(79 days)
No
The device description and performance studies focus on the material properties and mechanical function of the bone putty, with no mention of AI or ML.
Yes
The device is described as a 'Hemostatic Bone Putty' indicated for 'control of bleeding from cut or damaged bone by acting as a mechanical barrier or tamponade'. This function, addressing a physical condition (bleeding) and contributing to healing or amelioration, classifies it as a therapeutic device.
No
The device is described as a hemostatic bone putty intended for controlling bleeding by acting as a mechanical barrier. It does not perform diagnostic functions such as detecting, monitoring, or predicting diseases.
No
The device description clearly states it is a physical material (putty) comprised of various chemical components, not software.
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 cut or damaged bone by acting as a mechanical barrier. This is a direct therapeutic action on the patient's body.
- Device Description: The device is a material applied directly to bone surfaces. It functions as a physical barrier.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) for a therapeutic purpose.
N/A
Intended Use / Indications for Use
MONTAGE-QS 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.
Product codes (comma separated list FDA assigned to the subject device)
MTJ
Device Description
MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-QS device contains two separate components of putty-like consistency comprised of 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-QS device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. MONTAGE-QS must be mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone. MONTAGE-QS 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
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 MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to the predicate device in intended use, technological characteristics, and performance.
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 bench studies 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: cvtotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.
Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, local tissue response and to characterize resorption time.
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.
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, there is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below.
July 18. 2019
Orthocon, Inc. Howard Schrayer Official Correspondent 1 Bridge Street, Suite 121 Irvington, New York 10533
Re: K191140
Trade/Device Name: MONTAGE-QS Settable, Resorbable Hemostatic Bone, HBP5, Montage Rapid Set (RS) and Montage Fast Set (FS) Regulatory Class: Unclassified Product Code: MTJ Dated: April 29, 2019 Received: April 30, 2019
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 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,
Nina Mezu-Nwaba, PharmD., MPH. MSC. CAPT USPHS Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices 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) K191140
Device Name
MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty
Indications for Use (Describe)
MONTAGE-QS 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.
| 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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3
510(k) Summary
| Contact: | Howard Schrayer
Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533
Telephone: 914-357-2600
Fax: 914-231-7884
hs.ss@verizon.net |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | June 25, 2019 |
| Device Trade Name: | MONTAGE-QS Settable, Resorbable Hemostatic Bone
Putty |
| Manufacturer: | Orthocon, Inc.
1 Bridge Street, Suite 121
Irvington, NY 10533 |
| Common Name: | Bone Wax |
| Classification: | Unclassified |
| Product Code: | MTJ |
| Predicate Devices
Primary Predicate: | Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic
Bone Putty
510(k) K152005 |
| Reference Device: | Orthocon, Inc. HBP4 Hardening, Resorbable Hemostatic Bone
Putty
510(k) K141502 |
4
Indications for Use:
MONTAGE-QS 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.
Device Description:
MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty is a sterile. biocompatible, resorbable material of putty-like consistency for use in the control of bleeding from bone surfaces. The single use MONTAGE-QS device contains two separate components of putty-like consistency comprised of 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-QS device form a resorbable putty-like material that can be applied directly to bleeding bone. The resulting material is primarily comprised of calcium phosphate. MONTAGE-QS must be mixed immediately prior to use.
When applied to surgically cut or traumatically broken bone. MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty 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 bone hemostasis predicate device, Montage Settable, Resorbable Hemostatic Bone Putty (K152005).
Performance Testing:
Bench testing, biocompatibility and animal functionality testing performed on MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty demonstrate that the device is substantially equivalent to the predicate device 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 bench studies were completed: relative stiffness, spreadability, stickiness, temperature sensitivity, electrocautery compatibility, dissolution and swelling.
5
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: cvtotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity, implantation, systemic toxicity, hemolysis, endotoxicity and pyrogenicity.
Animal Testing included animal studies to demonstrate intraoperative in vivo hemostasis, resistance to irrigation, local tissue response and to characterize resorption time.
Technological Characteristics of MONTAGE-QS and the predicate Orthocon, Inc. MONTAGE Settable, Resorbable Hemostatic Bone Putty are nearly identical. MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty and the referenced predicate use similar configurations and formulations (i.e., two putty materials that are mixed together at the time of use, including a calcium salt and other resorbable materials for ease of application). Both function by the same principle (i.e., mechanical tamponade). MONTAGE-QS Settable, Resorbable Hemostatic Bone Putty and the predicate are formulated from the same materials with a single exception (that accelerates setting time). Both are primarily comprised (~70% by weight) of calcium phosphate: and rely on a reaction between two packaged components to produce a putty that hardens in situ. These devices are resorbable devices provided sterile by gamma irradiation.
The constituents of the MONTAGE-QS Settable. Resorbable Hemostatic Bone Putty device and the predicate device formulations have been shown to be as safe as the predicate device for the intended use. The devices are provided in packages designed for individual patient use.
Conclusion
MONTAGE-QS is substantially equivalent to the previously cleared bone wax predicate device [Montage Settable, Resorbable Hemostatic Bone Putty (K152005)] with respect to intended use, general technological characteristics and performance.