BioAggregate is a white hydraulic cement-like powder composed of biocompatible ceramic particles. The BioAggregate Powder promotes cementogenesis upon mixing with BioA Liquid and forms a hermetic seal inside the root canal.

AI/ML Overview

This document describes the 510(k) summary for BioAggregate, a root canal repair filling material. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a table format with numerical targets. Instead, it describes a comparison to a predicate device (WHITE MTA MATERIAL) and other predicate devices for specific chemical compounds. The performance is assessed based on substantial equivalence in various properties.

Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Physical state	Equivalent to WHITE MTA MATERIAL (powder-liquid mix)	BioAggregate is a "white hydraulic cement-like powder composed of biocompatible ceramic particles." It forms a hermetic seal upon mixing with BioA Liquid.
Working Time	Equivalent to WHITE MTA MATERIAL	Bench tests included Working Time; concluded as "substantially equivalent."
Setting Time	Equivalent to WHITE MTA MATERIAL	Bench tests included Setting Time; concluded as "substantially equivalent."
Solubility	Equivalent to WHITE MTA MATERIAL	Bench tests included Solubility; concluded as "substantially equivalent."
Radiopacity	Equivalent to WHITE MTA MATERIAL	Bench tests included Radiopacity; concluded as "substantially equivalent."
Chemical Compounds	Similar major chemical compounds to WHITE MTA MATERIAL and other predicate devices' specific compounds shown to be safe and effective.	BioAggregate has "similar major chemical compounds" to WHITE MTA MATERIAL, but is aluminum-free and includes calcium phosphate. Other chemical compounds in BioAggregate were found in predicate devices like Tantalum Beads, chronOS™, and PerioGlas, indicating their safety and effectiveness.
Non-mutagenic	Non-mutagenic (like WHITE MTA MATERIAL)	Biocompatibility tests determined BioAggregate is "non-mutagenic."
Non-cytotoxic	Non-cytotoxic (like WHITE MTA MATERIAL)	Biocompatibility tests determined BioAggregate is "non-cytotoxic."
Allergenic Potential	Does not cause allergenic potential	Biocompatibility tests determined BioAggregate "does not cause allergenic potential to tissues after multiple uses."
Subcutaneous Tolerance	Good tolerance by subcutaneous tissues	Biocompatibility tests determined BioAggregate "has good tolerance by subcutaneous tissues."
Indications for Use	Same as WHITE MTA MATERIAL	BioAggregate has the "same indications for use" (Repair of Root Perforations, Repair of Root Resorption, Root End Filling, Apexification, Pulp capping).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes "extensive bench and biocompatibility testing" but does not specify the sample sizes (e.g., number of units tested for working time, number of animals/cells for biocompatibility). The data provenance (country of origin, retrospective/prospective) is not provided. It's implied these are laboratory (bench) tests and biocompatibility studies.

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)

This section is not applicable as the study is not based on expert-established ground truth on clinical images or patient outcomes. The evaluation is against established properties of a predicate device and chemical safety/effectiveness.

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

This section is not applicable for the same reason as point 3.

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

This section is not applicable. This submission is for a dental filling material, not an AI-powered diagnostic or assistive device.

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

This section is not applicable. This is a material, not an algorithm.

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

The "ground truth" for the non-clinical tests is essentially the established and accepted properties of the predicate device (WHITE MTA MATERIAL) and scientific consensus on the safety and effectiveness of specific chemical compounds found in the additional predicate devices. For biocompatibility, it's based on standard biological evaluation tests (e.g., ISO 10993 series).

8. The sample size for the training set

This section is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This section is not applicable. There is no "training set" or corresponding ground truth establishment in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo and contact information for Innovative BioCeramix Inc. The logo includes the company name in bold, uppercase letters, followed by the letters "IBC" inside of a circle. The address is listed as 3650 Wesbrook Mall, Vancouver, BC V6S 2L2 Canada. The phone number is (604) 221 6800, and the fax number is (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.3650 Wesbrook MallVancouver, BC V6S 2L2 CanadaTel: 604-221-6800Fax: 604-677-6129	NOV 2 1 2006
CONTACT:	Dr. Quanzu Yang
SUMMARY PREPARED:	Jul 25, 2006
TRADE NAME:	BioAggregate
COMMON NAME:	Root Canal Repair Filling Material
CLASSIFICATION NAME:	Root Canal Filling Resin (21 CFR 872.3820, Product Code: KIF)
PREDICATE DEVICE:	Dentsply International WHITE MTA MATERIAL (K011009)
	For specific chemical compositions:• Biomet, Inc. Tantalum Beads - Radiographic Marker (K010348)• Synthes (USA) chronOSTM(K041350)• NovaBone Products, LLC PerioGlas - Bioglass Bone Graft Particulate(K040278)
DEVICE DESCRIPTION:	BioAggregate is a white hydraulic cement-like powder composed ofbiocompatible ceramic particles. The BioAggregate Powder promotescementogenesis upon mixing with BioA Liquid and forms a hermetic sealinside the root canal.
INTENDED USE:	• Repair of Root Perforations• Repair of Root Resorption• Root End Filling• Apexification• Pulp capping
TECHNOLOGICALCHARACTERISTICS:	BioAggregate is equivalent to WHITE MTA MATERIAL,in terms of the physical state (powder-liquid mix), working time, settingtime, solubility and radiopacity. Similar major chemical compounds areutilized in the production of both BioAggregate and WHITE MTAMATERIAL. Both materials are non-mutagenic and non-cytotoxic, and aredesignated for the same indications for use. The primary difference between

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Image /page/1/Picture/0 description: The image shows the logo for Innovative BioCeramix Inc. The logo includes the company name in bold, uppercase letters. Below the company name is the address, 3650 Wesbrook Mall.

Vancouver BC Tel. (604) 221 6800 Fax: (604) 677 6129

the two materials is that BioAggregate has an aluminum-free composition, which contains chemical compounds that improve BioAggregate's properties in terms of safety and effectiveness, and includes calcium phosphate.

The additional predicate devices include: Tantalum Beads - Radiographic Marker, Synthes (USA) chronOS™ and PerioGlas - Bioglass Bone Graft Particulate each containing specific chemical compounds that are equivalent to BioAggregate, providing evidence that these chemical compounds are safe and effective for medical devices use.

NON-CLINICAL TESTS BioAggregate has undergone extensive bench and biocompatibility testing PERFORMED: to provide evidences that BioAggregate's physico-chemical properties are substantially equivalent to WHITE MTA MATERIAL. Bench tests included Working Time, Setting Time, Solubility and Radiopacity. Biocompatibility tests results determined that BioAggregate is nonmutagenic, non-cytotoxic, does not cause allergenic potential to tissues after multiple uses and has good tolerance by subcutaneous tissues.

CONCLUSIONS: BioAggregate has the same indications for use, includes similar materials and comparable technological characteristics as WHITE MTA MATERIAL. In addition, the bench and biocompatibility testing performed demonstrates that any differences in their technological characteristics do not raise any new questions as to safety and effectiveness. The chemical compounds of BioAggregate that were not equivalent to MTA were found to be safe and effective in Tantalum Beads - Radiographic Marker, Synthes (USA) chronOSTM and PerioGlas - Bioglass Bone Graft Particulate. Therefore, it is concluded that BioAggregate is safe, effective and substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 1 2006

Innovative Bioceramix Incorporated C/O Mr. Neil E. Devine, Jr. Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087

Re: K063422

Trade/Device Name: BioAggregate Regulation Number: 21 CFR 872.3820 Regulation Name: Regulatory Class: II Product Code: KIF Dated: November 10, 2006 Received: November 13, 2006

Dear Mr. Devine:

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.

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Page 2 - Mr. Devine

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); 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Senitte y. Michieu Davis

Chiu Lin, Ph.D. 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

Koballing 510(k) Number (if Known): Device Name: BioAggregate Indications for Use: Repair of Root Perforation . Repair of Root Resorption . Root End Filling . Apexification . Pulp Capping .

ん Prescription Use _ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (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)

Susan Rump

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3.01-4.10) n of Anesthesiology, General Hospital, con Control, Dental Devices

0634122

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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.