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).

AI/ML Overview

The medical device in question is the MONTAGE™ Settable, Resorbable Hemostatic Bone Putty.

This device is a bone hemostat intended for the control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade.

1. A table of acceptance criteria and the reported device performance

The provided document describes the MONTAGE device as substantially equivalent to a predicate device, Orthocon HBP4 Hardening, Resorbable Hemostatic Bone Putty (K141502). The acceptance criteria are therefore implicitly aligned with demonstrating this substantial equivalence. The document does not list specific numerical acceptance criteria with corresponding performance values for the MONTAGE device itself, but rather states that it is "exactly the same device" as the predicate, with the only difference being the packaging configuration. Therefore, the performance criteria and results are based on the predicate device.

Acceptance Criteria Category	Predicate Device Performance / Evidence for MONTAGE
Intended Use	MONTAGE has the same indicated intended use as the predicate: "control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade."
Technological Characteristics	The document states MONTAGE is "exactly the same device" with the same materials (granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, a polyalcohol and a mixture of a lactide-diester and polyester-based polymers), radiopacity, resorbability, resorption time (>30 days), method of application, intended use (bone hemostasis), degradation process (dissolution, hydrolysis, cellular removal), mechanism of action (mechanical tamponade), sterility (gamma irradiation), and form of device (two-part settable putty).
Bench Testing	Testing performed on the predicate HBP4™ demonstrated acceptable handling properties (relative stiffness, spreadability, stickiness), temperature sensitivity, electrocautery compatibility, dissolution, and swelling. Since MONTAGE has the identical formulation, these results are considered relevant for MONTAGE.
Biocompatibility	Testing performed on the predicate HBP4™ met ISO 10993 recommendations for irritation, sensitization, acute systemic toxicity, implantation, subacute systemic toxicity, chronic systemic toxicity, hemolysis, endotoxicity, and pyrogenicity. Since MONTAGE has the identical formulation and sterilization method (gamma irradiation), these results are considered relevant for MONTAGE.
Animal Functionality Testing	Animal studies performed on the predicate HBP4™ demonstrated intraoperative in vivo hemostasis, resistance to irrigation, and characterized resorption time. Since MONTAGE has the identical formulation, these results are considered relevant for MONTAGE.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes for the bench, biocompatibility, or animal studies conducted on the predicate device.

Bench Testing: No specific sample sizes mentioned.
Biocompatibility Testing: No specific sample sizes mentioned. Conducted in accordance with GLP requirements.
Animal Testing: No specific sample sizes mentioned.

The data provenance is not specified regarding the country of origin. The studies appear to be prospective in nature, as they were conducted to evaluate the predicate device's safety and performance for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The studies mentioned (bench, biocompatibility, animal) typically involve laboratory testing and observation rather than expert ground truth establishment for a diagnostic output.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided in the document. The studies described are not clinical trials requiring adjudication of outcomes by multiple experts.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable and therefore not provided. The device is a bone hemostat, not an AI-powered diagnostic tool, so MRMC studies and AI assistance metrics are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable and therefore not provided. The device is a physical medical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The concept of "ground truth" as typically applied to diagnostic algorithms is not directly applicable here. Instead, the studies focused on:

Bench Testing: Engineering measurements and physical property characterization.
Biocompatibility: Standardized biological assays and histological evaluations.
Animal Testing: In vivo observations of hemostasis, resistance to irrigation, and histological assessment of resorption.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical product, not an algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided. As stated above, the device does not involve a training set for an algorithm.

Summary

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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)

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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

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INDICATIONS FOR USE

	DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration	Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See 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)
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510(k) Summary

Contact:	Howard SchrayerOrthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533Telephone: 914-357-2600Fax: 914-231-7884hs.ss@verizon.net
Date Prepared:	July 17, 2015
Device Trade Name:	MONTAGETM Settable, Resorbable Hemostatic Bone Putty
Manufacturer:	Orthocon, Inc.1 Bridge Street, Suite 121Irvington, NY 10533
Common Name:	Calcium phosphate bone hemostasis material
Classification:	Unclassified
Product Code:	MTJ
Primary Predicate:	HBP4TM Hardening, Resorbable Hemostatic Bone Putty510(k) K141502

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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:

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).

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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 BonePutty	HBP4 Hardening, ResorbableHemostatic 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 BonePutty is indicated in thecontrol of bleeding from cut ordamaged bone by acting as amechanical barrier ortamponade	HBP4 Hardening, ResorbableHemostatic Bone Putty isindicated in the control ofbleeding from cut or damagedbone by acting as amechanical barrier ortamponade	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 ofAction	Mechanical tamponade thatoccludes vascular openings indamaged bone	Mechanical tamponade thatoccludes vascular openings indamaged 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 BonePutty is formulated as a two-part putty/putty device thatforms a "settable" (hardening)putty when manually mixed atthe time of surgery.	HBP4 Hardening, ResorbableHemostatic Bone Putty isformulated as a two-partputty/putty device that forms a"settable" (hardening) puttywhen manually mixed at thetime of surgery.

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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.

Regulation Number and Section

N/A