Citric Acid 20% is a slightly thickened, water-soluble solution. It is slightly orange-tinted for easy identification and is provided in a 30 ml IndiSpense® Syringe. Citric Acid facilitates removal of calcium hydroxide materials (e.g., UltraCal®) from canal walls. It can also be used as a mild etchant/conditioner for smear layer removal.

AI/ML Overview

The Ultradent Citric Acid 20% Solution is a "Special 510(k)" device, which typically means it's a modification of an existing device and demonstrates substantial equivalence to a predicate device. For such submissions, extensive clinical studies or novel performance criteria as seen with entirely new devices are often not required. The information provided focuses on demonstrating substantial equivalence rather than establishing new performance acceptance criteria through a standalone study with detailed metrics like accuracy, sensitivity, or specificity.

Here's an analysis of the provided text based on the requested information:

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

The document doesn't explicitly define 'acceptance criteria' in terms of numerical performance metrics for the device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device (Citric Acid 10% Solution). The reported "performance" is a comparative assessment.

Property	Acceptance Criteria (Implicit - Substantial Equivalence to Predicate)	Reported Device Performance (Citric Acid 20% Solution)
Intended Use	Same as predicate: Facilitates removal of calcium hydroxide from canal walls, and functions as a mild etchant/conditioner for smear layer removal.	Same as predicate: Facilitates removal of calcium hydroxide from canal walls, and functions as a mild etchant/conditioner for smear layer removal.
Active Ingredient	Same active ingredient as predicate: Citric acid.	Same active ingredient as predicate: Citric acid.
Biocompatibility/Safety	Clinical literature demonstrates that citric acid (generally) is safe and non-cytotoxic.	Clinical literature demonstrates that citric acid (generally) is safe and non-cytotoxic (as stated in Section VII, Literature Review – not provided in full).
Technological Characteristics (Effectiveness)	To be effective in cleaning, chelating, and exposing dentinal tubules; comparable to or better than predicate.	A scanning electron microscope study showed 20% citric acid and EDTA were "slightly more effective than 10% citric acid; however, these differences did not appear to be significant." This supports equivalence.
Physical Properties	Orange-tinted, slightly thickened.	Orange-tinted, slightly thickened.
How Supplied	Supplied in a 30 mL IndiSpense® Syringe.	Supplied in a 30 mL IndiSpense® Syringe.

The "study that proves the device meets the acceptance criteria" is the scanning electron microscope (SEM) study mentioned. This study compared the 20% citric acid solution to 10% citric acid (the predicate) and EDTA.

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

The document does not specify the sample size for the SEM study (e.g., number of tooth samples, number of sections analyzed). It also doesn't specify the data provenance (e.g., country of origin, retrospective or prospective nature of sample acquisition). The study appears to be an in vitro laboratory test rather than a clinical human study.

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

The document does not mention the use of experts to establish ground truth or interpret the results of the SEM study. SEM analysis typically involves direct observation of physical characteristics, often interpreted by materials scientists or dental researchers, but no details are provided.

4. Adjudication method for the test set

Not applicable. The SEM study is a direct observation/measurement, not an interpretation requiring an adjudication method like those used for reader studies.

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. This device is a chemical solution (citric acid), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant.

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

Not applicable. This is not an algorithm or AI device. The standalone performance is the inherent performance of the chemical solution itself as assessed by the SEM study, which evaluated its effectiveness in cleaning and exposing dentinal tubules.

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

For the SEM study, the "ground truth" would be the direct visual evidence from the scanning electron microscope images regarding the presence/absence of smear layer, exposure of dentinal tubules, and cleanliness of root canal walls. This is an objective physical observation, not expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. As above, no training set is relevant for this type of device.

Summary

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SPECIAL 510(k) PREMARKET SUMMARY

Ultradent Citric Acid 20% Solution

UEL 2 1 2006

This summary of the Special 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807 for Citric Acid 20% Solution.

Applicant's Name and Address

Ultradent Products, Inc. 505 West 10200 South South Jordan, UT 84095

Contact Person:	Corey Jaseph
Title:	Regulatory Affairs Product Specialist
Telephone:	800-552-5512 x4586, 801-553-4586
FAX:	801-553-4609
Date Summary Prepared:	December 11, 2006

Name of the Device

Trade Name:	Citric Acid 20% Solution
Common Name:	Cleanser, Root Canal
Risk Classification:	Unclassified (pre-amendment)
Classification Product Code:	KJJ

Legally Marketed Predicate Devices to Which Equivalence is Claimed:

Predicate: Citric Acid 10% Solution, Ultradent Products, Inc. (K032627). Manufactured and distributed by Ultradent Products, Inc., 505 West, 10200 South, South Jordan, UT 84095.

Product Description and Intended Use:

Citric Acid 20% is a slightly thickened, water-soluble solution. It is slightly orangetinted for easy identification and is provided in a 30 ml IndiSpense® Syringe. Citric Acid facilitates removal of calcium hydroxide materials (e.g., UltraCal®) from canal walls. It can also be used as a mild etchant/conditioner for smear layer removal. Ultradent's EDTA 18%, a chelating agent, is an alternative for this purpose. Regardless of regimen used, we recommend a final rinse with clean, bacteria-free water, plain EDTA or local anesthetic.

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Property	Citric Acid 20% Solution	Citric Acid 10%Solution
Intended Use	Facilitates removal of calciumhydroxide from canal walls,and functions as a mildetchant/conditioner for smearlayer removal.	Same
Active Ingredient	Citric acid	Same
Biocompatibility/Safety	Clinical literaturedemonstrates that citric acidis safe and non-cytotoxic (seeSection VII)	Same
Properties	Orange-tinted, slightlythickened	Same
How Supplied	30 mL IndiSpense® Syringe	Same

Table 1: Product Comparison Table

Technological Characteristics

Citric acid has been used as an irrigant during root canal procedures for many years. One of its attractive features is its non-cytotoxicity, while still being effective in removing calcium hydroxide and the smear layer caused by instrumentation. Many different concentrations of citric acid have been used, with varying degrees of success. Both 10 and 20% solutions are used successfully for these purposes (see Section VII, Literature Review).

Brief Description of Testing Performed and Conclusion

A scanning electron microscope study was performed to evaluate the ability of EDTA, 10% citric acid and 20% citric acid in cleaning, chelating and exposing dentinal tubules. The results showed that more dwelling time allowed the irrigants to function more effectively in cleaning and exposing dentinal tubules. It appeared that 20% citric acid and EDTA were slightly more effective than 10% citric acid; however, these differences did not appear to be significant.

Substantial Equivalence

In conclusion, Citric Acid 20% Solution, to be manufactured and marketed by Ultradent Products, Inc., 505 West 10200 South, South Jordan, UT 84095, is substantially equivalent to Citric Acid 10% Solution, also manufactured by Ultradent Products, Inc. The two products are composed of the same materials, have the same intended use and both are safe and effective for use for the indications described.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Corey Jaseph Regulatory Affairs Product Specialist Ultradent Products, Incorporated 505 West 10200 South South Jordan, Utah 84095

DEC 2 1 2006

Re: K063703

Trade/Device Name: Ultradent Citric Acid 20% Solution Regulation Number: N/A Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 11, 2006 Received: December 13, 2006

Dear Ms. Jaseph:

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 - Ms. Corey Jaseph

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 (OS) 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" (21 CFR 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,

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

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

Citric Acid 20%, a root canal cleanser, is intended to etch root canal walls just prior to obturation to allow an optimum seal.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suser Gunner

University General Hospital
Central Sterile Services

K063703

Page_1_of_1

(Posted November 13, 2003)

Regulation Number and Section

N/A