(47 days)
No
The description focuses on the physical properties and delivery mechanism of the microspheres and delivery system, with no mention of AI/ML terms or functionalities.
Yes
The device is intended for embolization of arteriovenous malformations and hypervascular tumors, which involves blocking blood flow to target tissue to treat these conditions. This falls under the definition of a therapeutic device as it directly treats a medical condition.
No
Explanation: The device is intended for embolization (blocking blood flow) of arteriovenous malformations and hypervascular tumors, which is a therapeutic rather than diagnostic function.
No
The device description clearly outlines physical components: biocompatible glass microspheres, a delivery device, and a refill syringe. These are hardware components, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Easi-Vue embolic microspheres System is used for embolization, which is a procedure performed inside the body (in vivo) to block blood flow to a target tissue. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states "embolization of arteriovenous malformations and hypervascular tumors," which is a treatment procedure.
- Device Description: The description details a system for delivering microspheres into arteries, which is an invasive procedure.
The device is used in conjunction with radiographic imaging, but the device itself is not performing a diagnostic test on a sample. It is a therapeutic device used for a medical intervention.
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 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.
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 vascular system / arteries)
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 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.
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.
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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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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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 |
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
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
5
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).
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).
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 Microspheres
System | Easi-Vue™ Embolic
Microspheres 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 Microspheres
System is intended for use in
embolization of hypervascular
tumors and arteriovenous
malformations | Easi-Vue Embolic Microspheres
System is intended for use in
embolization of hypervascular
tumors and arteriovenous
malformations | Same |
| 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
into the patient's artery via a
catheter under radiographic imaging | Same |
| Material
Composition of | tantalum-barium-boron-sodium-
silicon oxide glass
Saline | tantalum-barium-boron-sodium-
silicon oxide glass
Saline | Same |
| Material
Composition of the
Delivery Device | Delivery Device composed of TPU
tubing, PC connectors and UV
adhesive, attached to a color-coded
backing plate corresponding to the
size range of microspheres. | Single Administration Kit
consisting of Cartridge Assembly,
which includes PVC tubing,
polycarbonate fluid connectors and
a 30 mL syringe, and a Control
Handle (composed of custom
plastic components and springs). | Material
differences raise
no new safety
concerns. |
| Size Range | 50 ±20 microns
100 ±35 microns
150 ±50 microns | 50 ±20 microns
100 ±35 microns
150 ±50 microns | Same |
| Physical
Characteristics | Biocompatible, radiopaque, non-
compressible, non-resorbable | Biocompatible, radiopaque, non-
compressible, non-resorbable | Same |
| 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 (gamma) to SAL 10-6 | Same |
| Quantity of
microspheres per
package | Each 1 mL syringe contains
approximately 1.25 g of
microspheres in saline. | Each 1 mL syringe contains
approximately 1.25 g of
microspheres in saline. | Same |
| Packaging | Tyvek pouch | Tyvek pouch | Same |
7
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.