(143 days)
NovoGro Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). NovoGro must be used with autograft as a bone extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device resorbs and is replaced with 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 particles 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 particles 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.
The provided text is a 510(k) summary for the medical device NovoGro Putty. It describes the device, its intended use, and substantial equivalence to legally marketed predicate devices. This document does not describe an acceptance criteria table or present a study that proves the device meets specific performance criteria in the context of an AI/ML-based medical device evaluation for diagnostic accuracy.
The "Performance Data" section details pre-clinical testing, chemical characterization, physical characterization, biocompatibility, sterilization validation, and limited comparative animal testing to demonstrate substantial equivalence to a predicate device, not to meet specific diagnostic accuracy thresholds.
Therefore, many of the requested details, particularly those pertaining to AI/ML device performance evaluation (e.g., sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training set details), are not applicable to this document as it concerns a bone void filler and its substantial equivalence based on material and structural properties, and in vivo integration/resorption in an animal model, rather than an AI/ML diagnostic or prognostic algorithm.
However, I can extract the information that is present and explain why other information is not available in this type of submission.
Acceptance Criteria and Study for NovoGro Putty (Based on Provided 510(k) Summary)
This 510(k) summary evaluates a bone void filler (NovoGro Putty), not an AI/ML device. Therefore, the concepts of "acceptance criteria" and "study proving the device meets acceptance criteria" are framed in terms of "substantial equivalence" to a predicate device, focusing on material properties, performance characteristics, and biological response, rather than diagnostic accuracy metrics like sensitivity, specificity, or AUC which are typical for AI/ML devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device, the "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to the predicate device across various non-clinical tests. The "performance" is the demonstration of similarity or comparable outcomes to the predicate device in these tests.
| Acceptance Criterion (Implicitly "Substantial Equivalence to Predicate") | Reported Device Performance (as demonstrated in the study) |
|---|---|
| Chemical Composition (Identification of crystalline/non-crystalline components, elemental composition, heavy metal content, calcium dissolution, pH) | Performed using PXRD, FTIR, ICP-MS, and methods described in ASTM F2024, ASTM F1185, ASTM F1926/F1926M. (Details of specific values for equivalence against predicate not explicitly quantified in this summary, but implied to be comparable). |
| Physical Characterization (SEM, particle size, mass, volume, density, surface area, porosity) | Performed using SEM, gas displacement pycnometry, gas adsorption, mercury intrusion porosimetry. NovoGro Putty: Granule Size 1-2 mm, Porosity 31.3%. (Comparison table shows predicate granules 0.5-1.6 mm, 80% porosity for granules - note the porosity comparison is not directly comparable as predicate's is for granules, not the overall mixed product.) Implied to be within acceptable range for substantial equivalence. |
| Biocompatibility (Cytotoxicity, sensitization, irritation, genotoxicity, material mediated pyrogenicity, bacterial endotoxin) | Performed using methods described in AAMI/ANSI/ISO 10993-1, -3, -5, -10, -12, -18, ISO 10993-11, and AAMI/ANSI ST72. (Implied to meet necessary safety standards; specific results indicating equivalence or passing scores are not detailed but are accepted by FDA). |
| Sterilization Validation & Shelf Life (Sterility, sterile barrier, product shelf life) | Performed according to AAMI/ANSI/ISO 11137-1, 11137-2, ASTM D4169, ASTM F1980, ASTM F1886/F1886M, ASTM F2096, ASTM F88/F88M. (Implied to meet necessary standards; specific results not detailed but accepted). Device is "Provided sterile for single use in volumes ranging from 1 cc to 20 cc." Sterilization: Gamma irradiation (similar to predicate). |
| In vivo Performance (Radiographic, histologic, histomorphometric characteristics in a bone fusion model) | Rabbit Posterolateral Spine Fusion Model Study: "The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate device K140375." Evaluation endpoints included manual palpation, range of motion/flexibility testing, plain and high-resolution radiography, micro-computed tomography (micro-CT) imaging, undecalcified histologic evaluation, and histomorphometric analysis. Histology sections graded per AAMI/ANSI/ISO 10993-6 (Annex E). No specific quantitative metrics of equivalence are provided in this summary. |
| Bioactivity (Apatitic calcium phosphate formation in simulated body fluid) | In vitro study comparing NovoGro, positive control (bioactive glass), and negative control (polyethylene). Apatitic calcium phosphate formation observed on NovoGro and positive control, but not negative control. (Implied to show desired bioactive properties). |
2. Sample size used for the test set and the data provenance
- Test Set (Animal Study): A "rabbit posterolateral spine fusion model" was used. The specific sample size (number of rabbits) is not provided in this 510(k) summary.
- Data Provenance: The study was an animal study (rabbit model), which is generally considered pre-clinical rather than human retrospective or prospective clinical data. The summary does not specify the country of origin, but given the FDA submission, it's typically conducted in a controlled environment compliant with US or international standards for animal research.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable in the context of an AI/ML-based diagnostic device. The "ground truth" in this study was established through objective measurements and evaluations in an animal model:
- Manual palpation
- Range of motion/flexibility testing
- Plain and high-resolution radiography
- Micro-CT imaging
- Undecalcified histologic evaluation
- Histomorphometric analysis
- Histology sections graded according to AAMI/ANSI/ISO 10993-6 (Annex E).
- Experts (e.g., pathologists, radiologists) would have been involved in the interpretation of these results, but their number and specific qualifications are not detailed as this is not an AI/ML diagnostic accuracy study requiring human consensus for "ground truth."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable for this type of device and study. Adjudication methods like 2+1 or 3+1 are used in consensus reading for establishing ground truth in human imaging studies, particularly for AI/ML performance evaluation. The animal study involved objective measurements and standard histological/radiographic interpretations.
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, not done. This is a non-clinical evaluation of a bone filler, not an AI/ML diagnostic tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/No. This device is a physical bone void filler, not an algorithm. Standalone performance refers to the accuracy of an AI algorithm without human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the animal study: The ground truth was established through a combination of radiographic imaging, micro-CT imaging, and histological/histomorphometric analysis in a rabbit model. These methods provide direct evidence of bone formation, integration, and resorption. It's essentially biological/pathological assessment in an animal model.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device, so there is no concept of a "training set" for an algorithm. The "training" for this product would be its manufacturing process and quality control.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, there is no corresponding ground truth establishment process.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 6, 2018
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: K173525
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: March 8, 2018 Received: March 9, 2018
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 of medical device-related adverse events) (21 CFR 803); good
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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.
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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 an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). NovoGro must be used with autograft as a bone extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device 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) | ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| ✓ Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary K173525 NovoGro OsteoNovus, Inc.
April 5, 2018
ADMINISTRATIVE INFORMATION
| Manufacturer Name | OsteoNovus, Inc. | |
|---|---|---|
| 1510 North Westwood Avenue, Suite 2040 | ||
| Toledo, OH 43606 | ||
| Telephone: | +1-419-530-5940 | |
| Fax | +1-419-530-5932 | |
| 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 K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc. The reference predicate device is K162087, NovoGro, OsteoNovus, Inc.
INDICATIONS FOR USE
NovoGro Putty is an implant intended to fill bony voids or gaps of the skeletal system (i.e. extremities, posterolateral spine and pelvis). NovoGro must be used with autograft as a bone extender in the posterolateral spine. These osseous defects may be surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The device resorbs and is replaced with 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 particles 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 particles 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, and chemical characterization was performed using methods described in ASTM F2024, ASTM F1185, and ASTM F1926/F1926M.
Physical characterization of the subject device included scanning 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 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 posterolateral spine fusion model. Animals implanted with autograft (positive control) also were evaluated. The study time points included baseline (time 0), 6 weeks, and 12 weeks. Evaluation endpoints included manual palpation, range of motion/flexibility testing, plain and 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). No clinical data were included in this submission.
Bioactivity testing included an in vitro study comparing the subject device NovoGro Putty, positive control (bioactive glass), and negative control (polyethylene) in the presence of simulated body fluid. Apatitic calcium phosphate formation was observed on surface of the NovoGro Putty and a positive
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control, but not on the surface of the negative control. Bioactivity has not been evaluated in human clinical trials.
EQUIVALENCE TO MARKETED DEVICE
OsteoNovus, Inc. submits the 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 devices, K140375, MASTERGRAFT® Strip; MASTERGRAFT® Putty, Medtronic Sofamor Danek USA, Inc., and K162087, NovoGro, OsteoNovus, Inc.
A comparison of the technological characteristics of the subject device and the primary predicate device K140375 is provided in the following table.
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Comparison | K173525NovoGroOsteoNovus, Inc. | K140375MASTERGRAFT® Strip; MASTERGRAFT® PuttyMedtronic Sofamor Danek USA, Inc. |
| Indications for Use | NovoGro Putty is an implant intended to fill bony voids orgaps of the skeletal system (i.e. extremities, posterolateralspine and pelvis). NovoGro must be used with autograft as abone extender in the posterolateral spine. These osseousdefects may be surgically created or the result of traumaticinjury to the bone and are not intrinsic to the stability of thebony structure. The device resorbs and is replaced with boneduring the healing process. | MASTERGRAFT® Putty combined with either autogenousbone marrow, and/or sterile water, and/or autograft isindicated as a bone void filler for bony voids or gaps that arenot intrinsic to the stability of the bony structure.Additionally, MASTERGRAFT® Putty can be used withautograft as a bone graft extender. MASTERGRAFT® Puttyis to be gently packed into bony voids or gaps of the skeletalsystem (e.g., the posterolateral spine, pelvis, ilium, and/orextremities). These defects may be surgically createdosseous defects or osseous defects created from traumaticinjury to the bone. MASTERGRAFT® Putty resorbs and isreplaced with bone during the healing process. |
| Product Code | MQV | MQV |
| Intended Use | Bone void filler for skeletal system (posterolateral spine,extremities, pelvis) | Bone void filler for skeletal system (posterolateral spine,extremities, pelvis) |
| Use in Spine | Mixed with autograft (required) | Mixed with autograft (optional) |
| Design | ||
| Form | Regularly shaped granules premixed with a solublepolymeric binder | Granules uniformly dispersed in collagen scaffold |
| Granule Size | 1-2 mm (1000 - 2000 um) | 0.5 mm - 1.6 mm in diameter |
| Porosity | 31.3% | Granules 80% |
| Materials | ||
| Calcium salts | monetite / newberyite / sodium hydrogen phosphate[CaHPO4 + Mg(PO3OH)*3(H2O) + NaH2PO4] | B-tricalcium phosphate (85%) andHydroxyapatite (15%) |
| Silicon | NovoGro Putty: 14% by weight | Not applicable |
| Scaffold/Binder | Sodium carboxymethyl cellulose (CMC) | Type I bovine collagen |
| How Supplied | ||
| Sizes, shapes | Provided in delivery/mixing syringeFinal graft volumes ranging from 1 cc - 20 cc | Provided in 0.75 cc, 1.5 cc, 3.0 cc, 6.0 cc, and 9.0 ccpackages |
| Sterility | Provided sterile to end-user | Provided sterile to end-user |
| Sterilization | Gamma irradiation | Not stated |
| Usage | Single-patient, single-use | Single-patient, single-use |
The primary predicate device is K140375 for substantial equivalence in the animal model performance testing. The reference predicate device is K162087 for support of substantial equivalence in terms of the device material composition and physical form.
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The subject device and the primary predicate device have intended use, the same product classification and product code (MQV), and have similar Indications for Use statements. The subject device and the primary predicate devices are bone void fillers that are intended for bony voids or gaps that are not intrinsic to the stability of the bony structure. The subject device and primary predicate device are indicated for use in the posterolateral spine with autograft bone (extender). Although the subject device and the primary 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 posterolateral spine.
The subject device and the primary predicate device each incorporate calcium phosphate materials within a polymeric binder or scaffold. The subject device polymeric binder is sodium carboxymethyl cellulose (CMC), and the primary predicate K140375 scaffold is type I bovine collagen. The subject device and the reference predicate device are identical in material composition and physical form. The subject device and the predicate devices are provided sterile for single-patient, single-use in similar ranges of graft volumes.
The subject device and the reference predicate device K162087 are the same except for the indications for use. The subject device is not to be hydrated after mixing of the dry powder component with the ultrapure water, the primary predicate K140375 is to be hydrated with bone marrow aspirate and/or sterile water prior to use. In the posterolateral spine the subject device must be mixed with autograft bone, whereas the primary predicate device may be used without or with autograft bone.
The radiographic, histologic, and histomorphometric performance of the subject device were compared to that of the primary predicate device K140375 in a rabbit posterolateral fusion model. The results of the study demonstrated that the performance of the subject device was equivalent to that of the predicate device K140375.
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 device and the predicate devices are provided sterile for single-patient, single-use in similar ranges of graft volumes, and 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.