(186 days)
No
The summary mentions "SmartMode™ Technology" and performance testing related to it, but there is no mention of AI, ML, or any related concepts like training data, algorithms, or image processing that would indicate the use of AI/ML. The performance testing focuses on functional aspects like speed control, wireless functionality, and safety.
No.
The device is used for cleaning and polishing teeth, which are cosmetic and maintenance procedures, not therapeutic interventions for a disease or condition.
No
The device is described as a cordless prophylaxis handpiece for cleaning and polishing procedures on teeth, which is a therapeutic rather than a diagnostic function.
No
The device description explicitly lists multiple hardware components including a cordless handpiece, charging base, cradle, power supply, and disposable prophy angles. While it mentions "SmartMode™ Technology" and Bluetooth, the core functionality is driven by physical hardware.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "to perform cleaning and polishing procedures on teeth." This is a direct treatment/procedure performed on the patient's teeth, not a test performed on a sample taken from the body.
- Device Description: The description details a cordless handpiece, charging base, power supply, and disposable prophy angles. These are all tools used for a physical procedure on the teeth.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
The device is clearly intended for a dental procedure performed directly on the patient's teeth, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / 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.
Product codes
EKX
Device Description
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental clinician / hygiene operatory
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)
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. The tests performed are:
- TP-566 Bluetooth Compatibility: Verify Foot Pedal can communicate with handpiece at distances of 15 Feet, when exposed to RF interference from other systems. Result: Pass
- TP-513 SmartMode™ Performance: Verify performance of SmartMode, including ability of the user to override and motor stop features. Result: Pass
- TP-602 SmartMode Technology Performance with Various Types of DPAs: Verify performance of SmartMode when using different types of DPAs. Result: Pass
- TP-509 Cordless Handpiece Inner Module Push Button, Battery Indicator, Sleep Mode Functionality: Verify functionality of the Inner Module button and battery indicator and proper functionality of sleep mode. Result: Pass
- TP-507 Speed Control and Level of Usage on a Single Charge: Verify that the Inner Module capable of performing one day's worth of procedures (10 procedures) on a single charge. Result: Pass
- TP-506 Speed Torque Performance: Verify that the speed performance of the Inner Module meets specifications when various loads are applied to simulate actual use. Result: Pass
- TP-515 Outer Sheath Insertion/Extraction Forces: Verify that the force required to insert and extract the Outer Sheath from the Inner Module is acceptable per the design specifications. Result: Pass
- TP-505 System Component Physical Attributes: Verify that the general size, shape, weight, and center of gravity attributes are acceptable per the design specifications. Result: Pass
- TP-517 Cordless Handpiece Inner Module Liquids Ingress Test: Verify that fluid does not accumulate in the Inner Module. Result: Pass
- TP-508 Foot Pedal Performance: To verify foot pedal battery capacity and the ability for it to operate on a fully drained battery when plugged in to the power supply. Result: Pass
Clinical Performance Data: Professional evaluations were conducted by practicing registered dental hygienists on dental typodonts to simulate intended use, users, and use environments. Data gathered supports the 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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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
1
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
2
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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3
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
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 | ||
| 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
4
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.
5
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® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODETM | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOM™ | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| 510(k) | K160825 | K110753 | N/A |
| 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. | The Midwest® RDH | ||
| Freedom™ Cordless | |||
| System is a high- | |||
| performance cordless | |||
| prophylaxis handpiece | |||
| with a wireless foot | |||
| pedal for use with | |||
| Freedom® disposable | |||
| prophylaxis angles in a | |||
| hygiene operatory to | |||
| perform cleaning and | |||
| polishing procedures on | |||
| teeth. | The wireless foot | ||
| pedal is an option | |||
| rather than a | |||
| requirement for | |||
| operation of the | |||
| cordless handpiece | |||
| for the proposed | |||
| device. Use of | |||
| SmartMode™ | |||
| provides the same | |||
| level of operation | |||
| and does not have a | |||
| negative effect on | |||
| the performance of | |||
| the device when | |||
| used as labeled. | |||
| Accessories | NUPRO Freedom® | ||
| Disposable Prophy Angles | |||
| Removable, autoclavable | |||
| outer sheath | NUPRO Freedom® | ||
| Disposable Prophy | |||
| Angles | |||
| Removable, autoclavable | |||
| outer sheath | None | ||
| Elimination of | |||
| aesthetic color ring | |||
| and pins for | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODE™ | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOM™ | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| Power supply and cord – | |||
| AC/DC wall plug adapter | Power supply and cord– | ||
| AC/DC wall plug | |||
| adapter | cordless handpiece | ||
| inner module does | |||
| not impact | |||
| substantial | |||
| equivalence. | |||
| Cradle for cordless | |||
| handpiece | Cradle for cordless | ||
| handpiece | None | ||
| Optional wireless foot | |||
| pedal | Required wireless foot | ||
| pedal | User has the choice | ||
| to use the optional | |||
| wireless foot pedal | |||
| for proposed device | |||
| but is required to | |||
| use the predicate | |||
| device foot pedal. | |||
| Material | |||
| Composition | Outer Sheath – | ||
| Aluminum with | |||
| stainless steel tip Cordless Handpiece | |||
| Inner Module Housing | |||
| – Plastic Charging Base for | |||
| Cordless Handpiece | |||
| Housing – Plastic Cradle for Cordless | |||
| Handpiece – Plastic Foot Pedal Housing – | |||
| Plastic | Outer Sheath – | ||
| Aluminum with | |||
| stainless steel tip Cordless Handpiece | |||
| Inner Module | |||
| Housing - Plastic Charging Base for | |||
| Cordless Handpiece | |||
| Housing - Plastic Cradle for Cordless | |||
| Handpiece - Plastic Foot Pedal Housing - | |||
| Plastic | None | ||
| Cordless | |||
| Handpiece | |||
| Control | The cordless handpiece can | ||
| be controlled without a | |||
| foot pedal via | |||
| SmartMode™ Technology, | |||
| or with an optional | |||
| wireless foot pedal. | The cordless handpiece | ||
| is controlled exclusively | |||
| by the required wireless | |||
| foot pedal. | The wireless foot | ||
| pedal is an option | |||
| rather than a | |||
| requirement for | |||
| operation of the | |||
| cordless handpiece | |||
| for the proposed | |||
| device. Use of | |||
| SmartMode™ | |||
| provides the same | |||
| level of operation. | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODETM | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOMTM | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| SmartMode™ | |||
| Technology | This device has | ||
| SmartMode™ Technology. | |||
| The output speed and | |||
| torque of the cordless | |||
| handpiece are controlled | |||
| by the amount of force the | |||
| user applies from the DPA | |||
| to the tooth, without the | |||
| use of the optional wireless | |||
| foot pedal. | This device does not | ||
| have SmartMode™ | |||
| Technology. The output | |||
| speed and torque of the | |||
| cordless handpiece are | |||
| controlled by the amount | |||
| of force applied to the | |||
| required wireless foot | |||
| pedal. | Addition of | ||
| SmartMode™ | |||
| feature allows the | |||
| user to conduct | |||
| procedures without | |||
| use of the wireless | |||
| foot pedal, provides | |||
| the same level of | |||
| operation and does | |||
| not have a negative | |||
| effect on the | |||
| performance of the | |||
| device when used | |||
| as labeled. | |||
| Cordless | |||
| Handpiece | |||
| Bluetooth | |||
| Wireless | |||
| Technology | |||
| Capabilities | The cordless handpiece has | ||
| Bluetooth low energy | |||
| (BLE) wireless technology | |||
| capabilities when used | |||
| with the optional wireless | |||
| foot pedal. | The cordless handpiece | ||
| has Zigbee wireless | |||
| technology capabilities | |||
| when used with the | |||
| required wireless foot | |||
| pedal | Similar wireless | ||
| technology which | |||
| results in the same | |||
| level of operation. | |||
| Cordless | |||
| Handpiece | |||
| Maximum | |||
| Speed; | Optional Wireless Foot | ||
| Pedal no load | |||
| $3400\pm300$ rpm | Required Wireless Foot | ||
| Pedal no load | |||
| $3300\pm300$ rpm | When used with the | ||
| optional wireless | |||
| foot pedal at no | |||
| load, the cordless | |||
| handpiece of the | |||
| proposed device | |||
| provides equivalent | |||
| speed compared to | |||
| the handpiece speed | |||
| at no load of the | |||
| predicate device | |||
| which uses the | |||
| required wireless | |||
| foot pedal. | |||
| Maximum | |||
| Torque using | |||
| Foot Pedal | $9$ mNm maximum load | ||
| $3000\pm10%$ rpm | $10$ mNm maximum load | ||
| $3000\pm10%$ rpm | |||
| Cordless | |||
| Handpiece | |||
| Maximum | $9$ mNm maximum load | ||
| $3000\pm10%$ rpm | SmartMode™ | ||
| technology is not | |||
| offered. | Addition of | ||
| SmartMode™ | |||
| technology allows | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODETM | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOM™ | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| Speed; | |||
| Maximum | |||
| Torque using | |||
| SmartMode™ | |||
| (without Foot | |||
| Pedal) | the user to perform | ||
| cleaning procedures | |||
| without the use of a | |||
| wireless foot pedal. | |||
| Cordless | |||
| Handpiece | |||
| Interface | The cordless handpiece has | ||
| a user pushbutton that | |||
| controls mode selection: | |||
| SmartMode™ or Foot | |||
| Pedal Use | The handpiece has one | ||
| user interface: Foot | |||
| Pedal Use. | Addition of mode | ||
| control and ability | |||
| to make a selection | |||
| on the cordless | |||
| handpiece allows | |||
| the user to see the | |||
| current mode and to | |||
| change modes. | |||
| Cordless | |||
| Handpiece | |||
| On/Off Switch | The cordless handpiece has | ||
| a user pushbutton that | |||
| controls power on/off. | The cordless handpiece | ||
| does not have a power | |||
| on/off control. | The proposed | ||
| device has a user | |||
| pushbutton on the | |||
| cordless handpiece | |||
| that controls power | |||
| on/off and offers | |||
| the user direct | |||
| control of the | |||
| power status. | |||
| Cordless | |||
| Handpiece | |||
| Power Light | The indicator "on" light is | ||
| illuminated when the | |||
| power is on. | The indicator "on" light | ||
| is illuminated when the | |||
| power is on. | None | ||
| Cordless | |||
| Handpiece | |||
| Visual Status | |||
| Indicators | A range of steady and | ||
| blinking LED indicator | |||
| lights on the cordless | |||
| handpiece display the | |||
| handpiece status | A range of steady and | ||
| blinking LED indicator | |||
| lights on the cordless | |||
| handpiece display the | |||
| handpiece status | The increased | ||
| number of indicator | |||
| colors on the | |||
| proposed device | |||
| Mode Status: | |||
| • Standby = Green | |||
| • SmartMode™ | |||
| Operation = Purple | |||
| • Foot Mode Operation = | |||
| Blue | |||
| • Internal Temperature of | |||
| 55°C or above = | |||
| Orange | Mode Status: | ||
| • Standby = Green | |||
| • Internal Temperature | |||
| of 55°C or above = | |||
| Orange | provides more | ||
| information to user | |||
| regarding mode | |||
| status, charging | |||
| status, level of | |||
| charge, | |||
| synchronization | |||
| status, and over- | |||
| temperature | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODETM | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOMTM | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| 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 in | |||
| charging base = Green | |||
| • Ready = Scrolling | |||
| Green and Orange | |||
| • Successful = Green | |||
| • Unsuccessful = | |||
| Orange | |||
| Cordless | |||
| Handpiece | |||
| Visual Alarm | Cordless handpiece Mode | ||
| indicator shows Orange | |||
| when internal printed | |||
| circuit board (PCB) | |||
| temperature is above | |||
| normal. Operator should | |||
| refrain from using the | |||
| handpiece for several | |||
| minutes. The light will turn | |||
| off when the temperature | |||
| returns to normal. | Cordless handpiece LED | ||
| indicator light shows | |||
| Orange when internal | |||
| PCB temperature is | |||
| above normal. Operator | |||
| should refrain from | |||
| using the handpiece for | |||
| several minutes. The | |||
| light will turn off when | |||
| the temperature returns | |||
| to normal. | None | ||
| Cordless | |||
| Handpiece | |||
| Power | The cordless handpiece can | ||
| be turned on and off | |||
| manually. | The cordless handpiece | ||
| does not have an on/off | |||
| button. The cordless | |||
| handpiece will not | |||
| activate when the | |||
| required wireless foot | |||
| pedal is more than 30 | |||
| degrees from horizontal. | The addition of an | ||
| on/off button on the | |||
| proposed device | |||
| allows the user to | |||
| have control over | |||
| power status of the | |||
| cordless handpiece. | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODE™ | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOM™ | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| When not in the charging | |||
| base for cordless | |||
| handpiece, the cordless | |||
| handpiece enters a low | |||
| current mode after 1 | |||
| minute of inactivity. The | |||
| cordless handpiece | |||
| "wakes-up" when the | |||
| On/Off/Mode button on the | |||
| cordless handpiece is | |||
| depressed or automatically | |||
| when it is picked up. | When not in the | ||
| charging base for | |||
| cordless handpiece, the | |||
| cordless handpiece will | |||
| enter a low current | |||
| (sleep) mode 1 within 1 | |||
| minute of inactivity. | |||
| "Wake-up" occurs by | |||
| moving the handpiece by | |||
| 45 degrees in any axis. | Actions to initiate | ||
| "wake-up" of the | |||
| devices differ | |||
| slightly but result in | |||
| the same operation | |||
| and do not affect | |||
| substantial | |||
| equivalence. | |||
| When not in the charging | |||
| base for cordless | |||
| handpiece, the cordless | |||
| handpiece enters a "Sleep" | |||
| mode after 24 hours of | |||
| inactivity. The cordless | |||
| handpiece "wakes-up" | |||
| when the On/Off/Mode | |||
| button on the cordless | |||
| handpiece is depressed, or | |||
| when placed in the | |||
| charging base for the | |||
| cordless handpiece. | When not in the | ||
| charging base for | |||
| cordless handpiece, the | |||
| cordless handpiece | |||
| enters a lower current | |||
| (sleep) mode 2 within a | |||
| time period of inactivity | |||
| after 7 days but not more | |||
| than 14 days of | |||
| inactivity. "Wake-up" | |||
| occurs by placing the | |||
| handpiece on the charger | |||
| for 5 seconds to enter | |||
| normal operating mode. | The proposed | ||
| handpiece enters a | |||
| lower current state | |||
| after 1 day rather | |||
| than 7 days for the | |||
| predicate. This | |||
| permits the battery | |||
| saving operation to | |||
| initiate more | |||
| quickly. Actions to | |||
| initiate "wake-up" | |||
| of the devices differ | |||
| slightly but result in | |||
| the same operation | |||
| and do not affect | |||
| substantial | |||
| equivalence. | |||
| Cordless | |||
| Handpiece | |||
| Battery | |||
| Recharging | |||
| Capability | The 3.7 volt Lithium Ion | ||
| handpiece battery is | |||
| recharged by placing the | |||
| cordless handpiece in the | |||
| included charging base for | |||
| the cordless handpiece. | The 3.7 volt Lithium Ion | ||
| handpiece battery is | |||
| recharged by placing the | |||
| cordless handpiece in the | |||
| included charging base | |||
| for the cordless | |||
| handpiece. | None | ||
| Cordless | |||
| Handpiece | |||
| Power | |||
| Connector | A 5 volt power supply and | ||
| cord provides battery | |||
| charging power through a | |||
| USB mini connector to the | |||
| charging base for the | A 5 volt power supply | ||
| and cord provides | |||
| battery charging power | |||
| through a barrel | |||
| connector to the | The proposed | ||
| device provides | |||
| power through a | |||
| USB mini | |||
| connector rather | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODE™ | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOM™ | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| cordless handpiece. | charging base for the | ||
| cordless handpiece. | than a barrel | ||
| connector | |||
| Handpiece | |||
| Battery Power | The handpiece battery has | ||
| sufficient power to | |||
| complete a day's worth of | |||
| hygiene procedures on a | |||
| single charge (average of | |||
| 10 procedures of an | |||
| average 3 minutes each, or | |||
| 30 minutes total). | The handpiece battery | ||
| has sufficient power to | |||
| complete a day's worth | |||
| of hygiene procedures on | |||
| a single charge (average | |||
| of 10 procedures of an | |||
| average 3 minutes each. | |||
| or 30 minutes total). | None | ||
| Handpiece | |||
| Battery Quick | |||
| Charge | The handpiece battery | ||
| permits the system to have | |||
| the capability of | |||
| completing one typical 3 | |||
| minute cleaning procedure | |||
| after only fifteen minutes | |||
| of charging. | The handpiece battery | ||
| permits the system to | |||
| have the capability of | |||
| completing one typical 3 | |||
| minute cleaning | |||
| procedure after only | |||
| fifteen minutes of | |||
| charging. | None | ||
| Handpiece | |||
| Battery | |||
| Replacement | The handpiece | ||
| rechargeable battery can be | |||
| replaced by factory | |||
| personnel only. | The handpiece | ||
| rechargeable battery can | |||
| be replaced by factory | |||
| personnel only. | None | ||
| Outer Sheath | Includes removable, | ||
| autoclavable outer sheath | |||
| to reduce the risk of patient | |||
| cross-contamination. | Includes removable, | ||
| autoclavable outer | |||
| sheath to reduce the risk | |||
| of patient cross- | |||
| contamination. | None | ||
| Outer Sheath | |||
| Surface | The outer sheath includes a | ||
| roughened surface for grip. | The outer sheath | ||
| includes a roughened | |||
| surface for grip. | None | ||
| Outer Sheath | |||
| Housing Design | The outer sheath housing | ||
| has an angled cut design | |||
| connection to the cap with | |||
| an angled termination of | |||
| the shot blast grip area. | The outer sheath housing | ||
| has a swoop cut design | |||
| connection to the cap | |||
| with a straight | |||
| termination of the shot | |||
| blast grip area. | The angled cut | ||
| design of the | |||
| proposed device is | |||
| an aesthetic choice | |||
| and does not affect | |||
| substantial | |||
| equivalence. | |||
| Outer Sheath | |||
| Housing | |||
| Removal | The outer sheath housing | ||
| does not have an aesthetic | |||
| color ring and does not | |||
| have pins. The outer sheath | The outer sheath housing | ||
| has a rubber aesthetic | |||
| color ring to cover press | |||
| fit pins that are used for | The proposed | ||
| device does not | |||
| have the aesthetic | |||
| color ring covering | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODETM | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOM™ | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| is removed by holding the | |||
| cap to rotate and slide the | |||
| outer sheath up the plastic | |||
| ramp of the handpiece | |||
| inner module or to pull the | |||
| sheath straight. | the twist-to-remove | ||
| sheath design. | press fit pins on the | ||
| predicate. The | |||
| plastic ramp on the | |||
| cordless handpiece | |||
| inner module on the | |||
| proposed device | |||
| serves the same | |||
| function as the | |||
| press fit pins on the | |||
| predicate outer | |||
| sheath. Removal of | |||
| the press fit pins | |||
| eliminates the need | |||
| for the aesthetic | |||
| color ring, the | |||
| requirement for the | |||
| user to remove the | |||
| color ring from the | |||
| outer sheath, and to | |||
| sterilize the color | |||
| ring and outer | |||
| sheath separately | |||
| and does not affect | |||
| substantial | |||
| equivalence. | |||
| Elimination of the | |||
| color ring and pins | |||
| from the outer | |||
| sheath of the | |||
| proposed device | |||
| does not affect | |||
| substantial | |||
| equivalence. | |||
| Foot Pedal | |||
| Wireless | |||
| Technology | |||
| Capabilities | The optional wireless foot | ||
| pedal has Bluetooth Low | |||
| Energy (BLE) wireless | |||
| technology capabilities | |||
| when used with the | |||
| cordless handpiece. | The required wireless | ||
| foot pedal has Zigbee | |||
| wireless technology | |||
| capabilities when used | |||
| with the cordless | |||
| handpiece. | Bluetooth wireless | ||
| radio frequency | |||
| provides the same | |||
| operational | |||
| capabilities as the | |||
| predicate, and does | |||
| not affect | |||
| substantial | |||
| equivalence. | |||
| ELEMENT | PROPOSED DEVICE: | ||
| MIDWEST® RDH | |||
| FREEDOM® | |||
| CORDLESS PROPHY | |||
| SYSTEM WITH | |||
| SMARTMODETM | |||
| TECHNOLOGY | PREDICATE | ||
| DEVICE: | |||
| MIDWEST® RDH | |||
| FREEDOM™ | |||
| CORDLESS SYSTEM | DIFFERENCES | ||
| WITH | |||
| PREDICATE | |||
| DEVICE | |||
| Foot Pedal | |||
| Visual Status | |||
| Indicators | A range of steady and | ||
| blinking LED indicator | |||
| lights in the optional | |||
| wireless foot pedal display | |||
| the foot pedal mode status | |||
| in 3 different colors: | |||
| • Ready to Sync = Blue | |||
| • Successful Sync = | |||
| Green | |||
| • Sync not Successful = | |||
| Orange |
A range of steady and
blinking LED indicator
lights in the optional
wireless foot pedal display
the foot pedal battery state
of charge in 2 different
colors:
• Charged = Green
• Requires Charging =
Orange | A range of steady and
blinking LED indicator
lights in the required
wireless foot pedal
display the foot pedal
mode status in 2
different colors:
• Ready to Sync =
Orange
• Successful Sync =
Green
• Sync not Successful =
Orange
Battery state of charge is
not shown on the
required wireless foot
pedal, but is shown by
an LED indicator light
on the cordless
handpiece:
• Standby = Green
• Requires Charging =
Orange | Proposed device
optional wireless
foot pedal shows
the foot pedal state
of charge and
synchronization
state. Proposed
device cordless
handpiece does not
display optional
wireless foot pedal
state of charge but
does show
synchronization
state. For the
predicate, the
required wireless
foot pedal state of
charge was shown
on the predicate
handpiece. There is
no negative impact
on substantial
equivalence. The
addition of the
color LED display
provides more
information to user
regarding mode and
charging status. |
| Foot Pedal
Battery | The optional wireless foot
pedal includes a
rechargeable Lithium Ion
(Lithium Cobalt Dioxide)
battery, with a protection
circuit. | The required wireless
foot pedal includes a
rechargeable Lithium
Ion (Lithium Cobalt
Dioxide) battery, with a
protection circuit. | None |
| Foot Pedal
Recharging
Capability | The 3.7 volt Lithium Ion
battery for the optional
wireless foot pedal can be
recharged multiple times
by inclusion of a power
supply and cord. | The 3.7 volt Lithium Ion
battery for the required
wireless foot pedal can
be recharged multiple
times by inclusion of a
power supply and cord. | None |
| ELEMENT | PROPOSED DEVICE:
MIDWEST® RDH
FREEDOM®
CORDLESS PROPHY
SYSTEM WITH
SMARTMODETM
TECHNOLOGY | PREDICATE DEVICE:
MIDWEST® RDH
FREEDOMTM
CORDLESS SYSTEM | DIFFERENCES
WITH
PREDICATE
DEVICE |
| Foot Pedal
Readiness | The optional wireless foot
pedal enters low current
mode after approximately
1 minute of inactivity;
wake-up occurs when the
foot pedal cover is
depressed.
The optional wireless foot
pedal does not offer an
even lower current (sleep)
mode. | The required wireless
foot pedal enters low
current (sleep) mode 1
within 1 minute of
inactivity; wake-up
occurs when the cover is
depressed by
approximately 25%.
The required wireless
foot pedal enters low
current (sleep) mode 2
after 7 days but not more
than 14 days of
inactivity; wake-up
occurs when the cover is
depressed by
approximately 25%. | The optional foot
pedal of the
proposed device
enters battery-
saving mode at the
same point at the
predicate but does
not have a lower
current (sleep)
mode. There is no
impact on
substantial
equivalence. |
| Foot Pedal
Safety
Mechanism | The optional wireless foot
pedal has a power button
situated on the bottom side
of the unit to prevent
accidentally turning on the
foot pedal and does not
require a safety
mechanism. | The required wireless
foot pedal does not have
a power button. If the
required wireless foot
pedal is more than 30
degrees from horizontal,
it will not request that
the cordless handpiece
rotate its motor, even
when pressed. | The presence and
location of a power
button on the
optional wireless
foot pedal offers
the user control of
power being turned
on for the optional
wireless foot pedal. |
| Sheath
Sterilization | Outer sheath steam
sterilizable at 135°C | Outer sheath steam
sterilizable at 135°C | None |
| Material
Compatibility | Biocompatibility meets
requirements | Biocompatibility meets
requirements | None |
| Electromagnetic
Compatibility
and Electrical
Safety | Meets requirements | Meets requirements | None |
6
7
8
9
10
11
12
13
14
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.
15
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.
16
| Comparison of Performance Data/Physical Properties | ||||
|---|---|---|---|---|
| Physical Property | Test Description | Standard | Proposed Device | |
| Midwest® RDH | ||||
| Freedom® Cordless | ||||
| Prophy System with | ||||
| SmartMode™M | ||||
| Technology(K160825) | Predicate Device | |||
| Midwest® RDH | ||||
| Freedom® Cordless | ||||
| System (K110753) | ||||
| TP-566 Bluetooth | ||||
| Compatibility | Verify Foot Pedal can | |||
| communicate with handpiece | ||||
| at distances of 15 Feet, when | ||||
| exposed to RF interference | ||||
| from other systems. | DENTSPLY Professional | |||
| Internal Test Method | Pass | |||
| Bluetooth | Pass | |||
| Zigbee | ||||
| TP-513 SmartMode™ | ||||
| Performance | Verify performance of | |||
| SmartMode, including | ||||
| ability of the user to override | ||||
| and motor stop features. | DENTSPLY Professional | |||
| Internal Test Method | Pass | N/A * | ||
| TP-602 SmartMode | ||||
| Technology Performance | ||||
| with Various Types of | ||||
| DPA's | Verify performance of | |||
| SmartMode when using | ||||
| different types of DPA's. | DENTSPLY Professional | |||
| Internal Test Method | Pass | N/A * | ||
| TP-509 Cordless Handpiece | ||||
| Inner Module Push Button, | ||||
| Battery Indicator, Sleep | ||||
| Mode Functionality | Verify functionality of the | |||
| Inner Module button and | ||||
| battery indicator and proper | ||||
| functionality of sleep mode. | DENTSPLY Professional | |||
| Internal Test Method | Pass | N/A ** | ||
| TP-507 Speed Control and | ||||
| Level of Usage on a Single | ||||
| Charge | Verify that the Inner Module | |||
| capable of performing one | ||||
| day's worth of procedures | ||||
| (10 procedures) on a single | ||||
| charge. | DENTSPLY Professional | |||
| Internal Test Method | Pass | Pass | ||
| Comparison of Performance Data/Physical Properties | ||||
| Physical Property | Test Description | Standard | Proposed Device | |
| Midwest® RDH | ||||
| Freedom® Cordless | ||||
| Prophy System with | ||||
| SmartMode™M | ||||
| Technology(K160825) | Predicate Device | |||
| Midwest® RDH | ||||
| Freedom® Cordless | ||||
| System (K110753) | ||||
| TP-506 Speed Torque | ||||
| Performance | Verify that the speed | |||
| performance of the Inner | ||||
| Module meets specifications | ||||
| when various loads are | ||||
| applied to simulate actual | ||||
| use. | DENTSPLY Professional | |||
| Internal Test Method | Pass | Pass | ||
| TP-515 Outer Sheath | ||||
| Insertion/Extraction Forces | Verify that the force required | |||
| to insert and extract the | ||||
| Outer Sheath from the Inner | ||||
| Module is acceptable per the | ||||
| design specifications. | DENTSPLY Professional | |||
| Internal Test Method | Pass | Pass | ||
| TP-505 System Component | ||||
| Physical Attributes | Verify that the general size, | |||
| shape, weight, and center of | ||||
| gravity attributes are | ||||
| acceptable per the design | ||||
| specifications. | DENTSPLY Professional | |||
| Internal Test Method | Pass | Pass | ||
| TP-517 Cordless Handpiece | ||||
| Inner Module Liquids | ||||
| Ingress Test | Verify that fluid does not | |||
| accumulate in the Inner | ||||
| Module. | DENTSPLY | |||
| Professional Internal | ||||
| Test Method/IEC | Pass | Pass | ||
| TP-508 Foot Pedal | ||||
| Performance | To verify foot pedal battery | |||
| capacity and the ability for it to | ||||
| operate on a fully drained | ||||
| battery when plugged in to the | ||||
| power supply. | DENTSPLY | |||
| Professional Internal | ||||
| Test Method | Pass | Pass |
17
18
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).