GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.

Device Description

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.

AI/ML Overview

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.

Summary

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Biocompatibles UK Ltd..

510(k) Pre-Market Notification

GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres

510(k) Summary

FEB - 4 2004

K033761
014
page 1 of

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™ Microspheres 510K Number: #023089 Product Code: HCG CFR Section: 882.5950

Indications for Use and Intended Population

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

Device Description

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Biocompatibles UK Ltd.. 510(k) Pre-Market Notifica GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres

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.

Similarities and Differences to Predicates

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.

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

Performance Standards

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

Guidance For Industry; 2000: 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.
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.

ge 2 of 3

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Biocompatibles UK Ltd..

510(k) Pre-Market Notit

GelSpheres™ Compressible Microspheres BeadBlock™ Compressible Microspheres

Ka33 761

ISO/EN 10993-13; 1995 Biological Evaluation of Medical Devices, t 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 200 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™/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. When used in accordance with the instructions for use, by qualified personnel, the Biocompatibles GelSpheres™/BeadBlock™ 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/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. Inside the circle is a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other and are connected by three horizontal lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2004

Biocompatibles U.K. Ltd c/o Mr. John Greenbaum Generic Devices Consulting 20310 SW 4811 Street Ft. Lauderdale, Florida 33332

Re: K033761

Trade/Devicc Name: Gelspheres™ Embolic Agent/Beadlock™ Embolic Agent Regulation Number: 21 CFR 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: November 28, 2003 Received: December 8, 2003

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 10 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 I'DA 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 sct forth in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic product radiation control provisions (Scctions 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. John 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 (301) 594-4659. Also, please note the regulation cntitled. "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,

Muriam 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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Indications for Use

Kossztel

510(k) Number (if known): K033761

Device Name: Gelspheres™ Embolic Agent/Beadlock™ Embolic Agent

Indications For Use: GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

lvision Sign-Ofl) f vision of General, Restorative ୍ୟ Neurological Devices

Page 1 of 1

K633761

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).