Oral Applications: A source of illumination for curing photo-activated dental restorative materials, adhesives, pit and fissure sealants and activating tooth whitening materials via a light emitting diode (LED).

Device Description

The Palmlight is a corded or cordless (battery operated) hand-held device. No filters are required to block out unnecessary rays. The light created by these diodes are specifically optimum for curing (430 to 500 nm). The Palmlight LED System is an instrument for use in the application of restorative compounds. sealants, and whitening compounds. The light is produced by a high intensity light emitting diode. With an adjustable light output of up to 500 Milliwatts. Therefore the applied for indications of use are warranted. Delivery devices (replacement tips) for the hand held probe are part of the package that allows the user to use the device with or without using direct current as rechargeable batteries are part of the handle.

AI/ML Overview

The provided document describes the Palmlight dental curing light, a device intended to polymerize dental materials. It largely focuses on establishing substantial equivalence to existing predicate devices rather than presenting detailed performance studies with acceptance criteria in the typical sense for a novel device.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is primarily about demonstrating substantial equivalence to predicate devices, the "acceptance criteria" are framed more in terms of matching the characteristics and performance of those predicates, especially concerning safety and fundamental functional parameters.

Acceptance Criteria	Reported Device Performance
(Implied) Light Spectrum: Optimized for curing.	"The light created by these diodes are specifically optimum for curing (430 to 500 nm)."
(Implied) Beam Integrity: Similar to predicate devices.	"share similar ... beam integrity."
(Implied) Delivery Power and Energy Type: Similar to predicate devices.	"Functional features such as delivery power and energy type are also similar to the aforementioned devices."
(Implied) Adjustable Light Output: Capability to vary output.	"With an adjustable light output of up to 500 Milliwatts." (Explicitly stated for the Palmlight) "The variable light output... is the same as the submitted device." (Comparing to Ultradent Palmlight predicate)
(Implied) Corded/Cordless Operation: Ability to operate with or without a power cord (rechargeable batteries).	"The Palmlight is a corded or cordless (battery operated) hand-held device." "The ability to use the device with or without power cord (rechargeable batteries) is the same as the submitted device." (Comparing to Ultradent Palmlight predicate)
(Implied) Safety Systems: Inclusion of control systems like interlocks.	"Control systems such as interlock devices, (safety systems) are constantly monitored for user intervention."
Regulatory Compliance: Adherence to specific FDA regulations.	"The Palmlight complies with the requirements of 21 CFR Sub Chapter J, as required by 21 CFR 1010.2" and "The Palmlight is designed to meet the electrical safety requirements of IEC 601-1."

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

None provided. The submission explicitly states: "Clinical Performance Data: None included with this submission." This indicates that no specific test set or clinical study was conducted to demonstrate device performance in terms of clinical outcomes or direct comparison. The reliance is on established equivalence.

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

Not applicable (N/A). As no clinical performance data was included, there was no test set requiring expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable (N/A). No test set, no adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not mention any MRMC study. The focus is on the device's characteristics and its equivalence to predicates, not on human reader performance with or without AI assistance.

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

Not applicable (N/A). This is a hardware device (a curing light), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

Since no original clinical performance data was provided, there was no ground truth explicitly established for this device's efficacy. The ground truth for its safety and effectiveness is implicitly tied to the established safety and effectiveness of the legally marketed predicate devices to which it claims substantial equivalence.

8. The Sample Size for the Training Set

Not applicable (N/A). This is a hardware device, not a machine learning model, so there is no "training set."

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

Not applicable (N/A). As there is no training set for a machine learning model, this question is not relevant.

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

The "study" presented is a demonstration of substantial equivalence rather than an independent clinical or laboratory performance study with novel acceptance criteria. The Palmlight is shown to meet its "acceptance criteria" by demonstrating that its design, technological characteristics, and intended uses are similar or identical to legally marketed predicate devices.

Key points of this "study" (i.e., the substantial equivalence argument):

Comparison to Predicates: The Palmlight is compared feature-by-feature to the Ultradent Palmlight and Jetlite 4000.
Similar Indications for Use: All devices are for polymerizing dental materials using light.
Similar Design Features: Light spectrum (430-500 nm), beam integrity, delivery power, energy type.
Similar Control Systems: Safety systems like interlock devices.
Identical Performance Characteristics: The Ultradent Palmlight is stated to be "identical in features and light output" to the submitted device, including variable light output and corded/cordless capability. The Jetlite 4000 also uses "similar transmission of light technology with similar light output."
Regulatory Compliance: The device complies with 21 CFR Sub Chapter J and IEC 601-1 for electrical safety.

The conclusion is that because the Palmlight is substantially equivalent to existing, legally marketed devices and raises no new safety or effectiveness issues, it is deemed to have met its requirements. No new clinical performance data was provided or deemed necessary for this 510(k) submission.

Summary

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K020057

AUG 2 7 2002

CAO GROUP 8685 South 7th West Sandy, Utah 84070 (801) 256-9282 (801) 256-9287 (fax) Tracv S. Best. Consultant for Regulatory Affairs Preparation Date: January 03, 2002

Summary of Safety and Effectiveness for the:

Palmlight 410-490 nm Trade Name: Common Name: Dental curing light Classification Name: Activator, Ultraviolet, for Polymerization

Legally Marketed Predicate Devices for Substantial Equivalence:

Ultradent Palmlight, Distributed by Ultradent Products, Inc.
Jetlite 4000, Manufactured by J. Morita USA, Inc.

Rationale for SE: The aforementioned devices and the accompanying delivery mechanisms share similar indications for use in oral application, similar design features including; light spectrum, and beam integrity. Control systems such as interlock devices, (safety systems) are constantly monitored for user intervention. Functional features such as delivery power and energy type are also similar to the aforementioned devices.

Description of Submitted Device:

Intended Uses of the Elite Family Lasers:

A dental device intended to polymerize dental pit and fissure sealants or restorative materials by transmission of light via a light emitting diode.

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Technological Characteristics and Substantial Equivalence:

The Ultradent Palmlight is identical in features and light output. The variable light output and the ability to use the device with or without power cord (rechargeable batteries) is the same as the submitted device. Both the submitted device and this predicate device are used in the curing of composites that are photoactivated including restorative and whitening materials.

The Jetlite 4000 uses similar transmission of light technology with similar light output by a blue Light Emitting Diode (LED). The indications for use are the same. This and the submitted device are used in dentistry for the photo-activation and curing of dental composites.

Performance Standards

The Palmlight complies with the requirements of 21 CFR Sub Chapter J, as required by 21 CFR 1010.2

Clinical Performance Data

None included with this submission.

Conclusion:

The Palmlight System is substantially equivalent to other existing oral systems in commercial distribution. The Palmlight is designed to meet the electrical safety requirements of IEC 601-1. The high intensity light emitting diode is operated by logic circuitry. Therefore, we believe that the Palmlight is substantially equivalent to its predicate devices cited above without raising any new safety and/or effectiveness issues.

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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 features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2002

Ms. Tracey S. Best Regulatory Consultant CAO Group, Incorporated 8685 South 7th West Sandy, Utah 84070

Re: K020057

Trade/Device Name: Palmlight Regulation Number: 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: May 30, 2002 Received: June 4, 2002

Dear Ms. Best:

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 - Ms. Best

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) 594-4618. 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,

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

Enclosure

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510(k) Number (if known):

Palmlight Device Name:

Indications For Use:

Oral Applications:

A source of illumination for curing photo-activated dental restorative materials, adhesives, pit and fissure sealants and activating tooth whitening materials via a light emitting diode (LED).

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Ruane

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number. K002005

Prescription Use
(Per 21 CFR 801.109)

OR Over-The-Counter Use __

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.