MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology
Device Facts
| Record ID | K160825 |
|---|---|
| Device Name | MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology |
| Applicant | Dentsply Sirona |
| Product Code | EKX · Dental |
| Decision Date | Sep 27, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4200 |
| Device Class | Class 1 |
| Attributes | Therapeutic |
Indications for Use
The MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ is a high-performance cordless prophylaxis handpiece with an optional wireless foot pedal for use with NUPRO Freedom® disposable prophy angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.
Device Story
Cordless prophylaxis handpiece for dental cleaning/polishing; consists of electric motor-driven inner module, outer sheath, charging base, and optional wireless foot pedal. Input: user-applied force on disposable prophy angle (DPA) or foot pedal displacement. Operation: SmartMode™ technology adjusts motor speed/torque based on DPA force; alternatively, Bluetooth Low Energy (BLE) wireless foot pedal controls speed. Output: rotational motion of DPA. Used in dental hygiene operatory by dental clinicians. Output allows clinicians to perform prophylaxis; benefits include cordless mobility and ergonomic control. Device includes LED status indicators for mode, battery, and synchronization. Must be used with Disposa-Shield® barrier.
Clinical Evidence
Bench testing only. No clinical human trials. Performance verified via internal test methods covering wireless functionality, SmartMode™ performance, battery life, speed/torque, and ingress protection. Human factors validation conducted using dental typodonts by registered dental hygienists to simulate clinical use and confirm mitigation of potential tissue damage risks.
Technological Characteristics
Materials: Aluminum outer sheath with stainless steel tip; plastic housings for inner module, charging base, and foot pedal. Energy: 3.7V Lithium Ion battery. Connectivity: Bluetooth Low Energy (BLE). Sterilization: Steam autoclavable outer sheath (135°C). Control: SmartMode™ (force-sensing) or wireless foot pedal. Standards: AAMI ANSI ES 60601-1, IEC 60601-1-2.
Indications for Use
Indicated for dental clinicians to perform cleaning and polishing procedures on teeth in a hygiene operatory setting using disposable prophy angles.
Regulatory Classification
Identification
A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.
Predicate Devices
- MIDWEST® RDH Freedom® Cordless System (K110753)
Reference Devices
- ProAngle™ Disposable Prophy Angle (K030603)
- Rite-Angle Disposable Prophy Angles (K954802)
- Disposa-Shield Disposable Barrier for Midwest RDH Freedom with SmartMode Technology Inner Module (K160232)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 27, 2016
Dentsply Sirona Helen Lewis Director, Corporate Regulatory Affairs 221 West Philadelphia Street Suite 60 York, Pennsylvania 17404
Re: K160825
Trade/Device Name: MIDWEST® RDH Freedom® Cordless Prophy System With SmartMode™ Technology Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EKX Dated: August 29, 2016 Received: August 30, 2016
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 device
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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of 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 D. 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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## Indications for Use
510(k) Number (if known)
Device Name
MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology
Indications for Use (Describe)
The MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ is a high-performance cordless prophylaxis handpiece with an optional wireless foot pedal for use with NUPRO Freedom® disposable prophy angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.
| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------|--|
| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | |
| <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | |
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Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17404
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## 510(k) SUMMARY
#### for
MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology
#### Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60 York, PA 17401
| Contact Person: | Helen Lewis |
|-------------------|--------------|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
Date Prepared: 16 September 2016
## Device Name:
| • Proprietary Name: | MIDWEST® RDH Freedom® Cordless Prophy<br>System with SmartMode™ Technology |
|------------------------|----------------------------------------------------------------------------|
| • Classification Name: | Dental Handpiece and Accessories |
| • Common Name: | Prophy System |
| • CFR Number: | 21 CFR 872.4200 |
| • Device Class: | I |
| • Product Code: | EKX |
## Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|------------------------------------------|---------|-----------------------------|
| MIDWEST® RDH Freedom® Cordless<br>System | K110753 | DENTSPLY International Inc. |
## Description of Device:
The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing procedures.
The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, is comprised of an electric motor-driven prophylaxis cordless handpiece (consisting of an inner module and outer sheath), a direct current (DC) powered charging base for cordless handpiece, cradle for cordless handpiece, direct current (DC) power supply and cord, and uses proprietary disposable prophy angles (DPAs). The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System
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with SmartMode™ Technology, uses a USB mini connector to provide battery charging power to the charging base for the cordless handpiece and operates using Bluetooth low energy (BLE) wireless radio frequency. An optional wireless foot pedal is sold separately.
Accessories include single use, proprietary NUPRO Freedom® disposable prophy angles [(cleared under premarket notification K030603 in April, 2003 by Pac-Dent International, Inc. as ProAngle™ Disposable Prophy Angle (manufactured by Pac-Dent International, Inc.) and under premarket notification K954802 in November, 1995 by DENTSPLY International as Rite-Angle Disposable Prophy Angles (manufactured by Angstrom Manufacturing, Inc.)] which are sold separately and available in a 90 degree angle and contra angle with multiple cup options: firm cup, soft cup, spiral cup, pedo (pediatric) cup, pointed tip and tapered brush. An optional wireless foot pedal (cleared under premarket notification K110753 in June, 2011 as MIDWEST RDH Freedom Cordless System) is sold separately.
The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, must be used with a Disposa-Shield® disposable barrier (cleared as Class II under premarket notification K160232 in June 2016 as Disposa-Shield Disposable Barrier for Midwest RDH Freedom with SmartMode Technology Inner Module), which is sold separately.
An FDA-Cleared lubricant can be used to lubricate the outer sheath nose of the proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartModeTM Technology, only if the DPA does not spin freely. A coupler prevents lubricant from contacting the cordless handpiece inner module. If lubricant is applied, the outer sheath must be sterilized prior to use.
The cordless handpiece can be operated in SmartMode™ mode without using the optional wireless foot pedal (K110753). SmartMode™ Technology allows the output speed and torque of the cordless handpiece to be controlled by the amount of force the user applies from the disposable prophylaxis angle (DPA) (K030603; K954802) to the tooth without the use of the optional wireless foot pedal (K110753).
The cordless handpiece can also be operated by using the optional wireless foot pedal (K110753) and the amount of vertical displacement corresponds to the output speed of the cordless handpiece supplied to the DPA (K030603; K954802). The optional wireless foot pedal (K110753) operates using Bluetooth low energy (BLE) communication. Engaging the optional wireless foot pedal (K110753) activates the Bluetooth low energy (BLE) mode of both the cordless handpiece and the optional wireless foot pedal (K110753), and will override the SmartMode™ mode for operation of the cordless handpiece.
## Indications for Use:
The Midwest® RDH Freedom® Cordless Prophy System with SmartMode™ Technology is a high-performance cordless prophylaxis handpiece with an optional wireless foot pedal for use with NUPRO Freedom® disposable prophy angles in a hygiene operatory to perform cleaning and polishing procedures on teeth.
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#### Identification of Risk Analysis Method
Risk analysis was performed on the MidWest® RDH Freedom® Cordless Prophy System with SmartMode™ Technology utilizing an FMEA process based on ISO 14971:2007 (Corrected 2007-10-01). The results of the risk analysis performed on the MidWest® RDH Freedom® Cordless Prophy System with SmartMode™ Technology concluded that all device design controls and process controls will be able to mitigate known potential failures and effects. In addition, performance testing, electrical safety and electromagnetic compatibility testing were performed to mitigate other potential risks. New biocompatibility testing was not required as the materials, manufacturing methods, and sterilization for the outer sheath are the same as the predicate device, MidWest® RDH Freedom® Cordless System (K110753). An FDA-cleared lubricant can be used to lubricate the outer sheath nose of the proposed device, MIDWEST® RDH Freedom Cordless Prophy System with SmartMode™ Technology, only if the DPA does not spin freely. A coupler prevents lubricant from contacting the cordless handpiece inner module. If lubricant is applied, the outer sheath must be sterilized prior to use.
| Substantial Equivalence: |
|--------------------------|
|--------------------------|
| Substantial Equivalence: | | | |
|------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ELEMENT | PROPOSED DEVICE:<br>MIDWEST® RDH<br>FREEDOM®<br>CORDLESS PROPHY<br>SYSTEM WITH<br>SMARTMODETM<br>TECHNOLOGY | PREDICATE<br>DEVICE:<br>MIDWEST® RDH<br>FREEDOM™<br>CORDLESS SYSTEM | DIFFERENCES<br>WITH<br>PREDICATE<br>DEVICE |
| 510(k) | K160825 | K110753 | N/A |
| Indications for<br>Use | The Midwest® RDH<br>Freedom® Cordless<br>Prophy System with<br>SmartMode™ Technology<br>is a high-performance<br>cordless prophylaxis<br>handpiece with an optional<br>wireless foot pedal for use<br>with NUPRO Freedom®<br>disposable prophy angles<br>in a hygiene operatory to<br>perform cleaning and<br>polishing procedures on<br>teeth. | The Midwest® RDH<br>Freedom™ Cordless<br>System is a high-<br>performance cordless<br>prophylaxis handpiece<br>with a wireless foot<br>pedal for use with<br>Freedom® disposable<br>prophylaxis angles in a<br>hygiene operatory to<br>perform cleaning and<br>polishing procedures on<br>teeth. | The wireless foot<br>pedal is an option<br>rather than a<br>requirement for<br>operation of the<br>cordless handpiece<br>for the proposed<br>device. Use of<br>SmartMode™<br>provides the same<br>level of operation<br>and does not have a<br>negative effect on<br>the performance of<br>the device when<br>used as labeled. |
| Accessories | NUPRO Freedom®<br>Disposable Prophy Angles<br>Removable, autoclavable<br>outer sheath | NUPRO Freedom®<br>Disposable Prophy<br>Angles<br>Removable, autoclavable<br>outer sheath | None<br>Elimination of<br>aesthetic color ring<br>and pins for |
| ELEMENT | PROPOSED DEVICE:<br>MIDWEST® RDH<br>FREEDOM®<br>CORDLESS PROPHY<br>SYSTEM WITH<br>SMARTMODE™<br>TECHNOLOGY | PREDICATE<br>DEVICE:<br>MIDWEST® RDH<br>FREEDOM™<br>CORDLESS SYSTEM | DIFFERENCES<br>WITH<br>PREDICATE<br>DEVICE |
| | Power supply and cord –<br>AC/DC wall plug adapter | Power supply and cord–<br>AC/DC wall plug<br>adapter | cordless handpiece<br>inner module does<br>not impact<br>substantial<br>equivalence. |
| | Cradle for cordless<br>handpiece | Cradle for cordless<br>handpiece | None |
| | Optional wireless foot<br>pedal | Required wireless foot<br>pedal | User has the choice<br>to use the optional<br>wireless foot pedal<br>for proposed device<br>but is required to<br>use the predicate<br>device foot pedal. |
| Material<br>Composition | Outer Sheath –<br>Aluminum with<br>stainless steel tip Cordless Handpiece<br>Inner Module Housing<br>– Plastic Charging Base for<br>Cordless Handpiece<br>Housing – Plastic Cradle for Cordless<br>Handpiece – Plastic Foot Pedal Housing –<br>Plastic | Outer Sheath –<br>Aluminum with<br>stainless steel tip Cordless Handpiece<br>Inner Module<br>Housing - Plastic Charging Base for<br>Cordless Handpiece<br>Housing - Plastic Cradle for Cordless<br>Handpiece - Plastic Foot Pedal Housing -<br>Plastic | None |
| Cordless<br>Handpiece<br>Control | The cordless handpiece can<br>be controlled without a<br>foot pedal via<br>SmartMode™ Technology,<br>or with an optional<br>wireless foot pedal. | The cordless handpiece<br>is controlled exclusively<br>by the required wireless<br>foot pedal. | The wireless foot<br>pedal is an option<br>rather than a<br>requirement for<br>operation of the<br>cordless handpiece<br>for the proposed<br>device. Use of<br>SmartMode™<br>provides the same<br>level of operation. |
| ELEMENT | PROPOSED DEVICE:<br>MIDWEST® RDH<br>FREEDOM®<br>CORDLESS PROPHY<br>SYSTEM WITH<br>SMARTMODETM<br>TECHNOLOGY | PREDICATE<br>DEVICE:<br>MIDWEST® RDH<br>FREEDOMTM<br>CORDLESS SYSTEM | DIFFERENCES<br>WITH<br>PREDICATE<br>DEVICE |
| SmartMode™<br>Technology | This device has<br>SmartMode™ Technology.<br>The output speed and<br>torque of the cordless<br>handpiece are controlled<br>by the amount of force the<br>user applies from the DPA<br>to the tooth, without the<br>use of the optional wireless<br>foot pedal. | This device does not<br>have SmartMode™<br>Technology. The output<br>speed and torque of the<br>cordless handpiece are<br>controlled by the amount<br>of force applied to the<br>required wireless foot<br>pedal. | Addition of<br>SmartMode™<br>feature allows the<br>user to conduct<br>procedures without<br>use of the wireless<br>foot pedal, provides<br>the same level of<br>operation and does<br>not have a negative<br>effect on the<br>performance of the<br>device when used<br>as labeled. |
| Cordless<br>Handpiece<br>Bluetooth<br>Wireless<br>Technology<br>Capabilities | The cordless handpiece has<br>Bluetooth low energy<br>(BLE) wireless technology<br>capabilities when used<br>with the optional wireless<br>foot pedal. | The cordless handpiece<br>has Zigbee wireless<br>technology capabilities<br>when used with the<br>required wireless foot<br>pedal | Similar wireless<br>technology which<br>results in the same<br>level of operation. |
| Cordless<br>Handpiece<br>Maximum<br>Speed; | Optional Wireless Foot<br>Pedal no load<br>$3400\pm300$ rpm | Required Wireless Foot<br>Pedal no load<br>$3300\pm300$ rpm | When used with the<br>optional wireless<br>foot pedal at no<br>load, the cordless<br>handpiece of the<br>proposed device<br>provides equivalent<br>speed compared to<br>the handpiece speed<br>at no load of the<br>predicate device<br>which uses the<br>required wireless<br>foot pedal. |
| Maximum<br>Torque using<br>Foot Pedal | $9$ mNm maximum load<br>$3000\pm10%$ rpm | $10$ mNm maximum load<br>$3000\pm10%$ rpm | |
| Cordless<br>Handpiece<br>Maximum | $9$ mNm maximum load<br>$3000\pm10%$ rpm | SmartMode™<br>technology is not<br>offered. | Addition of<br>SmartMode™<br>technology allows |
| ELEMENT | PROPOSED DEVICE:<br>MIDWEST® RDH<br>FREEDOM®<br>CORDLESS PROPHY<br>SYSTEM WITH<br>SMARTMODETM<br>TECHNOLOGY | PREDICATE<br>DEVICE:<br>MIDWEST® RDH<br>FREEDOM™<br>CORDLESS SYSTEM | DIFFERENCES<br>WITH<br>PREDICATE<br>DEVICE |
| Speed;<br>Maximum<br>Torque using<br>SmartMode™<br>(without Foot<br>Pedal) | | | the user to perform<br>cleaning procedures<br>without the use of a<br>wireless foot pedal. |
| Cordless<br>Handpiece<br>Interface | The cordless handpiece has<br>a user pushbutton that<br>controls mode selection:<br>SmartMode™ or Foot<br>Pedal Use | The handpiece has one<br>user interface: Foot<br>Pedal Use. | Addition of mode<br>control and ability<br>to make a selection<br>on the cordless<br>handpiece allows<br>the user to see the<br>current mode and to<br>change modes. |
| Cordless<br>Handpiece<br>On/Off Switch | The cordless handpiece has<br>a user pushbutton that<br>controls power on/off. | The cordless handpiece<br>does not have a power<br>on/off control. | The proposed<br>device has a user<br>pushbutton on the<br>cordless handpiece<br>that controls power<br>on/off and offers<br>the user direct<br>control of the<br>power status. |
| Cordless<br>Handpiece<br>Power Light | The indicator "on" light is<br>illuminated when the<br>power is on. | The indicator "on" light<br>is illuminated when the<br>power is on. | None |
| Cordless<br>Handpiece<br>Visual Status<br>Indicators | A range of steady and<br>blinking LED indicator<br>lights on the cordless<br>handpiece display the<br>handpiece status | A range of steady and<br>blinking LED indicator<br>lights on the cordless<br>handpiece display the<br>handpiece status | The increased<br>number of indicator<br>colors on the<br>proposed device |
| | Mode Status:<br>• Standby = Green<br>• SmartMode™<br>Operation = Purple<br>• Foot Mode Operation =<br>Blue<br>• Internal Temperature of<br>55°C or above =<br>Orange | Mode Status:<br>• Standby = Green<br>• Internal Temperature<br>of 55°C or above =<br>Orange | provides more<br>information to user<br>regarding mode<br>status, charging<br>status, level of<br>charge,<br>synchronization<br>status, and over-<br>temperature |
| ELEMENT | PROPOSED DEVICE:<br>MIDWEST® RDH<br>FREEDOM®<br>CORDLESS PROPHY<br>SYSTEM WITH<br>SMARTMODETM<br>TECHNOLOGY | PREDICATE<br>DEVICE:<br>MIDWEST® RDH<br>FREEDOMTM<br>CORDLESS SYSTEM | DIFFERENCES<br>WITH<br>PREDICATE<br>DEVICE |
| | Battery State of Charge:<br>• Level of Charge =<br>Green<br>• Needs to be Charged =<br>Orange | Battery State of Charge:<br>• Level of Charge =<br>Green<br>• Needs to be Charge =<br>Orange | condition. |
| | Synchronization Status:<br>• Ready = Blue<br>• Success = Green<br>• Unsuccessful = Orange | Synchronization Status:<br>• Positioned Properly in<br>charging base = Green<br>• Ready = Scrolling<br>Green and Orange<br>• Successful = Green<br>• Unsuccessful =<br>Orange | |
| Cordless<br>Handpiece<br>Visual Alarm | Cordless handpiece Mode<br>indicator shows Orange<br>when internal printed<br>circuit board (PCB)<br>temperature is above<br>normal. Operator should<br>refrain from using the<br>handpiece for several<br>minutes. The light will turn<br>off when the temperature<br>returns to normal. | Cordless handpiece LED<br>indicator light shows<br>Orange when internal<br>PCB temperature is<br>above normal. Operator<br>should refrain from<br>using the handpiece for<br>several minutes. The<br>light will turn off when<br>the temperature returns<br>to normal. | None |
| Cordless<br>Handpiece<br>Power | The cordless handpiece can<br>be turned on and off<br>manually. | The cordless handpiece<br>does not have an on/off<br>button. The cordless<br>handpiece will not<br>activate when the<br>required wireless foot<br>pedal is more than 30<br>degrees from horizontal. | The addition of an<br>on/off button on the<br>proposed device<br>allows the user to<br>have control over<br>power status of the<br>cordless handpiece. |
| ELEMENT | PROPOSED DEVICE:<br>MIDWEST® RDH<br>FREEDOM®<br>CORDLESS PROPHY<br>SYSTEM WITH<br>SMARTMODE™<br>TECHNOLOGY | PREDICATE<br>DEVICE:<br>MIDWEST® RDH<br>FREEDOM™<br>CORDLESS SYSTEM | DIFFERENCES<br>WITH<br>PREDICATE<br>DEVICE |
| | When not in the charging<br>base for cordless<br>handpiece, the cordless<br>handpiece enters a low<br>current mode after 1<br>minute of inactivity. The<br>cordless handpiece<br>"wakes-up" when the<br>On/Off/Mode button on the<br>cordless handpiece is<br>depressed or automatically<br>when it is picked up. | When not in the<br>charging base for<br>cordless handpiece, the<br>cordless handpiece will<br>enter a low current<br>(sleep) mode 1 within 1<br>minute of inactivity.<br>"Wake-up" occurs by<br>moving the handpiece by<br>45 degrees in any axis. | Actions to initiate<br>"wake-up" of the<br>devices differ<br>slightly but result in<br>the same operation<br>and do not affect<br>substantial<br>equivalence. |
| | When not in the charging<br>base for cordless<br>handpiece, the cordless<br>handpiece enters a "Sleep"<br>mode after 24 hours of<br>inactivity. The cordless<br>handpiece "wakes-up"<br>when the On/Off/Mode<br>button on the cordless<br>handpiece is depressed, or<br>when placed in the<br>charging base for the<br>cordless handpiece. | When not in the<br>charging base for<br>cordless handpiece, the<br>cordless handpiece<br>enters a lower current<br>(sleep) mode 2 within a<br>time period of inactivity<br>after 7 days but not more<br>than 14 days of<br>inactivity. "Wake-up"<br>occurs by placing the<br>handpiece on the charger<br>for 5 seconds to enter<br>normal operating mode. | The proposed<br>handpiece enters a<br>lower current state<br>after 1 day rather<br>than 7 days for the<br>predicate. This<br>permits the battery<br>saving operation to<br>initiate more<br>quickly. Actions to<br>initiate "wake-up"<br>of the devices differ<br>slightly but result in<br>the same operation<br>and do not affect<br>substantial<br>equivalence. |
| Cordless<br>Handpiece<br>Battery<br>Recharging<br>Capability | The 3.7 volt Lithium Ion<br>handpiece battery is<br>recharged by placing the<br>cordless handpiece in the<br>included charging base for<br>the cordless handpiece. | The 3.7 volt Lithium Ion<br>handpiece battery is<br>recharged by placing the<br>cordless handpiece in the<br>included charging base<br>for the cordless<br>handpiece. | None |
| Cordless<br>Handpiece<br>Power<br>Connector | A 5 volt power supply and<br>cord provides battery<br>charging power through a<br>USB mini connector to the<br>charging base for the | A 5 volt power supply<br>and cord provides<br>battery charging power<br>through a barrel<br>connector to the | The proposed<br>device provides<br>power through a<br>USB mini<br>connector rather |
| ELEMENT | PROPOSED DEVICE:<br>MIDWEST® RDH<br>FREEDOM®<br>CORDLESS PROPHY<br>SYSTEM WITH<br>SMARTMODE™<br>TECHNOLOGY | PREDICATE<br>DEVICE:<br>MIDWEST® RDH<br>FREEDOM™<br>CORDLESS SYSTEM | DIFFERENCES<br>WITH<br>PREDICATE<br>DEVICE |
| | cordless handpiece. | charging base for the<br>cordless handpiece. | than a barrel<br>connector |
| Handpiece<br>Battery Power | The handpiece battery has<br>sufficient power to<br>complete a day's worth of<br>hygiene procedures on a<br>single charge (average of<br>10 procedures of an<br>average 3 minutes each, or<br>30 minutes total). | The handpiece battery<br>has sufficient power to<br>complete a day's worth<br>of hygiene procedures on<br>a single charge (average<br>of 10 procedures of an<br>average 3 minutes each.<br>or 30 minutes total). | None |
| Handpiece<br>Battery Quick<br>Charge | The handpiece battery<br>permits the system to have<br>the capability of<br>completing one typical 3<br>minute cleaning procedure<br>after only fifteen minutes<br>of charging. | The handpiece batt…
