(65 days)
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No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The intended use describes a photochemical reaction, which is a physical process.
No.
The system is used to activate a photochemical polymerization reaction in dental materials, which describes a function within a therapeutic procedure rather than a direct therapeutic effect on the patient's condition.
No
The device is described as activating a photochemical polymerization reaction in light cure dental materials, which is a treatment function, not a diagnostic one.
No
The intended use describes activating a photochemical polymerization reaction, which strongly implies a hardware component (a light source) is involved, not just software.
Based on the provided information, the 3M™ Aurora System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "activate a photochemical polymerization reaction in light cure dental materials." This describes a process applied to materials outside of the human body, specifically dental materials.
- Lack of IVD Characteristics: IVDs are devices intended for use in the examination of specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or screening purposes. The provided information does not mention any interaction with human specimens or diagnostic purposes.
Therefore, the 3M™ Aurora System, as described, is a device used in a dental setting for processing dental materials, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The 3M™ Aurora System is indicated to activate a photochemical polymerization reaction in light cure dental materials.
Product codes
EBZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, positioned to the right of a circular text element. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" and is arranged around the circle's perimeter. The eagle is depicted in a simple, bold line style.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa A. Weik Requlatory Affairs 3M Company Dental Products 3M Center, Building 260-2B-09 St. Paul, Minnesota 55144-1000
AUG 2 9 1997
Re : K972355 3M Aurora System Trade Name: Requlatory Class: II Product Code: EBZ Dated: June 25, 1997 Received: June 25, 1997
Dear Ms. Weik:
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 The general controls provisions of the Act 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Ms. Weik
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
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) 594-4618. 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" (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
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
·
972355 510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: 3M™ Aurora System _______________________________________________________________________________________________________________________________________________
Indications For Use:
The 3M™ Aurora System is indicated to activate a photochemical polymerization
reaction in light cure dental materials.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | KA7235 |
|---|---|
| --------------- | -------- |
| Prescription Use
| (Per 21CFR 801.109) | |
|---|---|
| ----------------------------------------- | -- |
OR
| Over-the Counter Use | |
|---|---|
| ---------------------- | -- |