(8 days)
- Permanent obturation of the root canal following vital pulp-extirpation.
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
iRoot SP is suitable for use in the single cone and lateral condensation technique.
iRoot SP Root Canal Sealer (iRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP 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 SP does not shrink during setting and demonstrates excellent physical properties. iRoot SP is packaged in a pre-loaded syringe and is supplied with disposable Intra Canal Tips.
The provided text describes the iRoot SP Root Canal Sealer and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance or the study that proves these criteria are met in the way typically associated with AI/ML medical devices (e.g., diagnostic accuracy metrics).
Instead, this document focuses on demonstrating substantial equivalence through a comparison of physical, chemical, and biocompatible properties with established predicate devices. The "studies" mentioned are non-clinical bench and biocompatibility tests.
Therefore, many of the requested sections (sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for a traditional medical device like a root canal sealer.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the physical-chemical properties of the predicate devices. The "reported device performance" refers to the results of the non-clinical tests demonstrating that iRoot SP's properties are comparable to these predicates.
| Acceptance Criteria (Implicit from Predicates) | iRoot SP Performance (demonstrated by non-clinical tests) |
|---|---|
| Comparable Flow | Tested and found comparable |
| Comparable Working Time | Tested and found comparable |
| Comparable Setting Time | Tested and found comparable |
| Comparable Dimensional Change following setting | Tested and found comparable |
| Comparable Solubility | Tested and found comparable |
| Comparable Radiopacity | Tested and found comparable |
| Comparable Film Thickness | Tested and found comparable |
| Non-mutagenic | Confirmed non-mutagenic |
| Non-cytotoxic | Confirmed non-cytotoxic |
| No allergenic potential after multiple uses | BioAggregate data provides evidence; good tolerance by subcutaneous tissue |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of human data or AI model output. The "test set" here would refer to the samples used in bench and biocompatibility testing, but specific numbers are not provided.
- Data Provenance: The tests are non-clinical (bench and biocompatibility). The chemical composition is based on BioAggregate, and its biocompatibility data is referenced. This implies laboratory testing on materials, not patient data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for a root canal sealer is its physical, chemical, and biocompatible properties, not a diagnostic interpretation by human experts.
4. Adjudication method for the test set
- Not applicable as there is no human interpretation or diagnostic labeling process.
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
- Not applicable. iRoot SP is a physical material (root canal sealer), not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. iRoot SP is a physical material, not an algorithm.
7. The type of ground truth used
- The "ground truth" in this context is the established physical, chemical, and biocompatibility profiles of legally marketed predicate devices (AH® Plus™ Root Canal Sealer, BioAggregate, Apexit® Root Canal Sealer, Exactech Resorbable Bone Paste, MBCP Gel™, Diapex®). The performance of iRoot SP was compared to these established profiles.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device requiring a training set of data.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
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INNOVATIVE BIOCERAMIX INC.
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K080917". The characters are written in a bold, somewhat uneven style, suggesting they were written quickly or with a thick marker. The characters are all uppercase and numerical, with the "K" being the only alphabetical character in the string.
Image /page/0/Picture/2 description: The image shows contact information for an organization. The address is 1628 West 75th Avenue, Vancouver, BC V6P 6G2 Canada. The telephone number is 604-221-6800 and the fax number is 604-677-6129.
510(k) SUMMARY
APR - 9 2008
This summary of 510(k) is being submitted in accordance with 21 CFR 807.92
| SUBMITTER: | Innovative BioCeramix Inc.1628 West 75th AvenueVancouver, BCV6P 6G2CanadaTel: 604-221-6800 Fax: 604-677-6129 | |
|---|---|---|
| CONTACT: | Dr. Quanzu Yang | |
| SUMMARY PREPARED: | January 18, 2008 | |
| TRADE NAME: | iRoot SP | |
| COMMON NAME: | Root Canal Sealer | |
| CLASSIFICATION NAME: | Resin, Root Canal Filling (21 CFR 872.3820, Product Code: KIF) | |
| PREDICATE DEVICES: | AH® Plus™ Root Canal Sealer�For specific chemical compositions:BioAggregate●Apexit® Root Canal SealerExactech Resorbable Bone Paste●MBCP Gel™●For delivery system:Diapex® | (K960548)(K063422)(K893794)(K020078)(K060732)(K033585) |
| DEVICE DESCRIPTION: | iRoot SP Root Canal Sealer (iRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent rootcanal filling and sealing applications. iRoot SP is an insoluble, radiopaqueand aluminum-free material based on a calcium silicate composition, whichrequires the presence of water to set and harden. iRoot SP does not shrinkduring setting and demonstrates excellent physical properties. iRoot SP ispackaged in a pre-loaded syringe and is supplied with disposable Intra Canal |
Tips.
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INNOVATIVE BIOCERAMIX INC.
Image /page/1/Picture/1 description: The image shows contact information for a business or organization. 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. There is also a logo with the letters IBO.
INTENDED USE:
- . Permanent obturation of the root canal following vital pulp-extirpation
- Permanent obturation of the root canal following removal of infected or . necrotic pulp and placement of intracanal dressings.
iRoot SP is suitable for use in the single cone and lateral condensation technique.
TECHNOLOGICAL
CHARACTERISTICS: iRoot SP and AH® Plus™ Root Canal Sealer are available as radiopaque pastes essentially designated for the equivalent dental applications and have comparable physical properties, performance specifications and share a specific chemical component.
The principal composition of iRoot SP is based on BioAggregate. Additional predicate devices include: Apexit® Root Canal Sealer, Exactech Resorbable
Bone Paste and MBCP Gel", each contains specific chemical components that are equivalent to those found in iRoot SP, providing evidence that these chemical components are safe and effective for medical device use. Furthermore, iRoot SP and Diapex® have comparable delivery systems.
NON-CLINICAL TESTS PERFORMED:
iRoot SP has undergone extensive bench and biocompatibility testing to provide evidence that iRoot SP's physical-chemical properties are included: flow, working time, setting time, dimensional change following setting, solubility, radiopacity and film thickness.
Biocompatibility test results determined that iRoot SP is non-mutagenic and non-cytotoxic. Since iRoot SP's chemical composition is based on BioAggregate, the biocompatibility test data of BioAggregate provides biocompatibility evidence that iRoot SP does not cause an allergenic potential after multiple uses and has a good tolerance by subcutaneous tissue.
CONCLUSIONS: iRoot SP has the same indications for use, provides similar chemical, physical and biocompatible properties, and demonstrates comparable performance specifications to AH® Plus™ Root Canal Sealer. iRoot SP's main chemical composition is based on BioAggregate and the additional chemical components in iRoot SP's composition were found to be safe and effective in Apexit® Root Canal Sealer, Exactech Resorbable Bone Paste and MBCP Gel". In addition, iRoot SP has a comparable delivery system to Diapex . Therefore, it is concluded that iRoot SP is safe, effective and substantially equivalent to the predicate devices.
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Public Health Service
APR - 9 2008
Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Innovative BioCeramix Incorporated C/O Mr. Jay Y. Kogoma Responsible Third Party Official Intertek Testing Services NA, Incorporated 2307 East Aurora Road, Unit B7 Twinsburg, Ohio 44087
Re: K080917
Trade/Device Name: iRoot SP Root Canal Sealer Regulation Number: 21 CFR 872.3820 Regulation Name: Root Canal Filling Resin Regulatory Class: II Product Code: KIF Dated: March 31, 2008 Received: April 1, 2008
Dear Mr. Kogoma:
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. Kogoma
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Sayle Y. Michael DMD
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
510(k) Number (if Known):
Device Name:
Indications for Use:
iRoot SP Root Canal Sealer
- Permanent obturation of the root canal following vital pulp-◆ extirpation.
- Permanent obturation of the root canal following removal of . infected or necrotic pulp and placement of intracanal dressings.
iRoot SP is suitable for use in the single cone and lateral condensation technique.
イ 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, Qffice of Device Evaluation (ODE)
Susan Kunze
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
KOSCALT 510(k) Number:
Page 1 of 1
§ 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.