(71 days)
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials,
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.
The Satelec Mini L.E.D. product is classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070) because it is a device intended for the photopolymerization of light cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. The Mini L.E.D. is a universal photopolymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490 nm waveband of the spectrum with a power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-quide).
This Satelec Mini L.E.D. Polymerization Light-Curing Device 510(k) submission (K032465) focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study with a defined test set, ground truth, and expert adjudication.
Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not explicitly available or applicable in the provided 510(k) summary. The submission primarily relies on comparing the device's characteristics and intended use to already cleared devices.
Here's an attempt to answer the questions based on the provided text, indicating where information is not present:
1. A table of acceptance criteria and the reported device performance
The 510(k) summary does not present a formal table of acceptance criteria with corresponding device performance metrics in the way a clinical study or performance verification test would. Instead, the "performance" is implicitly demonstrated through the device's specifications and comparison to predicate devices, particularly regarding its ability to achieve sufficient power density within the stated wavelength band for polymerization.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Produces visible blue light in the 430 to 490 nm waveband. | Produces visible blue light in the 430 to 490 nm waveband of the spectrum. |
| Power density sufficient for intended uses. | Power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-guide). These power densities are sufficient for the Mini L.E.D. product intended uses. |
| Capable of photo-polymerization of VLC dental materials. | Intended for photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials. Shared intended use with predicate devices implies capability. |
| Capable of photo-polymerization of VLC restorative composite materials. | Intended for photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials. Shared intended use with predicate devices implies capability. |
| Capable of photo-polymerization of VLC orthodontic materials. | Intended for photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials. Shared intended use with predicate devices implies capability. |
| Substantially equivalent to predicate devices for safety and effectiveness. | The Mini L.E.D. has nearly identical characteristics and intended uses as the Satelec ACTA (K961735), 3M ESPE Epilar Freelight (K011154), and GC America GC E-Light (K012134). Predicates are "well established and determined to be safe and effective." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The submission does not describe a clinical or performance test set. The submission relies on technical specifications and comparison to predicate devices rather than new performance data from a "test set."
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)
This information is not provided as there is no described test set or ground truth established by experts within the context of a performance study in the 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no described test set or adjudication process in the 510(k) summary.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as this is a dental polymerization light-curing device. This type of study is more relevant for diagnostic AI devices where human reader performance is being evaluated with and without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A "standalone" performance study in the context of an algorithm or AI is not applicable here. This device is a physical light-curing tool. Its performance is inherent to its physical properties (wavelength, power density) and its ability to cure dental materials, not an "algorithm only" performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically defined for diagnostic or AI-driven devices is not directly applicable here. The "truth" for this device's function is its physical specifications (power density, wavelength output) and its ability to effectively polymerize various dental materials. This is assessed through physical measurements and material science principles, not expert consensus or pathology on a clinical dataset. The implicit "ground truth" for showing effectiveness is the established ability of the predicate devices to cure materials effectively.
8. The sample size for the training set
This information is not provided and is not applicable to this type of device. The device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This information is not provided and is not applicable to this type of device. There is no training set mentioned in the context of this 510(k) submission.
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OCT 2 1 2003
- SMDA Summary of Safety and Effectiveness "510(k) Summary" ல்
- A. Submittor Information
SATELEC Z.I. due Phare, BP 215 17 Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE 011-33-56-34-06-07 Telephone: Pascal Dupeyron Contact Person: Requlatory Affairs August 8, 2003 Date Prepared:
B. Device Identification
| Common/Usual Name: | Polymerization Light-Curing Device |
|---|---|
| Classification Name: | Ultraviolet Activator for Polymerization |
| Proprietary Name: | Mini L.E.D. |
| Model: Mini L.E.D. | |
| Model: Smartlite Mini |
C. Identification of Predicate Device(s)
The Mini L.E.D. is substantially equivalent to the following previously cleared and currently marketing devices:
Satelec ACTA (K961735) 3M ESPE Epilar Freelight (K011154) GC America GC E-Light (K012134) i
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D. Device Description and Intended Use
The Satelec Mini L.E.D. product is classified as an Ultraviolet Activator for Polymerization (21 C.F.R.§ 872.6070) because it is a device intended for the photopolymerization of light cured dental materials, restorative composite materials, and orthodontic bonding and sealing materials. The Mini L.E.D. is a universal photopolymerization light curing source working in cordless conditions and producing visible blue light in the 430 to 490 nm waveband of the spectrum with a power density comprised between 1,000 W/cm² (Universal 7.5 mm light-guide) and 2,000 W/cm² (BoosterTip 5.5 mm light-quide). These power densities are sufficient for the Mini L.E.D. product intended uses, namely: -
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental A materials,
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ア photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
-
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.
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E. Substantial Equivalence
The Satelec Mini L.E.D. product has nearly identical characteristics and intended uses as the 510(k) cleared light curing units, the Satelec ACTA (K961735), the 3M ESPE Epilar Freelight (K011154) and the GC America GC E-Light (K012134) for the photo-polymerization of dental materials, restorative composite materials, and polymerization of bonding and sealing materials. These devices are well established and determined to be safe and effective.
Image /page/0/Picture/17 description: The image shows a sequence of numbers, specifically "000026". The numbers are printed in a clear, sans-serif font, and they appear to be part of a larger document or label. The numbers are evenly spaced and aligned horizontally.
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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2003
SATELEC C/O Ms. Jaqueline E. Masse Senior Consultant Interactive Consulting 70 Walnut Street Wellesley, Massachusetts 02481
Re: K032465
Trade/Device Name(s): Mini LED and Smartlite Mini Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: August 08, 2003 Received: August 16, 2003
Dear Ms. Masse:
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 - Jaqueline E. Masse
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.
Patricia Lucente/foe
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
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510(k) Number (if known):
Device Name:
Satelec Mini L.E.D. Polymerization Light-Curing Device Model: Mini L.E.D. Model: Smartlite Mini
Indications For Use:
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photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) dental materials,
-
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) restorative composite materials, and
-
photo-polymerization in the 430-490 nm waveband of visible light cured (VLC) orthodontic brackets, and orthodontic bonding and sealing materials.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) (Division Sign-Oll)
Division of Anesthesiology, General Hospital,
Division of Anesthesiology, General.
Infection Control, Dental Devices
ICO 32468
510(k) Number:
OR
Prescription Use (Per 21 CFR 801.109) Over-The-Counter Use
(Optional Format 1-2-96)
§ 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.