(679 days)
No
The description focuses on the material composition and mechanical function of the bone putty, with no mention of AI or ML.
No
The device is described as a hemostatic bone putty used for controlling bleeding by acting as a mechanical barrier. It does not appear to treat a disease or condition, but rather assists in a surgical or traumatic injury scenario.
No
The device is a hemostatic bone putty used to control bleeding during surgical procedures and from traumatic injuries, acting as a mechanical barrier. It does not perform any diagnostic function.
No
The device description clearly states it is a physical material (putty) composed of various chemical components, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to control bleeding from bone surfaces by acting as a mechanical barrier. This is a direct therapeutic action on the body.
- Device Description: The device is a material applied to the bone surface. It does not analyze samples from the body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, measure a substance in the body, or provide information about a patient's health status based on in vitro analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely mechanical and therapeutic.
N/A
Intended Use / 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. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The MONTAGE device comprises two separate components of putty-like consistency containing 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 following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty 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
surgical procedures, treating traumatic injuries, cardiothoracic surgery
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)
Studies have been conducted which demonstrate that Montage can achieve hemostasis and allows for acceptable bone remodeling. Montage has been previously tested to demonstrate biocompatibility through an appropriate series of studies as required for compliance with ISO 10993. Montage has been evaluated for handling characteristics and shelf-life / stability. Each lot is evaluated for endotoxicity. The device is provided sterile with a Sterility Assurance Level (SAL) of 106. The studies demonstrate that the pre-established performance criteria were met using the well-established internal protocols.
A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures.
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.
MONTAGE Settable, Resorbable Hemostatic Bone Putty 510(k) K152005
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.
Hemasorb Resorbable Hemostatic Bone Putty 510(k) K111575
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
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 30, 2023
Orthocon, Inc. Howard Schrayer Official Correspondent 1 Bridge Street. Suite 121 Irvington, New York 10533
Re: K213418
Trade/Device Name: MONTAGE Settable, Resorbable Hemostatic Bone Putty Regulation Number: 21 CFR Regulation Name: Regulatory Class: Class II Product Code: MTJ Dated: October 19, 2021 Received: October 20, 2021
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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).
Sincerely.
David Krause -S
David Krause, Ph.D. Deputy Director OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213418
Device Name
MONTAGE 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. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
| 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 Schrayer
Orthocon, Inc.
700 Fairfield Avenue, Suite 1
Stamford, CT 06902
hs.ss@lucidmedical.net |
|----------------------|--------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | August 29, 2023 |
| Device Trade Name: | MONTAGE™ Settable, Resorbable Hemostatic Bone Putty |
| Manufacturer: | Orthocon, Inc.
700 Fairfield Avenue, Suite 1
Stamford, CT 06902 |
| Telephone: | (855) 475 - 9175 |
| Common Name: | Calcium phosphate bone hemostasis material |
| Classification: | Unclassified |
| Product Code: | MTJ |
| Primary Predicate: | MONTAGE Settable, Resorbable Hemostatic Bone Putty
510(k) K152005 |
| Reference Predicate: | Hemasorb Resorbable Hemostatic Bone Putty
510(k) K111575 |
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. The material may be used during surgical procedures and in treating traumatic injuries. MONTAGE is also indicated for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy.
4
Device Description:
MONTAGE Settable. Resorbable Hemostatic Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces. The MONTAGE device comprises two separate components of putty-like consistency containing 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 following application. The resulting hardened, resorbable material is primarily calcium phosphate. MONTAGE components must be mixed immediately prior to use. When applied to surgically cut or traumatically broken bone, MONTAGE Settable, Resorbable Hemostatic Bone Putty achieves local control of bleeding by acting as a mechanical barrier (tamponade).
Substantial Equivalence and Predicate Device:
The subject device is exactly the same device and is substantially equivalent to its previously cleared predicate and to the Hemasorb reference predicate. The only difference between the subject device and its predicate is the addition of a statement regarding the use of the device in sternotomy procedures.
Technological Characteristics:
The technological characteristics of the devices are unchanged. The only change is the addition of a statement regarding the use of the devices in sternotomy procedures.
Performance Testing:
Studies have been conducted which demonstrate that Montage can achieve hemostasis and allows for acceptable bone remodeling. Montage has been previously tested to demonstrate biocompatibility through an appropriate series of studies as required for compliance with ISO 10993. Montage has been evaluated for handling characteristics and shelf-life / stability. Each lot is evaluated for endotoxicity. The device is provided sterile with a Sterility Assurance Level (SAL) of 106. The studies demonstrate that the pre-established performance criteria were met using the well-established internal protocols.
Clinical Testing
A human clinical evaluation was conducted that supports the use of Montage during sternotomy procedures.
Conclusion
The subject device is substantially equivalent to the above-referenced (previously cleared) predicate devices with respect to intended use, general technological characteristics and performance.