(156 days)
Not Found
No
The summary describes a synthetic bone graft substitute material and its physical properties, intended uses, and performance testing related to biocompatibility, sterilization, and shelf life. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device, Straumann® BoneCeramic, is a synthetic bone graft substitute indicated for filling and/or augmenting osseous defects, which aligns with the definition of a therapeutic device as it is intended to directly treat or manage a medical condition.
No
The device is a synthetic bone graft substitute used for filling and augmenting osseous defects, not for diagnosing conditions.
No
The device description clearly states it is a "fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate," indicating it 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 clearly states that the device is for "filling and/or augmenting... intraoral/maxillofacial osseous defects." This is a therapeutic or reconstructive purpose, not a diagnostic one.
- Device Description: The description details a synthetic bone graft substitute, which is a material used to repair or replace bone tissue. This aligns with a therapeutic device.
- No mention of diagnostic testing: There is no indication that this device is used to test samples from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on biological samples (like blood, urine, tissue) to gain information about a person's health. This device is implanted into the body to aid in bone regeneration.
N/A
Intended Use / Indications for Use
Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:
- Intrabony periodontal osseous and furcation defects
- Augmentation of bony defects of the alveolar ridge
- Filling tooth extraction sites
- Sinus elevation grafting
Product codes (comma separated list FDA assigned to the subject device)
LYC
Device Description
Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling.
BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral/maxillofacial osseous defects
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)
Chemical characterization and biological testing were conducted according to the ISO standard for the biological evaluation of medical devices, ISO 10993, and to the FDA guidance document for this standard (FDA 2016, Use of International Standard ISO-10993). The new packaging material has been assessed in accordance to the above-mentioned standard and the biocompatibility of the device was confirmed. Furthermore, the packaging process and shelf life of the device have been validated per ISO 11607 and ASTM F1980.
The sterilization process for the subject device as indicated in the labeling has been validated according to ISO 11137 "Sterilization of health care products – Radiation", part 1 and 2. The devices will not be marketed as non-pyrogenic. Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis on every batch with a testing limit of 20 EU/device, based on a blood contacting and implanted device.
Device marketing and complaint history and review of the relevant clinical literature was provided. Over a period of 13.5 years, the overall complaint rate based on individual units sold globally for the subject devices was
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 24, 2020
Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801
Re: K201051
Trade/Device Name: Straumann® BoneCeramic Regulation Number: 21 CFR 872.3930 Regulation Name: Bone grafting material Regulatory Class: Class II Product Code: LYC Dated: August 23, 2020 Received: August 25, 2020
Dear Jennifer Jackson:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name:
Straumann® BoneCeramic
Indications for Use (Describe)
Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:
- Intrabony periodontal osseous and furcation defects
- Augmentation of bony defects of the alveolar ridge ●
- Filling tooth extraction sites ●
- Sinus elevation grafting .
Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)
□Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED
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 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."
Form Approved: OMB No. 0910-0120
3
Straumann® BoneCeramic
510(k) Summary
510(k) Summary 5
5.1 Submitter's Contact Information
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Registration No.: 1222315 Owner/Operator No.: 900505-
On the behalf of:
Institut Straumann AG
Peter Merian-Weg 12
CH-4002 Basel, Switzerland |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jennifer M. Jackson, MS
Director of Regulatory Affairs and Quality
Phone Number: +1-978-747-2509
Fax Number: +1-978-747-0023 |
| Prepared By: | Christelle Gerspach-Gasser
Senior Lead RA Biomaterials
Institut Straumann AG
Phone number: +41 61 965 1666 |
| Date Prepared: | September 23, 2020 |
Name of the Device 5.2
| Trade Names: | Straumann® BoneCeramic | |
|---|---|---|
| Common Name: | Bone Grafting Material | |
| Classification Name: | Bone Grafting Material, Synthetic | |
| Regulation Number: | §872.3930 | |
| Device Classification: | II | |
| Product Code(s): | LYC | |
| Classification Panel: | Dental |
4
Straumann® BoneCeramic
510(k) Summary
Predicate Device(s) 5.3
Primary Predicate:
- K040646 Straumann Granules .
5.4 -Device Description
Straumann® BoneCeramic is a fully synthetic bone graft substitute of medical grade purity in particulate form composed of biphasic calcium phosphate. It consists of a mixture of 60% hydroxyapatite (HA), which is 100% crystalline, and of 40% of the beta form of tricalcium phosphate (beta-TCP). BoneCeramic is 90% porous with interconnected pores of 100-500 microns in diameter. It is osteoconductive and gradually resorbed and replaced by vital bone during bone remodeling.
BoneCeramic is available in two granule sizes: 400-700 µm diameter and 500-1000 µm diameter and in three different filling volumes: 0.25g, 0.5g and 1.0g. It is delivered sterile.
Intended Use 5.5
Straumann® BoneCeramic is intended to be used for filling and/or augmenting intraoral/maxillofacial osseous defects.
5.6 Indications for Use
Straumann® BoneCeramic is indicated for filling and/or augmenting the following intraoral/maxillofacial osseous defects:
- . Intrabony periodontal osseous and furcation defects
- . Augmentation of bony defects of the alveolar ridge
- Filling tooth extraction sites .
- . Sinus elevation grafting
Technological Characteristics 5.7 -
The chemical composition, structure and indications for use of the subject device are identical to those of the predicate device. The only difference between the two relies in the different primary packaging utilized for the subject device. A comparison of the technological characteristics between the subject device and the primary predicate is provided in Table 1.
5
Straumann® BoneCeramic
510(k) Summary
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE |
|---|---|---|
| K Number | K201051 | K040646 |
| Indications for | ||
| use | Straumann® BoneCeramic is indicated for | |
| filling and/or augmenting the following | ||
| intraoral/maxillofacial osseous defects: | ||
| Intrabony periodontal osseous and | ||
| furcation defects Augmentation of bony defects of the | ||
| alveolar ridge Filling tooth extraction sites Sinus elevation grafting | Straumann Granules are indicated for filling | |
| and/or augmenting intraoral /maxillofacial | ||
| osseous defects, such as: | ||
| Intrabony periodontal osseous defects Furcation defects Augmentation of bony defects of the | ||
| alveolar ridge Filling of tooth extraction sites and | ||
| sinus elevation grafting. | ||
| Material | ||
| (Chemical | ||
| composition) | Hydroxyapatite (60%) and beta-tricalcium | |
| phosphate (40%) | Hydroxyapatite (60%) and beta-tricalcium | |
| phosphate (40%) | ||
| Structure / | ||
| Porosity | Matrix consisting of interconnected pores | |
| (90% porosity), the size of the pores lies | ||
| within a range of approx. 100 – 500 microns | ||
| in diameter. | Matrix consisting of interconnected pores | |
| (90% porosity), the size of the pores lies | ||
| within a range of approx. 100 – 500 microns | ||
| in diameter. | ||
| Particle sizes | 400 - 700 µm and 500 – 1000 µm | 400 - 700 µm and 500 – 1000 µm |
| Packaging | Sterile barrier system and protective | |
| packaging: |
- Primary packaging: polystyrene jar closed
with a polypropylene cap - Secondary packaging: PETG blister
sealed with a Tyvek lid (sterile barrier) - Tertiary packaging: cardboard box | Sterile barrier system and protective
packaging: - Primary packaging: PET blister with PE
sealing layer - Secondary packaging: PET blister sealed
with a Tyvek lid (sterile barrier) - Tertiary packaging: cardboard box |
| Sterilization | Gamma irradiation | Gamma irradiation |
| Biological
characteristics | Biocompatible | Biocompatible |
Performance Testing 5.8
Chemical characterization and biological testing were conducted according to the ISO standard for the biological evaluation of medical devices, ISO 10993, and to the FDA guidance document for this standard (FDA 2016, Use of International Standard ISO-10993). The new packaging material has been assessed in accordance to the above-mentioned standard and the biocompatibility of the device was confirmed. Furthermore, the packaging process and shelf life of the device have been validated per ISO 11607 and ASTM F1980.
The sterilization process for the subject device as indicated in the labeling has been validated according to ISO 11137 "Sterilization of health care products – Radiation", part 1 and 2. The
6
Straumann® BoneCeramic
510(k) Summary
devices will not be marketed as non-pyrogenic. Pyrogenicity information provided is based on FDA Guidance on "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile, issued on 21 January 2016." The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis on every batch with a testing limit of 20 EU/device, based on a blood contacting and implanted device.
Device marketing and complaint history and review of the relevant clinical literature was provided. Over a period of 13.5 years, the overall complaint rate based on individual units sold globally for the subject devices was