(129 days)
Not Found
No
The device description and performance studies focus on the material properties and biological activity of the bone graft substitute, with no mention of AI or ML technology.
Yes
The device is indicated for use as a bone void filler and bone graft substitute for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone, which are therapeutic applications.
No
Explanation: The device is indicated for use as a bone void filler and bone graft substitute, and its description details its composition and handling properties for surgical application. It does not mention diagnosis, disease detection, or measurement of physiological parameters.
No
The device description clearly states it is processed human bone combined with an absorbable carrier, indicating a physical, material-based device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is as a bone void filler and bone graft substitute for surgical and traumatic bone defects in the extremities and pelvis. This is a therapeutic use, not a diagnostic one.
- Device Description: The device is processed human bone combined with a carrier. It is applied directly to the patient's body during surgery. IVDs are typically used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze a sample or provide diagnostic information about a patient's condition. Its function is to physically fill a void and potentially promote bone growth.
Therefore, OsteoSelect™ (DBM) Putty falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
OsteoSelect™ DBM Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.
OsteoSelect™ DBM Putty is indicated for use as a bone void filler for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of the bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.
OsteoSelect™ (DBM) Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.
Product codes (comma separated list FDA assigned to the subject device)
MBP, MQV
Device Description
OsteoSelect™ Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose and phosphate buffered saline. OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
extremities and pelvis
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)
The 510(k) Notice contains summaries of physical test results, functionality (efficacy testinq) results and biocompatibility testing. The methods used for processing the DBM used in the device have been tested and validated for viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes was evaluated. The processing methods were determined to provide significant viral inactivation potential for a wide range of viruses.
OsteoSelect™ DBM Putty is osteoconductive and has been shown to have osteoinductive potential in an athymic rat model. Every final lot of OsteoSelect™ DBM Putty is tested in an in vivo rat model for osteoinductive potential. It is unknown how the osteoinductivity potential in the rat model correlates with human clinical performance.
The data presented demonstrate that the device is biocompatible and is suitable for its indicated use.
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
SEP 1 1 2009
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Per 21 CFR 807.92)
General Company Information
- Name: Bacterin International, Inc. Contact: Howard Schrayer Regulatory Affairs Consultant
- Bacterin International, Inc. Address: 600 Cruiser Lane Belgrade, MT 59714
- (406) 388 0480 Telephone: (406) - 388 - 0422 Fax:
May 4, 2009 Date Prepared
General Device Information
OsteoSelect™ Demineralized Bone Matrix Putty Product Name:
"Osteoinductive Bone Void Filler W/O Human Growth Factor", Classification: 21 CFR 888.3045 - Product code: MBP Class II
Predicate Devices
DBX® Demineralized Bone Matrix Putty Musculoskeletal Transplant Foundation 510(k) K040262
Grafton® DBM Osteotech, Inc. 510(k) K051195
Description
OsteoSelect™ Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose and phosphate
1
buffered saline. OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.
OsteoSelect™ DMB Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.
Intended Use (Indications)
OsteoSelect™ DBM Putty is indicated for use as a bone void filler for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of the bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.
Substantial Equivalence
This submission supports the position that OsteoSelectтм Demineralized Bone Matrix Putty is substantially equivalent to a number of pre-enactment and previously cleared devices, including:
DBX@ Demineralized Bone Matrix Putty - Musculoskeletal Transplant Foundation [510(k) K040262]
Grafton® DBM - Osteotech, Inc. [510(k) K051195]
The 510(k) Notice contains summaries of physical test results, functionality (efficacy testinq) results and biocompatibility testing. The methods used for processing the DBM used in the device have been tested and validated for viral inactivation potential. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes was evaluated. The processing methods were determined to provide significant viral inactivation potential for a wide range of viruses.
OsteoSelect™ DBM Putty is osteoconductive and has been shown to have osteoinductive potential in an athymic rat model. Every final lot of OsteoSelect™ DBM Putty is tested in an in vivo rat model for osteoinductive potential. It is unknown how the osteoinductivity potential in the rat model correlates with human clinical performance.
The data presented demonstrate that the device is biocompatible and is suitable for its indicated use.
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2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular and contains the department's name around the perimeter. In the center of the logo is an abstract image of an eagle.
Bacterin International, Inc. % Mr. Howard L. Schrayer 600 Cruiser Lane Belgrade, Montana 59714
FP 1 2009
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Re: K091321
Trade Name: OsteoSelect™ Demineralized Bone Matrix Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Regulatory Class: II Product Code: MQV, MBP Dated: July 9, 2009 Received: July 14, 2009
Dear Mr. Schrayer:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 - Mr. Howard L. Schraver
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Qerbare Brehup
Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: OSTEOSELECT™ Demineralized Bone Matrix Putty
Indications For Use:
OsteoSelect™ (DBM) Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(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 Surgical, Orthopedic, and Restorative Devices
510(k) Number K091321