(68 days)
Not Found
No
The summary describes a calcium phosphate cement for bone repair and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as "BoneSource® HAC Rapid Setting Cement" intended for "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," which indicates a therapeutic purpose.
No
The device is described as a self-setting cement intended for the repair and augmentation of bony contours; it is not indicated for the purpose of diagnosis.
No
The device description clearly states it is a "self-setting, calcium phosphate cement," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that BoneSource® HAC Rapid Setting Cement is for the repair and augmentation of bony defects in the craniofacial skeleton. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a self-setting calcium phosphate cement, which is a material used for bone repair.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a physiological state, health, or disease.
IVD devices are used to perform tests on samples taken from the body to diagnose or monitor conditions. This device is a surgical implant used for structural repair.
N/A
Intended Use / Indications for Use
BoneSource® HAC Rapid 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.
Product codes
84GXP, 79FWP
Device Description
BoneSource® HAC Rapid Setting Cement is a self-setting, calcium phosphate cement.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cranial, craniofacial skeleton
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS:
BoneSource® HAC Rapid Setting Cement
| Proprietary Name: | BoneSource® HAC Rapid Setting Cement |
|---|---|
| Common Name: | Hydroxyapatite Cement |
| Proposed Regulatory Class: | Class II |
| Device Classification: | 84GXP 882.5300 Methyl Methacrylate for Cranioplasty |
| 79FWP 878.3550 Prosthesis, Chin, Internal | |
| Submitter: | Stryker Leibinger |
| 4100 East Milham Avenue | |
| Kalamazoo, MI 49001 | |
| 269-323-4226 | |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 9610726 |
| Contact Person: | Wade T. Rutkoskie |
| Associate Manager RA QA | |
| Phone: 269-323-4226 | |
| Fax: 269-323-4215 | |
| Summary Preparation Date: | December 1, 2004 |
Intended Use
BoneSource® HAC Rapid 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. This indication for use is identical to the predicate device.
Substantial Equivalency Information
BoneSource® HAC Rapid Setting Cement is substantially equivalent to BoneSource® HAC (K032366).
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, human services, and well-being. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
FEB - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Wade T. Rutkoskie Manager Regulatory Affairs, Quality Assurance Stryker Instruments 4100 East Milham Ave. Kalamazoo, Michigan 49024
Re: K043334
Trade/Device Name: Bone Source® HAC Rapid Setting Cement Regulation Number: 21 CFR 882.5300, 21 CFR.878.3550 Regulation Name: Methyl methacrylate for cranioplasty, Chin prosthesis Regulatory Class: II Product Code: GXP, FWP Dated: January 24, 2005 Received: January 26, 2005
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. 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 (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 yours,
Mark N. Milken
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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Indications for Use
510(k) Number (if known): K
Device Name: BoneSource® HAC Rapid Setting Cement
Indications For Use:
BoneSource® HAC Rapid 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE: IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
al. Restorative, Division of Gener and Neurological Devices
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510(k) Number K093334