DENTAPURE DP40 CARTRIDGE by MRLB INTL., INC.

The DentaPure® DP40 Cartridge is for use on dental unit water lines attached to the dynamic dental instruments, i.e., high-speed handpiece, three-way air/water syringe and ultrasonic scaler. This cartridge in conjunction with currently recommended practices regarding sterilization and flushing of dental instruments reduces bacteria from the water supplied through the instruments to a level that will meet or exceed the current ADA recommendations for water quality having a maximum of 200 cfu/ml.

Device Description

The DentaPure® DP40 Cartridge is an in-line assembly incorporating iodinated resin and a polyolefin filter. The cartridge is connected to the pickup tube of a bottle water system. It consists of a polyolefin in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the water as it flows through. The filter portion is of a sufficiently small porosity to retain water-born particulate, and would thereby reduce the amount of particulate that would reach the patient from the dental water system. The iodine that is released reduces biofilm and the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter. The DentaPure® Cartridge is a disposable unit, retrofittable to all modern dental operatory units with independent bottle water systems. The cartridge is installed in the bottle reservoir tubing with quick connect fittings for ease of change.

AI/ML Overview

The provided document is a 510(k) summary for the DentaPure® DP40 Cartridge, a dental unit waterline purification cartridge, and a letter from the FDA regarding its substantial equivalence. It does not contain a study with detailed acceptance criteria and reported device performance in the format requested. The document describes the device's intended use and general performance claims but lacks the specific data points often found in a scientific study report.

However, based on the information provided, I can infer some elements as they relate to the device's performance claims.

Here's a breakdown of what can be extracted and what is missing:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Reduce bacteria levels in dental unit water lines to less than 200 cfu/ml (ADA recommendation).	Commonly reduce bacteria levels to less than 100 cfu/ml.

Missing Information Based on Request:

The document is a premarket notification for a medical device and describes its intended use and general performance claims. It is not a detailed study report, therefore much of the requested information about a specific study's methodology, sample sizes, expert involvement, and ground truth establishment is not present.

Sample size used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
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 not an AI-assisted diagnostic tool; it's a water purification cartridge.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance claim relies on microbial colony-forming unit (cfu/ml) counts, which is an objective laboratory measure of bacterial concentration in water samples.
The sample size for the training set: Not applicable. This device is not an AI/machine learning model that requires a "training set."
How the ground truth for the training set was established: Not applicable.

Summary of Device Performance Claims from the Document:

The DentaPure® DP40 Cartridge is designed to be connected to the pickup tube of a bottle water system in dental operatories. It incorporates an iodinated resin and a polyolefin filter. As water flows through, the resin imparts 2-6 ppm of iodine, which is stated to reduce biofilm and the chance of cross-contamination by acting as a germicide. The filter portion retains water-borne particulate.

The key performance claim states: "When used in conjunction with these normal practices, the DentaPure® DP40 Cartridges commonly reduce bacteria levels to less than 100 cfu/ml." This performance is presented as exceeding the current ADA recommendation of having less than 200 cfu/ml in dental unit water lines.

The document is a regulatory submission demonstrating substantial equivalence to a predicate device (DentaPure® DP1, K963548), not a detailed scientific report on a specific study. Therefore, it focuses on asserting that the device meets safety and efficacy claims rather than providing extensive experimental data in the format of a clinical trial.

Summary

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K992868

SEP 7 1999

"510 (K) SUMMARY" [As required by 807.92(c)]

Submitter:

MRLB INTERNATIONAL, INC. 2450 College Way Fergus Falls, Minnesota 56537

(218) 739-2222 Telephone: Fax: (218) 736-3241 Contact Person: B. J. Hammarback

August 8,1999 Date:

DentaPure® DP40 Cartridge Trade Name:

Common Name: Dental Unit Waterline Purification Cartridge

Classification Name: Accessory for "Unit, Dental Operative" per CFR 872.6640) Class I.

DentaPure® DP1 (K963548) Equivalent Device: Manufactured by: MRLB International, Inc. 2450 College Way Fergus Falls, MN 56537 [per 807.92(a) (3)]

Device Description and Intended Use:

A schematic of the cartridge is shown in Figure 2. It consists of a polyolefin in-line filter with the inner chamber filled with an iodinated ion exchange resin that imparts 2-6 ppm of iodine into the water as it flows through. The resin is registered with EPA. The

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filter portion is of a sufficiently small porosity to retain water-born particulate, and would thereby reduce the amount of particulate that would reach the patient from the dental water system. The iodine that is released reduces biofilm and the chance of cross contamination by introducing the germicide, iodine, into the water system downstream of the filter.

The DentaPure® Cartridge is a disposable unit, retrofittable to all modern dental operatory units with independent bottle water systems. The cartridge is installed in the bottle reservoir tubing with quick connect fittings for ease of change.

The instructions for use of the DentaPure® Cartridge require that the dental instruments be sterilized in conformity with current recommendations for sterilization and flushing. When used in conjunction with these normal practices, the DentaPure® DP40 Cartridges commonly reduce bacteria levels to less than 100 cfiv/ml. Current recommendations of the ADA recommend having less than 200 cfu/ml in dental unit water lines, so this device exceeds those recommendations.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three heads facing left, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 7 1999

Mr. B.J. Hammarback MRLB International, Incorporated 2450 College Way Fergus Falls, Minnesota 56537

K992868 Re : Trade Name: DentaPure DP40 Cartridge Requlatory Class: I Product Code: EIA Dated: August 23, 1999 Received: August 26, 1999

Dear Mr. Hammarback:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will

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Page 2 - Mr. Hammarback

verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA regarability further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Directdr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Indications for Use Statement

Page Contents

Ver/ 3 - 4/24/96

Applicant: MRLB International, Inc.

510(k) Number (if known):

Device Name: DentaPure DP40 Waterline Purification Cartridge

Indications For Use:

(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)

. . Capirol, 2 - 8 - 1 - 1 - 1 -

Susan Rumm

Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number .

(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 801.109)

C-1

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.