(64 days)
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
iRoot FS Fast Set Root Repair Material (iRoot FS) is a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. iRoot FS is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot FS does not shrink during setting and demonstrates excellent physical properties. iRoot FS is available as a preloaded syringe with disposable tips and a preloaded container.
This document is a 510(k) summary for the iRoot FS device, a root canal repair material. The submission aims to demonstrate substantial equivalence to predicate devices, namely iRoot BP, iRoot BP Plus, iRoot SP, and D-PBS.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This submission does not provide explicit numerical "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence in chemical and physical properties, and biocompatibility to existing predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (vs. Predicate iRoot BP) |
|---|---|
| Flowability | Comparable |
| Working Times | Comparable |
| Setting Times | Comparable |
| Dimensional Change Following Setting | Comparable |
| Solubility | Comparable |
| Shelf Life | Comparable |
| Biocompatibility (General) | Comparable |
| Biocompatibility (Non-cytotoxicity) | Non-cytotoxic |
| Biocompatibility (Non-mutagenic) | Biocompatibility test data for iRoot BP (which has principal chemical components in common with iRoot FS) provides evidence that iRoot FS is non-mutagenic. |
| Biocompatibility (Non-allergenic potential after multiple uses) | Biocompatibility test data for iRoot BP provides evidence that iRoot FS does not cause an allergenic potential after multiple uses. |
| Biocompatibility (Good tolerance by subcutaneous tissue) | Biocompatibility test data for iRoot BP provides evidence that iRoot FS has a good tolerance by subcutaneous tissue. |
| Equivalent Indications for Use | iRoot FS has the equivalent indications for use as iRoot BP: Repair of Root Perforation, Repair of Root Resorption, Root End Filling, Apexification, Pulp Capping. |
| Comparable Chemical Composition | iRoot FS is a modification of iRoot BP. Additional chemical components found in iRoot FS were found to be safe and effective in iRoot SP and D-PBS. (Implies overall composition is comparable and safe). |
| Comparable Physical Properties | iRoot FS and iRoot BP have comparable physical properties. |
| Comparable Performance Specifications | iRoot FS and iRoot BP have comparable performance specifications. |
| Comparable Packaging Containers and Delivery System | iRoot FS and iRoot BP Plus have equivalent device packaging containers and delivery systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical trial or a diagnostic device where a sample size of patient data would be relevant. The testing performed was "shelf life, bench and biocompatibility testing."
- Sample Size for Test Set: Not applicable in the context of clinical data for a diagnostic device. For bench testing, typical laboratory sample sizes would be used, but these are not specified in the summary.
- Data Provenance: The nature of the bench and biocompatibility testing means the data is likely generated in a laboratory setting, not from patient populations. No country of origin for such data is stated, nor is it specified if it's retrospective or prospective, as these terms usually apply to clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the submission focuses on non-clinical testing and substantial equivalence, not clinical performance or diagnostic accuracy validated by experts.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a diagnostic test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. This submission describes a dental material, not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. The device itself is a material for dental procedures, not an algorithm.
7. The Type of Ground Truth Used
For the "test set" (bench and biocompatibility testing), the "ground truth" would be the established scientific and regulatory standards/methods for evaluating chemical properties, physical properties (e.g., flow, setting time, solubility, dimensional change), and biocompatibility (e.g., cytotoxicity, mutagenicity, sensitization, tissue irritation). These are determined through standardized laboratory protocols and scientific literature, not clinical ground truth like pathology or outcomes data in the typical sense for a diagnostic device.
8. The Sample Size for the Training Set
Not applicable. The iRoot FS is a physical dental material, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm, there is no training set or associated ground truth establishment process.
In summary, this 510(k) submission for iRoot FS focuses entirely on demonstrating substantial equivalence to predicate devices through non-clinical (shelf life, bench, and biocompatibility) testing, rather than reporting on clinical performance or diagnostic accuracy assessed via expert review or human-in-the-loop studies. Therefore, most of the questions related to clinical study design, expert involvement, and AI performance are not applicable to the information provided in this document.
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INNOVATIVE BIOCERAMIX INC.
Image /page/0/Picture/1 description: The image shows a logo with the letters "IBC" stacked vertically. The letters are bold and white, set against a black background. The logo has a slightly distressed or textured appearance, giving it a vintage or worn look.
1628 West 75th Avenue Vancouver, BC V6P 6G2 Canada Tel: 604-221-6800 Fax: 604-677-6129
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 Avenue Vancouver, BC DEC - 3 2010 V6P 6G2 Canada Tel: 604-221-6800 Fax: 604-677-6129 CONTACT: Quanzu Yang October 27, 2010 SUMMARY PREPARED: iRoot FS TRADE NAME: Fast Set Root Repair Material COMMON NAME: Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) CLASSIFICATION NAME: (K082943) iRoot BP PREDICATE DEVICES: . (K092715) iRoot BP Plus . (K080917) . iRoot SP (K851606) D-PBS. Products No. D5652 . iRoot FS Fast Set Root Repair Material (iRoot FS) is a convenient ready-to-DEVICE use fast setting white hydraulic premixed bioceramic paste developed for DESCRIPTION: permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. iRoot FS is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot FS does not shrink during setting and demonstrates excellent physical properties. iRoot FS is available as a preloaded syringe with disposable tips and a preloaded container. Repair of Root Perforation INTENDED USE: . Repair of Root Resorption . Root End Filling . Apexification . Pulp Capping .
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Image /page/1/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The address is listed as 1628 West 75th Avenue, Vancouver, BC, V6P 6G2 Canada. The telephone number is 604-221-6800.
Fax: 604-677-6129
TECHNOLOGICAL CHARACTERISTICS:
iRoot FS is a modification of iRoot BP. iRoot FS and iRoot BP are designated for the equivalent dental applications, and have comparable chemical and physical properties, and performance specifications. The packaging for iRoot FS includes syringes, jars and unit dose cups.
Additional predicate devices include: iRoot SP and D-PBS each contains specific chemical components that are equivalent to those found in iRoot FS; providing evidence that these materials are safe and effective for medical Furthermore, iRoot FS and iRoot BP Plus have equivalent device use. packaging containers and delivery systems.
NON-CLINICAL TESTS PERFORMED:
iRoot FS has undergone shelf life, bench and biocompatibility testing to provide evidence that iRoot FS's chemical and physical properties are substantially equivalent to iRoot BP. Both iRoot FS and iRoot BP have comparable flowability, working times, setting times, dimensional change following setting, solubility, shelf life and biocompatibility properties.
Biocompatibility test results determined that iRoot FS is non-cytotoxic. Since iRoot FS's chemical composition is based on the principal chemical components in iRoot BP, the biocompatibility test data for iRoot BP provides biocompatibility evidence that iRoot FS is non-mutagenic, does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.
Consequently, the shelf life, bench and biocompatibility testing, provided evidence that iRoot FS's chemical and physical properties are substantially equivalent to iRoot BP.
iRoot FS has the equivalent indications for use, comparable chemical CONCLUSIONS: composition, physical properties and performance specifications to iRoot BP. The additional chemical components found in iRoot FS were found to be safe and effective in iRoot SP and D-PBS. In addition, iRoot FS has comparable packaging containers and delivery system to iRoot BP Plus. Therefore, it is concluded that iRoot FS is safe, effective and substantially equivalent to the predicate devices.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which consists of a stylized caduceus-like symbol with three horizontal lines curving downwards. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the logo. The seal is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC - 3 2010
Mr. Quanzu Yang President/CEO Innovative BioCeramix Incorporated 1628 West 75th Avenue Vancouver, British Columbia Canada V6P 6G2
Re: K102867
Trade/Device Name: iRoot FS Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: October 27, 2010 Received: November 3, 2010
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 Eederal the state the state of the state of the states of the states Register. Register
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Page 2- Mr. Yang
Enclosure
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mr for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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K 102867
INDICATIONS FOR USE
| 510(k) Number (if Known): | |
|---|---|
| Device Name: | iRoot FS |
| Indications for Use: | Repair of Root PerforationRepair of Root ResorptionRoot End FillingApexificationPulp Capping |
| 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)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K102867
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§ 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.