(323 days)
Not Found
No
The device description and performance studies focus on mechanical vibration and standard dental equipment connections, with no mention of AI/ML terms or data processing.
Yes.
The device is intended for canal preparation and cleaning, which are therapeutic actions to treat a condition (e.g., infected root canal).
No
The device is described as an endodontic tool for canal preparation and cleaning, generating mechanical vibrations for dentine debris removal. It is an active therapy device, not a diagnostic one.
No
The device description clearly outlines a physical handpiece with connections for air and water, a file holder, and accessories, indicating it is a hardware device. Performance studies also focus on physical characteristics like frequency, amplitude, and resistance to sterilization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "endodontics (canal preparation and canal cleaning)" and "removal of dentine debris in root canals." This is a therapeutic or procedural use within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a device used directly on the patient's tooth (specifically, the root canal) for mechanical action (vibration) and irrigation. This is consistent with a dental instrument used for treatment.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The device is intended to be used for endodontics (canal preparation and canal cleaning).
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The prosed device is used by dental professionals for removal of dentine debris in root canals in the field of endodontics. A turbine hose from a dental unit that supplies the device with compressed air and water is attached of the device in order to use 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. The device consists of the handpiece including the connection to a hose and file holder.
The proposed device has two model 4H connects to the Midwest 4-hole turbine hose and the model K A connects to the KaVo MULTIflex® quick-disconnect coupling.
The associated accessories include:
- file holder to attach endodontics files
- replacement wrench for the holder
The proposed device and accessories are supplied non-sterile and must be sterilized in an autoclave prior to the first use and after every patient by the end-user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental professionals
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)
Bench performance testing, including frequency output, amplitude, resistance to autoclave sterilization and corrosion was conducted in accordance with the following standards:
ISO 9168:2009, Dentistry -- Hose connectors for air driven dental handpieces,
ISO 18397:2016, Dentistry -- Powered scaler
The device passed all of the performance criteria.
Clinical performance testing was not conducted.
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.
Not Found
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a stylized image of a human figure.
Micron Corporation Takashi Terui Sales Department Section Manager 2-17-7 Ikegami Ota-ku, Tokyo, 146-0082 Jp
March 8, 2018
Re: K171150
Trade/Device Name: AW-100 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: Class II Product Code: ELC Dated: February 5, 2018 Received: February 6, 2018
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.
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 and Part 809); medical device 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
1
Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -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) K171150
Device Name AW-100
Indications for Use (Describe)
The device is intended to be used for endodontics (canal preparation and canal cleaning).
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)
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K171150
510(k) Summary
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: Mr. Takashi Terui Date Prepared: March 08, 2018 510(k) Number: K171150/S001
Name of Device: AW-100 Common or Usual Name: Ultrasonic scaler Classification Name: Ultrasonic scaler (21 CFR 872.4850) Regulatory Class: II Panel: Dental Product Code: ELC
PREDICATE DEVICE
Micro-Mega S.A. Sonic Air MM1500+ (MID), K081268
DESCRIPTION OF DEVICE
The prosed device is used by dental professionals for removal of dentine debris in root canals in the field of endodontics. A turbine hose from a dental unit that supplies the device with compressed air and water is attached of the device in order to use 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. The device consists of the handpiece including the connection to a hose and file holder.
The proposed device has two model 4H connects to the Midwest 4-hole turbine hose and the model K A connects to the KaVo MULTIflex® quick-disconnect coupling.
The associated accessories include:
- file holder to attach endodontics files
- replacement wrench for the holder
4
The proposed device and accessories are supplied non-sterile and must be sterilized in an autoclave prior to the first use and after every patient by the end-user.
TECHNOLOGICAL CHARACTERISTICS
When compressed air enters inside of the vibrator in the device, vibration generates and is transmitted to an endodontic file attached to the device.
Dental treatment with the devices is performed by use of the vibration.
COMPARISON OF TECHNOLOGY
* Similarities:
The proposed and predicate devices use compressed air supplied from a dental unit as energy source.
The both devices have very similar design: handpiece with a connection at the rear end to hose of a dental unit and a file holder or head to accept the specific instruments (endodontic files).
Their operation principle is same. When compressed air enters inside of the vibrator in the device, vibration generates and is transmitted to an endodontic file attached to the device. Dental treatment with the devices is performed by use of the vibration.
Both the proposed and predicate device are supplied non-sterile and require sterilization by the user.
* Differences:
The proposed device use a difference working air pressure and air consumption volume from the predicate device. The working air pressure is to gain the desired performance of endodontic treatment, and the air consumption volume is influenced by the working air pressure.
The output frequency of the proposed device is based on the actual measured values from the performance testing. No breakage of the endodontic files occurred in the performance testing when operated at the specified air pressure. Thus the submitter believes these points does not raise concerns about safety and effectiveness.
Performance testing of frequency output and amplitude was conducted at the air pressure of 0.28 MPa and passed the acceptance criteria of the applicable standard ISO 18397:2016 (see "NON-CLINICAL PERFORMANCE TESTING" below).
| K171150 | K081268 | |
|---|---|---|
| Product name | AW-100 | Sonic Air MM1500+ (MID) |
| 510(k) number | K171150/S001 | K081268 |
| Manufacturer / submitter | Micron Corporation | Micro Mega S.A. |
| Indications for use | The device is intended to be used for | |
| endodontics (canal preparation and | ||
| canal cleaning). | Endodontics |
- canal preparation
- canal cleaning |
* Comparison Chart with the Predicate Device
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| Energy source | Compressed air supplied from a dental unit. | |
|---|---|---|
| Device design | Dental handpieces connect to hose of a dental unit and have a file holder or | |
| head to accept the specific instruments (endodontic files). | ||
| Operation principle | The both devices are air-driven handpieces transmitting sonic waves along an | |
| endodontic file, which generates when compressed air enters inside of the | ||
| vibrator in the device. The handpiece produces subsonic vibrations. | ||
| The cutting action is produced by mechanical and physical movement on the | ||
| root canal (abrasive action) the handpieces remove dentine debris. | ||
| Performance | Output frequency 2000 to 3000 Hz. | Output frequency 1500 to 3000 Hz. |
| Working air pressure | 0.28 MPa (40.6 psi, 2.8 bar, 2.86 kgf/cm²) | 2.2 to 2.5 bar (31.9 to 36.2 psi) |
| Air consumption volume | 0 - 26 l/min | 18 -25 l/min |
| Water flow volume | 56 ml/min. (at water pressure 0.2 MPa). | Not available. |
| Weight | 71g (model 4H) or 72g (model KA) | Not available. |
| Material used | Stainless steel, aluminum alloy, | |
| silicone rubber and fluoro-rubber | Not available but metal and rubber | |
| materials that can withstand steam | ||
| autoclave sterilization are used. | ||
| Components | Handpiece and file holder or head to accept the specific instruments | |
| (endodontic files). | ||
| Sterile or non-sterile | Supplied non-sterile. | |
| Sterilization | Steam autoclave |
At a high level, the proposed and predicate devices are based on the same technological characteristics as above. There are some small different technological characters between the proposed device and the predicate including working air pressure, air consumption volume or the range of output frequency as in the chart above.
However, the working air pressure of 0.28 MPa is for the desired performance at the same level as the predicate device and this working air pressure accompanies the air consumption volume of 26/min.
The output frequency is based on the actual values measured in the performance testing. Bench performance testing was conducted at the working air pressure of 0.28 MPa and in this testing, no breakage of the endodontic files occurred.
NON-CLINICAL PERFORMANCE TESTING
The proposed device was evaluated in accordance with elements of applicable international standards for medical devices in which the proposed device is categorized (dental powered scaler).
Performance tests included evaluation of basic safety and performance requirements, risk management, biocompatibility testing, and reprocessing validation. The device passed all of the compliance tests.
Bench performance testing, including frequency output, amplitude, resistance to autoclave sterilization and corrosion was conducted in accordance with the following standards:
ISO 9168:2009, Dentistry -- Hose connectors for air driven dental handpieces,
ISO 18397:2016, Dentistry -- Powered scaler
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The device passed all of the performance criteria.
CLINICAL PERFORMANCE TESTING
Clinical performance testing was not conducted.
CONCLUSIONS
Based on the same intended use, principle of operation, comparison of technology and results of non-clinical performance testing, we conclude that AW-100 is substantially equivalent to Sonic Air MM1500+ (MID), K081268.