MINI LED AUTOFOCUS by SATELEC | FDA 510(k) Summary

photo-polymerization in the 420-480 nm waveband of visible light cured A (VLC) dental materials
A photo-polymerization in the 420-480 nm waveband of visible light cured (VLC) restorative composite materials, and
photo-polymerization in the 420-480 nm waveband of visible light cured A (VLC) orthodontic brackets, and orthodontic bonding and sealing materials

Device Description

The Satelec Mini LED AutoFocus is intended to be used by qualified dental practitioners as an ultraviolet activator for polymerizations intended for photopolymerization in the 420-480 nm waveband of visible light cured (VLC):

. dental materials
restorative composite materials, .
orthodontic brackets, and orthodontic bonding and sealing materials t
The Mini LED AutoFocus is available in two versions, a table top and an OEM (built-in). The table top uses a battery to power the handpiece and a base station for recharging the battery and storage of the handpiece and battery when not in use.
The OEM version is intended to be built into a chair or cart. A cord connects the handpiece to a power module which is built into the chair. When not in use, the handpiece is placed in a handpiece holder on the chair or cart.
The table top version consists of the following items:
The Mini LED AutoFocus handpiece with its protective lid, incorporating the Light Emitting Diode and the backlit LCD screen
The base station for recharging the device incorporating a wattmeter
The mains adapter
The Lithium Ion battery
The sterilizable light guide and the control tip
The protective light shield
The user's manual and accompanying documentation.
The OEM version consists of the following items:
The Mini LED AutoFocus handpiece with its protective lid, incorporating the Light Emitting Diode and the backlit LCD screen
Power module
Handpiece cord (allows connection of handpiece to power module)
The sterilizable light guide and the control tip
The protective light shield
The user's manual and accompanying documentation.

AI/ML Overview

The provided text is a 510(k) summary for the Satelec Mini LED AutoFocus, specifically a notification of intent to market a device based on substantial equivalence to a predicate device. It is a regulatory document and does not describe a study involving acceptance criteria, device performance, or human readers as would be typical for an AI/ML device.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth cannot be extracted from this document as it pertains to clinical performance studies, which are not detailed here for this type of device submission.

Here's what can be extracted based on the provided text, and where gaps exist:

1. A table of acceptance criteria and the reported device performance
This document does not contain specific acceptance criteria or reported device performance data in the context of a clinical study or benchmark performance testing with metrics like sensitivity, specificity, or AUC. The submission is based on substantial equivalence to a predicate device, meaning it asserts that the new device performs similarly to or better than the predicate without introducing new questions of safety or effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document does not describe a test set or data provenance for a clinical or performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This document does not describe the establishment of a ground truth for a test set by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This document does not mention an adjudication method for a test set.

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. This document does not describe an MRMC study or any AI component. The device is an "ultraviolet activator for polymerization," not an AI/ML diagnostic or assistive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. There is no mention of a ground truth in the context of performance evaluation for this device. The "ground truth" for this submission is implicitly the performance and safety established for the predicate device.

8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not an AI/ML device.

9. How the ground truth for the training set was established
Not applicable. There is no mention of a training set or its ground truth.

Summary based on the provided document:

The Satelec Mini LED AutoFocus is an ultraviolet activator for polymerization, a dental device used for curing dental materials. The submission to the FDA is a 510(k) premarket notification asserting substantial equivalence to a predicate device (Satelec Mini LED and Smartlite Mini, K032465) that was previously cleared.

The core argument for acceptance is the substantial equivalence to the predicate device. The document states:

"The Satelec Mini LED AutoFocus is substantially equivalent to the predicate device by Satelec, Mini LED and Smartlite Mini (K032465) previously cleared by the FDA and currently marketed."
"Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the Min LED AutoFocus."

Therefore, the "study" proving the device meets the "acceptance criteria" is essentially the comparison to the legally marketed predicate device, demonstrating that its intended use, technological characteristics, and performance are substantially similar to the predicate, such that it raises no new questions of safety or effectiveness. The FDA's clearance letter confirms this finding of substantial equivalence.

This type of submission does not typically involve the extensive clinical trials or performance metrics (like sensitivity/specificity) common for AI/ML devices or novel high-risk medical devices. Instead, safety and effectiveness are established by showing the new device is as safe and effective as a device already on the market.

Summary

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K07218/

12. SMDA Summary of Safety and Effectiveness - "510(k) Summary"

A. Submitter Information
SATELEC
Z.I. du Phare, BP 30216
17, Avenue Gustave Eiffel
33708 Merignac Cedex
FRANCE
Telephone: 011 33 556 34 0607
Fax: 011 33 556 34 9292

SEP 19 2007

Contact Person:	Steve Salesky
	SATELEC
	c/o Acteon, Inc.
	124 Gaither Drive, Suite 140
	Mt. Laurel, NJ 08054
	Telephone: 800 289-6367 Ext. 40
	Fax: 856 222-4726
	E-mail: steve.salesky@us.acteongroup.com
Date Prepared:	August 3, 2007

B. Device Identification
Common Usual Name:	Ultraviolet activator for polymerization
Proprietary Name:	Mini LED AutoFocus

C. Identification of Predicate Device

Device	Applicant	510(k) No.	Date Cleared
Mini LED andSmartlite Mini	Satelec	K032465	Oct. 21, 2003

The Satelec Mini LED AutoFocus is substantially equivalent to the predicate device by Satelec, Mini LED and Smartlite Mini (K032465) previously cleared by the FDA and currently marketed.

D. Device Description and Intended Use

. dental materials
restorative composite materials, .
orthodontic brackets, and orthodontic bonding and sealing materials t

The Mini LED AutoFocus is available in two versions, a table top and an OEM (built-in). The table top uses a battery to power the handpiece and a base station

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for recharging the battery and storage of the handpiece and battery when not in use.

The OEM version is intended to be built into a chair or cart. A cord connects the handpiece to a power module which is built into the chair. When not in use, the handpiece is placed in a handpiece holder on the chair or cart.

The table top version consists of the following items:

The Mini LED AutoFocus handpiece with its protective lid, incorporating the Light Emitting Diode and the backlit LCD screen

The base station for recharging the device incorporating a wattmeter
The mains adapter
The Lithium Ion battery
The sterilizable light guide and the control tip
The protective light shield
The user's manual and accompanying documentation.

The OEM version consists of the following items:

The Mini LED AutoFocus handpiece with its protective lid, incorporating the Light Emitting Diode and the backlit LCD screen

Power module

Handpiece cord (allows connection of handpiece to power module)

The sterilizable light guide and the control tip

The protective light shield
The user's manual and accompanying documentation.

E. Substantial Equivalence

Both the Satelec Mini LED AutoFocus and the predicate device, the Satelec Mini LED and Smartlite Mini, are intended to be used by qualified dental practitioners as ultraviolet activators for polymerizations intended for photo-polymerization of visible light cured (VLC) dental materials, restorative composite materials, orthodontic brackets, and orthodontic bonding and sealing materials.

Differences that exist between the devices relating to technical specifications, performances, and intended use are minor and do not affect the safety and effectiveness of the Min LED AutoFocus.

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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SATELEC C/O Mr. Steve Salesky Quality Manager ACTEON. Incorporated 124 Gaither Drive, Suite 140 Mount Laurel, New Jersey 08054

SEP 1 9 2007

Re: K072181 Trade/Device Name: Mini LED AutoFocus Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: August 3, 2007 Received: August 6, 2007

Dear Mr. Salesky:

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.

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Page 2- Mr. Salesky

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 (OS) 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), 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/industry/support/index.html.

Sincerely yours,

Safette y. Michaud.

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

Enclosure

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Indications for Use

510(k) Number:

1107218

Device Name:

Mini LED AutoFocus

Indications for Use:

The Satelec Mini LED AutoFocus is intended to be used by qualified dental practitioners as an ultraviolet activator for polymerization for:

photo-polymerization in the 420-480 nm waveband of visible light cured A (VLC) dental materials
A photo-polymerization in the 420-480 nm waveband of visible light cured (VLC) restorative composite materials, and
photo-polymerization in the 420-480 nm waveband of visible light cured A (VLC) orthodontic brackets, and orthodontic bonding and sealing materials

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rung

n Sign-Off ion of Anestheriology. General Hospital

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.