(87 days)
Not Found
No
The device description and performance studies focus on the material properties and mechanical function of a bone putty, with no mention of AI or ML technologies.
No
The device is a hemostatic bone putty used to control bleeding by acting as a mechanical barrier, which is not considered a therapeutic device in the traditional sense of treating a disease or condition with therapy.
No
Explanation: The device is indicated for controlling bleeding from bone, acting as a mechanical barrier or tamponade. This is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines a physical, resorbable material (putty) composed of various chemical components, intended for direct application to bone. It is a tangible medical device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- MONTAGE Device Function: The MONTAGE Settable, Resorbable Hemostatic Bone Putty is applied directly to the body (specifically, to bleeding bone) to control bleeding. It acts as a physical barrier.
- Intended Use: The intended use clearly states it's for "control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade." This is a therapeutic/surgical function, not a diagnostic one.
- Device Description: The description details its composition and how it works as a physical barrier on the bone surface. There is no mention of analyzing biological samples.
Therefore, based on the provided information, the MONTAGE device is a surgical/therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
MONTAGE Settable, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bleeding bone surface and remains in place upon application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE must be mixed immediately prior to use.
When applied to surgically cut or traumatically damaged bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces / cut or damaged bone
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)
Bench testing, biocompatibility and animal functionality testing performed on the predicate HBP4 Hardening, Resorbable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance. Because this device is exactly the same formulation as the predicate device the testing is completely relevant. This testing included the following:
Bench Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution properties. The following bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling.
Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiated sterile device in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity and pyrogenicity.
Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and to characterize resorption time.
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
N/A
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 15, 2015
Orthocon Incorporated Mr. Howard Schrayer 1 Bridge Street, Suite 121 Irvington, New York 1053
Re: K152005
Trade/Device Name: MONTAGE™ Settable, Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: September 14, 2015 Received: September 15, 2015
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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 [SELECT ONE: Part 801 [or, for IVDs only] Parts 801 and 809]); 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)
1
regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE
| | DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | | Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below. |
|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Indications for Use | | |
| 510(k) Number (if known) | K152005 | | |
| Device Name | MONTAGETM Settable, Resorbable Hemostatic Bone Putty | | |
| Indications for Use (Describe) | MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. | | |
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. | | |
| | This section applies only to requirements of the Paperwork Reduction Act of 1995. | | |
| | DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. | | |
| | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | | |
| | Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov | | |
| | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." | | |
3
1 of 5
510(k) Summary
| Contact: | Howard Schrayer
Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533
Telephone: 914-357-2600
Fax: 914-231-7884
hs.ss@verizon.net |
|--------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | July 17, 2015 |
| Device Trade Name: | MONTAGETM Settable, Resorbable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533 |
| Common Name: | Calcium phosphate bone hemostasis material |
| Classification: | Unclassified |
| Product Code: | MTJ |
| Primary Predicate: | HBP4TM Hardening, Resorbable Hemostatic Bone Putty
510(k) K141502 |
4
Indications for Use:
MONTAGE Settable, Resorbable Hemostatic Bone Putty is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.
Device Description:
MONTAGE Settable, Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE device contains two separate components of putty-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the MONTAGE device form a cohesive putty-like material that adheres to the bleeding bone surface and remains in place upon application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE must be mixed immediately prior to use.
When applied to surgically cut or traumatically damaged bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
Substantial Equivalence and Predicate Device:
MONTAGE Settable, Resorbable Hemostatic Bone Putty is exactly the same device and is substantially equivalent to the previously cleared Orthocon HBP4 Hardening, Resorbable Hemostatic Bone Putty (K141502). The only difference between MONTAGE Settable, Resorbable Hemostatic Bone Putty and the predicate device is the configuration of the packaging (blister package).
5
Technological Characteristics:
The tables below provide comparisons of MONTAGE Settable, Resorbable Hemostatic Bone Putty with the predicate devices.
| Predicate Comparison Table | |
|---|---|
| Manufacturer | Orthocon, Inc. | Orthocon, Inc | Radiopacity | Radiopaque – Contains calcium phosphate | Radiopaque – Contains calcium phosphate |
|---|---|---|---|---|---|
| Trade Name | MONTAGE Settable, | ||||
| Resorbable Hemostatic Bone | |||||
| Putty | HBP4 Hardening, Resorbable | ||||
| Hemostatic Bone Putty | Materials | Sterile mixture of two separate components of putty-like consistency comprised of granular calcium phosphate, (hydroxyapatite and β-tricalcium phosphate), calcium stearate, vitamin E acetate, triacetin, 1,4-butanediol and a mixture of a lactide-diester and polyester-based (lactide and caprolactone) absorbable polymers. MONTAGE is to be mixed immediately prior to use. Resulting hardening material from the two putties is primarily comprised of calcium phosphate similar to the mineral phase of native bone tissue. | Sterile mixture of two separate components of putty-like consistency comprised of granular calcium phosphate, (hydroxyapatite and β-tricalcium phosphate), calcium stearate, vitamin E acetate, triacetin, 1,4-butanediol and a mixture of a lactide-diester and polyester-based (lactide and caprolactone) absorbable polymers. HBP4 is to be mixed immediately prior to use. Resulting hardening material from the two putties is primarily comprised of calcium phosphate similar to the mineral phase of native bone tissue. | ||
| 510(k) Number | Subject Device | K141502 | Resorbable | Yes | Yes |
| Type of Device/ | |||||
| Product Code | Bone hemostat / MTJ | Bone hemostat / MTJ | Resorption Time | Greater than 30 days primarily due to presence of calcium phosphate. | Greater than 30 days primarily due to presence of calcium phosphate |
| Indications for Use | MONTAGE Settable, | ||||
| Resorbable Hemostatic Bone | |||||
| Putty is indicated in the | |||||
| control of bleeding from cut or | |||||
| damaged bone by acting as a | |||||
| mechanical barrier or | |||||
| tamponade | HBP4 Hardening, Resorbable | ||||
| Hemostatic Bone Putty is | |||||
| indicated in the control of | |||||
| bleeding from cut or damaged | |||||
| bone by acting as a | |||||
| mechanical barrier or | |||||
| tamponade | Method of Application | Manually applied and spread onto bone tissue | Manually applied and spread onto bone tissue | ||
| Intended Use | Bone hemostasis | Bone hemostasis | Degradation Process | The non-calcium salt and non-polymeric components degrade via dissolution; the polymer degrades via hydrolysis and calcium salts degrade via chemical dissolution and/or cellular removal | The non-calcium salt and non-polymeric components degrade via dissolution; the polymer degrades via hydrolysis and calcium salts degrade via chemical dissolution and/or cellular removal |
| Mechanism of | |||||
| Action | Mechanical tamponade that | ||||
| occludes vascular openings in | |||||
| damaged bone | Mechanical tamponade that | ||||
| occludes vascular openings in | |||||
| damaged bone | Sterility | Provided sterile for single use by gamma irradiation | Provided sterile for single use by gamma irradiation | ||
| Form of Device | MONTAGE Settable, | ||||
| Resorbable Hemostatic Bone | |||||
| Putty is formulated as a two- | |||||
| part putty/putty device that | |||||
| forms a "settable" (hardening) | |||||
| putty when manually mixed at | |||||
| the time of surgery. | HBP4 Hardening, Resorbable | ||||
| Hemostatic Bone Putty is | |||||
| formulated as a two-part | |||||
| putty/putty device that forms a | |||||
| "settable" (hardening) putty | |||||
| when manually mixed at the | |||||
| time of surgery. |
6
7
Performance Testing:
Bench testing, biocompatibility and animal functionality testing performed on the predicate HBP4™ Hardening, Resorbable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance. Because this device is exactly the same formulation as the predicate device the testing is completely relevant. This testing included the following:
Bench Testing was conducted to verify the device's handling properties, to characterize the device's performance over a range of temperatures and to evaluate the device's dissolution properties. The following bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling.
Biocompatibility Testing was conducted to evaluate the device's biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiated sterile device in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity and pyrogenicity.
Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, and to characterize resorption time.
Conclusion
MONTAGE is substantially equivalent to previously cleared bone wax devices with respect to intended use, general technological characteristics and performance.