(6 days)
Not Found
No
The device description and intended use focus on the material properties and mechanical function of a bone putty, with no mention of AI or ML capabilities.
Yes
The device is described as a medical material used in surgery and has an intended use for stopping bleeding and filling voids, which directly contributes to the treatment and recovery of patients.
No
The device is a bone putty used to control bleeding and fill voids, serving a therapeutic and supportive function, not a diagnostic one.
No
The device description clearly states it is a "sterile, biocompatible, resorbable material" with a "putty-like consistency" composed of various chemical components. This describes a physical material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for use on the sternum in cardiothoracic surgery to control bleeding, fill voids, and augment hardware. This is a direct application to the patient's body during surgery.
- Device Description: The description details a material that is applied to the bone surface and hardens in situ. This is a physical interaction with the patient's tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not involve the analysis of any biological specimens.
The device described is a surgical implant/material used directly on the patient during a procedure.
N/A
Intended Use / Indications for Use
Montage-XT Settable Bone Putty is indicated for use on the sternum in cardiothoracic surgery following sternotomy to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, as well as to fill bony voids or gaps in the sternum. When hardened in situ, Montage-XT may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.
Product codes
MTJ, MQV, OIS
Device Description
MONTAGE-XT Settable Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy and filling bony voids or gaps in the sternum. The MONTAGE-XT 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 polyesterbased polymers. When mixed together, the components of the MONTAGE-XT device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. MONTAGE-XT components must be mixed immediately prior to use. The device serves multiple clinical functions simultaneously that are integral to recovery after cardiac surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
sternum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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)
All the pre-clinical, and clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device.
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.
K242050, K233566, K232998, K220315
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.
Not Found
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
§ 888.3045 Resorbable calcium salt bone void filler device.
(a)
Identification. A resorbable calcium salt bone void filler device is a resorbable implant intended to fill bony voids or gaps of the extremities, spine, and pelvis that are caused by trauma or surgery and are not intrinsic to the stability of the bony structure.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA.” See § 888.1(e) of this chapter for the availability of this guidance.
0
November 18, 2024
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
Orthocon Inc. % Mehdi Kazemzadeh-Narbat, PhD Director, Regulatory Affairs MCRA. LLC 803 7th Street NW, Floor 3 Washington, District of Columbia 20001
Re: K243506
Trade/Device Name: Montage-XT Settable Bone Putty Regulatory Class: Unclassified Product Code: MTJ, MQV, OIS Dated: November 11, 2024 Received: November 12, 2024
Dear Dr. Kazemzadeh-Narbat:
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 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).
2
Sincerely, Digitally signed by TESSE JESSE MUIR -S MUIR-S Date: 2024.11.18 15:54:55 -05'00'
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
3
Indications for Use
Submission Number (if known)
K243506
Device Name
Montage-XT Settable Bone Putty
Indications for Use (Describe)
Montage-XT Settable Bone Putty is indicated for use on the sternum in cardiothoracic surgery following sternotomy to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, as well as to fill bony voids or gaps in the sternum. When hardened in situ. Montage-XT may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.
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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4
510(k) Summary
| Manufacturer: | Orthocon, Inc.
700 Fairfield Avenue, Suite 1
Stamford, CT 06902
Phone: 855.475.9175 |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mehdi Kazemzadeh-Narbat, PhD
Director, Regulatory Affairs
803 7th Street NW, Floor 3
Washington, DC 20001
Office: 202.552.6011
Email: mkazemzadeh@mcra.com |
| Prepared By: | MCRA LLC
Mehdi Kazemzadeh-Narbat
Director, Regulatory Affairs
803 7th Street NW, Floor 3
Washington, DC 20001
Office: 202.552.6011
Email: mkazemzadeh@mcra.com |
| Date Prepared: | November 11, 2024 |
| Device Trade Name: | Montage-XT Settable Bone Putty |
| Device Common Name: | Resorbable calcium salt bone void filler device |
| Classification: | 21 CFR 888.3045
Class II |
| Product Codes: | MOV, OIS, MTI |
Indications for Use:
Montage-XT Settable Bone Putty is indicated for use on the sternum in cardiothoracic surgery following sternotomy to control bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade, as well as to fill bony voids or gaps in the sternum. When hardened in situ, Montage-XT may be used on the sternum to augment hardware to help support bone during the cardiothoracic surgical procedure.
5
Primary Predicate Device:
Orthocon, Inc. MONTAGE Settable Bone Putty 510(k) K242050
Additional Predicate Devices:
Orthocon, Inc. MONTAGE-XT Settable, Resorbable Bone Putty 510(k) K233566
Orthocon. Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K232998
Orthocon, Inc. MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty 510(k) K220315
Device Description:
MONTAGE-XT Settable Bone Putty is a sterile, biocompatible, resorbable material for use in the control of bleeding from bone surfaces in cardiothoracic surgery following sternotomy and filling bony voids or gaps in the sternum. The MONTAGE-XT 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 polyesterbased polymers. When mixed together, the components of the MONTAGE-XT device form a cohesive putty-like material that adheres to the bone surface and remains in place following application. The resulting hardened material is primarily calcium phosphate. MONTAGE-XT components must be mixed immediately prior to use. The device serves multiple clinical functions simultaneously that are integral to recovery after cardiac surgery.
Purpose of this Submission:
The purpose of this Special 510(k) is to consolidate the Montage-XT Settable Bone Putty's indications for use (i.e., hemostasis, augmentation of cerclage wire stabilization/closure, and bone void filler) into a single indications for use statement (IFUS).
Substantial Equivalence and Predicate Devices:
The subject device is identical to its predicates in terms of materials, manufacturing process, sterilization, and packaging process. There is no difference between the subject device and the predicates. All the pre-clinical, and clinical testing conducted to support the previous 510(k) clearances are applicable to the subject device. The only modification proposed in this Special 510(k) is the consolidation of Indications for Use of previous 510(k) clearances.
Conclusion:
Montage-XT Settable Bone Putty is substantially equivalent to its predicate with respect to intended use, technological characteristics, and performance,