(162 days)
The product is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment.
Both the predicate and the new proposed devices are operated by connecting to a standard turbine connection of a dental unit, which supplies air and water. The device is activated when the dental unit is activated and compressed air and water are supplied to the device. Air enters into the powder chamber where it is mixed with the prophylaxis powder. The mixture of air and water leaves the powder chamber and exits the distal end of the device through the spraying nozzle where the mixture of air and water is enveloped by water spray and directed onto the tooth surface. The mixture of air, water and powder removes dental plaque, stain and discoloration from tooth surface.
Acceptance Criteria and Device Performance for QUICK JET M (K133170)
This document describes the acceptance criteria and supporting study for the QUICK JET M dental handpiece, as detailed in the 510(k) summary K133170.
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for QUICK JET M (K133170) does not explicitly define quantitative acceptance criteria or specific performance metrics for the device. Instead, the submission relies on a comparison to a predicate device, the AIR-FLOW handy 2 (K022119), through the demonstration of substantial equivalence.
The "Comparison result" table in the submission highlights similarities between the proposed device and the predicate device across various technological characteristics. This indicates that the "acceptance criteria" were implicitly met by demonstrating that the QUICK JET M performs equivalently to the legally marketed predicate device, especially for its intended use.
Here's an interpretation of the implied acceptance criteria and the device's reported performance based on the provided document:
| Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Intended Use: Device effectively removes dental plaque, stain, and discoloration from tooth surfaces. | "Similar" to predicate device. The device's description states it "removes dental plaque, stain and discoloration from tooth surface." |
| Indication for Use: Treatment by dental professionals. | "Identical" to predicate device. |
| Target Population: Patients requiring dental plaque, stain, and discoloration removal. | "Identical" to predicate device. |
| Anatomical Safety: Safe for use in the oral cavity. | "Identical" to predicate device. |
| Energy Used/Delivered: Employs compressed air and water for powder delivery. | "Identical" to predicate device. Device operates by connecting to a standard turbine connection of a dental unit, supplying air and water. |
| Human Factors: Ergonomically suitable for dental professional use. | "Identical" to predicate device. |
| Design: Overall functional design. | "Similar" to predicate device. Both are operated by connecting to a standard turbine connection and mix air, water, and prophylaxis powder. |
| Performance: Effectively cleans tooth surfaces. | "Similar" to predicate device. Implied by similar intended use and design. |
| Material Biocompatibility: Materials used are biocompatible for oral contact. | "Unknown" due to lack of specific testing, but similarity to predicate suggests no new biocompatibility issues. |
| Compatibility with Environment & Other Devices: Compatible with standard dental unit connections. | "Identical" to predicate device. Connects to standard turbine connection. |
| Sterility: Able to be sterilized or single-use. | "Similar" to predicate device; implies capable of meeting sterility requirements. |
| Mechanical Safety: Safe mechanical operation. | "Identical" to predicate device. |
| Chemical Safety: Safe use of prophylaxis powder and mixture. | "Similar" to predicate device; implies safe handling of relevant chemicals. |
| Compliance with Applicable Standards: Meets relevant international standards. | "The proposed device was designed and tested according to the applicable international standards and specifications developed by the manufacturer." (Specific standards not listed). |
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary explicitly states: "No clinical tests were performed for the proposed device." Therefore, there was no "test set" in the context of clinical data used to prove device performance. The assessment of substantial equivalence was based on non-clinical testing and comparison of technological characteristics to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
As no clinical testing was performed and no test set was used, there were no experts involved in establishing ground truth for a clinical test set.
4. Adjudication Method for the Test Set
Since no clinical test set was used, there was no adjudication method employed.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. The 510(k) summary clearly states that no clinical tests were performed, which would include MRMC studies.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a dental handpiece, a mechanical tool, not an algorithm or AI system. Therefore, the concept of a "standalone" or "algorithm only" performance study is not applicable to this device.
7. The Type of Ground Truth Used
As no clinical tests were performed, no clinical ground truth (e.g., expert consensus, pathology, outcomes data) was established or used for the QUICK JET M in this 510(k) submission. The "ground truth" for demonstrating substantial equivalence was effectively the established performance and safety profile of the predicate device, AIR-FLOW handy 2 (K022119), as assessed through non-clinical comparisons of technological characteristics.
8. The Sample Size for the Training Set
The device is a mechanical dental handpiece, not a machine learning or AI algorithm. Therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
As the concept of a training set is not applicable to this device, there was no ground truth established for a training set.
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K 133170
Micron Corporation, 510(k) Summary
5.510(k) Summary
5.1 SPONSOR / SUBMITTER
a. Company name: MICRON Corporation
- b. Address: 1-34-14, Higashiyukigaya, Ota-ku, Tokyo, 145-0065, Japan
- c. Contact person: Takashi Terui (Mr.)
- d. Phone number: +81-3-3755-0396
- f. Fax number: +81-3-5747-5396
- g. E-mail address: office@micdent.com
Date Prepared
11/08/2013
- 510(k) Number: K133170
5.2 DEVICE NAME
Trade/Proprietary Name:
QUICK JET M
Device Classification / Classification Panel
- a. Common / Usual Name: Dental Handpiece
- b. Classification Name: Dental Handpiece and Accessories
- c. Regulation Number: 21 CFR 872.4200
- d. Regulatory Class: I
- e. Product Code: EFB
5.3 PREDICATE DEVICE
| Name of the Manufactureror Specification developer | Product name | 510(k) Number | ClassificationProduct Code | Classification Name |
|---|---|---|---|---|
| E.M.S. Electro MedicalSystems S.A. | AIR-FLOW handy 2 | K022119 | EFB | Dental handpieceand Accessories |
5.4 DEVICE DESCRIPTION AND INTENDED USE
Device Description
Both the predicate and the new proposed devices are operated by connecting to a standard turbine
connection of a dental unit, which supplies air and water. The device is activated when the
dental unit is activated and compressed air and water are supplied to the device.
Air enters into the powder chamber where it is mixed with the prophylaxis powder.
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Micron Corporation, 510(k) Summary
The mixture of air and water leaves the powder chamber and exits the distal end of the device through the spraying nozzle where the mixture of air and water is enveloped by water spray and directed onto the tooth surface. The mixture of air, water and powder removes dental plaque, stain and discoloration from tooth surface.
Intended Use
The proposed device is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment
| Technological Characteristics of Handpiece | Comparison result |
|---|---|
| AIR-FLOW handy 2 | |
| intended use | Slimilar |
| Indication for use | Identical |
| Target population | Identical |
| Anatomical safety | Identical |
| Where used(hospital, home, ambulance, etc) | Identical |
| Engery used and/or delivered | Identical |
| Human factors | Identical |
| Design | Slimilar |
| Performance | Slimilar |
| Standards met | Unknown |
| Materials | Slimilar |
| Biocompatibility | Unknown |
| Compatibility with environment and other devices | Identical |
| Sterility | Slimilar |
| Electrical safety | N/A |
| Mechanical safety | Identical |
| Chemical safety | Slimilar |
| Thermal safety | N/A |
| Radiation safety | N/A |
5.5 SUBSTANTIAL EQUIVALENCE
5.6 SUMMARY OF NON-CLINICAL TESTING
The proposed device was designed and tested according to the applicable international standards and specifications developed by the manufacturer.
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Micron Corporation, 510(k) Summary
5.7 SUMMARY OF CLINICAL TESTING
No clinical tests were performed for the proposed device device.
5.8 CONCLUSION
The information above demonstrates that the proposed device is substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure with outstretched arms, representing care and protection, overlaid with a stylized caduceus, a symbol of medicine and health.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2014
MICRON Corporation Mr. Takashi Terui 1-34-14, Higashiyukigaya OTA-Ku, Tokyo 145-0065 Japan
Re: K133170
Trade/Device Name: Quick Jet M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: December 26, 2013 Received: January 2, 2014
Dear Mr. Terui:
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.
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Page 2 - Mr. Terui:
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 device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Salcty/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Mary S. Runner -S
Erin 1. Keith. M.S. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): Not Assigned
Device Name: Quick Jet M
Indications for Use:
. 1
The product is intended to remove dental plaque, stain, and discoloration from tooth surface etc. by dental professionals during dental treatment..
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
4-1
Sheena A. Green-S
2014.03.28 13:03:22 -04'00'
Page 1 of 1
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.