(274 days)
No
The summary describes a device combining existing technologies (endo motor, obturator, apex locator) and does not mention AI or ML capabilities. The apex locator uses electrical resistance, not AI/ML, for location.
Yes
The device is used to expand and fill the root canal, and assist in locating the front tip in the root canal, which directly addresses a diseased or damaged condition (root canal treatment) and is intended to restore normal function.
Yes.
The device includes an "electronic apex locator which assists the operator the location of the front tip in the root canal" by measuring the "electric resistance value," which is a diagnostic function.
No
The device description explicitly states it is a "dental unit" that combines an endo motor, an obturation unit, and an electronic apex locator, all of which are hardware components. While it has a touch screen interface and software validation is mentioned, the core functionality relies on physical hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EMS-200 Function: The EMS-200 is a dental device used directly on the patient's tooth and root canal. It performs procedures like ablating tooth structure, filling the root canal, and locating the apex. It does not analyze specimens taken from the body.
The device description and intended use clearly indicate that it is a tool used in vivo (within the living body) for dental procedures, not for in vitro (in glass/outside the body) diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.
Product codes (comma separated list FDA assigned to the subject device)
EKX, EKR, LQY
Device Description
The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth / Root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained 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)
Performance Data:
Safety Testing
- IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2007 Medical electrical equipment Part1-1: General requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic compatibility
- ISO 10993-1:2009 Biological evaluation of medical devices-Part 1
- ISO10993-10:2010 Biological evaluation of medical devices-Test for irritation and sensitization
- EN 60601-1-6:2010 Medical electrical equipment. General requirements for basic safety and essential performance. Collateral standard. Usability
- EN 62304:2006 Medical device software. Software life-cycle processes
- EN ISO 14971:2012 Medical devices Application of risk management to medical devices
- EN 1639:2009 Dentistry. Medical devices for dentistry. Instruments
- EN 62366:2008 Medical devices. Application of usability engineering to medical devices
- EN 1041: 2008 Information supplied by the manufacturer with medical devices
- EN 980:2008 Graphical symbols for use in the labeling of medical devices
- ISO 9001:2008 Quality management systems Requirements
- ISO 13485:2003 Medical devices Quality management systems Requirements for regulatory purposes
- ISO 11737-2:2009 Sterilization of medical devices Microbiological methods Part 2: Tests of sterility performed in the validation of a sterilization process
- Sterilization validation per ISO 17665-1 and ISO 17665-2 Sterilization was performed to demonstrate SAL of 10-6
- Software documentation and validation for software of moderate level of concern per the FDA Guidance Document for Software Contained in Medical Devices
- Bench testing for conformance to ISO 14457
- Referenced literature articles regarding the temperature of gutta percha to include: Obturation of Root Canal Systems, American Association of Endodontists; and Dentistry-Thermoplasticized root canal obturating material
Conclusion:
The EMS-200 performance was verified by a comparative bench test with the predicate devices according to ISO 14457. Usability testing by the intended user was performed to validate the user interface of the combined unit. Software documentation and validation for software of moderate level of concern was performed per the FDA Guidance Document for Software Contained in Medical Devices. Electrical Safety testing was performed according to IEC 60601-1:2005 Medical electrical equipment Part 1: General requirements for basic safety and essential performance and IEC 60601-1-2:2007 Medical electrical equipment Part1-1: General requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic compatibility to verify safe use. All testing was performed for mitigation of risk according to ISO 14971:2012 Medical devices -Application of risk management to medical devices. In addition biocompatibility testing according to ISO 10993-1 was performed on patient contacting materials.
It is the conclusion of Meta Systems, based on non-clinical testing that the EMS-200 introduces no new issues of safety and efficacy and is substantially equivalent to the primary predicate and reference predicate devices.
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.
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
§ 872.4200 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 12, 2016
Meta Systems Co., Ltd. c/o Ms. Yolanda Smith Consultant Smith Associates 1468 Harwell Ave Crofton, Maryland 21114
Re: K153285
Trade/Device Name: EMS-200 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX, EKR, LQY Dated: July 12, 2016 Received: July 13, 2016
Dear Ms. Smith:
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); 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 yours,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name EMS-200
Indications for Use (Describe)
The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
SPONSOR
| Company Name: | Meta Systems Co., Ltd. |
|---|---|
| Company Address | 55, Galmachi-ro 281beon-gil, |
| Jungwon-gu, Seongnam-si, | |
| Gyeonggi-do, Korea, | |
| Telephone: | +82 2 2627 3765 |
| Contact Person: | Ray Jeon |
| Summary Preparation Date: | August 8, 2016 |
DEVICE NAME
| Trade Name: | EMS-200 |
|---|---|
| Common/Usual Name: | Dental Handpiece and Accessories |
| Classification Name: | Dental Handpiece and Accessories |
| Regulation Number: | 21 CFR 878.4200 |
| Product Code: | EKX |
| Device Class: | Class 1 |
PREDICATE DEVICE
| Primary Predicate: | ||
|---|---|---|
| K Number | Device Name | Manufacturer |
| K133298 | Endo-Smart ES-100 | Metabiomed (S-Denti) |
Reference Predicates
| K Number | Device Name | Manufacturer |
|---|---|---|
| K112508 | I-Root 100 Electronic Apex Locator | S-Denti Co, Ltd |
| K031664 | Endodontic Obturation Unit | Sybron Endo |
DEVICE DESCRIPTION
The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.
| Model | EMS-200S | EMS-200C |
|---|---|---|
| Description | Stand Alone unit | |
| for portability | Combined with a rolling cart | |
| Components | Display panel- Control unit | |
| Handpieces (Micro-motor, Pack and Fill) | ||
| Additional accessories: | ||
| File holder A/B, Lip holder, Contra-angle, | Display panel- Control unit | |
| Handpieces (Micro-motor, Pack and Fill) | ||
| Additional accessories: | ||
| File holder A/B, Lip holder, Contra-angle, |
The EMS 200 unit is supplied as follow:
4
| Pack tip, Fill needle | Pack tip, Fill needle | |
|---|---|---|
| Stand for the unit | Cart | |
| Power supply | Adapter & Power cord | Adapter & Power cord |
| Battery |
EMS – 200 System Critical Components Description
Image /page/4/Figure/2 description: The image shows two different models of dental equipment, labeled EMS-200S and EMS-200C. Both models feature a screen labeled with the number 1 and a water line labeled with the number 2. The EMS-200S model has dental tools labeled 3, 4, and 5, while the EMS-200C model has dental tools labeled 3, 4, and 5 and a set of drawers labeled 6.
| Item | Description | K Number of previously
cleared Meta System
devices |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------|
| 1. Touch Screen | 7″ LCD Touchscreen for display of working components | |
| 2. Apex | Electronic Apex Locator
Micro signals consisting of dual frequencies coming from the
main body return to where they are sent after traveling along
the electric circuit that is composed of " main body – probe
cord – file holder – hand file – patient – lip holder – probe
cord" | K100450 |
| 3. Motor | Endo motor (Endodontic motor)
Endo motor forms a root canal by rotating the rotary file | K133298 |
| 4. Pack | Gutta percha Obturator | |
| 5. Fill | Continuous wave is essentially a vertical compaction (Down-
packing) of core material and sealer in the apical portion of the
root canal using commercially available heating devices and
then back filling the remaining portion of the root canal with
thermoplasticized core material using injection device. | |
| 6. Cart | Movable cart for the EMS200C | |
Critical Components Specifications
| 1. Control Unit with LED Touch Screen | |
|---|---|
| Dimensions | Control box- 128 mm × 192 mm × 49 mm, |
| Stand type - 253.mm × 13mm × 212.7mm | |
| Weight |