(145 days)
The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
Glass Fiber composite root canal post
The provided text describes a 510(k) premarket notification for the FIBIOCORE Glass Fiber Composite Posts. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than on detailed performance criteria typically associated with software or AI-based devices. Therefore, much of the information requested in your prompt (e.g., acceptance criteria tables, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance) is not applicable or available in this document.
Here's an analysis of the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission are based on demonstrating substantial equivalence to legally marketed predicate devices. This is achieved by showing the new device has similar:
- Quality of mechanical characteristics
- Mechanical safety
- Materials
- Design
- Performance
- Indications for use
- Reported Device Performance:
- Biocompatibility: Standard ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity : in vitro methods" was conducted, showing "no evidence of a cytotoxic response."
- Mechanical Strength: Mechanical tests were conducted in conformance with ISO 3597-2 (Three-point Bending Standards). The results "showed the material to be suitable for root canal posts." Other unspecified mechanical tests were also conducted to characterize the material.
| Acceptance Criteria Category | Specific Criteria / Standard | Reported Device Performance |
|---|---|---|
| Substantial Equivalence | Similar Mechanical Characteristics | Met (as claimed by submitter) |
| Similar Mechanical Safety | Met (as claimed by submitter) | |
| Similar Materials | Met (as claimed by submitter) | |
| Similar Design | Met (as claimed by submitter) | |
| Similar Performance | Met (as claimed by submitter) | |
| Similar Indications for Use | Met (as claimed by submitter) | |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | No evidence of cytotoxic response |
| Mechanical Strength | ISO 3597-2 (Three-point Bending) | Material suitable for root canal posts |
| Other Mechanical Tests | Material characterized (details not provided) |
2. Sample sized 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 in the document as it is not typically required for a 510(k) submission for a Class I dental device. The "test set" in this context refers to samples of the physical device used for mechanical and biological testing, not a dataset for an algorithm.
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. This device is a physical dental post, not an AI or imaging device requiring expert interpretation for ground truth. Technical experts would have conducted the ISO standard tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This refers to adjudication of expert interpretations for AI/imaging studies, which is not relevant here.
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
- No. This is not an AI-assisted device, so MRMC studies are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm, so standalone performance is not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is established by conformance to international standards (ISO 10993-5 for biocompatibility and ISO 3597-2 for mechanical strength) and by demonstrating similar physical and mechanical properties to predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. There is no training set for this device.
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JUL 3 2002
510(k) SUMMARY (As required by 21 C.F.R. 807.92)
| Date : | December 18, 2001 | |
|---|---|---|
| Submitter : | ANTHOGYR164, rue des 3 lacs74700 Sallanches - FRANCETel : 33 (0)4 50 58 02 37Fax : 33 (0)4 50 93 78 60Establishment registration number : #8020776 | |
| Contact | CHAIRMAN AND MANAGING DIRECTOR : Mr Claude ANTHOINETel : 33 (0)4 50 58 02 37E-Mail : prod@anthogyr.com | |
| Device Name | ||
| Proprietary Name : | FIBIOCORE | |
| Device Trade name : | FIBIOCORE | |
| Common/Usual Name : | Glass Fiber composite root canal post | |
| Proposed Classification Name : | Dental root canal post | |
| Device Classification | ||
| Class : | I | |
| Classification Regulation : | 21 CFR 872.3810 | |
| Product Code : | 76 ELR | |
| Performance Standards & Testing |
Standard ISO 10993-5 "Biological evaluation of medical devices - Tests for Cytotoxicity : in vitro methods" was conducted and shows no evidence of a cytotoxic response. Mechanical tests were conducted in conformance with ISO 3597-2 (Three-point Bending Standards). The results showed the material to be suitable for root canal posts. Others Mechanical tests were conducted to characterize the material.
Predicate Device - Substantial Equivalence
The modified device is substantially equivalent to the previously cleared Carbotech Snowpost (K012354), Bisco UM Aesthetic Post (K945370), Coltene ParaPost Fiber White (K000311), Jeneric/Pentron FibreKor Post (K983266), and the Harald Nordin Glassix post (K003221) devices.
The modified device is substantially equivalent in quality of mechanical characteristics, of mechanical safety, of materials, of design, of performance and of indications for use.
Modifications
The primary differences are minor changes to the material and dimensions.
Intended Use of the subject Devices
The modified device has the same intended use as the legally marketed predicate devices herein referenced. The FIBIOCORE composite posts are intented for use by dentists to give retention for reconstruction of non-vital teeth. The device is intended to be cemented into the root canal of a tooth to stabilize and support a restoration.
Technological Characteristics
The modified device has the same technological characteristics as the leggaly marketed predicate device mechanically supporting reconstruction.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
3 2002 JUL
Mr. Claude Anthoine Est. ANTHOGYR Chairman and Managing Director 164 Rue Des 3 Lacs 74700 Sallanches, FRANCE
Re: K020431
Trade/Device Name: FIBIOCORE Glass Fiber Composite Posts Regulation Number: 872.3810 Regulation Name: Root Canal Post Regulatory Class: I Product Code: ELR Dated: May 9, 2002 Received: May 9, 2002
Dear Mr. Anthoine:
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 requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.
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Page 2 - Mr. Anthoine
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,
Timothy A. Ulatowski
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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K 020431
INDICATIONS FOR USE STATEMENT
510(k) Number : (if known)
Device Name: FIBIOCORE Glass Fiber composite posts
The FIBIOCORE composite posts are intented for use by dentists Indications For Use : to give retention for reconstruction of non-vital teeth.
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 CFR 801.109)
OR
Over-The-Counter Use __
Susan Purrp
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices CATOR 510(k) Number
§ 872.3810 Root canal post.
(a)
Identification. A root canal post is a device made of austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be cemented into the root canal of a tooth to stabilize and support a restoration.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.