(287 days)
No
The description focuses on motor control, data transfer, storage, and display via a standard app on an iPad. There is no mention of learning, adaptation, or complex pattern recognition that would indicate AI/ML.
Yes
The device is a cordless motor hand-piece used for driving files during an endodontic procedure, which is a medical treatment.
No
The device is described as a cordless motor hand-piece used for driving files during endodontic procedures, which is a treatment function, not a diagnostic one. While it displays motor parameters, this information supports the procedural function rather than providing a medical diagnosis.
No
The device description explicitly lists hardware components such as a motor hand-piece, gears, power supplier, contra angle, spray nozzle, and an AC adapter. While it includes an iPad Mini with an app, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's a "cordless motor hand-piece with torque control used for driving files in both reciprocating and continuous mode during an endodontic procedure." This describes a device used directly on the patient during a dental procedure.
- Device Description: The description details a motor hand-piece, gears, power supply, and a console for controlling the motor. These are all components of a device used for mechanical action within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. There is no mention of specimen collection, analysis, or diagnostic information derived from samples in the provided text.
The device is a tool used by a dentist for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Test results indicated that the XSmart iQ contra angle complies with the applicable standards (EN ISO 10993-1:2009, EN ISO 10993-5:2009, ISO 7405:2008, DIN EN ISO 10993-5, 1999).
-
Electromagnetic compatibility and electrical safety: Testing was performed on the XSmart iQ to verify conformity to standards and demonstrate substantial equivalence to the predicate e3 Torque Control Motor (K103653). The device complies with IEC 60601-1:2005/A1:2012, IEC 80601-2-60:2012, EN 60601-1-2:2007, EN 60601-1-6:2010, and IEC 60601-1-8:2012.
-
Performance Testing: Performed in accordance with DIN EN ISO 14457-2012 (Dentistry-Hand-pieces and motors) to demonstrate basic performance and confirm intended use.
- Expected Life: Sample size n=15 for first pass, n=5 for second pass. XSmart iQ passed the test including contra angle connection test, impact on electronics and entire device, contra angle play measurement, and battery capacity.
- Micro-Motor Performance Test: Device withstood load (at least until 16 milli-Newton meters) with a failure rate of 0% and no impact or motor defects observed after 500 hours of runtime.
- Motor Hand-Piece and Contra Angle Endurance Test: Passed successfully; no major impact from stress is expected in the lifetime of the device after 500 hours (equivalent to 5 years operation), 1,600 contra angle application/removal cycles, and 25 contra angle lubrication cycles.
- Contra Angle Connection Test: Passed successfully; no major impact on the expected lifetime of the device through stress after 1,600 contra angle application/removal cycles, 500 hours of runtime, and 25 contra angle lubrication cycles.
- Battery Capacity Evaluation: 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: After 750 hours of runtime and 25 contra angle lubrication cycles, no ingress of oil could be observed. Test passed successfully.
- Performance Tests Motor Hand-Piece: XSmart iQ motors passed the defined examination; no device failure occurred during test phase. Parameters reviewed included speed, torque, and reciprocating movement, as well as warning beeps.
- Apex Pass Through: Resistance of housing isolation and capacity requirements are met. Display locations of two apex locators are not influenced by measurement through XSmart iQ internal contact.
- Blue Tooth Simultaneous Connection Test: No interference between the devices was observed.
- Marking Tests: No degradation in the readability of markings was observed after rubbing with distilled water, ethanol, and isopropyl alcohol.
- Endurance Battery Test: All tests passed. No major impact of charging/discharging on lifetime and function of batteries.
- Button Test: All buttons were functional after applying the defined push cycles (10,000, 38,000, and 50,000 push cycles).
- Alarm Test: XSmart iQ passed the alarm test as per IEC 60601-1-8:2012.
- Contra Angle Tests (ISO 14457:2012):
- Backlash fluctuated within stipulated tolerance of ±6°.
- Contact quality when transferring signal on sliding contact was good at all times and remained within stipulated range (above 895) on VDW Gold drive unit.
- Resistance value remained below 5 ohms at all times (below 15 ohms required).
- Sterilization did not reveal any decisive negative influences.
- Thermo washer disinfection does not affect usability of contra angle heads.
- Effectiveness of Contra Angle Test: Efficiency levels measured (90%–95%) are significantly over the 80% required. Ultimate moments fell within the same range (66 and 70 Ncm) on the drive side.
- Dimensional Benchmark: Maximum diameter of the complete IQ hand-piece was the smallest of the cordless benchmark and XSmart iQ passed the dimensional benchmark test.
- Docking Station Disinfection Test: Docking station passed the test after 250 spraying cycles according to ISO 21530 standard.
- Resistance to Closing Opening Cycle Test: XSmart iQ docking station will not suffer any wear problems during two year usage.
- Bluetooth Working Distance: XSmart iQ passed Bluetooth working distance test as per test criteria.
- Packaging Resistance Test: 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: Test results indicated that the XSmart iQ complies with the applicable standard (IEC 62366:2007).
Software Validation: Both devices meet software validation requirement per EN 62304:2006.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/1 description: The image 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
1
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
2
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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3
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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) ●
4
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 | |||
| for Use | The e3 Torque Control | |||
| Motor (K103653) is a | ||||
| medical device designed | ||||
| for use by dentists for use | ||||
| with dental root canal | ||||
| instruments in continuous | ||||
| rotation with torque | ||||
| control or in reciprocating | ||||
| movement. | 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. | No differences. | |||
| 2 | Features | Corded motor hand-piece | Cordless motor hand-piece | |
| No differences. | ||||
| Continuous rotation and | ||||
| reciprocating movement | Continuous rotation and | |||
| reciprocating movement | ||||
| Can be controlled by LED | ||||
| console or foot pedal | The motor parameters can | |||
| be transferred, stored and | ||||
| displayed via an Apple iPad | ||||
| Mini® application (Endo iQ | ||||
| app), via Bluetooth | ||||
| connection and controlled | ||||
| by the push button on the | ||||
| motor hand-piece. | XSmart iQ motor hand- | |||
| piece is controlled by push | ||||
| button on the motor hand- | ||||
| piece, while e3 Torque | ||||
| Control Motor is | ||||
| controlled by LED | ||||
| console and foot pedal. | ||||
| USB connection for | ||||
| software updates | Bluetooth connection for | |||
| software updates | XSmart iQ uses Bluetooth | |||
| to connect with iPad | ||||
| Mini® and to update the | ||||
| firmware while e3 Torque | ||||
| Control Motor uses USB | ||||
| port to update the | ||||
| 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 | ||||
| prevents the rotary file | ||||
| from exceeding required | ||||
| torque strength | The torque control feature | |||
| prevents the rotary file from | ||||
| exceeding required torque | ||||
| strength | No differences. | |||
| 3 | Console | LED console display with | ||
| membrane keypad | iPad Mini® display | |||
| with iPad Mini® application | ||||
| (Endo iQ app) | iPad Mini® application | |||
| gives interactive | ||||
| information (real time | ||||
| graphs, images) and | ||||
| access to pre- and post- | ||||
| operation information. | ||||
| LED screen for visual | ||||
| selection of | ||||
| preprogrammed setting or | ||||
| for preforming customized | ||||
| settings | iPad Mini® application | |||
| (Endo iQ app) with pre- | ||||
| defined torque and speed | ||||
| settings. | ||||
| Control unit has keypad | ||||
| interface for selection of | ||||
| desired functions which | ||||
| are as follows: |
- To switch device on
(LED on) and off (LED
off). - To show battery status;
- To scroll right/left in
the bottom row of the
display through the file
system, file, torque and
speed fields. Also used for
navigation of menu
functions. | A user management that can
be used for following: - To edit user profile
- To log out and change
user - statistics about
application - Pop-up menu that
contains parameter,
statistics - Record treatment with
treatment notes - Treatment reports
allows user to:
• Create, edit or
delete a patient.
• View, edit or delete
the treatments
associated with the
patients | |
| 4 | Safety
Mechanisms | The e3 Torque Control
Motor has safety
mechanisms for
preventing the file being
over-torqued while in
operation by
implementing a torque
control feature that will
reverse the direction of the
file if the torque exceeds a
predefined limit. | XSmart iQ has safety
mechanisms for preventing
the file being over-torqued
while in operation by
implementing a torque
control feature that will
reverse the direction of the
file if the torque exceeds a
predefined 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 Device
e3 Torque Control Motor
K103653 | Proposed Device
XSmart iQ
(K161213) | Similarities/Differences |
| 6 | Dimensions | 203.2 mm X 76.2mm X
76.2mm | 206 mm X 24.6 mm X 24.8 mm | It facilitates the motor
hand-piece
maneuverability in tight
spaces |
| Composition of Materials | | | | |
| 7 | Materials of
Motor Hand-
Piece | PC /ABS blend
PC-Polycarbonate
ABS- Acrylonitrile
butadiene Styrene | PBT/PET blend
(polybutylene terephthalate/
polyethylene terephthalate)
stainless steel 316L
silicone | Materials of XSmart iQ
motor hand-Piece are
more resistant to high-
level disinfectant
solutions. |
| Technical Specifications | | | | |
| 8 | Type of
Chuck | Push button | Push button | No differences. |
| 9 | Coupling
Dimensions | 2.35 mm, according to
ISO 1797-1/-2 | 2.35 mm, according to
ISO 1797-1/-2 | No differences. |
| 10 | Types of
Connectors | ISO 1797-1/-2 | ISO 1797-1/-2 | No differences. |
| 11 | Lubricant
Delivery
System | Spray nozzle | Spray nozzle | No differences. |
| 12 | Shank Length | ISO 1797-1/-2, latching | ISO 1797-1/-2, latching | No differences. |
| 13 | Reduction
Rate | 6:1 | 6:1 | No differences. |
| 14 | Weight | About 2 pounds(including
LED console) | About 0.4 pounds | XSmart iQ motor hand-
piece is lighter in weight
as compared to e3 Torque
Control Motor. |
| 15 | Power Supply | Recyko Ni-MH 6 Volt
rechargeable battery | Lithium ion battery: 3.6V ,
2000 mAh | Lithium ion batteries of
XSmart iQ are of higher
capacities and relatively
low self-discharge with
low maintenance. |
| 16 | Battery
Indicator | E3 Torque Control Motor
has three different color
LED lights to display
battery charging status: - Green: Battery has
sufficient capacity - Flashing red: Battery
needs to be charged
and the device can
operate on battery
power for only a few
minutes. Before the | Motor hand-piece battery
level is displayed on iPad
Mini® application.
The motor hand-piece of
XSmart iQ has two different
color LED lights with sound
which will inform user
about the status of the
battery. - All LEDs off- The
battery is completely flat - Green LED light-
Battery is completely | e3 Torque Control Motor
has Flashing orange LED
light when battery is
charging while XSmart iQ
motor hand-piece has
green LED light when
charging. Also XSmart iQ
has different audible
signals as compared to e3
Torque Control Motor
which make user aware
about different battery
situations. |
| No | Feature | Predicate Device | Proposed Device | Similarities/Differences |
| | | e3 Torque Control Motor
K103653 | XSmart iQ
(K161213) | |
| | | motor switches off, there is an audible warning signal - Flashing orange: The orange LED shows that the battery is charging. | charged or enough battery available to complete the treatment.
- Red LED light and audible signal with one short beep- battery charge level is low.
- Red LED light with three-second beep- battery charge level is critical. | |
| 17 | Charger
Power Supply | AC 100-240 Volts | AC 100-240 Volts | No differences. |
| 18 | Frequency of Supply
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
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
Mode | Rotary and reciprocating | Rotary and reciprocating | No differences. |
| 22 | Transport and
Storing
Conditions: | 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 Motor
K103653 | XSmart iQ
(K161213) | |
| 24 | Micro Motor | Brushless | Brushless | No differences. |
| 25 | Speed and
Torque
Adjustable | 40 Torque Settings, 75
speed steps | 50 Torque setting
60 speed steps | More speed and torque
settings of XSmart iQ
gives more options |
| 26 | Own Settings
Can Be Saved | Yes | Yes | No differences. |
| 27 | Auto Stop
Reverse | Yes | Yes | No differences. |
| 28 | Reverse
Signal | Yes | Yes | No differences. |
| 29 | Torque
Warning
Signal | Yes | Yes | No differences. |
| 30 | USB port | Yes | No | Bluetooth is used to
update firmware on the
XSmart iQ motor hand-
piece. |
| 31 | Motor
Operation by
Push Button
on Motor
Hand-Piece | No | Yes | Push button on the motor
hand-piece helps
clinicians to control the
device during endodontic
treatment. |
| 32 | Motor
Operation by
Foot Pedal | Optional | No | XSmart iQ motor hand-
piece is controlled by a
push button on the hand-
piece while e3 Torque
Control Motor is
controlled by the foot
pedal and LED console. |
| 33 | System
Performance
with Time
Stamp | No | Yes | Time stamps give the user
ability to identify actual
event time or endodontic
treatment time. |
| Contra Angle/Attachment | | | | |
| 34 | Contra Angle/
Attachment | 6:1 contra angle cleared
by FDA under K972436
(Product Code: EFB) | W& H contra angle
specific (exclusive) to
XSmart iQ | The design and materials of
XSmart iQ contra angle are
the same as the contra angle
sold with the e3 Torque
Control Motor. However,
the XSmart iQ contra angle
can only be used with
XSmart iQ motor hand-
piece. |
| 35 | Primary
Contra 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-
400
Oil spray can, 400 ml.
(K010127) | No differences. |
5
6
7
8
9
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 medical | |||
| devices - Part 1: Evaluation and testing within a risk | ||||
| management process | Test results indicated that the XSmart iQ | |||
| contra angle complies with the applicable | ||||
| Standard. | ||||
| 2 | EN ISO 10993-5:2009-Biological evaluation of medical | |||
| devices - Part 5: Tests for in vitro cytotoxicity | Test results indicated that the XSmart iQ | |||
| contra angle complies with the applicable | ||||
| Standard. | ||||
| 3 | ISO 7405:2008-Dentistry - Evaluation of | |||
| biocompatibility of medical devices used in dentistry. | Test results indicated that the XSmart iQ | |||
| contra angle complies with the applicable | ||||
| Standard. | ||||
| 4 | DIN EN ISO 10993-5, 1999 Biological evaluation of | |||
| medical devices Part 5: tests for cytotoxicity | Test results indicated that the XSmart iQ | |||
| contra angle complies with the applicable | ||||
| Standard. |
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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 electrical | |
| equipment -Part 1: General requirements for basic safety | ||
| and essential performance | Test results indicated that the | |
| XSmart iQ complies with the | ||
| applicable Standard. | ||
| 2 | IEC 80601-2-60:2012 Medical electrical equipment – Part 2- | |
| 60: Particular requirements for the basic safety and essential | ||
| performance of dental equipment. | Test results indicated that the | |
| XSmart iQ complies with the | ||
| applicable Standard. | ||
| 4 | EN 60601-1-2:2007 Medical electrical equipment Part 1-2: | |
| General requirements for basic safety and essential | ||
| performance— Collateral standard: Electromagnetic | ||
| compatibility — Requirements and tests | Test results indicated that the | |
| XSmart iQ complies with the | ||
| applicable Standard. | ||
| 5 | EN 60601-1-6:2010-Medical electrical equipment — Part 1- | |
| 6: General requirements for basic safety and essential | ||
| performance. | Test results indicated that the | |
| XSmart iQ complies with the | ||
| applicable Standard. | ||
| 6 | IEC 60601-1-8:2012 Medical electrical equipment - Part 1- | |
| 8: General requirements for basic safety and essential | ||
| performance — Collateral Standard: General requirements, | ||
| tests and guidance for alarm systems in medical electrical | ||
| equipment and medical electrical systems. | Test results indicated that the | |
| XSmart iQ complies with the | ||
| applicable 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 on | |||
| electronics and entire device and contra angle play measurement. Testing was | |||
| conducted to evaluate battery capacity. | |||
| All endurance tests were conducted with sample size of n=15 for the first pass | |||
| and n=5 for the second pass. | XSmart iQ passed the test. | ||
| 2 | Micro-Motor | ||
| Performance | |||
| Test | Motor performance testing was completed utilizing a Magtrol test bench at: | ||
| 850 rpm rotary, motor torque set at maximum, with driven torque ramp, and | |||
| then subsequently with no load | 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 | |||
| 3 | Motor Hand- | ||
| Piece and | |||
| Contra Angle | |||
| Endurance Test | Endurance testing for the motor hand-piece and contra angle were conducted | ||
| utilizing an oil-break test bench at 500 hours (equivalent to 5 years | |||
| operation); 1,600 contra angle application/removal cycles. (Equivalent to | |||
| 100% of 3 year expected life as worst case); and 25 contra angle lubrication | |||
| cycles. | Endurance testing passed successfully | ||
| and no major impact from stress is | |||
| expected in the lifetime of device. | |||
| 4 | Contra Angle | ||
| Connection Test | Endurance testing for the contra angle was conducted parallel to the micro- | ||
| motor and contra angle test with 1,600 contra angle application/removal | |||
| cycles. (Equivalent to 100% of 3 year expected life as worst case); 500 hours | |||
| of runtime and 25 contra angle lubrication cycles. | Endurance testing passed successfully | ||
| and no major impact on the expected | |||
| lifetime of device is expected through | |||
| stress | |||
| 5 | Battery | ||
| Capacity | |||
| Evaluation | Battery was fully charged and the motor hand-piece was then completely | ||
| discharged by disconnecting the charger and measuring discharge time while | |||
| running on an oil-break test bench with torque of 2 mNm (milli-Newton | |||
| meters) at 2 minutes reciprocating and a 1 minute pause to calculate the | |||
| capacity of the battery. | 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. | |||
| 6 | Oil-Ingress into | ||
| Motor Test | Oil ingress can be detected by significant change of micro-motor performance | ||
| and inability to calibrate contra angle successfully. | After 750 hours of runtime and 25 | ||
| contra angle lubrication cycles no | |||
| ingress of oil could be observed. This | |||
| test was passed successfully. | |||
| 7 | Performance | ||
| Tests Motor | |||
| Hand-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 and | |||
| performance of device is expressed by the movement of file. Following four | |||
| parameters were reviewed: speed torque and reciprocating movement. In | |||
| addition warning beeps indicating performance limits were examined. | XSmart iQ motors undergoing | ||
| performance test passed the defined | |||
| examination. No device failure | |||
| occurred 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: |
- Measurement of the backlash
- Lifespan test with VDW drive
- Sterilization resistance test in Nitram DAC Universal
- 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 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. |
| 15 | Effectiveness of
Contra Angle
Test | To determine the effectiveness of the XSmart iQ endodontic contra angle
head and determine the ultimate moment of the endodontic contra angle head
Efficiency:
The cut-out torques were determined on the KSM performance test bench at
300 rpm with different settings (10%, 20%, 30% etc.) and backed up
statistically (10 values for each setting).
Ultimate moment:
This is measured on the KSM performance test bench (ID no: 582.0000), axis - Here, the axis is set to 2 Nm in manual mode, i.e. virtually blocked. The
contra angle head is then powered manually until something breaks. The
torque is recorded over the entire period. | The efficiency levels measured (90%–
95%) are significantly over the 80%
required.
The test measured the two prototype
instruments without a serial number
that were also used to measure the
efficiency. At 66 and 70 Ncm (Newton
Centimeter), the ultimate moments fell
within the same range on the drive side. |
| 16 | Dimensional
Benchmark | The aim of this test was to compare various dimensional specifications of the
hand- piece and contra angle of the XSmart iQ motor compared to other
competitor cordless endo-motors. The docking station heights and footprints
were measured. | 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. |
| 17 | Docking Station
Disinfection
Test | The aim of this test was to test if all the pieces of the docking station resist to
disinfection with several solutions. The tests were made as described in the
ISO 21530 standard. | Docking station passed the test after
250 spraying cycles according to ISO
21530 standard. |
| 18 | Resistance to
Closing
Opening Cycle
Test | The aim of this test was to test if all the pieces of the docking station resist to
several closing-opening cycles corresponding to a normal usage during 2
years. | XSmart iQ docking station will not
suffer any wear problems during two
year usage. |
| 19 | Bluetooth
Working
Distance | The aim of this test was to measure the working distance of the Bluetooth
connection between the XSmart iQ motor hand-piece and its docking station. | XSmart iQ passed Bluetooth working
distance test as per test criteria. |
| 20 | Packaging
Resistance 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, high
loads, vibrations and high temperatures and humidity. | No visible cracks, color change and
deformation on docking station. No
mechanical damage visible and no |
| Table 5.4 Performance Test for XSmart iQ and Accessories | | | |
| No | Test | Method | Results |
| | | | electrical damage detected on the
devices contained in the packaging,
after the transportation test and the
climatic 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 XSmart
iQ complies with the applicable
Standard. |
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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 and | |
| adverse tissue reaction | Single use barrier covers for the iPad Mini® and motor hand-piece should be used to minimize the risk of | |
| cross contamination. The main risks arise from cross-contamination or lack of biocompatibility. Reprocessing | ||
| has been validated. The DFU section on sterilization was carefully written in order to comply with applicable | ||
| standards and best practices. All materials used are well-known and tested in other contra angles in order to | ||
| minimize 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 of | |
| a battery (electrical injury) | A number of risks arise from the use of a lithium-ion battery cell. Overcharge, overcurrent or excessive | |
| environmental 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 instructions | ||
| mitigate these risk. The battery is tested to comply with IEC 62133. An empty battery can also pose a risk. The | ||
| user interface (LEDs, warning tones) has been designed in such a way as to inform the user in time so that a | ||
| treatment can be completed before the device runs out of energy. Finally, batteries can leak toxic fluid. The | ||
| user is instructed on how to handle this problem in the directions for use (DFU). | ||
| 4 | Risk arising due to transfer of | |
| energy (Thermal Injury and | ||
| electromagnetic interference) | Heat, mechanical energy (vibrations), electromagnetic energy (EMC), noise has been considered. The motor | |
| control was designed to minimize vibrations. Heat dissipation was measured and shown to be below the limits | ||
| required by IEC 60601-1. Overall, no significant risks arise in this category. | ||
| 5 | Risks arising on behalf of user | |
| error, usability or foreseeable | ||
| misuse (improper use and | ||
| maintenance) | The user interface was designed and carefully validated with a goal of reducing complexity. Normed symbols | |
| were used, wherever possible. In the control unit, symbols and text were used together in order to minimize the | ||
| risk of mis-understanding. Great care was taken to distinguish reciprocating and rotary operating modes. The | ||
| understand-ability of symbols and labelling was validated in a user evaluation. Oil ingress into the micro | ||
| motor is a known problem from previous products. The support stand was designed in a way to minimize this | ||
| problem. A proprietary connector was used for the apex locator and charge adapter contact in order to prevent | ||
| the user from using other charge adaptors: a misuse which can potentially expose the patient to the risk of | ||
| electric 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-party | ||
| contra 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 wireless | |
| communication | 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 of | |
| the 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, or | ||
| vibrations 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.