(30 days)
No
The summary describes a bone graft material and its delivery system, focusing on its material composition and biological interaction. There is no mention of AI or ML technology.
Yes
The device is indicated for filling bony voids or gaps and supports bone regeneration, which is a therapeutic function.
No
Explanation: The device is a bone graft material used to fill bony voids or gaps and promote bone healing, which is a therapeutic function, not a diagnostic one.
No
The device is a bone graft material, which is a physical substance intended for implantation, not a software program.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that NovaBone MacroFORM is a bone graft device intended to be implanted directly into bony voids or gaps in the skeletal system. It is a physical material used to fill defects and promote bone healing.
- Lack of Diagnostic Function: The device does not analyze biological samples to provide diagnostic information. Its function is structural and regenerative within the body.
Therefore, NovaBone MacroFORM is a medical device used for surgical implantation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
Product codes (comma separated list FDA assigned to the subject device)
MQV
Device Description
NovaBone MacroFORM is an osteoconductive bioactive device used for grafting osseous defects. It is a composite of bioactive calcium-phospho-silicate granules and a collagen binder. The bioactive particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The collagen binder consists of bovine collagen. When mixed with bone marrow aspirate, the device forms a non-hardening graft that is applied directly to the intended graft site.
During absorption of the collagen binder, the particulate material remaining undergoes a time-dependent kinetic modification of the surface to stimulate osteoblast activity and guide the formation of bone across the graft site. Specifically, a series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. During healing, the graft particulate is absorbed and remodeled into new bone.
MacroFORM BIOACTIVE MIS is provided in an MIS Cartridge (tube) for delivery using the NovaBone MIS Cartridge Handle accessory, supplied separately. The graft formulation is identical to MacroFORM BIOACTIVE moldable composite (K140946, primary predicate). The MIS Cartridge/Handle system is equivalent to that of NovaBone Putty MIS (K112773, reference predicate).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
skeletal system (i.e. the extremities and pelvis)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
A hydration study was conducted to evaluate the amount of fluid needed to sufficiently hydrate the graft and identify the optimal setting time prior to extrusion. Test devices were prepared using various fluid amounts and setting times, and then evaluated for hydration, handling, and immersion resistance. The instructions for use were updated based on this testing.
Biocompatibility (cytotoxicity, genotoxicity and intracutaneous irritation) testing passed for the graft in the new MIS Cartridge (tube) format.
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
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three faces in profile, stacked one behind the other, representing the department's mission to protect the health of all Americans and provide essential human services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2015
Novabone Products, LLC % Ms. Lisa Simpson Consultant Simpson Regulatory Solutions, LLC 4401 North West 18th Place Gainesville, Florida 32605
Re: K152071
Trade/Device Name: NovaBone MacroFORM BIOACTIVE MIS Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: July 24, 2015 Received: July 27, 2015
Dear Ms. Simpson:
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. 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
1
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Mark N. Melkerson -S
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NovaBone MacroFORM BIOACTIVE MIS K152071
Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
NovaBone MacroFORM BIOACTIVE MIS
Indications for Use (Describe)
NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (1/14)
Page 1 of 2
PSC Publishing Services (301) 443-6740
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Image /page/3/Picture/3 description: The image shows the word "NOVABONE" in a stylized font. The letters are in shades of blue and teal. The "O" in "NOVABONE" is designed to look like a starburst.
Date Prepared: July 24, 2015
510(k) Holder / Submitter:
NovaBone Products, LLC 13510 NW US Highway 441 Alachua, FL 32615
Contact: Richard A. Davis Director of Eng/RA/QA Ph: (386) 462-1010 / Fax: (386) 462-7525 Email: rdavis@novabone.com
Regulatory Contact:
Simpson Regulatory Solutions, LLC 4401 NW 18 Place Gainesville, FL 32605
Contact: Lisa C. Simpson Email: regulatorysolutions@icloud.com Ph: (352) 562-5122
Name of Device:
| Trade Names: | NovaBone MacroFORM BIOACTIVE MIS |
|---|---|
| Common Name: | Osteoconductive Bone Void Filler Synthetic |
| Resorbable Bone Graft Material | |
| Regulation Number: | 21 CFR 888.3045 Regulation Name: Bone Void Filler |
| Regulatory Class: | Class II |
| Product Code: | MQV |
Legally Marketed Predicate Devices:
| K140946 | NovaBone MacroFORM BIOACTIVE (primary predicate) |
|---|---|
| K112773 | NovaBone Putty MIS (reference predicate) |
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Device Description
NovaBone MacroFORM is an osteoconductive bioactive device used for grafting osseous defects. It is a composite of bioactive calcium-phospho-silicate granules and a collagen binder. The bioactive particulate is composed solely of elements that exist in normal bone (Ca, P, Na, Si, O). The collagen binder consists of bovine collagen. When mixed with bone marrow aspirate, the device forms a non-hardening graft that is applied directly to the intended graft site.
During absorption of the collagen binder, the particulate material remaining undergoes a time-dependent kinetic modification of the surface to stimulate osteoblast activity and guide the formation of bone across the graft site. Specifically, a series of surface reactions on the particles results in the formation of a calcium phosphate layer that is substantially equivalent in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. During healing, the graft particulate is absorbed and remodeled into new bone.
MacroFORM BIOACTIVE MIS is provided in an MIS Cartridge (tube) for delivery using the NovaBone MIS Cartridge Handle accessory, supplied separately. The graft formulation is identical to MacroFORM BIOACTIVE moldable composite (K140946, primary predicate). The MIS Cartridge/Handle system is equivalent to that of NovaBone Putty MIS (K112773, reference predicate).
Intended Use
NovaBone MacroFORM devices are intended for prescription use only, to fill bony defects in the skeletal system. The device will be marketed with the following indications statement, which is identical to that of the primary predicate, MacroFORM BIOACTIVE moldable composite (K140946). Therefore, no new issues of safety or effectiveness are presented when MacroFORM BIOACTIVE MIS is used for the following indications, as labeled:
Indications for Use:
NovaBone MacroFORM bone graft devices are indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. NovaBone MacroFORM is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e. the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovaBone MacroFORM must be hydrated with autogenous bone marrow prior to implantation. The product provides a bone void filler that resorbs and is replaced with bone during the healing process.
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Technological Characteristics and Substantial Equivalence
MacroFORM BIOACTIVE MIS and the predicate device utilize biocompatible materials that fill bony voids and provide an environment for bone regeneration. The host bone remodels through an osteoconductive process as new bone grows into the porous matrix of the graft materials. The graft materials are slowly resorbed and replaced by the host bone. The proposed and predicate devices are not intended to be load bearing and are only intended for use in defects that are not intrinsic to the stability of the bony structure. MacroFORM MIS and the predicate devices have the same mode of action and therefore no new issues of safety or effectiveness are presented.
MacroFORM BIOACTIVE MIS and the primary predicate (MacroFORM BIOACTIVE moldable composite, K140946) have the same graft formulation. Both devices incorporate the bioactive component, a three-dimensional porous structure comprised of Bioglass® 45S5, an inorganic calcium phospho-silicate, which conforms to ASTM F1538-03. The bioglass particles are compressed and heated to form a porous mass. Likewise, the bovine collagen used for the production of MacroFORM BIOACTIVE MIS is the same as that used for the primary predicate. The collagen is obtained from a single source in Australia, which is recognized by the World Organization for Animal Health (OIE) to be free of BSE and other similar TSE pathogens. Australia also is termed a Geographical BSE Risk I, or GBR I country. The GBR I designation is the lowest risk rating, indicating the potential for one or more animals to infected with BSE agents as "Highly Unlikely". The processing steps used for the bovine collagen constituent for MacroFORM have viral inactivation benefits. Because the device formulations and collagen sources are identical, no new issues of safety or effectiveness are presented.
The primary packaging differs for the MacroFORM BIOACTIVE MIS as compared to the MacroFORM primary predicate device (K140946). Biocompatibility (cytotoxicity, genotoxicity and intracutaneous irritation) testing passed for the graft in the new MIS Cartridge (tube) format. Therefore, no new issues of biocompatibility safety are presented by the packaging change.
The MacroFORM predicate device is hydrated with bone marrow aspirate (BMA) in a tray whereas the MIS version is hydrated in the MIS Cartridge (tube). A hydration study was conducted to evaluate the amount of fluid needed to sufficiently hydrate the graft and identify the optimal setting time prior to extrusion. Test devices were prepared using various fluid amounts and setting times, and then evaluated for hydration, handling, and immersion resistance. The instructions for use were updated based on this testing. Therefore, no new issues of safety or effectiveness are presented by hydration of MacroFORM in the MIS Cartridge.
The accessory Handle used for MacroFORM BIOACTIVE MIS is identical to that of the reference predicate, K112773, NovaBone Putty MIS. Only the packaging graphics have been changed. The packaging materials and sterilization method are unchanged relative
6
to the reference predicate. There are no new issues of safety or effectiveness for the MIS Handle accessory are presented.
Like the predicates, MacroFORM BIOACTIVE MIS devices are supplied sterile for single use. The predicate and proposed devices are sterility assurance level (SAL) of 10 using an irradiation method. Therefore, no new issues of safety or effectiveness are presented for MacroFORM BIOACTIVE MIS as compared to the primary and reference predicate devices.
Conclusion
The proposed NovaBone MacroFORM BIOACTIVE Moldable Composite MIS device system is substantially equivalent to the primary predicate MacroFORM BIOACTIVE (moldable composite, K140946. The indications for use and graft formulation are identical to the primary predicate. The only difference is the MIS version of MacroFORM BIOACTIVE is provided in Cartridge (tube) packaging, equivalent to the reference predicate, NovaBone Putty MIS (K112773). The MIS Handle accessory device is unchanged relative to the reference predicate. The potential risks associated with the packaging modifications have been identified and properly mitigated as supported by biocompatibility testing and a hydration study.
The information provided for this premarket notification supports substantial equivalence of MacroFORM BIOACTIVE MIS to the primary predicate device, MacroFORM BIOACTIVE moldable composite (K140946), with reference to NovaBone Putty MIS (K112773) for the MIS Cartridge/Handle system.
Therefore, NovaBone MacroFORM BIOACTIVE MIS is substantially equivalent to NovaBone MacroFORM BIOACTIVE moldable composite (K140946) when used for the same indications for use, to fill bony defects.