(158 days)
No
The 510(k) summary describes a bone paste material and its physical properties and performance in laboratory and animal studies. There is no mention of AI or ML technology in the device description, intended use, or performance studies.
No
The device is a bone paste used for the repair of cranial defects, which is a restorative rather than a therapeutic function.
No
This device is a bone paste used for repairing cranial defects, which is a therapeutic function, not diagnostic.
No
The device description clearly states it is a "sterile, biocompatible, resorbable material" comprising two physical components that are mixed together to form a "cohesive putty-like material." This describes a physical substance, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description and Intended Use: The description and intended use of the Orthocon Montage Flowable Settable Bone Paste clearly state that it is a material used for the repair of bone defects within the human body (in vivo). It is a physical material implanted to help bone heal, not a test performed on a sample outside the body.
Therefore, based on the provided information, the Orthocon Montage Flowable Settable Bone Paste is a medical device used for surgical repair, not an In Vitro Diagnostic.
N/A
Intended 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.
Product codes
GXP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
neurosurgical burr holes, contiguous craniotomy cuts, cranial defects
Indicated Patient Age Range
skeletally mature individuals
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Bench Testing:
- Visual Inspection: Evaluated paste color using a reference scale. Conclusions: Paste color met specification.
- Paste Stiffness: Evaluated paste stiffness using a reference scale. Conclusions: Paste stiffness met specification.
- Package Leak Test: Bubble emission leak test. Conclusions: All test articles passed.
- Temperature Sensitivity: Acceptable maximum temperature increase observed. Conclusions: Acceptable maximum temperature increase observed.
- Water Uptake, Swelling and Dissolution: Measured volume and mass changes over time. Conclusions: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K193052, K231270, K221933, K191140, K231903
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
February 16, 2024
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. The FDA logo is on the right, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The logos are placed side by side.
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).
1
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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
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)
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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
4
510(k) SUMMARY (Per 21 CFR 807.92)
General Company Information
| Name: | Orthocon, Inc. |
|---|---|
| Contact: | Howard Schrayer |
| Regulatory Affairs Consultant | |
| Address: | 700 Fairfield Avenue, Suite 1 |
| Stamford, 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 II |
| GXP | |
| 21 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 Paste |
| Montage® 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 repair | |
| of neurosurgical burr holes, | |
| contiguous craniotomy cuts and other | |
| cranial defects with a surface area no | |
| larger than 25cm². | Stryker® Injectable Cement is intended for |
| use in the repair of neurosurgical burr | |
| holes, contiguous craniotomy cuts and | |
| other cranial defects. | |
| At the time of application, device is in | |
| the form of a paste-like material | At the time of application, device is in the |
| form of a paste-like material | |
| Device is designed to be applied to the | |
| cranial defect with a manually operated | |
| dispenser | Device is designed to be applied to the |
| cranial defect with a manually operated | |
| dispenser | |
| Montage Flowable Settable, | |
| Resorbable Bone Paste is formulated | |
| as a two-part paste/paste device that | |
| forms a "settable" (hardening) material | |
| when mixed at the time of surgery | Stryker Injectable cement is formulated as a |
| two-part powder/liquid device that forms a | |
| "settable" (hardening) material when mixed | |
| at the time of surgery | |
| 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, | |
| polyalcohols and a mixture of a lactide- | |
| diester and polyester-based (lactide | |
| and caprolactone) absorbable | |
| polymers. Montage Flowable is to be | Sterile mixture of two separate components, |
| a powder comprised of dicalcium | |
| phosphate dihydrate, tetracalcium | |
| phosphate and tri-sodium citrate; and a | |
| liquid comprised of sodium phosphate, | |
| polyvinylpyrrolidone and water. Stryker | |
| Injectable Cement is to be manually mixed | |
| immediately prior to use. Resulting settable | |
| material from the two components is | |
| primarily comprised of calcium phosphate. |
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
5
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
6
| mixed immediately prior to use.
Resulting settable material from the two
putties is primarily comprised of
| calcium phosphate. | |
|---|---|
| Implanted device is resorbable in | |
| greater than 30 days primarily due to | |
| presence of calcium phosphate. | Implanted device is resorbable in greater |
| than 30 days primarily due to presence of | |
| calcium phosphate. | |
| Single-patient-use device is provided | |
| sterile by gamma irradiation | Single-patient-use device is provided sterile |
| by gamma irradiation and ethylene oxide | |
| The bone putty is available in | |
| individual and/or multi-pack patient | |
| use sizes of up to 8cc. | The device is available in individual; and/or |
| multi-pack patient use sizes of 3, 5, 10 and | |
| 15cc. | |
| The paste is provided in a dual-barrel | |
| cartridge within a single outer foil | |
| pouch. The outer foil pouch contains | |
| a desiccant. The pouch is heat sealed | |
| and sterilized. | Each kit contains one liquid-filled glass |
| syringe and one plastic bowl of powder | |
| packaged within a double pre-formed tray | |
| with a Tyvek lid. | |
| Mixing for homogeneity is immediate | Mixing for homogeneity takes 45 sec. |
| Material is settable within 10 minutes | |
| of application | Material is settable within 10 minutes of |
| application | |
| Material provides a working time of 5 | |
| minutes. | Material provides a working time of 5 |
| minutes. | |
| Device cures with no appreciable | |
| exothermic reaction | Device cures with no appreciable |
| exothermic 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.
7
Bench Testing
| Test | Description | Conclusions |
|---|---|---|
| Visual Inspection | Evaluated paste color | |
| using a reference scale | Paste color | |
| met specification | ||
| Paste Stiffness | Evaluated paste stiffness | |
| using a reference scale | Paste stiffness met | |
| specification | ||
| Package Leak Test | Bubble emission leak test | All test articles passed |
| Temperature | ||
| Sensitivity | Acceptable maximum temperature | |
| increase observed | Acceptable maximum | |
| temperature increase observed | ||
| Water Uptake, | ||
| Swelling | ||
| and Dissolution | Measured volume and mass | |
| changes 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.