(596 days)
No
The device description and performance studies focus on the material properties and physical characteristics of a bone grafting material, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device description clearly states it is a "bone grafting material intended to fill, augment, or reconstruct periodontal or bony defects". This indicates it is used for structural repair and regeneration, not for treating a disease or disorder in a therapeutic sense.
No
The device description indicates it is a bone grafting material for filling, augmenting, or reconstructing defects, which are therapeutic actions rather than diagnostic.
No
The device description clearly states it is a "synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form" and is provided in a "disposable applicator." This indicates a physical material and delivery system, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a bone grafting material intended to fill, augment, or reconstruct periodontal or bony defects. This is a therapeutic and structural application within the body.
- Device Description: The description details the composition of the material (hydroxyapatite and calcium sulfate) and its form (granulated powder). This aligns with a material intended for implantation or placement within the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is used in vivo (within the body) for structural support and reconstruction.
N/A
Intended Use / Indications for Use
Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Product codes
LYC
Device Description
Bond Apatite is composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. The hydroxyapatite component is sintered hydroxyapatite granules that conform to ISO 13779-1 Implants for surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite and ISO 13779-3 Implants for surgery – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity and phase purity. The calcium sulfate material is Bond Bone™, a mixture of surgical grade calcium sulfate dihydrate and calcium sulfate hemihydrate, and cleared under K083858. The calcium suffate component conforms to the chemical requirements of ASTM F2224 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. Bone Apatite is provided sterile, in a single unit size of 1 cc in a disposable applicator that is used for mixing the dry powder with sterile saline and for delivery to the treatment site.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial region
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)
Data submitted, referenced, or relied upon to demonstrate substantial equivalence included: material characterization by Fourier transform infrared spectroscopy, x-ray diffraction, and inductively coupled plasma optical emission spectrometry; physical characterization by gravimetric methods, mechanical sieve separation, scanning electron microscopy; performance characteristics including setting time and reaction temperature measurements, compressive mechanical properties, pH. dissolution. device handling under simulated usage conditions, and clinical performance testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
510(k) Summary K121177
DEC 0 5 2013
510(k) Summary Augma Biomaterials, Ltd. Bond Apatite™ K121177
December 5, 2013
ADMINISTRATIVE INFORMATION
Augma Biomaterials. Ltd. Manufacturer Name Usishkin 8 Netanya. Israel 42273 Telephone: +972-(0)77-559-1945 +972-(0)4-627-5337 Fax:
Official Contact
Dr. Amos Yahav, DMD
Representative/Consultant
Kevin A. Thomas, PhD Linda K. Schulz, BSDH. RDH PaxMed International. LLC 11234 El Camino Real. Suite 200 San Diego. CA 92130 Telephone: +1 (858) 792-1235 Fax: +1 (858) 792-1236 kthomas@paxmed.com Email: lschulz@paxmed.com
DEVICE NAME AND CLASSIFICATION
| Trade/Proprietary Name | Bond Apatite™ |
|---|---|
| Classification Name | Bone Grafting Material, Synthetic. |
| Classification Regulations | 21 CFR 872.3930, Class II |
| Product Code | LYC |
| Classification Panel | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
INTENDED USE
Bond Apatite™ is a synthetic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. intended to fill. augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
1
510(k) Summary K121177
DEVICE DESCRIPTION
Bond Apatite is composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form. The hydroxyapatite component is sintered hydroxyapatite granules that conform to ISO 13779-1 Implants for surgery - Hydroxyapatite - Part 1: Ceramic Hydroxyapatite and ISO 13779-3 Implants for surgery – Hydroxyapatite – Part 3: Chemical analysis and characterization of crystallinity and phase purity. The calcium sulfate material is Bond Bone™, a mixture of surgical grade calcium sulfate dihydrate and calcium sulfate hemihydrate, and cleared under K083858. The calcium suffate component conforms to the chemical requirements of ASTM F2224 Standard Specification for High Purity Calcium Sulfate Hemihydrate or Dihydrate for Surgical Implants. Bone Apatite is provided sterile, in a single unit size of 1 cc in a disposable applicator that is used for mixing the dry powder with sterile saline and for delivery to the treatment site.
EQUIVALENCE TO MARKETED DEVICE
Augma Biomaterials, Ltd., demonstrated that, for the purposes of FDA's regulation of medical devices Bond Apatite is substantially equivalent in indications and design principles to the following legally marketed predicate devices:
Augma Biomaterials, Ltd., Bond Bone™, K083858;
BONESUPPORT AB, CERAMENT™BONE VOID FILLER (A0210-12), K090871; and
Lifecore Biomedical. Inc., HAPSET Hydroxylapatite Bone Graft Plaster, K910432.
The intended use, materials, design, and functional characteristics of Bond Apatite and the predicate devices are substantially the same. The subject device and the predicate device Bond Bone are indicated for use in dental bone regeneration procedures. The intended use of the subject device and both predicate devices is to fill bony defects. The calcium sulfate material in the subject device Bond Apatite is the predicate device. Bond Bone, cleared under K083858. By weight, Bone Apatite is approximately 38.6% hydroxyapatite and 61.4% biphasic calcium sulfate. The predicate devices CERAMENT™|BONE VOID FILLER and HAPSET Hydroxylapatite Bone Graft Plaster consist of powdered hydroxyapatite and calcium sulfate hemihvdrate.The subject device and the predicate devices are supplied as a dry powder to be mixed with saline or other liguid to form a putty before use, and all are provided sterile in a single unit mixing/deliverv applicator (syringe) for single patient use.
Any differences in the technological characteristics between the subject and predicate devices do not raise new issues of safety or efficacy.
Data submitted, referenced, or relied upon to demonstrate substantial equivalence included: material characterization by Fourier transform infrared spectroscopy, x-ray diffraction, and inductively coupled plasma optical emission spectrometry; physical characterization by gravimetric methods, mechanical sieve separation, scanning electron microscopy; performance characteristics including setting time and reaction temperature measurements, compressive mechanical properties, pH. dissolution. device handling under simulated usage conditions, and clinical performance testing.
2
510(k) Summary K121177
The data included in this submission demonstrates substantial equivalence to the predicate devices listed above.
Overall, Bond Apatite™ has the following similarities to the predicate devices:
- has the same intended use. o
- uses the same operating principle, .
- incorporates the same basic design, .
- incorporates the same or very similar materials, and .
- has similar packaging and is sterilized using the same materials and processes. .
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circular border.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 5, 2013
Augma Biomaterials, Limited C/O Kevin A. Thomas, PhD. PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, CA 92130
Re: K121177
Trade/Device Name: Bond Apatite™ Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: November 26, 2013 Received: December 2, 2013
Dear Dr. Thomas:
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.
4
Page 2 - Dr. Thomas
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 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 Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O.
Ulmer-S
for
Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Summary
Bond Apatite™
Indications for Use
510(k) Number:
Bond Apatite™ Device Name:
Indications for Use:
Bond Apatite™ is a synthctic osteoconductive, bioresorbable bone grafting material composed of hydroxyapatite and biphasic calcium sulfate in granulated powder form, intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
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Mary S. Runner -S BA 2013.12.05 14:40:01 -05'00'
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