(10 days)
3 i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.
The 3i TG OSSEOTITE® Wide Implants are trans-gingival implants designed with an internal morse-taper. The wider dimension of the seating surface provides a realistic size proportion of a natural tooth of the posterior area.
The provided document is a 510(k) summary for a medical device, the 3i TG OSSEOTITE® Wide Implants. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.
Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets them. It explicitly states under "Performance": "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."
The purpose of a 510(k) is to show that a new device is "substantially equivalent" to an already legally marketed device – meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness. It does not typically involve the presentation of acceptance criteria or a dedicated study to prove performance against those criteria in the same way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.
Based on the document, here's what can be extracted, and what cannot:
1. A table of acceptance criteria and the reported device performance
- Not available. The document states "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act." The submission is based on substantial equivalence to predicate devices, not on meeting specific performance criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not available. No clinical study or test set data is presented to demonstrate performance against acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices.
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. No test set or ground truth establishment based on expert consensus for performance evaluation is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. No test set requiring adjudication in the context of performance evaluation is described.
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
- Not applicable. This device is an endosseous dental implant, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission type.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Not applicable. This device is an endosseous dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The submission relies on substantial equivalence, not on establishing ground truth for performance evaluation.
8. The sample size for the training set
- Not applicable. No machine learning algorithm or training set is involved in the submission for this type of device.
9. How the ground truth for the training set was established
- Not applicable. No machine learning algorithm or training set is involved.
Summary of the Document's Content:
The document is a 510(k) premarket notification for the "3i TG OSSEOTITE® Wide Implants." Its primary conclusion is that the device is substantially equivalent to legally marketed predicate devices (TG OSSEOTITE® Dental Implants K972444 and OSSEOTITE® IOL Implants K031632). It describes the device as trans-gingival implants designed with an internal morse-taper and a wider seating surface, intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The technological characteristics are stated to be similar to the currently available TG OSSEOTITE® Implants. The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed.
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16033430
NOV - 7 2003 Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR § 807.93
| Submitter | Implant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410 |
|---|---|
| Contact | Tamara NelsonInternational Regulatory Affairs SpecialistImplant Innovations, Inc.4555 RiversidePalm Beach Gardens, FL 33410Tel. 561-776-6923Fax. 561-776-6852Email tnelson@3implant.com |
| Date Prepared | October 24, 2003 |
| Device Name | 3i TG OSSEOTITE® Wide Implants |
| Classification Name | Endosseous Dental Implant |
| DeviceClassification | Class IIIDental Devices Panel21 CFR § 872.3640 |
| PredicateDevices | TG OSSEOTITE® Dental ImplantsK972444OSSEOTITE® IOL ImplantsK031632 |
| Performance | Performance standards have not been established by theFDA under Section 514 of the Federal Food, Drug andCosmetic Act. |
| Device Description | The 3i TG OSSEOTITE® Wide Implants are trans-gingivalimplants designed with an internal morse-taper. The widerdimension of the seating surface provides a realistic sizeproportion of a natural tooth of the posterior area. |
| Indications forUse | The 3i TG OSSEOTITE® Wide Implants areindicated for surgical placement in the upper or lower jawto provide a means for prosthetic attachment. |
| TechnologicalCharacteristics | The 3i TG OSSEOTITE® Wide Implants contain featuresand functions which are similar to the currently availableTG OSSEOTITE® Implants. |
| Conclusion | The 3i TG OSSEOTITE® Wide Implants are substantiallyequivalent to the legally marketed TG OSSEOTITE®Implants. |
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and the comments of the comments of the comments of the comments of the comments of the comments of the contribution of the contribution of the contribution of the contributi
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 2003
Ms. Tamara Nelson International Regulatory Affairs Specialist Implant Innovations, Incorporation 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K033430
Trade/Device Name: 31 TG Osseotite Wide Implants, Models TG685, TG611, TG613 Regulation Number: 872.3640 Regulation Name: Dental Implant Regulatory Class: III Product Code: DZE Dated: October 27, 2003 Received: October 28, 2003
Dear Ms. Nelson:
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. Nelson
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,
Susie Runons
Sy 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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Page 1__ of 1
510(k) Number (if known): K033430
Device Name: 3i TG OSSEOTITE® Wide Implants
Indications for Use:
3 i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.
(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 Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | 1033430 |
|---|---|
| ---------------- | --------- |
| 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.