LC Bead 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). LC Bead 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 (LC Bead 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.

LC Bead 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 LC Bead /Bead Block™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL, and (2) 2.0mL LC Bead/Bead Block™ Compressible Microspheres in sterile PBS to a volume of 8 mL.

LC Bead and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100um to 1200um diameter.

At the time of use, LC Bead/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 text describes the 510(k) submission for "Bead Block and LC Bead" microspheres. However, the document does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically seen for AI/ML-driven devices (e.g., sensitivity, specificity, or reader study results). This submission is for a medical device (embolic microspheres), not a diagnostic algorithm or AI system.

Therefore, most of the requested information regarding acceptance criteria and study details (like sample size for test sets, data provenance, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable to this particular document.

Here's an attempt to address the request based only on the provided text, while highlighting the limitations:

1. A table of acceptance criteria and the reported device performance

The document lists "Performance Standards" which are primarily regulatory and quality standards for medical devices, rather than specific numerical performance metrics related to diagnostic accuracy or efficacy in the way an AI/ML device would be evaluated.

Acceptance Criteria (Performance Standard)	Reported Device Performance	Notes
FDA Guidance for Neurological Embolization Products (2004)	Met	The device's indications for use align with this guidance.
ISO/EN 10993-1 (1997) Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing	Met	Implies the device has undergone biological evaluation.
ISO/EN 10993-3 (1993) Biological Evaluation of Medical Devices, Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity	Met	Implies the device has been tested for these toxicities.
ISO/EN 10993-4 (1993) Biological Evaluation of Medical Devices, Part 4: Selection of tests for interaction with blood	Met	Implies the device has been tested for blood interaction.
ISO/EN 10993-6 (1995) Biological Evaluation of Medical Devices, Part 6: Test for local effects after implantation	Met	Implies the device has been tested for local effects.
ISO/EN 10993-10 (1995) Biological Evaluation of Medical Devices. Part 10: Tests for Irritation and Sensitization	Met	Implies the device has been tested for irritation and sensitization.
ISO/EN 10993-11 (1993) Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity	Met	Implies the device has been tested for systemic toxicity.
ISO/EN 11607 (1997) Packaging for terminally sterilized products	Met	Implies the device packaging meets sterilization standards.
AAMI 11134 (1993) Sterilization of Health Care Products Requirements for validation and routine control - Industrial moist heat sterilization	Met	Implies the sterilization process meets this 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	Met	Implies the sterilization process meets this standard.
EN 554: Sterilization of Medical Devices validation and Routine Control of Sterilization by Moist Heat	Met	Implies the sterilization process meets this standard.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes a medical device (microspheres) and its regulatory submission, not a study involving a test set of data for an AI/ML algorithm. The "Performance Standards" listed are for the device itself (biocompatibility, sterilization, etc.), not for evaluating an algorithm's performance on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided and is not applicable to the type of device described. Ground truth for an AI/ML test set would involve expert annotations or pathology, which is not relevant for the regulatory approval of embolic microspheres based on biocompatibility and manufacturing standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided and is not applicable.

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

This information is not provided and is not applicable. MRMC studies are typically for evaluating the impact of AI/ML systems on human reader performance, which is not the subject of this 510(k) submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not provided and is not applicable. The device is a physical medical product (microspheres), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the device itself, the "ground truth" would relate to its physical and biological properties meeting established standards (e.g., sterility confirmed by lab tests, biocompatibility confirmed by in-vitro/in-vivo studies, particle size confirmed by measurement). The document references various ISO/EN standards which would implicitly define the "ground truth" for compliance. There is no mention of expert consensus, pathology, or outcomes data in the context of proving the device meets acceptance criteria as would be relevant for an AI/ML system.

8. The sample size for the training set

This information is not provided and is not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established

This information is not provided and is not applicable.

Summary

{0}------------------------------------------------

Bead Block and LC Bead

510K Summary ব

Submitter:

DEC 2 4 2008

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 Microspheres 510K Number: #K023089 Product Code: HCG/KRD CFR Section: 882.5950

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: #K042231 Product Code: HCG CFR Section: 870.3300

{1}------------------------------------------------

4.1 Indications for Use and Intended Population "LC Bead/Bead Block™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).

4.1.1 Device Description

LC Bead and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100um to 1200um diameter.

Similarities and Differences to Predicates 4.2

The Intended Use of LC Bead /Bead Block™ Compressible Microspheres and the predicate device are the same and unchanged other than product names. This pre-

{2}------------------------------------------------

Bead Block and LC Bead

market notification addresses Biocompatibles UK Ltd. intent to market LC Bead with the Vascular (KRD) Code and to update its registration and listing with this code.

Other than trade name there are no differences when comparing Biocompatibles, LC Bead/Bead Block™ to the predicate devices.

Performance Standards 4.3

LC Bead/Bead Block Compressible Microspheres meet the following Performance Standards:

. Guidance For Industry; 2004: FDA Guidance for Neurological Embolization Products
1SO/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.
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 11607; 1997 Packaging for terminally sterilized products.
AAMI 11134; 1993 Sterilization of Health Care Products Requirements for validation and routine control - Industrial moist heat sterilization 201 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

Biocompatibles UK Ltd

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 4 2008

Generic Devices Consulting, Inc. c/o Mr. John Greenbaum 20310 SW 48th Street Ft. Lauderdale, FL 33332

Re: K083091

LC Bead Microspheres, Bead Block Compressible Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 11, 2008 Received: October 17, 2008

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.

{4}------------------------------------------------

Page 2 - Mr. John Greenbaum

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. 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 dcsire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological IIealth's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

elmpel

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

510(k) Number(if known): Ko 8309 ]

Device Name:

LC Bead Microspheres Bead Block™ Compressible Microspheres

Indications For Use:

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

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)
Certification Statement

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K083091

Biocompatibles UK Ltd

Regulation Number and Section

§ 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).