(118 days)
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.
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.
This document is a 510(k) Premarket Notification for the BIOMET 3i InterGro® Oral device, a bone grafting material. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device. As such, it does not contain a study demonstrating the device meets acceptance criteria for reported performance. Instead, it focuses on demonstrating equivalence to an already legally marketed device based on intended use, materials, select performance properties, and handling.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, and human reader performance is not applicable to this type of regulatory submission.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The document states: "Performance standards applicable to DBM base products have not been published by the FDA." Instead of specific performance metrics, the submission focuses on establishing substantial equivalence to a predicate device.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This document does not describe a performance study with a test set of data in the context of device performance metrics. It's a regulatory submission for substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. This document does not describe a performance study involving expert assessment of a test set to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No such test set or adjudication is described in the document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a bone grafting material, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study with human readers and AI assistance is not relevant or included.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a bone grafting material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. As no performance study with a defined test set and ground truth is described, this information is not available. The "ground truth" for this submission is implicitly the established safety and effectiveness of the predicate device (GRAFTON® DBM).
8. The sample size for the training set:
Not applicable. This document describes a new medical device (a bone grafting material), not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set, this information is not relevant.
Summary of what the document does provide regarding "performance":
The document states that BIOMET 3i intends to have Interpore Cross International manufacture and package the device "according to the regulations and standards that are appropriate to the risk that Class II devices reasonably present."
It further mentions the use of voluntary performance standards such as:
- Materials certifications
- In-house Standard Operating Procedures (SOPs)
- FDA Guidance Documents
- AATB Standards (American Association of Tissue Banks)
- ASTM Standards (American Society for Testing and Materials)
The "study" in this context is the 510(k) Premarket Notification process itself, which aims to demonstrate substantial equivalence to a predicate device, GRAFTON® DBM (Gel, Flex, Putty, Matrix, Crunch). The conclusion drawn is: "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."
This means that instead of proving the device meets specific numerical acceptance criteria (as one might find for a diagnostic tool's sensitivity/specificity), the "acceptance criterion" for this submission is that it is substantially equivalent to a legally marketed and safe/effective predicate device based on the factors listed above. Specific performance test results (e.g., biocompatibility testing, mechanical properties, osteoinductivity data for DBM) would have been part of the "materials data, and testing results" provided in the full 510(k) submission, even if not explicitly detailed in this summary.
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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 3i4555 Riverside DrivePalm Beach Gardens, FL 33410 |
|---|---|
| Establishment RegistrationNumber: | 1038806 |
| Contact: | Tamara J. NelsonRegulatory Affairs SupervisorBIOMET 3i4555 Riverside DrivePalm Beach Gardens, FL 33410Tel. 561-776-6923Fax. 561-514 6316Email 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, andosteoinductive bone graft substitute that resorbs and isreplaced with bone during the healing process. Itsmain component, demineralized cortical bone matrix(DBM), is derived from donor human tissue (allograftbone) and contains various growth factors includingosteoinductive proteins. The DBM has beengranulated, lyophilized and aseptically processed. Insome versions of the product, calcium salt granulesshall be incorporated to provide additionalosteoconduction and enhanced structural strength.The carrier for InterGro® Oral is a resorbable,biocompatible, semi-viscous lipid. InterGro® Oral isprovided ready-to-use in various physicalconsistencies. It is packaged in various sizes byvolume 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.
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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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§ 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.