Easi-Vue embolic microspheres are biocompatible, radiopaque, non-compressible, non-resorbable glass microspheres. The Easi-Vue embolic microspheres are included with the Easi-Vue embolic microspheres System which is comprised of Easi-Vue embolic microspheres Administration Kit and the Easi-Vue embolic microspheres Refill Syringe. The device utilizes the Administration Kit for controlled and targeted delivery of imageable radiopaque microspheres. The Easi-Vue™ embolic microspheres System is offered in three sizes: 50 um, and 150 um to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1).

The Easi-Vue™ embolic microsphere System is sterile, single use, and available only for prescription use. The device is compatible with a catheter with minimum inner diameter of 0.021'' and a length between 110-150 cm (as appropriate for the diameter of the intended treatment vessel).

AI/ML Overview

The provided text describes a medical device, the Easi-Vue™ embolic microspheres System, seeking 510(k) clearance based on substantial equivalence to a predicate device. The information provided focuses on the characteristics of the device itself and its comparison to a predicate, rather than an AI-driven diagnostic system that would typically have acceptance criteria focused on algorithm performance metrics (e.g., sensitivity, specificity, AUC) and a test set of patient data with ground truth.

Therefore, many of the requested points regarding acceptance criteria, study design, and performance metrics for an AI system are not directly applicable or derivable from the provided document.

However, I can extract information related to the device's performance based on the non-clinical performance summary.

Here's an attempt to answer the questions based on the available information, noting where information is not present or relevant to AI systems:

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

Since this is a non-AI device, the acceptance criteria are not typically presented as performance metrics like sensitivity/specificity but rather as successful completion of various tests.

Acceptance Criteria (from "Non-Clinical Performance Summary")	Reported Device Performance
Biocompatibility according to ISO 10993	Demonstrated to be biocompatible
Meet all acceptance criteria for bench testing (including simulated use, MR compatibility, and performance verification)	Met all acceptance criteria and performed as intended
Ease of delivery (in animal study)	Confirmed
Effectiveness of arterial occlusion (in animal study)	Confirmed
No clinically significant pathological abnormalities (in animal study)	Confirmed
No systemic abnormalities (in animal study)	Confirmed
No new safety or effectiveness concerns raised during testing	Confirmed

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

Sample Size for Test Set: This information is not explicitly provided in terms of "test set" for an AI system. The document mentions a GLP animal study. The number of animals used in this study is not specified.
Data Provenance: The GLP animal study is a prospective study. The country of origin for the animal study data is not specified in the provided text.

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 is not applicable as the study described is an animal study for a physical medical device, not an AI system being evaluated against human expert labeling of data. The "ground truth" was established through direct observation and pathological assessment in the animal study.

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

Not applicable for a non-AI device animal study. Adjudication methods are typically used for expert labeling of data in AI model evaluation.

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 is not an AI-assisted device, and no MRMC study is mentioned.

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

Not applicable as this is a physical medical device.

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

For the animal study, the ground truth was established through:

Direct observation of "ease of delivery" and "effectiveness of arterial occlusion."
Pathological assessment to confirm "no clinically significant pathological abnormalities or systemic abnormalities."

8. The sample size for the training set

Not applicable as this is a physical medical device, not an AI system that requires a training set.

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

Not applicable as this is a physical medical device, not an AI system.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 7, 2022

ABK Biomedical Inc Brandi Woods Director, Regulatory Affairs 155 Chain Lake Drive Unit 32 Halifax, NS B3S 1B3 Canada

Re: K220567

Trade/Device Name: Easi-Vue embolic microspheres System Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: August 18, 2022 Received: August 19, 2022

Dear Brandi Woods:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm = identifies = combination = product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical

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

device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-DICE website assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Misti Malone Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K220567

Device Name Easi-Vue™ embolic microspheres System

Indications for Use (Describe)

Easi-Vue™ embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

K220567 PAGE 1 OF 4

1 510(k) Summary

The following information is provided as required by 21 CFR § 807.92 and the Safe Medical Devices Act 1990.

1.1 General Information

Company:	ABK Biomedical155 Chain Lake DriveUnit 32Halifax Nova Scotia B3S 1B3Canada
Contact:	Brandi WoodsDirector, Regulatory Affairs919-619-6417b.woods@abkbiomedical.com

6 September 2022 Date of Summary:

1.2 Device Name and Classification

Proprietary Name:	Easi-Vue™ embolic microspheres System
Common Name:	Device, Vascular, For Promoting Embolization
Classification Name:	Vascular Embolization Device
Regulatory Class:	2
Regulation:	870.3300
Product Codes:	KRD

1.3 Predicate Device

Proprietary Name:	Embosphere® Microspheres
Common Name:	Device, Vascular, For Promoting Embolization
510(k) Number:	K021397
Regulatory Class:	2
Regulation:	870.3300
Product Codes:	KRD
	Predicate device has not been subject to a design-related recall.

1.4 Indication for Use

Easi-Vue™ embolic microspheres System is intended for embolization of arteriovenous malformations and hypervascular tumors.

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

Easi-Vue™ embolic microspheres System

1.5 Device Description

	Easi-Vue™ embolic microspheresAdministration Kit	Easi-Vue™ embolic microspheresRefill Syringe
50 µm size	EVA50	EVR50
100 µm size	EVA100	EVR100
150 µm size	EVA150	EVR150

Table 1: Product Availability

1.6 Technological Comparison

Easi-Vue™ Embolic Microspheres System is substantially equivalent, for the purpose of this 510(k), to Embosphere® Microspheres (K021397), the predicate device. The subject device and predicate devices are similar in intended use, design, and principle of operation. This is based upon the comparison of the operational characteristics, product technical characteristics, performance and safety characteristics, sterility, and product handling. Easi-Vue™ embolic microspheres are made from radiopaque glass, which is a different material compared to the predicate, acrylic polymer sphere impregnated with porcine gelatin. The differences in material composition has shown no new questions of safety based upon bench, biocompatibility and animal testing.

Unlike the predicate Easi-Vue™ embolic microspheres are non-compressible, meaning they are non-deformable during delivery. In animals, Easi-Vue™ embolic microspheres has demonstrated equivalent effectiveness at occluding the target vessel, with no migration observed.

While differences in the technology characteristics exist between the Easi-Vue™ embolic microspheres System and the predicate device, these differences, which are detailed in Table 2, do not raise different questions of safety or effectiveness.

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

Easi-Vue™ embolic microspheres System Table 2: Comparison to Predicate

	Easi-Vue™ EmbolicMicrospheres System	Embosphere® Microspheres	Comparison
Company	ABK Biomedical, Inc	Biosphere Medical, S.A.
	Subject Device	Predicate Device
510(k) Number	K220567	K021397
Product Code	KRD	KRD (also NAJ, NOY, & HCG)	Same
Intended use	Vascular Embolization Device	Vascular Embolization Device	Same
Indications forUse	Easi-Vue™ EmbolicMicrospheres System is intendedfor use in embolization ofhypervascular tumors andarteriovenous malformations	Embosphere Microspheres are indicatedfor use in embolization of arteriovenousmalformations, hypervascular tumors,and symptomatic uterine fibroids	EquivalentSubject devicehas morerestrictiveindication.
Mechanism ofAction	Mechanical occlusion	Mechanical occlusion	Same
Principle ofOperation	The microspheres areadministered into the patient'sartery via a catheter underradiographic imaging	The microspheres are administered withcontrast medium into the patient's arteryvia a catheter under radiographic imaging	EquivalentSubject devicedoes not requirecontrast mediumfor imaging.
MaterialComposition ofspheres	tantalum-barium-boron-sodium-silicon oxide glassSaline	Acrylic polymer sphere impregnated withPorcine gelatinSaline	No new safetyconcern
Size Range	50 ±20 microns100 ±35 microns150 ±50 microns	40- 120 microns100-300 microns300-500 microns500-700 microns700-900 microns900- 1200 microns	Equivalent
PhysicalCharacteristics	Biocompatible, radiopaque, non-compressible, non-resorbable	Biocompatible, hydrophilic,compressible, non-resorbable	No new safetyconcern
Performance	Controlled, targeted embolizationat the desired level of vesselocclusion	Controlled, targeted embolization at thedesired level of vessel occlusion	Same
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Same
MR Safe	MR Safe	MR Safe	Same
Sterility(method)	Sterile (gamma) to SAL 10-6	Sterile (steam) to SAL 10-6	Equivalent
Quantity ofmicrospheresper package	Each 1 mL syringe containsapproximately 1.25 g ofmicrospheres in saline.	Each 20 mL syringe or 8 mL glass vialcontains approximately 1.0 mL or 2.0 mLof microspheres in saline.	Equivalent
Packaging	Tyvek pouch	A peel-away tray	Equivalent

{6}------------------------------------------------

K220567

1.7 Non-Clinical Performance Summary

Bench testing, biocompatibility, and non-clinical studies were conducted to support substantial equivalence of Easi-Vue embolic microspheres System to the predicated device. Easi-Vue embolic microspheres System was demonstrated to be biocompatible according to ISO 10993. Bench testing, including simulated use, MR compatibility and performance verification confirmed that Easi-Vue embolic microspheres System met all the acceptance criteria and performed as intended. A GLP animal study confirmed the ease of delivery, effectiveness of arterial occlusion and there were no clinically significant pathological abnormalities or systemic abnormalities. No new safety or effectiveness concerns were raised during testing.

1.8 Conclusion

Based on the intended use, technological characteristics, performance characteristics and data included in this application, the Easi-Vue embolic microspheres System is substantially equivalent to the predicate device.

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).