(51 days)
Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm2.
Norian CRS Bone Cement is not intended for use in the spine and should not be used in the presence of active or suspected infection.
Norian CRS Bone Cement is an injectable, moldable, and biocompatible bone cement. The Reactants Pack contains sterile powder (calcium phosphate) and a syringe that contains sterile solution (dilute sodium phosphate). The Reactants Pack is designed to be placed in a reusable mixer where the 2 components are mixed together to form a smooth, viscous paste that remains injectable for approximately 5 minutes at 18 -23°C / 64°- 73°F. At body temperature (37°C / 98.6°F), Norian CRS Cement begins to harden after 2 minutes and sets in approximately 10 minutes. Norian CRS Cement is slowly resorbed and replaced by bone over a period of years. This material is provided sterile and is for single use only.
The provided document is a 510(k) summary for the Norian CRS Bone Cement. It describes the device, its indications for use, and its substantial equivalence to a predicate device. However, it does not contain any information regarding acceptance criteria, studies for device performance evaluation against such criteria, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, adjudication methods, or MRMC studies.
Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than detailed performance study results against acceptance criteria.
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3. 510(k) Summary
| Sponsor: | Synthes (USA)1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| Contact: | Angela SilvestriSynthes (USA)1230 Wilson DriveWest Chester, PA 19380(484) 356-9728 |
| Device Name: | Norian CRS Bone Cement |
| Device Classification: | 21 CFR 882.5300 - Methyl methacrylate for cranioplasty |
| Device Description: | Norian CRS Bone Cement is an injectable, moldable, andbiocompatible bone cement. The Reactants Pack contains sterilepowder (calcium phosphate) and a syringe that contains sterilesolution (dilute sodium phosphate). The Reactants Pack is designed tobe placed in a reusable mixer where the 2 components are mixedtogether to form a smooth, viscous paste that remains injectable forapproximately 5 minutes at 18 -23°C / 64°- 73°F. At body temperature(37°C / 98.6°F), Norian CRS Cement begins to harden after 2 minutesand sets in approximately 10 minutes. Norian CRS Cement is slowlyresorbed and replaced by bone over a period of years. This material isprovided sterile and is for single use only. |
| Indications for use: | Norian CRS Bone Cement is intended for filling craniofacial defectsin the restoration or augmentation of bony contours of the craniofacialskeleton (including fronto-orbital, malar, and mental areas) such asburr hole voids and other craniofacial defects, with a surface area nolarger than 25cm2.Norian CRS Bone Cement is not intended for use in the spine andshould not be used in the presence of active or suspected infection. |
| Predicate Device | Norian CRS Bone Cement K973789 |
| Substantial EquivalenceDetermination | This device is equivalent to the predicate in terms of materialcomposition, physical properties and performance characteristics. |
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Public Health Service
APR 1 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Synthes (USA) c/o Ms. Angel Silvestri Group Manager, Regulatory Affairs 1230 Wilson Drive West Chester, Pennsylvania 19380
Re: K060445
Trade/Device Name: Norian CRS Bone Cement Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl methacrylate for cranioplasty Regulatory Class: II Product Code: GXP Dated: February 16, 2006 Received: February 23, 2006
Dear Ms. Silvestri:
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.
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Angel Silvestri
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 (240) 276-0120 . 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/industry/support/index.html.
Sincerely vours.
eMell
Mark N. Melk Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2. Indications for Use Statement
Page _________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: __________ Norian CRS Bone Cement
Indications For Use:
Norian CRS Bone Cement is intended for filling craniofacial defects in the restoration or augmentation of bony contours of the craniofacial skeleton (including fronto-orbital, malar, and mental areas) such as burr hole voids and other craniofacial defects, with a surface area no larger than 25cm ..
Contraindications:
Norian CRS Bone Cement is not intended for use in the spine and should not be used in the presence of active or suspected infection.
Use Prescription X - AND/OR (Part 21 CFR 801 Subpart D) ·
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number_ K060445
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).