-Repair of Root Perforation
-Repair of Root Resorption
-Root End Filling
-Apexification
-Pulp capping
-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).

Device Description

iRoot BP, iRoot FS, and iRoot BP Plus are a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste. Which are developed for permanent root canal repair of root perorption, and root end filling, apexification and pulp capping applications in adult and pediatric cases. The aforementioned products are an insoluble, radiopaque and aluminum-free material based on a calcium slicate composition, which requires the presence of water to set and harden. The products do not shrink during setting and demonstrate excellent physical properties. Root BP is packaged in a preloaded syringe, iRoot BP Plus is packaged in a preloaded container and iRoot FS is available both in syringe and container form. The devices have not changed from their respective predicate devices of iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).

AI/ML Overview

Regarding iRoot BP Root Repair Material BioAggregate Paste, iRoot FS Fast Set Root Repair Material, and iRoot BP Plus Root Repair Material:

The provided text does not include acceptance criteria or a study proving the device meets specific acceptance criteria in the format requested. Instead, it is a 510(k) summary for a medical device seeking substantial equivalence to predicate devices, with an emphasis on adding an indication for pulpotomy in pediatric patients.

However, based on the provided text, I can infer some aspects and extract information relevant to your inquiry, particularly regarding the rationale for introducing a new indication:

Inferred Acceptance Criteria (for the new pediatric pulpotomy indication):

While explicit numerical acceptance criteria are not stated for this particular submission, the underlying acceptance criteria for the new indication are implied to be demonstrable equivalence in safety and effectiveness to the primary predicate device, ProRoot MTA (K142178), for pulpotomy in pediatric populations. This equivalence is asserted through reliance on existing independent third-party, peer-reviewed published medical literature.

Reported Device Performance:

The device performance is not reported in terms of specific metrics like sensitivity or specificity. Instead, the document asserts that:

The devices (iRoot BP, iRoot BP Plus, iRoot FS) are "identical to their corresponding predicate devices" in their technological characteristics.
They "still strictly abide by the ISO 6876 and ANSI/ADA No. 57".
"many independent third-party studies that have been performed on Root BP and iRoot BP Plus which show their equivalence to MTA(K142178) for the purposes of pediatric applications as well as their safety and effectiveness in that specific use."
The conclusion is that the proposed devices are "both safe and effective as well as performing as well if not better then MTA(K142178)."

Therefore, a table of acceptance criteria and reported performance in the requested format cannot be directly created from the provided text for this specific submission. The submission relies on existing data and prior clearances.

Here's a breakdown of the other requested information based on the text:

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified for any particular test set within this document. The submission relies on "many pieces of independent third-party, peer-reviewed published medical literature."
Data Provenance: The studies are from "independent third-party, peer reviewed published medical literature." The origin countries are not specified, nor is whether they are retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not specified.

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 and therefore no MRMC study involving human readers with/without AI assistance was performed or described. The device is a root repair material (bioceramic paste), not a diagnostic imaging or AI tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, this information is not applicable. The device is a physical material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The ground truth for the "many independent third-party studies" cited would likely involve clinical outcomes data from treating pediatric pulpotomy cases, potentially with histological evaluation or other clinical measures accepted in dental research for assessing treatment success. The specific nature of the ground truth is not detailed in this submission summary.

8. The sample size for the training set:

Not applicable / Not specified. The device is a physical material, not a "trained" algorithm in the machine learning sense. The referenced studies are clinical studies, not machine learning training sets.

9. How the ground truth for the training set was established:

Not applicable / Not specified. As above, this is not a machine learning submission. The "ground truth" for the clinical literature would be established through standard clinical trial methodologies and outcome assessments for dental procedures.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 22, 2022

Innovative BioCeramix Inc. % Quanzu Yang CEO Innovative BioCeramix, Inc. 101-8218 North Fraser Way Burnaby, V3N039 CANADA

Re: K222992

Trade/Device Name: iRoot BP Root Repair Material BioAggregate Paste, iRoot FS Fast Set Root Repair Material, iRoot BP Plus Root Repair Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: Class II Product Code: KIF. Dated: September 28, 2022 Received: September 28, 2022

Dear Quanzu 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K222992

Device Name

iRoot BP Root Repair Material BioAggregate Paste;

iRoot FS Fast Set Root Repair Material ;

iRoot BP Plus Root Repair Material

Indications for Use (Describe)

-Repair of Root Perforation

-Repair of Root Resorption

-Root End Filling

-Apexification

-Pulp capping

-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages >12-21 years).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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			510(k) Summary		Prepared on: 2022-09-22
Contact Details		K222992			21 CFR 807.92(a)(1)
Applicant Name		Innovative BioCeramix, Inc.
Applicant Address		101 - 8218 North Fraser Way Burnaby BC V3N0E9 Canada
Applicant Contact Telephone		6042216800
Applicant Contact		Dr. Quanzu Yang
Applicant Contact Email		quanzu@ibioceramix.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name		iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material;iRoot BP Plus Root Repair Material
Common Name		Root canal filling resin
Classification Name		Resin, Root Canal Filling
Regulation Number		872.3820
Product Code		KIF
Legally Marketed Predicate Devices			21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)			Product Code
K142178	ProRoot MTA			KIF
K082943	iRoot BP			KIF
K092715	iRoot BP Plus			KIF
K102867	iRoot FS			KIF

Device Description Summary

Intended Use/Indications for Use

-Repair of Root Perforation -Repair of Root Resorption -Root End Filling

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(4)

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-Apexification

-Pulp capping

-Pulpotomy of primary teeth in the children (ages >2-12 years) and adolescent (ages > 12-21 years).

Indications for Use Comparison

For the indications for use of the devices iRoot BP Plus, and iRoot FS we are claiming substantial equivalence to the primary predicate device ProRoot MTA(K142178) as they have the same intended use. The indications for use of Plus, and Root FS differ from the predicate devices Root BPK082943), Root BP Plus/K092715), and iRoot FS(K102867). We are adding the use for the pulpotomy of primary teeth in children and adolescents. Since the new indication for use of the device only adds a new age group that the device can be used on with the existing functionality of pulpotomy/pulp capping it does not change the intended use of the device.

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

The use of iRoot Bp, iRoot BP Plus, and iRoot FS in the pulpotorny of primary teeth has been studied in many pieces of independent third-party, peer reviewed published medical literature. These studies covered by this application are substantially equivalent to ProRoot MTA(K142178) in safety and effectiveness for the use on pediations. As such we judged it appropriate to add the pulpotomy of primary teeth in children and adolescents as an indication for use. The studies are included in the References section of this application

Technological Comparison

For the technological characteristics of the devices iRoot BP Plus, and iRoot FS we are claiming substantial equivalence with the predicate devices Root BP(K082943), iRoot BP Plus(K092715), and Root FS(K102867) respectively. The devices covered in this application are identical to their corresponding predicate devices as reason for this application is only to change the indication for use to support pediatric populations.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

This proposal does not change any qualities of Root BP, Root BP Plus, and iRootFS. As such, it is identical to the respective predicate devices iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867). The tests performed on the predicates were valid, so no other testing was done. In the attachments is the previous bench testing done on the submission of the predicate devices iRoot BP(K082943), iRoot BP Plus(K092715), and iRoot FS(K102867).

There were no clinical test that were performed by us at IBC. However iRoot BP Plus and its predecessors have been on the international market for over 10 years now. Due to this there are many independent third-party studies that have been performed on Root BP and iRoot BP Plus which show their equivalence to MTA(K142178) for the purposes of pediatric applications as well as their safety and effectiveness in that specific use. The summaries of some of these studies are attached in the References section of this submission.

As the qualities of the proposed devices iRoot BP, iRoot BP Plus, and iRootFS have not changed from their respective predicate devices Root BP(K082943), Root BP Plus(K092715), and Root FS(K102867), they still strictly abide by the ISO 6876 and ANSI/ADA No. 57 and are also backed up by many independent third party clinical studies. With this we can conclude that the proposed the devices are both safe and effective as well as performing as well if not better then MTA(K142178).

Regulation Number and Section

§ 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.