(315 days)
The AnyCheck IMT-100 is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
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.
The provided text describes the 510(k) submission for the AnyCheck IMT-100 Dental Implant Mobility Measuring Instrument. However, it explicitly states that "This submission does not include clinical performance data, similar to the predicate devices." Therefore, information regarding acceptance criteria and a study proving the device meets these criteria in the context of clinical performance (e.g., impact on human readers, expert ground truth, multi-reader studies) is not available within this document.
The document focuses on non-clinical tests to demonstrate substantial equivalence to predicate devices. Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
Since no clinical performance data is presented, a table of acceptance criteria for clinical performance and reported device performance in a clinical setting cannot be created from this text.
However, the text mentions non-clinical tests were performed against the company's specified design requirements. The generalized "acceptance criteria" for these non-clinical tests would be:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Non-Clinical) |
|---|---|
| Meet company's specified design requirement for Measurement accuracy | Performed |
| Meet company's specified design requirement for Output scale | Performed |
| Meet company's specified design requirement for Reproducibility | Performed |
| Compliance with IEC60601-1 (Electrical Safety) | Performed, in compliance |
| Compliance with ISO 10993-5 (Cytotoxicity) | Certified in compliance |
| Compliance with ISO 10993-10 (Oral Mucosa Irritation, Skin Sensitization) | Certified in compliance |
| Compliance with ISO 10993-12 (Insolubility) | Certified in compliance |
2. Sample size used for the test set and the data provenance:
- Test set sample size: Not applicable for clinical performance study as none was conducted. For non-clinical tests, specific sample sizes are not detailed, but it's implied that sufficient samples were used for the various engineering and biocompatibility tests.
- Data provenance: Not applicable for clinical data. For non-clinical tests, the tests were conducted by a certified laboratory (in compliance with ISO standards), implying laboratory-based testing rather than patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical study with human expert review was conducted.
4. Adjudication method for the test set:
Not applicable, as no clinical study with human expert review was conducted.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was conducted. The device is a "Dental Implant Mobility Measuring Instrument" and not an AI-assisted diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device itself is a measurement instrument, not an algorithm in the sense of AI software. Its "standalone performance" refers to its ability to accurately measure implant stability. The non-clinical tests (measurement accuracy, output scale, reproducibility) would constitute a form of standalone performance evaluation for its intended function.
7. The type of ground truth used:
- Clinical: Not applicable.
- Non-clinical: The ground truth for the non-clinical tests would have been established by calibrated laboratory standards and established engineering and biocompatibility test protocols (e.g., known electrical safety limits, recognized cytotoxicity assays, precisely manufactured test objects for accuracy/reproducibility).
8. The sample size for the training set:
Not applicable. This device is a physical measuring instrument, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for a machine learning model.
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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
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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
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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, 26339Republic of KoreaPhone. +82-33-742-3210Fax. +82-33-742-3219 |
|---|---|
| Contact Person | HWI JOON PARK8141 Lampson Ave. #4, Garden Grove, CA 92841, USAPhone: +1-972-800-0044Fax: +1-210-899-0079 |
| Submission Date | Jan 18, 2019 |
| Trade / Proprietary name | AnyCheck IMT-100 |
| Common / Usual Name | Dental Implant Mobility Measuring Instrument |
| Classification NameClassification CodeRegulatory ClassRegulation Number | Handpiece, Direct Drive, AC-PowerEKXClass I872.4220 |
| 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 Instrumentis a system designed to measure dental implant mobility (stability) in theoral cavity and maxillofacial region. The AnyCheck IMT-100 is aportable, handheld instrument to observe non-invasively the fixationstability of an implant at alveolar bone. The implant stability test (iST) isperformed using vibration generated by mechanical contacting of atapping rod. The AnyCheck IMT-100 numerically indicates a scale resultof 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 ofimplants in the oral cavity and maxillofacial region. |
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| Comparison ofTechnologicalCharacteristics withthe Predicate Devices | Comparison of Indication for UseThe AnyCheck IMT-100 and the predicate devices have identicalindications for use statements. |
|---|---|
| MaterialsABS, PEEK, Titanium Alloy, Aluminum, Silicon, polycarbonate resin,Accetal, Trimrite, Stainless Steel. | |
| DesignThe subject device has no "device setup menu", which is similar to Tellos ISQBuddy (K143445), while other predicates need various parameters to set upbefore use. The weight and power scale of the subject device is within therange of all the predicate devices (3-12VA). | |
| Technological CharacteristicsThe result of the measurement of the subject device and all other predicatedevices is calculated from the resonance frequency. For measuring, predicatedevices (K082523 and K142358) can be attached either to the implant orabutment, while the subject device should be attached only to the abutment.But the performance data shows the output values between the subject deviceand the predicate devices are similar and the difference is negligible.Also, OLED display does not raise any issues or concerns of safety andeffectiveness for the use of the subject device, compared to the predicatedevices which use LED or LCD display. | |
| Clinical TestsThis submission does not include clinical performance data, similar to thepredicate devices. | |
| Non-clinical TestsNon-clinical testing was performed and comparative performance testingwas conducted in order to validate the product against the company'sspecified design requirement. Measurement accuracy, output scale,reproducibility and electrical safety tests according to IEC60601-1 wereperformed.Also, cytotoxicity, oral mucosa irritation and skin sensitization test wereconducted with respect to biocompatibility according to ISO 10993-5, ISO10993-10 and ISO 10993-12. The laboratory certified that the insolubilityis in compliance with the requirements of the standard. There is noevidence that effects hazardous to the patient will arise by leachableingredients/contaminants. | |
| Conclusion | Based upon the similarities of indications for use, and similaritiesin technological characteristics, including materials and design,together with the results of non-clinical performance testing, wefind that the AnyCheck IMT-100 Dental Implant MobilityMeasuring Instrument is substantially equivalent to the predicatedevices. |
§ 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.