(118 days)
GRAFTON® DBM
Not Found
No
The document describes a bone graft substitute material and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is a bone filling material indicated for dental and oral/maxillofacial defects, intended to resorb and be replaced with bone during the healing process, which directly addresses a medical condition or ailment.
No
This device is a bone-filling material used for tissue repair and regeneration, not for diagnosing medical conditions.
No
The device description clearly states it is a bone filling material made from physical components like demineralized cortical bone matrix and calcium salt granules, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a bone filling material for surgical procedures to treat dental and oral/maxillofacial defects. This is a therapeutic use, not a diagnostic one.
- Device Description: The description details a bone graft substitute made from human tissue and other materials, designed to be implanted and resorb. This is a medical device used in a surgical context.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease. IVDs are specifically designed for these purposes.
- Anatomical Site: The anatomical site is within the body (intraosseous, oral/maxillofacial defects), which is consistent with a surgical implant, not an in vitro test.
Therefore, InterGro® Oral is a medical device used for surgical treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InterGro® Oral 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
InterGro® Oral is a resorbable, osteoconductive, and osteoinductive bone graft substitute that resorbs and is replaced with bone during the healing process. Its main component, demineralized cortical bone matrix (DBM), is derived from donor human tissue (allograft bone) and contains various growth factors including osteoinductive proteins. The DBM has been granulated, lyophilized and aseptically processed. In some versions of the product, calcium salt granules shall be incorporated to provide additional osteoconduction and enhanced structural strength. The carrier for InterGro® Oral is a resorbable, biocompatible, semi-viscous lipid. InterGro® Oral is provided ready-to-use in various physical consistencies. It is packaged in various sizes by volume for single patient use.
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)
Performance standards applicable to DBM base products have not been published by the FDA. BIOMET 3i intends to contract Interpore Cross International to manufacture and package this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present. Voluntary performance standards, such as materials certifications, in-house SOP's, FDA Guidance Documents, AATB Standards and/or ASTM Standards are used as appropriate.
Conclusion: The safety and effectiveness of InterGro® Oral is adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification. InterGro® Oral was found to be substantially equivalent to the predicate device based on the intended use, base materials, select performance properties, and use of a handling material.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GRAFTON® DBM
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
BIOMET 3i 510(k) Premarket Notification -InterGro® Oral
MAY 1 4 2007
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter: | BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Establishment Registration
Number: | 1038806 |
| Contact: | Tamara J. Nelson
Regulatory Affairs Supervisor
BIOMET 3i
4555 Riverside Drive
Palm Beach Gardens, FL 33410
Tel. 561-776-6923
Fax. 561-514 6316
Email tnelson @3implant.com |
| Date Prepared: | August 29, 2006 |
| Trade/Proprietary Name: | InterGro® Oral (Putty, Paste, Plus) |
| Common/Usual Name: | DBM Bone Graft Substitute |
| Classification Name: | Bone Grafting Material |
| Device Classification: | Class II |
| Predicate Device: | GRAFTON® DBM (Gel, Flex, Putty, Matrix, Crunch) |
| Device Formulation: | InterGro® DBM (Paste, Putty, Plus) |
| Performance: | Performance standards applicable to DBM base products have not been published by the FDA. BIOMET 3i intends to contract Interpore Cross International to manufacture and package this device according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present. Voluntary performance standards, such as materials certifications, in-house SOP's, FDA Guidance Documents, AATB Standards and/or ASTM Standards are used as appropriate. |
| Device Description: | InterGro® Oral is a resorbable, osteoconductive, and
osteoinductive bone graft substitute that resorbs and is
replaced with bone during the healing process. Its
main component, demineralized cortical bone matrix
(DBM), is derived from donor human tissue (allograft
bone) and contains various growth factors including
osteoinductive proteins. The DBM has been
granulated, lyophilized and aseptically processed. In
some versions of the product, calcium salt granules
shall be incorporated to provide additional
osteoconduction and enhanced structural strength.
The carrier for InterGro® Oral is a resorbable,
biocompatible, semi-viscous lipid. InterGro® Oral is
provided ready-to-use in various physical
consistencies. It is packaged in various sizes by
volume for single patient use. |
| Indications for Use: | InterGro® Oral is a bone filling material indicated for |
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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.
Conclusion: The safety and effectiveness of InterGro® Oral is adequately supported by the substantial equivalence information, materials data, and testing results provided within this premarket notification. InterGro® Oral was found to be substantially equivalent to the predicate device based on the intended use, base materials, select performance properties, and use of a handling material.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized eagle with three lines representing its wings, and a wavy line below representing water or a river.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tamara J. Nelson Regulatory Affairs Supervisor BIOMET 3i 4555 Riverside Drive Palm Beach Gardens, Florida 33410
MAY 1 4 2007
Re: K070147
Trade/Device Name: InterGro® Oral Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NUN Dated: March 8, 2007 Received: March 12, 2007
Dear Ms. Nelson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Nelson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Sudite Y. Michais Dass.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __KO 7 Oly7
Device Name: InterGro® Oral
Indications for Use:
InterGro® Oral 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.
Prescription Use V Prescription Use _____________________________________________________________________________________________________________________________________________________________
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sun Runner
Kiign-Off)
sion of Anesthesiology, General Hospital,
aon Control, Dental Devices
C(k) Number: K070147
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