(153 days)
Not Found
No
The document describes a bone cement kit and does not mention any AI or ML components or functionalities.
Yes
The device is used for the repair and augmentation/restoration of bony contour in the craniofacial skeleton, which directly treats anatomical defects.
No
The device is a hydroxyapatite cement intended for the repair and augmentation of bony defects in the craniofacial skeleton, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a kit containing physical components: hydroxyapatite cement powder, a prefilled syringe with solution, and a mixing spatula. This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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 a cement used for physical repair. It's not a reagent, instrument, or system intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, providing diagnostic information, or any other activity typically associated with IVD devices.
IVD devices are used to test samples like blood, urine, or tissue to diagnose diseases, monitor health, or determine compatibility. This device is a material used for structural repair within the body.
N/A
Intended Use / Indications for Use
The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated for use in the repair The Donesourgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface or nourcement but notes) e defect. BoneSource is also indicated for augmentation or arestoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.
Product codes
79FWP, 87GXP
Device Description
The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit contains the previouslycleared BoneSource hydroxyapatite cement powder along with a new prefilled syringe containing sodium phosphate solution and a mixing spatula. Kits are being provided in sizes ranging from 5 g to 50 g.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
craniofacial skeleton including the fronto-orbital, malar and mental areas.
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)
K953339, K864537, K970400, K973789
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
K99/358
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS: BONESOURCE® Hydroxyapatite Cement (HAC) Expanded Kit
General Information
| Proprietary Name: | BoneSource® Hydroxyapatite Cement (HAC)
Expanded Kit |
|--------------------------------|---------------------------------------------------------------------------------------------------------|
| Common Name: | Hydroxyapatite Cement (HAC) |
| Classification Name(s): | Prosthesis, Chin, Internal
Methyl Methacrylate for Cranioplasty |
| Classification Code(s): | 79FWP
87GXP |
| Submitter: | Stryker Leibinger
4100 East Milham Avenue
Kalamazoo, MI 49001
800-253-7370 |
| Submitter's Registration #: | 1811755 |
| Manufacturer's Registration #: | 2183449 |
| Contact Person: | Kristyn R. Kelley
Project Engineer
Quality Assurance and Regulatory Affairs
800-253-7370 x5045 |
| Summary Preparation Date: | April 14, 1999 |
Predicate Device
The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is substantially equivalent to BoneSource Hydroxyapatite Cement (K953339, K864537 and K970400) and to Norian® CRS™ Craniofacial Repair System (K973789).
Device Description
The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit contains the previouslycleared BoneSource hydroxyapatite cement powder along with a new prefilled syringe containing sodium phosphate solution and a mixing spatula. Kits are being provided in sizes ranging from 5 g to 50 g.
1
Public Health Service
SEP 2 2 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Kristyn R. Kelley Project Engineer Ouality Assurance and Regulatory Affairs Stryker®Leibinger 4100 East Milham Avenue Kalamazoo, Michigan 49001
Re: K991398
Trade Name: BoneSource Hydroxyapatite Cement (HAC) Regulatory Class: II Product Code: GXP, FWP Dated: July 19, 1999 Received: July 20, 1999
Dear Ms. Kelley:
We have reviewed your Section 510(k) notification of intent to market the device referenced above, and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General Regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Ms. Kristyn R. Kelley
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices). please contact the Office of Compliance at (301) 594-4659. Furthermore, for questions regarding the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification (21 CFR 807.97)." Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
CaNo. M. Witton, Ph.D., M.D.
- Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 0 | 0
1
œ
11 | |
|---|-------------------|--|
| 1 | | |
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The BoneSource® Hydroxyapatite Cement (HAC) Expanded Kit is indicated for use in the repair The Donesourgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface or nourcement but notes) e defect. BoneSource is also indicated for augmentation or arestoration of bony contour in the craniofacial skeleton including the fronto-orbital, malar and mental areas.
(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 Devices | |
| 510(k) Number | K991398 |
| Prescription Use
| (Per 21 CFR 801.109) | Yes |
|---|---|
| ------------------------------------------ | ----- |
OR
| Over-The-Counter Use | No |
|---|---|
| ---------------------- | ---- |
(Optional Format 1-2-96)