(315 days)
No
The description focuses on mechanical vibration and numerical output, with no mention of AI/ML terms or data processing methods indicative of AI/ML.
No
The device is indicated for measuring the stability of implants, which is a diagnostic function, not a therapeutic one.
Not Found
No
The device description explicitly states it is a "portable, handheld instrument" that uses "vibration generated by mechanical contacting of a tapping rod," indicating it is a physical hardware device, not software only.
Based on the provided information, the AnyCheck IMT-100 is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- AnyCheck IMT-100 function: The AnyCheck IMT-100 measures the mechanical stability of dental implants in situ (within the oral cavity). It does this by applying vibration and measuring the response. It does not analyze biological samples.
Therefore, the AnyCheck IMT-100 falls under the category of a medical device used for direct measurement on a patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The AnyCheck IMT-100 is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Product codes
EKX
Device Description
The AnyCheck IMT-100 Dental Implant Mobility Measuring Instrument is a system designed to measure dental implant mobility (stability) in the oral cavity and maxillofacial region. The AnyCheck IMT-100 is a portable, handheld instrument to observe non-invasively the fixation stability of an implant at alveolar bone. The implant stability test (iST) is performed using vibration generated by mechanical contacting of a tapping rod. The AnyCheck IMT-100 numerically indicates a scale result of iST. The higher number means better stability of the target implant.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity and maxillofacial region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-clinical Tests
Non-clinical testing was performed and comparative performance testing was conducted in order to validate the product against the company's specified design requirement. Measurement accuracy, output scale, reproducibility and electrical safety tests according to IEC60601-1 were performed.
Also, cytotoxicity, oral mucosa irritation and skin sensitization test were conducted with respect to biocompatibility according to ISO 10993-5, ISO 10993-10 and ISO 10993-12. The laboratory certified that the insolubility is in compliance with the requirements of the standard. There is no evidence that effects hazardous to the patient will arise by leachable ingredients/contaminants.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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February 20, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out as "U.S. Food & Drug Administration" below it.
DMS Co., Ltd. % Soojung Moon Consultant Allura Medical Solution, Inc. 8141 Lampson Ave. #4 Garden Grove, California 92841
Re: K180953
Trade/Device Name: AnyCheck IMT-100 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EKX Dated: January 15, 2019 Received: January 18, 2019
Dear Soojung Moon:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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 -S3 -s3 Date: 2019.02.20 18:26:54 -05'00
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
2
Indications for Use
510(k) Number (if known) K180953
Device Name AnyCheck IMT-100
Indications for Use (Describe)
The AnyCheck IMT-100 is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K180953
| Submitter | DMS Co., Ltd.
#201, #202 & #204, Oriental Medical Industry Development Center,
Sangji University, 83, Sangjidae-gil, Wonju-si, Gangwon-do, 26339
Republic of Korea
Phone. +82-33-742-3210
Fax. +82-33-742-3219 |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | HWI JOON PARK
8141 Lampson Ave. #4, Garden Grove, CA 92841, USA
Phone: +1-972-800-0044
Fax: +1-210-899-0079 |
| Submission Date | Jan 18, 2019 |
| Trade / Proprietary name | AnyCheck IMT-100 |
| Common / Usual Name | Dental Implant Mobility Measuring Instrument |
| Classification Name
Classification Code
Regulatory Class
Regulation Number | Handpiece, Direct Drive, AC-Power
EKX
Class I
872.4220 |
| Predicate Device | Osstell® ISQ Implant Stability Meter (Osstell AB)
(K082523 - Primary predicate)
Osstell® IDx (Osstell AB)
(K142358 - Reference predicate)
Tellos ISQ Buddy (Tellos Medical AB)
(K143445 - Reference predicate) |
| Description of Device | The AnyCheck IMT-100 Dental Implant Mobility Measuring Instrument
is a system designed to measure dental implant mobility (stability) in the
oral cavity and maxillofacial region. The AnyCheck IMT-100 is a
portable, handheld instrument to observe non-invasively the fixation
stability of an implant at alveolar bone. The implant stability test (iST) is
performed using vibration generated by mechanical contacting of a
tapping rod. The AnyCheck IMT-100 numerically indicates a scale result
of iST. The higher number means better stability of the target implant. |
| Indication for Use | The AnyCheck IMT-100 is indicated for use in measuring the stability of
implants in the oral cavity and maxillofacial region. |
4
| Comparison of
Technological
Characteristics with
the Predicate Devices | Comparison of Indication for Use
The AnyCheck IMT-100 and the predicate devices have identical
indications for use statements. |
|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Materials
ABS, PEEK, Titanium Alloy, Aluminum, Silicon, polycarbonate resin,
Accetal, Trimrite, Stainless Steel. |
| | Design
The subject device has no "device setup menu", which is similar to Tellos ISQ
Buddy (K143445), while other predicates need various parameters to set up
before use. The weight and power scale of the subject device is within the
range of all the predicate devices (3-12VA). |
| | Technological Characteristics
The result of the measurement of the subject device and all other predicate
devices is calculated from the resonance frequency. For measuring, predicate
devices (K082523 and K142358) can be attached either to the implant or
abutment, while the subject device should be attached only to the abutment.
But the performance data shows the output values between the subject device
and the predicate devices are similar and the difference is negligible.
Also, OLED display does not raise any issues or concerns of safety and
effectiveness for the use of the subject device, compared to the predicate
devices which use LED or LCD display. |
| | Clinical Tests
This submission does not include clinical performance data, similar to the
predicate devices. |
| | Non-clinical Tests
Non-clinical testing was performed and comparative performance testing
was conducted in order to validate the product against the company's
specified design requirement. Measurement accuracy, output scale,
reproducibility and electrical safety tests according to IEC60601-1 were
performed.
Also, cytotoxicity, oral mucosa irritation and skin sensitization test were
conducted with respect to biocompatibility according to ISO 10993-5, ISO
10993-10 and ISO 10993-12. The laboratory certified that the insolubility
is in compliance with the requirements of the standard. There is no
evidence that effects hazardous to the patient will arise by leachable
ingredients/contaminants. |
| Conclusion | Based upon the similarities of indications for use, and similarities
in technological characteristics, including materials and design,
together with the results of non-clinical performance testing, we
find that the AnyCheck IMT-100 Dental Implant Mobility
Measuring Instrument is substantially equivalent to the predicate
devices. |