(49 days)
The Deep Blue® is a dental curing light that is intended for use in dental procedures requiring the photopolymerization of materials.
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.
The provided text is a 510(k) summary for the E.M.S. ELECTRO MEDICAL SYSTEMS SA Deep Blue® dental curing light. While it describes the device, its intended use, and substantial equivalence to predicate devices, it does not contain the specific details required to answer your questions about acceptance criteria and a study proving those criteria are met.
Here's why and what information is missing:
- Acceptance Criteria Table: The document mentions "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." However, it does not provide a specific table of acceptance criteria (e.g., light intensity thresholds, curing depths, temperature limits) or the reported performance against those criteria in a quantitative manner.
- Study Details: The document states that "Performance testing has been conducted," but it does not describe the study itself. Therefore, it lacks information on:
- Sample size for the test set.
- Data provenance (country, retrospective/prospective).
- Number and qualifications of experts.
- Adjudication method.
- MRMC comparative effectiveness study (effect size).
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Conclusion:
Based only on the provided text, I cannot complete the table or answer the detailed questions you've posed. The document confirms that performance testing occurred and demonstrated the device's ability to cure resin without thermal damage, which served as a basis for substantial equivalence, but it does not elaborate on the specifics of that testing or the defined acceptance criteria.
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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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Page 1 of 1
§ 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.