(258 days)
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultra consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter. Demi Ultra is required to be used with an FDA cleared barrier sleeve.
The provided text describes a 510(k) premarket notification for a dental light-curing device called Demi Ultra. The submission asserts substantial equivalence to a previously cleared predicate device, the Demi Ultra (K123468).
Here's an analysis of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that the device needs to meet. Instead, it lists performance tests that were conducted and compares the technological characteristics of the proposed device to a predicate device. The core argument for acceptance is substantial equivalence to the predicate device.
| Element (Performance Test/Characteristic) | Predicate Demi Ultra Performance/Characteristic | Proposed Demi Ultra Performance/Characteristic | Acceptance Criteria (Implicit) |
|---|---|---|---|
| Depth of Cure | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Performance comparable to predicate, meeting standards |
| Irradiance (Intensity & Peak Wavelength) | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Tested per ISO 10650:2015 & ANSI/ADA 48-2:2010 | Performance comparable to predicate, meeting standards |
| Charge Time | 35 seconds, 60 seconds | 40 seconds, 70 seconds | Functionally equivalent/acceptable to predicate (slight increase in charge time noted) |
| Run Time | 4 minutes | 4 minutes, 10 seconds | Functionally equivalent/acceptable to predicate (slight increase in run time noted) |
| Biocompatibility | Tested per ISO 10993 | Tested per ISO 10993 | Compliant with ISO 10993, comparable to predicate |
| Electromagnetic Compatibility (EMC) | Tested per IEC 60601 | Tested per IEC 60601 | Compliant with IEC 60601 |
| Electrical Safety | Tested per IEC 60601 | Tested per IEC 60601 | Compliant with IEC 60601 |
| Software Validation | Performed | Performed | Software functions as intended |
| Cleaning Validation | Performed on worst case conditions, following FDA guidance | Performed on worst case conditions, following FDA guidance | Cleaning efficacy validated per FDA guidance |
| Peak Wavelength | 450-470 nm | 450-470 nm | Matches predicate |
| Wavelength Range @ 50% | 438-485 nm | 438-485 nm | Matches predicate |
| Typical Output Intensity (8mm turbo light guide) | 1100mW/cm2 pulsed to 1330mW/cm2 | 1100mW/cm2 pulsed to 1330mW/cm2 | Matches predicate |
The document explicitly states: "The nonclinical performance testing demonstrates that the Demi Ultra performs as well as the predicate device Demi Ultra." This implies that the acceptance criteria for these tests were to demonstrate comparable performance to the predicate and compliance with relevant standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on specific sample sizes for the performance tests (e.g., number of cure samples for depth of cure, number of units for charge/run time). The data provenance is not explicitly stated beyond the fact that the tests were performed by Sybron Dental Specialties as part of their product lifecycle and design validation. It is implied to be prospective testing for the proposed device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The performance tests (e.g., depth of cure, irradiance) are objective measurements based on standards, not expert interpretation of data points.
4. Adjudication Method for the Test Set
This information is not provided. Given that the tests are objective physical measurements, a traditional adjudication method for subjective assessments would not be applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study typically assesses the impact of a device (often AI-driven) on human reader performance, which is not applicable to a dental light-curing device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone algorithm performance study was not done. The Demi Ultra is a physical medical device, not an AI/software algorithm, so this type of study is irrelevant.
7. The Type of Ground Truth Used
For the performance tests, the "ground truth" would be the physical measurements obtained from testing the device against established international and national standards (ISO 10650:2015, ANSI/ADA 48-2:2010, ISO 10993, IEC 60601). For instance, the "ground truth" for depth of cure would be the actual measured depth under standardized conditions.
8. The Sample Size for the Training Set
This information is not applicable. The Demi Ultra is a hardware device, not an AI/machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of device.
{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 caduceus symbol, which is a staff with two snakes entwined around it, overlaid on three human profiles facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 18, 2017
Kerr Corporation % Mohammad Ansari Regulatory Affairs Specialist II Sybron Dental Specialties 1717 W. Collins Ave Orange, California 92867
Re: K163064
Trade/Device Name: Demi Ultra Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: June 27, 2017 Received: June 28, 2017
Dear Mohammad Ansari:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Mary S. Runner -A for Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) (Not yet assigned) K163064
Device Name
Demi Ultra
Indications for Use (Describe)
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals.
| Type of Use (Select one or both, as applicable) | |
|---|---|
X | Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY FOR DEMI ULTRA
Image /page/3/Picture/2 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a bold, sans-serif font, with a curved line above the letters. Below the letters, the words 'Sybron Dental Specialties' are written in a smaller, sans-serif font.
Demi Ultra K163064
-
- Submitter Information: Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687
| Contact Person: | Mohammad Saad Ansari |
|---|---|
| Telephone Number: | 714-516-7334 |
| Fax Number: | 909-962-5694 |
| Date Prepared: | July 13, 2017 |
-
- Device Name:
| Classification Name | Ultraviolet activator for polymerization |
|---|---|
| Proprietary Name | Demi Ultra |
| FDA CDRH Panel | Dental |
| Product Code | EBZ |
| Regulation Number | 872.6070 |
| Class # | II |
-
- Predicate Device:
The proposed Demi Ultra is substantially equivalent to the legally marketed device Demi Ultra (K123468) cleared on March 20, 2013, product code EBZ.
- Predicate Device:
-
- Description of Device:
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. The Demi Ultra consists of a handpiece, LED light curing attachment, and charging dock. The aluminum and plastic molded handpiece contains two (2) ultracapacitors (electric double-layer capacitors), printed circuit boards containing the electronics and user interface buttons, receptacle for retaining the LED light curing attachment, and receptacle for interfacing with the charging dock. The LED light curing attachment contains the curing LED, clear lens and two (2) copper head spreaders, all over molded in plastic. The charging dock contains printed circuit boards containing electronics to support charging the handpiece and built-in LED radiometer functionality. For the handpiece, a digital circuit and microprocessor is utilized to control three (3) different curing modes (5, 10 and 20 seconds). Each mode specifies LED curing output and optional audible beep timing. The
- Description of Device:
{4}------------------------------------------------
handpiece uses one button to activate the LED curing output and another to select the curing time mode. For the charging dock, a digital circuit and microprocessor is utilized to monitor the charging of the handpiece ultracapacitors, as well as respond to light at the radiometer input by illuminating lights on a radiometer meter. Demi Ultra is required to be used with an FDA cleared barrier sleeve.
-
న. Statement of Intended Use:
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. -
Indications For Use 6.
The Demi Ultra is a Light Emitting Diode (LED) visible light curing device used for the polymerization of light-cured materials by dental professionals. -
- Summary of Non-Clinical Performance Data:
The technological characteristics of Demi Ultra are identical to the predicate Demi Ultra (K123468). The following performance tests were completed during the product lifecycle:
- Summary of Non-Clinical Performance Data:
Depth of Cure Irradiance with Light Intensity and Peak Wavelength per ISO 10650:2015 and ANSI/ADA 48-2:2010 Charge Time and Run Time Biocompatibility per ISO 10993 Electromagnetic Compatibility (EMC) and Electrical Safety Testing per IEC 60601 Software Validation
A cleaning validation study on manual cleaning efficacy was performed on the worst case use conditions following the FDA Guidance: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
| Element | PredicateDemi Ultra | ProposedDemi Ultra |
|---|---|---|
| 510(k) number | K123468 | K163064 |
| Trade Name | Demi Ultra | Demi Ultra |
| Product Classification | Class 2 | Class 2 |
| Product Code | EBZ | EBZ |
| Cordless | Yes | Yes |
| Light Source | LED | LED |
| Handpiece power source | 2 Ultracapacitors | 2 Ultracapacitors |
| AC supply connection | 100-240V AC, 1.0-0.5A, 50-60 Hz | 100-240V AC, 1.0-0.5A, 50-60 Hz |
| Operating time | 4 minutes | 4 minutes, 10 seconds |
| Recharge Time | 35 seconds, 60 seconds | 40 seconds, 70 seconds |
| Built-in radiometer | Yes | Yes |
| Microprocessor control | Yes (8-bit uc) | Yes (8-bit uc) |
-
- Summary of Technological Characteristics:
{5}------------------------------------------------
| 3 | ||
|---|---|---|
| Element | PredicateDemi Ultra | ProposedDemi Ultra |
| Power status indicator | Yes | Yes |
| Standard light guide | 8mm tapered | 8mm tapered |
| Reusable light guide | Yes | Yes |
| User replaceablepower source | No | No |
| Handpiece digitaldisplay | No (LED indicators) | No (LED indicators) |
| User selectable(operational) curingmodes | (5, 10 & 20 seconds) | (5, 10 & 20 seconds) |
| Cooling fan | No | No |
| Audible beep | Yes | Yes |
| Continuous curing | Yes | Yes |
| Handpiece Material | Valox 357U | Valox 357U |
| Charging BaseMaterial | Valox 357U | Valox 357U |
| LED LightAttachment (LLA) | HX215HP | HX420HP |
| Light Shield | Lexan 243R or Lexan 143 | Sumitomo SD2173M |
| Peak wavelength | 450-470 nm | 450-470 nm |
| Wavelength range @50% (spectrum) | 438-485 nm | 438-485 nm |
| Typical outputintensity: 400-500nm, using 8mm turbolight guide | 1100mW/cm2 pulsed to1330mW/cm2 | 1100mW/cm2 pulsed to 1330mW/cm2 |
9. Clinical Performance Data
Design Validation activities were performed as required per 21CFR820.30
10. Conclusion as to Substantial Equivalence
The modifications made to Demi Ultra do not affect the intended use of the device, indications for use, or alter the fundamental scientific technology of the device. The technological characteristics of the subject device Demi Ultra are very similar to the predicate Demi Ultra (K123468). The proposed Demi Ultra has similarities in select performance characteristics and all design features as compared to the predicate. The nonclinical performance testing demonstrates that the Demi Ultra performs as well as the predicate device Demi Ultra. Demi Ultra is indicated to be used with a FDA cleared barrier sleeve. Based on biocompatibility studies, identical intended use and indications for use, and performance characteristics, the Demi Ultra is substantially equivalent to the predicate Demi Ultra (K123468).
§ 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.