The ClearView™ Handpiece Lubricator is used for the delivery of ClearView™M Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.

Device Description

Lubricator: This information is detailed on the manufacturing drawings and photographs included in the body of this submission.

Lubricant: ClearView™ Dental Handpiece Lubricant is a liquid lubricant specifically intended for use with the ClearView™ Dental Handpiece Lubricator for the purpose outlined above. Detailed information is contained in the body of this submission.

AI/ML Overview

The provided text describes a 510(k) summary for the ClearView™ Dental Handpiece Lubricator and Lubricant, which is a submission to the FDA seeking market clearance based on substantial equivalence to existing predicate devices. This type of submission focuses on comparing the new device's characteristics, safety, and effectiveness to legally marketed predicate devices, rather than presenting a study with specific acceptance criteria and detailed performance data like those found for novel or higher-risk medical devices requiring clinical trials.

Therefore, based on the provided text, many of the requested details about acceptance criteria and studies (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not applicable because such a detailed study was not presented or required for this type of 510(k) submission.

Here's the breakdown of what can be extracted or inferred from the text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) substantial equivalence submission for a Class I device, specific quantitative "acceptance criteria" and "reported device performance" in the way one might expect for a new, high-risk device with a clinical trial are not explicitly stated or provided in the document.

Instead, the acceptance criteria for this type of submission are implicitly "substantial equivalence" to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness. The reported "performance" is a qualitative comparison demonstrating this equivalence.

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence)	Reported Device Performance (as stated in the document)
Intended Use Equivalence: The device serves the same purpose as the predicate devices.	The ClearView™ Handpiece Lubricator is used for the delivery of ClearView™ Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization, which aligns with the purpose of predicate devices.
Technological Characteristics Equivalence: The device operates on similar principles and has similar features to the predicate devices.	Lubricator Comparison: Both the ClearView™ and the Assistina have a reservoir for lubricant, a cover to contain exhaust, a method of connecting handpieces, push button operation, a hose and connection to a pressurized air supply. Both devices use pressurized air for power and do not have electrical components. Lubricant Comparison: Both ClearView™ Dental Handpiece Lubricant and Phase Change Dental Lubricant are liquids suitable for lubrication of dental handpieces.
Safety and Effectiveness Equivalence: The device is as safe and effective as the predicate devices and does not raise new questions of safety or effectiveness.	The differences between ClearView™ and the predicate devices do not raise questions regarding safety and effectiveness. The device employs the same technological characteristics to support its intended use. Both lubricant types are considered completely safe under normal usage and have no expected hazards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. The document does not describe a "test set" in the context of performance testing with a specific sample size. The review focuses on comparing the device's design and intended function to predicate devices, not on a clinical or performance study with a distinct test dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. No ground truth establishment for a test set is described. The entire submission is reviewed by the FDA, with the "ground truth" essentially being the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No test set or expert adjudication process is described for this type of submission.

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 is a mechanical device (lubricator and lubricant), not an AI/software device. Therefore, no MRMC study or AI assistance evaluation was performed or is relevant.

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

Not Applicable. This is a mechanical device; there is no "algorithm only" performance to evaluate.

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

The "ground truth" in a 510(k) substantial equivalence submission for this type of device is the established safety and effectiveness of the legally marketed predicate devices. The applicant's submission aims to demonstrate that its new device is "substantially equivalent" to these already-approved devices, meaning it works comparably and is just as safe and effective.

8. The sample size for the training set

Not Applicable. No "training set" in the context of machine learning or complex algorithm development is mentioned or relevant for this mechanical device submission.

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

Not Applicable. As no training set is described, the process for establishing its ground truth is also not applicable.

Summary

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K070297

Section 5 - 510(k) Summary (continued)

Characteristics of the device in comparison to those of the predicate device(s) 6.

Lubricant Comparison:

Both the ClearView™ Dental Handpiece Lubricant and the Phase Change Dental Lubricant are liquids demonstrated to be suitable for lubrication of dental handpieces. They are both considered completely safe under normal usage and have no expected hazards.

Lubricator Comparison:

Both the ClearView™ and the Assistina have a reservoir for lubricant, a cover to contain exhaust, a method of connecting handpieces, push button operation, a hose and connection to a pressurized air supply. Both devices use pressurized air for power and do not have electrical components. Both devices lubricate dental handpieces; however, the ClearView™ does not spray cleaner through the chip air and water line as does the Assistina. The fact that the ClearView™ does not spray cleaner through the chip air and water line does not affect the safety and efficacy of the ClearView™ Dental Handpiece Lubricator for its intended use of lubricating handpieces.

Safety and Performance: 7.

The difference between the ClearView™ Dental Handpiece Lubricator and Lubricant and the above mentioned predicate devices do not raise any questions regarding the safety and effectiveness of the lubricator or lubricant. The ClearView™ Dental Handpiece Lubricator employs the same technological characteristics to support the intended use of lubricating air-driven dental handpieces with rotating turbines and purge old lubricant for the purpose of maintenance prior to sterilization as the W & H Assistina. In addition, the ClearView™ Dental Handpiece Lubricant and the predicate device, the Phase Change Dental Lubricant, are commonly used in equipment with incidental food contact. The devices, as designed, are as safe and effective as their predicate devices.

Conclusion 8.

Based on the design, material, function and intended use discussed herein, Dental Air Solutions of NC, Inc., believes the ClearView™ Dental Handpiece Lubricator and Lubricant is substantially equivalent to predicate devices currently marketed under the Federal Food, Drug and Cosmetic Act.

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Section 5 - 510(k) Summary

Applicant Contact: 1.

....

Thomas K. Fee, President Dental Air Solutions of NC, Inc. 224 Branchside Lane Holly Springs, NC 27540 Phone: 919-771-7545 Fax: 919-762-9070 Email: tomf(@dentalairsolutions.com

Date Prepared: November 17, 2006

Name of Device: ClearView™ Dental Handpiece Lubricator and Lubricant 2. Common Name: Dental Handpiece Accessory (maintenance, lubrication) Accessory to Dental Handpiece, Class I medical device Classification Name: Regulation 21 CFR 872.4200, Product Code EFB

Identification of device(s) to which the submitted claims equivalence: 3.

The Clear View™ Dental Handpiece Lubricator and Lubricant is substantially equivalent to the following predicate devices:

a. Predicate for Lubricator:
- W & H Assistina, 510(k) K010127 트
b. Predicate for Lubricant:
- Phase Change Dental Lubricant, 510(k) K954991 u

4. Device Description:

Lubricator: This information is detailed on the manufacturing drawings and photographs included in the body of this submission.

Intended Use of the Device: ડ.

The ClearView7M Handpiece Lubricator is used for the delivery of ClearView™ Handpiece Lubricant to air driven dental handpieces, turbines and air motors for the purpose of maintenance prior to sterilization.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dental Air Solutions of North Carolina, Incorporated C/O Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated FEB 5 2007 12 Laboratory Drive Research Triangle Park, North Carolina 27709-3995

Re: K070297

Trade/Device Name: ClearView™ Dental Handpiece Lubricator and Lubricant Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: January 24, 2007 Received: January 31, 2007

Dear Mr. Rongero:

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. Rongero

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 vours.

Qur

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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Section 4 - Indications for Use Statement

510k number if known:

1070297

ClearView™ Dental Handpiece Lubricator and Lubricant Device Name:

Indications for Use:

Prescription Use ﮯ (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)

Susan Runner

ClearView™ Dental Handpiece Lubricator and Lubricant

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.