(287 days)
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.
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) ●
The provided document is a 510(k) premarket notification for the Dentsply Sirona XSmart iQ, a cordless motor hand-piece for endodontic procedures. It details the device's characteristics and compares it to a predicate device, the e3 Torque Control Motor (K103653). The document primarily focuses on demonstrating substantial equivalence through non-clinical performance data and risk analysis.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly present a single table labeled "Acceptance Criteria." Instead, it lists various tests performed and their successful outcomes. The "acceptance criteria" are implied by the statement "Test results indicated that the XSmart iQ complies with the applicable Standard" or "XSmart iQ passed the test" for each study.
Here's a consolidated table based on the non-clinical performance data:
| Acceptance Criteria (Implied by Standard Compliance/Test Pass) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-5:2009, EN ISO 10993-1:2009, ISO 7405:2008, DIN EN ISO 10993-5, 1999 (Cytotoxicity for contra angle) | All patient contact components (including contra angle) demonstrated biocompatibility. Test results indicated that the XSmart iQ contra angle complies with the applicable standards. |
| Electromagnetic Compatibility & Electrical Safety: | |
| IEC 60601-1:2005/A1:2012 (3rd Ed.) (Basic safety & essential performance) | Test results indicated that the XSmart iQ complies with the applicable Standard. |
| IEC 80601-2-60:2012 (Basic safety & essential performance of dental equipment) | Test results indicated that the XSmart iQ complies with the applicable Standard. |
| EN 60601-1-2:2007 (EMC - Requirements and tests) | Test results indicated that the XSmart iQ complies with the applicable Standard. |
| EN 60601-1-6:2010 (General requirements for basic safety & essential performance) | Test results indicated that the XSmart iQ complies with the applicable Standard. |
| IEC 60601-1-8:2012 (Alarm systems) | Test results indicated that the XSmart iQ complies with the applicable Standard. XSmart iQ passed the alarm test. |
| Performance Testing (Implied by successful completion of tests outlined in DIN EN ISO 14457-2012): | |
| Expected Life / Endurance (Micro motor, contra angle connection, impact on electronics, contra angle play, battery capacity) | XSmart iQ passed the test. Endurance testing passed successfully and no major impact from stress is expected in the lifetime of device. |
| Micro-Motor Performance (Withstand load until 16 mNm, 0% failure rate, no motor defects after 500 hrs) | The device withstood load (at least until 16 milli-Newton meters) with a failure rate of 0% and no impact or motor defects observed after a 500 hours of runtime. |
| Motor Hand-Piece and Contra Angle Endurance (500 hrs, 1,600 application/removal cycles, 25 lubrication cycles) | Endurance testing passed successfully and no major impact from stress is expected in the lifetime of device. |
| Contra Angle Connection Test (1,600 application/removal cycles, 500 hrs runtime, 25 lubrication cycles) | Endurance testing passed successfully and no major impact on the expected lifetime of device is expected through stress. |
| Battery Capacity Evaluation (Minor changes after 500 hrs runtime, 300 charge cycles, no degradation) | Battery capacity showed minor changes after 500 hours of runtime and approximately 300 charge cycles. No degradation of the cells was observed and the test was passed successfully. |
| Oil-Ingress into Motor Test (No ingress observed after 750 hrs runtime, 25 lubrication cycles) | After 750 hours of runtime and 25 contra angle lubrication cycles no ingress of oil could be observed. This test was passed successfully. |
| Performance Tests Motor Hand-Piece (Speed, torque, reciprocating movement, warning beeps) | XSmart iQ motors undergoing performance test passed the defined examination. No device failure occurred during test phase. |
| Apex Pass Through (Resistance, housing isolation, capacity requirements, no influence on external apex locators) | Test has shown the resistance the housing isolation and capacity requirements are met by XSmart iQ. Also the display locations of two apex locators are not influence by measurement through XSmart iQ internal contact. |
| Bluetooth Simultaneous Connection Test (No interference during simulated normal use) | No interference between the devices was observed. |
| Marking Tests (No degradation in readability after rubs with water, ethanol, isopropanol) | No degradation in the readability of marking was observed. |
| Endurance Battery Test (No major impact on lifetime/function after 300 charge/discharge cycles) | All test passed. No major impact of charging/discharging on lifetime and function of batteries. |
| Button Test (Buttons functional after 50,000 push cycles) | All buttons were functional after applying the defined push cycles. |
| Contra Angle Tests (ISO 14457:2012: Backlash, lifespan, sterilization resistance, thermodisinfectability) | The backlash fluctuated within the stipulated tolerance of ±6°. The contact quality when transferring the signal on the sliding contact was good at all times and remained within the stipulated range, above 895, on the VDW Gold drive unit. The resistance value remained below 5 ohms at all time (below 15 ohms required). The sterilization did not reveal any decisive negative influences that would affect the use of the test objects in practice. The thermo washer disinfection does not affect the usability of the contra angle heads. There were no incidents during the test affecting use to an extent that would raise concerns about releasing the product. |
| Effectiveness of Contra Angle Test (Efficiency > 80%, ultimate moment within expected range) | The efficiency levels measured (90%–95%) are significantly over the 80% required. At 66 and 70 Ncm (Newton Centimeter), the ultimate moments fell within the same range on the drive side. |
| Dimensional Benchmark (Smallest diameter among cordless benchmarks, passes test criteria) | The maximum diameter of the complete IQ hand- piece was the smallest of the cordless benchmark and XSmart iQ passed the dimensional benchmark test as per test criteria. |
| Docking Station Disinfection Test (Resists disinfection after 250 spraying cycles per ISO 21530) | Docking station passed the test after 250 spraying cycles according to ISO 21530 standard. |
| Resistance to Closing Opening Cycle Test (No wear problems during two years usage) | XSmart iQ docking station will not suffer any wear problems during two year usage. |
| Bluetooth Working Distance (Passes test criteria) | XSmart iQ passed Bluetooth working distance test as per test criteria. |
| Packaging Resistance Test (No visible cracks, deformation, mechanical or electrical damage after transport/climatic conditioning) | No visible cracks, color change and deformation on docking station. No mechanical damage visible and no electrical damage detected on the devices contained in the packaging, after the transportation test and the climatic conditioning. |
| Usability Test (Complies with IEC 62366:2007) | Test results indicated that the XSmart iQ complies with the applicable Standard. |
| Software Validation: | |
| EN 62304:2006 (Software validation requirements) | Both devices (presumably XSmart iQ and its predicate) meet software validation requirement per EN 62304:2006. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size:
- For "Expected Life" testing, the sample size was n=15 for the first pass and n=5 for the second pass for the micro motor and contra angle.
- For "Micro-Motor Performance" and "Button Test", the specific sample size isn't explicitly stated, but the Button Test mentions visual inspection after various push cycles, implying testing on some sample units.
- For "Contra Angle Tests" and "Effectiveness of Contra Angle Test", specific numbers of instruments or units are mentioned (e.g., two prototype instruments for ultimate moment), but a general sample size for these tests is not provided beyond the contra angle specific tests.
- For other tests like Biocompatibility, EMC/Electrical Safety, Marking Tests, Docking Station Disinfection, Packaging Resistance, Usability, and Bluetooth tests, a specific sample size is not explicitly stated in the document. However, performing such tests implies they were done on a representative number of devices.
- Data Provenance: The document does not specify the country of origin of the data. All studies are non-clinical bench testing, meaning they were performed in a lab setting rather than on human subjects. They are inherently prospective in nature, as they were conducted specifically to evaluate the XSmart iQ device's performance against predefined standards and criteria.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This category is not applicable to the provided document. The studies described are non-clinical bench tests and do not involve human interpretation or a "ground truth" derived from expert consensus in the clinical sense. The "ground truth" for these tests is defined by objective engineering and safety standards (e.g., ISO, IEC, EN standards) and the physical properties of the device and its accessories.
4. Adjudication Method for the Test Set:
Not applicable. As the studies are non-clinical bench tests evaluated against objective standards, there is no need for an adjudication method involving multiple human readers or experts. The results are based on measurement and observation against established criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states "Clinical Performance Data: Not applicable." The studies are non-clinical bench tests comparing the device's technical specifications and performance to a predicate device and relevant standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described, the XSmart iQ, is a physical dental hand-piece with integrated software (Endo iQ app on an iPad Mini). It is not an "algorithm only" device. The performance tests evaluate the device as a whole, including its mechanical, electrical, and software components, in its intended operational context. Therefore, a "standalone algorithm only" performance test, as might be done for AI-driven diagnostic software, is not relevant and was not performed.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests is based on:
- Established International Standards: Such as ISO 10993, IEC 60601, EN 60601, ISO 14457, ISO 21530. Compliance with these standards is the primary "ground truth."
- Defined Performance Parameters: Explicit mechanical or electrical limits (e.g., "withstood load until 16 milli-Newton meters," "efficiency levels measured (90%–95%) are significantly over the 80% required," "backlash fluctuated within the stipulated tolerance of ±6°").
- Absence of Adverse Events: (e.g., "no impact or motor defects observed," "no degradation of the cells," "no ingress of oil could be observed," "no device failure occurred," "no visual cracks").
There is no mention of pathology, expert consensus (in a clinical sense), or outcomes data used to establish ground truth for the evaluations presented.
8. The Sample Size for the Training Set:
This question is not applicable. The XSmart iQ is a hardware device with associated software, not a machine learning or AI model that requires a "training set" in the conventional sense. The "software validation" mentioned refers to standard software engineering verification and validation, not training of a learned model.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no "training set" for this type of medical device's evaluation.
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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" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other, with flowing lines beneath them.
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)
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)
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ 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 | Indicationfor Use | The e3 Torque ControlMotor (K103653) is amedical device designedfor use by dentists for usewith dental root canalinstruments in continuousrotation with torquecontrol or in reciprocatingmovement. | XSmart iQ is a cordlessmotor hand-piece withtorque control used fordriving files in bothreciprocating andcontinuous rotation modeduring an endodonticprocedure. | No differences. |
| 2 | Features | Corded motor hand-piece | Cordless motor hand-piece | |
| No differences. | ||||
| Continuous rotation andreciprocating movement | Continuous rotation andreciprocating movement | |||
| Can be controlled by LEDconsole or foot pedal | The motor parameters canbe transferred, stored anddisplayed via an Apple iPadMini® application (Endo iQapp), via Bluetoothconnection and controlledby the push button on themotor hand-piece. | XSmart iQ motor hand-piece is controlled by pushbutton on the motor hand-piece, while e3 TorqueControl Motor iscontrolled by LEDconsole and foot pedal. | ||
| USB connection forsoftware updates | Bluetooth connection forsoftware updates | XSmart iQ uses Bluetoothto connect with iPadMini® and to update thefirmware while e3 TorqueControl Motor uses USBport to update thefirmware. | ||
| 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 featureprevents the rotary filefrom exceeding requiredtorque strength | The torque control featureprevents the rotary file fromexceeding required torquestrength | No differences. | ||
| 3 | Console | LED console display withmembrane keypad | iPad Mini® displaywith iPad Mini® application(Endo iQ app) | iPad Mini® applicationgives interactiveinformation (real timegraphs, images) andaccess to pre- and post-operation information. |
| LED screen for visualselection ofpreprogrammed setting orfor preforming customizedsettings | iPad Mini® application(Endo iQ app) with pre-defined torque and speedsettings. | |||
| Control unit has keypadinterface for selection ofdesired functions whichare as follows:1. To switch device on(LED on) and off (LEDoff).2. To show battery status;3. To scroll right/left inthe bottom row of thedisplay through the filesystem, file, torque andspeed fields. Also used fornavigation of menufunctions. | A user management that canbe used for following:1. To edit user profile2. To log out and changeuser3. statistics aboutapplication4. Pop-up menu thatcontains parameter,statistics5. Record treatment withtreatment notes6. Treatment reportsallows user to:• Create, edit ordelete a patient.• View, edit or deletethe treatmentsassociated with thepatients | |||
| 4 | SafetyMechanisms | The e3 Torque ControlMotor has safetymechanisms forpreventing the file beingover-torqued while inoperation byimplementing a torquecontrol feature that willreverse the direction of thefile if the torque exceeds apredefined limit. | XSmart iQ has safetymechanisms for preventingthe file being over-torquedwhile in operation byimplementing a torquecontrol feature that willreverse the direction of thefile if the torque exceeds apredefined limit | No differences. |
| 5 | Manufacturer | Dentsply Sirona /ATR | Dentsply Sirona/ATR/W&H | No differences. |
| Table 5.1 Comparison between e3 Torque Control Motor (K103653) and XSmart iQ | ||||
| No | Feature | Predicate Devicee3 Torque Control MotorK103653 | Proposed DeviceXSmart iQ(K161213) | Similarities/Differences |
| 6 | Dimensions | 203.2 mm X 76.2mm X76.2mm | 206 mm X 24.6 mm X 24.8 mm | It facilitates the motorhand-piecemaneuverability in tightspaces |
| Composition of Materials | ||||
| 7 | Materials ofMotor Hand-Piece | PC /ABS blendPC-PolycarbonateABS- Acrylonitrilebutadiene Styrene | PBT/PET blend(polybutylene terephthalate/polyethylene terephthalate)stainless steel 316Lsilicone | Materials of XSmart iQmotor hand-Piece aremore resistant to high-level disinfectantsolutions. |
| Technical Specifications | ||||
| 8 | Type ofChuck | Push button | Push button | No differences. |
| 9 | CouplingDimensions | 2.35 mm, according toISO 1797-1/-2 | 2.35 mm, according toISO 1797-1/-2 | No differences. |
| 10 | Types ofConnectors | ISO 1797-1/-2 | ISO 1797-1/-2 | No differences. |
| 11 | LubricantDeliverySystem | Spray nozzle | Spray nozzle | No differences. |
| 12 | Shank Length | ISO 1797-1/-2, latching | ISO 1797-1/-2, latching | No differences. |
| 13 | ReductionRate | 6:1 | 6:1 | No differences. |
| 14 | Weight | About 2 pounds(includingLED console) | About 0.4 pounds | XSmart iQ motor hand-piece is lighter in weightas compared to e3 TorqueControl Motor. |
| 15 | Power Supply | Recyko Ni-MH 6 Voltrechargeable battery | Lithium ion battery: 3.6V ,2000 mAh | Lithium ion batteries ofXSmart iQ are of highercapacities and relativelylow self-discharge withlow maintenance. |
| 16 | BatteryIndicator | E3 Torque Control Motorhas three different colorLED lights to displaybattery charging status:1. Green: Battery hassufficient capacity2. Flashing red: Batteryneeds to be chargedand the device canoperate on batterypower for only a fewminutes. Before the | Motor hand-piece batterylevel is displayed on iPadMini® application.The motor hand-piece ofXSmart iQ has two differentcolor LED lights with soundwhich will inform userabout the status of thebattery.1. All LEDs off- Thebattery is completely flat2. Green LED light-Battery is completely | e3 Torque Control Motorhas Flashing orange LEDlight when battery ischarging while XSmart iQmotor hand-piece hasgreen LED light whencharging. Also XSmart iQhas different audiblesignals as compared to e3Torque Control Motorwhich make user awareabout different batterysituations. |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| e3 Torque Control MotorK103653 | XSmart iQ(K161213) | |||
| motor switches off, there is an audible warning signal3. Flashing orange: The orange LED shows that the battery is charging. | charged or enough battery available to complete the treatment.3. Red LED light and audible signal with one short beep- battery charge level is low.4. Red LED light with three-second beep- battery charge level is critical. | |||
| 17 | ChargerPower Supply | AC 100-240 Volts | AC 100-240 Volts | No differences. |
| 18 | Frequency of SupplyVoltage | 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 MicroMotor 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 | OperatingMode | Rotary and reciprocating | Rotary and reciprocating | No differences. |
| 22 | Transport andStoringConditions: | Ambient temperature: -20°C - +50°C (-4°F - 122°F)Relative humidity : 20-90% | Ambient temperature: -20°C - +50°C (-4°F - 122°F)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 MotorK103653 | XSmart iQ(K161213) | |||
| 24 | Micro Motor | Brushless | Brushless | No differences. |
| 25 | Speed andTorqueAdjustable | 40 Torque Settings, 75speed steps | 50 Torque setting60 speed steps | More speed and torquesettings of XSmart iQgives more options |
| 26 | Own SettingsCan Be Saved | Yes | Yes | No differences. |
| 27 | Auto StopReverse | Yes | Yes | No differences. |
| 28 | ReverseSignal | Yes | Yes | No differences. |
| 29 | TorqueWarningSignal | Yes | Yes | No differences. |
| 30 | USB port | Yes | No | Bluetooth is used toupdate firmware on theXSmart iQ motor hand-piece. |
| 31 | MotorOperation byPush Buttonon MotorHand-Piece | No | Yes | Push button on the motorhand-piece helpsclinicians to control thedevice during endodontictreatment. |
| 32 | MotorOperation byFoot Pedal | Optional | No | XSmart iQ motor hand-piece is controlled by apush button on the hand-piece while e3 TorqueControl Motor iscontrolled by the footpedal and LED console. |
| 33 | SystemPerformancewith TimeStamp | No | Yes | Time stamps give the userability to identify actualevent time or endodontictreatment time. |
| Contra Angle/Attachment | ||||
| 34 | Contra Angle/Attachment | 6:1 contra angle clearedby FDA under K972436(Product Code: EFB) | W& H contra anglespecific (exclusive) toXSmart iQ | The design and materials ofXSmart iQ contra angle arethe same as the contra anglesold with the e3 TorqueControl Motor. However,the XSmart iQ contra anglecan only be used withXSmart iQ motor hand-piece. |
| 35 | PrimaryContra Angle | 6:1 | 6:1 | No differences. |
| 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) | |||
| Gear Ratio | ||||
| Lubricant | ||||
| 37 | Lubricant | W&H Service Oil F1(K010127) | W&H Service Oil F1 MD-400Oil spray can, 400 ml.(K010127) | No differences. |
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The differences between the proposed device and the predicate device as shown in in Table 5.1 do not affect substantial equivalence. The underlying performance of the proposed device remains unchanged with the addition of an iPad interface and the speed and torque change remains within endodontic treatment parameters as summarized in the Non-Clinical Performance Data section, Table 5.4.
Summary of Non-Clinical Performance Data
Biocompatibility: Cytotoxicity was performed on all patient contacting materials including contra angle in accordance with ISO 10993-5:2009, EN ISO 10993-1:2009 and ISO 7405:2008-Dentistry -Evaluation of biocompatibility of medical devices used in dentistry. All patient contact components demonstrated biocompatibility.
| Table 5.2 Biocompatibility testing standards and results for XSmart iQ contra angle | ||||
|---|---|---|---|---|
| No | Biocompatibility Testing: | Results | ||
| 1 | EN ISO 10993-1:2009 Biological evaluation of medicaldevices - Part 1: Evaluation and testing within a riskmanagement process | Test results indicated that the XSmart iQcontra angle complies with the applicableStandard. | ||
| 2 | EN ISO 10993-5:2009-Biological evaluation of medicaldevices - Part 5: Tests for in vitro cytotoxicity | Test results indicated that the XSmart iQcontra angle complies with the applicableStandard. | ||
| 3 | ISO 7405:2008-Dentistry - Evaluation ofbiocompatibility of medical devices used in dentistry. | Test results indicated that the XSmart iQcontra angle complies with the applicableStandard. | ||
| 4 | DIN EN ISO 10993-5, 1999 Biological evaluation ofmedical devices Part 5: tests for cytotoxicity | Test results indicated that the XSmart iQcontra angle complies with the applicableStandard. |
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Electromagnetic compatibility and electrical safety: The following Electrical safety and electromagnetic compatibility (EMC) testing were performed on the XSmart iQ to verify conformity to standards and demonstrate substantial equivalence to the predicate e3 Toque Control Motor (K103653).
| Table 5.3 Electromagnetic compatibility and electrical safety testing for XSmart iQ | ||
|---|---|---|
| No | Standards | Results |
| 1 | IEC 60601-1:2005/A1:2012 (3rd Ed.) Medical electricalequipment -Part 1: General requirements for basic safetyand essential performance | Test results indicated that theXSmart iQ complies with theapplicable Standard. |
| 2 | IEC 80601-2-60:2012 Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essentialperformance of dental equipment. | Test results indicated that theXSmart iQ complies with theapplicable Standard. |
| 4 | EN 60601-1-2:2007 Medical electrical equipment Part 1-2:General requirements for basic safety and essentialperformance— Collateral standard: Electromagneticcompatibility — Requirements and tests | Test results indicated that theXSmart iQ complies with theapplicable Standard. |
| 5 | EN 60601-1-6:2010-Medical electrical equipment — Part 1-6: General requirements for basic safety and essentialperformance. | Test results indicated that theXSmart iQ complies with theapplicable Standard. |
| 6 | IEC 60601-1-8:2012 Medical electrical equipment - Part 1-8: General requirements for basic safety and essentialperformance — Collateral Standard: General requirements,tests and guidance for alarm systems in medical electricalequipment and medical electrical systems. | Test results indicated that theXSmart iQ complies with theapplicable Standard. |
Performance testing was performed in accordance to international standards DIN EN ISO 14457-2012 Dentistry-Hand-pieces and motors and demonstrates substantial equivalence to the predicate e3 Toque Control Motor (K103653). The following testing were conducted to demonstrate the basic performance of the XSmart iQ and its accessories and confirmed that the XSmart iQ performs as intended.
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| Table 5.4 Performance Test for XSmart iQ and Accessories | |||
|---|---|---|---|
| No | Test | Method | Results |
| 1 | Expected Life | Testing was conducted to evaluate the expected life of the micro motor,contra angle. Test included contra angle connection test, the impact onelectronics and entire device and contra angle play measurement. Testing wasconducted to evaluate battery capacity.All endurance tests were conducted with sample size of n=15 for the first passand n=5 for the second pass. | XSmart iQ passed the test. |
| 2 | Micro-MotorPerformanceTest | Motor performance testing was completed utilizing a Magtrol test bench at:850 rpm rotary, motor torque set at maximum, with driven torque ramp, andthen subsequently with no load | The device withstood load (at leastuntil 16 milli-Newton meters) with afailure rate of 0% and no impact ormotor defects observed after a 500hours of runtime |
| 3 | Motor Hand-Piece andContra AngleEndurance Test | Endurance testing for the motor hand-piece and contra angle were conductedutilizing an oil-break test bench at 500 hours (equivalent to 5 yearsoperation); 1,600 contra angle application/removal cycles. (Equivalent to100% of 3 year expected life as worst case); and 25 contra angle lubricationcycles. | Endurance testing passed successfullyand no major impact from stress isexpected in the lifetime of device. |
| 4 | Contra AngleConnection Test | Endurance testing for the contra angle was conducted parallel to the micro-motor and contra angle test with 1,600 contra angle application/removalcycles. (Equivalent to 100% of 3 year expected life as worst case); 500 hoursof runtime and 25 contra angle lubrication cycles. | Endurance testing passed successfullyand no major impact on the expectedlifetime of device is expected throughstress |
| 5 | BatteryCapacityEvaluation | Battery was fully charged and the motor hand-piece was then completelydischarged by disconnecting the charger and measuring discharge time whilerunning on an oil-break test bench with torque of 2 mNm (milli-Newtonmeters) at 2 minutes reciprocating and a 1 minute pause to calculate thecapacity of the battery. | Battery capacity showed minor changesafter 500 hours of runtime andapproximately 300 charge cycles. Nodegradation of the cells was observedand the test was passed successfully. |
| 6 | Oil-Ingress intoMotor Test | Oil ingress can be detected by significant change of micro-motor performanceand inability to calibrate contra angle successfully. | After 750 hours of runtime and 25contra angle lubrication cycles noingress of oil could be observed. Thistest was passed successfully. |
| 7 | PerformanceTests MotorHand-Piece | The battery is fully charged and contra angle is lubricated prior to testings.During the test, device is not connected to main power. The output andperformance of device is expressed by the movement of file. Following fourparameters were reviewed: speed torque and reciprocating movement. Inaddition warning beeps indicating performance limits were examined. | XSmart iQ motors undergoingperformance test passed the definedexamination. No device failureoccurred during test phase. |
| No | Test | Method | Results |
| 8 | Apex Pass Through | Proof of functionality test: To test functionality and length measurement accuracy with external apex locators.A multimeter is used to measure the electrical resistance. To determine the resistance of the pass through the file and the apex output contacted. To measure the isolation of contra angle the contra angle and housing parts are contacted. The capacity measured through LCR meter. Display readings of two external apex locators were measured. | Test has shown the resistance the housing isolation and capacity requirements are met by XSmart iQ. Also the display locations of two apex locators are not influence by measurement through XSmart iQ internal contact. |
| 9 | Blue Tooth Simultaneous Connection Test | To test the Bluetooth functionality of XSmart iQ.The motor hand-piece and iPad Mini® were paired one at a time. After pairing, normal use was simulated. | No interference between the devices was observed. |
| 10 | Marking Tests | Markings on XSmart iQ were rubbed by hand, first for 15 seconds with cloth soaked in distilled water then with ethanol then with isopropyl alcohol. And pictures were taken after each marking. | No degradation in the readability of marking was observed. |
| 11 | Endurance Battery Test | To evaluate the performance of batteries used in the XSmart iQ. 300 charging /discharging cycles- charge battery until the battery voltage reached 4.14V and then discharge battery with 1000mA. The time to discharge was recorded. And then inner resistance was calculated. | All test passed. No major impact of charging/discharging on lifetime and function of batteries. |
| 12 | Button Test | To evaluate performance of the system buttons on XSmart iQ.Test robot pushing button (1) and button (2).Test person performs visual inspection after 10,000, 38,000 and 50,000 push cycles. | All buttons were functional after applying the defined push cycles. |
| 13 | Alarm Test | To verify that XSmart iQ motor hand-piece fulfills the IEC 60601-1-8:2012 "General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems" in regard to alarm tones. | XSmart iQ passed the alarm test. |
| 14 | Contra Angle Tests | Test was performed on the contra angle head as per ISO 14457:2012.Following tests were performed:1. Measurement of the backlash2. Lifespan test with VDW drive3. Sterilization resistance test in Nitram DAC Universal4. Thermodisinfectability test in Miele G7835CD | The backlash fluctuated within the stipulated tolerance of ±6°. The contact quality when transferring the signal on the sliding contact was good at all times and remained within the stipulated range, above 895, on the VDW Gold drive unit. The resistance value remained below 5 ohms at all time (below 15 ohms required). The sterilization did not reveal any decisive negative influences that would affect the use of the test objects in practice. |
| No | Test | Method | Results |
| The thermo washer disinfection doesnot affect the usability of the contraangle heads. There were no incidentsduring the test affecting use to anextent that would raise concerns aboutreleasing the product. | |||
| 15 | Effectiveness ofContra AngleTest | To determine the effectiveness of the XSmart iQ endodontic contra anglehead and determine the ultimate moment of the endodontic contra angle headEfficiency:The cut-out torques were determined on the KSM performance test bench at300 rpm with different settings (10%, 20%, 30% etc.) and backed upstatistically (10 values for each setting).Ultimate moment:This is measured on the KSM performance test bench (ID no: 582.0000), axis2. Here, the axis is set to 2 Nm in manual mode, i.e. virtually blocked. Thecontra angle head is then powered manually until something breaks. Thetorque is recorded over the entire period. | The efficiency levels measured (90%–95%) are significantly over the 80%required.The test measured the two prototypeinstruments without a serial numberthat were also used to measure theefficiency. At 66 and 70 Ncm (NewtonCentimeter), the ultimate moments fellwithin the same range on the drive side. |
| 16 | DimensionalBenchmark | The aim of this test was to compare various dimensional specifications of thehand- piece and contra angle of the XSmart iQ motor compared to othercompetitor cordless endo-motors. The docking station heights and footprintswere measured. | The maximum diameter of thecomplete IQ hand- piece was thesmallest of the cordless benchmark andXSmart iQ passed the dimensionalbenchmark test as per test criteria. |
| 17 | Docking StationDisinfectionTest | The aim of this test was to test if all the pieces of the docking station resist todisinfection with several solutions. The tests were made as described in theISO 21530 standard. | Docking station passed the test after250 spraying cycles according to ISO21530 standard. |
| 18 | Resistance toClosingOpening CycleTest | The aim of this test was to test if all the pieces of the docking station resist toseveral closing-opening cycles corresponding to a normal usage during 2years. | XSmart iQ docking station will notsuffer any wear problems during twoyear usage. |
| 19 | BluetoothWorkingDistance | The aim of this test was to measure the working distance of the Bluetoothconnection between the XSmart iQ motor hand-piece and its docking station. | XSmart iQ passed Bluetooth workingdistance test as per test criteria. |
| 20 | PackagingResistance Test | The aim of this validation was to control if the docking station and the X-Smart IQ packaging would resist to hard conditions, like drops, crashes, highloads, vibrations and high temperatures and humidity. | No visible cracks, color change anddeformation on docking station. Nomechanical damage visible and no |
| Table 5.4 Performance Test for XSmart iQ and Accessories | |||
| No | Test | Method | Results |
| electrical damage detected on thedevices contained in the packaging,after the transportation test and theclimatic conditioning. | |||
| 21 | Usability Test | To verify or validate the usability requirements (usability engineering)according to IEC 62366:2007 on XSmart iQ | Test results indicated that the XSmartiQ complies with the applicableStandard. |
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Software validation:
Both devices meet software validation requirement per EN 62304:2006.
The performance of the XSmart iQ satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence. Along with the above tests, sterilization, speed and torque accuracy testing, and motor hand-piece endurance tests were also conducted. All testing demonstrated compliance with requirements of the standards and there are no safety hazards.
Human Factors:
All established Human Factors test requirements were met as developed from the FDA Guidance, Applying Human Factors and Usability Engineering to Medical Devices. All participants in the user evaluation exhibited efficiency with no significant residual use related risk remaining after testing.
Clinical Performance Data
Not applicable.
Risk analysis method & actions:
A Risk Management Plan to identify the risks and activities for managing those risks was carried out during design and development of the XSmart iQ motor hand-pieces and accessories. The risk analysis of the XSmart iQ was conducted in accordance with ISO 14971: 2012.
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| Table 5.5 Risk identification and mitigation for XSmart iQ | ||
|---|---|---|
| No | Identified Risk | Mitigation Measure |
| 1 | Cross contamination andadverse tissue reaction | Single use barrier covers for the iPad Mini® and motor hand-piece should be used to minimize the risk ofcross contamination. The main risks arise from cross-contamination or lack of biocompatibility. Reprocessinghas been validated. The DFU section on sterilization was carefully written in order to comply with applicablestandards and best practices. All materials used are well-known and tested in other contra angles in order tominimize the risk of biocompatibility issues |
| 2 | Device malfunction | Testing was conducted to minimize the risk of loss of function due to corrosion or wear and tear. |
| 3 | Risks arising due to the use ofa battery (electrical injury) | A number of risks arise from the use of a lithium-ion battery cell. Overcharge, overcurrent or excessiveenvironmental temperatures could lead to spontaneous fire. Torque control, an appropriate charge circuitry,use of a medical (IEC 60601-1 compliant) charge adapter and training procedures and work instructionsmitigate these risk. The battery is tested to comply with IEC 62133. An empty battery can also pose a risk. Theuser interface (LEDs, warning tones) has been designed in such a way as to inform the user in time so that atreatment can be completed before the device runs out of energy. Finally, batteries can leak toxic fluid. Theuser is instructed on how to handle this problem in the directions for use (DFU). |
| 4 | Risk arising due to transfer ofenergy (Thermal Injury andelectromagnetic interference) | Heat, mechanical energy (vibrations), electromagnetic energy (EMC), noise has been considered. The motorcontrol was designed to minimize vibrations. Heat dissipation was measured and shown to be below the limitsrequired by IEC 60601-1. Overall, no significant risks arise in this category. |
| 5 | Risks arising on behalf of usererror, usability or foreseeablemisuse (improper use andmaintenance) | The user interface was designed and carefully validated with a goal of reducing complexity. Normed symbolswere used, wherever possible. In the control unit, symbols and text were used together in order to minimize therisk of mis-understanding. Great care was taken to distinguish reciprocating and rotary operating modes. Theunderstand-ability of symbols and labelling was validated in a user evaluation. Oil ingress into the micromotor is a known problem from previous products. The support stand was designed in a way to minimize thisproblem. A proprietary connector was used for the apex locator and charge adapter contact in order to preventthe user from using other charge adaptors: a misuse which can potentially expose the patient to the risk ofelectric shock. The charge connector over-molding was designed in a way to prevent wrong insertion.Likewise, a proprietary coupling was used for the contra angle and designed in such a way that third-partycontra angles will not couple. This will prevent users from using a contra angle with a different reduction ratio,resulting in wrong speed/torque threshold at the file. |
| 6 | Risks arising due to wirelesscommunication | The standard risks arising from using wireless communication are considered (loss of data. corrupted data,inappropriate timing, unexpected receipt of data, etc.). A communication protocol between the motor hand-piece and control unit has been designed to deal with these risks. The protocol has been tested extensively,using automated, model-based tests. |
| 7 | Risks arising due to the use ofthe contra angle | In general, the risk arising from the use of a contra angle in endodontic applications is lower than for high-speed applications: the speed range considered is from 250rpm to 850rpm. Transfer of heat, noise, orvibrations to patient or operator have been considered. |
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Conclusion Regarding Substantial Equivalence
The cordless motor hand-piece allows the customer to experience the functionality of e3 Toque Control Motor (K103653) without any wires attached. XSmart iQ has Bluetooth for software updates while the e3 Toque Control Motor (K103653) has a USB port for software updates. XSmart iQ has more torque than e3 Toque Control Motor (K103653) which makes it well suited for endodontic procedures. The updated speed range and torque range is compatible with all Dentsply Sirona file products sold in North America which also helps in endodontic techniques. XSmart iQ contra angle compares favorably with the e3 Toque Control Motor (K103653) in terms of compactness.
Test data to verify the performance of the XSmart iQ has been provided including: biocompatibility, electrical safety, electromagnetic compatibility and non-clinical performance testing for both hardware and software functions and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.
§ 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.