Orthocon Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous cranial defects with a surface area no larger than 25cm2. Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.

Device Description

Montage Flowable Settable, Resorbable Bone Paste is a sterile, biocompatible, resorbable material for use in repair of cranial defects. The Montage Flowable device comprises two separate components of putty consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together, the components of the Montage Flowable device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. Montage Flowable components must be mixed immediately prior to use.

AI/ML Overview

The provided document is a 510(k) summary for the Orthocon Montage Flowable Settable, Resorbable Bone Paste. This document is a premarket notification for a medical device and is not a study proving the device meets acceptance criteria for an AI/ML-based medical device.

The document discusses:

The device's name, regulation, and product code.
Its intended use (repair of neurosurgical burr holes, cranial defects).
Comparisons of technological characteristics with a predicate device (Stryker HydroSet Injectable Cement).
Biocompatibility and performance testing (bench testing and in-vivo animal testing).
A clear statement that no clinical studies have been conducted in support of this 510(k).

Therefore, the requested information about acceptance criteria and a study proving device performance for an AI/ML-based medical device cannot be extracted from this document, as it pertains to a different type of medical device (a bone paste) and the regulatory submission is not based on AI/ML performance.

To answer your prompt, I would need a document describing the regulatory submission for an AI/ML-based medical device, which would typically include detailed information on clinical performance studies, ground truth establishment, expert adjudication, and sample sizes for training and test sets.

Summary

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February 16, 2024

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Orthocon, Inc. Howard Schrayer Regulatory Consultant 8 Lookout Hilton Head Island, South Carolina 29928

Re: K232771

Trade/Device Name: Montage Flowable Settable, Resorbable Bone Paste Regulation Number: 21 CFR 882.5300 Regulation Name: Methyl Methacrylate For Cranioplasty Regulatory Class: Class II Product Code: GXP Dated: January 16, 2024 Received: January 16, 2024

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 (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).

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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 product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS 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 (QS) 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).

Image /page/1/Picture/5 description: The image shows a digital signature. The signature is for Adam D. Pierce -S. The date of the signature is 2024.02.16 and the time is 14:38:47 -05'00'.

Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices

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Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K232771

Device Name

Montage Flowable Settable, Resorbable Bone Paste

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 (Per 21 CFR 807.92)

General Company Information

Name:	Orthocon, Inc.
Contact:	Howard SchrayerRegulatory Affairs Consultant
Address:	700 Fairfield Avenue, Suite 1Stamford, CT 06902
Telephone:	(855) 475 - 9175
Date Prepared	February 14, 2024
General Device Information
Product Name:	Montage Flowable™ Settable Resorbable Bone Paste
Common Name:	Calcium Phosphate Cement
Classification:Product codes:Regulation:	Class IIGXP21 CFR 882.5300
Predicate Devices:Primary Predicate:Stryker	HydroSet Injectable Cement[510(k) Number K060763]
Reference Devices:
Orthocon, Inc.	HBP6 Flowable Settable, Resorbable Hemostatic Bone PasteMontage® Flowable Settable, Resorbable Bone Paste[510(k) Number K193052 and K231270]
Orthocon, Inc.	Montage® Settable, Resorbable Bone Putty[510(k) Number K221933]
Orthocon, Inc.	Montage-QS Settable, Resorbable Bone Putty[510(k) Number K191140 and K231903]
Device is intended for use in the repairof neurosurgical burr holes,contiguous craniotomy cuts and othercranial defects with a surface area nolarger than 25cm².	Stryker® Injectable Cement is intended foruse in the repair of neurosurgical burrholes, contiguous craniotomy cuts andother cranial defects.
At the time of application, device is inthe form of a paste-like material	At the time of application, device is in theform of a paste-like material
Device is designed to be applied to thecranial defect with a manually operateddispenser	Device is designed to be applied to thecranial defect with a manually operateddispenser
Montage Flowable Settable,Resorbable Bone Paste is formulatedas a two-part paste/paste device thatforms a "settable" (hardening) materialwhen mixed at the time of surgery	Stryker Injectable cement is formulated as atwo-part powder/liquid device that forms a"settable" (hardening) material when mixedat the time of surgery
Sterile mixture of two separatecomponents of putty-like consistencycomprised of granular calciumphosphate, (hydroxyapatite and β-tricalcium phosphate), calciumstearate, vitamin E acetate, triacetin,polyalcohols and a mixture of a lactide-diester and polyester-based (lactideand caprolactone) absorbablepolymers. Montage Flowable is to be	Sterile mixture of two separate components,a powder comprised of dicalciumphosphate dihydrate, tetracalciumphosphate and tri-sodium citrate; and aliquid comprised of sodium phosphate,polyvinylpyrrolidone and water. StrykerInjectable Cement is to be manually mixedimmediately prior to use. Resulting settablematerial from the two components isprimarily comprised of calcium phosphate.

Device Description

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place following application. The resulting hardened, resorbable material is primarily calcium phosphate. Montage Flowable components must be mixed immediately prior to use.

Indications for Use

Orthocon Montage Flowable Settable, Resorbable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm². Montage Flowable Settable, Resorbable Bone Paste should be used only in skeletally mature individuals.

The following table shows comparisons of characteristics of Montage Flowable Settable, Resorbable Bone Paste and the predicate device.

SUBSTANTIAL EQUIVALENCE INFORMATION

Orthocon, Inc. Montage Flowable Settable, Resorbable Bone Paste 510(k) — K232771

Stryker Injectable Cement HydroSet

510(k) - K060763

Comparisons of Technological Characteristics

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mixed immediately prior to use.Resulting settable material from the twoputties is primarily comprised ofcalcium phosphate.
Implanted device is resorbable ingreater than 30 days primarily due topresence of calcium phosphate.	Implanted device is resorbable in greaterthan 30 days primarily due to presence ofcalcium phosphate.
Single-patient-use device is providedsterile by gamma irradiation	Single-patient-use device is provided sterileby gamma irradiation and ethylene oxide
The bone putty is available inindividual and/or multi-pack patientuse sizes of up to 8cc.	The device is available in individual; and/ormulti-pack patient use sizes of 3, 5, 10 and15cc.
The paste is provided in a dual-barrelcartridge within a single outer foilpouch. The outer foil pouch containsa desiccant. The pouch is heat sealedand sterilized.	Each kit contains one liquid-filled glasssyringe and one plastic bowl of powderpackaged within a double pre-formed traywith a Tyvek lid.
Mixing for homogeneity is immediate	Mixing for homogeneity takes 45 sec.
Material is settable within 10 minutesof application	Material is settable within 10 minutes ofapplication
Material provides a working time of 5minutes.	Material provides a working time of 5minutes.
Device cures with no appreciableexothermic reaction	Device cures with no appreciableexothermic reaction

Testing Completed

Biocompatibility Testing

Testing was conducted to evaluate biocompatibility in accordance with the recommendations of ISO 10993. The following biocompatibility studies were conducted on the final, finished, gamma-irradiation sterilized device and in accordance with the GLP requirements: cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity, local tissue toxicity, hemolysis, pyrogenicity and neurotoxicity.

Performance Data

Performance testing included a series of laboratory evaluations and in vivo testing. These evaluations are summarized below.

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Bench Testing

Test	Description	Conclusions
Visual Inspection	Evaluated paste colorusing a reference scale	Paste colormet specification
Paste Stiffness	Evaluated paste stiffnessusing a reference scale	Paste stiffness metspecification
Package Leak Test	Bubble emission leak test	All test articles passed
TemperatureSensitivity	Acceptable maximum temperatureincrease observed	Acceptable maximumtemperature increase observed
Water Uptake,Swellingand Dissolution	Measured volume and masschanges over time	Acceptable water uptake,swelling and dissolution

In-Vivo Testing

In-vivo animal testing was used to demonstrate substantial equivalence of Montage Flowable Settable. Resorbable Bone Paste in the repair of a critical sized cranial bone defect in an animal model compared to the predicate device. Substantial equivalence was assessed from histopathologic evaluation.

Clinical Testing

No clinical studies have been conducted in support of this 510(k).

Conclusions

This submission supports the position that Orthocon Montage Flowable Settable, Resorbable Bone Paste is substantially equivalent to the predicate device.

The information provided establishes that similar legally marketed devices, including the primary predicate, have been used for the same clinical applications as Orthocon Montage Flowable Settable, Resorbable Bone Paste and that Substantial Equivalence to the predicate device has been established. Each of the tests conducted passed the requirements as stated in the protocols and in recognized standards. The data presented demonstrate that the device is suitable for its indicated use. The materials from which the Orthocon device is fabricated have an established history of use, and the devices have been tested in accordance with applicable FDA guidelines. Any differences between Montage Flowable and the predicate do not raise new concerns or risks.

Regulation Number and Section

§ 882.5300 Methyl methacrylate for cranioplasty.

(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).