(66 days)
EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. EOVIA Calcium Phosphate Ceramic is to be gently packed into bony voids or gaps of the skeletal system (e.g., the spine, pelvis, ilium, and/or extremities). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. EOVIA Calcium Phosphate Ceramic provides a bone void filler that is resorbed and is replaced with bone during the healing process.
EOVIA is a synthetic, resorbable calcium phosphate bone void filler. It is an osteoconductive material, which provides a porous scaffold upon which bone formation can occur. The interconnected porosity ranges from 60 to 80% with a pore size range between 200-500μm. EOVIA is available in granule or rods shapes.
The provided text does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) summary for the EOVIA™ Calcium Phosphate Ceramic, detailing its description, intended use, materials, and a declaration of substantial equivalence to previously cleared devices.
Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample size, data provenance, expert qualifications, adjudication method, MRMC study details, standalone performance, ground truth type, or training set information.
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Y040514
Attachment VIII 510k Summary
| Sponsor: | Eurosurgical, SAB.P.23-18 rue RobespierreBeaurains, France 62217Phone: 33-3-2121 5960, Fax: 33-3-2121 5970 |
|---|---|
| ContactPerson: | Emmanuel Margerit, Regulatory Affairs and Quality Manager |
| ProprietaryTrade Name: | EOVIA™ Calcium Phosphate Ceramic |
| DeviceDescription: | EOVIA is a synthetic, resorbable calcium phosphate bone void filler. It is anosteoconductive material, which provides a porous scaffold upon which boneformation can occur. The interconnected porosity ranges from 60 to 80% with apore size range between 200-500μm. EOVIA is available in granule or rodsshapes. |
| Intended Use: | EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gapsthat are not intrinsic to the stability of the bony structure. EOVIA CalciumPhosphate Ceramic is to be gently packed into bony voids or gaps of theskeletal system (e.g., the spine, pelvis, ilium, and/or extremities). Thesedefects may be surgically created osseous defects or osseous defects createdfrom traumatic injury to the bone. EOVIA Calcium Phosphate Ceramicprovides a bone void filler that is resorbed and is replaced with bone duringthe healing process. |
| Materials: | The EOVIA Calcium Phosphate Ceramic is manufactured from tricalciumphosphate (80%) and hydroxyapatite (20%) according to ASTM F1088 and1185, respectively. |
| SubstantialEquivalence: | Documentation was provided which demonstrated the EOVIA CalciumPhosphate Ceramic to be substantially equivalent to previously cleared devices.The substantial equivalence is based upon equivalence in indications for use.anatomic sites, design, material and function. |
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or birds in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 3 2004
Eurosurgical, SA C/o Karen E. Warden, MEBE Representative/Consultant REO Spine Line 7000 Hampton Center, Suite G-1 Morgantown, West Virginia 26505
Re: K040514
Trade/Device Name: EOVIA® Calcium Phosphate Ceramic Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler Regulatory Class: II Product Code: MQV Dated: February 25, 2004 Received: February 27, 2004
Dear Ms. Warden:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your been wined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the 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). and Cosmotie Press, market the device, subject to the general controls provisions of the Act. The Four mayy mere reveisions 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the elcctronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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 a legally marketed predicate device results in a classification for your device and thus, permits 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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark A. Walker
Celia M. Witten, PhD, MD Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement Attachment II
510(k) Number (if known):_K040514
Device Name: EOVIA® Calcium Phosphate Ceramic
Indications for Use:
EOVIA Calcium Phosphate Ceramic is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. EOVIA Calcium Phosphate Ceramic is to be gently packed into the stability of the bolly strated system (e.g., the spine, pelvis, ilium, and/or extremities). These bolly volus of gaps of the cited or secus defects or osseous defects created from traumatic injury to delcos may oc surgiourly croated case as ramic provides a bone void filler that is resorbed and is replaced with bone during the healing process.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K040514
Page 22
ノF Calcium Phosphate Ceramic
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.