(90 days)
BoneSource® is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid, sodium phosphate sterile solution in a syringe or vial, and a polycarbonate mixing spatula packaged in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Kits may be provided in several different sizes.
This document is a 510(k) premarket notification for a medical device called Bonesource® HAC Fast Setting Cement. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device.
The provided text describes a traditional medical device (hydroxyapatite cement) and its substantial equivalence to previously marketed devices. There are no mentions of an algorithm, AI, machine learning, or any performance metrics like sensitivity, specificity, or AUC, nor any study conducted on such a system.
Therefore, I cannot fulfill the request to provide information regarding acceptance criteria and a study proving an AI/ML device meets them, as the provided input does not pertain to an AI/ML device.
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OCT 3 0 2003
K032366
10F2
.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS: Bonesource® HAC
Bonesource® HA
General Information
·
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| Proprietary Name: | Bonesource® HAC |
|---|---|
| Common Name: | Hydroxyapatite Cement (HAC) |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 84GXP 882.5300 Methyl Methacrylate forCranioplasty79FWP 878.3550 Prosthesis, Chin, Internal |
| Submitter: | Stryker InstrumentsLeibinger Division4100 East Milham AvenueKalamazoo, MI 49001800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. RutkoskieAssociate Manager RA/QATelephone: 269-323-4226Fax: 269-323-4215 |
| Summary Preparation Date: | July 28, 2003 |
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Equivalent Products
BoneSource® HAC Fast Setting Cement is substantially equivalent to BoneSource® HAC (K021440) and Walter Lorenz QuickSet Mimix™ (K023718). See Appendix 1.
Device Description
The packaging contains the following: BoneSource® powder in a plastic bowl with a foil lid, sodium phosphate sterile solution in a syringe or vial, and a polycarbonate mixing spatula packaged in a Polyethylene Terephthalate Glycol Modified (PETG) tray. The kit is terminally sterilized by gamma irradiation. Kits may be provided in several different sizes.
Indications for Use
BoneSource® HAC Fast Setting Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
Substantial Equivalence
BoneSource® HAC Fast Setting Cement is substantially equivalent to BoneSource® HAC K021440 and Walter Lorenz QuickSet Mimix™ K023718. The subject device and equivalent products are all classified as Methyl Methacrylate for Cranioplasty, intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton. BoneSource® HAC Fast Setting Cement raises no new issues of safety and effectiveness.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
OCT 3 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wade T. Rutkoskie Associate Manager RA/QA Stryker Leibinger 4100 E. Milham Avenue Kalamazoo, MI 49024
Re: K032366
Trade Name: BoneSource™ HAC Fast Setting Cement Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate for Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: July 28, 2003 Received: August 1, 2003
Dear Mr. Rutkoskie:
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 (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
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Page 2 – Mr. Wade T. Rutkoskie
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,
Sincerely yours,
Mark A. Milliken
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K032366
Device Name: Bonesource® HAC Fast Setting Cement
Indication For Use: ﻴﺔ
BoneSource® is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
or
Concurrence of CDRH, Office of device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
for Mark N. Millican
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number K032366
Over-The-Counter Use
(Optional Format 1-2-96)
§ 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).