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.

AI/ML Overview

The Metabiomed, Inc. Endo Smart, ES-100 is an endo motor designed to assist dentists and dental surgeons in standard endodontic procedures using rotary endodontic files and drills.

Here's an analysis of the acceptance criteria and the study presented:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance for Endo Smart ES-100
Intended Use	- Indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.	- Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.
Patient Contacting Elements	- Patient contacting elements should have prior market clearance.	- Patient contacting elements supplied with Endo Smart ES-100 (motor hand piece, contra angle headpiece, and files) have been previously cleared for marketing (K111616).
Biocompatibility	- Biocompatibility testing should be performed for patient-contacting components.	- The Endosmart ES-100 Endo Motor (controller unit) does not contact patients, therefore no biocompatibility testing was performed on the controller. (This implies that the contacting elements, already cleared, met biocompatibility criteria under their previous clearance).
Electromagnetic Compatibility (EMC) and Electrical Safety	- Conformance to relevant IEC standards for medical electrical equipment.	- Conforms with IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance.
		- Conforms with IEC 60601-1-2 Medical electric equipment, General requirements for safety collateral standard electromagnetic compatibility.
		- Conforms with IEC 61000-3-2 Electromagnetic Compatibility (EMC) Part 3: Limits -Section 3: Limitations of Voltage Fluctuations.
Performance (Functional Equivalence to Predicate devices)	- Similar technological characteristics to predicate devices (e.g., torque range, mode of operation, accessories, display, protection type against electric shock).	- Torque Range: 0.6~6.4Ncm (Gear 16:1 basis) (Predicate E-CUBE: 0.6 to 5.2 Ncm (Gear ratio: 16:1)) - Mode of Operation: Rotary, Auto Stop/Forward and Reverse (Predicate E-CUBE: Rotary, Auto Stop/Forward and Reverse) - Micro motor Manufacturer: SAESHIN PRECESION CO., Ltd. (Same as predicate) - Micro motor Model: CUBE EP (Same as predicate) - Contra Angle: ACL(B)-42EP, 16:1 (Same as predicate) - Display: LCD (Same as predicate) - Protection type and level against electric shock: Class IIa /Type B applied part, internal powered device (Predicate E-CUBE: Class I/ Type BF) - Physical Characteristics (Size, Weight): (Close but not identical. ES-100: 110 x 134 x 116.5 mm, 443g. E-CUBE: 110 x 196 x 139 mm, 582g) - Power: Lithium Ion, DC 7.2V Rechargeable, 2.2 Amp (Predicate E-CUBE: AC or DC powered)
Software Validation	- Adherence to FDA Software Validation Guidance.	- Software Validation FDA Software Validation Guidance mentioned as performed.

2. Sample size used for the test set and the data provenance

The document indicates that conformity to standards (IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2, and FDA Software Validation Guidance) was used to establish performance and safety. There is no mention of a traditional "test set" in the context of clinical or diagnostic performance with a specified sample size of patients/cases. The studies performed are engineering tests demonstrating adherence to safety and performance standards for an electro-mechanical device.

Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) submission for this device type, as it relies on engineering testing rather than clinical study data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The performance testing described relates to adherence to technical standards and the functional characteristics of the device, not a diagnostic or clinical assessment where ground truth would be established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This type of adjudication pertains to clinical studies where expert consensus often establishes ground truth for diagnostic accuracy, which is not the nature of the testing described for this endo motor.

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

Not applicable. The device is not an AI-based diagnostic tool. It is an electro-mechanical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is not an algorithm, and its function inherently involves a human operator (dentist/dental surgeon).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the device's acceptable performance is established through adherence to recognized international and electrical safety standards (IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2) and FDA Software Validation Guidance. For the functional aspects, the ground truth is comparative equivalence to legally marketed predicate devices in terms of intended use and technological characteristics (e.g., torque range, mode of operation, use of specific micro motor/contra angle).

8. The sample size for the training set

Not applicable. The device is not a machine learning or AI model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. No training set for an AI/ML model is mentioned.

Summary

{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)

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."

FORM FDA 3881 (1/14)

{3}------------------------------------------------

510(k) Summary

1. 510(k) Submitter:	Metabiomed, Inc.110 Gibraltar Road, suite 106Horsham, PA 19044USAPh: 267-282-5893Fax: 267-282-5899Email: metabiomed@gmail.com		Characteristics	Endo Motor ES-100	ECube Endodontic motor
2. Company Contact:Title:	Ian YunSales 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 WinstonACMD Consulting, LLC.2600 Mullinix Mill RoadMt. Airy, MD 21771USAPh: 301-607-9185Email: 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-100Endo Motor and accessoriesHandpiece, Direct drive, AC-powered872.4200IEKX	Regulation number	872.4200	872.4200
6. Predicate Devices:	Manufacturer :Device :510(k) Number :Manufacturer:Device:510(k) number:	Saeshin Precision Co., Ltd.E-CUBEK111616DENTSPLY InternationalX-Smart EasyK082167

{4}------------------------------------------------

1. 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.

1. Intended Use:
  Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.
1. 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 EndoMotor is indicated for use instandard endodonticprocedures using rotaryendodontic files and rotaryendodontic drills.	The E-CUBE is indicatedfor use by dentists instandard endodonticprocedures using rotaryendodontic files androtary 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 7.2VRechargeable2.2 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 16:1basis)	0.6 to 5.2 Ncm (Gearratio: 16:1)
Mode of Operation	RotaryAuto Stop/ Forward andReverse	RotaryAuto Stop/ Forward andReverse
Environmental Conditions foruse
Temperature	10~40°C	N/A
Humidity	30~75%	N/A
Transport and Storageconditions
Temperature	-20~70°C	N/A
Relative Humidity	0~95%	N/A
Accessories
Micro motor Manufacturer	SAESHIN PRECESION CO.,Ltd.	SAESHIN PRECESIONCO., Ltd
Model	CUBE EP	CUBE EP
Contra Angle	ACL(B)-42EP16:1	ACL(B)-42EP16:1
Characteristics	Endo Motor ES-100	ECube Endodonticmotor
Display	LCD	LCD
Protection type and levelagainst electric shock	Class IIa /Type B appliedpart, internal powereddevice	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 FDASoftware ValidationGuidance

{6}------------------------------------------------

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.

Regulation Number and Section

§ 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.