Whip Mix Preppies Plus is an innovative blend of polishing and cleaning agents including 2% Chlorhexidine Gluconate (CHG) relative to liquid component and is in a paste form. Each cup provides enough flour of pumice paste for a single use. Preppies Plus has no fluoride, oils, or added flavoring agents.

AI/ML Overview

The provided text is a 510(k) summary for a dental abrasive polishing agent, Preppies Plus®. It does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria through quantitative metrics.

The document primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding safety and intended use, rather than presenting a performance study with specific acceptance criteria and outcome metrics.

Here's a breakdown of what can be extracted from the text in relation to your request, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Cannot be provided: The document does not define specific quantitative acceptance criteria (e.g., minimum abrasive effectiveness, maximum sensitivity reduction, etc.) or report detailed performance metrics against such criteria. The "Substantial Equivalence" table compares device characteristics and intended uses, but not performance against pre-defined success/acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance:

Cannot be provided: There is no mention of a "test set" in the context of a performance study. The document refers to "non-clinical tests for bio-compatibility performed," but no details on sample size, methodology, or data provenance (country of origin, retrospective/prospective) are given for these tests.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Cannot be provided: Since no performance study utilizing a "test set" with ground truth is described, information about experts or their qualifications is absent.

4. Adjudication Method for the Test Set:

Cannot be provided: As no performance study with a test set is detailed, there's no mention of an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No: The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it refer to AI assistance or human reader improvement with AI. This is a medical device, not an AI/software device in the context of diagnostic imaging.

6. Standalone (Algorithm Only) Performance Study:

No: This is a physical dental product, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable and not mentioned.

7. Type of Ground Truth Used:

Cannot be provided: No performance study establishing ground truth (e.g., pathology, outcomes data, expert consensus) is described for this device. The closest concept is the "known risks associated with chlorhexidine in the FDA database," used as input for a risk management process, but this is not establishing ground truth for device performance.

8. Sample Size for the Training Set:

Not Applicable/Cannot be provided: This is a physical dental product, not a machine learning model, so there is no "training set" in that context.

9. How the Ground Truth for the Training Set was Established:

Not Applicable/Cannot be provided: As there's no training set, there's no method for establishing its ground truth.

Summary of Device Safety and Effectiveness provided in the document:

The document states that the safety and effectiveness are established through:

The established use of chlorhexidine in medical device applications since the 1970s and in many dental applications.
A thorough search of the FDA database for known risks associated with chlorhexidine, which informed their risk management process.
Adherence to ISO 14971 for risk management, identifying and mitigating known hazards to an acceptable level.
Comparison to their existing 510(k) exempt device (Preppies Flour of Pumice), with the only difference being the addition of 2% Chlorhexidine Gluconate (CHG).
"Acceptable results of the non-clinical tests for bio-compatibility performed." (No details on what these tests were, their methodology, or results are provided).
The conclusion that the new device "introduces no new risks and is considered substantially equivalent" to predicate devices.

In essence, this 510(k) summary primarily asserts substantial equivalence based on material composition (addition of CHG), intended use, and a risk management process, rather than presenting a detailed performance study with quantitative acceptance criteria.

Summary

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510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92

Date Prepared: 05/24/2013

1. APPLICANT

Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

PHONE: 502-634-5357 502-634-4512 FAX: EMAIL: jwaters@whipmix.com

2. SUBMITTER and CONTACT

John P. Waters Regulatory Compliance Officer & Official Correspondent for Whip Mix Corporation 361 Farmington Avenue Louisville, KY 40217

502-634-5357 PHONE: PHONE: FAX: 502-634-4512 EMAIL: jwaters@whipmix.com DATE: 05/24/2013

3. DEVICE NAME

Preppies Plus®

4. COMMON OR USUAL NAME AND CLASSIFICATION

Oral Cavity Abrasive Polishing Agent Regulation Number: 872.6030 Product Code: EJR Classification: Class I

5. PREDICATE DEVICE INFORMATION

Preppies flour of pumice (Whip Mix product 510(k) exempt)

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Bisco Cavity Cleanser (K915668) Ultradent Consepsis Scrub (K925375)

DEVICE DESCRIPTION

6. INTENDED USE

Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

. Restoration cementation.
. Acid etching procedures:
- o Sealants
- o Orthodontic brackets
- o Composite restorations

SUBSTANTIAL EQUIVALENCE WITH PREDICATE DEVICES

(new) Preppies Plus	Whip MixPreppies flour ofPumice	Bisco CavityCleanser	UltradentConsepsis Scrub
Class I Device	Class I device	Class II device	Class II device
510(k) Pending	510(k) Exempt	K915668	K925375
Whip Mix Preppies Plus ® PumicePaste is a device specificallyformulated with 2.0% ChlorhexidineGluconate. Each cup provides enoughPreppies Plus for a single patient.Contains no fluoride, oils, oradded flavoring agents. For use on tooth surface priorto restoration cementation For use prior to acid etchingprocedures Sealants Compositerestorations **Minimizes the potential for post-opsensitivity	Cleans the toothsurface prior toacid etchingprocedures;-sealants-orthodonticbrackets-compositerestorationsCleans the toothsurface prior torestorationcementation.Polishingamalgam orcompositerestorations.	Used to clean andmoisten toothstructure	Used forremoval ofresidualtemporarycement prior topermanentcementationand/or forcleaning debriswhiledisinfecting.

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	Prophylaxis ofheavily stainedteeth.Prepping thetooth surfaceprior to bleachingprocedures.
Paste solution	Paste solution	Aqueous solution	Slurry
Contains 2% (relative to liquidcomponent) Chlorhexidine Gluconate	Contains noChlorhexidine	Contains 2%ChlorhexidineDigluconate (CHD)	Contains 2%(relative to liquidcomponent)ChlorhexidineGluconate

7. SAFETY AND EFFECTIVNESS

The use of chlorhexidine in medical device applications have been cleared since the 1970's and is used in many dental applications as well. A thorough search for known risks associated with chlorhexidine in the FDA database was performed. This information was an input to our risk management process. In accordance with ISO 14971 our risk management process has identified the known hazards associated with our new product and all have been mitigated to an acceptable level. Whip Mix's new device, Preppies Plus, is exactly the same as our 510(k) exempt device, Preppies Flour of Pumice except for the addition of 2% Chlorhexidine Gluconate (CHG). Based on the acceptable results of the non-clinical tests for bio-compatibility performed and comparison to the predicates Whip Mix Preppies Plus ® device introduces no new risks and is considered substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three overlapping profiles facing to the right.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 26, 2014

Whip Mix Corporation Mr. John P. Waters Regulatory Compliance Officer & Official Correspondent 361 Farmington Avenue Louisville, KY 40217

Re: K131760

Trade/Device Name: Preppies Plus® Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: I Product Code: EJR Dated: December 20, 2013 Received: December 30, 2013

Dear Mr. Waters:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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 addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Waters

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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/Resources/or You/Industry/default.htm. Also. please note

the regulation cntitled, "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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Mary S. Runner -S

Erin 1. Keith. M.S. Acting Division Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K131760 510(k) NUMBER (IF KNOWN)

DEVICE NAME: PREPPIES PLUS®

INDICATIONS FOR USE:

Whip Mix Preppies Plus ® is a device used as part of a professionally administered prophylaxis treatment. It is used on the tooth surface prior to;

. Restoration cementation.
Acid etching procedures: .
- o Sealants
- Orthodontic brackets o
- 0 Composite restorations

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE) :

Prescription Use _X

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Sheena A. Green -S 2014.03.26 11:42:34 -04'00'

Regulation Number and Section

§ 872.6030 Oral cavity abrasive polishing agent.

(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.