(191 days)
Not Found
No
The summary describes a physical device (microspheres and delivery system) and its performance characteristics. There is no mention of AI, ML, or any software-based analysis or decision-making component.
Yes
The device is described as an "embolic microspheres System" intended for "embolization of arteriovenous malformations and hypervascular tumors," indicating its use in treating a medical condition by blocking blood flow to target tissues.
No
The device is intended for embolization (blocking blood flow to a target tissue), which is a therapeutic intervention, not a diagnostic one.
No
The device description clearly outlines physical components (microspheres, administration kit, refill syringe) and their material properties and physical characteristics, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the embolization of arteriovenous malformations and hypervascular tumors. This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The device is a system for delivering microspheres into the body. It is used for a physical intervention (embolization).
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status based on in vitro testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device is used for treatment within the body.
N/A
Intended Use / Indications for Use
Easi-Vue™ embolic microspheres System is intended for embolization of arteriovenous malformations and hypervasular tumors.
Product codes
KRD
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic imaging
Anatomical Site
arteriovenous malformations and hypervascular tumors (implies arterial system)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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
155 Chain Lake Drive
Unit 32
Halifax Nova Scotia B3S 1B3
Canada |
|----------|--------------------------------------------------------------------------------------------|
| Contact: | Brandi Woods
Director, Regulatory Affairs
919-619-6417
b.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.
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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
Administration Kit | Easi-Vue™ embolic microspheres
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.
5
Easi-Vue™ embolic microspheres System Table 2: Comparison to Predicate
| | Easi-Vue™ Embolic
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
Use | Easi-Vue™ Embolic
Microspheres System is intended
for use in embolization of
hypervascular tumors and
arteriovenous malformations | Embosphere Microspheres are indicated
for use in embolization of arteriovenous
malformations, hypervascular tumors,
and symptomatic uterine fibroids | Equivalent
Subject device
has more
restrictive
indication. |
| Mechanism of
Action | Mechanical occlusion | Mechanical occlusion | Same |
| Principle of
Operation | The microspheres are
administered into the patient's
artery via a catheter under
radiographic imaging | The microspheres are administered with
contrast medium into the patient's artery
via a catheter under radiographic imaging | Equivalent
Subject device
does not require
contrast medium
for imaging. |
| Material
Composition of
spheres | tantalum-barium-boron-sodium-
silicon oxide glass
Saline | Acrylic polymer sphere impregnated with
Porcine gelatin
Saline | No new safety
concern |
| Size Range | 50 ±20 microns
100 ±35 microns
150 ±50 microns | 40- 120 microns
100-300 microns
300-500 microns
500-700 microns
700-900 microns
900- 1200 microns | Equivalent |
| Physical
Characteristics | Biocompatible, radiopaque, non-
compressible, non-resorbable | Biocompatible, hydrophilic,
compressible, non-resorbable | No new safety
concern |
| Performance | Controlled, targeted embolization
at the desired level of vessel
occlusion | Controlled, targeted embolization at the
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 (steam) to SAL 10-6 | Equivalent |
| Quantity of
microspheres
per package | Each 1 mL syringe contains
approximately 1.25 g of
microspheres in saline. | Each 20 mL syringe or 8 mL glass vial
contains approximately 1.0 mL or 2.0 mL
of microspheres in saline. | Equivalent |
| Packaging | Tyvek pouch | A peel-away tray | Equivalent |
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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.