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 Delivery Device and the Easi-Vue embolic microspheres Refill Syringe. The Delivery Device provides for controlled and targeted delivery of imageable radiopaque microspheres contained in the Refill Syringe. The Easi-Vue® embolic microspheres System is offered in three sizes: 50um, 100μm, and 150μm 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 document does not describe acceptance criteria for a study proving device performance in the context of an AI/ML medical device.

The document is a 510(k) premarket notification letter from the FDA for a medical device called "Easi-Vue® embolic microspheres System." This device is a vascular embolization device, not an AI/ML-driven device.

Therefore, the specific information requested in the prompt, which is tailored to the evaluation of AI/ML device performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance, training set details), is not present in the provided text.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Easi-Vue™ embolic microspheres System, K220567), primarily through:

Indications for Use Comparison: Stating that the indications for use are equivalent.
Technological Comparison (Table 2): Highlighting similarities in mechanism of action, principle of operation, material composition of the microspheres, size range, physical characteristics, performance, pyrogenicity, MR safety, sterility, and packaging. It notes differences in the material composition and design of the "Delivery Device" but concludes these differences "raise no new safety concerns."
Non-Clinical Performance Summary: Briefly mentioning that bench testing (including simulated use and performance verification) and biocompatibility studies were conducted and that the system "met all the acceptance criteria and performed as intended." However, the document does not elaborate on what those acceptance criteria were or provide detailed results from these studies.

In summary, none of the requested information regarding acceptance criteria and studies for an AI/ML device is available in this document. The document pertains to a traditional medical device demonstrating substantial equivalence via non-clinical (bench and biocompatibility) testing, not AI/ML performance evaluation.

Summary

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February 13, 2024

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

Re: K234123

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: December 28, 2023 Received: December 28, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and 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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe 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.

Misti L. Malone -S

Misti Malone, PhD Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K234123

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)

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K234123

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 Biomedical
	155 Chain Lake Drive
	Unit 32
	Halifax Nova Scotia B3S 1B3
	Canada

Registration number: 3013505221

Contact: Brandi Woods Director, Regulatory Affairs 919-619-6417 b.woods@abkbiomedical.com
Date of Summary: 9-Feb-2024

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:	Easi-Vue™ embolic microspheres System
Common Name:	Device, Vascular, For Promoting Embolization
510(k) Number:	K220567
Regulatory Class:	2
Regulation:	870.3300
Product Codes:	KRD
Predicate device has not been subject to a design-related recall.

Device Description 1.4

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K234123 Page 2 of 4

Easi-Vue® embolic microspheres System

and targeted delivery of imageable radiopaque microspheres contained in the Refill Syringe. The Easi-Vue® embolic microspheres System is offered in three sizes: 50um, 100μm, and 150μm to occlude various size arteries for the purpose of blocking blood flow to a target tissue (as summarized in Table 1).

Table 1: Product Availability

Size and Color Code	Easi-Vue embolic microspheres	Easi-Vue embolic microspheres
	Delivery Device	Refill Syringe
50 μm size, Red	EVD50	EVR50
100 μm size, Yellow	EVD100	EVR100
150 μm size, Blue	EVD150	EVR150

1.5 Indication for Use

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

1.6 Indications for Use Comparison

The intended use and indication for use of Easi-Vue Embolic Microspheres System and the predicate device are equivalent. The intended use is for the embolization of hypervascular tumors and arteriovenous malformations.

1.7 Technological Comparison

Easi-Vue Embolic Microspheres System is substantially equivalent to the predicate device, which is the previously approved Easi-Vue Embolic Microspheres System (K220567). The subject device and predicate devices are the same in regard to 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 no different than the predicate. Easi-Vue embolic microspheres Delivery Device has different materials of construction and design than the previously approved Administration Device. The current Administration Device is composed of a tubing assembly, cartridge, rack, and control handle. The new Easi-Vue Delivery Device will consist only of a tubing assembly on a backing plate. The differences in material composition has shown no new questions of safety based upon bench and biocompatibility testing.

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

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K234123 Page 3 of 4

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

	Easi-Vue® Embolic MicrospheresSystem	Easi-Vue™ EmbolicMicrospheres System	Comparison
Company	ABK Biomedical, Inc	ABK Biomedical, Inc
	Subject Device	Predicate Device
510(k) Number	K234123	K220567
Product Code	KRD	KRD	Same
Intended use	Vascular Embolization Device	Vascular Embolization Device	Same
Indications for Use	Easi-Vue Embolic MicrospheresSystem is intended for use inembolization of hypervasculartumors and arteriovenousmalformations	Easi-Vue Embolic MicrospheresSystem is intended for use inembolization of hypervasculartumors and arteriovenousmalformations	Same
Mechanism ofAction	Mechanical occlusion	Mechanical occlusion	Same
Principle ofOperation	The microspheres are administeredinto the patient's artery via acatheter under radiographic imaging	The microspheres are administeredinto the patient's artery via acatheter under radiographic imaging	Same
MaterialComposition of	tantalum-barium-boron-sodium-silicon oxide glassSaline	tantalum-barium-boron-sodium-silicon oxide glassSaline	Same
MaterialComposition of theDelivery Device	Delivery Device composed of TPUtubing, PC connectors and UVadhesive, attached to a color-codedbacking plate corresponding to thesize range of microspheres.	Single Administration Kitconsisting of Cartridge Assembly,which includes PVC tubing,polycarbonate fluid connectors anda 30 mL syringe, and a ControlHandle (composed of customplastic components and springs).	Materialdifferences raiseno new safetyconcerns.
Size Range	50 ±20 microns100 ±35 microns150 ±50 microns	50 ±20 microns100 ±35 microns150 ±50 microns	Same
PhysicalCharacteristics	Biocompatible, radiopaque, non-compressible, non-resorbable	Biocompatible, radiopaque, non-compressible, non-resorbable	Same
Performance	Controlled, targeted embolization atthe desired level of vessel occlusion	Controlled, targeted embolization atthe desired 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 (gamma) to SAL 10-6	Same
Quantity ofmicrospheres perpackage	Each 1 mL syringe containsapproximately 1.25 g ofmicrospheres in saline.	Each 1 mL syringe containsapproximately 1.25 g ofmicrospheres in saline.	Same
Packaging	Tyvek pouch	Tyvek pouch	Same

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Easi-Vue® embolic microspheres System

K234123 Page 4 of 4

1.8 Non-Clinical Performance Summary

Bench testing and biocompatibility 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 and performance verification confirmed that Easi-Vue embolic microspheres System met all the acceptance criteria and performed as intended. No new safety or effectiveness concerns were raised during testing.

1.9 Conclusion

Based on the intended use, technological characteristics, and nonclinical data included in this application, the Easi-Vue embolic microspheres System meets the requirements that are essential for its intended use and 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).