(264 days)
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.
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.
This document is a 510(k) premarket notification for a medical device called NovoGro, a resorbable calcium salt bone void filler device. It is not an AI/ML device, therefore, the information requested in the prompt related to acceptance criteria for an AI/ML device and its validation study (e.g., sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable.
However, based on the document, I can extract information about the device's performance criteria and the study that supported its substantial equivalence to a predicate device.
Here's a summary of the requested information, adjusted for a non-AI/ML medical device:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is not an AI/ML device, the "acceptance criteria" are not framed in terms of performance metrics like sensitivity or specificity. Instead, acceptance is based on demonstrating substantial equivalence to a legally marketed predicate device through various tests. The performance of the subject device (NovoGro) was deemed equivalent to the predicate (Actifuse ABX).
| Performance Aspect | Acceptance Criteria (demonstrated equivalence to predicate) | Reported Device Performance (NovoGro) |
|---|---|---|
| Chemical Composition | Similar crystalline/non-crystalline components, elemental composition, calcium dissolution, pH measurements compared to predicate. | Demonstrated similarities in PXRD, FTIR, ICP-MS; calcium dissolution and pH reported comparative to Actifuse ABX. |
| Physical Properties | Similar particle size distribution, mass, volume, density, surface area, and porosity compared to predicate. | Granule size (1-2 mm) matches predicate. Porosity (31.3%) similar to predicate (20%). |
| Biocompatibility | Meets ISO 10993 standards and material-mediated pyrogenicity/bacterial endotoxin tests. | Biocompatibility performed per AAMI/ANSI/ISO 10993 standards. |
| Sterilization & Shelf-Life | Validated sterilization, sterile barrier, and product shelf-life. | Sterilization validated per AAMI/ANSI/ISO 11137-1/2, ASTM D4169, ASTM F1980, ASTM F1886/F1886M, ASTM F2096, ASTM F88/F88M. |
| In Vivo Performance (Bone Regeneration) | Radiographic, histologic, and histomorphometric characteristics of bone repair equivalent to predicate in an animal model. | Demonstrated equivalent performance to Actifuse ABX in a rabbit distal femoral condyle critical-sized defect model for radiographic, histologic, and histomorphometric characteristics. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Animal Study): Not explicitly stated how many animals were in the "rabbit distal femoral condyle critical-sized defect model." The document mentions "baseline (time 0) animals" and "empty (unfilled) defects (negative control) evaluated at 6 weeks and 12 weeks," implying multiple animals within each group and time point, but the exact number isn't provided.
- Data Provenance: The animal study was conducted as pre-clinical testing, but the country of origin is not specified. It is a prospective study designed to compare the subject device against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Ground Truth Establishment: For the animal study, the "ground truth" or evaluative endpoints were based on objective scientific analyses.
- Evaluators: The document mentions "high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis." Histology sections were also "graded according to AAMI/ANSI/ISO 10993-6 (Annex E)."
- Number and Qualifications of Experts: Not specified. It can be inferred that these evaluations were performed by qualified personnel (e.g., veterinary radiologists, histopathologists, scientists trained in histomorphometry), but the specific number or their credentials are not detailed in this document.
4. Adjudication Method for the Test Set
- Given the objective nature of the evaluations (radiography, micro-CT, histology, histomorphometry, and grading against a standard), a formal "adjudication method" in the sense of expert consensus for subjective findings is less relevant here. The analyses rely on scientific methods and specified standards (e.g., AAMI/ANSI/ISO 10993-6). Any discrepancies would likely be resolved through re-evaluation or adherence to established protocols. The document does not describe a specific adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done. This is not an AI/ML device meant to assist human readers. The study performed was a comparative animal study of the device itself.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This refers to AI/ML algorithms. The device is a physical bone void filler.
7. The type of ground truth used
- For the animal study: The ground truth was established through a combination of radiographic imaging, micro-CT imaging, undecalcified histologic evaluation, and histomorphometric analysis. These are objective scientific measurements and observations of tissue response and bone formation in an in-vivo model. Histology sections were also graded against a standard (AAMI/ANSI/ISO 10993-6 Annex E).
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a training set. The "training" for this type of device would refer to its development and refinement through pre-clinical testing, but not in the context of a "training set" for AI.
9. How the ground truth for the training set was established
- Not applicable, as there is no AI/ML training set for this device.
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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
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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 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.comflarson@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.
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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 LimitedActifuse ™ ABX E-Z-fil Bone Graft SubstituteK071206 |
| Indications for Use | NovoGro Putty is intended for use as a bone void filler forgaps and voids that are not intrinsic to the stability of thebony structure. NovoGro Putty is intended to be hydratedwith sterile water and gently packed into bony voids or gapsof the skeletal system, i.e., extremities and pelvis. Thesedefects may be surgically created osseous defects or osseousdefects created from traumatic injury to the bone. NovoGroPutty provides a bone void filler that resorbs and is replacedby bone during the healing process. | Actifuse is a bone void filler intended only for orthopaedicapplications as a filler for gaps and voids that are notintrinsic to the stability of the bony structure. Actifuse isindicated to be packed gently into bony voids or gaps of theskeletal system, i.e., extremities, pelvis, and spine, includinguse in posterolateral fusion procedures with appropriatestabilizing hardware. These defects may be surgicallycreated osseous defects or osseous defects created fromtraumatic injury to the bone. The product provides a bonevoid filler that resorbs and is replaced by bone during thehealing 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 asoluble polymeric binder | Irregularly shaped granules premixed with a solubleaqueous 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 syringeFinal graft volumes ranging from 1 cc - 20 cc | Provided in delivery syringeVolumes ranging from 1.5 mL to 20 mL |
| Single use | Yes | Yes |
| Sterile | Yes | Yes |
| Sterilization | Gamma irradiation | E-beam irradiation |
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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.
§ 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.