(200 days)
No
The device description and intended use are focused on a bone grafting material and its physical properties and performance in animal studies. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
Yes.
The device is intended for augmentation or reconstructive treatment of various defects, filling, and elevation within the maxillo-facial complex, which are therapeutic interventions.
No
Explanation: The provided text describes OSSIX™ BONE as a bone grafting material intended for reconstructive and regenerative treatments, not for diagnosing conditions. Its intended uses involve filling defects and augmenting bone, which are therapeutic actions.
No
The device description clearly states that OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material composed of synthetic crystalline non-sintered hydroxylapatite and collagen. This is a physical material intended for implantation, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
- OSSIX™ BONE's Intended Use: The intended uses listed for OSSIX™ BONE are all related to surgical implantation for bone regeneration and augmentation within the body (in vivo). This is a therapeutic or reconstructive purpose, not an in vitro diagnostic test.
- Device Description: The description details a bone grafting material designed to be implanted and gradually resorbed, acting as a scaffold for bone growth. This aligns with an implantable medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of examining specimens, performing tests on samples outside the body, or providing diagnostic information based on such tests.
Therefore, OSSIX™ BONE is a medical device intended for surgical implantation, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
OSSIX™ BONE is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge; .
- Filling of periodontal defects; .
- Filling of defects after root resection, apicoectomy and cystectomy; .
- . Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor; ●
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
- . Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Product codes
NPM
Device Description
OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. OSSIX™ BONE is designed as a 3-D highly porous scaffold with physiological pH.
OSSIX™ BONE is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide; the shelf life of the device is 36 months.
Due to its porous and fibered microstructure, the matrix readily absorbs fluids, adheres to the surrounding tissues, and provides a scaffold that guides bone growth and regeneration. After implantation, OSSIX™ BONE undergoes gradual resorption in the body. Preclinical studies demonstrated that 50% or greater implant material remains at the 6-month time point.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge; periodontal defects; defects after root resection, apicoectomy and cystectomy; extraction sockets; maxillary sinus floor; peri-implant defects; maxillo-facial complex
Indicated Patient Age Range
Adults
Intended User / Care Setting
trained dentists or oral surgeons in clinics during routine dental surgical procedures
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
Biocompatibility testing: The biocompatibility evaluation of OSSIX™ BONE was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, 2016, and International Standard ISO10993-1:2009 (Cor 1:2010) Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing. The final sterile device was tested for: cytotoxicity, pyrogenicity, sensitization, intracutaneous reactivity, genotoxicity, implantation, systemic toxicity (acute), subchronic toxicity, chronic toxicity. OSSIX™ BONE is categorized as an implant device in contact with bone/tissue.
Sterility validation: The sterilization process is established and validated according to: ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --. Requirements for the development, validation and routine control of a sterilization process for medical devices. The ability of the packaging to maintain the sterility of the product was demonstrated in packaging and shelf life studies. Viral inactivation studies were conducted to demonstrate the ability of the manufacturing process to remove or inactivate viruses.
In vitro product characterization: Testing was performed using Scanning Electron Microscope (SEM), X-ray Diffraction (XRD), Mechanical properties (compression), Chemical Analysis before and after manufacturing process, Infra-Red spectroscopy before and after manufacturing process, Amino acid analysis, and Porosity, density measurement.
Animal study: An in vivo animal study was conducted in an L-shape buccal mandibular defect model system in Beagle dogs to evaluate the in vivo performance and degradation of the device to support substantial equivalence. The study was conducted on 19 animals followed up for 1, 3 and 6 months. The performance of the subject OSSIX™ BONE in this study was compared to the predicate device, Geistlich Bio-Oss Collagen®, using a cleared OSSIX™ PLUS membrane in both treatments. The subject and predicate devices performed similarly in an L-shape buccal mandibular defect model system in Beagle dogs.
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2017
Datum Dental Ltd % Janice Hogan Partner Hogan Lovells US LLP 1835 Market St, 29th Floor Philadelphia, Pennsylvania 19103
Re: K163714
Trade/Device Name: Ossix Bone Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: July 5, 2017 Received: July 5, 2017
Dear Janice Hogan:
This letter corrects our substantially equivalent letter, indications for use and the correct 510(k) Summary of July 18, 2017.
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
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comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -S
for
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page
510(k) Number (if known)
K163714
Device Name
OSSIX™ BONE
Indications for Use (Describe)
OSSIX™ BONE is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge:
- Filling of periodontal defects;
- Filling of defects after root resection, apicoectomy and cystectomy; .
- . Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor;
- Filling of periodontal defects in coniunction with products intended for Guided Tissue Regeneration (GTR) . and Guided Bone Regeneration (GBR);
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR). .
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
O Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
I. Submitter
Datum Dental Ltd. 1 Bat Sheva st., PO Box 6170 Lod 7116003 Israel Phone: 1-972-8-6705400 Fax: 1-972-8-6705429 Arie Goldlust, CEO, VP R&D Contact person:
Date prepared: July 5, 2017
II. Device
| Trade name: | OSSIX™ BONE |
|---|---|
| Common name: | Dental bone grafting material |
| Classification name: | Bone grafting material (21 CFR 872.3930) |
| Regulatory class: | II |
| Product code: | NPM |
III. Predicate Device
Primary predicate: Geistlich Bio-Oss Collagen® (K122894)
References devices: OSSIX® PLUS (K160281), OSSIX® VOLUMAX (K153549)
IV. Device Description
OSSIX™ BONE is a biodegradable, osteoconductive, and biocompatible bone grafting material intended for guided tissue and bone regeneration. The OSSIX™ BONE matrix is composed of 80% synthetic crystalline non-sintered hydroxylapatite and 20% collagen, which is derived from veterinary certified pigs and is purified and cross-linked. OSSIX™ BONE is designed as a 3-D highly porous scaffold with physiological pH.
OSSIX™ BONE is packed in a double blister and an outer cardboard box and is sterilized by ethylene oxide; the shelf life of the device is 36 months.
Due to its porous and fibered microstructure, the matrix readily absorbs fluids, adheres to the surrounding tissues, and provides a scaffold that guides bone growth and regeneration. After implantation, OSSIX™ BONE undergoes gradual resorption in the body. Preclinical studies demonstrated that 50% or greater implant material remains at the 6-month time point.
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datumdental
OSSIX™ BONE is available in the following sizes: 0.125 CC (5x5x5 mm), 0.25 CC . (5x5x10 mm) and 0.5 CC (5x10x10 mm).
OSSIX™ BONE is for prescription use only; it is intended to be implanted by trained dentists or oral surgeons in clinics during routine dental surgical procedures on adults with periodontal and bony defects of the maxillo-facial complex.
V. Indications for Use
OSSIX™ BONE is intended for the following uses:
- Augmentation or reconstructive treatment of the alveolar ridge; .
- Filling of periodontal defects; .
- Filling of defects after root resection, apicoectomy and cystectomy; .
- . Filling of extraction sockets to enhance preservation of the alveolar ridge;
- Elevation of the maxillary sinus floor; ●
- Filling of periodontal defects in conjunction with products intended for Guided . Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR);
- . Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
VI. Comparison of Technological Characteristics with the Predicate Device
OSSIX™ BONE has the same intended use and indications for use and similar technological characteristics as the predicate device, Geistlich Bio-Oss Collagen® (K122894). Both products are similar in their chemical composition (porcine type I collagen and crystalline hydroxylapatite), their structure (porous spongoius matrix made of hydroxylapatite particles embedded in a lattice network of collagen fibers), and mode of action (osteoconductive bone grafting material that acts as a scaffold for new bone growth and is slowly resorbed and replaced by new bone). Both products are designed as sterile, biodegradable, biocompatible, hydrophilic, moldable, trimmable, highly porous spongious matrices.
As outlined in more detail in the table below, the subject device differs slightly from the predicate device by the HA:collagen ratio, HA source (synthetic versus bovine), particle size, the sterilization method, and product size. The technological differences between the two products in composition, material characteristics and sterilization methodology do not affect the product performance as was demonstrated by the biocompatibility, bench, and animal studies.
Thus, the subject device is substantially equivalent to the predicate device.
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dətumdentəl
| Feature | OSSIX™ BONE | Geistlich Bio-Oss Collagen® |
|---|---|---|
| Intended use/ | ||
| Indications for | ||
| use | • Augmentation or reconstructive | |
| treatment of the alveolar ridge; | ||
| • Filling of periodontal defects; | ||
| • Filling of defects after root resection, | ||
| apicoectomy and cystectomy; | ||
| • Filling of extraction sockets to enhance | ||
| preservation of the alveolar ridge; | ||
| • Elevation of the maxillary sinus floor; | ||
| • Filling of periodontal defects in | ||
| conjunction with products intended for | ||
| Guided Tissue Regeneration (GTR) | ||
| and Guided Bone Regeneration (GBR); | ||
| • Filling of peri-implant defects in | ||
| conjunction with products intended for | ||
| Guided Bone Regeneration (GBR). | • Augmentation or reconstructive | |
| treatment of the alveolar ridge; | ||
| • Filling of infrabony periodontal defects; | ||
| • Filling of defects after root resection, | ||
| apicoectomy, and cystectomy; | ||
| • Filling of extraction sockets to enhance | ||
| preservation of the alveolar ridge; | ||
| • Elevation of the maxillary sinus floor; | ||
| • Filling of periodontal defects in | ||
| conjunction with products intended for | ||
| Guided Tissue Regeneration (GTR) and | ||
| Guided Bone Regeneration (GBR); | ||
| • Filling of peri-implant defects in | ||
| conjunction with products intended for | ||
| Guided Bone Regeneration (GBR). | ||
| Mode of action | Conductive bone grafting material | Conductive bone grafting material |
| Design | Sterile, biodegradable, biocompatible, | |
| hydrophilic, moldable, trimmble, highly | ||
| porous spongious matrix | Sterile, biodegradable, biocompatible, | |
| hydrophilic, moldable, trimmble, highly | ||
| porous spongious matrix | ||
| Composition | ||
| and source of | ||
| materials | Crystalline synthetic hydroxyapatite | |
| (80%) combined with porcine type I | ||
| collagen (20%) | Crystalline bovine derived hydroxyapatite | |
| (90%) combined with porcine type I | ||
| collagen (10%) | ||
| Porosity | High porosity | High porosity |
| Density | 2-3 g/cm³ | 2-3 g/cm³ |
| Particle size | 1 - 10 μm | 250 - 1000 μ |
| Form | Block | Block |
| Max load | About 40 N | About 40 N |
| Sterility | ETO | r-irradiation |
| Resorption | ||
| profile | Slow resorption | Slow resorption |
| Prescription | ||
| designation | Rx | Rx |
| Reusability | Single use only | Single use only |
| Product Size | 0.125 cc | |
| 0.25 cc | ||
| 0.5 cc | 100 mg block | |
| 250 mg block | ||
| 500 mg block | ||
| Unit package | Double blister | Double blister |
| Environment of | ||
| use | OSSIX™ BONE should only be used by | |
| trained dentists or oral surgeons. | Geistlich Bio-Oss Collagen® should only | |
| be used by trained dentists or oral | ||
| surgeons. | ||
| Intended patient | ||
| population | Adults | Adults |
| Frequency and | ||
| duration of use | Routine procedure | Routine procedure |
| Shelf life | The expiration date of the device is | |
| indicated on the outer box and the | ||
| internal blister. The product has a 36- | ||
| month shelf life. | The expiration date of the device is | |
| indicated on the outer box and the | ||
| internal blister. |
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datumdental
VII. Summary of Data to Support Substantial Equivalence
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation of OSSIX™ BONE was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, 2016, and International Standard ISO10993-1:2009 (Cor 1:2010) Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing. The final sterile device was tested for:
- cytotoxicity, ●
- pyrogenicity, ●
- sensitization, .
- . intracutaneous reactivity,
- genotoxicity,
- implantation,
- systemic toxicity (acute), subchronic toxicity, ●
- chronic toxicity. .
OSSIX™ BONE is categorized as an implant device in contact with bone/tissue.
Sterility validation
The sterilization process is established and validated according to:
- ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide --. Requirements for the development, validation and routine control of a sterilization process for medical devices.
The ability of the packaging to maintain the sterility of the product was demonstrated in packaging and shelf life studies.
Viral inactivation studies were conducted to demonstrate the ability of the manufacturing process to remove or inactivate viruses.
In vitro product characterization
The in vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate device, as summarized in the table below.
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| Test | Method |
|---|---|
| Scanning Electron | |
| Microscope (SEM) | Microscopic appearance of OSSIXTM BONE and the predicate was |
| performed using A Scanning Electron Microscope. | |
| X-ray Diffraction | |
| (XRD) | The crystalline structure of the hydroxylapatite of OSSIXTM BONE and |
| the predicate was measured using an XRD instrument. | |
| Mechanical | |
| properties | |
| (compression) | The capability of OSSIXTM BONE and Geistlich Bio-Oss Collagen® to |
| withstand pressure (compression resistance) was tested on using a tensile | |
| machine. | |
| Chemical Analysis | |
| before and after | |
| manufacturing | |
| process | Elemental analysis of OSSIXTM BONE and Geistlich Bio-Oss Collagen® |
| for calcium, oxygen and phosphorus was performed by means of energy- | |
| dispersive X-ray spectroscopy (EDS). | |
| Infra-Red | |
| spectroscopy | |
| before and after | |
| manufacturing | |
| process | The FT-IR (Fourier Transform Infrared spectroscopy) analysis of |
| OSSIXTM BONE and Geistlich Bio-Oss Collagen® was performed by | |
| using a Fourier transform infrared spectroscopy (FTIR) | |
| spectrophotometer. | |
| Amino acid | |
| analysis | Amino acid analysis was performed using an amino acid analyzer. |
| Porosity, density | Mercury intrusion porosity meter. |
The HA component conforms to the following standards:
- ISO 13779-3:2008, Implants for surgery - Hydroxyapatite - Part 3: Chemical analysis and characterization of crystallinity and phase purity;
- . ASTM F1185-3:2014, Standard specification for composition of Hydroxylapatite for surgical implants.
Animal study
An in vivo animal study was conducted in an L-shape buccal mandibular defect model system in Beagle dogs to evaluate the in vivo performance and degradation of the device to support substantial equivalence. The study was conducted on 19 animals followed up for 1, 3 and 6 months. The performance of the subject OSSIX™ BONE in this study was compared to the predicate device, Geistlich Bio-Oss Collagen®, using a cleared OSSIX™ PLUS membrane in both treatments. The subject and predicate devices performed similarly in an L-shape buccal mandibular defect model system in Beagle dogs.
VIII. Conclusion
The subject and predicate devices have the same intended use/indications for use and substantially similar technological characteristics and principles of operation. In addition, minor technological differences between the two products do not affect the product performance, as supported by the results of the non-clinical data provided within the 510(k) submission, as summarized above. Therefore, the subject OSSIX™ BONE is substantially equivalent to the predicate device.