(184 days)
No
The device description and performance studies focus on the material properties and physical form of a bone graft substitute, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for reconstructive treatment, filling defects, and augmenting bone, all of which are medical treatments aimed at restoring health or function.
No
The device description indicates that InterOss® is a hydroxyapatite material for filling bony voids and promoting bone ingrowth, not for diagnosing conditions. Its intended use is for reconstructive and augmentation procedures.
No
The device is a physical bone graft material (hydroxyapatite granules) and associated delivery mechanisms (vials and syringe-like applicators), not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described for InterOss® are all related to surgical procedures for bone augmentation and filling defects in the oral cavity. These are therapeutic interventions performed directly on the patient's body.
- Device Description: The device is a material (hydroxyapatite granules) intended to be implanted into bony voids or gaps to act as a scaffold for bone growth. This is a medical device used in a surgical context.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on samples taken from the body, not to be implanted into the body for therapeutic purposes. InterOss® falls under the category of a medical device used for surgical reconstruction and augmentation.
N/A
Intended Use / Indications for Use
InterOss® small granules are recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge .
- . Filling of infrabony periodontal defects
- . Filling of defects after root resection, apicocectomy, 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)
InterOss® large granules are recommended for:
- . Augmentation or reconstructive treatment 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)
Product codes (comma separated list FDA assigned to the subject device)
NPM
Device Description
InterOss® is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps, InterOss acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process.
InterOss® is available in granule form and is packaged in vials or a syringe-like applicator.
InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm).
InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm).
The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting.
During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes.
All InterOss® products are supplied sterile and are intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alveolar ridge, infrabony periodontal defects, defects after root resection, apicocectomy, and cystectomy, extraction sockets, maxillary sinus floor, periodontal defects, peri-implant defects, Human Oral, Periodontal
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)
Physical Testing:
- Assessments: Crystallinity ratio (106%), phase purity (100% hydroxyapatite), Ca/P ratio (1.67) using X-ray diffraction. Phase analysis using Fourier Transform Infrared spectroscopy. Morphology (granular and porous), average granule size (568 um for small, 1625 um for large), and pore interconnectivity using scanning electron microscopy. Absence of heavy metals using inductively coupled plasma analysis. Elution of Ca and P. Pore size (149.1660 Å for small, 47.3236 Å for large) using Barrett-Jonhner-Halenda method. Surface area (114.4452 m²/g for small, 109.0581 m²/g for large) using Brunauer-Emmett-Teller method. Solubility (74.274 ± 13.599 µg/mm3 for small, 70.247 ± 12.612 µg/mm3 for large). Average pH (7.86 ± 0.05 for small, 7.83 ± 0.05 for large). Average compressive strength (1.00 MPa for small, 1.17 MPa for large).
- Key Results: The physiochemical properties of InterOss® and Bio-Oss® were found to be comparable.
Biocompatibility Testing:
- Assessments: Skin Sensitization test (LLNA), Micronucleus and AMES test (mutagenicity), Intracutaneous Reactivity Test, Pyrogen test, Hemolysis test, Acute Systemic Injection Test (systemic toxicity), Cytotoxicity Test. Sterility test, Bacterial Endotoxin (LAL) tests. Extractables test from syringe, second LAL test, Minimum Essential Media test on extractables from the syringe.
- Key Results: No abnormal clinical signs of toxicity; non-mutagenic; no skin reactions; non-pyrogenic; no hemolytic reaction; non-toxic; non-cytotoxic; negative for signs of systemic toxicity due to leachable compounds; passed sterility and LAL tests. Syringe extractables showed no cell lysis.
Animal Testing:
- Study Type: In-vivo performance evaluation in a dental application, comparing InterOss® to Bio-Oss® and an empty control in critical sized supra-alveolar ridge defects in beagles.
- Sample Size: Four treatment groups of beagle dogs, three groups of nine and one group of six.
- Key Results: Biocompatibility and healing of InterOss® treated defects were indistinguishable from those treated with the Predicate, Bio Oss® and in some cases, superior to untreated defects. Radiographic comparison showed similar mean scores for graft resorption and boney integration. No statistical differences were observed between Test Article and Predicate with respect to percent mineralized volume and density. Both InterOss® and Bio-Oss® showed statistically greater amounts of bone present within the defect sites compared to empty controls and appeared to help preserve alveolar walls. Histomorphometry supported similarity in performance (percent residual implant and percent bone marrow values). Microscopic examination showed equivalent performance. Residual implant material was similar for both. InterOss® had a higher mean percent bone value compared to Bio-Oss® at all timepoints. Low incidence of inflammation indicative of good biocompatibility. No evidence of necrosis. Fibrosis scores similar or slightly higher in Test Article.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three faces in profile, representing health, services, and people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the top and left side of the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6, 2015
SigmaGraft, Inc. Megan Holden R&D Manager 335 North Puente Street, Unit A Brea, California 92821
Re: K151209
Trade/Device Name: InterOss® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: NPM Dated: October 29, 2015 Received: October 29, 2015
Dear Megan Holden:
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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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 Part 801), 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" (21 CFR 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 yours,
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indication for Use:
InterOss® small granules are recommended for:
- Augmentation or reconstructive treatment of the alveolar ridge .
- . Filling of infrabony periodontal defects
- . Filling of defects after root resection, apicocectomy, 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)
InterOss® large granules are recommended for:
- . Augmentation or reconstructive treatment 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)
| Prescription Use | AND/OR | Over-The-Counter |
|---|---|---|
| (Part 21 CFR 801 Subpart D) | (Per 21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
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510(k) Summary
Submitter and Official Correspondent
SigmaGraft, Inc. Megan Holden 335 N. Puente St. Unit A. Brea, CA 92821 USA Email: meganholden@sigmagraft.com Phone: 714-525-0114 Fax: 714-525-0116
Device Information
Trade Name: InterOss® Common Name: Bone Grafting Material Classification Name: Bone Grafting Material Regulation Number: 21 CFR 872.3930 Product Code: NPM Device Class: Class II Date of Submission: 10/30/2015
Predicate Devices
The subject device is substantially equivalent to the following predicate device:
- Primary Predicate Device o
- . Bio-Oss® (K970321) manufactured by Geistlich Pharma AG.
- Reference Predicate Device (Vial) o
- OCS-B® (K113246) manufactured by Nibec Company, Limited. .
- O Reference Predicate Device (Syringe)
- . GEISTLICH Bio-Oss Pen (K120601) manufactured by Geistlich Pharma AG.
General Description
InterOss® is a hydroxyapatite material derived from Australian bovine bone. The osteoconductive mineral structure is produced from bone through a multi-step purification process. Following placement in bony voids or gaps, InterOss acts as an osteoconductive scaffold for the ingrowth of adjacent viable bone. InterOss® gradually resorbs and is replaced with bone during the healing process.
InterOss® is available in granule form and is packaged in vials or a syringe-like applicator.
4
InterOss®, in the vial form, will be available to the United States market in 8 versions: Filled with 0.25g, 0.5g, 1.0g, 2.0g, or 5.0g of small granules (0.25 - 1.0mm) or filled with 0.5g, 1.0g, or 2.0g of large granules (1.0 - 2.0mm).
InterOss , in the syringe-like applicator form, will be available to the United States market in 6 versions: Filled with 0.25cc, 0.5cc, or 1.0cc of small granules (0.25 - 1.0mm) or filled with 0.5cc, 1.0cc, or 1.5cc of large granules (1.0mm - 2.0mm).
The syringe-like applicator was designed to deliver InterOss® granules more precisely to the intended treatment site without having to use other sterile instruments. The InterOss® granules can be wetted with either the patient's blood or sterile physiological saline solution back and then pressing down on the plunger. A removable filter cap prevents granules from falling out of the syringe-like applicator during storage and wetting.
During the manufacturing process of InterOss®, the granules are placed into a polymer syringe-like applicator or a glass vial, the vial or syringe is then capped with a rubber cap (the vial is also sealed with an aluminum cap), packaged into a polyethylene terephthalate tray, covered with a Tyvek lid, sealed, and then sterilized by gamma irradiation. The sterilized device is place in a protective package (outer box) along with its Instructions for Use and doctors notes.
All InterOss® products are supplied sterile and are intended for single use only.
Indications for Use
InterOss® small granules are recommended for:
- . Augmentation or reconstructive treatment of the alveolar ridge
- . Filling of infrabony periodontal defects
- . Filling of defects after root resection, apicocectomy, 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)
5
-
. Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR)
InterOss® large granules are recommended for: -
Augmentation or reconstructive treatment 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)
Product Testing
- a. Physical
The crystallinity ratio (106%), phase purity (100% hydroxyapatite), and Ca/P ratio (1.67) of InterOss® was assessed using X-ray diffraction. Additionally, phase analysis of InterOss® using Fourier Transform Infrared spectroscopy confirmed the presence of hydroxyapatite. The morphology (granular and porous), average granule size (568 um and 1625 um for small and large granules respectively), and pore interconnectivity (positive for pore interconnectivity) of InterOss was assessed using scanning electron microscopy. Inductively coupled plasma analysis was used to confirm the absence of heavy metals in InterOss . the elution of Ca (0.533 ± 0.016 at 3 days, 0.322 ± 0.012 at 7 days, and 0.366 ± 0.024 at 14 days) and P (3.723 ± 0.004 at 3 days, 6.277 ± 0.079 at 7 days, and 5.865 ± 0.019 at 14 days) from InterOss® small granules, and the elution of Ca (0.513 ± 0.018 at 3 days, 0.315 ± 0.009 at 7 days, and 0.351 ± 0.021 at 14 days) and P (3.640 ± 0.085 at 3 days, 6.241 ± 0.041 at 7 days, and 5.847 ± 0.019 at 14 days) from InterOss® large granules. The Barrett-Jonhner-Halenda method was used to determine the pore size (149.1660 Å for small granules and 47.3236 Å for large granules) of InterOss®. The surface area of InterOss® small (114.4452 m²/g) and large (109.0581 m²/g) granules was determined using the Brunauer-Emmett-Teller method. The solubility of InterOss® was found to be 74.274 ± 13.599 µg/mm3 for small granules and 70.247 ± 12.612 µg/mm3 for large granules and the average pH of InterOss® was found to be 7.86 ± 0.05 for small granules and 7.83 ± 0.05 for large granules. Lastly, the average compressive strength of InterOss® was found to be 1.00 MPa for small granules and 1.17 MPa for large granules.
6
Additionally, the physiochemical properties (pore structure, microstructure, phase structure, chemical composition, and residual organic substance) of InterOss® and Bio-Oss® were found to be comparable.
Biocompatibility b.
None of the tested animals exhibited abnormal clinical signs indicative of toxicity during test period for the Skin Sensitization test (LLNA; Stimulation Index = 1.03±0.26). InterOss® was determined to be non-mutagenic via the Micronucleus and AMES test. No skin reactions to InterOss® were observed for the Intracutaneous Reactivity Test. InterOss® was determined to be non-pyrogenic. The hemolysis test indicates that InterOss® does not cause a hemolytic reaction. InterOss was determined to be non-toxic and non-cytotoxic based upon the results of the Acute Systemic Injection Test and Cytotoxicity Test, respectively. Inteross® was also considered negative for signs of systemic toxicity due to leachable compounds. Additionally, InterOss® passed sterility test and Bacterial Endotoxin (LAL) tests.
Lastly, we performed an extractables test (