(36 days)
Not Found
No
The device description and performance studies focus on the physical properties and clinical outcomes of the microspheres, with no mention of AI or ML.
Yes
The device is intended for embolization of hypervascular tumors and arteriovenous malformations, which is a therapeutic intervention blocking blood flow to treat these conditions.
No
Explanation: The device is intended for embolization, which involves blocking blood flow to target tissues for treatment purposes (e.g., hypervascular tumors, arteriovenous malformations). It does not diagnose conditions.
No
The device description clearly states that the device is composed of physical microspheres made from sodium polymethacrylate and coated with Polyzene®-F, supplied in syringes. This indicates a physical medical device, not a software-only one.
Based on the provided information, Embozene® Microspheres are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "embolization of hypervascular tumors and arteriovenous malformations." This describes a therapeutic procedure performed within the body to block blood flow.
- Device Description: The description details a physical object (microspheres) designed to be introduced into the vasculature for a physical effect (occlusion).
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens in vitro.
Therefore, Embozene® Microspheres are a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
Embozene® Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
Product codes
KRD
Device Description
Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of different sizes.
Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes and vials are available with 1 ml or 2 ml microsphere volume per syringe or vial.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Vasculature to a target tissue
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
The clinical evaluation included in the 510(k) reviews Transarterial Embolization (TAE) using various embolic agents to physically occlude vessels to restrict blood flow over the last ten years. The overall review of the scientific literature, unpublished data and post market surveillance, indicate that Embozene® Microspheres including 1100 um are reasonably safe and effective for the treatment of hypervascular tumors and arteriovenous malformations. Therefore, it could be concluded that the benefits of TAE with Embozene microspheres family including the additional 1100 and 1300 um microspheres for the treatment of hypervascular tumors and arteriovenous malformations outweigh the potential risk when used within their labeled application.
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
510(k) Summary of Safety and Effectiveness
| Summary Date: | August 23, 2013 |
|---|---|
| Submitter: | CeloNova BioSciences, Inc. |
| 18615 Tuscany Stone, Ste. 100 | |
| San Antonio | |
| Texas 78258, USA | |
| ОСТ 0 3 2013 | |
| Contact : | Nicole C. Barber |
| Manager, Regulatory Affairs | |
| 1. Common name, Trade name & Classification of Subject Device | |
| Trade Name : | Embozene® Microspheres |
| Common Name(s) : | Vascular Embolization device, embolization, arterial |
| Product Code: | KRD, 21 CFR 870.3300 |
| Classification: | Class II |
| 2. 510(k) Number and Product Code of Predicate Device | |
| Trade Name: | Embozene® Microspheres |
| Manufacturer: | CeloNova BioSciences, Inc. |
| 510(k) Number: | K073417 |
| Product Code: | KRD, 21 CFR 870.3300 |
| 3. Indications for Use and Intended Purpose |
3. Indications for Use and Intended Purpose
Embozene® Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
4. Device Description
Embozene® Microspheres are tightly calibrated, compressible microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue such as hypervascular tumor (HVT) or arteriovenous malformation (AVM). Embozene® Microspheres are manufactured from sodium polymethacrylate and coated with proprietary Polyzene®-F. The
1
microspheres are compressible to enable smooth delivery through the indicated delivery catheter. Embozene® Microspheres are color coded by size to allow easy identification of different sizes.
Embozene® Microspheres are supplied sterile and packaged in 20ml polycycloolefin syringes with a standard 7ml fill volume across the range. Embozene® Microspheres syringes and vials are available with 1 ml or 2 ml microsphere volume per syringe or vial. Product configurations are shown in the Tables below.
| Product REF Codes
Embozene® Color-Advanced
Microspheres | | Volume of Color Embozene®
Microspheres per Syringe | | Volume of Color
Embozene Microspheres
per Vial | |
|---------------------------------------------------------------|-----------------|-------------------------------------------------------|-----------|------------------------------------------------------|-----------|
| Nominal Size | Specifications | 1ml | 2ml | 1ml | 2ml |
| 40 μm | 40 μm ±10 μm | 10410-S1 | 10420-S1 | 10401-V1 | 10402-V1 |
| 75 μm | 75 μm ±15 μm | 10710-S1 | 10720-S1 | 10701-V1 | 10702-V1 |
| 100 μm | 100 μm ±25 μm | 11010-S1 | 11020-S1 | 11001-V1 | 11002-V1 |
| 250 μm | 250 μm ± 50 μm | 12010-S1 | 12020-S1 | 12001-V1 | 12002-V1 |
| 400 μm | 400 μm ± 50 μm | 14010-S1 | 14020-S1 | 14001-V1 | 14002-V1 |
| 500 μm | 530 μm ± 50 μm | 15010-S1 | 15020-S1 | 15001-V1 | 15002-V1 |
| 700 μm | 700 μm ± 50 μm | 17010-S1 | 17020-S1 | 17001-V1 | 17002-V1 |
| 900 μm | 900 μm ± 75 μm | 19010-S1 | 19020-S1 | 19001-V1 | 19002-V1 |
| 1100 μm | 1100 μm ± 75 μm | 111010-S1 | 111020-S1 | 111001-V1 | 111002-V1 |
| 1300 μm | 1300 μm ± 75 μm | 113010-S1 | 113020-S1 | 113001-V1 | 113002-V1 |
Product REF Codes for Embozene Color-Advanced Microspheres in Syringe and Vial
Product REF Codes for Embozene Opaque (Non-Colored) Microspheres in Syringe and Vial
| Product REF Codes
Embozene® Opaque
Microspheres | | Volume of Opaque
Embozene® Microspheres
per Syringe | | Volume of Opaque
Embozene Microspheres
per Vial | |
|-------------------------------------------------------|-----------------|-----------------------------------------------------------|-----------|-------------------------------------------------------|-----------|
| Nominal Size | Specifications | 1ml | 2ml | 1ml | 2ml |
| 40 μm | 40 µm ±10 µm | 10410-S0 | 10420-S0 | 10401-V0 | 10402-VO |
| 75 μm | 75 µm ±15 µm | 10710-S0 | 10720-S0 | 10701-V0 | 10702-VO |
| 100 μm | 100 µm ±25 µm | 11010-S0 | 11020-S0 | 11001-V0 | 11002-VO |
| 250 μm | 250 µm ± 50 μm | 12010-S0 | 12020-50 | 12001-V0 | 12002-VO |
| 400 μm | 400 μm ± 50 μm | 14010-S0 | 14020-50 | 14001-V0 | 14002-V0 |
| 500 μm | 530 μm ± 50 μm | 15010-50 | 15020-50 | 15001-V0 | 15002-V0 |
| 700 μm | 700 μm ± 50 μm | 17010-50 | 17020-50 | 17001-V0 | 17002-V0 |
| 900 μm | 900 μm ± 75 μm | 19010-50 | 19020-50 | 19001-V0 | 19002-VO |
| 1100 μm | 1100 µm ± 75 µm | 111010-50 | 111020-50 | 111001-V0 | 111002-V0 |
| 1300 µm | 1300 µm ± 75 µm | 113010-50 | 113020-50 | 113001-VO | 113002-V0 |
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5. Similarities and Differences to Predicate device
The intended use of the subject device remains unchanged as compared to the predicate. The subject device and the predicate have the same design, specifications, fundamental scientific technology, and packaging. The only change is the addition of 1100 um and 1300 µm sizes of Embozene® Microspheres. The additional sizes are available in gray and pink colors, respectively. The colorants used to create those colors are the same as those used in the predicate.
6. Summary of Technological Characteristics
| Point of Comparison | Embozene®
Subject | Embozene®
Predicate |
|----------------------------------|----------------------------------------------------------|----------------------------------------------------------|
| Chemical composition | unchanged | unchanged |
| Osmolarity of transport solution | unchanged | unchanged |
| pH of transport solution | unchanged | unchanged |
| Size Range and Colors | 40 ± 10 µm
Black | 40 ± 10 µm
Black |
| | 75 ± 15 µm
Burgundy | 75 ± 15 µm
Burgundy |
| | 100 ± 25 µm
Orange | 100 ± 25 µm
Orange |
| | 250 ± 50 µm
Yellow | 250 ± 50 µm
Yellow |
| | 400 ± 50 µm
Blue | 400 ± 50 µm
Blue |
| | 500 ±50 µm
Red | 500 ±50 µm
Red |
| | 700 ± 50 µm
Green | 700 ± 50 µm
Green |
| | 900 ± 75 µm
Purple | 900 ± 75 µm
Purple |
| | 1100 ± 75 µm
Gray | |
| | 1300 ± 75 µm
Pink | |
| Color Availability | Color or opaque | Color or opaque |
| Sterility | Pyrogen-free, sterile | Pyrogen-free, sterile |
| Packaging | Syringe or vial | Syringe or vial |
| Syringe total fill volume | 7ml | 7ml |
| Microsphere volume per syringe | 1 or 2 ml | 1 or 2 ml |
| Shelf life | 3 years | 3 years |
| Indication for Use | Hypervascularized Tumors,
Arteriovenous Malformations | Hypervascularized Tumors,
Arteriovenous Malformations |
Comparison between the Subject Device (Embozene®) and the Predicate Device (Embozene®)
7. Summary of In-Vitro Testing
Size distribution and catheter compatibility testing were conducted on the subject device and concluded to be equivalent to the predicate.
- Summary of Clinical Experience
3
The clinical evaluation included in the 510(k) reviews Transarterial Embolization (TAE) using various embolic agents to physically occlude vessels to restrict blood flow over the last ten years. The overall review of the scientific literature, unpublished data and post market surveillance, indicate that Embozene® Microspheres including 1100 um are reasonably safe and effective for the treatment of hypervascular tumors and arteriovenous malformations. Therefore, it could be concluded that the benefits of TAE with Embozene microspheres family including the additional 1100 and 1300 um microspheres for the treatment of hypervascular tumors and arteriovenous malformations outweigh the potential risk when used within their labeled application.
9. Summary
The subject device and the predicate have the same indications for use, design, and fundamental scientific technology. The subject device Embozene® Microspheres with the addition of 1100 um and 1300 um sizes are substantially equivalent to the cleared Embozene® Microspheres (K073417).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
October 3, 2013
CeloNova BioSciences, Inc. C/O Nicole C. Barber, RAC Manager, Regulatory Affairs 18615 Tuscany Stone Suite 100 San Antonio, TX 78258
Re: K132675
Trade/Device Name: Embozene® Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: September 2, 2013 Received: September 4, 2013
Dear Ms. Barber:
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. 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 device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G605 Silver Spring MD 20993-0002
5
Page 2 - Nicole C. Barber]
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Bram D. Zury Berman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| -------------------------- | -- |
Device Name Vascular Embolization Device
Indications for Use Embozene® Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.
Prescription Use × (Per 21 CFR 801. 109) AND/ OR
Over-The-Counter Use_
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)