(264 days)
No
The device description focuses on the material composition and physical properties of a bone void filler. There is no mention of software, algorithms, or any computational processing that would suggest the use of AI or ML. The performance studies describe animal testing and evaluation of physical characteristics, not algorithmic performance.
Yes.
The device is intended to resorb and be replaced by bone during the healing process, which directly addresses a condition (bone voids/gaps) to restore function.
No
NovoGro Putty is described as a bone void filler that resorbs and is replaced by bone during the healing process, indicating its use in treatment rather than diagnosis.
No
The device description clearly states that NovoGro Putty is a physical material (dry powder and aqueous solution) that is mixed and implanted as a bone void filler. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that NovoGro Putty is a "bone void filler" intended for direct implantation into the skeletal system to fill gaps and voids. This is a therapeutic and structural function within the body.
- Device Description: The description details the composition of the putty and how it is mixed for implantation. This aligns with a medical device intended for direct application to tissue.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies described involve animal testing to evaluate the device's ability to fill bone voids and be replaced by bone during healing. This is a functional assessment of a therapeutic device, not a diagnostic one.
In Vitro Diagnostic devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnostic purposes. NovoGro Putty does not fit this description.
N/A
Intended Use / Indications for Use
NovoGro Putty is intended for use as a bone void filler for gaps and voids that are not intrinsic to the stability of the bony structure. NovoGro Putty is intended to be hydrated with sterile water and gently packed into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovoGro Putty provides a bone void filler that resorbs and is replaced by bone during the healing process.
Product codes
MQV
Device Description
NovoGro Putty is provided to the end-user as two components (dry powder and aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a moldable cohesive putty-like graft. The dry powder component of NovoGro Putty contains spherical beads that are composed primarily of a co-precipitate of dicalcium phosphate anhydrite Imonetite. CaHPO4], magnesium phosphate trihydrate [newberyite, Mg(PO2OH)+3(H2O)] and sodium hydrogen phosphate [NaH2PO4]. Small amounts of silica (SiO2) and magnesium oxide (MgO) are combined with this co-precipitate during manufacturing. These spherical beads are mixed heterogeneously with dry sodium carboxymethyl cellulose (CMC) powder to enhance the handling properties of the final mixed graft. The aqueous component of NovoGro is ultrapure reverse osmosis deionized water (DI H2O). NovoGro Putty is provided sterile for single use in volumes ranging from 1 cc to 20 cc. NovoGro Putty is provided in a kit with a mixing system, a vial of ultrapure water for mixing, and a graduated syringe to measure the correct volume of the supplied ultrapure water to add to the dry component.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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
Animal testing performed to demonstrate substantial equivalence included determination of radiographic, histologic and histomorphometric characteristics of the subject device and the predicate device in a rabbit distal femoral condyle critical-sized defect model. The study time points included baseline (time 0), 6 weeks, and 12 weeks. The baseline (time 0) animals provided information on the initial amount of material implanted to fill the defects. Empty (unfilled) defects (negative control) were evaluated at 6 weeks and 12 weeks. Evaluation endpoints included high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate Actifuse ABX device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, with flowing lines extending from the head.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2017
OsteoNovus, Inc. % Kevin A. Thomas, Ph.D. Vice President and Director of Regulatory Affairs Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130
Re: K162087
Trade/Device Name: NovoGro Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: February 21, 2017 Received: February 22, 2017
Dear Dr. Thomas:
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
NovoGro
Indications for Use (Describe)
NovoGro Putty is intended for use as a bone void filler for gaps and voids that are not intrinsic to the stability of the bony structure. NovoGro Putty is intended to be hydrated with sterile water and gently packed into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovoGro Putty provides a bone void filler that resorbs and is replaced by 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) |
|---|---|
| --------------------------------------------------------------------------- | -------------------------------------------------------------------------- |
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FORM FDA 3881 (8/14)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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510(k) Summary
OsteoNovus, Inc.
NovoGro
February 21, 2017
ADMINISTRATIVE INFORMATION
| Manufacturer Name | OsteoNovus, Inc. | |
|---|---|---|
| 1510 North Westwood Avenue, Suite 1080 | ||
| Toledo, OH 43606 | ||
| Telephone: | +1-617-717-8867 | |
| Official Contact | Brian M. Schlossberg, PhD | |
| Director of Research and Development | ||
| Representative/Consultant | Kevin A. Thomas, PhD | |
| Floyd G. Larson, MS, MBA | ||
| PaxMed International, LLC | ||
| 12264 El Camino Real, Suite 400 | ||
| San Diego, CA 92130 | ||
| Telephone: | +1-858-792-1235 | |
| Fax: | +1-858-792-1236 | |
| Email: | kthomas@paxmed.com | |
| flarson@paxmed.com |
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | NovoGro |
|---|---|
| Common Name | Filler, bone void, calcium compound |
| Classification Name | Resorbable calcium salt bone void filler device |
| Classification Regulations | 21 CFR 888.3045, Class II |
| Product Code | MQV |
| Classification Panel | Orthopaedic and Rehabilitation Devices Panel |
| Reviewing Branch | Restorative and Repair Devices Branch (RRDB) |
PREDICATE DEVICE INFORMATION
The primary predicate device is K071206, Actifuse ™ ABX E-Z-fil Bone Graft Substitute, ApaTech Limited.
INDICATIONS FOR USE
NovoGro Putty is intended for use as a bone void filler for gaps and voids that are not intrinsic to the stability of the bony structure. NovoGro Putty is intended to be hydrated with sterile water and gently packed into bony voids or gaps of the skeletal system, i.e., extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. NovoGro Putty provides a bone void filler that resorbs and is replaced by bone during the healing process.
4
SUBJECT DEVICE DESCRIPTION
NovoGro Putty is provided to the end-user as two components (dry powder and aqueous solution) that must be mixed intra-operatively prior to implantation using the supplied mixing system to form a moldable cohesive putty-like graft. The dry powder component of NovoGro Putty contains spherical beads that are composed primarily of a co-precipitate of dicalcium phosphate anhydrite Imonetite. CaHPO4], magnesium phosphate trihydrate [newberyite, Mg(PO2OH)+3(H2O)] and sodium hydrogen phosphate [NaH2PO4]. Small amounts of silica (SiO2) and magnesium oxide (MgO) are combined with this co-precipitate during manufacturing. These spherical beads are mixed heterogeneously with dry sodium carboxymethyl cellulose (CMC) powder to enhance the handling properties of the final mixed graft. The aqueous component of NovoGro is ultrapure reverse osmosis deionized water (DI H2O). NovoGro Putty is provided sterile for single use in volumes ranging from 1 cc to 20 cc. NovoGro Putty is provided in a kit with a mixing system, a vial of ultrapure water for mixing, and a graduated syringe to measure the correct volume of the supplied ultrapure water to add to the dry component.
PERFORMANCE DATA
Pre-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included chemical composition, physical properties, biocompatibility, and performance characteristics.
Chemical characterization of the subject device included identification of crystalline and non-crystalline components using powder x-ray diffraction (PXRD) and Fourier transform infrared spectroscopy (FTIR), and elemental composition analysis (including heavy metal content) using ion coupled plasma mass spectrometry (ICP-MS). Calcium dissolution and pH measurement testing were performed for the subject device NovoGro Putty and the predicate device Actifuse ABX. Chemical characterization was performed using methods described in ASTM F2024, ASTM F1185, and ASTM F1926/F1926M.
Physical characterization of the subject device included scaming electron microscopy (SEM); particle size distribution; device mass, volume, and density by gas displacement pycnometry; surface area by gas adsorption; and device porosity by mercury intrusion porosimetry.
Biocompatibility testing was performed using methods described in AAMI/ANSI/ISO 10993-1, ISO 10993-3. AAMI/ANSI/ISO 10993-5. ISO 10993-10. ISO 10993-12, and ISO 10993-12. and ISO 10993-18. Material mediated pyrogenicity testing and bacterial endotoxin testing were performed using the using methods described in ISO 10993-11 and AAMI/ANSI ST72, respectively.
Sterilization validation, sterile barrier shelf life, and product shelf life testing were performed according to AAMI/ANSI/ISO 11137-1, AAMI/ANSI/ISO 11137-2, ASTM D4169, ASTM F1980, ASTM F1886/F1886M, ASTM F2096, and ASTM F88/F88M.
Animal testing performed to demonstrate substantial equivalence included determination of radiographic, histologic and histomorphometric characteristics of the subject device and the predicate device in a rabbit distal femoral condyle critical-sized defect model. The study time points included baseline (time 0), 6 weeks, and 12 weeks. The baseline (time 0) animals provided information on the initial amount of material implanted to fill the defects. Empty (unfilled) defects (negative control) were evaluated at 6 weeks and 12 weeks. Evaluation endpoints included high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Histology sections also were graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
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No clinical data were included in this submission.
EQUIVALENCE TO MARKETED DEVICE
OsteoNovus, Inc. submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the legally marketed predicate device, Actifuse ™ ABX E-Z-fil Bone Graft Substitute, ApaTech Limited, K071206.
A comparison of the technological characteristics of the subject device and the predicate device K071206 is provided in the following table.
| Subject Device | Predicate Device | |
|---|---|---|
| Comparison | OsteoNovus, Inc. | |
| NovoGro | ApaTech Limited | |
| Actifuse ™ ABX E-Z-fil Bone Graft Substitute | ||
| K071206 | ||
| Indications for Use | NovoGro Putty is intended for use as a bone void filler for | |
| gaps and voids that are not intrinsic to the stability of the | ||
| bony structure. NovoGro Putty is intended to be hydrated | ||
| with sterile water and gently packed into bony voids or gaps | ||
| of the skeletal system, i.e., extremities and pelvis. These | ||
| defects may be surgically created osseous defects or osseous | ||
| defects created from traumatic injury to the bone. NovoGro | ||
| Putty provides a bone void filler that resorbs and is replaced | ||
| by bone during the healing process. | Actifuse is a bone void filler intended only for orthopaedic | |
| applications as a filler for gaps and voids that are not | ||
| intrinsic to the stability of the bony structure. Actifuse is | ||
| indicated to be packed gently into bony voids or gaps of the | ||
| skeletal system, i.e., extremities, pelvis, and spine, including | ||
| use in posterolateral fusion procedures with appropriate | ||
| stabilizing hardware. These defects may be surgically | ||
| created osseous defects or osseous defects created from | ||
| traumatic injury to the bone. The product provides a bone | ||
| void filler that resorbs and is replaced by bone during the | ||
| healing process. | ||
| Product Code | MQV | MQV |
| Intended Use | Bone void filler for skeletal system (extremities, pelvis) | Bone void filler for skeletal system (extremities, pelvis) |
| and posterolateral spine | ||
| Design | ||
| Form | NovoGro Putty: Regularly shaped granules premixed with a | |
| soluble polymeric binder | Irregularly shaped granules premixed with a soluble | |
| aqueous gel carrier | ||
| Granule Size | 1 - 2 mm (1000 – 2000 μm) | 1 - 2 mm (1000 – 2000 μm) |
| Porosity | NovoGro Putty: 31.3% | 20 % |
| Materials | ||
| Calcium salts | monetite / newberyite / sodium hydrogen phosphate | |
| [CaHPO4 + Mg(PO3OH)•3(H2O) + NaH2PO4] | Hydroxyapatite (HA) | |
| Silicon | NovoGro Putty: 14% by weight | 0.8 % by weight |
| Scaffold/Binder | Sodium carboxymethyl cellulose (CMC) | Aqueous gel carrier (resorbable polymer, not specified) |
| How Supplied | ||
| Sizes, shapes | Provided in delivery/mixing syringe | |
| Final graft volumes ranging from 1 cc - 20 cc | Provided in delivery syringe | |
| Volumes ranging from 1.5 mL to 20 mL | ||
| Single use | Yes | Yes |
| Sterile | Yes | Yes |
| Sterilization | Gamma irradiation | E-beam irradiation |
6
The subject device and the predicate device have the same intended use, the same product classification and product code (MQV), and have similar indications for use. The subject device and predicate device are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure (extremities and pelvis); the predicate device has an additional indication for use in the posterolateral spine. Although the subject device and the predicate have slightly different Indications for Use language, this difference in language does not change the intended use as a bone void filler in the extremities and pelvis.
The subject device and the predicate device both incorporate calcium phosphate materials, Si, and a polymeric scaffold or binder. NovoGro Putty contains approximately 14% Si by weight and the predicate Actifuse ABX contains approximately 0.8% Si by weight. The subject device and the predicate device have the same range of granule size (1 mm - 2 mm), and have similar porosities. The subject device and the predicate device are provided sterile for single use in similar ranges of graft volumes.
The radiographic, histologic and histomorphometric performance of the subject device was compared to that of the predicate device in a rabbit distal femoral condyle critical-sized defect model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate Actifuse ABX device.
CONCLUSION
The subject device and the predicate devices have the same intended use, have similar technological characteristics, and are made of similar materials. The subject and predicate devices are packaged in similar materials and are sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate device listed above.