(104 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 to occlude vasculature to block blood flow to target tissues, such as tumors or malformations, which is a therapeutic action aimed at treating a medical condition.
No
Explanation: Embozene® Microspheres are intended for therapeutic embolization of vasculature to block blood flow, not for diagnosing medical conditions.
No
The device description clearly describes a physical medical device (microspheres) intended for embolization, not a software-only product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for embolization of arteriovenous malformations and hypervascular tumors, including uterine fibroids. This is a therapeutic procedure performed in vivo (within the body) to block blood flow.
- Device Description: The device is a physical microsphere intended to be delivered into the vasculature. It is not designed to analyze samples of human origin (like blood, urine, or tissue) in vitro (outside the body) to provide diagnostic information.
- Lack of Diagnostic Purpose: The device's function is to physically occlude blood vessels, not to diagnose a condition or provide information about a patient's health status based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
Embozene® Microspheres are intended for embolization of arteriovenous malformations, and hypervascular tumors, including uterine fibroids.
Product codes (comma separated list FDA assigned to the subject device)
NAJ, 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 a 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 the 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 or vials are available in 1 ml or 2 ml microsphere volume.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical information submitted included a review of embolization using various embolic agents to physically occlude vessels to restrict blood flow over the last ten years, published and unpublished data on the use of Embozene® for the treatment of uterine fibroids (outside the United States) and postmarket experience with the cleared device.
The published data provided included a study conducted by Smeets et al. [Ref.: Smeets AJ, Nijenhuis RJ, van Rooij WJ et al. Embolization of uterine leiomyomas with Polyzene Fcoated hydrogel microspheres: initial experience. JVIR 2010; 21(12): 1830-1834]. This study included data on fibroid-specific outcomes using the Uterine Fibroid Symptom Quality of Life (UFS-QOL) patient reported outcomes instrument. It also evaluated the uterine and fibroid volume and percent fibroid infarction as determined by MRI. A fibroid-specific quality of life outcomes instrument was used as the primary clinical outcome measure in a previously-cleared device with this indication (i.e., Boston Scientific Contour Emboli PVA, K030966). Results from the Smeets et al. study demonstrated that mean fibroid symptom severity scores on the UFS-QOL instrument dropped from 64 at baseline to 23 at three months (n=85). (A reduction in score constitutes an improvement in patient symptoms.) At a mean follow-up of 12.8 months, mean uterine fibroid symptom severity scores were 16 (n=81). At three months, the mean volume reduction of the dominant fibroid was 45% and the mean volume reduction of the entire uterus was 42%. At three months, there was a 94% rate of >90% infarction of the dominant fibroid and a 91% rate of >90% infarction of the total fibroid load. Regarding adverse events, one subject underwent hysterectomy at two months due to incomplete fibroid expulsion, and two subjects had hysterectomy at five- and seven-months post-procedure due to persistent pain.
Review of published and unpublished data regarding adverse events associated with Embozene® Microspheres did not identify any unique safety concerns regarding use of Embozene® Microspheres for uterine fibroid embolization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K073417/ K132675, K021397, K030966
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
FEB 2 4 2014
510(k) Summary of Safety and Effectiveness
February 21, 2014 Summary Date: CeloNova BioSciences, Inc. Submitter: 18615 Tuscany Stone, Ste. 100 San Antonio Texas 78258, USA Nicole C. Barber Contact: Manager, Regulatory Affairs 1. Common name, Trade name & Classification of Subject Device Embozene® Microspheres Trade Name: Common Name(s): Vascular Embolization device, embolization, arterial Product Code: NAJ, KRD, 21 CFR 870.3300 Class II (special control) Classification: 2. 510(k) Numbers and Product Codes of Predicate Devices Embozene® Microspheres Trade Name: CeloNova BioSciences, Inc. Manufacturer: 510(k) Number: K073417/ K132675 KRD, 21 CFR 870.3300 Product Code: Embosphere® Microspheres Trade Name: Manufacturer: BioSphere Medical, Inc. (Acquired by Merit Medical Systems, Inc.) 510(k) Number: K021397 NAJ, 21 CFR 870.3300 Product Code: Contour® PVA Embolization Particles Trade Name: Boston Scientific Corporation Manufacturer: Page 1 of 6 CeloNova BioSciences, Inc.
1
| 510(k) Number: | K030966 |
|---|---|
| Product Code: | NAJ, 21 CFR 870.3300 |
Product Code,
ARM, 21-OPR-3133-S
3. Indications for Use and Intended Purpose
Embozene® Microspheres are intended for embolization of arteriovenous malformations, and hypervascular tumors, including uterine fibroids.
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 a 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 the 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 or vials are available in 1 ml or 2 ml microsphere volume. Product configurations are shown in the following tables.
| Product REF Codes
Embozene® Color-Advanced
Microspheres | | Volume of Embozene®
Color-Advanced
Microspheres per Syringe | | Volume of Embozene®
Color-Advanced
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 um | 1300 μm ± 75 um | 113010-S1 | 113020-S1 | 113001-V1 | 113002-V1 |
Product REF Codes for Embozene® Color-Advanced Microspheres in Syringe and Vial
2
| Product REF Codes
Embozene® Opaque
Microspheres | | Volume of Embozene®
Opaque Microspheres per
Syringe | | Volume of Embozene®
Opaque Microspheres per
Vial | |
|-------------------------------------------------------|-----------------|-----------------------------------------------------------|-----------|--------------------------------------------------------|-----------|
| Nominal Size | Specifications | 1ml | 2ml | 1ml | 2ml |
| 40 μm | 40 μm ±10 μm | 10410-S0 | 10420-S0 | 10401-V0 | 10402-V0 |
| 75 μm | 75 μm ±15 μm | 10710-S0 | 10720-S0 | 10701-V0 | 10702-V0 |
| 100 μm | 100 μm ±25 μm | 11010-S0 | 11020-S0 | 11001-V0 | 11002-V0 |
| 250 μm | 250 μm ± 50 μm | 12010-S0 | 12020-S0 | 12001-V0 | 12002-V0 |
| 400 μm | 400 μm ± 50 μm | 14010-S0 | 14020-S0 | 14001-V0 | 14002-V0 |
| 500 μm | 530 μm ± 50 μm | 15010-S0 | 15020-S0 | 15001-V0 | 15002-V0 |
| 700 μm | 700 μm ± 50 μm | 17010-S0 | 17020-S0 | 17001-V0 | 17002-V0 |
| 900 μm | 900 μm ± 75 μm | 19010-S0 | 19020-S0 | 19001-V0 | 19002-V0 |
| 1100 μm | 1100 μm ± 75 μm | 111010-S0 | 111020-S0 | 111001-V0 | 111002-V0 |
| 1300 μm | 1300 μm ± 75 μm | 113010-S0 | 113020-S0 | 113001-V0 | 113002-V0 |
Product REF Codes for Embozene® Opaque (Non-Colored) Microspheres in Syringe and Vial
Only microspheres of 500 um or greater should be used for embolization of uterine fibroids.
5. Similarities and Differences Compared to Predicate Devices
To demonstrate substantial equivalence. CeloNova has identified two legally marketed predicate devices; Embozene Microspheres cleared through 510(k)s (K073417 and /K 132675 and Merit Medical's Embospheres Microspheres cleared through 510(k) K021397. The Embozene® Microspheres that are the subject of this 510(k) are the same as the legally marketed Embozene® Microspheres, previously cleared by FDA, in regard to intended use and technological characteristics. The only difference between the subject of this 510(k) and our legally marketed predicate devices relates to the indications for use statement. The indications for use statement related to this 510(k) includes greater specificity than our predicates by explicitly identifying "uterine fibroids" as being among the tumors treated with vascular embolization devices, as established by 21 CFR § 870.3300.
In comparison to the second predicate device, Merit Medical's Embosphere® Microspheres (K021397), the intended use of the subject device is the same. Furthermore, the subject device and the predicate have the same design, specifications, fundamental scientific technology, and packaging.
In comparison to the third predicate device, Boston Scientific's Contour® PVA Embolization Particles (K030966), the intended use of the subject device is the same.
3
6. Summary of Technological Characteristics
Comparison between the Subject Device (Embozene®) and the Primary Predicate Device (Embozene®)
| | Subject Embozene®
Microspheres | Predicate
Embozene®
Microspheres |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Administrative Elements | | |
| Manufacturer | CeloNova BioSciences, Inc. | Same |
| Premarket Notification | K133447 | K073417 and
K132675 |
| Classification | Class II (special controls) | Class II (special controls) |
| Classification
Regulation | 21 CFR 870.3300 | 21 CFR 870.3300 |
| Product Code | NAJ- Agents, Embolic, For
Treatment Of Uterine Fibroids
KRD - Device, Vascular,
For Promoting Embolization | KRD - Device, Vascular, For
Promoting Embolization |
| Intended Use | | |
| Indications for Use
Statement | Embozene® Microspheres
are intended for embolization of
arteriovenous malformations and
hypervascular tumors, including
uterine fibroids. | Embozene®
Microspheres are intended for
embolization of hypervascular tumors
and arteriovenous malformations. |
| Method of Delivery | Microcatheter under
fluoroscopic visualization with
contrast | Same |
| OTC or Rx | Rx | Same |
| Technological Characteristics | | |
| Mechanism of Action | Mechanical Occlusion | Same |
| Material Class | Crosslinked polyacrylate
hydrogel | Same |
| Material Design | Spherical | Same |
| Material Composition | Crosslinked polyacrylate
hydrogel
with Polyzene-F | Same |
4
| Sizes [µm] | $40 \pm 10$ | Same |
|---|---|---|
| $75 \pm 15$ | ||
| $100 \pm 25$ | ||
| $250 \pm 50$ | ||
| $400 \pm 50$ | ||
| $530 \pm 50$ | ||
| $700 \pm 50$ | ||
| $900 \pm 75$ | ||
| $1100 \pm 75$ | ||
| $1300 \pm 75$ | ||
| Biocompatibility of | ||
| patient-contacting | ||
| materials | Yes | Same |
| Microsphere Volume | ||
| [ml] | 1 or 2 | Same |
| Sterility Assurance | ||
| Level | Supplied sterile to SAL $10^{-6}$ | Same |
| Pyrogen-free | Yes | Same |
| Packaging | Syringe or vial | Same |
| Shelf-life | 3 years | Same |
7. Summary of Non-Clinical Performance Testing
There are no performance standards applicable to the device is subject Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices issued on December, 29 2004. The following non-clinical performance testing was conducted on the primary predicate device:
- . Chemical analysis
- Size range .
- . Catheter compatibility
- . Density
- Packaging performance .
- . Shelf Life
- . Sterility
- . Biocompatibility
No new testing was conducted since the primary predicate device and the subject device have identical technological characteristics, manufacturing, processing, and sterilization.
5
Bench testing was conducted to compare Embozene® Microspheres with the predicate Embosphere
8. Summary of Clinical Experience
The clinical information submitted included a review of embolization using various embolic agents to physically occlude vessels to restrict blood flow over the last ten years, published and unpublished data on the use of use of Embozene® for the treatment of uterine fibroids (outside the United States) and postmarket experience with the cleared device.
The published data provided included a study conducted by Smeets et al. [Ref.: Smeets AJ, Nijenhuis RJ, van Rooij WJ et al. Embolization of uterine leiomyomas with Polyzene Fcoated hydrogel microspheres: initial experience. JVIR 2010; 21(12): 1830-1834]. This study included data on fibroid-specific outcomes using the Uterine Fibroid Symptom Quality of Life (UFS-QOL) patient reported outcomes instrument. It also evaluated the uterine and fibroid volume and percent fibroid infarction as determined by MRI. A fibroid-specific quality of life outcomes instrument was used as the primary clinical outcome measure in a previously-cleared device with this indication (i.e., Boston Scientific Contour Emboli PVA, K030966). Results from the Smeets et al. study demonstrated that mean fibroid symptom severity scores on the UFS-QOL instrument dropped from 64 at baseline to 23 at three months (n=85). (A reduction in score constitutes an improvement in patient symptoms.) At a mean follow-up of 12.8 months, mean uterine fibroid symptom severity scores were 16 (n=81). At three months, the mean volume reduction of the dominant fibroid was 45% and the mean volume reduction of the entire uterus was 42%. At three months, there was a 94% rate of >90% infarction of the dominant fibroid and a 91% rate of >90% infarction of the total fibroid load. Regarding adverse events, one subject underwent hysterectomy at two months due to incomplete fibroid expulsion, and two subjects had hysterectomy at five- and seven-months post-procedure due to persistent pain.
Review of published and unpublished data regarding adverse events associated with Embozene® Microspheres did not identify any unique safety concerns regarding use of Embozene® Microspheres for uterine fibroid embolization.
9. Conclusion
The Embozene® Microspheres that are the subject of this 510(k) submission are substantially equivalent to the primary predicate device (Embozene® Microspheres, K073417 and K132675) and the second predicate device (Embosphere® Microspheres, K021397) based on intended use, technological characteristics, and bench performance data. The Embozene® Microspheres that are the subject of this 510(k) submission are substantially equivalent to the third predicate device (Contour® PVA Embolization Particles, K030966) based on intended use and clinical performance data.
CeloNova BioSciences, Inc.
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure embracing or protecting another smaller figure, symbolizing the department's mission to protect and promote the health and well-being of the nation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2014
CeloNova BioSciences, Inc. Nicole C. Barber Manager, Regulatory Affairs 18615 Tuscany Stone Suite 100 San Antonio, TX 78258
Re: K133447
Trade/Device Name: Embozene® Microspheres Regulation Number: 21 CFR& 870.3300 Regulation Name: Vascular embolization device Regulatory Class: II (special controls) Product Code: NAJ, KRD Dated: November 25, 2013 Received: November 26, 2013
Dear Nicole C. 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
7
medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Herbert P. Lerner -S
for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Embozene® Microspheres
Indications for Use (Describe)
Embozene® Microspheres are indication of arteriovenous malformations and hypervascular turnors, including uterine fibroids.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON A SEPARATE PAGE IF NEEDED.
年度的第一次 FOR FOR FDA USE ONLY . . . . : 标签:: :: Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Herbert P. Lerner 2014.02.24 11:29:57 -05'00'
FORM FDA 3881 (1/14)