(456 days)
No
The device description focuses on the material composition, manufacturing process (3D printing), and physical properties of a synthetic bone grafting material. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance studies described are based on animal models and histomorphometric analysis, not on the output of an AI/ML algorithm.
Yes.
The device is used to fill and/or augment osseous defects, promoting new bone growth, which addresses a health condition.
No
The device is a synthetic bone grafting material used for filling and augmenting osseous defects, not for diagnosing conditions.
No
The device description clearly states that CMFlex™ is a synthetic bone grafting material provided in block form, composed of hydroxyapatite powder and polylactide-co-glycolide, fabricated via 3D-printing. This describes a physical, implantable material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- CMFlex™ Function: CMFlex™ is a synthetic bone grafting material intended for direct implantation into the body to fill and augment bone defects. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly describes surgical procedures for bone repair and augmentation, not laboratory testing of biological samples.
- Device Description: The description focuses on the material composition, structure, and physical properties of the implantable block.
- Performance Studies: The performance studies described involve animal models and assessments of bone growth and integration within the body, not diagnostic accuracy based on in vitro testing.
Therefore, CMFlex™ falls under the category of an implantable medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include:
- Intrabony periodontal osseous defects
- Furcation defects
- Bony defects or bony deficiencies of the alveolar ridge
- Intraoral, maxillofacial, and mandibular augmentation
- Bony defects of the upper or lower jaw
- Filling of tooth extraction sites
- Sinus elevation grafting
Product codes
LYC
Device Description
CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillofacial, mandibular, intraoral osseous defects, intrabony periodontal osseous defects, furcation defects, bony defects or bony deficiencies of the alveolar ridge, Intraoral, maxillofacial, and mandibular augmentation, Bony defects of the upper or lower jaw, tooth extraction sites, Sinus elevation grafting
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
Study Type: Performance in animal model
Sample Size: Not specified, canine critical sized defect model
Key results: CMFlexTM was evaluated for performance and biocompatibility as compared to the predicate device in a one-wall dental defect canine model at 4, 8, and 12 weeks. Assessments included radiography, microCT, and histomorphometric analysis. Endpoints included new bone growth, residual implant material, preservation of ridge (height, width, depth), changes to surrounding bone, and any significant adverse findings (i.e., exuberant necrosis, proliferative granulation tissue/fibrosis, extensive inflammation, or evidence of infection). Results demonstrated that CMFlexTM was able to maintain ridge height, width, and depth and showed similar bone forming capacity and steady state inflammatory response accompanying the absorption process when compared to the predicate device.
Study Type: Chemical composition
Key results: The subject and predicate devices are composed of a majority calcium phosphate component and minority biodegradable polyester component.
Study Type: Crystallinity (of calcium phosphate component)
Key results: The subject and predicate devices have calcium phosphate crystallinities >90%.
Study Type: Calcium phosphate particle morphology
Key results: The subject and predicate devices possess spherical calcium phosphate particles.
Study Type: Pore structure
Key results: The subject and predicate devices have interconnected pores around 0.2mm and primary pores around 1mm.
Study Type: Porosity
Key results: The subject and predicate devices have porosities greater than 50%.
Study Type: Mechanical strength (compressive)
Key results: The devices provide adequate handling properties and strength to ensure dimensional integrity when handled by the surgeon and delivered to bony application sites; devices have similar compressive properties.
Study Type: pH in phosphate buffered saline
Key results: The subject and predicate device have similar pH.
Study Type: Biocompatibility
Key results: Devices passed cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity testing according to ISO 10993.
Study Type: Sterilization Validation
Key results: CMFlexTM passed all acceptance criteria for validating the end sterilization method.
Study Type: Shelf Life
Key results: CMFlexTM had no significant mechanical property changes or clinically meaningful compositional (ceramic and polymer component) and microstructural changes after accelerated (12-month simulation) and real-time aging (6 months and 12 months).
Study Type: Package Integrity Testing (Initial and aged samples)
Key results: CMFlexTM packaging passed all package integrity testing as is and after accelerated (12-month simulation) and real-time aging (6 months and 12 months).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
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 the FDA logo, which 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.
Dimension Inx Corp. Ramille Shah Chief Science Officer 3440 S Dearborn St. Suite 142S Chicago, Illinois 60616
Re: K213260
Trade/Device Name: CMFlex™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: December 19, 2022 Received: December 19, 2022
Dear Ramille Shah:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K21360
Device Name CMFlex(TM)
Indications for Use (Describe)
CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include: 22552
- · Intrabony periodontal osseous defects
- · Furcation defects
- · Bony defects or bony deficiencies of the alveolar ridge
- · Intraoral, maxillofacial, and mandibular augmentation
- · Bony defects of the upper or lower jaw
- · Filling of tooth extraction sites
- · Sinus elevation grafting
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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K213260 CMFlex™
510(K) Summary
DEVICE TRADE NAME CMFlex™
MANUFACTURER
Dimension Inx 3440 S. Dearborn St., Suite 142S Chicago, IL 60616 Phone: (312) 235-3510
CONTACT
Ramille Shah, Ph.D. ramilleshah(@dimensioninx.com
Consultant:
Mehdi Kazemzadeh-Narbat, PhD, PMP, CQA Associate Director, Regulatory Affairs, MCRA, LLC Office: (202) 552-6011 mkazemzadeh(@mcra.com
DATE PREPARED
December 30, 2022
CLASSIFICATION
Bone Grafting Material, Synthetic (21 CFR 872.3930)
PRODUCT CODE LYC
PRIMARY PREDICATE
Trade name: OsteoScaf™ Common name: Bone Grafting Material, Synthetic 510(k) number: K101827
REFERENCE DEVICE
Trade name: Easy-Graft® Common name: Bone Grafting Material, Synthetic 510(k) number: K131385
INDICATIONS FOR USE
CMFlex™ is indicated for filling and/or augmenting maxillofacial, mandibular, and intraoral osseous defects. Indications include:
- -Intrabony periodontal osseous defects
- Furcation defects
- Bony defects or bony deficiencies of the alveolar ridge -
- -Intraoral, maxillofacial, and mandibular augmentation
- Bony defects of the upper or lower jaw -
- -Filling of tooth extraction sites
- -Sinus elevation grafting
4
DEVICE DESCRIPTION
CMFlex™ is a synthetic bone grafting material provided in block form of varying sizes (See Table 1.1) that can be easily trimmed or cut by the surgeon to fit the patient's bone defect(s). CMFlex™ is composed of majority synthetic hydroxyapatite powder bound by minority biodegradable polylactide-co-glycolide. CMFlex™ is fabricated via extrusion-based 3D-printing of liquid inks into regular porous structures. The combined macroscopic 3D-printed porosity, microporosity within the printed struts, and micron-sized hydroxyapatite particles gives CMFlex unique microstructural and physical properties. CMFlex™ is an osteoconductive, highly absorbent, and flexible bone graft that can be used in defects where new bone is needed. Although it is not intended for immediate load bearing applications, the implant remodels over time and is replaced by new bone tissue, functioning in the same manner as the predicate device. The blocks are provided sterile and are intended for single use. There are no accessories associated with CMFlex™.
CMFLEXTM BLOCK SIZES AND VOLUMES
| Product | Dimensions (mm) | Approximate
Volume |
|---------------------|-------------------|-----------------------|
| CMFlex™ Block, 1cc |
15
15
5 | 1 cc |
| CMFlex™ Block, 6cc |
38
38
4 | 6 cc |
| CMFlex™ Block, 13cc |
38
38
9 | 13 cc |
Table 1.1. CMFlex™ Block Sizes and Volumes
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Table 1.2. CMFlex™ as Compared to Predicate and Reference Devices | |
|---|---|
| -- | ------------------------------------------------------------------- |
| | Subject Device | Primary Predicate
Device | Secondary Predicate
Device | Comparison |
|--------------------------|---------------------|-------------------------------------------------------|-------------------------------|----------------------------|
| Trade Name | CMFlex™ | OsteoScaf™ | Easy-Graft® | N/A |
| Manufacturer | Dimension Inx Corp. | Texas Innovative
Medical Devices
(DBA) Skeletal | Guidor® | N/A |
| 510(k) Number | K213260 | K101827 | K131385 | N/A |
| Product Code | | LYC | | Same product code |
| Device Class | | Class II | | Same device class |
| Device
Classification | | Bone grafting material, synthetic | | Same device classification |
5
Dimension Inx
| Indications for Use | Indicated for filling
and/or augmenting
maxillofacial,
mandibular, and
intraoral osseous
defects. Indications
may include:
- Intrabony
periodontal osseous
defects - Furcation defects
- Bony defects or bony
deficiencies of the
alveolar ridge - Intraoral,
maxillofacial, and
mandibular
augmentation - Bony defects of the
upper or lower jaw - Filling of tooth
extraction sites - Sinus elevation
grafting | Indicated for filling
and/or augmenting
intraoral/maxillofacial
osseous defects, such
as intrabony
periodontal osseous
defects, furcation
defects, augmentation
of bony defects of the
alveolar ridge, filling
of tooth extraction
sites, and sinus
elevation grafting. | Indicated for the
treatment of intraoral /
maxillofacial osseous
defects. Dental and
maxillo-facial
indications may
include: extraction
defects (alveolar ridge
preservation),
periodontal defects,
pen-implant defects,
augmentation of
deficient alveolar crest,
sinus floor
augmentation, defects
after surgical
extractions, defects
after removal of bony
cysts, defects after root
resection or
apicoectomy, defects
after removal of
autologous bone. | Intended use includes
elements of the predicate
devices, supported by
performance testing in canines |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
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| Prescription/OTC | Prescription | All require prescription | ||
|---|---|---|---|---|
| Composition | 90% HA | |||
| 10% PLG | 78% CP | |||
| 22% PLG | 99% β-TCP | |||
| 1% PLG | ||||
| N-methyl-2- | ||||
| pyrrolidone | All devices comprised of a | |||
| majority calcium phosphate | ||||
| component combined with a | ||||
| degradable polymer | ||||
| component | ||||
| Physical | ||||
| Morphology | Interconnecting pore structure | Similar pore morphology | ||
| Porosity (Nominal) | 85% | 80% | 53% | Similar porosity to primary |
| predicate | ||||
| Pore Size | 0.20 - 0.27 mm | 0.20 mm | 0.23 mm | All devices have similar pore |
| sizes | ||||
| Form | Block | Particulate, Cylinder, | ||
| Block | Granule | Similar form factor to primary | ||
| predicate | ||||
| Crystallinity | 96% | Not Available | 92% | Similar crystallinity to |
| secondary predicate | ||||
| Resorption1 | Resorbable | Resorbable | Resorbable | Similar resorption |
| characteristics to primary | ||||
| predicate | ||||
| Sterility | Sterile; One-time | |||
| single patient use | Sterile; One-time | |||
| single patient use | Sterile; One-time | |||
| single patient use | All devices are sterile and for | |||
| single use only |
1Based on composition
Device Intended Use and Descriptions
CMFlex™, OsteoScaf™, and Easy-Graft® are all sterile, porous, ceramic-polymer composite single-use bone grafting materials intended for use in the filling, augmenting, or treating intraoral/maxillofacial defects. All three are class II devices and fall under the same product code, LYC.
Device Compositions and Resorption
CMFlex™, OsteoScaf™ and Easy-Graft® are comprised of discrete micro-scale, spherical calcium phosphate ceramic particles (90. 78. 99 wt.%, respectively) and the biodegradable polyester binder, poly(lactide-co-glycolide), or PLG, (10, 22, 1 wt.%, respectively). The phase of the calcium phosphate component of CMFlex™ is primarily synthetic hydroxyapatite, with minor amounts of beta tricalcium phosphate (B-TCP), while the phases of the calcium phosphate components of OsteoScaf™ and Easy-Graft® are minority hydroxyapatite, with majority di/tetra calcium phosphate and ß-TCP, respectively. The calcium phosphate components of CMFlex™ and Easy-Graft® are primarily crystalline (>90%) and the particles comprising CMFlex™ are 23 um in diameter on average, while those of OsteoScaf™ are 27.5 um on average. The difference in composition among the devices primarily affect the rate of resorption of the devices, but do not affect the substantial equivalanceof the devices for their intended use.
7
Device Porositv
Like CMFlex™, OsteoScaf™, and Easy-Graft® possess interconnected micro-and macro-pores formed by overlapping fibers or bound calcium phosphate particles. While CMFlex™ and OsteoScaf™ have total porosity exceeding 80 vol. %, Easy-Graft® had a measured porosity of 53.4 vol.%; however, this value does not include the interconnected porosity within the larger calcium phosphate particles that comprise the majority of Easy-Graft® (which could not be accurately measured). Thus, the actual total porosity of Easy-Graft® may be significantly greater than 53.4 vol.%. and more similar to CMFlex™ and OsteoScaf™ (both >80% porosity with 0.25-1.20 mm pore size). Like CMFlex™, OsteoScaf™ and Easy-Graft® are flexible or moldable, absorb fluid, and are bioresorbable.
Device Form Factors and Volumes
CMFlex™ and OsteoScaf™ are comparable in form factors and sizing: CMFlex™ is available in blocks of varying volumes, while OsteoScaf™ is available in blocks, cylinders, and particulates. Like the various OsteoScaf™ form factors, the various CMFlex™ block volume options are provided as a convenience to the surgeon. Both CMFlex™ and OsteoScaf™ may be further trimmed to ensure an appropriate, custom fit to the patient's defect. Easy-Graft® is available in multiple volumes, but rather than solid form factors, it comes as a kit of PLG coated calcium phosphate particles that are mixed with solvent prior to injection into boney defect. All CMFlex™ volumes share a single "indications for use" statement, which is common to the "indications for use" statement provided for the OsteoScaf™ and Easy-Graft® predicate devices.
PERFORMANCE DATA
The following non-clinical and preclinical tests were performed to support a demonstration of substantial equivalence:
| Purpose | Method | Conclusions
(based on testing results and published information) |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemical composition | Thermogravimetric analysis | The subject and predicate devices are composed of a majority calcium phosphate component and minority biodegradable polyester component. |
| Crystallinity (of calcium phosphate component) | X-ray diffraction, ASTM F2024-10R21 | The subject and predicate devices have calcium phosphate crystallinities >90%. |
| Calcium phosphate particle morphology | Scanning electron microscopy | The subject and predicate devices possess spherical calcium phosphate particles. |
| Pore structure | Scanning electron microscopy | The subject and predicate devices have interconnected pores around 0.2mm and primary pores around 1mm. |
| Porosity | Porosimetry (BET analysis) | The subject and predicate devices have porosities greater than 50%. |
| Mechanical strength (compressive) | Compressive mechanical testing, ASTM D695-15 | The devices provide adequate handling properties and strength to ensure dimensional integrity when handled by the surgeon and delivered to bony application sites; devices have similar compressive properties. |
| pH in phosphate buffered saline | ASTM F1635-16 | The subject and predicate device have similar pH. |
| Biocompatibility | ISO 10993 series of standards | Devices passed cytotoxicity, sensitization, irritation, material-mediated pyrogenicity, genotoxicity, and systemic toxicity testing according to ISO 10993. |
| Performance in animal
model | Canine critical sized
defect model and ISO
10993-6 | CMFlexTM was evaluated for performance and
biocompatibility as compared to the predicate device in a
one-wall dental defect canine model at 4, 8, and 12 weeks.
Assessments included radiography, microCT, and
histomorphometric analysis. Endpoints included new bone
growth, residual implant material, preservation of ridge
(height, width, depth), changes to surrounding bone, and
any significant adverse findings (i.e., exuberant necrosis,
proliferative granulation tissue/fibrosis, extensive
inflammation, or evidence of infection). Results
demonstrated that CMFlexTM was able to maintain ridge
height, width, and depth and showed similar bone forming
capacity and steady state inflammatory response
accompanying the absorption
process when compared to the predicate device. |
| Sterilization Validation | Pre-Sterilization
Bioburden (ISO 11737-
1); LAL Endotoxin
(USP); Chamber
Mapping; Residuals
testing; Bioburden
Recovery, Inactivation
Kinetics (ISO 11138-1);
Performance
Qualification (ISO
11138-1:2017, ISO
11138-7:2019, ISO
14937:2009) | CMFlexTM passed all acceptance criteria for validating the
end sterilization method. |
| Shelf Life | Device properties after
accelerated and real time
aging: Compressive
mechanical testing,
polymer molecular
weight, ceramic
composition and
crystallinity (ASTM
F2024:2021), and
microstructure (SEM) | CMFlexTM had no significant mechanical property changes
or clinically meaningful compositional (ceramic and
polymer component) and microstructural changes after
accelerated (12-month simulation) and real-time aging (6
months and 12 months). |
| Package Integrity Testing
(Initial and aged
samples) | ASTM F2096; ASTM
F88 | CMFlexTM packaging passed all package integrity testing
as is and after accelerated (12-month simulation) and real-
time aging (6 months and 12 months). |
Table 1.3 Substantial Equivalence Performance Testing Summary
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CONCLUSIONS
CMFlex™ was compared with the identified predicate devices based on the indications for use, composition, porosity, mechanical strength, biocompatibility testing, and performance studies. CMF lex™ has similar compositional components (e.g., a combination of a biodegradable polymer and calcium phosphate particles), microstructural properties (percent porosity and pore size), pH, and compressive mechanical characteristics. Furthermore, CMFlex™ passed all biocompatibility testing per ISO 10993, and head-to-head comparison with the predicate in a canine critically sized dental defect model showed similar bone forming capacity associated with device remodeling and osteoconduction over time. Based on these studies, the subject device, CMFlex™ is found to be substantially equivalent to the predicate device.