(111 days)
The Swiss Master Light® is a dental curing light that is designed for use in the photopolymerization of dental resins, activation of tooth whitening agents in bleaching procedures.
The Swiss Master Light® consists of a control unit with a handpiece connected to the Main Unit by a detachable handpiece cord. The handpiece contains the halogen light source and a light guide that directs light to the treatment area on the patient. The control unit provides power and cooling water to the handpiece and controls handpiece function.
Here's a breakdown of the acceptance criteria and study information for the Swiss Master Light® as derived from the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ability to cure resin within specified timeframe without causing thermal damage to tissue. | Performance testing confirmed that the halogen light technology used for the Swiss Master Light® is able to cure resin within the specified timeframe without causing thermal damage to the tissue. |
| Ability to activate tooth bleaching agents within specified timeframe without causing thermal damage to tissue. | Performance testing confirmed that the halogen light technology used for the Swiss Master Light® is able to activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue. |
| Substantial equivalence in intended use, technical specifications, and functional performance to predicate devices (Optilux 501 and Elipar® TriLight). | Concluded to be substantially equivalent based on similarities in intended use, technical specifications, and functional performance, with the primary difference being increased light intensity for faster procedures. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for the test set.
The data provenance is not explicitly stated as retrospective or prospective, nor is the country of origin mentioned for the specific performance testing. However, given that the sponsor is in Switzerland and the filing is with the US FDA, it's possible testing occurred in either region.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the performance testing.
4. Adjudication Method for the Test Set
The document does not provide any information on the adjudication method used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as described in the provided summary. This document focuses on the device's technical performance rather than reader interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is an electromechanical device, a dental curing light, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not conducted. The "performance testing" described refers to the physical output and effect of the light itself.
7. Type of Ground Truth Used
The ground truth for the performance testing appears to be based on objective measurements of material polymerization and thermal effects. For example, the ability to "cure resin" would be assessed by laboratory tests measuring the degree of polymerization (e.g., hardness, depth of cure) and "without causing thermal damage to tissue" would involve temperature measurements or biological assays.
8. Sample Size for the Training Set
This is an electromechanical device, not an AI algorithm, and therefore does not have a "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As this is not an AI algorithm, the concept of a training set and its associated ground truth is not applicable.
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OCT 2 7 2003
510(k) Summary for Swiss Master Light®
1. SPONSOR
EMS ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
Contact Person: Suzanne Fassio-Hardy Telephone: 022 994 47 00
Date Prepared: October 8, 2003
2. DEVICE NAME
| Proprietary Name: | Swiss Master Light® |
|---|---|
| Common/Usual Name: | dental curing light |
| Classification Name: | ultraviolet activator for polymerization |
3. PREDICATE DEVICES
4. INTENDED USE
The Swiss Master Light® is a dental curing light that is designed for use in the r photopolymerization of dental resins, activation of tooth whitening agents in bleaching procedures.
5. DEVICE DESCRIPTION
The Swiss Master Light® consists of a control unit with a handpiece connected to the Main Unit by a detachable handpiece cord. The handpiece contains the halogen light source and a light guide that directs light to the treatment area on the patient. The control unit provides power and cooling water to the handpiece and controls handpiece function.
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TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Both the proposed Swiss Master Light® and the predicate curing lights offer multiple curing programs for photopolymerization of dental resins and activation of bleaching materials. These programs differ in the intensity of the light delivered and the length of the light exposure.
The operational principles of the proposed and predicate devices are identical. The operator chooses the appropriate program and sets the treatment parameters, if necessary. The tip of the handpiece is oriented appropriately relative to the material being photopolymerized, or the tooth surface (for bleaching procedures), and the selected treatment is initiated.
The major difference between the proposed Swiss Master Light® and the predicate curing lights is the intensity of the light power delivered. The increased light intensity of the proposed Swiss Master Light® allows the resin curing and tooth whitening agent activation to be conducted in a much shorter timeframe. Performance testing has been conducted that confirms that the halogen light technology used for the Swiss Master Light® is able to cure resin and activate tooth bleaching agents within the specified timeframe without causing thermal damage to the tissue.
The similarities in intended use, technical specifications, and functional performance between the Swiss Master Light®, Optilux 501, and Elipar® TriLight curing lights leads to a conclusion of substantial equivalence between the proposed and predicate devices.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 27 2003
E.M.S. Electro Medical Systems SA C/O Cynthia J. M. Nolte, PhD., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K032099
Trade/Device Name: Swiss Master Light® Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: October 08, 2003 Received: October 10, 2003
Dear Dr. Nolte:
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 - Cynthia J. M. Nolte, PhD
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 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 (301) 594-4613. 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) you may obtain. 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,
r Chiu S. Lin, PhD 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): K032099
Device Name: Swiss Master Light®
Indications for Use:
The Swiss Master Light® is a dental curing light that is designed for use in the photopolymerization of dental resins, activation of tooth whitening agents in bleaching procedures.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Suser Pearson
(Division Sign-Off) y. General Hospital, (Division Sign-Off)
Division of Anesthesiology Infection Control, 510(k) Number
Prescription Use √ (Per 21 CFR 801.109) OR
Over-The-Counter Use ________
Electro Medical Systems SA 510(k) Swiss Master Light®
§ 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.