SMEARCLEAR

• K Number: K024198
• Device Name: SMEARCLEAR
• Manufacturer: SYBRON DENTAL SPECIALTIES, INC.
• Date Cleared: 2003-03-05 ( 75 days)
• Product Code: KJJ
• Regulation Number: N/A
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Device Description

SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

AI/ML Overview

This is a 510(k) premarket notification for a medical device called SmearClear, an endodontic irrigating solution. The document states that the device is substantially equivalent to a legally marketed predicate device, "PulpDent's EDTA Solution."

Here's an analysis of the provided text regarding acceptance criteria and study information:

Based on the information provided in the 510(k) summary, there is no detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for a typical diagnostic or AI-driven device. This document is a premarket notification for a Class II medical device, and its primary purpose is to demonstrate substantial equivalence to a predicate device rather than to provide detailed performance study results against predefined acceptance criteria.

Therefore, many of your requested fields cannot be filled directly from this document.

Here's what can be inferred or stated based on the provided text:

Acceptance Criteria and Device Performance

Since this is a substantial equivalence submission for a solution, the "acceptance criteria" revolve around demonstrating that SmearClear functions in a manner similar to and is intended for the same use as the predicate device (PulpDent's EDTA Solution). The document does not provide a table with numerical acceptance criteria and reported device performance in the context of, for example, sensitivity, specificity, or accuracy, which would be typical for a diagnostic or AI device.

Study Information (as inferable from the document's type)

1. Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the format of specific numerical acceptance criteria and study results. The "acceptance criteria" here are implied by the FDA's "substantial equivalence" determination, meaning the device's characteristics and performance are deemed comparable to the predicate device for its intended use.

2. Sample Size used for the test set and the data provenance: Not applicable or not provided. This type of submission (510(k) for a basic solution) typically relies on chemical composition, intended use comparison, and existing knowledge of the predicate device rather than a new clinical performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. There's no mention of a test set requiring expert ground truthing.

4. Adjudication method for the test set: Not applicable or not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable or not provided. This type of study is relevant for diagnostic devices where human interpretation plays a significant role, often with AI assistance. SmearClear is an irrigating solution, not a diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable or not provided. SmearClear is a chemical solution, not an algorithm.

7. The type of ground truth used: Not applicable. For a chemical solution, "ground truth" often relates to its chemical properties and biological effects, which would be assessed through standard laboratory tests (e.g., pH, concentration, efficacy in dissolving debris in vitro), but these specific results are not detailed in this 510(k) summary. The "ground truth" for substantial equivalence is the established safe and effective use of the predicate device.

8. The sample size for the training set: Not applicable or not provided. This concept is relevant for machine learning models, not for a chemical solution.

9. How the ground truth for the training set was established: Not applicable or not provided.

Summary of what is known from the document about the "study":

The "study" in this context is the 510(k) submission process itself, where Sybron Dental Specialties demonstrates that SmearClear is "substantially equivalent" to PulpDent's EDTA Solution. This involves comparing:

• Intended Use: Both devices are "designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation."
• Technological Characteristics: While not detailed in this summary, the submission would have included information on the chemical composition and physical properties of SmearClear, comparing them to EDTA solutions.
• Performance: The claim is that SmearClear "functions in a manner similar to" the predicate device. This implies that any testing performed would have shown comparable efficacy for its intended use, typically through in-vitro studies for a product of this nature, but specific study details are not in this summary.

In essence, this document is a regulatory filing focused on establishing market clearance via substantial equivalence, not a detailed scientific publication of a performance study against specific, quantifiable acceptance criteria.

Summary

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Image /page/0/Picture/0 description: The image is a logo for Sybron Dental Specialties. The logo features the letters "sds" in a stylized font, with a curved line above the letters. Below the letters, the words "SYBRON DENTAL SPECIALTIES" are written in a serif font. The logo is black and white.

MAR 0 5 2003

KO24198

Section III - 510(k) Summary of Safety and Effectiveness

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: December 2002

Device Name:

• Trade Name SmearClear .
• Common Name Endodontic Irrigating Solution .
• Classification Name Root Canal Cleanser .

Devices for Which Substantial Equivalence is Claimed:

• PulpDent Corporation, PulpDent's EDTA Solution .

Device Description:

SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Intended Use of the Device:

The intended use of SmearClear is designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.

Substantial Equivalence:

Smear Clear is substantially equivalent to other legally marketed devices in the United States. SmearClear functions in a manner similar to and is intended for the same use as PulpDent's EDTA Solution manufactured by PulpDent Corporation.

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Image /page/1/Picture/11 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 0 5 2003

Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867

Re: K024198

Trade/Device Name: SmearClear Regulation Number: Unclassified Regulation Name: Root Canal Cleanser Regulatory Class: Unclassified Product Code: KJJ Dated: December 18, 2002 Received: December 20, 2002

Dear Ms. Boswell:

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. Colleen Boswell

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Roanes

Susan Runner, DDS, MA Interim 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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Section I

Indications for Use Statement

Ver/3-4/24/96

Applicant: Sybron Endo, a division of Ormco Corporation

Labels	Values
510(k) Number (if known):	K024198
Device Name:	SmearClear

Indications For Use:

SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the
walls of root canals prior to obturation.

Ken Muky for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

Labels	Values
510(k) Number.	K024198

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Regulation Number and Section

N/A