(329 days)
No
The summary describes a motor controller for endodontic procedures and does not mention any AI or ML capabilities.
Yes
The device is indicated for use in standard endodontic procedures, which are medical procedures aimed at treating dental pulp diseases.
No
The device is described as a controller for a micromotor and contra-angle headpiece used to assist dentists and dental surgeons in performing standard endodontic procedures by providing power to the hand-held micromotor and contra-angle, which holds the drill bit and/or file. Its function is to power tools for performing procedures, not to diagnose a condition.
No
The device description explicitly states it is a "controller for micro motor and contra angle headpieces" and "provides power to the hand-held micromotor and contra angle," indicating it is a hardware device with electrical components, not software only.
Based on the provided information, the Endo Smart ES-100 Endo Motor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "standard endodontic procedures using rotary endodontic files and rotary endodontic drills." This describes a procedure performed directly on a patient's tooth, not a test performed on a sample taken from the body.
- Device Description: The device is a "controller for micro motor and contra angle headpieces" used to "assist dentists and dental surgeons perform standard endodontic procedures." It provides power to tools used within the mouth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), detecting substances, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Endo Smart ES-100 is a tool used for a surgical/procedural purpose within the mouth.
N/A
Intended Use / Indications for Use
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
Endo Smart, Model ES-100 is a controller for micro motor and contra angle headpieces which is designed to assist dentists and dental surgeons perform standard endodontic procedures. It provides power to the hand-held micromotor and contra angle which holds the drill bit and/or file used in endodontic procedures.
Endosmart is only intended to be used with motor hand piece (manufactured by Saeshin Precision Company; part name CUBE EP) and Contra angle headpiece (Manufactured by Saeshin Precision Company; part name ACL (B) - 42P) at 16:1 gear ratio.
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
dentists and dental surgeons
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 Testing:
Technological Characteristics
Patient contacting elements supplied with Endo Smart ES-100, the motor hand piece, contra angle headpiece and files have been previously cleared for marketing (K111616)
Biocompatibility:
The Endosmart ES-100 Endo Motor (controller unit) does not contact patients and no biocompatibility testing was performed on the controller.
Electromagnetic Compatibility and Electrical Safety
The Endo Smart ES-100 Endo Motor Conforms with IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility and IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits -Section 3: Limitations of Voltage Fluctuations.
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
§ 872.4200 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are oriented to the right and are connected to form a single, flowing shape. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2014
Metabiomed, Inc. C/O Mr. Blix Winston Submission Correspondent ACMD Consulting, LLC 2600 Mullinix Mill Road Mount Airy, Maryland 21771
Re: K133298
Trade/Device Name: Endo Smart, ES-100 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: August 21, 2014 Received: August 22, 2014
Dear Mr. Winston:
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.
1
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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,
Mary S. Runner -S
Erin I. Keith, M.S. 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
510(k) Number (if known) K133298
Device Name Endosmart ES-100
Indications for Use (Describe)
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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FORM FDA 3881 (1/14)
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510(k) Summary
| 1. 510(k) Submitter: | Metabiomed, Inc.
110 Gibraltar Road, suite 106
Horsham, PA 19044
USA
Ph: 267-282-5893
Fax: 267-282-5899
Email: metabiomed@gmail.com | | Characteristics | Endo Motor ES-100 | ECube Endodontic motor |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------|-------------------|-------------------------------|
| 2. Company Contact:
Title: | Ian Yun
Sales Director | | Manufacturer | S-Denti | Saeshin Precision Co.,
Ltd |
| 3. Date of Submission | 10/24/2013 | | 510(k) number | Applied for | K111616 |
| 4. 510(k) Preparer: | Blix Winston
ACMD Consulting, LLC.
2600 Mullinix Mill Road
Mt. Airy, MD 21771
USA
Ph: 301-607-9185
Email: fblixwinston@aol.com | | Class | I | I |
| 5. Device Name and Classification: | Trade name –
Common name –
Classification name –
Regulation number:
Class:
Product Code: | Endo Smart, ES-100
Endo Motor and accessories
Handpiece, Direct drive, AC-powered
872.4200
I
EKX | Regulation number | 872.4200 | 872.4200 |
| 6. Predicate Devices: | Manufacturer :
Device :
510(k) Number :
Manufacturer:
Device:
510(k) number: | Saeshin Precision Co., Ltd.
E-CUBE
K111616
DENTSPLY International
X-Smart Easy
K082167 | | | |
4
-
- Device Description:
Endo Smart, Model ES-100 is a controller for micro motor and contra angle headpieces which is designed to assist dentists and dental surgeons perform standard endodontic procedures. It provides power to the hand-held micromotor and contra angle which holds the drill bit and/or file used in endodontic procedures.
- Device Description:
Endosmart is only intended to be used with motor hand piece (manufactured by Saeshin Precision Company; part name CUBE EP) and Contra angle headpiece (Manufactured by Saeshin Precision Company; part name ACL (B) - 42P) at 16:1 gear ratio.
-
- Intended Use:
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.
- Intended Use:
-
- Performance Testing:
Technological Characteristics
Patient contacting elements supplied with Endo Smart ES-100, the motor hand piece, contra angle headpiece and files have been previously cleared for marketing (K111616)
Biocompatibility:
The Endosmart ES-100 Endo Motor (controller unit) does not contact patients and no biocompatibility testing was performed on the controller.
Electromagnetic Compatibility and Electrical Safety
The Endo Smart ES-100 Endo Motor Conforms with IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance, IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility and IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits -Section 3: Limitations of Voltage Fluctuations.
10. Comparison table:
5
| Characteristics | Endo Motor ES-100 | ECube Endodontic motor |
|---|---|---|
| Intended use | Endo Smart ES-100 Endo | |
| Motor is indicated for use in | ||
| standard endodontic | ||
| procedures using rotary | ||
| endodontic files and rotary | ||
| endodontic drills. | The E-CUBE is indicated | |
| for use by dentists in | ||
| standard endodontic | ||
| procedures using rotary | ||
| endodontic files and | ||
| rotary endodontic drills | ||
| (Gates-Glidden) | ||
| Product Code | EKX | EKX |
| Use | Rx Only | Rx Only |
| Physical Characteristics | ||
| Size W mm x D mm x Hmm | 110 x 134 x 116.5 | 110 x 196 x 139 |
| Weight g | 443 | 582 |
| Power V and Amps | Lithium Ion, DC 7.2V | |
| Rechargeable | ||
| 2.2 Amp | AC or DC powered | |
| AC Adapter Input Voltage | 100-240 V~, 50 Hz /60Hz | 100-240V, 47/63 Hz |
| Torque Range | 0.6~6.4Ncm (Gear 16:1 | |
| basis) | 0.6 to 5.2 Ncm (Gear | |
| ratio: 16:1) | ||
| Mode of Operation | Rotary | |
| Auto Stop/ Forward and | ||
| Reverse | Rotary | |
| Auto Stop/ Forward and | ||
| Reverse | ||
| Environmental Conditions for | ||
| use | ||
| Temperature | 10~40°C | N/A |
| Humidity | 30~75% | N/A |
| Transport and Storage | ||
| conditions | ||
| Temperature | -20~70°C | N/A |
| Relative Humidity | 0~95% | N/A |
| Accessories | ||
| Micro motor Manufacturer | SAESHIN PRECESION CO., | |
| Ltd. | SAESHIN PRECESION | |
| CO., Ltd | ||
| Model | CUBE EP | CUBE EP |
| Contra Angle | ACL(B)-42EP | |
| 16:1 | ACL(B)-42EP | |
| 16:1 | ||
| Characteristics | Endo Motor ES-100 | ECube Endodontic |
| motor | ||
| Display | LCD | LCD |
| Protection type and level | ||
| against electric shock | Class IIa /Type B applied | |
| part, internal powered | ||
| device | Class I/ Type BF | |
| Foot Pedal | None | Yes |
| Performance Testing | ||
| IEC 60601-1: 2005 + CORR. 1 | ||
| (2006) + CORR. 2 (2007) / | ||
| EN 60601-1: 2006 | IEC 60601-1 | |
| IEC 60601-1-2 | IEC 60601-2 | |
| Software Validation FDA | ||
| Software Validation | ||
| Guidance |
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11. Substantial Equivalence
Endo Smart ES-100 has an intended use similar to the predicate devices, and similar features and technological characteristics as X-Smart Easy (K092614) and E-CUBE (K111616). Additionally, ES-100 used identical Micro Motor, Contra Angle hand piece and files used by E-Cube and ES-100 conforms to the electromagnetic compatibility and electrical safety standards that were used to test safety and efficacy of predicate devices.
12. Conclusion
Based on performance testing and product description Metabiomed Inc. concludes that Endosmart ES-100 is substantially equivalent to X-Smart Easy Endo motor and ECube.