(71 days)
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
The Osteo-Mesh ™ TM-300 titanium ridge augmentation mesh is fabricated from Grade 1 titanium as described by ASTM-F-67 or its ISO equivalent. The Osteo-Mesh™ TM-300is supplied nonsterile in two sizes: 25 mm x 30 mm and 12 mm x 25 mm.
The biocompatibility of titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been performed with this device.
This document is a 510(k) premarket notification for a medical device, specifically a titanium mesh for bone graft stabilization. It does not contain information about a study proving the device meets acceptance criteria through performance metrics as would be expected for an AI/software-as-a-medical-device (SaMD) submission.
Instead, this document focuses on demonstrating substantial equivalence to a predicate device already on the market. The core argument for acceptance is that the device is similar in composition and intended use to existing, legally marketed devices.
Therefore, many of the requested categories (e.g., acceptance criteria, device performance, sample sizes, expert ground truth, MRMC studies, standalone performance, training set details) are not applicable to this type of device submission.
Here's an analysis based on the provided text, indicating where information is present and where it is not:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This submission relies on substantial equivalence to a predicate device, not on meeting specific performance metrics through a clinical study or benchmark.
2. Sample Sizes Used for the Test Set and Data Provenance
Not Applicable. No test set or associated data are described for performance evaluation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. Ground truth establishment for a test set is not part of this type of submission.
4. Adjudication Method for the Test Set
Not Applicable. No test set is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not Applicable. This is not a software or AI device; therefore, an MRMC study is not relevant.
6. 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.
7. The Type of Ground Truth Used
Not Applicable. No ground truth is established in the context of device performance evaluation for this submission. The "ground truth" for this submission is the established safety and effectiveness of the predicate device.
8. The Sample Size for the Training Set
Not Applicable. This is not a machine learning or AI device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. There is no training set.
Summary of Device Acceptance Rationale (Based on the document):
The acceptance of the Osteo-Mesh™ TM-300 is based on its substantial equivalence to a legally marketed predicate device, the OsteoMed TRAM™ (Titanium Ridge Augmentation Material) (K963394).
- Comparison Basis: The submission states that the Osteo-Mesh™ TM-300 is "similar in composition, and intended use" to the TRAM™.
- Composition: Both devices are made from Grade 1 titanium (ASTM-F-67 or ISO equivalent). The biocompatibility of titanium is cited as "established through a long history of use in a variety of implant devices."
- Intended Use: Both devices are "For stabilization and support of bone grafts in dento-alveolar bony defect sites."
The FDA's review concludes that the device is substantially equivalent to predicate devices, allowing it to be marketed under the general controls provisions of the Federal Food, Drug, and Cosmetic Act. This indicates that the safety and effectiveness are inferred from the predicate device's history and not from new, extensive performance studies detailed in this 510(k) summary.
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4 1999 FEB
510 (k) SUMMARY
ADMINISTRATIVE 1.
Osteogenics Biomedical, Inc Submitter: 3234 64th Street Lubbock, TX 79413 (806) 792-2311
Contact Person: Chad Bartee
Date of Preparation: November 24, 1998
DEVICE NAME 11.
Proprietary Name: Osteo-Mesh™ TM-300 Common Name: Titanium Ridge Augmentation Mesh Classification Name: Bone Plate
PREDICATE DEVICE ll.
TRAM" (Titanium Ridge Augmentation Material); K963394: OsteoMed OsteoMed Corporation.
IV. DEVICE DESCRIPTION
The Osteo-Mesh ™ TM-300 titanium ridge augmentation mesh is fabricated from Grade 1 titanium as described by ASTM-F-67 or its ISO equivalent. The Osteo-Mesh™ TM-300is supplied nonsterile in two sizes: 25 mm x 30 mm and 12 mm x 25 mm.
The biocompatibility of titanium has been established through a long history of use in a variety of implant devices. No additional biocompatibility testing has been performed with this device.
V. INTENDED USE
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
VI. COMPARISON TO PREDICATE DEVICES
The Osteo-Mesh™ TM-300 is similar in composition, and intended use to legally marketed predicate devices, such as the OsteoMed TRAM™ (Titanium Ridge Augmentation Material).
Accordingly, Osteogenics Biomedical Inc. concluded that the Osteo-Mesh™ TM-300 is safe and effective for its intended use and performs at least as well as legally marketed predicate devices.
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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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 4 1999
Osteogenics Biomedical, Incorporated C/O Mr. Richard A. Hamer Requlatory Consultant Richard Hamer Associates, Incorporated P.O.Box 16598 Fort Worth, Texas 76162-0598
K984230 Re: Osteo-Mesh TM-300 Trade Name: Regulatory Class: II Product Code: JEY 1998 Dated: November 24, November 25, 1998 Received:
Dear Mr. Hamer:
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 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). 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 (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 Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note:
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Page 2 - Mr. Hamer
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acborizon in postantial 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 requlation (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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). 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/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Ulatowski r A. 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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Page 1 of 1
510(k) Number (if known):
Device Name:
Osteo - Mesh ™ TM-300 Titanium Ridge Augmentation Mesh
Indications for Use:
For stabilization and support of bone grafts in dento-alveolar bony defect sites.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use(Per 21 CFR 801.109) | OR | Over-the-Counter Use | |
|---|---|---|---|
| ------------------------------------------ | ----------------------------------- | ---- | ---------------------- |
(Optional Format 1-2-96)
| Susan Ranger (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices | |
|---|---|
| 510(k) Number | KC984030 |
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.