(141 days)
OSSEOTITE NT™ Implant System is indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
Implant Innovation's dental implant systems include screw-form (i.e. threaded) titanium implants with a machined, external HEX to assist in placement and to provide antirotation features for the restoration. The OSSEOTTE® Brand implants have a special dual acid-etched treatment process to increase surface roughness.
The OSSEOTITE NTTM Dental Implants are tapered implants designed to mimic the shape and form of a natural tooth. The taper aspect ratio varies depending upon the length and diameter. The NT implants will be available in diameters of 3.25, 4.0, 5.0 and 6.0 mm and lengths of 8.5, 10.0, 11.5, 13.0 and 15.0 mm.
The provided document, K014235 for OSSEOTITE NT™ Implants and Accessories, is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through clinical trials with specific acceptance criteria, as might be seen with a PMA (Premarket Approval) application.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific study designs (test set sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a training set.
However, I can extract the information that is present concerning performance data and substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Demonstrated Equivalence) | Reported Device Performance |
|---|---|
| Mechanical strength at least equivalent to currently marketed OSSEOTITE® Dental Implants (predicate device). | "mechanical testing of the implants demonstrated that the OSSEOTITE NTTM Dental Implants possess mechanical strength at least equivalent to the currently marketed OSSEOTITE® Dental Implants." |
2. Sample Size Used for the Test Set and Data Provenance:
- The document mentions "mechanical testing of the implants." This implies in vitro testing.
- Sample Size: Not specified.
- Data Provenance: In vitro testing (laboratory-based), not specified geographical origin. This is not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.
4. Adjudication Method for the Test Set:
- Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC study was not done. This device is not an AI/imaging device where human reader performance would be assessed.
6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:
- Not applicable. This device is an implant, not an algorithm.
7. The Type of Ground Truth Used:
- For the mechanical performance, the "ground truth" would be the measured mechanical properties (e.g., strength, fatigue resistance) of the predicate device, against which the new device was compared. This is a scientific measurement, not an expert-derived ground truth.
8. The Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. This is a physical medical device, not an AI model.
In summary, this 510(k) filing relies on demonstrating substantial equivalence primarily through comparison of physical characteristics and mechanical testing to existing predicate devices, rather than clinical efficacy studies with specific acceptance criteria or expert-based ground truth evaluations.
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MAY 1 6 2002
Implant Innovations, Inc. 510(k) Premarket Notification OSSEOTITE NT™ Implants and Accessories
Image /page/0/Picture/3 description: The image is a logo for Implant Innovations, Inc., a Biomet company. The logo features a stylized "3i" with the "i" being a vertical line. Below the "3i" is the text "IMPLANT INNOVATIONS, INC." and "A BIOMET COMPANY" in smaller font. The logo is in black and white.
Summary of Safety & Effectiveness
COMPANY: Implant Innovations, Inc. 4555 Riverside Drive
Palm Beach Gardens, FL 33410
CONTACT: Jacquelyn A. Hughes, RAC Director, Regulatory Affairs & Quality Assurance Telephone: 561-776-6819 FAX: 561-776-6852 E-mail: jhughes@3implant.com
DATE PREPARED: December 21, 2001
NAME OF THE DEVICE: OSSEOTITE NT™ Implant System
Classification: DZE Class III Common Name: Endosseous Implant
PREDICATE DEVICES:
OSSEOTITE® Dental Implants and Accessories cleared for marketing via the following premarket notifications:
- K935544 for an acid-etched process to create the OSSEOTITE® Brand surface . cleared on March 13, 1995,
- K980549 for a performance claim cleared on April 28, 1998, .
- K983347 for a performance claim cleared on January 1, 1999, and .
- K013570 for Instructions for Use changes cleared on December 18, 2001. .
The OSSEOTITE NTTM Dental Implants taper feature is substantially equivalent to at least two currently marketed dental implants:
- · Nobel Biocare USA, Inc. (Steri-Oss), Replace™ TPS Coated Implants cleared via K002475 on November 9, 2000, and the
- · Friadent GmbH FRIALITTN-2 Stepped Screw Implant cleared via K994376 on March 24, 2000.
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Color coding is substantially equivalent to the Nobel Biocare USA, Inc. (Steri-Oss), Replace™ TPS Coated Implants.
DEVICE DESCRIPTION:
Implant Innovation's dental implant systems include screw-form (i.e. threaded) titanium implants with a machined, external HEX to assist in placement and to provide antirotation features for the restoration. The OSSEOTTE® Brand implants have a special dual acid-etched treatment process to increase surface roughness.
The OSSEOTITE NTTM Dental Implants are tapered implants designed to mimic the shape and form of a natural tooth. The taper aspect ratio varies depending upon the length and diameter. The NT implants will be available in diameters of 3.25, 4.0, 5.0 and 6.0 mm and lengths of 8.5, 10.0, 11.5, 13.0 and 15.0 mm.
INDICATIONS FOR USE:
The OSSEOTITE NTTM Implant System is indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.
CONTRAINDICATIONS:
Placement of 3i dental implants may be precluded by patient conditions that are contraindications for surgery.
3i implants should not be placed on patients where the remaining jaw bone is too diminished to provide adequate implant stability.
PERFORMANCE DATA:
Data consistent with the recommendations in the FDA guidance document Information Necessary for Premarket Notification Submissions for Screw-Type Endosseous Implants, December 9, 1996, mechanical testing of the implants demonstrated that the OSSEOTITE NTTM Dental Implants possess mechanical strength at least equivalent to the currently marketed OSSEOTITE® Dental Implants.
CONCLUSION:
Based on the information provided herein and the 510(k) "Substantial Equivalence" Decision Making Process Chart, we conclude that OSSEOTITE NTTM Dental Implants and Accessories are substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act.
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Image /page/2/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles forming a bird-like shape.
MAY 1 6 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jeannette G. Dailey Regulatory Affairs Manager Implants Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K014235
Trade/Device Name: OSSEOTITE NTTM Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: III Product Code: DZE Dated: March 26, 2002 Received: March 27, 2002
Dear Ms. Dailey:
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.
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
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Page 2 - Ms. Dailey
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Patricia Ciceritffor
Timothy A. Ulatowski 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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Implant Innovations, Inc. 510(k) Premarket Notification OSSEOTITE NT™ Implants and Accessories
Page of 1
510(k) Number (if known): _
Device Name: OSSEOTITE NT™ Implant System
Indications for Use:
OSSEOTITE NT™ Implant System is indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a 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) (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices K614295 510(k) Number __ Prescription Use:_ OR Over the Counter Use:_ (Per 21 CFR 801.109)
§ 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.