(129 days)
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.
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.
The provided text describes a 510(k) premarket notification for the OsteoSelect™ Demineralized Bone Matrix Putty. It does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner typically associated with studies demonstrating AI or software device performance (e.g., sensitivity, specificity, or reader performance metrics).
However, the document does describe the "study" and "acceptance criteria" in the context of demonstrating substantial equivalence to predicate devices, focusing on the material's properties and biological activity.
Here's an interpretation based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly Accepted) | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Equivalence to predicate devices (DBX®, Grafton® DBM) in intended use, technology, and performance. | The submission "supports the position that OsteoSelectтм Demineralized Bone Matrix Putty is substantially equivalent". |
| Biocompatibility | Device is biocompatible. | "The data presented demonstrate that the device is biocompatible." |
| Functionality (Efficacy) | Osteoinductive potential in an in vivo model. Osteoconductive. | "OsteoSelect™ DBM Putty is osteoconductive and has been shown to have osteoinductive potential in an athymic rat model." |
| Viral Inactivation | Processing methods provide significant viral inactivation potential. | "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... was evaluated. The processing methods were determined to provide significant viral inactivation potential for a wide range of viruses." |
| Absorption Time | Absorption within 90 days. | "The putty will be absorbed within a period of 90 days." |
| Physical Characteristics | Putty-like consistency, virtually odorless, tan in color, easy to spread with minimal adhesion to surgical gloves. | "The combination... results in a putty-like consistency for ease and flexibility of use... OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves." |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Viral Inactivation: A "panel of model potential human viruses" was used. The exact number of viruses is not specified.
- Osteoinductivity: "an athymic rat model" for testing, and "Every final lot of OsteoSelect™ DBM Putty is tested in an in vivo rat model". The exact sample size (number of rats) for the initial testing or for lot release is not specified.
- Physical/Biocompatibility/Absorption: Not specified, but likely involved laboratory testing of the material, not a "test set" in the sense of a clinical dataset.
- Data Provenance: The document does not specify country of origin for the data. The studies are described as pre-clinical (in vivo rat model, in vitro viral inactivation). They are not human clinical trials data.
3. Number of Experts and Qualifications for Ground Truth
This information is not applicable to the type of device and studies described. The ground truth for this medical device (a bone void filler) is established through laboratory and animal model testing, not through expert review of clinical images or data.
4. Adjudication Method
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving multiple human readers for diagnostic accuracy assessments. The described studies are pre-clinical (viral inactivation, animal models).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is not mentioned and would be irrelevant for this kind of medical device. MRMC studies are used to evaluate the performance of diagnostic tools (often AI-assisted) by comparing human reader performance with and without the tool on a set of cases.
6. Standalone Performance Study
Yes, in a way. The studies described (viral inactivation, osteoinductive potential in rats, physical properties, biocompatibility) are assessments of the device's inherent properties and performance without human-in-the-loop interaction for diagnostic purposes. These are "standalone" in the sense that they evaluate the device itself.
7. Type of Ground Truth Used
- Viral Inactivation: Laboratory assay results determining the reduction in viral titer.
- Osteoinductivity: Histological and/or other biological markers observed in the athymic rat model, indicating new bone formation.
- Biocompatibility: Results from standard biocompatibility tests (e.g., cytotoxicity, sensitization, irritation).
- Physical Properties: Laboratory measurements of consistency, color, adhesion, etc.
8. Sample Size for the Training Set
Not applicable. This device is a bone void filler, not an AI or software algorithm that requires a "training set" in the machine learning sense. The "training set" concept is irrelevant to the development of this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this device.
{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.
27
{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
§ 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.