iRoot BP Plus Root Repair Material (iRoot BP Plus) is a convenient ready-to-use white hydraulic premixed bioceramic paste developed for permanent root canal repair and surgical applications. iRoot BP Plus 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 BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP Plus is packaged in a preloaded container.

AI/ML Overview

The provided text describes a 510(k) summary for the iRoot BP Plus Root Repair Material. This submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical (bench and shelf life) testing, rather than a clinical study with acceptance criteria and device performance metrics in the typical sense of diagnostic performance (e.g., sensitivity, specificity).

Therefore, the requested information elements related to clinical study design, ground truth, expert consensus, and reader performance are not applicable in this context. The acceptance criteria here would be demonstrating equivalent chemical, physical properties, and performance specifications through bench and shelf-life testing.

Here's an adaptation of the requested table and information based on the provided document:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (Specifics from document)	Reported Device Performance (Specifics from document)
Chemical Composition	Comparable to iRoot BP	Stated as "comparable chemical composition" to iRoot BP.
Physical Properties	Comparable to iRoot BP	Stated as "comparable physical properties" to iRoot BP.
Performance Specifications	Equivalent to iRoot BP	Stated as "equivalent...performance specifications" to iRoot BP.
Safety and Effectiveness of Packaging Materials	Equivalent to materials in BioAggregate, Cavit-W, and VitalCare I.V. Administration Set deemed safe and effective.	Additional material components in iRoot BP Plus's packaging were found to be safe and effective based on predicate devices BioAggregate, Cavit-W, and VitalCare I.V. Administration Set.
Delivery System	Comparable to Cavit-W	Stated as having "a comparable delivery system to Cavit-W."
Indications for Use	Equivalent to iRoot BP	Stated as having "equivalent indications for use" to iRoot BP.

Study Details (as applicable to a 510(k) for substantial equivalence based on non-clinical data):

Sample size used for the test set and the data provenance:
- Test Set: Not applicable in the context of a clinical test set with human or patient data. The "test set" here refers to the iRoot BP Plus product itself undergoing bench and shelf-life testing. The sample size for these non-clinical tests is not specified, but it would have involved multiple samples of the material.
- Data Provenance: The data is from non-clinical (bench and shelf-life) testing conducted by the manufacturer, Innovative BioCeramix Inc. The location of the testing is not specified, but the company is based in Vancouver, BC, Canada. This is not retrospective or prospective clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to the measured chemical, physical, and performance properties of the materials themselves, established through laboratory testing, not expert interpretation of clinical data.
Adjudication method for the test set:
- Not applicable. There was no clinical test set requiring adjudication.
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:
- Not applicable. This was a 510(k) for a root repair material, not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This was a 510(k) for a root repair material, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" (or reference standard) for this submission consisted of the known chemical compositions, physical properties, and performance specifications of the predicate device (iRoot BP) and other materials (BioAggregate, Cavit-W, VitalCare I.V. Administration Set), established through validated laboratory methods and existing regulatory approvals.
The sample size for the training set:
- Not applicable. There was no "training set" in the machine learning sense for this medical device submission. The device itself (iRoot BP Plus) was developed based on existing knowledge and materials (the predicate devices).
How the ground truth for the training set was established:
- Not applicable, as there was no training set in the machine learning sense. The "ground truth" for the development of iRoot BP Plus would be the established scientific and engineering principles for dental materials and the properties of its predecessor and other predicate devices.

Summary

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K092715

... ..........................................................................................................................................................................

INNOVATIVE BIOCERAMIX INC.

SEP 2 9 2009

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 AvenueVancouver, BCV6P 6G2 CanadaTel: 604-221-6800 Fax: 604-677-6129
CONTACT:	Quanzu Yang
SUMMARYPREPARED:	August 21, 2009
TRADE NAME:	iRoot BP Plus
COMMON NAME:	Root Repair Material
CLASSIFICATIONNAME:	Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF)
PREDICATE DEVICES:	iRoot BP (K082943)BioAggregate (K063422)Cavit-W (K875133)VitalCare I.V. Adminstration Set (K050906)
DEVICEDESCRIPTION:	iRoot BP Plus Root Repair Material (iRoot BP Plus) is a convenient ready-to- use white hydraulic premixed bioceramic paste developed for permanent root canal repair and surgical applications. iRoot BP Plus 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 BP does not shrink during setting and demonstrates excellent physical properties. iRoot BP Plus is packaged in a preloaded container.
INTENDED USE:	Repair of Root Perforation

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 and the fax number is 604-677-6129.

TECHNOLOGICAL CHARACTERISTICS:

iRoot BP Plus and iRoot BP are designated for the equivalent dental applications, and have comparable chemical and physical properties, and iRoot BP Plus is a modification of iRoot BP. performance specifications. The packaging for iRoot BP Plus includes jars and unit dose cups.

Additional predicate devices include: BioAggregate, Cavit-W and VitalCare I.V. Administration Set, each contains specific material components that are equivalent to those found in the packaging for iRoot BP Plus; providing evidence that these materials are safe and effective for medical device use. Furthermore, iRoot BP Plus and Cavit-W have similar delivery systems.

NON-CLINICAL TESTS PERFORMED:

iRoot BP Plus has undergone bench and shelf life testing, which provides evidence that iRoot BP's chemical and physical properties are substantially equivalent to iRoot BP.

CONCLUSIONS:

iRoot BP Plus has the equivalent indications for use, comparable chemical composition, physical properties and performance specifications to iRoot BP. The additional material components found in iRoot BP Plus's packaging were found to be safe and effective in BioAggregate, Cavit-W and VitalCare I.V. Administration Set. In addition, iRoot BP Plus has a comparable delivery system to Cavit-W. Therefore, it is concluded that iRoot BP Plus is safe, effective and substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol featuring a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

Image /page/2/Picture/2 description: The image shows the date "SEP 29 2009" in a bold, sans-serif font. The letters and numbers are clearly printed, with a slight blurriness around the edges. The date is likely part of a document or label.

Food and Drug Administration 10903 New Hampshire Avenne Document Mail Center - WO66-G609 Silver Spring, MD 20993-00007

Mr. Quanzu Yang President/Chief Executive Officer Innovative BioCeramix Incorporated 1628 West 75th Avenue Vancuver, BC V6P 6G2 CANADA

Re: K092715

Trade/Device Name: iRoot BP Plus Root Repair Material Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: August 21, 2009 Received: September 3, 2009

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.

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 1 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 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

foo

Susan Runner, D.D.S., M.A. Acting 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):

09 2715

Device Name:

iRoot BP Plus Root Repair Material

Indications for Use:

Repair of Root Perforation
Repair of Root Resorption
Root End Filling
Apexification
Pulp Capping

ー 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)

Kai Mclay for WSP

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K092715

Page 1 of 1

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.