(8 days)
OsteoGraf/N-700 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.
The OsteoGraf/N-700 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.
The provided text is a 510(k) summary for a medical device called OsteoGraf/N-700, a bone grafting material. This document outlines the device's characteristics, intended use, and its substantial equivalence to previously marketed predicate devices.
However, the document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically understood for performance claims based on clinical or technical parameters. Instead, the summary focuses on substantial equivalence to predicate devices. This means that for this particular device (a bone grafting material), the FDA clearance is based on its similarity to existing, legally marketed devices, rather than a new performance study against specific acceptance criteria.
Therefore, many of the requested sections regarding acceptance criteria, sample sizes, expert involvement, and ground truth establishment cannot be answered from the provided text.
Here's a breakdown of what can be extracted or inferred based on the document's nature:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated as specific performance metrics (e.g., success rate in bone regeneration studies). The primary "acceptance criterion" for this 510(k) is substantial equivalence to predicate devices, meaning it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness.
- Reported Device Performance: The document states: "We believe that the prior use of the components of OsteoGraf/N-700 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/N-700 for the indicated uses." The "performance data provided" is not detailed in this summary.
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Sample size used for the test set and the data provenance: Not applicable. There's no mention of a "test set" in the context of a performance study with a sample size. The "performance data" mentioned is not described in detail.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There's no test set or ground truth established by experts mentioned in the document for performance evaluation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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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-powered diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly stated. The basis for safety and effectiveness is largely based on the prior use of its components and its similarity to predicate devices already cleared for market. Any "performance data" referred to is not detailed enough to determine the type of ground truth.
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The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
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How the ground truth for the training set was established: Not applicable.
Summary based on available information:
| Criterion/Information | Details from K072058 Summary |
|---|---|
| Acceptance Criteria | Primarily based on Substantial Equivalence to legally marketed predicate devices (K981214, K960368, K921469) concerning: - Same intended use - Similar technological characteristics - No new questions of safety or effectiveness. The document also mentions "conforms to applicable industry standards" and that "biocompatibility testing was not necessary" due to prior use of components. |
| Reported Device Performance | The device's "performance data" (not detailed in this summary) and biocompatibility, supported by the prior use of its components, are stated to support its safety and effectiveness for indicated uses. |
| Study Type to Meet Acceptance Criteria | The clearance is based on a 510(k) Substantial Equivalence Determination, not a de novo performance study against specific, quantified acceptance criteria for novel claims. |
| Sample Size (Test Set) | Not applicable; no specific performance test set or sample size mentioned. |
| Data Provenance (Test Set) | Not applicable. |
| Number of Experts / Qualifications (Test Set GT) | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. This is not an AI/diagnostic device. |
| Standalone Performance Study (Algorithm Only) | No. This is not an algorithm/AI device. |
| Type of Ground Truth Used (for performance evaluation, if applicable) | Not explicitly stated in this summary. The safety and effectiveness are supported by the known characteristics and prior use of the materials. |
| Sample Size (Training Set) | Not applicable; this is not an AI/ML device. |
| How Ground Truth for Training Set was Established | Not applicable. |
In conclusion, the K072058 submission for OsteoGraf/N-700 relies on demonstrating substantial equivalence to already cleared predicate devices, rather than presenting a performance study against specific acceptance criteria like those expected for novel technologies or AI/ML-based devices. The "performance data" mentioned is not detailed in this summary.
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510(k) SUMMARY
AUG - 3 2007
DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872
CONTACT: Helen Lewis
July 18, 2007 DATE PREPARED:
TRADE OR PROPRIETARY NAME: OsteoGraf/N-700
CLASSIFICATION NAME: Bone Grafting Material 21 CFR 872.3930
OsteoGraf/N-700, (K981214, K960368, K921469) PREDICATE DEVICES:
DEVICE DESCRIPTION: The OsteoGraf/N-700 material is a high purity, high density, nonresorbable, radiopaque, polycrystalline particulate form of hydroxylapatite, the major mineral phase of bone and dental enamel.
INTENDED USE: Treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, and filling of extraction sites.
TECHNOLOGICAL CHARACTERISTICS: All of the components found in OsteoGraf/N-700 have been used in legally marketed devices and/or were found safe for dental use. The modifications made to the legally marketed device do not affect biocompatibility. Therefore, it was determined that biocompatibility testing was not necessary. OsteoGraf/N-700 conforms to applicable industry standards.
We believe that the prior use of the components of OsteoGraf/N-700 in legally marketed devices, the performance data provided, and biocompatibility support the safety and effectiveness of OsteoGraf/N-700 for the indicated uses.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the bird symbol.
AUG - 3 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvanian 17405-0872
Re: K072058
Trade/Device Name: OsteoGraf/N-700 Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 18, 2007 Received: July 26, 2007
Dear Ms. Lewis:
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. Lewis
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) 276-0120. 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 vours.
Clus
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 STATEMENT
510(k) Number (if known):
Device Name: OsteoGraf/N-700
Indications for Use:
OsteoGraf/N-700 is indicated for treatment of intrabony periodontal defects, augmentation of bony defects in the alveolar ridge, filling of extraction sites, and sinus elevation grafting.
These are the same indications for use previously cleared for K981214, K960368, K921469
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suren Kumar
Division Sign-Off) ("Jivision Sign-Off")
Division of Anesthesiology, General Hospital, Civision Control, Dental Devices
510(k) Number:_
000008
§ 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.