(588 days)
For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
These indications include application in:
- Apexification
- Periapical Lesions
- Root Resorption ●
- Temporary Root Filling ●
- Perforations ●
- Underdeveloped pulpless teeth ●
iRoot FM Injectable Root Canal Filling Material (iRoot FM) is a convenient premixed ready-to-use injectable, radiopaque, white hydraulic bioceramic paste developed for root canal filling applications. iRoot FM is an aluminum-free material based on a calcium silicate composition, which requires the presence of water to set. iRoot FM is packaged in a pre-loaded syringe and is supplied with disposable tips.
This document is a 510(k) premarket notification for the iRoot FM Injectable Root Canal Filling Material. The provided text, however, does not describe the acceptance criteria or a specific study that proves the device meets those criteria in the typical format of a clinical or analytical performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments.
Here's a breakdown of the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this submission document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Tests: | |
| Flow | Met, substantially equivalent to iRoot SP |
| Working Time | Met, substantially equivalent to iRoot SP |
| Setting Time | Met, substantially equivalent to iRoot SP |
| Radiopacity | Met, substantially equivalent to iRoot SP |
| Biocompatibility: | |
| Cytotoxicity | Non-cytotoxic |
| Mutagenicity | Non-mutagenic (based on predicate data) |
| Allergenic Potential | No allergenic potential after multiple uses (based on predicate data) |
| Subcutaneous Tissue Tolerance | Good tolerance (based on predicate data) |
Notes on the table:
- Acceptance Criteria: These are inferred from the types of tests performed. The document states "iRoot FM has undergone extensive bench and biocompatibility NON-CLINICAL TESTS testing to provide evidence that iRoot FM's chemical and physical properties are substantially equivalent to iRoot SP." Specific quantitative thresholds for "acceptance criteria" are not given in this summary; rather, the performance is reported as meeting the criteria because it was found to be "substantially equivalent" to the predicate device, iRoot SP.
- Reported Device Performance: This column reflects the conclusions drawn from the non-clinical tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for the bench tests or biocompatibility tests.
- Data Provenance: Not specified. The submission is from Innovative BioCeramix Inc. in Vancouver, BC, Canada, but the origin of the test data (e.g., where the tests were conducted) is not provided. The study appears to be entirely non-clinical bench testing, not a clinical study.
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)
- Number of Experts: Not applicable. This was a non-clinical bench study, not a study involving expert readers to establish ground truth from clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This was a non-clinical bench study.
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
- MRMC Comparative Effectiveness Study: No, this was not a MRMC study. The device is a root canal filling material, and the evaluation was based on non-clinical bench testing and biocompatibility, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the context of clinical "ground truth." For the non-clinical tests, the "ground truth" was established based on standard material testing methods and biocompatibility assays, comparing the results to those expected for a substantially equivalent device or predicate device (iRoot SP, iRoot FS, BioAggregate, and Diapex).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This was a non-clinical evaluation of a material, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document details a 510(k) submission focused on demonstrating substantial equivalence of the iRoot FM Injectable Root Canal Filling Material to existing predicate devices (iRoot SP, iRoot FS, BioAggregate, Diapex) through non-clinical bench testing (flow, working time, setting time, radiopacity) and biocompatibility assessments. It does not describe a clinical study with human subjects, expert readers, or AI performance evaluation.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the shape of a bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2014
Innovative BioCeramix, Inc. Quanzu Yang President/CEO 1628 West 75th Avenue Vancouver, BC V6P 6G2 CANADA
Re: K130312
Trade/Device Name: iRoot FM Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Codes: KIF Dated: June 26, 2014 Received: June 30, 2014
Dear Mr. Yang:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Yang
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT 6.0
The following document is included in this section:
- INDICATIONS FOR USE STATEMENT ●
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INDICATIONS FOR USE
510(k) Number (if Known): K130312
Device Name: iRoot FM Injectable Root Canal Filling Material
Indications for Use:
For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
These indications include application in:
- Apexification
- Periapical Lesions
- Root Resorption ●
- Temporary Root Filling ●
- Perforations ●
- Underdeveloped pulpless teeth ●
Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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7.0 510(k) SUMMARY
The following document is included in this section:
- 510(k) SUMMARY .
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Image /page/5/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in blue text and the letters "IBC" in a green circle. The contact information includes the company's address, phone number (604-221-6800), and fax number (604-677-6129).
a
510(k) SUMMARY
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92
| SUBMITTER: | Innovative BioCeramix Inc.1628 West 75th AvenueVancouver, BCV6P 6G2 CanadaTel: 604-221-6800Fax: 604-677-6129 |
|---|---|
| CONTACT: | Quanzu Yang |
| SUMMARYPREPARED: | June 4, 2014 |
| TRADE NAME: | iRoot FM |
| COMMON NAME: | Injectable Root Canal Filling Material |
| CLASSIFICATIONNAME: | Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) |
| PREDICATE DEVICES: | iRoot SP(K080917)(K063422)BioAggregate●(K033585)Diapex● |
| DEVICEDESCRIPTION: | iRoot FM Injectable Root Canal Filling Material (iRoot FM) is aconvenient premixed ready-to-use injectable, radiopaque, whitehydraulic bioceramic paste developed for root canal filling |
supplied with disposable tips.
to set.
applications. iRoot FM is an aluminum-free material based on a calcium silicate composition, which requires the presence of water
iRoot FM is packaged in a pre-loaded syringe and is
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Image /page/6/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in blue text, followed by the letters "IBC" in a green circle. The contact information includes the company's address, phone number (604-221-6800), and fax number (604-677-6129).
INTENDED USE:
For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with guttapercha.
These indications include application in:
- Apexification
- Periapical Lesions
- Root Resorption
- . Temporary Root Filling
- Perforations ●
- . Underdeveloped pulpless teeth
TECHNOLOGICAL CHARACTERISTICS:
The main chemical composition and performance specifications of iRoot FM is based on iRoot SP. Additional predicate devices iRoot FS and Diapex, each contains specific chemical include: components that are equivalent to those found in iRoot FM; providing evidence that these chemical components are utilized for medical device use.
iRoot FM and Diapex are designated for the equivalent dental applications. In addition, iRoot FM has a comparable delivery system and similar labeling to iRoot SP and Diapex.
iRoot FM has undergone extensive bench and biocompatibility NON-CLINICAL TESTS testing to provide evidence that iRoot FM's chemical and physical PERFORMED: properties are substantially equivalent to iRoot SP. Bench tests included: flow, working time, setting time and radiopacity.
Biocompatibility test results determined that iRoot FM is noncytotoxic. Since iRoot FM's chemical composition is based on the principal chemical components in iRoot SP, iRoot FS and BioAggregate, the biocompatibility test data of these devices provides biocompatibility evidence that iRoot FM is nonmutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.
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Image /page/7/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in blue text and the letters "IBC" in a green circle. The contact information includes the company's address at 1628 West 75th Avenue, Vancouver, BC, V6P 6G2 Canada, as well as their phone number (604-221-6800) and fax number (604-677-6129).
CONCLUSIONS:
demonstrates chemical, physical, iRoot FM performance specifications and biocompatible properties to iRoot SP. iRoot FM's main chemical composition is based on iRoot SP. In addition, BioAggregate provides biocompatibility verification for iRoot FM. iRoot FM and Diapex have equivalent indications for use. Furthermore, iRoot FM has a comparable delivery system and similar labeling to iRoot SP and Diapex. Therefore, it is concluded that iRoot FM is substantially equivalent in safety and effectiveness to the predicate devices.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.