HYGENICLEAR WKR 1, WATER-DELIVERY DEVICE ULTRACLEAR by HYGENITEK, INC.

To isolate water delivery lines in the dental operatory unit and reduce the contamination due to To isolate watch delivery mics in the dental operation, to dental handpieces and other dental instruments.

Device Description

Accessory to dental unit, dental line-cleaner, Water-Delivery Device

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental water-delivery device called Hygeniclear™ WKR 1 (also known as Ultraclear™).

However, the document is a regulatory submission for substantial equivalence and does not contain acceptance criteria, specific device performance data, or details of a study proving the device meets acceptance criteria.

The 510(k) process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials with pre-defined acceptance criteria and detailed performance studies like those often seen for novel, higher-risk devices.

Therefore, most of the information requested in your prompt cannot be extracted from this document. I will fill in what can be gathered and explain why other sections are not present.

Summary of Acceptance Criteria and Study Information (Based on the provided document):

This document is a 510(k) submission for demonstrating substantial equivalence to predicate devices. It does not contain pre-defined acceptance criteria or a study designed to prove the device meets specific performance metrics in the way a clinical trial would. Instead, the "acceptance criteria" are implied by the FDA's "substantial equivalence" decision, meaning the device's technological characteristics and intended use are similar enough to existing, legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied by 510(k) Path)	Reported Device Performance (as per document)
Intended Use: - Provide cleaner water supply for dental operative units. - Assist in lubricating dental instruments. - Isolate water delivery lines and reduce contamination to handpieces and other dental instruments.	"Has the same intended use, to provide a cleaner water supply for use with dental operative units and to assist in lubricating dental instruments." "To isolate water delivery lines in the dental operatory unit and reduce the contamination due to to dental handpieces and other dental instruments."
Technological Characteristics: - Similar to predicate devices. - Technological features vary but have same intended use of keeping waterlines free of contaminants.	"The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for differences in methods of use." "The technological features vary but the devices have the same intended use of keeping waterlines free of contaminants."
Materials: - Substantially equivalent to similar products.	"Descriptive information provided shows that the materials from which the delivery unit of Hygeniclear™ WKR 1 is made are substantially equivalent to those of similar products, used for identical purposes, currently on the market."
Patient Contact: - No patient contact. - Operating instructions for proper use, including acceptable disinfectants.	"This product does not contact patients. Operating instructions clearly indicate proper use of the device, either with or without disinfectant/lubricant added to the water. The instructions prescribe acceptable disinfectants which have been cleared by the FDA through the 510(k) process."
Safety and Effectiveness: - Demonstrated through substantial equivalence to predicate devices.	The FDA deemed the device substantially equivalent, implying it is as safe and effective as the predicate devices.

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 / Not provided. The document does not describe a test set or associated data for direct performance evaluation in the way a clinical study would. The submission relies on a comparison to predicate devices. The submitter is based in Canada (Markham, Ontario) and the FDA in the USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. There is no mention of a test set requiring expert-established ground truth for performance evaluation.

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

Not applicable / Not provided. No test set or adjudication method is described.

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 / Not provided. This device is a physical dental accessory, not an AI-assisted diagnostic tool.

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

Not applicable / Not provided. This is a physical device, not an algorithm.

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

Not applicable / Not provided. The "ground truth" in a 510(k) is essentially the established safety and effectiveness of the predicate devices to which the new device is compared. This is a regulatory assessment, not a scientific "ground truth" derived from patient data.

8. The sample size for the training set:

Not applicable / Not provided. No training set is mentioned as this is not an AI/machine learning device.

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

Not applicable / Not provided. No training set is mentioned.

Summary

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K990479

XI. SAFE MEDICAL DEVICES ACT OF 1990 SUMMARY OF SAFETY AND EFFECTIVENESS. Feb. 1, 1999. [Separate Pages]

I. Submitter: Katie Lubin, President, Hygenitek, Inc., 7370 Woodbine Ave., Unit 5, Markham, Ontario, Canada L3R1A5, Phone: 905-642-8138.

II. Classification Names and numbers: Dental Operative unit, accessory 76EIA.

III. Common/Usual Name: Accessory to dental unit, dental line-cleaner,

IV. Proprietary Names: Hygeniclear™ WKR1, Ultraclear™

V. Establishment Registration Number: In process

VI. Classification: Dental operative unit and accessories, Class I, reserved, Described in CFR 872.6640.
VII. Substantial Equivalence: Hygeniclear™ WKR 1 is substantially equivalent to other devices cleared for marketing by the 510(k) process under K-971278 (Pure Company), K-971727 (DCI Water Purifier), K-964271 (IGN Waterline Unit), and K-882491, K-973765 (Micryllum Labs).

The "510(k) "Substantial Equivalence" Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed as described below:

These products have the same intended use, to provide a cleaner water supply for use with dental operative units and to assist in lubricating dental instruments.
The technological characteristics for this product are similar to those for the predicate devices and those currently on the market except for differences in methods of use. The technological features vary but the devices have the same intended use of keeping waterlines free of contaminants. The methods used with these equivalent products also vary widely including daily or weekly change, overnight soak or elution of traces of bactericide, use of a bactericide/lubricant with the water, and filtering or non-filtering.
Descriptive information provided shows that the materials from which the delivery unit of Hygeniclear™ WKR 1 is made are substantially equivalent to those of similar products, used for identical purposes, currently on the market.
This product does not contact patients. Operating instructions clearly indicate proper use of the device, either with or without disinfectant/lubricant added to the water. The instructions prescribe acceptable disinfectants which have been cleared by the FDA through the 510(k) process.

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There are no specific guidance documents applicable to biofilm removal from dental lines. However, we have complied fully with general guidance documents and usual practices in preparing premarket notifications. If additional information or explanation is needed, please call me at 905-642-8138 or fax me at 905-642-1773. Alternately, you may contact Dr. H. N. Dunning at 301-229-2138, 8309 Bryant Dr., Bethesda, MD 20817, who is acting on my behalf, for a local response.

Sincerely yours

Katie Lubin

President

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the seal is a stylized image of a human figure in profile, with three overlapping lines forming the body and head.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 3 1999

Ms. Katie Lubin President Hygenitek, Incorporated 7370 Woodbine Avenue, Unit 5 Markham, Ontario CANADA L3R1A5

Re: K990479 Hygeniclear™ WKR 1, Water-Delivery Device Trade Name: Ultraclear™ Regulatory Class: I Product Code: EIA February 10, 1999 Dated: Received: February 16, 1999

Dear Ms. Lubin:

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. ಕ್ಕಿ 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 verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish 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.

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Page 2 - Ms. Lubin

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA described in your tial equivalence of your device to a legally rinding of bubbandaa of coults in a classification for your marketed predicator with 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 compriation 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 ene regaracter onoroson" (21 CFR 807.97). Other general premation on your responsibilities under the Act may be Information on Journal Manufacturers Assistance obcarned from one (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

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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VIII.1 Indications for Use: [Separate Page]

510(k) Number:

Device Name: Hygeniclear™ WKR 1

Indications for use:

(PLEASE DO NOT WRITE BBLOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEBDBD)

Concurrence of CDRH, Office of Device Evaluation (ODE)
	Susan Guase
	(Division Sign-Off)
	Division of Dental, Infection Control,
	and General Hospital Devices
510(k) Number	K990479
OR
Prescription Use	Over-The-Counter Use
(Per 21 CFR 801.109	(Optional Format 1-2-96)

repl. ಿ

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.