BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a two-part liquid and powder product. Part A is the liquid and Part B is the powder. The mixed solution cleanses the root canal, removes the smear layer, and kills the bacteria in an instrumented root canal without harming the tooth structure or soft tissue.

AI/ML Overview

The provided document is a 510(k) summary for the BIOPURE™ MTAD™ ROOT CANAL CLEANSER, a root canal cleanser. It states that the device is "substantially equivalent" to a predicate device (EndoPure™ Root Canal Cleanser, K032361) based on the prior use of components, performance data, and biocompatibility data. However, the document does not describe acceptance criteria for performance or a specific study that proves the device meets such criteria.

The 510(k) submission process for a Class I unclassified device like a root canal cleanser, especially in 2005, often relied on substantial equivalence based on material composition, intended use, and general safety and effectiveness, rather than rigorous comparative clinical performance studies with predefined acceptance criteria as might be expected for novel or higher-risk devices.

Therefore, many of the requested details about acceptance criteria and a performance study cannot be extracted from the provided text.

Here is a summary of what can and cannot be inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not described in the provided text. The submission focuses on substantial equivalence to a predicate device rather than meeting specific quantifiable performance targets.
Reported Device Performance: The document generally states that "the performance data provided" supports its safety and effectiveness, but it does not detail what that performance data is or what metrics were used.

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

Not described in the provided text. No specific "test set" in the context of a performance study is mentioned.

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

Not applicable/Not described. There is no mention of a ground truth established by experts for a test set.

4. Adjudication method for the test set:

Not applicable/Not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No, a multi-reader multi-case comparative effectiveness study is not mentioned. This type of study is more typically associated with imaging diagnostics or AI-assisted interpretation, not a chemical root canal cleanser.

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

Not applicable. This device is a chemical cleanser, not an algorithm.

7. The type of ground truth used:

Not applicable/Not described. The basis for safety and effectiveness is substantial equivalence to a predicate device, supported by component usage, performance data (undescribed), and biocompatibility data.

8. The sample size for the training set:

Not applicable. This device is a chemical cleanser, not an AI/ML algorithm requiring a training set.

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

Not applicable.

In summary: The provided 510(k) summary for BIOPURE™ MTAD™ ROOT CANAL CLEANSER is a regulatory document focused on demonstrating substantial equivalence to a legally marketed predicate device. It does not contain the detailed information about specific performance acceptance criteria or a dedicated study with statistical endpoints, ground truth, or expert involvement that would be present for a medical device relying on such a performance study for approval. Instead, its approval hinges on the argument that its technological characteristics, intended use, and component safety are similar enough to existing products.

Summary

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K053167

DEC 8 2005

510(k) SUMMARY

DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, PA 17405-0872

CONTACT:	Helen Lewis
DATE PREPARED:	December 5, 2005
TRADE OR PROPRIETARY NAME:	BIOPURE™ MTAD™ ROOT CANAL CLEANSER
CLASSIFICATION NAME:	Root canal cleanser, Unclassified
PREDICATE DEVICES:	EndoPure™ Root Canal Cleanser, K032361

DEVICE DESCRIPTION:

INTENDED USE:

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.

TECHNOLOGICAL CHARACTERISTICS:

All of the components found in BIOPURE™ MTAD™ ROOT CANAL CLEANSER have been used in legally marketed devices or were found safe for dental use. We believe that the prior use of components in legally marketed devices, the performance data provided, and the biocompatibility data provided support the safety and effectiveness of BIOPURE™ MTAD™ ROOT CANAL CLEANSER for the indicated uses.

BIOPURE™ MTAD™ ROOT CANAL CLEANSER Premarket Notification

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three curved lines representing its wings or body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 8 2005

Ms. Helen Lewis Director of Corporate Compliance and Regulatory Affairs DENTSPLY International Susquehanna Commerce Center West 221 West Philadelphia Street, Suite 60 York, Pennsylvania 17405-0872

Re: K053167

K055107
Trade/Device Name: BioPure™ MTAD™ Root Canal Cleanser Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: November 09, 2005 Received: November 14, 2005

Dear Ms. Lewis:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your bection of the device is substantially equivalent (for the indications for referenced in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass bated in 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 nure occh footable in a mot 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 connells provized on the prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your device to such additional controls. Existing major regulations affecting your device can be may or store 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 - Ms. Helen Lewis

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act or that 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 premated 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" (21 CFR 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,

Juliette Y. Mcclain-Owens

Chiu S. Lin, PhD 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

14053167

510(K) Number (if known):

BIOPURE™ MTAD™ ROOT CANAL CLEANSER Device Name:

Indications for Use:

BIOPURE™ MTAD™ ROOT CANAL CLEANSER is used to chemically clean the canal and disinfect the root canal system after endodontic instrumentation.

Prescription Use _ X ___ (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 NEEDEDI

Concurrence of CDRH, Office of Device Evaluation (ODE)

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sion of Anesthesinlo General Hospital. Solion Control, Dental Device

Number. K53167

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Regulation Number and Section

N/A