The proSonic™ Ultraviolet Toothbrush Sanitizer is intended for use in reducing bacterial contamination that naturally accrues on toothbrushes under normal conditions of use.

Device Description

The proSonic Ultraviolet Toothbrush Sanitizer unit sanitizes toothbrushes hung inside the unit by reducing the amount of bacteria that accrues on them under normal conditions of use. Sanitization is accomplished via ultraviolet (UV) radiation produced by a UV lamp housed within the unit. When activated, the proSonic Ultraviolet Toothbrush Sanitizer completes an initial sanitization cycle in one (1) hour. Afterwards, a built-in timer in the unit alternately causes the UV lamp to be turned off for sixty (60) minutes and turned on for five (5) minutes in between brushing cycles. Depending on usage, the UV lamp will typically be activated for approximately one hundred-sixty five (165) minutes per day. The bulb has an effective Iife of ten thousand (10,000) hours. The sanitizer is designed so that the UV lamp can be activated only when the unit door is fully closed, and the level of ozone emitted by the sanitizer is within FDA regulatory limits. The proSonic Ultraviolet Toothbrush Sanitizer is sold with four (4) accompanying toothbrushes and a power handgrip (which converts the toothbrushes into powered toothbrushes).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Prosonic™ Ultraviolet Toothbrush Sanitizer based on the provided document:

This document is a 510(k) premarket notification for a medical device seeking substantial equivalence to a predicate device. It primarily focuses on demonstrating that the device is "as safe, as effective, and performs as well as or better than" the predicate. Therefore, the "acceptance criteria" presented are implicitly derived from the performance of the predicate and the general safety standards for similar devices. There isn't a clearly defined set of numerical acceptance criteria like you would typically find for a more novel device performance study.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (Prosonic™ Ultraviolet Toothbrush Sanitizer)
Bacterial Contamination Reduction: Significant reduction in bacterial contamination on toothbrushes.	"bacterial contamination on toothbrushes is significantly reduced by the device"
Ozone Emissions: Within FDA regulatory limits (specified at 21 C.F.R. § 801.415).	"the ozone emitted by this product is minimal and within limits specified at 21 C.F.R. § 801.415 (2002)."
Safety Feature (Door Interlock): UV lamp can only be activated when the unit door is fully closed.	"The sanitizer is designed so that the UV lamp can be activated only when the unit door is fully closed."
Material and Design Equivalence: Substantially equivalent to the predicate device.	"Both devices are substantially equivalent in terms of materials and design."
Technological Characteristics: Substantially equivalent to the predicate device (e.g., uses UV light, similar ozone emissions, similar UV bulb wavelengths).	"Both the proSonic and the Purebrush sanitizers use ultraviolet light to reduce bacterial contamination. ... Ozone emissions for the two devices are similar... The UV lamps in both devices cannot be activated unless the units are fully closed. The wavelengths emitted by the UV bulbs in the two devices are also substantially equivalent."
Effective UV Lamp Life: (Predicate's effective life)	"The bulb has an effective life of ten thousand (10,000) hours." (While different from the predicate, this difference is stated to "not significant to the safety or effectiveness.")
Sanitization Cycle Length: (Predicate's cycle length)	"completes an initial sanitization cycle in one (1) hour." (While different from the predicate, this difference is stated to "not significant to the safety or effectiveness.")

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated. The document mentions "Laboratory and actual use tests" were conducted but does not provide specific numbers of toothbrushes, test subjects, or samples examined for bacterial reduction or ozone emission.
Data Provenance: The study was conducted for Hwadong International Company, Ltd., which is based in Korea. The document does not specify if the testing itself was performed in Korea, the US, or elsewhere, nor does it explicitly state if the data was retrospective or prospective. Given the context of a premarket notification for a new device, it is most likely prospective testing specifically performed for this submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: Not applicable/not specified. For bacterial reduction and ozone emissions, the ground truth would be based on objective laboratory measurements rather than expert consensus. No specific experts are mentioned as establishing ground truth in this context.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not specified. Since the measurements are objective (bacterial counts, ozone levels), there wouldn't typically be a separate adjudication process for ground truth.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study relates to the performance of human readers (e.g., radiologists) with and without AI assistance, which is not relevant to a physical device like a toothbrush sanitizer.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Yes, in essence. The entire evaluation focuses on the performance of the device itself ("algorithm only" in a conceptual sense for a physical product) in reducing bacteria and emitting ozone, without human intervention or human-in-the-loop performance being a factor in the device's function or evaluation.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for bacterial reduction would be based on microbiological assay results (i.e., direct counts of bacterial colonies from samples before and after sanitization). The ground truth for ozone emissions would be based on chemical analysis/sensor readings using established testing protocols to detect and quantify ozone levels. These are objective laboratory measurements.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable/not specified. This device is a physical product, not an AI/ML algorithm that requires a "training set" in the computational sense. The "development" of the device would involve engineering and physical testing, not data training.

9. How the Ground Truth for the Training Set Was Established

How Ground Truth for Training Set Was Established: Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 8 2005

Hwadong International Company Limited C/O Ms. Marian Cochran Atico International USA, Incorporated 501 South Andrews Avenue Ft. Lauderdale, Florida 33301

Re: K023662

Trade/Device Name: Prosonic™ Ultraviolet Toothbrush Sanitizer Regulation Number: 21 CFR 872.6855 Regulation Name: Manual Toothbrush Regulatory Class: I Product Code: MCF Dated: February 25, 2003 Received: March 5. 2003

Dear Ms. Cochran:

This letter corrects our substantially equivalent letter of May 28, 2003.

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 (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 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. Cochran

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 continue 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/dsma/dsmamain.html

Sincerely yours.

Suser Junar
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

ళాని విద్యా

Enclosure

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K 023662

Safety and Effectiveness Summary VIII.

Submitter:	Hwadong International Company, Ltd.#298-12, Kongse-RiKieheung-Eup, Yongin-CityKyungki-DoKorea
Official Correspondent:	Marian Harding Cochran, Esq.Atico International USA, Inc.501 S. Andrews AvenueFt. Lauderdale, FL 33301Phone: (954) 779-2500, Ext. 540Fax: (954) 779-3901
Date Summary Prepared:	October 10, 2002
Device Trade Name:	proSonic™ Ultraviolet Toothbrush Sanitizer
Device Common Name:	Ultraviolet Toothbrush Sanitizer
Predicate Device:	Purebrush Ultraviolet Toothbrush Sanitizer (PurebrushAssociates)

Summary of Device Description:

Intended Use:

The proSonic Ultraviolet Toothbrush Sanitizer is intended for use in reducing bacterial contamination that naturally accrues on toothbrushes under normal conditions of use.

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Substantial Equivalence Comparison:

The proSonic Ultraviolet Toothbrush Sanitizer is substantially equivalent to the Purebrush Ultraviolet Toothbrush Sanitizer. The intended use of both devices is identical - to reduce bacterial contamination that accrues on toothbrushes under normal conditions of use. [Both devices are substantially equivalent in terms of materials and design.] Additionally, the technological characteristics of both devices are substantially equivalent. Both the proSonic and the Purebrush sanitizers use ultraviolet light to reduce bacterial contamination. Both devices house a UV lamp that effectively eliminates most bacteria on toothbrushes stored therein. Ozone emissions for the two devices are similar and comply with acceptable FDA regulatory limits. The UV lamps in both devices cannot be activated unless the units are fully closed. The wavelengths emitted by the UV bulbs in the two devices are also substantially equivalent. Additionally, although their sanitization cycle lengths and the lifetimes of their respective UV bulbs are different, these differences are not significant to the safety or effectiveness of the proSonic device. Like the Purebrush, the proSonic UV toothbrush sanitizer is safe and effective for toothbrush sanitization.

Summary of Performance Testing:

Laboratory and actual use tests were conducted to demonstrate the effectiveness of the proSonic Ultraviolet Toothbrush Sanitizer in reducing bacterial contamination on toothbrushes, as well as the extent to which the device emits ozone. These tests demonstrate that bacterial contamination on toothbrushes is significantly reduced by the device and that the ozone emitted by this product is minimal and within limits specified at 21 C.F.R. § 801.415 (2002).

Conclusion:

Based on the comparison of features of the proSonic and Purebrush UV sanitizers and the performance testing discussed above, it is concluded that the proSonic Ultraviolet Toothbrush Sanitizer is as safe, as effective, and performs as well as or better than the Purebrush Predicate Device for the intended use of reducing bacterial contamination on toothbrushes, and is thus substantially equivalent thereto.

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Indications for Use Statement

Page 1 of 1

510(k) Number (if known): K023662

Device Name: Prosonic™ Ultraviolet Toothbrush Sanitizer

Indications for Use:

The Prosonic™ Ultraviolet Toothbrush Sanitizer is intended for use in reducing bacterial contamination that naturally accrues on toothbrushes under in-use conditions.

TMTrademark of Hwadong International Company Ltd.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109 OR

Over-the-Counter Use XX (Optional Format 1)

Dr. Robt. Betz DDS for Dr. K. Mulvey

v. General Hospital. Division of Anesthesiolog Infection Control, Den

510(k) Number: K023662

Regulation Number and Section

§ 872.6855 Manual toothbrush.

(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.