(83 days)
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for a dental prosthesis.
The device consists of the implant (root component), collar, collar retaining screw, coping, coping retaining screw, healing cap, and healing cap retaining screw. Alternatively, the overdenture abutment (with an overdenture abutment retaining screw) is available; this assembly incorporates the coping retaining screw, collar, and collar retaining screw into a combined component for attachment to the root component. All of the component parts of the Endopore Implant are fabricated from a surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (TicAl;V) alloy. The bone-contacting portion of the implant component has a powder-sintered porous coating of a surgical grade titanium-aluminum-vanadium alloy. The bonccontacting portion of the implant component is a truncated conical design with tapered sides.
The provided text describes a 510(k) summary for the Innova LifeSciences Corporation Endopore® Endosseous Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria or detailing a clinical study with performance metrics in the way a diagnostic algorithm or AI device submission would.
Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details, ground truth for training set) are not applicable to this type of device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical/Physical Equivalence | The modification to the dimensions (addition of a 5 mm length) does not alter its indications for use or its fundamental scientific technology. The new 5 mm implant length is within the range of lengths of other previously cleared implants (as short as 4 mm). |
| Clinical Performance (Lack of Adverse Impact) | Performance data included in the submission demonstrates that the shorter length does not adversely impact device performance. (Specific metrics not provided in this summary) |
| Material Composition | All component parts are fabricated from surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (Ti-Al-V) alloy. The bone-contacting portion has a powder-sintered porous coating of the same alloy. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a medical device (dental implant), not a diagnostic algorithm or AI device that would typically involve a "test set" in the computational sense. The "performance data" mentioned likely refers to mechanical testing or a summary of existing clinical data related to the predicate devices or the modified device. The document does not specify human subject data for this particular submission's performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See explanation above.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. See explanation above.
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 is a hardware medical device; it does not involve AI or human readers in an MRMC study context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware medical device; it does not involve algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate dental implants through their long-standing use and prior FDA clearances, supported by material characterization and mechanical testing to demonstrate that the new, shorter length of the implant does not compromise these established performance parameters. The "performance data" mentioned would likely consist of engineering and bench test results.
8. The sample size for the training set
- Not Applicable. This is a hardware medical device and does not use a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not Applicable. See explanation above.
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510(K) SUMMARY FOR THE INNOVA LIFESCIENCES CORPORATION ENDOPORE® ENDOSSEOUS DENTAL IMPLANT SYSTEM
Submitter's Name. Address. Telephone Number, And Contact Person
Innova LifeSciences Corporation 525 University Avenue, Suite 777 Toronto, Ontario M5G 2L3 Canada
Contact: Michael A. Kehoe, President Telephone: (416) 340-8818 Facsimile: (416) 340-0415
Date Prepared
June 30, 2003
Name of the Device
5.0 x 5 mm Endopore® Endosseous Dental Implant System
Common or Usual Name
Endosseous Implant
Classification Name
Endosseous Implant (DZE)
Predicate Devices
Endopore® Endosseous Dental Implant System in 4.1 mm diameter (K926354) and 5.0 mm diameter (K971196);
Bud Industries, Inc. Dental Implant System 4 mm Length; Bicon, Inc. 6.0 x 5.7 mm Dental Implant; Cherchève Implant, 3.5 x 4 mm; Branemark Integration AB Implant, 4.1 x 7 mm.
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Intended Use
The Endopore Implant is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis.
Principles of Operation
The principles of operation of the modified device are identical to the previously cleared Endopore Implant System. Like the predicate endosseous implants, the 5.0 x 5 mm Endopore Implant is inserted in a standard two-stage surgical procedure.
Technological Characteristics
The technological characteristics of the modified Endopore Implant also are identical to the predicate Endopore Implant System, except for the addition of a shorter implant length (5 mm) of the 5.0 mm diameter implant size. The device consists of the implant (root component), collar, collar retaining screw, coping, coping retaining screw, healing cap, and healing cap retaining screw. Alternatively, the overdenture abutment (with an overdenture abutment retaining screw) is available; this assembly incorporates the coping retaining screw, collar, and collar retaining screw into a combined component for attachment to the root component. All of the component parts of the Endopore Implant are fabricated from a surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (TicAl;V) alloy. The bone-contacting portion of the implant component has a powder-sintered porous coating of a surgical grade titanium-aluminum-vanadium alloy. The bonccontacting portion of the implant component is a truncated conical design with tapered sides.
Summary Basis for the Finding of Substantial Equivalence
The modification to the dimensions of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Furthermore, the new 5 mm implant length is within the range of lengths of other previously cleared and preamendments endosseous implants, which are available in lengths as short as 4 mm. Performance data included in the submission demonstrates that the shorter length does not adversely impact device performance. Therefore, the modified device is substantially equivalent to the predicates.
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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 wavy lines, which are meant to represent the flow of people.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT - 2 2003
Innova Life Sciences Corporation Mr. Howard M. Holstein Regulatory Counsel Hogan & Hartson, L.L.P. 555 13th Street N.W. Washington, DC 20004
Re: K032140
Trade/Device Name: 5.0 x 5mm Endopore® Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: July 11, 2003 Received: July 11, 2003
Dear Mr. Holstein:
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. Holstein
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 (OS) 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 Runne
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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Indications for Use Statement
0,2216 510(k) Number (if known): __
Device Name: 5.0 x 5 mm Endopore® Endosseous Dental Implant System
Indications for Use:
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for a dental prosthesis.
Kein Mulvey for HSE
esthesiology, General Hospital. Control Dental Devices
510(k) Number: K032140
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 C.F.R. 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.