.
4. Adjudication method for the test set
Not applicable. No new clinical test set is presented.
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 an embolization agent, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an embolization agent, not an algorithm.
7. The type of ground truth used
For the purpose of this 510(k), the "ground truth" for the device's safety and effectiveness is largely based on:
- The established safety and efficacy profile of the predicate device (K023089).
- Adherence to recognized national and international performance standards (e.g., ISO, AAMI, FDA Guidance) for medical devices, particularly regarding biocompatibility, sterility, and manufacturing quality.
8. The sample size for the training set
Not applicable. There is no "training set" in the context of device performance testing for this 510(k). Performance is established through physical, chemical, and biological testing against standards, and by demonstrating equivalence to a legally marketed predicate device.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The "study" or justification for meeting acceptance criteria in this 510(k) is a comparative analysis and documentation of adherence to recognized standards and guidance.
- Comparative Analysis: The core of the submission is a comparison stating, "There are more similarities than differences between the predicate device and the Biocompatibles GelSpheres™/BeadBlock™ Compressible Microspheres. The product and primary packaging are identical and unchanged from K023089. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres have the same intended use, warnings and contraindications. The predicate device and GelSpheres™/BeadBlock™ Compressible Microspheres are identical in design, and unchanged from K023089." This establishes that because the new device is essentially the same as the predicate (which has already been, or its clinical performance has been, demonstrated to the FDA), it can be considered safe and effective for the stated indications. The only change highlighted is the final packager.
- Adherence to Performance Standards: The submission also lists numerous ISO, EN, AAMI standards, and FDA guidance documents that the device "meets." These standards cover aspects like biological evaluation (biocompatibility, genotoxicity, systemic toxicity, local effects), packaging, and sterilization. By conforming to these standards, the manufacturer demonstrates that the device meets generally accepted criteria for safety and performance in its physical and biological characteristics.
In essence, the device's acceptance is based on its substantial equivalence to a previously cleared device and its compliance with a comprehensive set of recognized industry standards for medical devices. No new clinical efficacy study was required or performed for this specific 510(k) submission.
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(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 § 882.1(e).