XSmart iQ
Device Facts
| Record ID | K161213 |
|---|---|
| Device Name | XSmart iQ |
| Applicant | Dentsply Sirona |
| Product Code | EBW · Dental |
| Decision Date | Feb 10, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous rotation mode during an endodontic procedure.
Device Story
XSmart iQ is a cordless endodontic motor hand-piece; utilizes a motor hand-piece, contra angle, and Apple iPad Mini® console; communicates via Bluetooth 4.0 low energy. Dentist operates hand-piece; iPad Mini® with Endo iQ app displays motor parameters, treatment statistics, and patient records; provides real-time graphs and images. Torque control feature prevents file over-torque by reversing direction if limits are exceeded. Device facilitates endodontic procedures by driving files with adjustable speed/torque settings; improves maneuverability via cordless design and compact contra angle. Output affects clinical decision-making by providing controlled rotation/reciprocation and monitoring treatment parameters. Benefits include enhanced control, reduced risk of file breakage, and digital documentation of endodontic treatments.
Clinical Evidence
No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-5, ISO 7405), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (ISO 14457). Endurance testing (500 hours runtime, 1,600 contra angle cycles) and battery capacity evaluation confirmed device reliability. Usability validated per IEC 62366.
Technological Characteristics
Cordless motor hand-piece; PBT/PET blend, 316L stainless steel, silicone materials. Brushless motor; 3.6V 2000mAh Li-ion battery. Bluetooth 4.0 connectivity. Contra angle (ISO 1797-1:2011 Type 1) with 6:1 reduction. Software-controlled torque/speed settings. Sterilization via validated reprocessing. Complies with IEC 60601-1, IEC 80601-2-60, and ISO 14457.
Indications for Use
Indicated for use by dentists for driving endodontic files in reciprocating and continuous rotation modes during root canal procedures.
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
- e3 Torque Control Motor (K103653)
Reference Devices
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
February 10, 2017
Dentsply Sirona Helen Lewis Director Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404
Re: K161213
Trade/Device Name: XSmart iQ Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EBW Dated: January 13, 2017 Received: January 17, 2017
Dear Helen Lewis:
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
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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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K161213
Device Name XSmart iO
Indications for Use (Describe)
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous mode during an endodontic procedure.
Type of Use (Select one or both, as applicable)
| <span style="padding-right: 5px;">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="padding-right: 5px;">□</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# K161213
#### 510(k) SUMMARY
Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Helen Lewis |
|-------------------|--------------------------------|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
| Email Address: | helen.lewis@dentsplysirona.com |
Date Prepared: February 9, 2017
#### Device Name:
| • Proprietary Name: | XSmart iQ |
|------------------------|-----------------------------------|
| • Classification Name: | Dental hand-piece and accessories |
| • CFR Number: | 872.4200 |
| • Device Class: | II |
| • Product Code: | EBW |
#### Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|-------------------------|---------|-----------------|
| e3 Torque Control Motor | K103653 | Dentsply Sirona |
#### Description of Device:
The XSmart iQ is a cordless motor hand-piece having a power stage (motor hand-piece, gears and power supplier), a console based on an Apple iPad Mini® and a communication system (Bluetooth). The motor parameters can be transferred, stored and displayed via a dedicated iPad Mini® application (Endo iQ app), connected to the cordless motor hand-piece through a Bluetooth communication protocol.
Device components (including accessories):
- Motor hand-piece support and case ●
- Motor hand-piece
- Contra angle
- Spray nozzle (used for lubrication)
- iPad Mini® Protective case (Rubber Plugs and Protective case opener) ●
- AC adapter ●
- Getting started guide
- iPad Mini® with Endo iQ iOS App (not part of the kit) ●
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The contra angle is an attachment to motor hand-piece and is physically manufactured by W&H. The contra angle is specific to XSmart iQ motor hand-piece. The contra angle is designed to transmit the rotational movement of the motor axle to the shank of a bur or file that will be inserted into the output end of the contra angle. The output end of the contra angle contains chuck systems to accommodate standardized bur and file shanks. The contra angle is compatible with rotary and reciprocating files, with a 2.35 mm shaft conforming to ISO 1797-1:2011, Type 1.The contra angle is designed to be used for driving files in both reciprocating and continuous rotation mode during an endodontic procedure.
### Indications for Use:
XSmart iQ is a cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous rotation mode during an endodontic procedure.
### Substantial Equivalence:
Technological similarities and differences are as follows:
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor | XSmart iQ | |
| | | K103653 | (K161213) | |
| 1 | Indication<br>for Use | The e3 Torque Control<br>Motor (K103653) is a<br>medical device designed<br>for use by dentists for use<br>with dental root canal<br>instruments in continuous<br>rotation with torque<br>control or in reciprocating<br>movement. | XSmart iQ is a cordless<br>motor hand-piece with<br>torque control used for<br>driving files in both<br>reciprocating and<br>continuous rotation mode<br>during an endodontic<br>procedure. | No differences. |
| 2 | Features | Corded motor hand-piece | Cordless motor hand-piece | |
| | | | | No differences. |
| | | Continuous rotation and<br>reciprocating movement | Continuous rotation and<br>reciprocating movement | |
| | | Can be controlled by LED<br>console or foot pedal | The motor parameters can<br>be transferred, stored and<br>displayed via an Apple iPad<br>Mini® application (Endo iQ<br>app), via Bluetooth<br>connection and controlled<br>by the push button on the<br>motor hand-piece. | XSmart iQ motor hand-<br>piece is controlled by push<br>button on the motor hand-<br>piece, while e3 Torque<br>Control Motor is<br>controlled by LED<br>console and foot pedal. |
| | | USB connection for<br>software updates | Bluetooth connection for<br>software updates | XSmart iQ uses Bluetooth<br>to connect with iPad<br>Mini® and to update the<br>firmware while e3 Torque<br>Control Motor uses USB<br>port to update the<br>firmware. |
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor | XSmart iQ | |
| | | K103653 | (K161213) | |
| | | The torque control feature<br>prevents the rotary file<br>from exceeding required<br>torque strength | The torque control feature<br>prevents the rotary file from<br>exceeding required torque<br>strength | No differences. |
| 3 | Console | LED console display with<br>membrane keypad | iPad Mini® display<br>with iPad Mini® application<br>(Endo iQ app) | iPad Mini® application<br>gives interactive<br>information (real time<br>graphs, images) and<br>access to pre- and post-<br>operation information. |
| | | LED screen for visual<br>selection of<br>preprogrammed setting or<br>for preforming customized<br>settings | iPad Mini® application<br>(Endo iQ app) with pre-<br>defined torque and speed<br>settings. | |
| | | Control unit has keypad<br>interface for selection of<br>desired functions which<br>are as follows:<br>1. To switch device on<br>(LED on) and off (LED<br>off).<br>2. To show battery status;<br>3. To scroll right/left in<br>the bottom row of the<br>display through the file<br>system, file, torque and<br>speed fields. Also used for<br>navigation of menu<br>functions. | A user management that can<br>be used for following:<br>1. To edit user profile<br>2. To log out and change<br>user<br>3. statistics about<br>application<br>4. Pop-up menu that<br>contains parameter,<br>statistics<br>5. Record treatment with<br>treatment notes<br>6. Treatment reports<br>allows user to:<br>• Create, edit or<br>delete a patient.<br>• View, edit or delete<br>the treatments<br>associated with the<br>patients | |
| 4 | Safety<br>Mechanisms | The e3 Torque Control<br>Motor has safety<br>mechanisms for<br>preventing the file being<br>over-torqued while in<br>operation by<br>implementing a torque<br>control feature that will<br>reverse the direction of the<br>file if the torque exceeds a<br>predefined limit. | XSmart iQ has safety<br>mechanisms for preventing<br>the file being over-torqued<br>while in operation by<br>implementing a torque<br>control feature that will<br>reverse the direction of the<br>file if the torque exceeds a<br>predefined limit | No differences. |
| 5 | Manufacturer | Dentsply Sirona /ATR | Dentsply Sirona<br>/ATR/W&H | No differences. |
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
| No | Feature | Predicate Device<br>e3 Torque Control Motor<br>K103653 | Proposed Device<br>XSmart iQ<br>(K161213) | Similarities/Differences |
| 6 | Dimensions | 203.2 mm X 76.2mm X<br>76.2mm | 206 mm X 24.6 mm X 24.8 mm | It facilitates the motor<br>hand-piece<br>maneuverability in tight<br>spaces |
| Composition of Materials | | | | |
| 7 | Materials of<br>Motor Hand-<br>Piece | PC /ABS blend<br>PC-Polycarbonate<br>ABS- Acrylonitrile<br>butadiene Styrene | PBT/PET blend<br>(polybutylene terephthalate/<br>polyethylene terephthalate)<br>stainless steel 316L<br>silicone | Materials of XSmart iQ<br>motor hand-Piece are<br>more resistant to high-<br>level disinfectant<br>solutions. |
| Technical Specifications | | | | |
| 8 | Type of<br>Chuck | Push button | Push button | No differences. |
| 9 | Coupling<br>Dimensions | 2.35 mm, according to<br>ISO 1797-1/-2 | 2.35 mm, according to<br>ISO 1797-1/-2 | No differences. |
| 10 | Types of<br>Connectors | ISO 1797-1/-2 | ISO 1797-1/-2 | No differences. |
| 11 | Lubricant<br>Delivery<br>System | Spray nozzle | Spray nozzle | No differences. |
| 12 | Shank Length | ISO 1797-1/-2, latching | ISO 1797-1/-2, latching | No differences. |
| 13 | Reduction<br>Rate | 6:1 | 6:1 | No differences. |
| 14 | Weight | About 2 pounds(including<br>LED console) | About 0.4 pounds | XSmart iQ motor hand-<br>piece is lighter in weight<br>as compared to e3 Torque<br>Control Motor. |
| 15 | Power Supply | Recyko Ni-MH 6 Volt<br>rechargeable battery | Lithium ion battery: 3.6V ,<br>2000 mAh | Lithium ion batteries of<br>XSmart iQ are of higher<br>capacities and relatively<br>low self-discharge with<br>low maintenance. |
| 16 | Battery<br>Indicator | E3 Torque Control Motor<br>has three different color<br>LED lights to display<br>battery charging status:<br>1. Green: Battery has<br>sufficient capacity<br>2. Flashing red: Battery<br>needs to be charged<br>and the device can<br>operate on battery<br>power for only a few<br>minutes. Before the | Motor hand-piece battery<br>level is displayed on iPad<br>Mini® application.<br>The motor hand-piece of<br>XSmart iQ has two different<br>color LED lights with sound<br>which will inform user<br>about the status of the<br>battery.<br>1. All LEDs off- The<br>battery is completely flat<br>2. Green LED light-<br>Battery is completely | e3 Torque Control Motor<br>has Flashing orange LED<br>light when battery is<br>charging while XSmart iQ<br>motor hand-piece has<br>green LED light when<br>charging. Also XSmart iQ<br>has different audible<br>signals as compared to e3<br>Torque Control Motor<br>which make user aware<br>about different battery<br>situations. |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor<br>K103653 | XSmart iQ<br>(K161213) | |
| | | motor switches off, there is an audible warning signal<br>3. Flashing orange: The orange LED shows that the battery is charging. | charged or enough battery available to complete the treatment.<br>3. Red LED light and audible signal with one short beep- battery charge level is low.<br>4. Red LED light with three-second beep- battery charge level is critical. | |
| 17 | Charger<br>Power Supply | AC 100-240 Volts | AC 100-240 Volts | No differences. |
| 18 | Frequency of Supply<br>Voltage | 47-63 Hz | 50-60 Hz | XSmart iQ motor hand-piece operates at a narrow frequency range of supply voltage while e3 Torque Control Motor hand-piece operates at broad frequency range of supply voltage. |
| 19 | Torque Range | 20-410 gram-cm | 50-510 gram-cm | More torque of the XSmart iQ motor hand-piece gives more energy/power during endodontic treatment as compared to e3 Torque Control Motor. |
| 20 | Speed Range of the Micro<br>Motor Shaft | 250-1000 RPM (in rotary mode) | 1200 - 5100 RPM (in rotary mode) | More speed of XSmart iQ motor hand-piece produces more power which delivers constant torque. |
| 21 | Operating<br>Mode | Rotary and reciprocating | Rotary and reciprocating | No differences. |
| 22 | Transport and<br>Storing<br>Conditions: | Ambient temperature: -20°C - +50°C (-4°F - 122°F)<br>Relative humidity : 20-90% | Ambient temperature: -20°C - +50°C (-4°F - 122°F)<br>Relative humidity: 20% - 80% | No differences. |
| 23 | Bluetooth | No Bluetooth | Bluetooth 4.0 low energy | Bluetooth is a communication mean for XSmart iQ motor hand-piece to connect with iPad Mini® and update |
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | | | | |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor<br>K103653 | XSmart iQ<br>(K161213) | |
| 24 | Micro Motor | Brushless | Brushless | No differences. |
| 25 | Speed and<br>Torque<br>Adjustable | 40 Torque Settings, 75<br>speed steps | 50 Torque setting<br>60 speed steps | More speed and torque<br>settings of XSmart iQ<br>gives more options |
| 26 | Own Settings<br>Can Be Saved | Yes | Yes | No differences. |
| 27 | Auto Stop<br>Reverse | Yes | Yes | No differences. |
| 28 | Reverse<br>Signal | Yes | Yes | No differences. |
| 29 | Torque<br>Warning<br>Signal | Yes | Yes | No differences.…
