(82 days)
"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
A cylinder shaped commercially pure titanium dental implant with external threads and a Hydroxylapatite Coating.
The provided text is a 510(k) premarket notification for a medical device called the "O" Butment HS Implant, a type of dental implant. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study for meeting specific acceptance criteria for performance.
Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not available in the provided document. The document describes a regulatory process for market clearance, not an evaluation of device performance against pre-defined acceptance criteria through a clinical or non-clinical study designed for that purpose.
Here's a breakdown based on the information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided | Not provided |
| (No specific performance metrics or acceptance thresholds are mentioned in the document.) | The document states that "physical integrity of the implant has not been compromised by the modifications" based on stress analysis, but quantitative performance against specific criteria is not given. |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable / Not provided. No test set in the sense of patient data or clinical images was used for performance evaluation against acceptance criteria. The "test" mentioned relates to non-clinical stress analysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable / Not provided. No ground truth established by experts is mentioned, as there was no test set of clinical cases.
4. Adjudication Method for the Test Set:
- Not applicable / Not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study was not done. The submission focuses on substantial equivalence based on design, materials, and non-clinical testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical dental implant, not an algorithm.
7. The Type of Ground Truth Used:
- Not applicable / Not provided. The evaluation was based on design comparison and non-clinical engineering stress analysis, not clinical ground truth.
8. The Sample Size for the Training Set:
- Not applicable / Not provided. This is not a machine learning device; therefore, no training set is relevant.
9. How the Ground Truth for the Training Set was Established:
- Not applicable / Not provided.
Summary of Relevant Information from the Document:
- Non-clinical tests: Lateral and vertical stress analysis performed by Rocky Mountain Testing.
- Finding: "It has been determined that the physical integrity of the implant has not been compromised by the modifications."
- Basis for Substantial Equivalence: Design, function, labeling, material composition, and intended use compared to predicate devices ("O" Butment ES Implant and Screw-Vent Implant).
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JAN - 5 1998
510(K) SUMMARY
September 30, 1997
| Contact Person: | David D. DalisePresident / owner, "O" Company, Inc. |
|---|---|
| Trade Name:Common Name: | "O" Butment HS ImplantEndosseous Screw ImplantClassification Name: Dental Implant Endosseous / Code 76DZE |
| Substantial Equivalence to: | "O" Butment ES Implant referenced as K923889 andScrew-Vent Implant referenced as K900179 |
| Description of Device: | A cylinder shaped commercially pure titanium dentalimplant with external threads and a Hydroxylapatite Coating. |
| Intended Use: | The titanium endosseous implant is a device intended to be surgicallyplaced in the bone of the upper or lower jaw arches to provide support forprosthetic devices. |
| Substantial Equivalence: | Substantial Equivalence for the "O" Butment HS Implant isis based on the following comparison of predicate devices such as "O"Company's "O" Butment ES Implant and Dentsply's Screw VentImplant. The design, function, labeling, material composition and intended use isequivalent to the devices currently marketed. |
| Non-clinical tests: | Based on lateral and vertical stress analysis performed by Rocky MountainTesting, it has been determined that the physical integrity of the implanthas not been compromised by the modifications. |
This data supports our determination that the "O" Butment HS Implant is substantially equivalent to the "O" Company's "O" Butment ES Implant (K923889) and Dentsply's Screw Vent Implant (K900179).
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is facing to the right. The logo is simple and clean, and it is easily recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 1998
Dr. David D. Dalise ·President / Owner "O" Company, Incorporated 600 Paisano, N.E., Suite A Albuquerque, New Mexico 87123
Re : K973926 "O" Butment HS Implant Trade Name: Requlatory Class: III Product Code: DZE September 30, 1997 Dated: Received: October 15, 1997
Dear Dr. Dalise:
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, 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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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 sections 531
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Page 2 - Dr. Dalise
through 542 of the Act for devices under the Electronic enrough Size of Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as first receir wire 510 k) premarket notification. The FDA finding of substantial equivalence of your device to a legally rinang or earsome device results in a classification for your marketed productorermits 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) 594-4618. 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 premarket notification" (21 CFR 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.fdal.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr 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__
K973926
n/a
510(k) Number (if known):
Dental Implant Endosseous Device Name:
Indications For Use:
"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ewald Shipp
(Division Sian-Off and Ga 510k) Nu
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.