(377 days)
Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations. Embozene™ Microspheres may be used for vasculturion of blood vessels within the neurovascular system.
Celonova BioSciences, Inc. Embozene™ Microspheres are spherical embolic hydrogels. They are artificial embolization devices used to obstruct or reduce blood flow to hypervascularized tumors or artenovenous mall ormations via selective microcatheter delivery.
The embolization particles are available in seven (7) size ranges of 40, 100, 250, 400, 500, 700 and 900 um diameters to enable appropriate size selection for the turnor or malformation to be treated. Embozene™ Microspheres are designed for use under fluoroscopic guidance through compatible delivery catheters. The product is provided as a sterile, non pyrogenic, single use device. It is an uncolored or color-coded particle that is opaque under fluoroscopy. The product and its delivery container are steam sterlized.
The provided text is a 510(k) summary for the Embozene™ Microspheres. It states "Clinical Data: None required." and does not contain information about acceptance criteria or a study proving the device meets said criteria. Therefore, most of the requested information cannot be extracted from the given text.
However, I can provide what little information is available:
1. A table of acceptance criteria and the reported device performance
Not provided. The submission states, "Clinical Data: None required."
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as no clinical data was required or provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical data was required or provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical data was required or provided.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable, as no clinical data was required or provided, and this is not an AI/imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/algorithm device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable, as no clinical data was required or provided. The device relies on substantial equivalence to predicate devices.
8. The sample size for the training set
Not applicable, as no clinical data was required or provided, and this is not an AI/algorithm device.
9. How the ground truth for the training set was established
Not applicable, as no clinical data was required or provided, and this is not an AI/algorithm device.
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DEC 1 5 2008
510(k) Summary
Contact Information: CeloNova BioSciences, Inc.
49 Spring Street Newnan, GA 30263 Telephone: (770) 502-0304 Facsimile: (770) 502-0773
Trade Name: Embozene™ Microspheres Embozene™ Color Advanced Microspheres
Common Name: Vascular Embolization Particles
Classification Name: Artificial Embolization Device
Device Product Codes: KRD
Regulation Numbers: 21 CFR 870.3300
Substantial Equivalence: The CeloNova BioSciences, Inc. Embozene™ Microspheres and Embozene™ Color Advanced Microspheres are substantially equivalent in basic design, construction, indication for use, and performance characteristics to other commercially available vascular embolization particles.
Device Description: Celonova BioSciences, Inc. Embozene™ Microspheres are spherical embolic hydrogels. They are artificial embolization devices used to obstruct or reduce blood flow to hypervascularized tumors or artenovenous mall ormations via selective microcatheter delivery.
The embolization particles are available in seven (7) size ranges of 40, 100, 250, 400, 500, 700 and 900 um diameters to enable appropriate size selection for the turnor or malformation to be treated. Embozene™ Microspheres are designed for use under fluoroscopic guidance through compatible delivery catheters. The product is provided as a sterile, non pyrogenic, single use device. It is an uncolored or color-coded particle that is opaque under fluoroscopy. The product and its delivery container are steam sterlized.
Indications for Use: Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations. Embozene™ Microspheres may be used for vasculturion of blood vessels within the neurovascular system.
Predicate Devices: Embozene™ Microspheres are substantially equivalent to these predicate devices:
Biocompatibles Gelspheres™ Microspheres (Vial) (colored) - K033761 Biocompatibles Bead Block™ Microspheres (Syringe) (colored) · K033761 Boston Scientific Contour SE™ Microspheres K032707 Boston Scientific Contour SE™ Microspheres K034068 Boston Scientific Contour SE™ Microspheres K071634
Clinical Data: None required.
Adverse Safety & Effectiveness Information: None.
Signature
Ralph E. Gaskins, Jr, MD, JD Vice President, Legal and Intellectual Property
Date 28 Apr 2008
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with its wings spread, positioned within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Public Health Service
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 2008
CeloNova BioSciences, Inc. c/o Mr. Thomas A. Gordy President and Chief Executive Officer 49 Spring Street Newnan, GA 30263
Re: K073417
Enbozene™ Microspheres Regulation Number: 21 CFR 870.3300 Regulation Name: Vascular Embolization Device Regulatory Class: Class II Product Code: KRD Dated: October 8, 2008 Received: October 9, 2008
Dear Mr. Gordy:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Thomas A. Gordy
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 not 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); 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 1000-1000. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1 legally marketed predicate device results in a classification for your device and thus, perceite your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliary, pro (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at ites toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
R.V.Ames
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Eyaluation Center for Devices and Radiological Health
. Enclosure
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Indications for Use
510(k) Number (if known): K073417 Device
Name: Embozene™ Microspheres Indications
For Use:
Embozene™ Microspheres are indicated for the embolization of hypervascular tumors and arteriovenous malformations.
X___ AND/OR Over-The-Counter Use ________________ (Part 21 CFR Prescription Use _ 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
uma R. Varlines
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K073417
K073417, Embozene™ Microspheres Reply to FDA letter of January 22, 2008 May 8, 2008
CONFIDENTIAL INFORMATION CELONOVA BIOSCIENCES, INC. Page 52 of 1002
§ 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).