(108 days)
Not Found
No
The device description focuses on the physical properties and composition of the microspheres, and there is no mention of AI, ML, image processing, or any computational analysis of data. The performance study describes a comparison of physical embolization properties.
Yes.
The device is intended for embolization of hypervascular tumors and arteriovenous malformations, which is a therapeutic intervention to block blood flow to target tissues.
No
Explanation: The device description and intended use clearly state that this product, LC Bead/Bead Block, is used for embolization, which is a therapeutic procedure to block blood flow to target tissues like tumors or arteriovenous malformations. It does not mention any diagnostic capabilities.
No
The device description clearly states that the device is comprised of physical microspheres made from polyvinyl alcohol (PVA) and supplied in vials or syringes. This is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for embolization of hypervascular tumors and arteriovenous malformations." This describes a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The description details a physical object (microspheres) designed to be delivered into arteries to occlude them. This is a medical device used for treatment, not for testing samples in vitro.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is used to directly treat a condition within the body.
N/A
Intended Use / Indications for Use
"LC Bead Microspheres & Bead Block™ Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations."
Product codes (comma separated list FDA assigned to the subject device)
KRD, HCG
Device Description
LC Bead/Bead Block 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). LC Bead/Bead Block consists 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. Bead Block is dyed blue (LC Bead are available as blue and in natural color) 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.
LC Bead is supplied sterile and packaged in sealed glass vials. Bead Block is supplied sterile and packaged in polycarbonate syringes. The product configurations are described in the table. LC Bead/Bead Block are supplied in several unit sizes covering the range from 100-1200um diameter. At the time of use, LC Bead/Bead Block is mixed with a nonionic contrast agent, e.g. Omnipaque™, to make a 30-50% by weight solution.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Pre-clinical testing in a large animal model:
The purpose of this study was to evaluate, characterize and compare the performance of LC Bead Embolic Agent (n=36) and Embosphere® microspheres (n=36) in a swine bilateral partial renal artery embolization model in order to assess the ability of these agents to occlude the vessel.
The primary outcomes for this study were assessment of:
- (1) recanalization of the vessels, and,
- (2) local and systemic foreign body tissue reactions.
The secondary outcomes were assessment of:
- (1) ease of delivery of the embolic agent,
- (2) the occurrence of blood vessel rupture
- (3) non-target embolization/device migration.
LC Bead Embolic Agent and Embospheres microspheres performed in a substantially equivalent manner at 2, 7 and 28 days for all parameters except recanalization, where LC Bead appears to have an advantage of having a more durable embolization effect. The tissue reaction for both LC Bead and Embospheres was very mild and was essentially the same. Both embolic agents delivered easily, but Embospheres had six cases of catheter clogging out of 36 cases. There was only one case of catheter clogging with LC Bead. There were no incidents of blood vessel rupture during the embolization procedures. There was one case of unexplained non-target embolization with Embospheres and none with LC Bead. Alternatively, there was one potential case of device migration with LC Bead and none with Embospheres.
In-Vitro testing:
LC Bead and Bead Block have been extensively tested and subject to product and process validation and verification testing.
Key characteristics tested:
- Size distribution: Data was provided for verification and validation of the new size range of LC Bead (70-150µm). All product met specification with respect to bead size.
- Compressibility: LC Bead has equivalent compressibility to other marketed embolic agents.
- Catheter Delivery: Catheter delivery characteristics have been tested in accordance with a written protocol to assure performance with typical microcatheters. The table provides a summary of test results for current marketed LC Bead product and the 70-150μm size fraction.
- Other tests: Residual starting materials, Residual solvents, Product visual inspection for presence of fibres, Product catheter deliverability (Bead Aggregation/Clogging, Ease of Delivery, Shape after embolic after injection, Bead Deliverability, Levels of broken or bead fragments after catheter delivery), Time to Suspension Studies, Bead aspiration from vial, Bead sizing, pH Testing. All these tests passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
510K Summary (K094018)
Submitter:
Biocompatibles UK Ltd. Chapman House Weydon Lane, Farnham, Surrey, GU9 8QL United Kingdom
APR 1 6 2010
・・
+44 1252732732
Contact:
Dr. Alistair Taylor, Director of Quality and Regulatory Affairs
Common name, Trade name(s) & Classification 1
Trade name(s): LC Bead Microspheres & BeadBlock Microspheres Common name(s) & Codes:
Vascular Embolization Device, embolization, arterial (Code: KRD) Neurovascular Embolization Device, artificial embolization (Code: HCG)
510(k) Numbers and Product Codes of equivalent devices. ଧ
Biocompatibles UK Ltd GelSpheres Microspheres Bead Block Compressible Microspheres 510K Number: K033761 Product Code: HCG/KRD CFR Section: 882.5950
Biocompatibles UK Ltd. GelSpheres Microspheres Bead Block Compressible Microspheres 510K Number(s): K042231/K083091 Product Code: HCG/KRD CFR Section: 870.3300/882.5950
1
Indications for Use and Intended Population e
"LC Bead Microspheres & Bead Block Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations."
Device Description 4
LC Bead/Bead Block 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). LC Bead/Bead Block consists 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. Bead Block is dyed blue (LC Bead are available as blue and in natural color) 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.
LC Bead is supplied sterile and packaged in sealed glass vials. Bead Block is supplied sterile and packaged in polycarbonate syringes. The product configurations are described in the table. LC Bead/Bead Block are supplied in several unit sizes covering the range from 100-1200um diameter. At the time of use, LC Bead/Bead Block is mixed with a nonionic contrast agent, e.g. Omnipaque™, to make a 30-50% by weight solution.
| Product | Volume of beads (mL) | Volume PBS (mL) | Total volume (mL) |
|---|---|---|---|
| LC Bead | |||
| Microspheres | 1 | 7 | 8 |
| 2 | 6 | 8 | |
| Bead Block | |||
| Compressible | |||
| Microspheres | 1 | 5 | 6 |
| 2 | 4 | 6 |
LC Bead/Bead Block product configurations.
Similarities and Differences to Predicates 5
The intended use of LC Bead/Bead Block and the predicate device are the same and unchanged. Biocompatibles UK Ltd intend to market LC Bead with an additional SKU in the size range of 70-150μm. Only minor process modifications were made to allow for the
2
production of this size range. Other than the additional size range, there are no differences when comparing L.C Bead/Bead Block to the predicate device.
6 Physical Properties and Characteristics
LC Bead & Bead Block are preformed, soft, deformable microspheres which 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. Compressed beads will recover to their original size (e.g. when compressed passing though a catheter, the beads will return to their original size after exiting the catheter). This Pre-Market notification adds the size range of 70-150μm for the blue dyed version of LC Bead. Both products are supplied in a variety of size ranges as follows:
| Product Code | Size Range (µm) | Quantity Bead Block (mL) | Quantity PBS (mL) |
|---|---|---|---|
| EB1S103 | 100-300 | 1 | 5 |
| EB1S305 | 300-500 | 1 | 5 |
| EB1S507 | 500-700 | 1 | 5 |
| EB1S709 | 700-900 | 1 | 5 |
| EB1S912 | 900-1200 | 1 | 5 |
| EB2S103 | 100-300 | 2 | 4 |
| EB2S305 | 300-500 | 2 | 4 |
| EB2S507 | 500-700 | 2 | 4 |
| EB2S709 | 700-900 | 2 | 4 |
| EB2S912 | 900-1200 | 2 | 4 |
Bead Block available size ranges
| Product Code | Size Range (μm) | Quantity LC Bead (mL) | Quantity PBS (mL) |
|---|---|---|---|
| UB1V103 | 100-300 | 1 | 7 |
| UB1V305 | 300-500 | 1 | 7 |
| UB1V507 | 500-700 | 1 | 7 |
| UB1V709 | 700-900 | 1 | 7 |
| UB1V912 | 900-1200 | 1 | 7 |
| UB2V103 | 100-300 | 2 | 6 |
| UB2V305 | 300-500 | 2 | 6 |
| UB2V507 | 500-700 | 2 | 6 |
| UB2V709 | 700-900 | 2 | 6 |
| UB2V912 | 900-1200 | 2 | 6 |
LC Bead (undyed) available size ranges
3
| Product Code | Size Range (μm) | Quantity LC Bead (mL) | Quantity PBS (mL) |
|---|---|---|---|
| VE110GS | 70-150 | 1 | 7 |
| VE210GS | 100-300 | 1 | 7 |
| VE410GS | 300-500 | 1 | 7 |
| VE610GS | 500-700 | 1 | 7 |
| VE810GS | 700-900 | 1 | 7 |
| VE1010GS | 900-1200 | 1 | 7 |
| VE120GS | 70-150 | 2 | 6 |
| VE220GS | 100-300 | 2 | 6 |
| VE420GS | 300-500 | 2 | 6 |
| VE620GS | 500-700 | 2 | 6 |
| VE820GS | 700-900 | 2 | 6 |
| VE1020GS | 900-1200 | 2 | 6 |
LC Bead (dyed) available size ranges
6.1 Differences between LC Bead and Bead Block
Bead Block is dyed blue using an FDA approved dye (used in contact lenses) to aid in the visualization of the microspheres in the delivery syringe (LC Bead are available as blue and in natural color). Bead Block is provided in a polycarbonate sterile syringe, LC Bead is provided in a sterile glass vial. The primary difference between LC Bead and Bead Block products, aside from the packaging relates to the degree of functionalisation of the macromer and the ratios of initiators used in the reaction which results in differences in the degree of crosslinking of the polymer in the microspheres.
This pre-market notification relates only to the addition of a size fraction for LC Bead in the range of 70-150µm which is a subgroup of the currently marketed LC Bead 100-300µm product and the 70-150µm size specification falls within that of the cleared 100-300 µm LC Bead size range. Please refer to Section 8: In-Vitro testing for further product characterization information. There is no change to the product supplied under the Bead Block trade name.
Summary of Non-clinical data 7
LC Bead and Bead Block have been tested in pre-clinical models for biocompatibility and safety in accordance with the FDA Guidance for Industry and staff; Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.
Tests of Biocompatibility 7.1
Tests for biocompatibility were conducted in accordance with ISO 10993 parts 1, 3, 4, 6, 10 and 11 (listed in section 9), the products conform to the relevant requirements of these standards.
4
| Biocompatibility Test | Pass/Fail |
|---|---|
| Genotoxicity: In Vitro Chromosomal Aberration Study in Mammalian | |
| Cells | Pass |
| Mouse Bone Marrow Micronucleus Study | Pass |
| In Vitro Hemolysis Study (Modified ASTM-Direct Contact Method) | Pass |
| ISO Muscle Implantation Study in the Rabbit | Pass |
| Cytotoxicity Study using the ISO Elution Method | Pass |
| ISO Sensitization Study in the Guinea Pig | Pass |
| ISO Acute Intracutaneous Reactivity Study in the Rabbit | Pass |
| Chronic Toxicity Study in the Rat following Subcutaneous Implantation | |
| (13 weeks) | Pass |
| Subchronic Intravenous Toxicity Study in the Rat (14 day, saline | |
| extract) | Pass |
| Genotoxicity: Bacterial Reverse Mutation Study | Pass |
| ISO Acute Systemic Toxicity Study in the Mouse (liquid/chemical) | Pass |
| ISO Surgical Muscle Implantation in the Rabbit (26 weeks) | Pass |
Pre-clinical testing in a large animal model 7.2
Summary of the Evaluation of LC Bead (formerly Gelspheres) Embolic Agent in a Swine Embolization Model
The purpose of this study was to evaluate, characterize and compare the performance of LC Bead Embolic Agent (n=36) and Embosphere® microspheres (n=36) in a swine bilateral partial renal artery embolization model in order to assess the ability of these agents to occlude the vessel.
The primary outcomes for this study were assessment of:
- (1) recanalization of the vessels, and,
- (2) local and systemic foreign body tissue reactions.
The secondary outcomes were assessment of:
- (1) ease of delivery of the embolic agent,
- (2) the occurrence of blood vessel rupture
- (3) non-target embolization/device migration.
LC Bead Embolic Agent and Embospheres microspheres performed in a substantially equivalent manner at 2, 7 and 28 days for all parameters except recanalization, where LC Bead appears to have an advantage of having a more durable embolization effect. The tissue reaction for both LC Bead and Embospheres was very mild and was essentially the same. Both embolic agents delivered easily, but Embospheres had six cases of catheter clogging out of 36 cases. There was
5
only one case of catheter clogging with LC Bead. There were no incidents of blood vessel rupture during the embolization procedures. There was one case of unexplained non-target embolization with Embospheres and none with LC Bead. Alternatively, there was one potential case of device migration with LC Bead and none with Embospheres.
Summary of In-Vitro testing 8
Both LC Bead and Bead Block have been extensively tested and subject to product and process validation and verification testing. A summary of key characteristics for which test data has been provided in this 510K, are described in this section.
8.1 Size distribution
Data was provided in this pre market notification regarding the verification and validation of the new size range of LC Bead. The table and illustration below provide the results of these tests and demonstrate that all product met specification with respect to bead size.
| Product | Sizing Specification | Fibres Specification |
|---|---|---|
| Current LC Bead | ||
| 100-300μm | Pass | Pass |
| LC Bead 70-150μm | Pass |
6
Image /page/6/Figure/0 description: The figure is a graph titled "70-150µm Bead Size Distribution". The x-axis is labeled "Bead size (µm)" and ranges from 0 to 350. The y-axis is labeled "% Frequency" and ranges from 0 to 30. There are three lines plotted on the graph, labeled "Lot A", "Lot B", and "Lot C", which all show a similar distribution.
Compressibility 8.2
LC Bead has equivalent compressibility to other marketed embolic agents.
Catheter Delivery 8.3
Catheter delivery characteristics have been tested in accordance with a written protocol to assure performance with typical microcatheters. The table below provides a summary of the test results for the current marketed LC Bead product and the 70-150μm size fraction.
7
| Catheter ID | Microcatheter | LC Bead/ size ranges (µm) | |||||
|---|---|---|---|---|---|---|---|
| (inches) | (µm) | Name | 70-150 | 100-300 | 300-500 | 500-700 | 700-900 |
| 0.024 | 610 | 5Fr. Angio | |||||
| Dynamics | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| 0.024 | 610 | FasTracker® | |||||
| 325 | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| 0.021 | 540 | FasTracker® | |||||
| 18 | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| 0.021 | 540 | Cook 3.0 Fr | ✓ | ✓ | ✓ | ✓ | |
| 0.016 | 420 | Prowler® 14 | ✓ | ✓ | ✓ | ||
| 0.022 | 570 | 2.4Fr | |||||
| Progreat™ | |||||||
| Terumo | ✓ | ✓ | ✓ | ||||
| 0.018 | 457 | Spinnaker | |||||
| Elite1.8 | ✓ | ✓ | ✓ |
Catheter can be used for the effective delivery of the LC Bead product.