ENDO SMART

K133298 · Meta Biomed, Inc. · EKX · Sep 19, 2014 · Dental

Device Facts

• Record ID: K133298
• Device Name: ENDO SMART
• Applicant: Meta Biomed, Inc.
• Product Code: EKX · Dental
• Decision Date: Sep 19, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.

Device Story

Endo Smart ES-100 is a controller unit for a handheld micromotor and contra-angle handpiece; assists dentists/dental surgeons in standard endodontic procedures. Device provides power to the micromotor (Saeshin CUBE EP) and contra-angle (Saeshin ACL(B)-42P) which hold rotary files/drills. Operates in rotary mode with auto-stop, forward, and reverse functions. Controlled via LCD interface. Used in clinical dental settings. Benefits include controlled mechanical rotation for endodontic instrumentation.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2, IEC 61000-3-2) testing. Software validation performed per FDA guidance.

Technological Characteristics

Controller unit for micromotor; lithium-ion battery powered (7.2V, 2.2A). Components: Saeshin CUBE EP micromotor, ACL(B)-42P contra-angle (16:1 gear ratio). LCD display. Standards: IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2. Class IIa/Type B applied part. Dimensions: 110x134x116.5mm; Weight: 443g.

Indications for Use

Indicated for use by dentists and dental surgeons in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.

Regulatory Classification

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.

Predicate Devices

• E-CUBE (K111616)
• X-Smart Easy (K082167)

Reference Devices

• X-Smart Easy (K092614)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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

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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)

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## 510(k) Summary

| 1. 510(k) Submitter: | Metabiomed, Inc.<br>110 Gibraltar Road, suite 106<br>Horsham, PA 19044<br>USA<br>Ph: 267-282-5893<br>Fax: [phone]<br>Email: [e-mail] | | Characteristics | Endo Motor ES-100 | ECube Endodontic motor |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|-------------------|-------------------|-------------------------------|
| 2. Company Contact:<br>Title: | Ian Yun<br>Sales Director | | Manufacturer | S-Denti | Saeshin Precision Co.,<br>Ltd |
| 3. Date of Submission | 10/24/2013 | | 510(k) number | Applied for | K111616 |
| 4. 510(k) Preparer: | Blix Winston<br>ACMD Consulting, LLC.<br>2600 Mullinix Mill Road<br>Mt. Airy, MD 21771<br>USA<br>Ph: 301-607-9185<br>Email: [e-mail] | | Class | I | I |
| 5. Device Name and Classification: | Trade name –<br>Common name –<br>Classification name –<br>Regulation number:<br>Class:<br>Product Code: | Endo Smart, ES-100<br>Endo Motor and accessories<br>Handpiece, Direct drive, AC-powered<br>872.4200<br>I<br>EKX | Regulation number | 872.4200 | 872.4200 |
| 6. Predicate Devices: | Manufacturer :<br>Device :<br>510(k) Number :<br>Manufacturer:<br>Device:<br>510(k) number: | Saeshin Precision Co., Ltd.<br>E-CUBE<br>K111616<br>DENTSPLY International<br>X-Smart Easy<br>K082167 | | | |

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- 7. 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.

- 8. Intended Use:
Endo Smart ES-100 Endo Motor is indicated for use in standard endodontic procedures using rotary endodontic files and rotary endodontic drills.

- 9. 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:

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| Characteristics | Endo Motor ES-100 | ECube Endodontic motor |
|-----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Endo Smart ES-100 Endo<br>Motor is indicated for use in<br>standard endodontic<br>procedures using rotary<br>endodontic files and rotary<br>endodontic drills. | The E-CUBE is indicated<br>for use by dentists in<br>standard endodontic<br>procedures using rotary<br>endodontic files and<br>rotary endodontic drills<br>(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<br>Rechargeable<br>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<br>basis) | 0.6 to 5.2 Ncm (Gear<br>ratio: 16:1) |
| Mode of Operation | Rotary<br>Auto Stop/ Forward and<br>Reverse | Rotary<br>Auto Stop/ Forward and<br>Reverse |
| Environmental Conditions for<br>use | | |
| Temperature | 10~40°C | N/A |
| Humidity | 30~75% | N/A |
| Transport and Storage<br>conditions | | |
| Temperature | -20~70°C | N/A |
| Relative Humidity | 0~95% | N/A |
| Accessories | | |
| Micro motor Manufacturer | SAESHIN PRECESION CO.,<br>Ltd. | SAESHIN PRECESION<br>CO., Ltd |
| Model | CUBE EP | CUBE EP |
| Contra Angle | ACL(B)-42EP<br>16:1 | ACL(B)-42EP<br>16:1 |
| Characteristics | Endo Motor ES-100 | ECube Endodontic<br>motor |
| Display | LCD | LCD |
| Protection type and level<br>against electric shock | Class IIa /Type B applied<br>part, internal powered<br>device | Class I/ Type BF |
| Foot Pedal | None | Yes |
| Performance Testing | | |
| | IEC 60601-1: 2005 + CORR. 1<br>(2006) + CORR. 2 (2007) /<br>EN 60601-1: 2006 | IEC 60601-1 |
| | IEC 60601-1-2 | IEC 60601-2 |
| | Software Validation FDA<br>Software Validation<br>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.