(49 days)
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No
The description focuses on basic electronic components and power sources, with no mention of AI/ML terms or functionalities.
No
A therapeutic device is one that treats a disease or condition. This device is a dental curing light used for photopolymerization of materials, which is a functional process rather than a therapeutic one.
No
Explanation: The device is a dental curing light, which is used for the photopolymerization of materials, not for diagnosing conditions or diseases.
No
The device description explicitly details hardware components such as a handpiece, LED light source, microprocessor control system, and light guide.
Based on the provided information, the Deep Blue® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for use in dental procedures requiring the photopolymerization of materials." This describes a therapeutic or procedural function performed directly on a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a device that emits light to cure dental materials within the patient's mouth. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The Deep Blue® is a dental device used for a specific treatment procedure (curing dental materials), not for diagnosing a condition.
N/A
Intended Use / Indications for Use
The Deep Blue® is a dental curing light that is intended for use in dental procedures requiring the photopolymerization of materials.
Product codes
EBZ
Device Description
The Deep Blue® consists of a detachable handpiece that contains the LED (light emitting diode) light source, microprocessor control system, a light guide that directs light to the treatment area on the patient, and a connector for connection of the device to a power source. Two versions of the device will be marketed in the U.S., the Doris I and Doris II. The Doris I and Doris II configurations differ in the power source. The Doris I configuration is powered by a connection to a commercially available EMS Electro Medical Systems ultrasonic scaler. The Doris II configuration is powered by an electrical connection to a dental operative unit. The function of the connected ultrasonic scaler or the dental operative unit is limited to providing power to the handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing has been conducted that confirms that the Deep Blue" is able to cure resin within the specified timeframe without causing thermal damage to the tissue.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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510(k) Summary for the E.M.S. ELECTRO MEDICAL SYSTEMS SA Deep Blue®
1. SPONSOR
EMS ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
AUG 1 0 2007
| Contact Person: | Sandra Baumgartner |
|---|---|
| Telephone: | 022 994 47 00 |
Date Prepared: June 22, 2007
2. DEVICE NAME
| Proprietary Name: | Deep Blue® |
|---|---|
| Common/Usual Name: | dental curing light |
| Classification Name: | ultraviolet activator for polymerization |
3. PREDICATE DEVICES
4. INTENDED USE
The Deep Blue® is a dental curing light that is intended for use in dental procedures requiring the photopolymerization of materials.
DEVICE DESCRIPTION 5.
The Deep Blue® consists of a detachable handpiece that contains the LED (light emitting diode) light source, microprocessor control system, a light guide that directs light to the treatment area on the patient, and a connector for connection of the device to a power source. Two versions of the device will be marketed in the U.S., the Doris I and Doris II. The Doris I and Doris II configurations differ in the power source. The
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Doris I configuration is powered by a connection to a commercially available EMS Electro Medical Systems ultrasonic scaler. The Doris II configuration is powered by an electrical connection to a dental operative unit. The function of the connected ultrasonic scaler or the dental operative unit is limited to providing power to the handpiece.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
Both the proposed Deep Blue® and the predicate curing lights are designed for the photopolymerization of dental resins (see table on following page). The operational principles of the proposed and predicate devices are identical. The light source is an LED in a handpiece with a light guide inserted. The operator orients the tip of the light guide relative to the material being photopolymerized and activates the curing light using the foot switch to initiate a treatment session.
Differences between the proposed Deep Blue® and the predicate curing lights are limited to design differences, light output power, and available operational modes, Performance testing has been conducted that confirms that the Deep Blue" is able to cure resin within the specified timeframe without causing thermal damage to the tissue.
The similarities in intended use, technical specifications, and functional performance between the Deep Blue®, Mini LED, and LED Turbo PEN curing lights leads to a conclusion of substantial equivalence between the proposed and predicate devices.
June 22, 2007
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
E.M.S. Electro Medical Systems SA C/O Cynthia J. M. Nolte, Ph.D., RAC Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
AUG 1 0 2007
Re: K071722 Trade/Device Name: Deep Blue® Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: June 22, 2007 Received: June 22, 2007
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 - Dr. Nolte
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 (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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours,
Chris Rice, D.D.S.
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
14071722 510(k) Number (if known):
Device Name: Deep Blue®
Indications for Use:
The Deep Blue® is a dental curing light that is intended for use in dental procedures requiring the photopolymerization of materials.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Reaver
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K071722
June 22, 2007
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