(48 days)
The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.
Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.
The provided document is a 510(k) Pre-Market Notification for a dental implant (Immediate Stabilizing Implant - ISI). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.
Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it's not a clinical study report. The information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is typically found in documentation for devices that require extensive performance validation, often through clinical or non-clinical testing that directly measures performance against pre-defined criteria.
Instead, the document focuses on comparing the ISI device's design, function, labeling, material composition, and intended use to existing predicate devices to assert substantial equivalence.
Here's a breakdown of why the requested information is absent:
- Acceptance Criteria and Reported Device Performance: These are usually established for new devices undergoing rigorous testing for safety and efficacy. For a 510(k), the "performance" is primarily assessed against the predicate device's characteristics and historical safety/effectiveness.
- Sample Sizes and Data Provenance: This relates to clinical or analytical studies. The 510(k) summary provided does not describe such a study.
- Number of Experts, Qualifications, Adjudication Method: These are elements of studies involving expert review, common for diagnostic or imaging devices. This is a physical implant, not a diagnostic tool.
- MRMC Comparative Effectiveness Study: This is specific to diagnostic aids that influence human reader performance.
- Standalone Performance: While aspects of a device's physical/mechanical performance might be tested, a "standalone" performance in the context of an algorithm's output (as typically asked) is not relevant here.
- Type of Ground Truth: Ground truth (e.g., pathology, outcomes data) is used to validate the accuracy or effectiveness of a diagnostic or predictive device. For a dental implant, the "effectiveness" is determined by successful integration and function, which is typically demonstrated over time in clinical use, not usually by a single ground truth in a 510(k) submission.
- Training Set Sample Size and Ground Truth for Training Set: These are concepts related to machine learning and AI, which are not applicable to the ISI dental implant.
In summary, the provided document demonstrates substantial equivalence based on a comparison to predicate devices, not through a study with defined acceptance criteria and performance metrics in the way a diagnostic or AI-powered device would.
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K03392
510(K) SUMMARY
Date: 10/07/03
| Contact Person: | David D. DalisePresident/Owner "O" Company, Inc. |
|---|---|
| Trade Name: | (ISI) Immediate Stabilizing Implant |
| Common Name: | Endosseous Screw Implant |
| Classification Name: | Dental Implant Endosseous / Code 76DZE |
| Substantial Equivalence to: | Bicortical Screw K983120 Cleared 7/29/99LaminOss K982925 Cleared 5/15/99Altiva K992512 Cleared 11/1/99Crystal Stabledent K011502 10/22/01 |
| Description of Device: | Self-tapping one-piece CP Titanium threaded dentalimplant, with a roughened surface treatment. Availablein 3.25mm, 4.0mm, and 5.0mm diameter, and in lengthsof 8mm 10mm, 12mm, 14mm & 16mm. |
| Indications for Use: | The Immediate Stabilizing Implant (ISI) is a one-piecethreaded dental implant with the abutment incorporatedinto the design for a single stage surgical procedure.The implant is intended to be surgically placed in thebone of the upper or lower jaw arches providingsupport for prosthetic devices resulting in therestoration of the patient's chewing function. Immediateloading can be obtained if implants are rigidly splinted. |
| Substantial Equivalence: | Substantial Equivalence for the Immediate StabilizingImplant (ISI) is based on the following comparison of apredicate devices such as, Bicortical Screw Implant#K983120, LaminOss # K982925, Altiva K992512,and Crystal Stabledent K011502. The design,function, labeling, material composition and intendeduse are equivalent to these devices currently on themarket. |
This data supports our determination that the Immediate Stabilizing Implant (ISI) is Substantially equivalent to the Bicortical Screw Implant, LaminOss, Altiva, and Crystal Stabledent.
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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center is a stylized depiction of a bird-like figure, possibly an eagle, with three curved lines representing its wings or body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2003
"O" Company Incorporated Mr. David D. Dalise President/ Owner 600 Paisano NE Suite A Albuguerque, New Mexico 87123
Re: K033392
Trade/Device Name: Immediate stabilizing Implant (ISI) Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: October 10, 2003 Received: October 23, 2003
Dear Mr. Dalise:
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. Dalise
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 vours.
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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Indications for Use
510(k) Number (if known):K033392
Device Name: Immediate Stabilizing Implant (ISI)
Indications For Use:
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AND/OR Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Gunn
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device
510(k) Number. K033342
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§ 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.