(42 days)
Endobon is used in the following dental and/or oral surgical procedures :
- alveolar ridge augmentation/reconstruction
- filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall
- filling of periodontal bone pockets in the jaw (granules I)
- filling bone defects after apicetomy
- filling alveoli after tooth extraction
This product should not be used in non-periodontal mandibular applications.
Endobon is available in pre-formed shapes (i.e. blocks or cylinders) and granules sizes. This material is intended to fill voids or defects in bone and should not be used in nonperiodontal mandibular applications. Endobon is a porous hydroxyapatite ceramic made from bovine cancellous bone. Hydroxyapatite (pentacalcium hydroxide [tris] phosphate) is both the main constituent of this ceramic bone substitute and a major constituent of the inorganic phase of human and animal bone. Endobon is considered nonresorbable and is used to permanently fill or reconstruct bony defects.
The provided text is a 510(k) summary for the Endobon device, a porous hydroxyapatite ceramic used as a bone substitute. It describes the device, its intended uses, and asserts its biocompatibility and effectiveness based on preclinical and clinical studies. However, it does not contain the specific details required to complete your request for acceptance criteria and a detailed study description.
Here's a breakdown of why and what information is missing:
- Acceptance Criteria and Reported Performance Table: The document states "The efficacy of Endobon® is based on biomechanical testing and clinical documentation. Clinical, radiologic, and histologic findings from clinical trials demonstrate the biocompatibility of Endobon® and confirmed its suitability for the desired indications." This is a high-level statement but does not provide specific quantitative acceptance criteria (e.g., bone density increase by X%, fusion rate of Y%) or the numerical performance results against those criteria.
- Sample Size and Data Provenance for Test Set: The document mentions "over five years of clinical experience" and "clinical trials" but does not specify the sample size of these trials for a test set, nor the country of origin, or if they were retrospective or prospective.
- Number of Experts and Qualifications for Ground Truth: There is no mention of independent experts used to establish ground truth in any clinical study, their number, or their qualifications.
- Adjudication Method: The document does not describe any adjudication methods used for a test set.
- MRMC Comparative Effectiveness Study: There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study, or any effect size related to human readers improving with or without AI assistance. This is likely because the device is a bone substitute, not an AI diagnostic tool.
- Standalone Performance Study: The concept of "standalone performance" for an algorithm without human-in-the-loop is not applicable here as Endobon is a physical implant, not a software device or AI.
- Type of Ground Truth Used: While it mentions "clinical, radiologic, and histologic findings," it doesn't specify how these were integrated or prioritized to form a definitive "ground truth" for evaluating the device's efficacy. For example, was a specific histology finding paramount, or a composite score?
- Sample Size for Training Set: The document does not discuss a training set, as it pertains to AI/machine learning models, which is not applicable to this medical device.
- How Ground Truth for Training Set Was Established: Not applicable.
In summary, the provided 510(k) only offers a general affirmation of safety and effectiveness based on existing studies and clinical experience, but it lacks the granular detail about specific study designs, acceptance criteria, and performance metrics that your request asks for. This level of detail is typically found in the full clinical trial reports or FDA review memoranda, which are not part of the publicly available 510(k) summary.
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APR - 3 1998
510(k) Summary of Safety and Effectiveness
Submitter: Biomet, Inc. P.O. Box 578 Airport Industrial Park Warsaw, IN 46581-0587 Contact Person: Mary L. Verstynen Product Code: 76LYC
Device Name: Endobon®
Endobon® is used in the following dental and/or oral surgical procedures :
- alveolar ridge augmentation/reconstruction ﻭ
- filling of resection defects in benign bone tumor, bone ﺍ cysts, or other defects in the alveolar ridge or wall
- filling of periodontal bone pockets in the jaw (granules I) l
- filling bone defects after apicetomy l
- filling alveoli after tooth extraction
Endobon® is available in pre-formed shapes (i.e. blocks or cylinders) and granules sizes. ( This material is intended to fill voids or defects in bone and should not be used in nonperiodontal mandibular applications.
Endobon® is a porous hydroxyapatite ceramic made from bovine cancellous bone. Hydroxyapatite (pentacalcium hydroxide [tris] phosphate) is both the main constituent of this ceramic bone substitute and a major constituent of the inorganic phase of human and animal bone. Endobon® is considered nonresorbable and is used to permanently fill or reconstruct bony Use of hydroxyapatite ceramics as bone substitutes defects. are well documented in the literature. In vitro and in vivo studies demonstrate that Endobon® has good biocompatibility and well tolerated by the human body.
The efficacy of Endobon® is based on biomechanical testing and clinical documentation. Clinical, radiologic, and histologic findings from clinical trials demonstrate the biocompatibility of Endobon® and confirmed its suitability for the desired indications.
The safety and effectiveness of Endobon® as a bone substitute has been determined in extensive preclinical studies and with over five years of clinical experience.
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Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR - 3 1998
Mr. Mary L. Verstynen Clinical Research Manager Biomet® Incorporated P.O. Box 587 Warsaw, Indiana 46581-0587®
K980679 Re : Trade Name: Endobon Requlatory Class: II Product Code: LYC February 19, 1998 Dated: February 20, 1998 Received:
Dear Ms. Verstynen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements; as set --forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, FDA will verify such Failure to comply with the GMP regulation may assumptions. result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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Page 2 - Ms. Verstynen
On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Reqister, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990. FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beqinning on page 43447.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address
"http://www.fda.gov/cdrh/dsma/dsmaman.html".
Sincerely yours,
Timothy A. Ulatowski
் மக்கள் வெள்ளி முறைய புக Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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of Page 1
| 510(k) NUMBER (IF KNOWN): | K180679 |
|---|---|
| --------------------------- | --------- |
DEVICE NAME: Endobon
INDICATIONS FOR USE:
Endobon is used in the following dental and/or oral surgical procedures :
-
alveolar ridge augmentation/reconstruction
-
filling of resection defects in benign bone tumor, bone cysts, or other defects in the alveolar ridge or wall
-
Cysts, of other acreases in the jaw (granules I) ﺍ
-
filling bone defects after apicetomy
-
filling alveoli after after tooth axtraction
This product should not be used in non-periodontal mandibular applications.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
n Al Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use $\frac{No}{(Optional Format 1-2-96)}$
Susan Runger
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K980674
§ 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.