Easi-Vue embolic microspheres System

K220567 · Abk Biomedical, Inc. · KRD · Sep 7, 2022 · Cardiovascular

Device Facts

• Record ID: K220567
• Device Name: Easi-Vue embolic microspheres System
• Applicant: Abk Biomedical, Inc.
• Product Code: KRD · Cardiovascular
• Decision Date: Sep 7, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3300
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

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

Device Story

Easi-Vue embolic microspheres System consists of radiopaque, non-compressible, non-resorbable glass microspheres (tantalum-barium-boron-sodium-silicon oxide glass) provided with an administration kit and refill syringe. Used by physicians in clinical settings for targeted vascular embolization. Microspheres are delivered via catheter into target arteries to mechanically occlude blood flow to hypervascular tumors or arteriovenous malformations. Unlike compressible polymer-based predicates, these glass spheres are non-deformable. Radiopacity allows for visualization during delivery without requiring additional contrast media. Benefits include controlled, targeted vessel occlusion and potential reduction in blood flow to target tissues.

Clinical Evidence

No human clinical data provided. Evidence consists of bench testing (simulated use, MR compatibility, performance verification) and a GLP animal study. Animal study confirmed ease of delivery and effective arterial occlusion with no clinically significant pathological or systemic abnormalities. Biocompatibility testing performed per ISO 10993.

Technological Characteristics

Materials: Tantalum-barium-boron-sodium-silicon oxide glass microspheres in saline. Sizes: 50, 100, 150 microns. Principle: Mechanical occlusion via catheter delivery. Radiopaque, non-compressible, non-resorbable. MR Safe. Sterilization: Gamma radiation (SAL 10^-6). Packaging: Tyvek pouch. Compatible with catheters (min ID 0.021", length 110-150 cm).

Indications for Use

Indicated for embolization of arteriovenous malformations and hypervascular tumors in patients requiring vascular occlusion.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Embosphere® Microspheres (K021397)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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)

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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 Biomedical<br>155 Chain Lake Drive<br>Unit 32<br>Halifax Nova Scotia B3S 1B3<br>Canada |
|----------|--------------------------------------------------------------------------------------------|
| Contact: | Brandi Woods<br>Director, Regulatory Affairs<br>919-619-6417<br>[e-mail] |

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.

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Easi-Vue™ embolic microspheres System

#### 1.5 Device Description

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).

| | Easi-Vue™ embolic microspheres<br>Administration Kit | Easi-Vue™ embolic microspheres<br>Refill 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.

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

| | Easi-Vue™ Embolic<br>Microspheres 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 for<br>Use | Easi-Vue™ Embolic<br>Microspheres System is intended<br>for use in embolization of<br>hypervascular tumors and<br>arteriovenous malformations | Embosphere Microspheres are indicated<br>for use in embolization of arteriovenous<br>malformations, hypervascular tumors,<br>and symptomatic uterine fibroids | Equivalent<br>Subject device<br>has more<br>restrictive<br>indication. |
| Mechanism of<br>Action | Mechanical occlusion | Mechanical occlusion | Same |
| Principle of<br>Operation | The microspheres are<br>administered into the patient's<br>artery via a catheter under<br>radiographic imaging | The microspheres are administered with<br>contrast medium into the patient's artery<br>via a catheter under radiographic imaging | Equivalent<br>Subject device<br>does not require<br>contrast medium<br>for imaging. |
| Material<br>Composition of<br>spheres | tantalum-barium-boron-sodium-<br>silicon oxide glass<br>Saline | Acrylic polymer sphere impregnated with<br>Porcine gelatin<br>Saline | No new safety<br>concern |
| Size Range | 50 ±20 microns<br>100 ±35 microns<br>150 ±50 microns | 40- 120 microns<br>100-300 microns<br>300-500 microns<br>500-700 microns<br>700-900 microns<br>900- 1200 microns | Equivalent |
| Physical<br>Characteristics | Biocompatible, radiopaque, non-<br>compressible, non-resorbable | Biocompatible, hydrophilic,<br>compressible, non-resorbable | No new safety<br>concern |
| Performance | Controlled, targeted embolization<br>at the desired level of vessel<br>occlusion | Controlled, targeted embolization at the<br>desired level of vessel occlusion | Same |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| MR Safe | MR Safe | MR Safe | Same |
| Sterility<br>(method) | Sterile (gamma) to SAL 10-6 | Sterile (steam) to SAL 10-6 | Equivalent |
| Quantity of<br>microspheres<br>per package | Each 1 mL syringe contains<br>approximately 1.25 g of<br>microspheres in saline. | Each 20 mL syringe or 8 mL glass vial<br>contains approximately 1.0 mL or 2.0 mL<br>of microspheres in saline. | Equivalent |
| Packaging | Tyvek pouch | A peel-away tray | Equivalent |

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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.