(191 days)
No reference devices were used in this submission.
No
The device description focuses on mechanical vibration powered by compressed air and water, with no mention of AI or ML capabilities.
No.
The device is used for removal of plaque and calculus and general cleaning, which are not considered therapeutic interventions in this context.
No
The device is intended for the removal of plaque and calculus and for cleaning in periodontics, endodontics, and prosthetics, which are therapeutic and maintenance functions, not diagnostic ones.
No
The device description clearly outlines physical components like a handpiece, connection to a hose, working tips, and accessories, which are hardware. It also describes a mechanism of action involving compressed air and mechanical vibration.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The described device is used directly on the patient's teeth and gums to physically remove plaque and calculus and for cleaning. It is a mechanical device that operates within the patient's mouth.
- Intended Use: The intended use is for dental procedures performed in vivo (within the living body).
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics. It is a dental device used for direct treatment within the oral cavity.
N/A
Intended Use / Indications for Use
The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The proposed device is used by dental professionals for removal of dental plaque and calculus, and for cleaning in periodontics, endodontics and prosthetics.
To use the device, a hose from a dental unit that supplies the device with compressed air and water is attached to the back end of the device. The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site. When compressed air enters inside of the vibrator in the device, it generates mechanical vibration at the working tip attached to the front end of the device. The working tip contacts teeth and in certain cases, gum of the patient. The removal of plaque and calculus or cleaning is performed by utilizing the vibration. The device consists of the handpiece, connection to a hose and working tips.
The associated accessories include:
- tips for removal of plaque and calculus
- holder tips to attach endodontics files or tooth cleaning brushes
- tooth cleaning brushes
- tip replacement wrench
The proposed device and accessories are supplied non sterilized in an autoclave prior to the first use by the end-user.
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
Not Found
Intended User / Care Setting
Dental professionals.
Dental offices or clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The proposed device was evaluated in accordance with elements of applicable international standards for medical devices in which the proposed device is categorized (dental air scaler). Compliance tests included evaluation of basic safety and requirements, risk management, biological evaluation and reprocessing of medical devices. The device passed all of the compliance tests.
The proposed device was evaluated for device performance features including frequency output, amplitude, resistance to autoclave sterilization and corrosson. The device passed all of the performance criteria.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Micron Corporation Takashi Terui Sales Department Section Manager 2-17-7 Ikegami Ota-ku, Tokyo, 146-0082 JAPAN
Re: K161639 Trade/Device Name: Y-MIC Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: June 10, 2016 Received: June 14, 2016
Dear Takashi 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.
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.
Michael J. Ryan -S
for Tina Kiang, Ph.D. 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)
Device Name Y-MIC
Indications for Use (Describe)
The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.
| Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 201.3 Subject D) Over-The-Counter Use (21 CFR 201.3 Subject C) | Prescription Use (Part 21 CFR 201.3 Subject D) | Over-The-Counter Use (21 CFR 201.3 Subject C) |
|---|---|---|---|
| Prescription Use (Part 21 CFR 201.3 Subject D) | |||
| Over-The-Counter Use (21 CFR 201.3 Subject C) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary (2nd revision)
807.92(a) (1) Sponsor / Submitter
Company name: Micron Corporation Address: 2-17-7 Ikegami, Ota-ku, Tokyo, 146-0082 Country: Japan Phone: +81-3-3755-03964 Fax: +81-3-5747-5396 E-mail: office@micdent.com Contact Person: Takashi Terui (Mr.) Date Prepared: September 27, 2016 510(k) Number: K161639/S001
807.92(a) (2) DEVICE
Name of Device: Y-MIC Common or Usual Name: Dental air scaler Classification Name: Ultrasonic scaler (21 CFR 872.4850) Regulatory Class: II Product Code: ELC
807.92(a) (3) PREDICATE DEVICE
Sybron Dental Specialties, Inc. SONICflex 2003, K080089 No reference devices were used in this submission.
807.92(a) (4) DESCRIPTION OF DEVICE
The prosed device is used by dental professionals for removal of dental plaque and calculus, and for cleaning in periodontics, endodontics and prosthetics.
Both the predicate and the proposed devices are categorized in "Ultrasonic scaler" (FDA Product Code: ELC, Regulation No. 872.4850), but the both devices are not electric powered but air driven same as air-powered dental handpieces (FDA Product Code: EFB, Regulation No. 872.4200).
To use the device, a hose from a dental unit that supplies the device with compressed air and water is attached to the back end of the device.
携鐵顯孢克 1 / 4
4
The compressed air is the energy source of the device to generate mechanical vibration. Water from the dental unit is used for cooling and cleaning the treatment site.
When compressed air enters inside of the vibrator in the device, it generates mechanical vibration at the working tip attached to the front end of the device. The working tip contacts teeth and in certain cases, gum of the patient.
The removal of plaque and calculus or cleaning is performed by utilizing the vibration. The device consists of the handpiece, connection to a hose and working tips.
The associated accessories include:
- tips for removal of plaque and calculus
- holder tips to attach endodontics files or tooth cleaning brushes
- tooth cleaning brushes
- tip replacement wrench
The proposed device and accessories are supplied non sterilized in an autoclave prior to the first use by the end-user.
807.92(a) (5) INTENDED USE
The proposed device is intended to remove plaque and calculus in the areas of dental scaling, and for use in periodontics, endodontics and prosthetic by dental professionals.
| Proposed device | Predicate device | |
|---|---|---|
| Product name | Y-MIC | SONICflex 2003 |
| 510(k) number | K161639/A001 | K080089 |
| Manufacturer / submitter | Micron Corporation | Sybron Dental Specialties |
| Device type | Dental air scaler | Dental air scaler |
| Energy source | Compressed air supplied from | |
| a dental unit. | Compressed air supplied from | |
| a dental unit. | ||
| Design | Connects to hose of a dental units. | Connects to hose of a dental units. |
| Performance | Output frequency about 6,000 Hz. | Output frequency about 6,000 Hz. |
| Target population | Dental patients. | Dental patients. |
| Where used | Dental offices or clinics. | Dental offices or clinics. |
| Human factor | Used by trained dental | |
| professionals. | Used by trained dental | |
| professionals. | ||
| Sterile or non-sterile | Supplied non-sterile. | Supplied non-sterile. |
807.92(a) (6) COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
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| Electrical safety and EMC | An air-driven device. N/A | An air-driven device but the
model with illumination may
be applicable. |
|---------------------------|---------------------------|-------------------------------------------------------------------------------|
| Software | Not incorporated. | Not incorporated. |
Vibration generated by compressed air supplied from a dental unit is the operating principle for both the proposed and predicate devices.
Both the proposed and predicate devices connect to the dental unit that supplies the devices with compressed air via the connectors at the rear end of the devices.
Dental treatment with the devices is performed by use of this vibration.
At a high level, the predicate and predicate devices are based on the same technological elements below:
- Energy source compressed air supplied from a dental unit
- No use of electricity as energy source
- Creation of mechanical vibration by utilizing the compressed air
- Use of the mechanical vibration to achieve the treatment effect
- Frequency output of the vibration about 6,000 Hz
- Working tips attached to the front end
- Connector located at the rear end to connect to the dental unit
- Handpiece design like dental handpieces
- No use of software to activate and/or control the devices
However, though the predicate has a model with fiber optic illumination, the proposed device has not yet.
807.92(b) (1) NON CLINICAL TESTS
* General
The proposed device was evaluated in accordance with elements of applicable international standards for medical devices in which the proposed device is categorized (dental air scaler). Compliance tests included evaluation of basic safety and requirements, risk management, biological evaluation and reprocessing of medical devices. The device passed all of the compliance tests. Although the standards applied to the predicate are not known to the submitter, but because both the proposed and predicate devices are dental devices of the submitter believes the applicable standards to the predicate should be same as and common to those applicable to the proposed device at a high level.
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* Performance test
The proposed device was evaluated for device performance features including frequency output, amplitude, resistance to autoclave sterilization and corrosson. The device passed all of the performance criteria.
- Electrical safety and electromagnetic compatibility (EMC)
The proposed device is not electric-powered but air-driven like the predicate device. It is not subject to the IEC 60601 standards and no testing for electrical safety or EMC according to these standards were performed.
* Software
The proposed device is not software controlled and incorporates no software like the predicate device. The proposed device has no concern about software.
807.92(b) (2) CLINICAL TESTS
Not applicable, no changes in indication for use.
807.92(b) (3) CONCLUSIONS
The proposed device is operated utilizing the same operating principle and used to the same intended use as the predicate device.
The non-clinical data support that the proposed device performs as intended and conforms to the applicable standards.
Thus the submitter believes the information submitted demonstrates that the proposed device is substantially equivalent to the predicate device.