(36 days)
Not Found
No
The device description focuses on the material composition and mechanical properties of a bone putty for hemostasis. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies. The performance studies described are standard bench, biocompatibility, and animal tests for a material-based medical device.
Yes
The device is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, which constitutes a therapeutic effect.
No
The device is a hemostatic bone putty intended for controlling bleeding by acting as a mechanical barrier. It is a therapeutic device, not a diagnostic one as it does not diagnose or detect a condition.
No
The device description clearly states it is a "sterile, biocompatible, resorbable material of putty-like consistency" comprised of various physical components, indicating it is a physical medical 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 to control bleeding from bone by acting as a mechanical barrier. This is a direct therapeutic action on the body.
- Device Description: The device is a material applied directly to bone. It does not analyze samples taken from the body (like blood, urine, or tissue) to provide diagnostic information.
- Mechanism of Action: It works as a mechanical barrier (tamponade) and hardens in place. This is a physical interaction with the tissue, not a diagnostic test.
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
MONTAGE-XT 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-XT 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-XT 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-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone. MONTAGE-XT 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
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 was conducted to verify the device's handling properties, to characterize the device's performance. The following bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility and working time.
Biocompatibility Testing was conducted on a representative device to evaluate biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.
Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation.
Evaluations performed to compare MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty with the predicate device demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance.
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
March 11, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Orthocon, Inc. Mr. Howard Schrayer Regulatory Consultant 8 Lookout Hilton Head Island. South Carolina 29928
Re: K220315
Trade/Device Name: MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: February 2, 2022 Received: February 3, 2022
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for
Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220315
Device Name
MONTAGE-XTTM Settable, Resorbable Hemostatic Bone Putty
Indications for Use (Describe)
MONTAGE-XT 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)
X 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
Exhibit E - 510(k) Summary 510(k) K220315
| 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: | March 8, 2022 |
| Device Trade Name: | MONTAGE-XT 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 |
| Predicate Device: | Orthocon, Inc. MONTAGE Settable, Resorbable
Hemostatic Bone Putty
510(k) K141502 and K152005 |
4
Indications for Use:
MONTAGE-XT 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-XT 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-XT 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-XT device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting hardening material is primarily comprised of calcium phosphate. MONTAGE-XT must be mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
Substantial Equivalence and Predicate Devices:
The purpose of this submission is to obtain clearance for a version of the device with extended working time. MONTAGE-XT was shown to be substantially equivalent to previously cleared bone hemostasis devices including Montage, Resorbable Hemostatic Bone Putty (K141502 and K152005).
The table below provides a comparison of MONTAGE-XT and the predicate Montage device.
5
Predicate Comparison Table
| Manufacturer | Orthocon, Inc. | Orthocon, Inc. |
|---|---|---|
| Trade Name | MONTAGE-XT Settable, Resorbable | |
| Hemostatic Bone Putty | MONTAGE Settable, Resorbable | |
| Hemostatic Bone Putty | ||
| 510(k) Number | Subject Device | K141502 and K152005 |
| Product Code | MTJ | MTJ |
| Indications for Use | MONTAGE-XT 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 | 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 | ||
| Intended Use | Bone hemostasis | Bone hemostasis |
| Mechanism of | ||
| Action | Mechanical tamponade that occludes | |
| vascular openings in damaged bone | Mechanical tamponade that occludes | |
| vascular openings in damaged bone | ||
| Form of Device | MONTAGE-XT 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. | 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. |
6
| Radiopacity | Radiopaque – Contains hydroxyapatite | Radiopaque – Contains hydroxyapatite |
|---|---|---|
| and β-tricalcium phosphate | and β-tricalcium phosphate | |
| 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, a triglyceride, a | ||
| polyalcohol and a mixture of a lactide- | ||
| diester and polyester-based polymers. | ||
| MONTAGE-XT is to be mixed | ||
| immediately prior to use. Resulting | ||
| settable material from the two putties is | ||
| primarily comprised (~70% by weight) | ||
| 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, a triglyceride, a polyalcohol and | ||
| a mixture of a lactide-diester and | ||
| polyester-based polymers. MONTAGE- | ||
| XT is to be mixed immediately prior to | ||
| use. Resulting settable material from the | ||
| two putties is primarily comprised (~70% | ||
| by weight) of calcium phosphate similar to | ||
| the mineral phase of native bone tissue. | ||
| Resorbable | Yes | Yes |
7
| Resorption Time | Greater than 30 days primarily due to presence of calcium phosphate. | Greater than 30 days primarily due to presence of calcium phosphate |
|---|---|---|
| Method of Application | Manually applied and spread onto bone tissue | Manually applied and spread onto bone tissue |
| 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 |
| Sterility | Provided sterile for single use by gamma irradiation | Provided sterile for single use by gamma irradiation |
| Settability | Sets following application | Sets following application |
| Working Time | Working time up to 4 minutes | Working time up to 2 minutes |
8
Performance Testing:
Evaluations performed to compare MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty with the predicate device demonstrate that the device is substantially equivalent to predicate devices in intended use, technological characteristics, and performance. This testing included the following:
Bench Testing was conducted to verify the device's handling properties, to characterize the device's performance. The following bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility and working time.
Biocompatibility Testing was conducted on a representative device to evaluate biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted in accordance with the GLP requirements: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.
Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation.
Conclusion
MONTAGE-XT is substantially equivalent to previously cleared bone hemostasis devices with respect to intended use, general technological characteristics and performance.