(207 days)
Not Found
No
The summary describes a ceramic bone void filler material and its injection device. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device's function is purely material-based and mechanical for delivery.
Yes
It is a bone void filler intended for orthopedic applications as a filler for gaps and voids, providing osteoconductive support for in-growth of new bone during the healing process.
No
The device is described as a "bone void filler" and a "bone substitute material" intended for orthopedic applications to fill gaps and voids in the skeletal system. Its function is to resorb and be replaced by bone during healing, indicating a therapeutic rather than a diagnostic purpose.
No
The device is a physical bone void filler material and an accompanying injection device, not a software application.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that CERAMENT™|BONE VOID FILLER is a "ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure." It is injected into the skeletal system to fill bone voids. This is a therapeutic and structural application, not a diagnostic one.
- Device Description: The description details the composition of the material and how it is injected into bone voids. It describes a physical material used to fill a space, not a test or analysis performed on a biological sample to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.
CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.
CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate hemihydrate and sintered hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with the combined mixing injection device, results in a viscous material suitable for percutaneous injection into a bone void. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone. The ceramic bone substitute material is injected into the bone void in a percutaneous procedure, under visual inspection or under radiographic monitoring, with the use of the accompanying injection device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic monitoring
Anatomical Site
Skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine).
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)
Extensive in vitro and in vivo testing has shown CERAMENT™|BONE VOID FILLER to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed CERAMENT™|BONE VOID FILLER to be safe and effective.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Bone Support. The logo has the words "BONE SUPPORT" in all caps, with a diamond shape in between the two words. Below the words "BONE SUPPORT" is the phrase "injecting new strength" in a smaller font.
510(k) Summary
JUN 2 0 2008
Submitter Information
| Manufacturer | BONESUPPORT AB
Scheelevägen 19 A
Ideon Science Park
SE-223 70 LUND, SWEDEN | |
|--------------------------|------------------------------------------------------------------------------------------------------|----------------|
| Telephone
Company fax | + 46 46 286 53 70
- 46 46 286 53 71 | |
| Contact person | Ann-Christine Provoost
ann-christine.provoost@bonesupport.com - 46 46 286 53 22 (direct phone) | |
| Date of preparation | 10th of June, 2008 | |
| | Trade name, Classification name, Class, Regulation | |
| Trade Name | CERAMENT™ BONE VOID FILLER (A0210) | |
| Classification Name | Resorbable calcium salt bone void filler device, MQV | |
| Class | CLASS II (Special Control) | |
| Regulation Number | CFR 888.3045 | |
| Predicate devices | | |
| 510(k) number | Trade name | Manufacturer |
| K051951 | CERAMENT™ BONE VOID FILLER (A 0066) | BONESUPPORT AB |
| Device description | | |
CERAMENT™|BONE VOID FILLER is an injectable ceramic bone substitute material intended for bone voids. The material consists of a powder and a liquid component. The major constituents of the powder are calcium sulfate hemihydrate and sintered hydroxyapatite. The liquid component contains iohexol as a radio-opacity enhancer. Mixing the components, with
COMPANY CONFIDENTIAL
the combined mixing injection device, results in a viscous material suitable for percutaneous
BONESUPPORT AB Scheelevägen 19 A SE- 223 70 LUND, Sweden
Tel: +46 46 286 53 70 Fax: +46 46 286 53 71
1
Image /page/1/Picture/1 description: The image shows the logo for Bone Support. The logo has the words "BONE" and "SUPPORT" in a sans-serif font, with a diamond shape in between the two words. Underneath the words is the tagline "injecting new strength" in a smaller font.
injection into a bone void. During resorption of the calcium sulfate dihydrate, the hydroxyapatite remains intact providing osteoconductive support for in-growth of new bone.
The ceramic bone substitute material is injected into the bone void in a percutaneous procedure, under visual inspection or under radiographic monitoring, with the use of the accompanying injection device.
Intended use
CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or qaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.
CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.
CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.
Pre-clinical Testing
Extensive in vitro and in vivo testing has shown CERAMENT™|BONE VOID FILLER to meet the requirements of all relevant standards for Calcium Salt Bone Void Fillers. Extensive preclinical testing has confirmed CERAMENT™|BONE VOID FILLER to be safe and effective.
Summary
Based on the information provided in this premarket notification, the CERAMENT™ BONE VOID FILLER is equivalent to the predicate device in intended use, technological characteristics and principles of operation.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three streams emanating from its wing, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
BONESUPPORT AB % Ms. Ann-Christine Provoost Contact Person Regulatory Affairs Scheclevägen 19A Ideon Science Park SE-223 70 LUND, SWEDEN
JUN 2 0 2008
Re: K073316
Trade/Device Name: Cerament™ Bone Void Filler Regulation Number: CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: April 17, 2008 Received: April 22, 2008
Dear Ms. Provoost:
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.
3
Page 2 - Ms. Ann-Christine Provoost
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark H. Millikan
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K073316 510(k) Number (if known):
CERAMENT™|BONE VOID FILLER (A0210) Device Name:
Indications for Use:
CERAMENT™|BONE VOID FILLER is a ceramic bone void filler intended only for orthopedic applications as a filler for gaps and voids that are not intrinsic to the stability of the bony structure. CERAMENT™|BONE VOID FILLER is indicated to be injected into bony voids or gaps in the skeletal system, i.e. extremities, pelvis and spine (only during open surgery in spine). These defects may be surgically created osseous defects or osseous defects from traumatic injury to the bone.
CERAMENT™|BONE VOID FILLER provides a bone void filler that resorbs and is replaced by bone during the healing process.
CERAMENT™|BONE VOID FILLER is not intended for use in load bearing applications such as vertebroplasty or kyphoplasty.
| Prescription Use | X |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 801 Subpart C) |
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neilke Dede-Foreman
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K073316