(39 days)
No
The device description and performance studies focus on the biological and physical properties of a bone filling material, with no mention of AI or ML technologies.
No
The device is a bone filling material used to augment deficient bone or fill bone defects, which assists in the healing and regeneration of tissue rather than directly treating a disease or condition in a therapeutic manner.
No
This device is a bone filling material used for augmentation and filling defects, not for diagnosing conditions.
No
The device description clearly states it is a "Bone Filling Material" containing human allograft bone tissue and mineralized cancellous chips, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a "bone filling material indicated for dental intraosseous and oral/maxillofacial defects." This is a therapeutic use, not a diagnostic one.
- Device Description: The description confirms it's a "Bone Filling Material" made of allograft bone tissue. This is a material used to treat or repair tissue, not to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples from the human body (like blood, urine, or tissue) to provide information about a disease or condition.
- Performance Studies: The performance studies focus on osteoinductive potential and functional characteristics (solubility, handling), which are relevant to its use as a bone graft material, not a diagnostic test.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects.
Product codes
NUN
Device Description
Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental intraosseous and oral/maxillofacial
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)
Osteoinductive potential of the modified device compared to the predicate device has been evaluated in the athymic rat ectopic bone growth model. Results indicate comparable levels of osteoinductive performance (as indicated by histological scoring of new bone formation) of the predicate device compared to the modified device in this model.
Product functional testing was performed, including solubility testing in an aqueous environment and handling evaluation (extrudability, moldability and disintegration). Results indicate that the solubility and handling characteristics of the modified device are comparable to that of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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Biomel 3i 510(k) K113645 RegenerOss Allograft Putty Plus Mineralızed
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JAN 2 0 2012
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Section 6
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92
| Sponsor/Applicant | Biomet 3i
4555 Riverside Drive
Palm Beach Gardens, Florida 33410 |
|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Number | 1-800-342-5454
Fax: 561-514-6316
www.biomet3i.com |
| Establishment Registration | 1038806 |
| Sponsor/Applicant Contact | Mayank Choudhary
Regulatory Affairs Specialist
Mayank.choudhary@biomet.com
561-776-6831 |
| Date Prepared | December 10, 2012 |
| Preparer | Biomet Interpore Cross
181 Technology Drive
Irvine, California 92618
949-453-3200
Fax: 949-453-3225
Establishment Number: 2029012 |
| Contact for Review/Questions | Kathleen Olivares, Regulatory Affairs Associate
Kathleen.olivares@biomet.com
949-453-3200, extension 104 |
| Trade/Proprietary Name | RegenerOss Allograft Putty Plus Mineralized |
| Common/User Name | Demineralized Bone Matrix (DBM) with Mineralized
Cancellous Chips in a Lipid Carrier |
| Classification Name | Class II |
| Legally Marketed Devices to Which
Substantial Equivalence is Claimed | 510(k) K070147- InterGro Oral |
| Other Marketed Devices in the Same | 510(k) K080418- Regenaform; Altiva DBM with Cortical |
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Biomel 3i 510(k) K113645 RegenerOss Allograft Putty Plus Mineralized
Classification Using Cancellous Bone Cancellous Chips; Regeneration Technologies Inc. Chips 510(k) K060332- OrthoBlast II DBM Paste and Putty with Cancellous Chips; IsoTis OrthoBiologics, Inc. Description of the Device Bone Filling Material used for augmenting deficient bone or filling bone defects in oral/dental applications. Allograft (Bone) Putty containing human allograft bone tissue (DBM) and mineralized cancellous chips, from the same donor, combined with a lipid carrier. How the Device Functions A resorbable, osteoconductive bone graft substitute with osteoinductive potential that promotes bone formation. The implant is resorbed and is replaced with bone during the healing process. Scientific Concepts and Significant Demineralized cortical bone matrix, (DBM) is derived from Characteristics donated human tissue allograft bone which has been granulated, demineralized, and lyophilized and contains various growth factors including osteoinductive proteins. Mineralized cancellous bone chips from the same donor as the DBM are added for radiopacity, osteoconduction, and to enhance the structural strength of the product. An added carrier is a resorbable, biocompatible, semi-viscous lipid. By combining the DBM and cancellous chips with the carrier it allows for easier intra-operative handling and improves holding properties of the DBM at the site of transplantation. Intended Use of the Device The indication for use statement is the same as the predicate device, InterGro Oral, legally marketed by Biomet 3i. RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including:localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectomy, and periodontal defects. Summary of New Device Comparison to The technological characteristics of the new device are the Predicate Device same in comparison to those of the predicate. RegenerOss Allograft Putty Plus Mineralized Cancellous Bone Chips is a modification of a Biomet cleared device, InterGro Oral. The difference between the two devices, or change, is to a secondary material ingredient. For marketing purposes one
source of calcium salt granules, a hydroxyapatite material
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(Pro Osteon), is being replaced with another source of calcium salt or hydroxyapatite material, Cancellous Bone Chips, from the same donor as the DBM. The use of cancellous bone chips serves the same purpose as the Pro Osteon calcium salt granules, to improve the radiopacity, osteoconduction, and structural strength of the product.
Cancellous Bone Chips are legally marketed in other devices within the same classification regulation, for the same intended use.
A rigorous design control process is the basis for a substantial equivalence determination. This well defined modification to the currently marketed Biomet device followed a predetermined set of requirements and activities in the management of the design and development of the product. The process included documentation of design inputs, risk analysis, design output, test procedures, generation and completion of verification and validation steps, and the completion and documentation of formal design reviews.
All verification and validation activities have been performed successfully, as identified by the risk analysis, ensuring the modified device is as safe and effective as the predicate device. The predetermined acceptance criteria have been met.
Additional testing was performed in accordance with the risk analysis and design control process to characterize RegenerOss Allograft Putty plus Mineralized and to demonstrate substantial equivalence to the predicate device.
Osteoinductive potential of the modified device compared to the predicate device has been evaluated in the athymic rat ectopic bone growth model. Results indicate comparable levels of osteoinductive performance (as indicated by histological scoring of new bone formation) of the predicate device compared to the modified device in this model.
Product functional testing was performed, including solubility testing in an aqueous environment and handling evaluation (extrudability, moldability and disintegration). Results indicate that the solubility and handling characteristics of the modified device are comparable to that of the predicate device.
Substantial Equivalence
Non-Clinical Studies
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Biomel 3i 510(k) K113645 RegenerOss Allograft Putty Plus Mineralized
Conclusion
The safety and effectiveness of RegenerOss Allograft Putty Plus Mineralized was verified and documented through Biomet's design control process. Substantial equivalence to the predicate device is based on the same intended use and base material, (DBM and Carrier) of the Biomet cleared device, Intergro Oral; use of a secondary material ingredient cleared as part of other legally marketed devices within the same classification and same intended use; and verification and validation of selected performance properties and acceptance criteria.
113645
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with healthcare, with three parallel lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kathleen Olivares Regulatory Affairs Associate Biomet Interpore Cross 181 Technology Drive Irvine, California 92618
JAN 2 0 2012
Re: K113645
Trade/Device Name: RegenerOss Allograft Putty Plus Mineralized Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: January 18, 2012 Received: January 19, 2012
Dear Ms. Olivares:
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.
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Page 2 - Ms. Olivares
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 1 1 5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Image /page/6/Picture/0 description: The image shows a sequence of alphanumeric characters. The sequence starts with the letter 'K', followed by the numbers '113645'. The characters are written in a clear, sans-serif font, and they appear to be part of a code or identification number.
Indications for Use
KI13645 510(k) Number (if known): ,
Device Name: RegenerOss Allograft Putty Plus Mineralized
Indications For Use:
RegenerOss Allograft Putty Plus Mineralized is a bone filling material indicated for dental intraosseous and oral/maxillofacial defects including: localized ridge augmentations, extraction sockets, cystic defects, sinus lifts, peri-implant defects, defects associated with root resection or apicoectorny, and periodontal defects.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use NO (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K113645
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