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. The material may be used during surgical procedures and in treating traumatic injuries. Montage-XT is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

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

This FDA 510(k) summary is for a medical device called MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty. The submission is to add a new indication for use: "in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy." The new device is compared to a previously cleared predicate device, Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty (K213418).

Here's the breakdown of the acceptance criteria and supporting studies as described in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state "acceptance criteria" in a quantitative format for the new sternotomy indication. Instead, it relies on demonstrating substantial equivalence to the predicate device, Montage, and leveraging clinical data from the Montage device. The core argument is that the devices are nearly identical, with the only clinically meaningful difference being an extended working time for Montage-XT.

The comparison table provided focuses on similarities and differences between the subject device (Montage-XT) and the predicate device (Montage). The "performance" for the new indication is implied by the clinical efficacy shown for the predicate device in a sternotomy setting.

Device Characteristic/Requirement	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Montage-XT Performance
Intended Use (New Indication)	Control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy (as demonstrated by predicate)	Montage-XT is being cleared for this indication based on substantial equivalence and clinical data from Montage.
Formulation	Sterile mixture of granular calcium phosphate, calcium stearate, vitamin E acetate, triglyceride, polyalcohol, lactide-diester, polyester-based polymers. Forms a settable (hardening) material when mixed. Primarily (~70% by weight) comprised of calcium phosphate.	Identical to predicate.
Application Method	Manually applied and spread onto bleeding bone tissue.	Identical to predicate.
Resorbability	Resorbable in >30 days.	Identical to predicate.
Degradation Mechanism	Non-calcium salt and non-polymeric components degrade via dissolution; polymer degrades via hydrolysis; calcium salts degrade via chemical dissolution and/or cellular removal.	Identical to predicate.
Sterilization	Sterile by gamma irradiation.	Identical to predicate.
Packaging	Two putties provided separately within a single outer foil pouch with a desiccant.	Identical to predicate.
Mixing for Homogeneity	45 seconds.	Identical to predicate.
Working Time	Acceptable working time for surgical procedures. (Predicate: 2 min, Montage-XT: 4 min)	4 minutes (This is the only clinically meaningful difference from the predicate, allowing for a longer application window).
Exothermic Reaction during Cure	No appreciable exothermic reaction.	Identical to predicate.
Biocompatibility	Meets ISO 10993 recommendations.	Studies conducted: irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, pyrogenicity. (Reported as compliant with GLP requirements).
Bench Testing (Handling)	Comparable to predicate.	Relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, working time. (All demonstrated substantial equivalence to predicate, except working time variation which is acceptable).
Animal Testing (Performance)	Demonstrates intraoperative in vivo hemostasis and resistance to irrigation.	Studies conducted to demonstrate these aspects. (Assumed successful based on substantial equivalence claim).

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

Test Set Sample Size: The document states that "A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures." However, it does not specify the sample size of this clinical evaluation.
Data Provenance: The document implies the clinical data is from a prospective study ("A human clinical evaluation was conducted"). The country of origin is not explicitly stated. It refers to "clinical data obtained from a sternotomy study" relevant to the Montage device.

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

This information is not provided in the document. The description of the clinical evaluation does not detail the methodology for establishing ground truth or the involvement of experts beyond the general statement of a "human clinical evaluation."

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is a hemostatic bone putty, not an AI-powered diagnostic or assistive tool. The clinical evaluation described would likely be a direct clinical trial evaluating the putty's efficacy, not a reader study.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical product (bone putty), not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is irrelevant. Its performance is directly tied to its physical application and biological interaction.

7. Type of Ground Truth Used

For the clinical study on the predicate device (Montage) used to support the new indication for Montage-XT, the ground truth would have been based on clinical observation of hemostasis (cessation of bleeding) during sternotomy procedures. This would fall under outcomes data (i.e., successful control of bleeding).

8. Sample Size for the Training Set

Not applicable. This product is a physical medical device. It does not employ machine learning algorithms that require a "training set" of data.

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

Not applicable for the same reason as point 8.

Summary

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October 12, 2023

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in two lines.

Orthocon, Inc. Howard Schrayer Regulatory Consultant 700 Fairfield Ave. - Suite 1 Stamford, Connecticut 06902

Re: K232998

Trade/Device Name: Montage- XT Settable, Resorbable Hemostatic Bone Putty Regulatory Class: Unclassified Product Code: MTJ Dated: September 22, 2023 Received: September 22, 2023

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming

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product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products): good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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.

Sara S. Thompson -S

For

Jesse Muir, 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

Submission Number (if known)

K232998

Device Name

Montage- XT Settable, Resorbable Hemostatic Bone Putty

Indications for Use (Describe)

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)

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510(k) Summary

Contact:	Howard SchrayerOrthocon, Inc.8 LookoutHilton Head Island, SC 29928Telephone: 609-273-7350hs.ss@lucidmedical.net
Date Prepared:	October 12, 2023
Device Trade Name:	MONTAGE-XT Settable, Resorbable Hemostatic BonePutty
Manufacturer:	Orthocon, Inc.700 Fairfield Avenue, Suite 1Stamford, CT 10533
Telephone:	(855) 475 - 9175
Common Name:	Calcium phosphate bone hemostasis material
Classification:	Unclassified
Product Code:	MTJ
Primary Predicate Device:	Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty510(k) K213418
Reference Predicate Device:

Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K220315

Indications for Use:

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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).

Purpose of this Submission:

Montage-XT was previously cleared for use in the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade. The purpose of this submission is to add an indication for Montage-XT for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.

Substantial Equivalence and Predicate Devices:

The subject device is nearly identical to and is substantially equivalent to its previously cleared predicate, Montage. The only difference between the subject device and its predicate is the addition of a statement regarding the use of the device in sternotomy procedures.

The following table shows comparisons of the several characteristics of Montage-XT and the primary predicate device. The differences noted in the table below do not impact substantial equivalence.

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SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. Montage-XT Settable, Resorbable Hemostatic Bone Putty Resorbable Hemostatic Bone Putty

Orthocon, Inc. Montage Settable,

510(k) - K232998

510(k) - K213418

Similarities and Differences

Montage-XT Settable, ResorbableHemostatic Bone Putty is indicated forthe control of bleeding from cut ordamaged bone by acting as amechanical barrier or tamponade.The material may be used duringsurgical procedures and in treatingtraumatic injuries. Montage-XT is alsoindicated for use in the control ofbleeding from bone surfaces incardiothoracic surgery followingsternotomy.	Montage Settable, ResorbableHemostatic Bone Putty is indicatedfor the control of bleeding from cut ordamaged bone by acting as amechanical barrier or tamponade.The material may be used duringsurgical procedures and in treatingtraumatic injuries. Montage-XT isalso indicated for use in the control ofbleeding from bone surfaces incardiothoracic surgery followingsternotomy.
At the time of application, device is inthe form of a putty-like material	At the time of application, device is inthe form of a putty-like material
Device is designed to be manuallyapplied and spread onto bleedingbone tissue	Device is designed to be manuallyapplied and spread onto bleedingbone tissue
Montage-XT Settable, ResorbableHemostatic Bone Putty is formulatedas a two-part putty/putty device thatforms a “settable” (hardening)material when mixed at the time ofsurgery	Montage-XT Settable, ResorbableHemostatic Bone Putty is formulatedas a two-part putty/putty device thatforms a “settable” (hardening)material when mixed at the time ofsurgery
Sterile mixture of two separatecomponents of putty-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and β-tricalcium phosphate), calciumstearate, vitamin E acetate, atriglyceride, a polyalcohol and amixture of a lactide diester and	Sterile mixture of two separatecomponents of putty-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and β-tricalcium phosphate), calciumstearate, vitamin E acetate, atriglyceride, a polyalcohol and amixture of a lactide diester and
polyester-based (lactide andcaprolactone) absorbable polymers.Montage-XT is to be mixedimmediately prior to use. Resultingsettable material from the two puttiesis primarily comprised (~70% byweight) of calcium phosphate similarto the mineral phase of native bonetissue.	polyester-based (lactide andcaprolactone) absorbable polymers.Montage is to be mixed immediatelyprior to use. Resulting settablematerial from the two putties isprimarily comprised (~70% by weight)of calcium phosphate similar to themineral phase of native bone tissue.
Implanted device is resorbable ingreater than 30 days primarily due topresence of calcium phosphate.	Implanted device is resorbable ingreater than 30 days primarily due topresence of calcium phosphate.
The non-calcium salt and non-polymeric components degrade viadissolution; the polymer degrades viahydrolysis and calcium salts degradevia chemical dissolution and/orcellular removal	The non-calcium salt and non-polymeric components degrade viadissolution; the polymer degrades viahydrolysis and calcium salts degradevia chemical dissolution and/orcellular removal
Single-patient-use device is providedsterile by gamma irradiation	Single-patient-use device is providedsterile by gamma irradiation
The two putties are providedseparately within a single outer foilpouch. The outer foil pouch containsa desiccant.	The two putties are providedseparately within a single outer foilpouch. The outer foil pouch containsa desiccant.
Mixing for homogeneity takes 45 sec.	Mixing for homogeneity takes 45 sec.
Working time is 4 minutes	Working time is 2 minutes
Device cures with no appreciableexothermic reaction	Device cures with no appreciableexothermic reaction

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Technological Characteristics:

The technological characteristics of the devices are unchanged. The only change is the addition of a statement regarding the use of the devices in sternotomy procedures.

Performance Testing:

Evaluations were previously conducted to compare MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty with the predicate device. The evaluations

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demonstrated that Montage-XT is substantially equivalent to the Montage predicate 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. Both devices are sterilized with the same validated gamma irradiation process and both have the same established shelf-life / stability characteristics.

Biocompatibility Testing was conducted 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.

Clinical Testing

A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures. The only clinically meaningful difference between Montage and Montage-XT is the extension of working time from 2 to 4 minutes. Because the devices have nearly identical formulations and have been found to be substantially equivalent in all other respects, the clinical data obtained from a sternotomy study is relevant to Montage-XT.

Conclusion

MONTAGE-XT is substantially equivalent Montage Settable. Resorbable Bone Hemostat with respect to intended use, general technological characteristics, and performance.

Regulation Number and Section

N/A