(86 days)
No
The summary describes a bone graft material and its clinical performance, with no mention of AI or ML technology.
Yes
Perioglas® is used to treat infraboney pockets caused by periodontal disease, extraction sites, and for ridge augmentation, directly addressing medical conditions and restoring body structures.
No
Explanation: The device, Perioglas®, is a bone graft particulate used for treatment (filling infraboney pockets, extraction sites, and ridge augmentation) rather than for diagnosing a condition. Its performance studies focus on healing and integration, not on diagnostic accuracy.
No
The device description explicitly states it is a "bioactive glass particulate," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use of Perioglas® is for use in infraboney pockets, extraction sites, and ridge augmentation. These are all procedures performed in vivo (within the living body) to treat or augment bone tissue.
- Device Description: Perioglass® is a bone graft particulate, a material implanted into the body.
- Lack of In Vitro Testing: The description focuses on clinical use and radiographic analysis of bone integration in vivo. There is no mention of testing samples of human origin in vitro (outside the body) to diagnose a condition or monitor a physiological state.
IVD devices are typically used to examine specimens (like blood, urine, or tissue) in vitro to provide information for diagnosis, monitoring, or screening. Perioglas® is a therapeutic device used directly on the patient's bone.
N/A
Intended Use / Indications for Use
The intended uses have been extended to extraction sites and ridge augmentation based upon additional clinical data and determination of substantial equivalence to the legally marketed device Orthovita- Biogran™ (Ref. [510(k)]# K952922, K941780).
Product codes
76LYC
Device Description
Perioglass® Bone Graft Particulate is a bioactive glass particulate (90-710 microns).
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
To confirm safety and efficacy, a recently completed human clinical study in extraction sites demonstrated favorable results for Perioglas® which documented significant new trabecular bone growth at two months after implantation. In this clinical study 16 patients and 20 sites were treated. At eight (8) weeks, radiographic analysis indicated that the Perioglas® integrated well into the bone tissue and by palpitation of the surgical sites, bone was pronounced solid. At six (6) months radiographic differences between the glass particles and bone tissue had nearly disappeared. Healing was uneventful without complaints from subjects. Two years follow-up demonstrated that Perioglas® is an effective osseous grafting material for the prevention of alveolar bone collapse restoration in extraction sites.
Key Metrics
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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.
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Section X- 510(k) Summary
510(k) Summary Statement (as required by section 807.92(c) Perioglas®-Bioglass® Bone Graft Particulate
Trade Name : Perioglas - Bioglass® Bone Graft Particulate Common Name : Synthetic Bone Grafting Material Classification Name and No.: Bone Implant, Endosseous for Bone Filling and/or Augmentation 76LYC Device Classification : Class III Federal Register, Vol. 52, No. 155, Wednesday August 12, 1987, Section 872.3640, Docket Number 78N-2887.
Perioglass® Bone Graft Particulate is a bioactive glass particulate (90-710 microns). Perioglas® has previously been shown to be substantially equivalent to a number of hydroxyapatite materials currently marketed, including Hapset™, Osteogen®, and Periograf® synthetic bone grafting materials. This equivalency was determined in Premarket Notification [510(k)] Number K930115. November 1993, in which Perioglas® is indicated for use in infraboney pockets caused by periodontal disease.
The intended uses have been extended to extraction sites and ridge augmentation based upon additional clinical data and determination of substantial equivalence to the legally marketed device Orthovita- Biogran™ (Ref. [510(k)]# K952922, K941780).
To confirm safety and efficacy, a recently completed human clinical study in extraction sites demonstrated favorable results for Perioglas® which documented significant new trabecular bone growth at two months after implantation. In this clinical study 16 patients and 20 sites were treated. At eight (8) weeks, radiographic analysis indicated that the Perioglas® integrated well into the bone tissue and by palpitation of the surgical sites, bone was pronounced solid. At six (6) months radiographic differences between the glass particles and bone tissue had nearly disappeared. Healing was uneventful without complaints from subjects. Two years follow-up demonstrated that Perioglas® is an effective osseous grafting material for the prevention of alveolar bone collapse restoration in extraction sites.
Physicians conclude that Perioglas® is both safe and effective in extraction sites and in reconstruction and augmentation of the alveolar ridge. Positive long-term results are expected, consistent with those documented for many years in the refereed literature in medicine and biomaterials.
Daphna Rachel Ariel
Daphna Rachel Ariel / Submitter Date: 6/22/96
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