(186 days)
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.
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 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.
This document describes the Dentsply Sirona MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology (K160825), a dental handpiece used for cleaning and polishing teeth. The submission compares this new device to a predicate device, the MIDWEST® RDH Freedom® Cordless System (K110753).
Acceptance Criteria and Device Performance:
The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data. It does not explicitly state acceptance criteria in a quantitative, pass/fail manner for features beyond "Pass," but rather compares performance to the predicate device and internal Dentsply Professional test methods.
| Physical Property / Test Description | Standard | Acceptance Criteria (Implied) | Reported Device Performance (K160825) | Predicate Device Performance (K110753) |
|---|---|---|---|---|
| Bluetooth Compatibility | DENTSPLY Professional Internal Test Method | Verify communication at 15 feet when exposed to RF interference. | Pass (Bluetooth) | Pass (Zigbee) |
| SmartMode™ Performance | DENTSPLY Professional Internal Test Method | Verify SmartMode™ performance, user override, and motor stop features. | Pass | N/A (Predicate does not have SmartMode™ Technology) |
| SmartMode™ Technology Performance with Various Types of DPA's | DENTSPLY Professional Internal Test Method | Verify SmartMode™ performance with different DPA types. | Pass | N/A (Predicate does not have SmartMode™ Technology) |
| Cordless Handpiece Inner Module Push Button, Battery Indicator, Sleep Mode Functionality | DENTSPLY Professional Internal Test Method | Verify functionality of button, battery indicator, and sleep mode. | Pass | N/A (Predicate lacks some features) |
| Speed Control and Level of Usage on a Single Charge | DENTSPLY Professional Internal Test Method | Verify capability to perform one day's worth (10 procedures) on a single charge. | Pass | Pass |
| Speed Torque Performance | DENTSPLY Professional Internal Test Method | Verify speed performance meets specifications under various loads. | Pass | Pass |
| Outer Sheath Insertion/Extraction Forces | DENTSPLY Professional Internal Test Method | Verify acceptable insertion/extraction forces per design specifications. | Pass | Pass |
| System Component Physical Attributes | DENTSPLY Professional Internal Test Method | Verify general size, shape, weight, and center of gravity attributes. | Pass | Pass |
| Cordless Handpiece Inner Module Liquids Ingress Test | DENTSPLY Professional Internal Test Method/IEC | Verify fluid does not accumulate in the Inner Module. | Pass | Pass |
| Foot Pedal Performance | DENTSPLY Professional Internal Test Method | Verify battery capacity and ability to operate on drained battery when plugged in. | Pass | Pass |
| Cordless Handpiece Maximum Speed (no load with foot pedal) | Not explicitly stated | Proposed: 3400 ± 300 rpm; Predicate: 3300 ± 300 rpm | 3400 ± 300 rpm | 3300 ± 300 rpm |
| Maximum Torque using Foot Pedal | Not explicitly stated | 9 mNm maximum load @ 3000 ± 10% rpm | 9 mNm maximum load @ 3000 ± 10% rpm | 10 mNm maximum load @ 3000 ± 10% rpm |
| Maximum Torque using SmartMode™ (without Foot Pedal) | Not explicitly stated | 9 mNm maximum load @ 3000 ± 10% rpm | 9 mNm maximum load @ 3000 ± 10% rpm | N/A (Not offered) |
Study Information:
-
Sample Size used for the test set and the data provenance:
The document does not specify exact sample sizes for the non-clinical performance tests. It mentions "multiple professional evaluations with typodonts" for the clinical performance section, but does not quantify the number of typodonts or treatments. The data provenance is internal to DENTSPLY Professional ("DENTSPLY Professional Internal Test Method"). The studies are effectively prospective as they were conducted to test the performance of the proposed device. The country of origin is not explicitly stated but can be inferred as the US, given the FDA submission. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
The document states that "Professional evaluations were conducted considering the proposed device intended use, users, and use environments. All studies were completed by practicing registered dental hygienists." The number of dental hygienists is not specified, nor are their exact qualifications beyond "practicing registered dental hygienists." -
Adjudication method for the test set:
The document does not describe a formal adjudication method (e.g., 2+1, 3+1) for the non-clinical or clinical performance evaluations. The results are presented as "Pass" based on internal test methods, implying a direct comparison to pre-defined technical specifications or successful operation. -
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC comparative effectiveness study was done. This device is a dental handpiece, not an AI-powered diagnostic tool, so such a study would not be applicable. The "SmartMode™ Technology" refers to an automated control mechanism based on force applied, not an AI feature involving human "readers" or diagnostic improvement. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The non-clinical performance tests described, particularly those for SmartMode™ functionality, speed, and torque, represent a form of standalone performance evaluation of the device's automated capabilities. These tests verify the device's technical specifications and how it responds to various inputs (e.g., applied force, different DPAs). -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests, the "ground truth" is based on internal engineering specifications and standards (e.g., "meet specifications," "acceptable per design specifications," "fluid does not accumulate"). For the "clinical human factor validations," the "ground truth" seems to be the absence of "unacceptable risks or unacceptable use related hazards related to SmartMode™ Technology" as assessed by practicing registered dental hygienists. This implies an expert assessment of performance and safety on typodonts. -
The sample size for the training set:
Not applicable. This is a medical device clearance, not an AI model requiring a training set. The "SmartMode™ Technology" is described as a control mechanism, not a learned AI algorithm. -
How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI model.
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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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 ProphySystem 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® CordlessSystem | 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:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODETMTECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOM™CORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| 510(k) | K160825 | K110753 | N/A |
| Indications forUse | The Midwest® RDHFreedom® CordlessProphy System withSmartMode™ Technologyis a high-performancecordless prophylaxishandpiece with an optionalwireless foot pedal for usewith NUPRO Freedom®disposable prophy anglesin a hygiene operatory toperform cleaning andpolishing procedures onteeth. | The Midwest® RDHFreedom™ CordlessSystem is a high-performance cordlessprophylaxis handpiecewith a wireless footpedal for use withFreedom® disposableprophylaxis angles in ahygiene operatory toperform cleaning andpolishing procedures onteeth. | The wireless footpedal is an optionrather than arequirement foroperation of thecordless handpiecefor the proposeddevice. Use ofSmartMode™provides the samelevel of operationand does not have anegative effect onthe performance ofthe device whenused as labeled. |
| Accessories | NUPRO Freedom®Disposable Prophy AnglesRemovable, autoclavableouter sheath | NUPRO Freedom®Disposable ProphyAnglesRemovable, autoclavableouter sheath | NoneElimination ofaesthetic color ringand pins for |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODE™TECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOM™CORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| Power supply and cord –AC/DC wall plug adapter | Power supply and cord–AC/DC wall plugadapter | cordless handpieceinner module doesnot impactsubstantialequivalence. | |
| Cradle for cordlesshandpiece | Cradle for cordlesshandpiece | None | |
| Optional wireless footpedal | Required wireless footpedal | User has the choiceto use the optionalwireless foot pedalfor proposed devicebut is required touse the predicatedevice foot pedal. | |
| MaterialComposition | Outer Sheath –Aluminum withstainless steel tip Cordless HandpieceInner Module Housing– Plastic Charging Base forCordless HandpieceHousing – Plastic Cradle for CordlessHandpiece – Plastic Foot Pedal Housing –Plastic | Outer Sheath –Aluminum withstainless steel tip Cordless HandpieceInner ModuleHousing - Plastic Charging Base forCordless HandpieceHousing - Plastic Cradle for CordlessHandpiece - Plastic Foot Pedal Housing -Plastic | None |
| CordlessHandpieceControl | The cordless handpiece canbe controlled without afoot pedal viaSmartMode™ Technology,or with an optionalwireless foot pedal. | The cordless handpieceis controlled exclusivelyby the required wirelessfoot pedal. | The wireless footpedal is an optionrather than arequirement foroperation of thecordless handpiecefor the proposeddevice. Use ofSmartMode™provides the samelevel of operation. |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODETMTECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOMTMCORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| SmartMode™Technology | This device hasSmartMode™ Technology.The output speed andtorque of the cordlesshandpiece are controlledby the amount of force theuser applies from the DPAto the tooth, without theuse of the optional wirelessfoot pedal. | This device does nothave SmartMode™Technology. The outputspeed and torque of thecordless handpiece arecontrolled by the amountof force applied to therequired wireless footpedal. | Addition ofSmartMode™feature allows theuser to conductprocedures withoutuse of the wirelessfoot pedal, providesthe same level ofoperation and doesnot have a negativeeffect on theperformance of thedevice when usedas labeled. |
| CordlessHandpieceBluetoothWirelessTechnologyCapabilities | The cordless handpiece hasBluetooth low energy(BLE) wireless technologycapabilities when usedwith the optional wirelessfoot pedal. | The cordless handpiecehas Zigbee wirelesstechnology capabilitieswhen used with therequired wireless footpedal | Similar wirelesstechnology whichresults in the samelevel of operation. |
| CordlessHandpieceMaximumSpeed; | Optional Wireless FootPedal no load$3400\pm300$ rpm | Required Wireless FootPedal no load$3300\pm300$ rpm | When used with theoptional wirelessfoot pedal at noload, the cordlesshandpiece of theproposed deviceprovides equivalentspeed compared tothe handpiece speedat no load of thepredicate devicewhich uses therequired wirelessfoot pedal. |
| MaximumTorque usingFoot Pedal | $9$ mNm maximum load$3000\pm10%$ rpm | $10$ mNm maximum load$3000\pm10%$ rpm | |
| CordlessHandpieceMaximum | $9$ mNm maximum load$3000\pm10%$ rpm | SmartMode™technology is notoffered. | Addition ofSmartMode™technology allows |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODETMTECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOM™CORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| Speed;MaximumTorque usingSmartMode™(without FootPedal) | the user to performcleaning procedureswithout the use of awireless foot pedal. | ||
| CordlessHandpieceInterface | The cordless handpiece hasa user pushbutton thatcontrols mode selection:SmartMode™ or FootPedal Use | The handpiece has oneuser interface: FootPedal Use. | Addition of modecontrol and abilityto make a selectionon the cordlesshandpiece allowsthe user to see thecurrent mode and tochange modes. |
| CordlessHandpieceOn/Off Switch | The cordless handpiece hasa user pushbutton thatcontrols power on/off. | The cordless handpiecedoes not have a poweron/off control. | The proposeddevice has a userpushbutton on thecordless handpiecethat controls poweron/off and offersthe user directcontrol of thepower status. |
| CordlessHandpiecePower Light | The indicator "on" light isilluminated when thepower is on. | The indicator "on" lightis illuminated when thepower is on. | None |
| CordlessHandpieceVisual StatusIndicators | A range of steady andblinking LED indicatorlights on the cordlesshandpiece display thehandpiece status | A range of steady andblinking LED indicatorlights on the cordlesshandpiece display thehandpiece status | The increasednumber of indicatorcolors on theproposed device |
| Mode Status:• Standby = Green• SmartMode™Operation = Purple• Foot Mode Operation =Blue• Internal Temperature of55°C or above =Orange | Mode Status:• Standby = Green• Internal Temperatureof 55°C or above =Orange | provides moreinformation to userregarding modestatus, chargingstatus, level ofcharge,synchronizationstatus, and over-temperature | |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODETMTECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOMTMCORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| Battery State of Charge:• Level of Charge =Green• Needs to be Charged =Orange | Battery State of Charge:• Level of Charge =Green• Needs to be Charge =Orange | condition. | |
| Synchronization Status:• Ready = Blue• Success = Green• Unsuccessful = Orange | Synchronization Status:• Positioned Properly incharging base = Green• Ready = ScrollingGreen and Orange• Successful = Green• Unsuccessful =Orange | ||
| CordlessHandpieceVisual Alarm | Cordless handpiece Modeindicator shows Orangewhen internal printedcircuit board (PCB)temperature is abovenormal. Operator shouldrefrain from using thehandpiece for severalminutes. The light will turnoff when the temperaturereturns to normal. | Cordless handpiece LEDindicator light showsOrange when internalPCB temperature isabove normal. Operatorshould refrain fromusing the handpiece forseveral minutes. Thelight will turn off whenthe temperature returnsto normal. | None |
| CordlessHandpiecePower | The cordless handpiece canbe turned on and offmanually. | The cordless handpiecedoes not have an on/offbutton. The cordlesshandpiece will notactivate when therequired wireless footpedal is more than 30degrees from horizontal. | The addition of anon/off button on theproposed deviceallows the user tohave control overpower status of thecordless handpiece. |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODE™TECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOM™CORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| When not in the chargingbase for cordlesshandpiece, the cordlesshandpiece enters a lowcurrent mode after 1minute of inactivity. Thecordless handpiece"wakes-up" when theOn/Off/Mode button on thecordless handpiece isdepressed or automaticallywhen it is picked up. | When not in thecharging base forcordless handpiece, thecordless handpiece willenter a low current(sleep) mode 1 within 1minute of inactivity."Wake-up" occurs bymoving the handpiece by45 degrees in any axis. | Actions to initiate"wake-up" of thedevices differslightly but result inthe same operationand do not affectsubstantialequivalence. | |
| When not in the chargingbase for cordlesshandpiece, the cordlesshandpiece enters a "Sleep"mode after 24 hours ofinactivity. The cordlesshandpiece "wakes-up"when the On/Off/Modebutton on the cordlesshandpiece is depressed, orwhen placed in thecharging base for thecordless handpiece. | When not in thecharging base forcordless handpiece, thecordless handpieceenters a lower current(sleep) mode 2 within atime period of inactivityafter 7 days but not morethan 14 days ofinactivity. "Wake-up"occurs by placing thehandpiece on the chargerfor 5 seconds to enternormal operating mode. | The proposedhandpiece enters alower current stateafter 1 day ratherthan 7 days for thepredicate. Thispermits the batterysaving operation toinitiate morequickly. Actions toinitiate "wake-up"of the devices differslightly but result inthe same operationand do not affectsubstantialequivalence. | |
| CordlessHandpieceBatteryRechargingCapability | The 3.7 volt Lithium Ionhandpiece battery isrecharged by placing thecordless handpiece in theincluded charging base forthe cordless handpiece. | The 3.7 volt Lithium Ionhandpiece battery isrecharged by placing thecordless handpiece in theincluded charging basefor the cordlesshandpiece. | None |
| CordlessHandpiecePowerConnector | A 5 volt power supply andcord provides batterycharging power through aUSB mini connector to thecharging base for the | A 5 volt power supplyand cord providesbattery charging powerthrough a barrelconnector to the | The proposeddevice providespower through aUSB miniconnector rather |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODE™TECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOM™CORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| cordless handpiece. | charging base for thecordless handpiece. | than a barrelconnector | |
| HandpieceBattery Power | The handpiece battery hassufficient power tocomplete a day's worth ofhygiene procedures on asingle charge (average of10 procedures of anaverage 3 minutes each, or30 minutes total). | The handpiece batteryhas sufficient power tocomplete a day's worthof hygiene procedures ona single charge (averageof 10 procedures of anaverage 3 minutes each.or 30 minutes total). | None |
| HandpieceBattery QuickCharge | The handpiece batterypermits the system to havethe capability ofcompleting one typical 3minute cleaning procedureafter only fifteen minutesof charging. | The handpiece batterypermits the system tohave the capability ofcompleting one typical 3minute cleaningprocedure after onlyfifteen minutes ofcharging. | None |
| HandpieceBatteryReplacement | The handpiecerechargeable battery can bereplaced by factorypersonnel only. | The handpiecerechargeable battery canbe replaced by factorypersonnel only. | None |
| Outer Sheath | Includes removable,autoclavable outer sheathto reduce the risk of patientcross-contamination. | Includes removable,autoclavable outersheath to reduce the riskof patient cross-contamination. | None |
| Outer SheathSurface | The outer sheath includes aroughened surface for grip. | The outer sheathincludes a roughenedsurface for grip. | None |
| Outer SheathHousing Design | The outer sheath housinghas an angled cut designconnection to the cap withan angled termination ofthe shot blast grip area. | The outer sheath housinghas a swoop cut designconnection to the capwith a straighttermination of the shotblast grip area. | The angled cutdesign of theproposed device isan aesthetic choiceand does not affectsubstantialequivalence. |
| Outer SheathHousingRemoval | The outer sheath housingdoes not have an aestheticcolor ring and does nothave pins. The outer sheath | The outer sheath housinghas a rubber aestheticcolor ring to cover pressfit pins that are used for | The proposeddevice does nothave the aestheticcolor ring covering |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODETMTECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOM™CORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| is removed by holding thecap to rotate and slide theouter sheath up the plasticramp of the handpieceinner module or to pull thesheath straight. | the twist-to-removesheath design. | press fit pins on thepredicate. Theplastic ramp on thecordless handpieceinner module on theproposed deviceserves the samefunction as thepress fit pins on thepredicate outersheath. Removal ofthe press fit pinseliminates the needfor the aestheticcolor ring, therequirement for theuser to remove thecolor ring from theouter sheath, and tosterilize the colorring and outersheath separatelyand does not affectsubstantialequivalence.Elimination of thecolor ring and pinsfrom the outersheath of theproposed devicedoes not affectsubstantialequivalence. | |
| Foot PedalWirelessTechnologyCapabilities | The optional wireless footpedal has Bluetooth LowEnergy (BLE) wirelesstechnology capabilitieswhen used with thecordless handpiece. | The required wirelessfoot pedal has Zigbeewireless technologycapabilities when usedwith the cordlesshandpiece. | Bluetooth wirelessradio frequencyprovides the sameoperationalcapabilities as thepredicate, and doesnot affectsubstantialequivalence. |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODETMTECHNOLOGY | PREDICATEDEVICE:MIDWEST® RDHFREEDOM™CORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| Foot PedalVisual StatusIndicators | A range of steady andblinking LED indicatorlights in the optionalwireless foot pedal displaythe foot pedal mode statusin 3 different colors:• Ready to Sync = Blue• Successful Sync =Green• Sync not Successful =OrangeA range of steady andblinking LED indicatorlights in the optionalwireless foot pedal displaythe foot pedal battery stateof charge in 2 differentcolors:• Charged = Green• Requires Charging =Orange | A range of steady andblinking LED indicatorlights in the requiredwireless foot pedaldisplay the foot pedalmode status in 2different colors:• Ready to Sync =Orange• Successful Sync =Green• Sync not Successful =OrangeBattery state of charge isnot shown on therequired wireless footpedal, but is shown byan LED indicator lighton the cordlesshandpiece:• Standby = Green• Requires Charging =Orange | Proposed deviceoptional wirelessfoot pedal showsthe foot pedal stateof charge andsynchronizationstate. Proposeddevice cordlesshandpiece does notdisplay optionalwireless foot pedalstate of charge butdoes showsynchronizationstate. For thepredicate, therequired wirelessfoot pedal state ofcharge was shownon the predicatehandpiece. There isno negative impacton substantialequivalence. Theaddition of thecolor LED displayprovides moreinformation to userregarding mode andcharging status. |
| Foot PedalBattery | The optional wireless footpedal includes arechargeable Lithium Ion(Lithium Cobalt Dioxide)battery, with a protectioncircuit. | The required wirelessfoot pedal includes arechargeable LithiumIon (Lithium CobaltDioxide) battery, with aprotection circuit. | None |
| Foot PedalRechargingCapability | The 3.7 volt Lithium Ionbattery for the optionalwireless foot pedal can berecharged multiple timesby inclusion of a powersupply and cord. | The 3.7 volt Lithium Ionbattery for the requiredwireless foot pedal canbe recharged multipletimes by inclusion of apower supply and cord. | None |
| ELEMENT | PROPOSED DEVICE:MIDWEST® RDHFREEDOM®CORDLESS PROPHYSYSTEM WITHSMARTMODETMTECHNOLOGY | PREDICATE DEVICE:MIDWEST® RDHFREEDOMTMCORDLESS SYSTEM | DIFFERENCESWITHPREDICATEDEVICE |
| Foot PedalReadiness | The optional wireless footpedal enters low currentmode after approximately1 minute of inactivity;wake-up occurs when thefoot pedal cover isdepressed.The optional wireless footpedal does not offer aneven lower current (sleep)mode. | The required wirelessfoot pedal enters lowcurrent (sleep) mode 1within 1 minute ofinactivity; wake-upoccurs when the cover isdepressed byapproximately 25%.The required wirelessfoot pedal enters lowcurrent (sleep) mode 2after 7 days but not morethan 14 days ofinactivity; wake-upoccurs when the cover isdepressed byapproximately 25%. | The optional footpedal of theproposed deviceenters battery-saving mode at thesame point at thepredicate but doesnot have a lowercurrent (sleep)mode. There is noimpact onsubstantialequivalence. |
| Foot PedalSafetyMechanism | The optional wireless footpedal has a power buttonsituated on the bottom sideof the unit to preventaccidentally turning on thefoot pedal and does notrequire a safetymechanism. | The required wirelessfoot pedal does not havea power button. If therequired wireless footpedal is more than 30degrees from horizontal,it will not request thatthe cordless handpiecerotate its motor, evenwhen pressed. | The presence andlocation of a powerbutton on theoptional wirelessfoot pedal offersthe user control ofpower being turnedon for the optionalwireless foot pedal. |
| SheathSterilization | Outer sheath steamsterilizable at 135°C | Outer sheath steamsterilizable at 135°C | None |
| MaterialCompatibility | Biocompatibility meetsrequirements | Biocompatibility meetsrequirements | None |
| ElectromagneticCompatibilityand ElectricalSafety | Meets requirements | Meets requirements | None |
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The difference in Indications for Use between the proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, and the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753) is that use of the wireless foot pedal (K110753) is optional for the proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology.
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Use of SmartMode™ technology to operate the cordless handpiece meets the same intended use as that of the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753). When activated, SmartMode™ mode operates the cordless handpiece with similar speeds and torques as the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753), and does not affect the substantial equivalenceof the device when used as labeled.
The user has the option to use an optional wireless foot pedal (K110753) with the proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, which is similar to the required foot pedal (K110753) of the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753).
The MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™M Technology, and the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753) use the same materials and energy source with essentially the same design.
Non-Clinical Performance Data:
Because the proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, and the predicate device. MIDWEST® RDH Freedom® Cordless System (K110753) use the same materials and energy source with essentially the same design, new biocompatibility testing was not required for the outer sheath to support substantial equivalence. Biocompatibility testing was submitted with the predicate device, MIDWEST® RDH Freedom® Cordless System, and cleared under premarket notification K110753 in June, 2011.
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 should be sterilized prior to use.
The NUPRO Freedom® disposable prophy angles were previously 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.
An optional wireless foot pedal was cleared under premarket notification K110753 in June, 2011 by DENTSPLY International Inc. as MIDWEST® RDH Freedom® Cordless System.
A Disposa-Shield® disposable barrier was 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.
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| Comparison of Performance Data/Physical Properties | ||||
|---|---|---|---|---|
| Physical Property | Test Description | Standard | Proposed DeviceMidwest® RDHFreedom® CordlessProphy System withSmartMode™MTechnology(K160825) | Predicate DeviceMidwest® RDHFreedom® CordlessSystem (K110753) |
| TP-566 BluetoothCompatibility | Verify Foot Pedal cancommunicate with handpieceat distances of 15 Feet, whenexposed to RF interferencefrom other systems. | DENTSPLY ProfessionalInternal Test Method | PassBluetooth | PassZigbee |
| TP-513 SmartMode™Performance | Verify performance ofSmartMode, includingability of the user to overrideand motor stop features. | DENTSPLY ProfessionalInternal Test Method | Pass | N/A * |
| TP-602 SmartModeTechnology Performancewith Various Types ofDPA's | Verify performance ofSmartMode when usingdifferent types of DPA's. | DENTSPLY ProfessionalInternal Test Method | Pass | N/A * |
| TP-509 Cordless HandpieceInner Module Push Button,Battery Indicator, SleepMode Functionality | Verify functionality of theInner Module button andbattery indicator and properfunctionality of sleep mode. | DENTSPLY ProfessionalInternal Test Method | Pass | N/A ** |
| TP-507 Speed Control andLevel of Usage on a SingleCharge | Verify that the Inner Modulecapable of performing oneday's worth of procedures(10 procedures) on a singlecharge. | DENTSPLY ProfessionalInternal Test Method | Pass | Pass |
| Comparison of Performance Data/Physical Properties | ||||
| Physical Property | Test Description | Standard | Proposed DeviceMidwest® RDHFreedom® CordlessProphy System withSmartMode™MTechnology(K160825) | Predicate DeviceMidwest® RDHFreedom® CordlessSystem (K110753) |
| TP-506 Speed TorquePerformance | Verify that the speedperformance of the InnerModule meets specificationswhen various loads areapplied to simulate actualuse. | DENTSPLY ProfessionalInternal Test Method | Pass | Pass |
| TP-515 Outer SheathInsertion/Extraction Forces | Verify that the force requiredto insert and extract theOuter Sheath from the InnerModule is acceptable per thedesign specifications. | DENTSPLY ProfessionalInternal Test Method | Pass | Pass |
| TP-505 System ComponentPhysical Attributes | Verify that the general size,shape, weight, and center ofgravity attributes areacceptable per the designspecifications. | DENTSPLY ProfessionalInternal Test Method | Pass | Pass |
| TP-517 Cordless HandpieceInner Module LiquidsIngress Test | Verify that fluid does notaccumulate in the InnerModule. | DENTSPLYProfessional InternalTest Method/IEC | Pass | Pass |
| TP-508 Foot PedalPerformance | To verify foot pedal batterycapacity and the ability for it tooperate on a fully drainedbattery when plugged in to thepower supply. | DENTSPLYProfessional InternalTest Method | Pass | Pass |
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Performance testing focused on verification of design, prophylaxis cleaning and polishing performance, and safety of the MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology. Below is a list of the standards to which testing was performed:
- AAMI ANSI ES 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (2005; reapproved 2012)
- -IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility (2007)
- FDA Dental Handpieces Premarket Notification [510(k)] Submissions -
- -FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation
The results of these performance tests support the substantial equivalence of the proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartModeTM Technology, with the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753).
Clinical Performance Data.
Professional evaluations were conducted considering the proposed device intended use, users, and use environments. All studies were completed by practicing registered dental hygienists on dental typodonts to simulate intended use, users, and use environments.
As a result of multiple professional evaluations with typodonts and clinical human factor validations involving performance testing, data was gathered to support our assessment that the risk of potential for tissue damage has been adequately mitigated and no unacceptable risks or unacceptable use related hazards related to SmartModeTM Technology were identified.
Conclusion Regarding Substantial Equivalence
The proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, is a high-performance cordless prophylaxis handpiece with an optional wireless foot pedal (K110753) for use with proprietary disposable prophy angles (K030603; K954802) which is intended to clean and polish teeth. The MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate, MIDWEST® RDH Freedom® Cordless Prophy System (K110753). MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, uses the same material and energy source, and has essentially the same design as the predicate device. MIDWEST® RDH Freedom® Cordless System (K110753).
Use of SmartMode™ technology to operate the cordless handpiece meets the same intended use as that of the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753). When activated. SmartMode™ drives operation of the cordless handpiece with similar speeds and torques as the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753), and does not affect the device when used as labeled. The user has the option to use an optional wireless foot pedal (K110753) with the
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proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, which is similar to the required foot pedal (K110753) of the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753).
Test data to verify the performance of the proposed device, MIDWEST® RDH Freedom® Cordless Prophy System with SmartMode™ Technology, have been provided including: wireless functionality; SmartMode™ performance; module and indicator functionality; speed control and level of usage for a single charge; speed, current and torque; cordless handpiece inner module and outer sheath insertion/extraction forces; system physical dimensions and weight; liquids ingress; and foot pedal performance.
The results of this performance testing, combined with the design and intended use comparison with the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753), support substantial equivalence to, the predicate device, MIDWEST® RDH Freedom® Cordless System (K110753).
§ 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.