(130 days)
No
The summary describes a bone graft material and its biological mechanism of action, with no mention of AI or ML technology.
Yes.
The device is indicated for bony voids or gaps and acts as a bone void filler that resorbs and is replaced with bone during the healing process, making it a therapeutic device.
No
The device is a bone graft material designed to fill bony voids and promote bone growth, not to diagnose medical conditions.
No
The device description clearly indicates it is a physical bone graft material composed of granules and a collagen binder, not software.
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 in vivo (within the body).
- Lack of Mention of Samples or Testing: The text does not mention any analysis of biological samples or any diagnostic testing being performed with this device.
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 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 process.
Product codes
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. The device is slowly absorbed during graft site healing.
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 is provided in three basic forms: loose granules, a composite plug and a composite block.
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
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
Functional in vivo testing in an animal model (rabbit tibia defect) was performed on MacroFORM using the primary predicate (K090731, NovaBone Porous) as a control. The results demonstrate that bone remodeling process for MacroFORM is equivalent to that of NovaBone Porous.
Biocompatibility testing was conducted.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2014
NovaBone Products. LLC Ms. Lisa Simpson Manager, Regulatory Affairs 13510 Northwest U.S. Highway 441 Alachua, Florida 32615
Re: K140946
Trade/Device Name: NovaBone MacroFORM BIOACTIVE – Packable Graft NovaBone MacroFORM BIOACTIVE - Moldable Composite Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 1, 2014 Received: August 5, 2014
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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forth in the quality systems (QS) 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.
RonaldfødJean -S for
Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K140946
Device Name
NovaBone MacroFORM - BIOACTIVE Packable Graft, NovaBone MacroFORM - BIOACTIVE Moldable Composite
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 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 process.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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Image /page/3/Picture/0 description: The image shows the words "510(k) SUMMARY" and "MacroFORM BIOACTIVE" in bold, black font. Below that is the logo for "NOVABONE" in a blue font. Underneath the logo are the words "DRIVING INNOVATION IN OSTEOBIOLOGICS" in a smaller, blue font.
Date Prepared: August 14, 2014
510(k) Holder / Submitter:
| Name: | NovaBone Products, LLC |
|---|---|
| Address: | 13510 NW US Highway 441 |
| Alachua, FL 32615 | |
| Telephone: | (386) 462-7661, ext 216 |
| Fax: | (386) 462-7525 |
| Contact: | Lisa Simpson / Manager, Regulatory Affairs |
Name of Device:
| Trade Names: | NovaBone MacroFORM – BIOACTIVE Packable Graft |
|---|---|
| NovaBone MacroFORM – BIOACTIVE Moldable Composite | |
| 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:
| K090731 /
| K060432 | NovaBone Porous – Synthetic Bone Graft Scaffold |
|---|---|
| K083033 | Orthovita Vitoss Foam Bone Graft Substitute |
NovaBone Products, LLC NOT CONFIDENTIAL VOL_001 / SECTION 005 Page 1 of 4
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Image /page/4/Picture/0 description: The image contains the text "510(k) SUMMARY" and "MacroFORM BIOACTIVE" in bold font. Below this text is the logo for "NOVABONE" in blue and teal. Underneath the logo is the text "DRIVING INNOVATION IN OSTEOBIOLOGICS" in a smaller font.
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. The device is slowly absorbed during graft site healing.
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 is provided in three basic forms: loose granules, a composite plug and a composite block.
Intended Use
NovaBone MacroFORM devices are intended to be used to fill bony defects in the skeletal system. The device will be marketed with the following indications statement, which is equivalent to that of the primary predicate, NovaBone Porous (K090731/K060432). The only difference is addition of the last sentence to emphasize the requirement for rigid fixation. MacroFORM does not include spine indications like the reference predicate (K083033. Vitoss) as MacroFORM will not be marketed for such uses. Therefore, no new issues of safety or effectiveness are presented when NovaBone MacroFORM is used for the following indications, as labeled:
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Image /page/5/Picture/0 description: The image contains the text "510(k) SUMMARY" and "MacroFORM BIOACTIVE" in bold font. Below this text is the logo for "NOVABONE" in a teal color. Underneath the logo is the text "DRIVING INNOVATION IN OSTEOBIOLOGICS".
MacroFORM - 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.
Technological Characteristics and Substantial Equivalence
NovaBone MacroFORM and the predicate devices 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 to be used in defects that are not intrinsic to the stability of the bony structure. MacroFORM and the predicates have similar mode of action, therefore no new issues of safety or effectiveness are presented.
MacroFORM and the primary predicate (NovaBone Porous, K090731) incorporate the same bioactive component, a three-dimensional porous structure comprised of Bioglass 45S5, an inorganic calcium phospho-silicate, which conforms to ASTM F1538-03. For both devices, the Bioglass particles are compressed and heated to form a porous mass. Therefore, no new issues of safety or effectiveness are raised by the bioactive agent in the proposed MacroFORM devices.
MacroFORM includes a handling agent derived from bovine collagen; however, the primary predicate, NovaBone Porous (K090731) is 100% Bioglass (without a handling agent). Biocompatibility testing demonstrates that MacroFORM materials do not raise new issues of biocompatibility safety.
Functional in vivo testing in an animal model (rabbit tibia defect) was performed on MacroFORM using the primary predicate (K090731, NovaBone Porous) as a control. The results demonstrate that bone remodeling process for MacroFORM is equivalent to that of NovaBone Porous. Therefore, no new issues of safety or effectiveness are raised by the in vivo performance of MacroFORM.
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Image /page/6/Picture/0 description: The image contains the text "510(k) SUMMARY" and "MacroFORM BIOACTIVE" in bold font. Below that is the logo for NOVABONE in a blue font. The tagline "DRIVING INNOVATION IN OSTEOBIOLOGICS" is below the logo.
The bovine collagen used for the production of MacroFORM devices is obtained from a single source in Australia 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. Therefore, no new issues of safety or effectiveness are presented by the collagen source for MacroFORM.
Like the predicate devices, MacroFORM is supplied as a single-use sterile implantable graft, with double-barrier packaging. The device is sterilized to a sterility assurance level (SAL) of 106 using an irradiation method.
The processing and packaging methods employed to ensure biological safety of the finished device demonstrate that no new safety issues are raised for MacroFORM as compared to the predicate devices.
Conclusion
NovaBone MacroFORM BIOACTIVE is similar to the predicate devices with respect to technical characteristics, performance, and intended use. The information provided for this premarket notification supports substantial equivalence to the primary predicate device, NovaBone Porous (K090731/K060432), with reference to Vitoss (K083033), for the bovine collagen constituent.
In vivo performance testing (rabbit tibia defect model) and biocompatibility testing were conducted in accordance with the "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device," June Passing biocompatibility testing demonstrates MacroFORM BIOACTIVE 2, 2003. devices are safe for implantation. In the rabbit tibia study MacroFORM BIOACTIVE performed in an equivalent manner to NovaBone Porous, the primary predicate.
Therefore, NovaBone MacroFORM BIOACTIVE bone void fillers are substantially equivalent to the NovaBone Porous predicate device (K090731/K060432).