Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Description

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The single use device contains two separate components of paste-like consistency comprised of granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols, a mixture of a lactide-diester and polyester-based polymers and barium sulfate. When mixed together, the components of the device form a resorbable paste-like material that can be applied directly to bleeding bone by means of a single-use applicator (delivery device). The resulting hardening paste is primarily comprised of calcium phosphate. Montage Flowable XRO is mixed immediately prior to use.

When applied to surgically cut or traumatically broken bone. Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste achieves local control of bleeding by acting as a mechanical barrier (tamponade).

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste." This document aims to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

However, the 510(k) summary does not contain information about acceptance criteria or a study that rigorously proves the device meets specific acceptance criteria in the manner you've outlined for AI/diagnostic devices.

This type of document for a conventional medical device (like a hemostatic bone paste) primarily focuses on demonstrating substantial equivalence to a predicate device through comparisons of:

Intended Use: The new device has the same intended use as the predicate.
Technological Characteristics: The new device has similar technological characteristics to the predicate. Any differences do not raise new questions of safety or effectiveness.
Performance Data: This typically involves bench testing, biocompatibility, and sometimes animal studies to show that the device performs as intended and is safe.

Therefore, for your specific request regarding acceptance criteria and a study proving performance, I must state that the provided text does not contain the requested information in the format or detail typically associated with AI/diagnostic device performance studies.

Here's why and what the document does provide:

Table of Acceptance Criteria and Reported Device Performance: This is not present for specific diagnostic metrics (e.g., sensitivity, specificity, AUC). The document lists comparisons of technological characteristics between the subject device and a predicate. The "performance" section describes general types of testing (bench, biocompatibility, animal) but no quantitative results against predefined acceptance criteria for diagnostic accuracy.
Sample Size Used for the Test Set and Data Provenance: No test set is described in terms of human subjects or data for diagnostic evaluation. The document mentions "animal testing," but not in the context of a diagnostic test set.
Number of Experts Used to Establish Ground Truth and Qualifications: Not applicable as there's no diagnostic test set with ground truth established by experts.
Adjudication Method: Not applicable.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks.
Standalone (Algorithm Only) Performance: Not applicable. This device is a physical paste, not an algorithm.
Type of Ground Truth Used: Not applicable. No diagnostic ground truth mentioned.
Sample Size for the Training Set: Not applicable. This device is not an AI algorithm that requires a training set.
How the Ground Truth for the Training Set was Established: Not applicable.

What the document does describe as "Performance Testing" includes:

Bench Testing:
- Evaluations: Relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution, and swelling.
- Purpose: To verify handling properties, characterize performance over a range of temperatures, and evaluate dissolution properties.
- Results: Stated as demonstrating substantial equivalence to predicate devices, but no quantitative acceptance criteria or specific results are provided.
Biocompatibility Testing:
- Evaluations: Irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity, and pyrogenicity.
- Standards: Conducted in accordance with ISO 10993 and GLP requirements.
- Results: Stated as demonstrating substantial equivalence.
Animal Testing:
- Purpose: To demonstrate intraoperative in vivo hemostasis and resistance to irrigation.
- Results: Stated as demonstrating substantial equivalence.
Sterility:
- Validation: Gamma sterilization process validated to provide a SAL (Sterility Assurance Level) of 10^-6.
- Lot Release: Each lot tested for bacterial endotoxin.

In summary, the provided FDA 510(k) letter and summary are for a physical medical device (hemostatic bone paste) and demonstrate substantial equivalence based on similar intended use, technological characteristics, and general performance testing (bench, biocompatibility, animal studies). It does not contain the detailed diagnostic performance metrics, acceptance criteria, or study designs typically requested for AI/diagnostic devices.

Summary

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July 11, 2023

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

Orthocon, Inc. % Howard Schrayer Consultant Orthocon. Inc 700 Fairfield Ave - Suite 1 Stamford. CT 06902

Re: K231386

Trade/Device Name: Montage XRO Settable, Resorbable Hemostatic Bone Paste Regulatory Class: Unclassified Product Code: MTJ Dated: May 12, 2023 Received: May 12, 2023

Dear Howard 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

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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-reportingcombination-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).

Sincerelv.

Jesse Muir -S

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

510(k) Number (if known) K231386

Device Name

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste

Indications for Use (Describe)

Montage Flowable XRO Settable Hemostatic Bone Paste 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)
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X 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.700 Fairfield Avenue - Suite 1Stamford, CT 06902 USATelephone: 609-273-7350hs.ss@lucidmedical.net
Date Prepared:	May 12, 2023
Device Trade Name:	Montage Flowable XRO Settable, ResorbableHemostatic Bone Paste
Manufacturer:	Orthocon, Inc.700 Fairfield Avenue - Suite 1Stamford, CT 06902 USA
Common Name:	Calcium phosphate bone hemostasis material
Classification:	Unclassified
Product Code:	MTJ
Predicate Devices:Primary Predicate:	Orthocon, Inc.HBP6 Settable, Resorbable Hemostatic Bone Putty510(k) K193052
Reference Device:	Synthes, Inc.Norian® XR (Extra Radiopaque) Calcium PhosphateBone Void Filler510(k) K023862

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Indications for Use:

Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste is indicated for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

Device Description:

Substantial Equivalence and Predicate Devices:

The device was shown to be substantially equivalent to the previously cleared, predicate, HBP6 Settable, Resorbable Hemostatic Bone Putty (K193052).

The following table shows comparisons of the several characteristics of Montage Flowable XRO Settable, Resorbable Bone Paste and the primary predicate device. The differences noted in the table below do not impact substantial equivalence.

Manufacturer	Orthocon, Inc.Predicate Device	Orthocon, Inc.Subject Device
Trade Name	HBP6 Settable, ResorbableHemostatic Bone Paste	Montage Flowable XRO Settable,Resorbable Hemostatic Bone Paste
510(k) Number	K193052	TBD
Type of Device/Product Code	Bone wax / MTJ	Bone wax / MTJ
	HBP6 Settable, Resorbable	Montage Flowable XRO Settable,
Indications for Use	HBP6 Settable, ResorbableHemostatic Bone Paste is indicatedin the control of bleeding from cut ordamaged bone by acting as amechanical barrier ortamponade	Resorbable Hemostatic Bone Pasteis indicated in the control ofbleeding from cut or damaged boneby acting as a mechanical barrier ortamponade
Intended Use	Bone hemostasis	Bone hemostasis
Mechanism ofAction	Mechanical tamponade thatoccludes vascular openings indamaged bone	Mechanical tamponade thatoccludes vascular openings indamaged bone
Form of Device	HBP6 Settable, ResorbableHemostatic Bone Paste isformulated as a two-partpaste/paste device that forms a"settable" (hardening) paste whenmixed at the time of surgery.	Montage Flowable XRO Settable,Resorbable Hemostatic BonePaste is formulated as a two-partpaste/paste device that forms a"settable" (hardening) paste whenmixed at the time of surgery.
Radiopacity	Radiopaque – Containshydroxyapatite and β-tricalciumphosphate	Radiopaque – Containshydroxyapatite, ß-tricalciumphosphate and barium sulfate
Composition	Sterile mixture of two separatecomponents of paste-likeconsistency comprised of granularcalcium phosphate,(hydroxyapatite and β- tricalciumphosphate), calcium stearate,vitamin E acetate, triacetin, 1,4-butanediol, triethanolamine and amixture of a lactide-diester andpolyester-based (lactide andcaprolactone) absorbablepolymers.HBP6 is to be mixed immediatelyprior to use. Resulting settabledevice from the two pastes isprimarily comprised of calciumphosphate similar to themineral phase of native bone tissue.	Sterile mixture of two separatecomponents of paste-likeconsistency comprised of granularcalcium phosphate,(hydroxyapatite and ß-tricalciumphosphate), calcium stearate,vitamin E acetate, triacetin, 1,4-butanediol, triethanolamine, amixture of a lactide-diester andpolyester-based (lactide andcaprolactone) absorbablepolymers and barium sulfate.Montage Flowable XRO is to bemixed immediately prior to use.Resulting settable device from thetwo pastes is primarily comprisedof calcium phosphate similar to themineral phase of native bonetissue.
Resorbable	Yes	Yes

Resorption Time	Greater than 30 days primarily dueto presence of calcium phosphate.	Greater than 30 days primarily dueto presence of calcium phosphate
Method ofApplication	Manually applied with deliveryinstrument and spread onto bonetissue	Manually applied with deliveryinstrument and spread onto bonetissue
DegradationProcess	The non-calcium salt and non-polymeric components degrade viadissolution; the polymer degradesvia hydrolysis and calcium saltsdegrade via chemical dissolutionand/or cellular removal	The non-calcium salt and non-polymeric components degrade viadissolution; the polymer degradesvia hydrolysis and the calciumsalts and barium sulfate degradevia chemical dissolution and/orcellular removal
Sterility	Provided sterile for single use bygamma irradiation	Provided sterile for single use bygamma irradiation
MRI Safety	Device is safe in the MRIenvironment	Device is safe in the MRIenvironment

Predicate Comparison Table

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Performance Testing:

Bench testing, biocompatibility and animal functionality testing performed on the predicate and Montage Flowable XRO Settable, Resorbable Hemostatic Bone Paste 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 over a range of temperatures and to evaluate the device's dissolution properties. The following evaluations 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, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.

Animal Testing included studies to demonstrate intraoperative in vivo hemostasis and resistance to irrigation.

Sterilitv

The gamma sterilization process has been validated to provide a SAL of 10-6. Each lot of finished devices is tested for bacterial endotoxin for lot release.

Conclusion

Montage Flowable XRO is substantially equivalent to the predicate HBP6 Settable Hemostatic Bone Putty and previously cleared bone hemostasis devices with respect to intended use, general technological characteristics and performance.

Regulation Number and Section

N/A