(85 days)
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None
No
The device description focuses on the material composition and physical form of a bioresorbable calcium particle product, with no mention of software, algorithms, or any AI/ML related terms.
No
The device, Bii-GRAFT™ 6140 Bioresorbable Calcium Particles, is described as an "osteoconductive biomatrix" used to fill "osseous defects such as periodontal lesions." While it aids in bone regeneration, it is a material that promotes a biological process rather than actively treating a condition in a therapeutic sense like a drug or a device that delivers energy. It functions more as an implant or a regenerative medical material.
No
The device description indicates Bii-GRAFT™ 6140 Bioresorbable Calcium Particles are an "osteoconductive biomatrix" used to approximate "the chemical constituent of natural bone" for "osseous defects". This description points to a therapeutic or reconstructive function rather than diagnosis. There is no mention of identifying or characterizing diseases or conditions.
No
The device description explicitly states it is "Bii-GRAFT™ 6140 Bioresorbable Calcium Particles," which are physical particles, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description states the device is used for "osseous defects such as periodontal lesions." This indicates a direct application to the body for a therapeutic purpose (bone regeneration), not for testing samples in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a "bioresorbable calcium particles" material used as an "osteoconductive biomatrix." This is consistent with a medical device used for tissue repair, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
Therefore, the information strongly suggests this is a medical device used for bone grafting, not an IVD.
N/A
Intended Use / Indications for Use
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Product codes
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Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Bio-Interfaces, Inc. Pre Market Notification
ATTACHMENT IV
The calcium phosphate materials have a well-established biocompatibility profile, based on many years of clinical experience. The ability of calcium phosphate biomaterials in the size range of Bii-GRAFT™ to support bone adaptation is supported by many years of preclinical studies and clinical usage, demonstrating the attractiveness of such calcium phosphates as an endosseous implant material for filling and contouring osseous defects such as periodontal lesions. Such an indication represents a low- or no-load reconstructive or augmentation clinical condition.
Bio-Interfaces. Inc. has conducted a reasonable search of materials research and clinical experience from available published literature and oral communications and presentations at professional forums, as well as private communications with clinicians, regarding the performance of bioresorbable calcium phosphate bone graft substitute materials. Additionally, in-vitro characteristics have been performed and specifications developed for the Bii-GRAFT™ Bioresorbable Calcium Phosphate Particulate material. A review of available clinical results on similar materials indicate efficacy as a synthetic bone graft substitute material, when used in accordance with the guidelines provided in the Instructions for Use. We have concluded that the Bli-GRAFT™ Bioresorbable Calcium Phosphate Particles are substantially equivalent to the referenced devices and are safe and effective for their stated uses. Extensive literature citings have been included with this application.
Bil-GRAFT™ 6140 Bioresorbable Calcium Particles are substantially equivalent to allogeneic freeze-dried bone, Bii-GRAFT™ 1860, Osteograf-LD™ synthetic materials. The determination of equivalence has also been based on the chemical and physical characteristics of Bii-GRAFT™:
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Bii-GRAFT™ 6140 is an osteoconductive biomatrix that approximates the chemical constituent of natural bone. The physical form of the material is particulate particles in the range of 105-250u. The nominal composition is 75 percent HA.
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Bil-GRAFT™ meets or exceeds specifications for trace elements and HA/TCP content (chemistry), as specified in ASTM F-1185 and F-1088, the Standard Specifications of Ceramic Hydroxylapatite and Tricalcium Phosphate for Surgical Implants.
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Trace element analysis of Bii-GRAFT™ indicates that the material is at or below the limits established in ASTM F-1088 and F-1185 for TCP and HA, respectively.
v
1
Bio-Interfaces, Inc. Pre Market Notification
ATTACHMENT IV
- That sterilization or re-sterilization using the methods and cycles indicated have no significant effect on the material.
A reasonable attempt has been made to anticipate adverse safety and effectiveness conditions for the submitted device. Like any other implant, this type of bone graft substitute is susceptible to potential clinical problems, but it is believed that they are secondary to the response to the material itself. It is felt that some complications are a result of a failure to heed stated contraindications and practices dictated in the Instructions for Use. Such problems as migration, extrusion, dehiscence, sloughing, delayed healing, paresthesia, edema, hematoma, latent infection, inflammation and local and/or generalized allergic reactions can occur. Conditions such as wound breakdown and dehiscence many times can be traced to clinical placement errors, such as overfilling or failure to properly contain the particulate material after placement. Major load-bearing defects should not be filled with particulate grafting material and it is also important to place the particles in direct contact with bleeding bone. Care needs to be exercised in the use of the material to avoid surqical-related complications.
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