GelSpheres™ Embolic Agent are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascualr tumor or arteriovenous malformations (AVM's). GelSpheres™ Embolic Agent 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. GelSpheres™ Embolic Agent 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.

The product is supplied sterile and packaged in sealed glass bottles for V-Series Model numbers, and in pre-filled syringes for S- Series model numbers. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ Embolic Agent in sterile physiologic buffered saline (PBS) to a volume of 8 mL. and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 8 mL. Two quantities will be available in a pre-filled syringe: (1) 1.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL, and (2) 2.0mL GelSpheres™ Embolic Agent in sterile PBS to a volume of 5 mL.

GelSpheres™ Embolic Agent is supplied in several units covering the range from 100um to 1200um diameter.

At the time of use, GelSpheres™ Embolic Agent 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 is a 510(k) Pre-Market Notification for the GelSpheres™ Embolic Agent. It details the device's indications for use, description, similarities and differences to predicate devices, and performance standards it meets.

However, the document does not contain information about the acceptance criteria and the results of a specific study to prove the device meets those criteria. The performance standards listed are general regulatory and biological evaluation standards (e.g., ISO/EN, AAMI guidance) that the device must comply with for a 510(k) submission, not specific clinical or performance acceptance criteria for its intended use that would be evaluated in a study with stated performance metrics.

Therefore, I cannot provide the requested table and study details as they are not present in the input text.

Here’s what I can extract based on the available information:

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

Not applicable / Not found in the provided text. The document lists general performance standards (e.g., ISO for biological evaluation), but not specific acceptance criteria for "device performance" in terms of its embolization efficacy or measurable outcomes with associated performance metrics.

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

Not applicable / Not found in the provided text. The document describes the device and regulatory compliance, but not a specific study with a test set.

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)

Not applicable / Not found in the provided text. No information on establishing ground truth for a test set is provided.

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

Not applicable / Not found in the provided text. No information on an adjudication method for a test set is provided.

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 / Not found in the provided text. This device is an embolic agent, not an AI-assisted diagnostic or interpretative tool. No MRMC study is mentioned.

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

Not applicable / Not found in the provided text. This device is an embolic agent, not an algorithm.

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

Not applicable / Not found in the provided text. No study employing ground truth is detailed.

8. The sample size for the training set

Not applicable / Not found in the provided text. No training set is mentioned as this is a physical medical device, not a machine learning model.

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

Not applicable / Not found in the provided text. No training set or ground truth establishment relevant to it is discussed.

Summary of what the document does provide regarding "performance":

The document states that the GelSpheres™ Embolic Agent "meets 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.
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

These are regulatory and manufacturing standards, not specific clinical performance metrics with acceptance criteria and corresponding study results. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices based on intended use, design, and adherence to these general standards, which implies safety and effectiveness without detailing a performance study with specific outcome measures.

Summary

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K02 3089

Original 510(k) Pre-Market Notification GelSpheres™ Embolic Agent

510(k) Summary

DEC 1 6 2002

September 13, 2002

Submitter: BioCure, Inc 2975 Gateway Drive Suite 100 Norcross, GA (678) 966-3422

Contact: Dennis Goupil. PhD

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

Biosphere Medical, Inc.

Embospheres® Microspheres 510K Number: #K991549 Product Code: HCG CFR Section: 882.5950

Biosphere Medical, Inc.

EmboGold™ Microspheres 510K Number: #K010026 Product Code: HCG CFR Section: 882.5950

Indications for Use and Intended Population

GelSpheres™ Embolic Agent are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's)

Device Description

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GelSpheres™ Embolic Agent is supplied in several units covering the range from 100um to 1200um diameter. The product size ranges are listed below:

Size Range	1 ML Vial(7-11)	2 ML Vial(7-11)	1 ML Syringe(7-1)	2 ML Syringe(7-1)
100-300μm	V210GS	V220GS	S210GS	S220GS
300-500μm	V410GS	V420GS	S410GS	S420GS
500-700μm	V610GS	V620GS	S610GS	S620GS
700-900μm	V810GS	V820GS	S810GS	S820GS
900-1200μm	V1010GS	V1020GS	S1010GS	S1020GS

Similarities and Differences to Predicates

The Intended Use of GelSpheres™ Embolic Agent and the predicate devices is the same. All devices are intended to be delivered to selected sites through catheters with a diameter appropriate for the vascular target and the size of the emboli. Accurate placement of all of the embolization devices is assured through visualization of the embolization process using radiographic imaging. All of the devices are mixed with a radiopacity agent prior to iniection to permit visualization. GelSpheres™ Embolic Agent, like the predicate devices are available in a range of sizes to permit selection of the most appropriate size for target vessels. GelSpheres™ Embolic Agent are made from polyvinyl alcohol, whereas Embospheres® Microspheres and EmboGold™ Microspheres are comprised of acrylic polymer impregnated with gelatin. GelSpheres™ Embolic Agent and Embospheres® Microspheres are deformable microspheres. GelSpheres™ Embolic Agent and EmboGold™ microspheres are colored to make the device more visible to the physician when preparing and injecting the embolic agents in a syringe. GelSpheres™ Embolic Agent and the substantially equivalent

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devices are intended for single use and are supplied sterile and non pyrogenic. GelSpheres™ Embolic Agent , Embospheres™ Microspheres and EmboGold™ are all supplied in both bottles and syringes.

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

Performance Standards

The BioCure GelSpheres™ Embolic Agent meets 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.
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.

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

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 devices and the BioCure, Inc. GelSpheres™ Embolic Agent. Both the predicate devices and GelSpheres™ have the same intended use, warnings and contraindications. Both the predicate devices and GelSpheres are similar in design. When used in accordance with the instructions for use, by qualified personnel, the BioCure, Inc. GelSpheres™ are safe and effective, as indicated, for the intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN" around the top half and what appears to be "SERVICES" around the bottom half. Inside the circle is a stylized symbol of three human profiles facing to the right, stacked on top of each other.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2007

BioCure, Inc. c/o Mr. John Greenbaum Generic Devices Consulting, Inc. 20310 SW 48th Street Fort Lauderdale, Florida, 33332

Re: K023089

Trade/Device Name: GelSpheres Embolic Agent Regulation Number: 21 CFR 882,5950; 21 CFR 870,3300 Regulation Name: Artificial embolization device; Arterial Embolization Device Regulatory Class: III Product Code: HCG; KRD Dated: September 13, 2002 Received: September 17, 2002

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. 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.

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Page 2 - Mr. John Greenbaum

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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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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KOZ 3089

000008

Page 1 of 1

510(k) Number(if known):_

Device Name: GelSpheres™ Embolic Agent

Indications For Use:

"GelSpheres™ Embolic Agent is intended for embolization of hypervascular tumors and arteriovenous malformations."

: :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_X_(Per 21 CRF 801.109)	OR	Over-The-Counter Use_
---------------------------------------------	----	-----------------------

(Optional Format 1-2-96)

Miriam C. Provost

(Division Sign-Off)

Division of General, Restorative
and Neurological Devices

510(k) Number	K023089
---------------	---------

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).