GelSpheres™ and Bead Block™ 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 Bead Block ™ 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. Bead Block™ Compressible Microspheres is dyed blue (GelSpheres™ are available 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.

GelSpheres ™ Microspheres is supplied sterile and packaged in sealed glass vials. Bead Block™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /Bead Block™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL, and (2) 2.0mL GelSpheres™/Bead Block™ Compressible Microspheres in sterile PBS to a volume of 8 mL.

GelSpheres™ and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200um diameter. At the time of use, GelSpheres"™/Bead Block™ 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.

AI/ML Overview

The provided FDA 510(k) Pre-Market Notification for GelSpheres™ Microspheres and Bead Block™ Compressible Microspheres does not describe a study that uses acceptance criteria related to device performance metrics, nor does it report on such performance metrics for the device itself.

Instead, this submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K023089 and K033761). The core of the submission is that the current device (K042231) is identical in design, intended use, warnings, contraindications, product, manufacturing, and primary packaging to the predicates. The only reported change is the final packager from BioCure, Inc. to Biocompatibles UK Ltd.

Therefore, the information requested in your prompt regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not present in this document.

The document lists Performance Standards that the device meets, but these are generic regulatory and biological evaluation standards, not specific performance metrics (e.g., accuracy, sensitivity, specificity) for evaluating its efficacy in embolization. These standards ensure the device meets safety and manufacturing requirements, but not a clinical performance standard regarding, for example, the success rate of embolization or reduction in tumor size.

Specifically:

A table of acceptance criteria and the reported device performance: Not applicable. No performance metrics (e.g., embolization success rate, AVM reduction) or associated acceptance criteria are stated or evaluated in this document. The "acceptance criteria" here are implied to be meeting the listed performance standards (e.g., ISO, AAMI for biocompatibility, sterility, packaging), and the "device performance" is deemed equivalent to the predicate devices.
Sample sizes used for the test set and the data provenance: Not applicable. No clinical or performance test set data is presented.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for performance evaluation is established or discussed.
Adjudication method (e.g. 2+1, 3+1, none) 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 device is a medical implant (microspheres for embolization), not an AI-powered diagnostic or assistive tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

In summary, this 510(k) submission primarily relies on demonstrating substantial equivalence based on design and intended use rather than presenting new clinical or performance data against pre-defined acceptance criteria for efficacy. The "study that proves the device meets the acceptance criteria" refers to the entire 510(k) submission process, which asserts equivalence and compliance with general safety and performance standards rather than specific performance metrics directly related to its therapeutic effect.

Summary

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Biocompatibles UK Ltd..

K042231
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510(k) Pre-Market Notification
GelSpheres ™ Microspheres
Bead Block™ Compressible Microspheres

510(k) Summary NOV 1 2 2004

Submitter: Biocompatibles UK Ltd. Weydon Lane Chapman House Weydon Lane, Farnham, Surrey +44 1252732732

Contact: Dr. Alistair Taylor

510(k) Numbers and Product Codes of equivalent devices.

Biocure, Inc.

GelSpheres TM Microspheres 510K Number: #K023089 Product Code: HCG CFR Section: 882.5950

Biocompatibles UK Ltd. GelSpheres™ Microspheres Bead Block™ Compressible Microspheres 510K Number: #K033761 Product Code: HCG CFR Section: 882.5950

Indications for Use and Intended Population

"GelSpheres™/Bead Block™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).

Device Description

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available 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.

Similarities and Differences to Predicates

The Intended Use of GelSpheres™ /Bead Block™ 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.

There are more similarities than differences when comparing Biocompatibles, GelSpheres ™/Bead Block™ to the predicate devices.

Performance Standards

GelSpheres™/BeadBlock Compressible Microspheres meet the following Performance Standards:

Guidance For Industry; 2004: FDA Guidance for Neurological . Embolization Products
ISO/EN 10993-1; 1997 Biological Evaluation of Medical Devices, . Part I: Evaluation and Testing
ISO/EN 10993-3; 1993 Biological Evaluation of Medical Devices, . Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity.
ISO/EN 10993-4; 1993 Biological Evaluation of Medical Devices, . Part 4: Selection of tests for interaction with blood.

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Biocompatibles UK Ltd..

10472

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ISO/EN 10993-6; 1995 Biological Evaluation of Medical Devices, . Part 6: Test for local effects after implantation.
ISO/EN 10993-10; 1995 Biological Evaluation of Medical Devices, . Part 10: Tests for Irritation and Sensitization.
ISO/EN 10993-11: 1993 Biological Evaluation of Medical Devices. . Part 11: Tests for Systemic Toxicity.
ISO/EN 10993-13; 1995 Biological Evaluation of Medical Devices. . Part 13: Identification and Quantification of potential degradation products from polymers.
ISO/EN 11607; 1997 Packaging for terminally sterilized products. .
AAMI TIR 22;1998 -- Guidance for application of EN 11607. . Packaging for terminally sterilized products
AAMI 11134; 1993 Sterilization of Health Care Products -. Requirements for validation and routine control - Industrial moist heat sterilization 2nd edition.
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.
EN 554: Sterilization of Medical Devices -- validation and Routine Control of Sterilization by Moist Heat

Conclusion

There are more similarities than differences between the predicate device and the Biocompatibles GelSpheres™/Bead Block™ Compressible Microspheres. The product, manufacturing and primary packaging are unchanged from K023089/K033761. The predicate device and GelSpheres™/Bead Block™ Compressible Microspheres have the same intended use, warnings and contraindications. The predicate device and GelSpheres ™/Bead Block™ Compressible Microspheres are identical in design, and unchanged from K023089. When used in accordance with the instructions for use, by qualified personnel, the Biocompatibles GelSpheres™/Bead Block™ Compressible Microspheres are safe and effective, as indicated, for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/11 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the department's name written around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 2 2004

Biocompatibles U.K. Ltd. C/o John Greenbaum Generic Devices Consulting, Inc. 20310 SW 48th Street Ft. Lauderdale, Florida 33332

Re: K042231 Trade/Device Name: GelSpheres™ Microspheres Bead Block™ Compressible Microspheres Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial embolization device Regulatory Class: III Product Code: HCG Dated: August 14, 2004 Received: August 17, 2004

Dear Mr. Greenbaum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Greenbaum

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K042231

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Page 1 of 1

510(k) Number(if known):

Device Name: GelSpheres™ Microspheres Bead Block TM Compressible Microspheres

Indications For Use:

"GelSpheres"M Microspheres & Bead Block™ Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations."

Muriam C. Provost

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number K04223/

Prescription Use X (Per 21 CRF 801.109) Over-The-Counter Use

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 1-2-96)

Regulation Number and Section

§ 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).