KaVo QUATTROcare is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.
NOTE: QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.

Device Description

The KaVo QUATTROcare is an aerosol product with hydrocarbon propellants and lubricant and flavor/odor ingredients for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to their sterilization.

AI/ML Overview

The provided documentation for the KaVo QUATTROcare device does not contain a study that presents specific acceptance criteria and detailed performance data in the typical format found for medical device evaluations measuring metrics like sensitivity, specificity, accuracy, etc. This is because the device, a dental handpiece accessory for maintenance, was evaluated for substantial equivalence based on comparisons of formulation and intended uses to a predicate device (KaVo Spray), rather than through performance testing against pre-defined quantitative criteria.

Here's a breakdown based on the information available:

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

Acceptance Criteria	Reported Device Performance
Primary Criterion: Substantial equivalence to predicate device (KaVo Spray) regarding formulation and intended use.	Conclusion: "Based on the information in the notification KaVo America believes that QUATTROcare is substantially equivalent to the claimed predicate (i.e., KaVo Spray, a pre-amendments product)."
Intended Use: Internal cleaning, purging of old lubricant, for maintenance of rotating dental and surgical instruments.	The device's description and indications for use align with the intended purpose, being a dental handpiece accessory for maintenance (cleaning, lubrication).
Safety: General controls provisions of the Act (annual registration, listing, good manufacturing practice, labeling, prohibitions against misbranding and adulteration).	FDA's letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." This indicates an expectation of compliance rather than

                    a specific performance metric. |

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

Sample Size: Not applicable. No formal test set involving device performance data on a specific sample size of biological or simulated cases was conducted. The evaluation was based on a comparison of the device's characteristics (formulation, intended use) to a predicate device.
Data Provenance: Not applicable. No specific country of origin or retrospective/prospective nature of data for a "test set" is mentioned as it wasn't a performance study.

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. Ground truth, in the context of device performance, was not established by experts adjudicating cases for a test set. Substantial equivalence was determined by regulatory review based on product description and comparison to a legally marketed predicate.

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

Not applicable. There was no test set requiring an adjudication method.

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 dental handpiece maintenance accessory, not an AI-assisted diagnostic or therapeutic tool where MRMC studies involving human readers aiding AI would be relevant.

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

Not applicable. As noted above, this device is not an algorithm or AI system.

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

The "ground truth" for the regulatory approval was effectively the established safety and effectiveness of the predicate device (KaVo Spray) based on its pre-amendment market clearance. The comparison was focused on the new device's formulation and intended use being similar enough to the predicate to warrant similar regulatory standing.

8. The sample size for the training set:

Not applicable. There was no training set, as this is not an AI/machine learning device.

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

Not applicable. There was no training set.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or evaluation that proves the KaVo QUATTROcare meets its acceptance criteria is a substantial equivalence determination process, as outlined by the FDA under 510(k) regulations.

Instead of a traditional performance study with a test set and quantitative metrics, the manufacturer (KaVo America) demonstrated substantial equivalence to a legally marketed predicate device (KaVo Spray, a pre-amendments product) by comparing:

Formulation: Both devices are aerosol products with hydrocarbon propellants and lubricant/flavor/odor ingredients.
Intended Use: Both are designed for the routine maintenance (cleaning, lubrication, purging of old lubricant) of dental and surgical instruments prior to sterilization.

The acceptance criteria were met when the FDA, based on the submitted information, concluded that the KaVo QUATTROcare was substantially equivalent to the predicate device. This implies that the differences between the new device and the predicate do not raise new questions of safety or effectiveness. The FDA's letter officially confirms this determination.

Summary

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JUN 2 6 2002

K012308

SECTION 9

510(k) SUMMARY

This 510(k) summary of safety and effectiveness for KaVo QUATTROcare (unit and pressurized cans) is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

KaVo America Applicant:
340 East Main Street Address: Lake Zurich, IL 60045
Manufacturer: KaVo Dental GmbH Bahnhofstr. 20 D-8847 Warthausen Biberach GERMANY
Contact Person: Mr. John Westermeier
Telephone: 847-550-6800 847-550-6825 (Fax) 800-323-8029
February 2002 Preparation Date: (of the Summary)

KaVo QUATTROcare (Unit 2104 A; 6-pack of pressurized cans 2106 A) Device Name:

Dental Handpiece Accessory (for maintenance; cleaning, and lubrication) Common Name:
Classification: Accessory to Dental Handpieces (Class I medical device: (21 CFR 872,4200),

Product Code: EFB (Product Code for Dental Handpieces) Panel: 76

Predicate devices: KaVo Spray

Description: The KaVo QUATTROcare is an aerosol product with hydrocarbon propellants and lubricant and flavor/odor ingredients for use in the routine maintenance (cleaning and lubrication) of dental handpieces prior to their sterilization.

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Indications: KaVo QUATTROcare is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments .
NOTE: QUATTROcare should be used only with pre-cleaned dental handpieces and before they are sterilized.

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

None required. The claim of substantial equivalence is based on Performance Data: comparisons of formulations and intended uses of the QUATTROcare and its claimed predicate.
CONCLUSION: Based on the information in the notification KaVo America believes that QUATTROcare is substantially equivalent to the claimed predicate (i.e., KaVo Spray, a pre-amendments product).

Rev. April 2002

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines suggesting movement or progress.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Mr. John Westermeir Kavo America 340 East Main Street Lake Zurich, Illinois 60045

Re: K012308 Trade/Device Name: KaVo QUATTROcare

Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: April 12, 2002 Received: April 17, 2002

Dear Mr. Westermeier:

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.

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.

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Page 2 - Mr. Westermeier

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Klatruds

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 7 INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K012308 -

Device Name: KaVo QUATTROcare

Indications for Use Statement:

KaVo QUATTROcare is intended for internal cleaning, i.e., purging of old lubricant, for the maintenance of rotating dental and surgical instruments.

NOTE: QUATTROcare should be used with only pre-cleaned dental handpieces and before they are sterilized.

KaVo proposes that KaVo QUATTROcare carry the following label:

CAUTION: Federal (US) law restricts the use of this device to licensed professionals.

Rev. April 2002

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use کر (Per 21 CFR 801.109) OR

Over-The Counter Use

Susan Pum
(Division Sign-Off)

Division of Dental, Infection Control,
and General Hospital, Infection Control, and General Hospi 510(k) Number

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.