(60 days)
No
The device description and performance studies focus on the material properties and mechanical function of the bone paste, with no mention of AI or ML.
Yes
The device is indicated for the control of bleeding from cut or damaged bone, acting as a mechanical barrier or tamponade, which is a therapeutic function.
No
The device is described as a hemostatic bone paste for controlling bleeding, acting as a mechanical barrier. Its function is to treat or control bleeding, not to identify or diagnose a condition.
No
The device description clearly states it is a "sterile, biocompatible, resorbable material" comprised of various physical components (granular calcium phosphate, polymers, etc.) and delivered via a "single-use applicator (delivery device)". This indicates a physical medical device, not a software-only one.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding from bone by acting as a mechanical barrier. This is a direct therapeutic action on the body.
- Device Description: The device is a paste applied directly to bone. It is a physical material that interacts with the tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
MTJ
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bone surfaces; cut or damaged bone
Indicated Patient Age Range
Not Found
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
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
1
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
2
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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
| Contact: | Howard Schrayer
Orthocon, Inc.
700 Fairfield Avenue - Suite 1
Stamford, CT 06902 USA
Telephone: 609-273-7350
hs.ss@lucidmedical.net |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | May 12, 2023 |
| Device Trade Name: | Montage Flowable XRO Settable, Resorbable
Hemostatic Bone Paste |
| Manufacturer: | Orthocon, Inc.
700 Fairfield Avenue - Suite 1
Stamford, 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 Putty
510(k) K193052 |
| Reference Device: | Synthes, Inc.
Norian® XR (Extra Radiopaque) Calcium Phosphate
Bone Void Filler
510(k) K023862 |
4
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:
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).
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, Resorbable
Hemostatic 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, Resorbable
Hemostatic Bone Paste is indicated
in the control of bleeding from cut or
damaged bone by acting as a
mechanical barrier or
tamponade | Resorbable Hemostatic Bone Paste
is indicated in the control of
bleeding from cut or damaged bone
by acting as a mechanical barrier or
tamponade |
| Intended Use | Bone hemostasis | Bone hemostasis |
| Mechanism of
Action | Mechanical tamponade that
occludes vascular openings in
damaged bone | Mechanical tamponade that
occludes vascular openings in
damaged bone |
| Form of Device | HBP6 Settable, Resorbable
Hemostatic Bone Paste is
formulated as a two-part
paste/paste device that forms a
"settable" (hardening) paste when
mixed at the time of surgery. | Montage Flowable XRO Settable,
Resorbable Hemostatic Bone
Paste is formulated as a two-part
paste/paste device that forms a
"settable" (hardening) paste when
mixed at the time of surgery. |
| Radiopacity | Radiopaque – Contains
hydroxyapatite and β-tricalcium
phosphate | Radiopaque – Contains
hydroxyapatite, ß-tricalcium
phosphate and barium sulfate |
| Composition | Sterile mixture of two separate
components of paste-like
consistency comprised of granular
calcium phosphate,
(hydroxyapatite and β- tricalcium
phosphate), calcium stearate,
vitamin E acetate, triacetin, 1,4-
butanediol, triethanolamine and a
mixture of a lactide-diester and
polyester-based (lactide and
caprolactone) absorbable
polymers.
HBP6 is to be mixed immediately
prior to use. Resulting settable
device from the two pastes is
primarily comprised of calcium
phosphate similar to the
mineral phase of native bone tissue. | Sterile mixture of two separate
components of paste-like
consistency comprised of granular
calcium phosphate,
(hydroxyapatite and ß-tricalcium
phosphate), calcium stearate,
vitamin E acetate, triacetin, 1,4-
butanediol, triethanolamine, a
mixture of a lactide-diester and
polyester-based (lactide and
caprolactone) absorbable
polymers and barium sulfate.
Montage Flowable XRO is to be
mixed immediately prior to use.
Resulting settable device from the
two pastes is primarily comprised
of calcium phosphate similar to the
mineral phase of native bone
tissue. |
| Resorbable | Yes | Yes |
| | | |
| Resorption Time | Greater than 30 days primarily due
to presence of calcium phosphate. | Greater than 30 days primarily due
to presence of calcium phosphate |
| Method of
Application | Manually applied with delivery
instrument and spread onto bone
tissue | Manually applied with delivery
instrument and spread onto bone
tissue |
| 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 the calcium
salts and barium sulfate degrade
via chemical dissolution and/or
cellular removal |
| Sterility | Provided sterile for single use by
gamma irradiation | Provided sterile for single use by
gamma irradiation |
| MRI Safety | Device is safe in the MRI
environment | Device is safe in the MRI
environment |
Predicate Comparison Table
5
6
7
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.