(87 days)
Not Found
No
The device description and performance studies focus on the material composition and biological properties of the bone graft material, with no mention of AI or ML.
Yes.
PerioGlas is a bone graft material intended to treat oral/maxillofacial and dental intraosseous defects, which is a therapeutic purpose.
No
Explanation: PerioGlas is a bone graft material and void filler used for oral/maxillofacial and dental intraosseous defects. It is used in procedures like ridge augmentation, extraction sites, and sinus lifts. Its purpose is to facilitate bone formation and not to diagnose conditions.
No
The device description clearly states that PerioGlas is a synthetic osteoconductive particulate bone/void filler composed of Bioglass, which is a physical material. It is supplied as a sterile particulate and mixed with liquid for application. This is a physical medical device, not software.
Based on the provided information, PerioGlas is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that PerioGlas is a synthetic bone graft material for use in oral/maxillofacial and dental intraosseous defects. It is applied directly to the patient's body to fill voids and promote bone growth.
- Device Description: The description details the composition and physical form of the material, which is a particulate bone/void filler. It is mixed with sterile water or blood and applied to the defect.
- Lack of Diagnostic Purpose: There is no mention of PerioGlas being used to diagnose a disease or condition, or to examine specimens derived from the human body for diagnostic purposes.
- Performance Studies: The performance studies focus on bone formation, biomechanical properties, and clinical outcomes related to bone grafting, not diagnostic accuracy.
IVD devices are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. PerioGlas is a therapeutic device used to treat a physical defect.
N/A
Intended Use / Indications for Use
PerioGlas® is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:
- Periodontal defects ●
- Ridge augmentation .
- Extraction Sites ●
- Cranio-facial Augmentation .
- Sinus Lifts .
- Cystic Defects .
The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses include:
- Periodontal/Infrabony defects .
- Ridge augmentation .
- Extraction sites .
- Cranio-facial augmentation .
- Cystic cavities .
- . Sinus lifts
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
PerioGlas® is a synthetic osteoconductive particulate bone/void filler that is intended for oral/maxillofacial and dental intraosseous defects use. The material composed of Bioglass® (24.5 wt % CaO, 24.5 wt % Na20, 45 wt % SiO2, 6 wt % P2O5) with a particle size range of 90-710 um. It is supplied sterile in a Tyvek sealed PET-G cup that is protected by a shrink wrapped cardboard box. It is mixed with sterile water (saline) or the patient's own blood to form a wet sandy paste which is applied to the defect.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral/maxillofacial, dental intraosseous
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, sample size, AUC, MRMC, standalone performance, key results)
The performance of PerioGlas® was evaluated in animal models versus hydroxylapatite predicate devices. The rate of bone formation, amount of bone formed and the biomechanical properties including peak compressive loads and compressive stiffness were substantially equivalent to each other and normal bone.
PerioGlas® Bioglass® particulate was also evaluated as a graft extender with finely ground autogenous bone in a rabbit calvarial defect model and a canine split-rib model. In both of these models, bone formation or graft site augmentation was greater for the mixture of bone and Bioglass® than for either alone.
Clinical Data including prospective, retrospective and case studies were reviewed and evaluated for various dental and oral/maxillofacial intraosseous defects including a variety of ridge, periodontal, extraction sites, sinus augmentation and cystic defects using PerioGlas® alone and/or as a graft extender.
Periodontal studies showed no significant differences between PerioGlas®/Bone graft mixtures and PerioGlas® alone for a variety of clinical parameters including Clinical Attachment Level (CAL), Pocket Depth Reduction (PDR) and osseous fill. Results did suggest that there may be a synergistic effect when the two graft materials are combined.
Ridge augmentation, extraction site, sinus augmentation, cystic defect and general osseous reconstruction studies demonstrated safe and efficacious use of PerioGlas® alone and/or as a graft extender in these indications. Results from a four clinician retrospective study, as measured by the overall implant success rate (91%), indicate that the use of PerioGlas® as a bone graft extender is safe and efficacious for ridge augmentation, extraction sites and sinus augmentation.
Documented case reports representing all of the summarized categories with clinical evaluations and radiographs support the safety and efficacy of PerioGlas® alone or as a bone graft extender in bone/void filling.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Overall implant success rate (91%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 1 5 1999
Ka9q2416
510(k) Summary
General Information
| Classification Name: | Endosseous Implant for Bone Filling and/or Augmentation |
|---|---|
| Common Name: | Bioglass® Synthetic Bone Graft Particulate |
| Trade Name: | PerioGlas® |
| Submitter's Name : | USBiomaterials Corporation |
| Address: | One Progress Boulevard, #23 |
| Alachua, FL 32615 | |
| Telephone: | (904) 462-7660 |
| Facsimile: | (904) 462-7605 |
| Contact: | Albert Fosmoe II, Director of Quality Assurance and Regulatory Affairs |
| Date of Summary: | July 1999 |
Device Description
PerioGlas® is a synthetic osteoconductive particulate bone/void filler that is intended for oral/maxillofacial and dental intraosseous defects use. The material composed of Bioglass® (24.5 wt % CaO, 24.5 wt % Na20, 45 wt % SiO2, 6 wt % P2O5) with a particle size range of 90-710 um. It is supplied sterile in a Tyvek sealed PET-G cup that is protected by a shrink wrapped cardboard box. It is mixed with sterile water (saline) or the patient's own blood to form a wet sandy paste which is applied to the defect.
Predicate Device
PerioGlas® is substantially equivalent to legally marketed osteoconductive bone filling and/or augmentation devices in the U.S. including Calcitite (K852682) and Bio-Oss (K970321). Any minor differences between PerioGlas® and the predicate devices do not raise new questions of safety or effectiveness.
Intended Use
PerioGlas® is intended to fill and/or augment dental intraosseous and oral/maxillofacial defects including:
- Periodontal defects ●
- Ridge augmentation .
- Extraction Sites ●
- Cranio-facial Augmentation .
- Sinus Lifts .
- Cystic Defects .
Device Testing
The performance of PerioGlas® was evaluated in animal models versus hydroxylapatite predicate devices. The rate of bone formation, amount of bone formed and the biomechanical
1
properties including peak compressive loads and compressive stiffness were substantially equivalent to each other and normal bone.
PerioGlas® Bioglass® particulate was also evaluated as a graft extender with finely ground autogenous bone in a rabbit calvarial defect model and a canine split-rib model. In both of these models, bone formation or graft site augmentation was greater for the mixture of bone and Bioglass® than for either alone.
Clinical Data including prospective, retrospective and case studies were reviewed and evaluated for various dental and oral/maxillofacial intraosseous defects including a variety of ridge, periodontal, extraction sites, sinus augmentation and cystic defects using PerioGlas® alone and/or as a graft extender.
Periodontal studies showed no significant differences between PerioGlas®/Bone graft mixtures and PerioGlas® alone for a variety of clinical parameters including Clinical Attachment Level (CAL), Pocket Depth Reduction (PDR) and osseous fill. Results did suggest that there may be a synergistic effect when the two graft materials are combined.
Ridge augmentation, extraction site, sinus augmentation, cystic defect and general osseous reconstruction studies demonstrated safe and efficacious use of PerioGlas® alone and/or as a graft extender in these indications. Results from a four clinician retrospective study, as measured by the overall implant success rate (91%), indicate that the use of PerioGlas® as a bone graft extender is safe and efficacious for ridge augmentation, extraction sites and sinus augmentation.
Documented case reports representing all of the summarized categories with clinical evaluations and radiographs support the safety and efficacy of PerioGlas® alone or as a bone graft extender in bone/void filling.
Conclusions
The animal and/or clinical performance, safety and effectiveness data show that the device performs as well as or better than predicate hydroxylapatite devices as an osteoconductive bone void filler both alone or as a bone graft extender.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, resembling a bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 5 1999
Mr. Albert Fosmoe II Director of Regulatory Affairs US Biomaterials Corporation One Progress Boulevard #23 Alachua, Florida 32615
K992416 Re : Perioglas - Bioglass Bone Graft Particulate Trade Name: Regulatory Class: Unclassified • Product Code: LYC Dated: July 16, 1999 Received: July 20, 1999
Dear Mr. Fosmoe II:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A . substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
3
Paqe 2 - Mr. Fosmoe II
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patrucco Cacciola Hoz
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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| 510(k) Number (if known): | K992416 |
|---|---|
| Device Name: | PerioGlas® |
Indications For Use:
The intended use of PerioGlas is to provide a safe, biocompatible synthetic bone graft material for oral/maxillofacial and dental intraosseous defects use. It is to be used alone in a manner comparable to autogenous bone graft chips or allograft bone particulate (DFDBA demineralized freeze dried bone) or may be mixed with each as a bone graft extender. Typical uses include:
- Periodontal/Infrabony defects .
- Ridge augmentation .
- Extraction sites .
- Cranio-facial augmentation .
- Cystic cavities .
- . Sinus lifts
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | KC992416 |
|---|---|
| --------------- | ---------- |
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