(426 days)
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fine intended as belients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
The BTI Dental Implant System is designed to server as support for prosthetic devices to restore chewing function. The implants have a surgical diameter range of from 3.3 to 4.0 mm for the universal platform implant and 4.5 to 5.5 mm for wide platform. Lengths range from 7,0 to 18,0 mm. Narrow platform implants are 3,3 wide in the surgical area, with lengths ranqing from 10,0 to 15,0 mm.
This document is a 510(k) premarket notification for the B.T.I. Dental Implant System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study of acceptance criteria and device performance. Therefore, most of the requested information regarding acceptance criteria, study details, and performance metrics for a specific study proving the device meets those criteria is not available in the provided text.
Here is an attempt to address the requested information based on what is available and to indicate what is missing:
Description of Acceptance Criteria and Study Proving Device Meets Acceptance Criteria
The provided 510(k) notification for the B.T.I. Dental Implant System is a premarket submission to the FDA. The primary objective of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to provide detailed performance data against specific acceptance criteria in the way a clinical trial or device validation study would. Therefore, the document does not contain a typical "acceptance criteria" table with corresponding performance data from a specific study designed to meet those criteria.
Instead, the submission focuses on demonstrating that the B.T.I. Dental Implant System has the same intended use as, and similar technological characteristics to, an existing predicate device (Osseotite Dental Implants manufactured by Implant Innovation Inc, K013570). The FDA's letter confirms substantial equivalence based on the information provided, which would typically include comparisons of materials, design, manufacturing processes, and potentially some bench testing data, but the specifics of such comparisons or any defined acceptance criteria are not detailed in the provided excerpts.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the provided document. The document aims to establish substantial equivalence to a predicate device rather than report against specific performance acceptance criteria. | Not specified in the provided document. No specific performance metrics or data from a study are reported. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified. (The manufacturer, B.T.I. Biotechnology Institute, S.L., is located in Spain).
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 / Not specified. This type of information is usually relevant for studies involving human interpretation (e.g., image analysis), which is not the primary focus of this device's 510(k) submission as presented here.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Not relevant to the type of information presented in this 510(k) summary.
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:
- No. This is a dental implant system (a physical medical device), not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI improvement effect size are not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical dental implant device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified in the context of device performance data. For a physical device like a dental implant, "ground truth" often relates to in-vitro testing results (e.g., mechanical strength, material compatibility), animal studies, or clinical outcomes from previous versions or similar devices. However, no such specific "ground truth" establishment details are provided in this summary. The "ground truth" for the 510(k) submission itself is based on the established safety and effectiveness of the predicate device.
8. The sample size for the training set:
- Not applicable / Not specified. This is a physical dental implant device, not a machine learning model that would require a 'training set'.
9. How the ground truth for the training set was established:
- Not applicable / Not specified. As above, this is not relevant for a physical medical device.
Summary of available information:
The provided document is a 510(k) summary focused on establishing substantial equivalence for the B.T.I. Dental Implant System to a predicate device (Osseotite Dental Implants, K013570). It defines the device, its intended use, and the predicate. The FDA's review confirms this substantial equivalence. However, it does not include detailed device-specific acceptance criteria or a study report demonstrating the device's performance against such criteria. The FDA letter is confirmation of regulatory clearance, not a performance report.
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K0.2258
FP 1 2003
510(k) Notification BTI Dental Implant System
4. 510(k) Summary
Manufacturer's Information
| Submitter's name: | B.T.I. Biotechnology Institute, S.L |
|---|---|
| Address: | Parque Tecnologico de AlavaLeonardo da Vinci 14B01510 Miñano (Alava)España |
| Contact's name: | Alfredo Gómez |
| phone: | +34 945 297030 |
fax: +34 945 297031
Device Name
| Common Name: | Implant |
|---|---|
| Trade Name: | B.T.I. Dental Implant System |
| Classification name: | Endosseous Implant |
Predicative Device
The B.T.I. Dental Implant Systems are substantially equivalent to the following device: Osseotite Dental Implants manufactured by Implant Innovation Inc, . (31) number K013570.
Device Description
The BTI Dental Implant System is designed to server as support for prosthetic devices to restore chewing function. The implants have a surgical diameter range of from 3.3 to 4.0 mm for the universal platform implant and 4.5 to 5.5 mm for wide platform. Lengths range from 7,0 to 18,0 mm. Narrow platform implants are 3,3 wide in the surgical area, with lengths ranqing from 10,0 to 15,0 mm.
Intended Use
To replace missing tooth roots for single tooth, partial tooth and fully edentulous patients.
It is designated to become osseointegrated elements allowing the attachment of a partial or a complete prosthodontic appliance.
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Image /page/1/Picture/1 description: The image is a black and white seal for the U.S. Department of Health & Human Services. The seal is circular and contains the department's logo, which is a stylized caduceus. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.
Public Health Service
SEP 1 1 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
B.T.I. Biotechnology Institute S.L. C/O Mr. Alfredo Gomez Ouality Assurance and Certifications Deputy Manager Parque Tecnologico de Alava Leonardo Da Vinci, 14B 01510 Minano (Alava)- ESPANA
Re: K022258
Trade/Device Name: B.T.I Biotechnology Institute, S.L. Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE . Dated: June 11, 2003 Received: June 13, 2003
Dear Mr. Gomez:
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 -Mr. Gomez
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 (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
Susan Runno
Susan Runner, DDS, MA Interim 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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Page 1 of 1
510(k) Number (if known): __ K 0222 58
Device Name: BTI DENTAL IMPLANT SYSTEM
Indications For Use:
Dental implant system comprising endosseous titanium implants and prosthetic elements to be attached to the implants, as well as auxiliary elements for surgical and prosthetic procedures.
The intended use of the system is the restoration of missing teeth in partially or fine intended as belients and/or the fixation of overdentures to restore or enhance the chewing capacity of patients.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Mulen for MSR
(Division Sign-Off) Division of Anesthesiology, General Hospitali, Infection Control, Dental Device
(Optional Format 3-10-98)
510(k) Number: K022258
§ 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.