(27 days)
For use as an endosseous dental implant in the upper or lower jaw arches to provide support for prosthetic devices.
The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.
The provided text is a 510(k) summary for a dental implant system. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with acceptance criteria and device performance results in the way commonly associated with AI/ML device evaluations.
Therefore, many of the requested categories for AI/ML study reporting cannot be directly extracted from this document, as they are not applicable to the type of information presented in a 510(k) for a physical medical device like a dental implant.
Here's an attempt to address the applicable points or explain why certain points cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. For a physical device like a dental implant, acceptance criteria would typically relate to mechanical strength, biocompatibility, design specifications, and manufacturing quality. The document states that the "minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology," suggesting that the previous performance and acceptance criteria of the predicate devices apply.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided as this document does not describe a clinical study in the context of assessing algorithms or AI performance. The evaluation is based on technological characteristics and comparison to predicate devices, not on a test set of data.
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)
This information is not applicable/provided. There is no "ground truth" establishment in the context of expert review for a test set as described for an AI/ML device. The evaluation is a regulatory review for substantial equivalence.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable/provided.
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
This information is not applicable/provided. This is a physical medical device, not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/provided. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices.
8. The sample size for the training set
This information is not applicable/provided. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established
This information is not applicable/provided.
Summary of Device Information Found in the Document (relevant to the 510(k) process):
- Device Name: Scalloped Endopore® Endosseous Dental Implant System
- Intended Use: For use in the upper or lower jaw arches to provide support for a dental prosthesis.
- Predicate Devices: Endopore® Endosseous Dental Implant System (K926354, K971196, K032140).
- Summary Basis for Substantial Equivalence: "The minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicates."
- Technological Characteristics of Modified Device:
- Identical to predicates except for:
- Addition of a 1.5 mm lightly-acid etched region immediately apical to the smooth coronal region.
- A scalloped coronal margin.
- Dimensions: 10.5 mm in length x 4.8 mm diameter (within range of previously cleared Endopore implants).
- Principles of operation are identical to previously cleared Endopore Implant System except for attachment of abutments via an internal connection.
- Identical to predicates except for:
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510(K) SUMMARY FOR THE INNOVA CORPORATION SCALLOPED ENDOPORE IMPLANT
DEC 1 4 2004
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
November 12, 2004
Name of the Device
Scalloped Endopore® Endosseous Dental Implant System
Common or Usual Name
Endosseous Implant and Abutment
Classification Name
Endosseous Implant (DZE) ; Endosseous Dental Implant Abutment (NHA)
Predicate Devices
Endopore® Endosseous Dental Implant System in 4.1 mm diameter
(K926354) and 5.0 mm diameter (K971196); 5 mm long x 5.0 mm diameter
Endopore Endosseous Dental Implant System (K032140).
Intended Use
The Endopore Implant is indicated for use in the upper or lower jaw arches to provide support for a dental prosthesis.
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The principles of operation of the modified device are identical to the previously cleared Endopore Implant System except for the attachment of abutments via an internal connection.
Technological Characteristics
The technological characteristics of the modified Scalloped Endopore Implant also are identical to the predicates, except for the addition of a 1.5 mm lightly-acid etched region immediately apical to the smooth coronal region, and a scalloped coronal margin. The dimensions of the modified Scalloped Endopore Implant, 10.5 mm in length x 4.8 mm diameter, are within the range of the dimensions of previously cleared Endopore implants.
Summary Basis for the Finding of Substantial Equivalence
The minor modification to the surface of the Endopore Implant does not alter its indications for use or its fundamental scientific technology. Therefore, the modified device is substantially equivalent to the predicates.
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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized symbol that resembles three abstract shapes stacked on top of each other, possibly representing human figures or abstract forms.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 4 2004
Mr. Howard M. Holstein Innova LifeSciences Corporation 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K043190
Trade/Device Name: Scalloped Endopore Endosseous Dental Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: NHA Dated: December 10, 2004 Received: December 10, 2004
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 (240) 276-0115. 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,
Chiu Lin, Ph.D.
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): K (H3190
Device Name: Scalloped 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 prosthetic devices.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
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)
Suoer Rumm
(Division Sign-Off)
Division of Anesthesiology, General Hospital.
Division of Anesthesiology, Gental Devices Division of Anesthesion of Anesther Devices
510(k) Number:__
Page 1 of 1
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)