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).

AI/ML Overview

The FDA document describes the MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty, which is a medical device for controlling bone bleeding. The submission seeks to prove the substantial equivalence of the new device (MONTAGE-XT) to a previously cleared predicate device (MONTAGE) by Orthocon, Inc. The primary difference highlighted is an extended working time for MONTAGE-XT.

Here's an analysis of the provided text in relation to the requested information:

Acceptance Criteria and Study for MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty

The acceptance criteria for this device are based on demonstrating substantial equivalence to a predicate device (MONTAGE Settable, Resorbable Hemostatic Bone Putty, K141502 and K152005). The studies conducted primarily revolve around characterizing the new device's properties and comparing them to the predicate, especially regarding the extended working time. This is not a study proving clinical effectiveness through outcome measures in an AI/software context, but rather a characterization and comparison study for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence Goal)	Reported Device Performance (MONTAGE-XT)
Intended Use Equivalence:	MONTAGE-XT is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, identical to the predicate.
Technological Characteristics Equivalence:	Composition: 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. (Identical to predicate).Form of Device: Two-part putty/putty device that forms a "settable" (hardening) putty when manually mixed at the time of surgery. (Identical to predicate).Radiopacity: Radiopaque – Contains hydroxyapatite and β-tricalcium phosphate. (Identical to predicate).Resorbable: Yes. (Identical to predicate).Resorption Time: Greater than 30 days primarily due to presence of calcium phosphate. (Identical to predicate).Method of Application: Manually applied and spread onto bone tissue. (Identical to predicate).Degradation Process: Similar to predicate (dissolution of non-calcium salt and non-polymeric components; hydrolysis of polymer; chemical dissolution and/or cellular removal of calcium salts).Sterility: Provided sterile for single use by gamma irradiation. (Identical to predicate).Settability: Sets following application. (Identical to predicate).Working Time: Up to 4 minutes (Predicate: Up to 2 minutes). This is the key difference and the specific performance metric highlighted.
Performance Equivalence:	Handling Properties: Verified through bench testing (relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility). Specific metrics not provided, but stated to demonstrate substantial equivalence.Biocompatibility: Evaluated in accordance with ISO 10993 (irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity) and deemed compliant.Hemostasis (in vivo): Demonstrated intraoperative in vivo hemostasis in animal studies.Resistance to Irrigation: Demonstrated in animal studies.

2. Sample Size Used for the Test Set and Data Provenance

The document does not provide specific sample sizes for the performance tests.

Bench Testing: Performed on the device to characterize properties like stiffness, spreadability, stickiness, working time, etc. No specific count of samples is given.
Biocompatibility Testing: Conducted on a "representative device." No specific sample size (e.g., number of animals for toxicity tests) is provided within this summary.
Animal Testing: Included "animal studies" to demonstrate intraoperative in vivo hemostasis and resistance to irrigation. The specific number or details of animals used are not provided.

The provenance of this data is from the manufacturer, Orthocon, Inc., as part of their 510(k) submission to the FDA. The studies appear to be prospective as they were conducted specifically for this submission to characterize the new device. The country of origin for the data generation is not explicitly stated, but it's generated by a US-based company for FDA submission, implying US-based or internationally accepted GLP/ISO standards were followed.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This submission is for a physical medical device, not an AI/Software as a Medical Device (SaMD). Therefore, the concept of "ground truth" established by experts (like radiologists for imaging data) is not directly applicable in the same way. The "ground truth" here is established by validated laboratory methods and animal models to measure physical properties, biocompatibility, and hemostatic efficacy.

The relevant "experts" would be the scientists, engineers, and veterinarians conducting the bench and animal studies, following established protocols (e.g., ISO, GLP). Their qualifications are implied by their ability to conduct such studies according to regulatory standards, but specific numbers or qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable as this is not an expert-driven AI/SaMD ground truth establishment process. Performance is objectively measured through defined test methods.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not a study involving human readers and AI assistance for diagnostic or interpretative tasks. It's a characterization of a physical medical device.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Not applicable. This is not an AI/SaMD. The device is a physical bone putty. Its performance is inherent to its physical and chemical properties and how it interacts with the biological environment.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation comes from:

Bench Test Results: Quantifiable measurements of physical properties (e.g., working time, stiffness, spreadability).
Biocompatibility Study Results: Standardized tests (e.g., ISO 10993) assessing biological responses.
Animal Study Results: Direct observation and measurement of hemostatic efficacy and resistance to irrigation in a live biological model.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

As there is no training set, this question is not applicable.

Summary

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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

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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

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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)

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Exhibit E - 510(k) Summary 510(k) K220315

Contact:	Howard SchrayerOrthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533Telephone: 914-357-2600Fax: 914-231-7884hs.ss@verizon.net
Date Prepared:	March 8, 2022
Device Trade Name:	MONTAGE-XT Settable, Resorbable Hemostatic BonePutty
Manufacturer:	Orthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533
Common Name:	Calcium phosphate bone hemostasis material
Classification:	Unclassified
Product Code:	MTJ
Predicate Device:	Orthocon, Inc. MONTAGE Settable, ResorbableHemostatic Bone Putty510(k) K141502 and K152005

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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:

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.

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Predicate Comparison Table

Manufacturer	Orthocon, Inc.	Orthocon, Inc.
Trade Name	MONTAGE-XT Settable, ResorbableHemostatic Bone Putty	MONTAGE Settable, ResorbableHemostatic Bone Putty
510(k) Number	Subject Device	K141502 and K152005
Product Code	MTJ	MTJ
Indications for Use	MONTAGE-XT Settable, ResorbableHemostatic Bone Putty is indicated inthe control of bleeding from cut ordamaged bone by acting as amechanical barrier or tamponade	MONTAGE Settable, ResorbableHemostatic Bone Putty is indicated in thecontrol of bleeding from cut or damagedbone by acting as a mechanical barrieror tamponade
Intended Use	Bone hemostasis	Bone hemostasis
Mechanism ofAction	Mechanical tamponade that occludesvascular openings in damaged bone	Mechanical tamponade that occludesvascular openings in damaged bone
Form of Device	MONTAGE-XT Settable, ResorbableHemostatic Bone Putty is formulated asa two-part putty/putty device that formsa "settable” (hardening) putty whenmanually mixed at the time of surgery.	MONTAGE Settable, ResorbableHemostatic Bone Putty is formulated asa two-part putty/putty device that forms a"settable" (hardening) putty whenmanually mixed at the time of surgery.

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Radiopacity	Radiopaque – Contains hydroxyapatite	Radiopaque – Contains hydroxyapatite
	and β-tricalcium phosphate	and β-tricalcium phosphate
Materials	Sterile mixture of two separatecomponents of putty-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and β-tricalcium phosphate), calcium stearate,vitamin E acetate, a triglyceride, apolyalcohol and a mixture of a lactide-diester and polyester-based polymers.MONTAGE-XT is to be mixedimmediately prior to use. Resultingsettable material from the two putties isprimarily comprised (~70% by weight)of calcium phosphate similar to themineral phase of native bone tissue.	Sterile mixture of two separatecomponents of putty-like consistencycomprised of granular calcium phosphate,(hydroxyapatite and β-tricalciumphosphate), calcium stearate, vitamin Eacetate, a triglyceride, a polyalcohol anda mixture of a lactide-diester andpolyester-based polymers. MONTAGE-XT is to be mixed immediately prior touse. Resulting settable material from thetwo putties is primarily comprised (~70%by weight) of calcium phosphate similar tothe mineral phase of native bone tissue.
Resorbable	Yes	Yes

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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

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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.

Regulation Number and Section

N/A