RAPICURE 200 (CURING AND WHITENING LIGHT) by MEDIPHOTONIX, LC

The RapiCure 2000 is a high pressure mercury light source filtered and transmitted through an optical fiber for the curing of composite resins, as an aid in the whitening of teeth, and for other dental purposes. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.

AI/ML Overview

The provided text is a 510(k) summary for the Mediphotonix RapiCure 2000™ Curing and Whitening Light. This document focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with detailed acceptance criteria and results as would be found for a novel, high-risk device.

Therefore, the document does not contain the information needed to fill out all requested sections regarding acceptance criteria and a study proving device performance in the way a typical AI/software device submission would.

However, I can extract the available information and explain why other sections cannot be completed based on this specific document.

Missing Information:

The document is a 510(k) submission summary for a physical medical device (a light source). It focuses on demonstrating substantial equivalence to predicate devices already on the market, rather than proving performance against specific quantitative acceptance criteria through a clinical study. As such, the concept of "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the context of an AI/software device (e.g., accuracy, sensitivity, specificity thresholds) is not present.

Specifically, the following details are not available in the provided text:

A table of acceptance criteria and the reported device performance: This type of data is not required or typically included in a 510(k) for a light-curing device where substantial equivalence is the primary pathway to market. There are no specific quantitative metrics (like accuracy, sensitivity, specificity) for a software algorithm's performance.
Sample size used for the test set and the data provenance: Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
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.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Available Information (related to "performance" and "equivalence" as presented):

The document states that "Performance standards: None established under section 514." This indicates that the device operates under general controls and does not have specific performance standards set by regulation that it must meet.

The "study" or justification provided is the Substantial Equivalence argument. The device's performance is implicitly proven by demonstrating that it is similar in design, intended use, and technological characteristics to legally marketed predicate devices that have already been deemed safe and effective.

Summary of Substantial Equivalence Information (as a proxy for "study"):

Device Name: RapiCure 2000™ Curing and Whitening Light
Indications for Use:
1. Source of illumination for curing dental restorative materials.
2. Assisting in the whitening process in a dental office.
Predicate Devices:
- Plasma Arc Curing system (American Dental Technologies, K-952333)
- Apollo 95 curing and whitening system (Dental/Medical Diagnostic Systems, Inc., K-981948)
- Ardent Radiance Curing Light (Air Techniques, Inc., K-982615)
- Spectrum 800 Curing Unit (Dentsply, K-982318)
- CU-100A Light Cure Unit (K-980792)
- O-Luxpro V/Q-Luxpro II Light Unit (K-980793)
- "several other curing lights cleared under code EBF as accessories to composite materials classified as 'tooth-shade resin and described in CFR 872.3690."
Technological Characteristics (briefly described as justification for equivalence): High pressure mercury light source filtered and transmitted through an optical fiber. Emits filtered light in the range from 400 to 500 nm. Accepts voltages from 100-230 VAC.
Methodology for establishing equivalence: Followed the "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3."

In conclusion, for this specific type of device and 510(k) submission, the concept of "acceptance criteria" and "study results" as typically requested for AI/software-based medical devices is not directly applicable. The device's safety and effectiveness are established through demonstrating substantial equivalence to predicate devices, implying that its performance is comparable to those already on the market.

Summary

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NOV - 1 1999

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XII. 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Separate Page)
A. Submitter: Robert McClane, Mediphotonix, LC, 484 H Street, Salt Lake City, UT 84103, phone: 801-363-4418.
I. Classification: Class II and Class I.
II. Common or usual name: Curing and whitening light.
III. Proprietary Name: RapiCure 2000™ Curing and Whitening Light
IV. Registration No .: In process
V. Classification Name: Tooth-shade resin (Accessory) EBF, Class II; and, Heat source for bleaching teeth EEG, Class I.
VI. Performance standards: None established under section 514.
VII. Description: The RapiCure 2000 is a high pressure mercury light source filtered and transmitted through an optical fiber for the curing of composite resins, as an aid in the whitening of teeth, and for other dental purposes. The device emits filtered light in the range from 400 to 500 nm. It accepts voltages from 100-230 VAC.
VIII. Labels and Labeling: Labels and Instructions for Use are provided. Competitive labels and labeling are provided and the products are compared.
IX. Indications for Use: source of illumination for curing dental restorative materials, and for tooth whitening activities.
X. Substantial Equivalence: RapiCure 2000™ Curing and Whitening Light is substantially equivalent to the Plasma Arc Curing system cleared by American Dental Technologies in K-952333, to the Apollo 95 curing and whitening system cleared in K-981948 by Dental/Medical Diagnostic Systems, Inc., to the Ardent Radiance Curing Light cleared by Air Techniques, Inc., in K-982615, to the Spectrum 800 Curing Unit, cleared by Dentsply in K-982318, the CU-100A Light Cure Unit cleared in K-980792, the O-Luxpro V/Q-Luxpro II Light Unit cleared in K-980793 and several other curing lights cleared under code EBF as accessories to composite materials classified as "tooth-shade resin and described in CFR 872.3690.

The "510(k) Substantial Equivalence Decision-making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines representing its wings and two curved lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 1 1999

Mr. Robert McClane Official Correspondent Mediphotonix, LC 484 H Street Salt Lake City, UT 84103

K993223 Re :

Rapicure 2000 (Curing and Whitening Light) Trade Name: Regulatory Class: II Product Code: EBZ Dated: September 21, 1999 Received: September 27, 1999

Dear Mr. McClane:

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 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 (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. A 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 regulation 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

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Page 2 - Mr. McClane

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

thy A. Ulatowski Tir 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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IX. Indications for Use: [Separate Page]

510(k) Number: NA

Device Name: RapiCure 2000 ™ Curing and Whitening Light.

This device is intended for use:

1. As a source of illumination for curing dental restorative materials,
1. Assisting in the whitening process in a dental office.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Susan Punner

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

Regulation Number and Section

§ 872.6070 Ultraviolet activator for polymerization.

(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.