Young INFINITY Cordless Handpiece System

K171377 · Young Dental Manufacturing Co. 1, LLC · EKX · Aug 20, 2018 · Dental

Device Facts

• Record ID: K171377
• Device Name: Young INFINITY Cordless Handpiece System
• Applicant: Young Dental Manufacturing Co. 1, LLC
• Product Code: EKX · Dental
• Decision Date: Aug 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1

Intended Use

Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.

Device Story

The Young INFINITY Cordless Handpiece System is a battery-powered dental handpiece used for cleaning and polishing tooth surfaces and fillings. It consists of a handpiece, removable nosecone, charging cradle, and a wireless foot controller. The clinician operates the device by using the foot controller, which communicates with the handpiece via Bluetooth Low Energy (BLE). Vertical pressure on the foot controller regulates the handpiece speed (500–3000 RPM). The handpiece features an LED indicator for battery status, charging, foot control power, excessive pressure, and wireless pairing. The device is used in a dental hygiene operatory. The removable nosecone is steam-sterilized between patients, while the handpiece is protected by an FDA-cleared disposable barrier sleeve. The system provides a cordless, ergonomic alternative to traditional corded handpieces, facilitating dental hygiene procedures.

Clinical Evidence

Bench testing only. Validation included component specifications, speed/torque control, BLE connectivity, battery life, noise, software validation, chemical compatibility, sterilizability (ISO 17665-1/2), biocompatibility (ISO 10993-1/5), fluid ingress, and electrical safety (IEC 60601-1, IEC 60601-1-2). Performance was compared to the predicate device regarding speed, torque, weight, and dimensions. Risk analysis performed per ISO 14971.

Technological Characteristics

Battery-powered (Lithium-Ion) cordless handpiece; rotary operation; 500-3000 RPM speed range; 1Ncm torque. Connectivity via Bluetooth Low Energy (BLE). Removable, autoclavable nosecone. Complies with ISO 14457. Software classified as moderate level of concern.

Indications for Use

Indicated for dental clinicians to perform cleaning and polishing of tooth surfaces and fillings in a hygiene operatory setting.

Regulatory Classification

Identification

A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.

Predicate Devices

• Midwest RDH Freedom Cordless Prophy System (K110753)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Young Dental Manufacturing Co 1, LLC Brian Prange Sr. Engineer, New Product Development 13705 Shoreline Ct East Earth City, Missouri 63045

Re: K171377

Trade/Device Name: Young INFINITY Cordless Handpiece System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX Dated: July 19, 2018 Received: July 20, 2018

Dear Brian Prange:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

August 20, 2018

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -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}------------------------------------------------

#### 7.1 Indications for Use Statement

### Indications for Use

510(k) Number: K171377

Device Name: Young INFINITY Cordless Handpiece System

Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.

| Prescription Use | X |
|-----------------------------|--------|
| (Part 21 CFR 801 Subpart D) | |
| | AND/OR |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) | |

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

# 510(k) Summary

As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.93, 510(k) summary is provided.

### DATE: August 17, 2018

#### l. SUBMITTER

Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045

Tel: [phone] Email: [e-mail]

### II. OFFICIAL CORRESPONDENCE/CONTACT PERSON

Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045

Tel: [phone] Email: [e-mail]

#### III. 510(K) PREPARER

Scott Edwards 8888 Keystone Crossing Suite 1550 Indianapolis, IN 46240

Tel: [phone] Email: [e-mail]

#### IV. DEVICE

Brand Name of Device: Young INFINITY Cordless Handpiece System Common or Usual Name: Handpiece, Direct Drive, AC Powered Classification Name: Dental Handpiece and Accessories Regulation: 21 CFR 872.4200 Device Classification: Class: I Product Code: EKX

{4}------------------------------------------------

### V. PREDICATE DEVICE

Trade Name: Midwest RDH Freedom Cordless Prophy System Common Name: Prophy System 510(k) Number: K110753 (Decision Date: June 6, 2011) Manufacturer: Dentsply International Inc.

# VI. DEVICE DESCRIPTION

The proposed device, the Young INFINITY Cordless Handpiece System, is a cordless handpiece which is intended for use by a dental clinician during dental cleaning and polishing of tooth surfaces and fillings.

The Young INFINITY Cordless Handpiece System is comprised of a cordless, battery-powered handpiece, a removable nosecone, a cradle for the cordless handpiece, a direct current (DC) power supply and charging cord, and a wireless foot controller.

Accessories to the Young INFINITY Cordless Handpiece System include a single-use doriot style Disposable Prophy Angle (DPA), which can be purchased from any DPA manufacturer. Additionally, the Young Infinity Cordless Handpiece System must be used with a disposable barrier (cleared as Class II, Product Classification Code PEM, under premarket notification K151123 in 03/03/2016 as Cover-It™ Barrier Film).

The handpiece features a removable nosecone that is to be cleaned and steam sterilized prior to first use and after each patient use.

The handpiece utilizes an on-board user control for on/off and an LED indicator to communicate handpiece battery life, handpiece battery charging, foot control low power level, excessive pressure being applied, and wireless pairing status, The handpiece can only be operated by the appropriately paired wireless foot controller.

The Young INFINITY Cordless Handpiece System is operated by using a wireless foot controller, where the amount of vertical actuation on the wireless foot controller correlates to the speed of the handpiece supplied to the DPA. The corresponding variable speed range of the DPA is between 500RPM and 3000RPM.

{5}------------------------------------------------

The wireless foot controller operates using a Bluetooth low energy (BLE) communication protocol. When the handpiece has been turned ON, engaging the wireless foot controller activates the (BLE) mode of both the cordless handpiece and the wireless foot controller. The wireless foot controller features LEDs to indicate when the BLE mode on the foot controller has been activated, battery charging and adequate battery power level.

#### VII. INDICATIONS FOR USE

Battery driven electrical drive unit with wireless foot controller for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing of tooth surfaces and fillings.

{6}------------------------------------------------

#### SUBSTANTIAL EQUIVALENCE VIII.

K110753: Midwest RDH Freedom Cordless Prophy System

| Product Comparison - Similarities and Differences | | | |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Proposed Device | Midwest RDH<br>Freedom Cordless<br>Prophy System | Similarities &<br>Differences |
| Manufacturer | Young Dental | DENTSPLY | |
| 510(k) Number | K171377 | K110753 | |
| Class | I | I | No difference |
| Regulation Number | 872.4200 | 872.4200 | No difference |
| Intended Use /<br>Indications for Use | Battery driven<br>electrical drive unit<br>with wireless foot<br>controller for use with<br>disposable<br>prophylaxis angles in<br>hygiene operatory to<br>perform cleaning and<br>polishing of tooth<br>surfaces and fillings. | The MIDWEST® RDH<br>FREEDOM™ Cordless<br>Prophy System is a<br>high-performance<br>cordless prophylaxis<br>handpiece with a<br>wireless foot pedal<br>for use with Freedom<br>disposable<br>prophylaxis angles in<br>a hygiene operatory<br>to perform cleaning<br>and polishing<br>procedures on teeth. | No significant<br>differences. Both<br>devices have the<br>same components,<br>and are intended to<br>clean and polish<br>teeth. The proposed<br>device has small<br>differences in user<br>population, but are<br>more syntax than<br>practical differences. |
| Product Code | EKX | EKX | No difference |
| Use | Rx Only | Rx Only | No difference |
| Handpiece geometry | Cylindrical shape with<br>reverse radius<br>geometry to aid in<br>device handling.<br>Tapered, swiveled<br>nosecone area. | Cylindrical shape with<br>tapered nosecone. | Both shapes are<br>designed to fit in the<br>user's hand |
| Handpiece Power | Lithium-Ion Battery<br>capable of being re-<br>charged multiple<br>times by inclusion of<br>an AC/DC power<br>supply. | Lithium-Ion Battery<br>capable of being re-<br>charged multiple<br>times by inclusion of<br>an AC/DC power<br>supply. | No difference |
| Handpiece Charge<br>time | Approximately 2<br>hours | At least 90 minutes | Both products can<br>be charged over night |

| Table 1. Device Comparison (Similarities and Differences) |
|------------------------------------------------------------|
|------------------------------------------------------------|

{7}------------------------------------------------

# Young Dental Manufacturing Co. | Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for Young INFINITY Cordless Handpiece System

| Product Comparison – Similarities and Differences | | | |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Characteristic | Proposed Device | Midwest RDH<br>Freedom Cordless<br>Prophy System | Similarities &<br>Differences |
| Handpiece<br>Dimensions | 25mm Dia x 156mm | 30mm Dia X 190mm<br>length | Both products allow<br>for similar interaction<br>with the user. |
| Foot Pedal Power | Foot pedal contains a<br>lithium ion battery<br>capable of being re-<br>charged multiple<br>times by inclusion of<br>AC/DC power supply. | Foot pedal contains a<br>lithium ion battery<br>capable of being re-<br>charged multiple<br>times by inclusion of<br>AC/DC power supply. | No difference |
| Prophy Angle Fit | Similar to most<br>corded handpieces on<br>the market today, our<br>device will have a<br>Doriot style nose<br>which allows most<br>prophy angles to be<br>used on the device. | Proprietary<br>Disposable Prophy<br>Angles that work<br>exclusively with the<br>system. | The prophy angle fit<br>does not impact the<br>user experience<br>during cleaning and<br>polishing procedures. |
| Nose Cone | Nose cone will<br>swivel. The nosecone<br>will also be<br>removable and<br>autoclavable for<br>infection control. | Contains a<br>removable,<br>autoclavable outer<br>sheath for infection<br>control. | Both products aid<br>users reprocessing |

This area left intentionally blank

{8}------------------------------------------------

| Characteristic | Proposed Device | Midwest RDH<br>Freedom Cordless<br>Prophy System | Similarities &<br>Differences |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Infection Control /<br>Sterilization Method | Remove nosecone<br>and sterilize via<br>autoclave.<br><br>The nosecone is to be<br>cleaned and sterilized<br>prior to first use and<br>after each patient<br><br>Do not sterilize the<br>handpiece cradle,<br>handpiece, or foot<br>control. These<br>devices may only be<br>disinfected. The<br>handpiece is to be<br>covered with an FDA<br>cleared disposable<br>barrier sleeve. | Outer sheath is to be<br>to cleaned and<br>sterilized prior to first<br>use and after each<br>patient.<br><br>Do not sterilize the<br>inner module or<br>charging station.<br>These may be wiped<br>with intermediate<br>level disinfectants.<br>The handpiece is to<br>be covered with an<br>FDA cleared<br>disposable barrier<br>sleeve. | Both products utilize<br>a steam sterilization<br>procedure for the<br>removeable<br>nosecone, and<br>disinfection<br>procedure for the<br>handpiece. |
| Lubrication Method | Lubricant Free motor.<br>Do not use<br>lubrication. | Lubricant Free motor.<br>Do not use<br>lubrication. | No difference |
| Product Comparison - Similarities and Differences | | | |
| Characteristic | Proposed Device | Midwest RDH<br>Freedom Cordless<br>Prophy System | Similarities &<br>Differences |
| User Interface on<br>Handpiece | That handpiece will<br>have a POWER<br>button, which will<br>enable connection to<br>the foot pedal for<br>activation. | Handpiece does not<br>have any user<br>interface, and the<br>handpiece is<br>controlled exclusively<br>by the cordless foot<br>pedal. | Both devices have<br>clear methods for<br>turning the device ON |
| Auto-Off | Handpiece will enter<br>a standby mode if idle<br>for more than 4<br>minutes. The user<br>would then have to<br>press the POWER<br>button to activate the<br>handpiece again. | Handpiece will enter<br>standby mode if idle<br>for more than 1<br>minute<br>Product goes into<br>enhanced battery-<br>saving mode after 1<br>week of non-use. | Both devices have<br>clear methods for<br>automatically turning<br>the device OFF to<br>save battery power.<br>The timing of auto-off<br>sequences does not<br>impact use. |
| Mode of Operation | Rotary | Rotary | No difference |
| Speed Control | Speed is controlled<br>and adjusted through<br>varying pressure on<br>the foot pedal. The<br>motor itself has a<br>limit of 3000RPM<br>(±10%). | Speed is controlled<br>and adjusted through<br>varying pressure on<br>the foot pedal. | No difference |
| Speed Range | 500 - 3000 RPM<br>(±10%) | 3000 RPM MAX | The top speed is the<br>same on both devices.<br>The low end speed<br>limit does not impact<br>use. |
| Torque Range | 1Ncm torque | 10 mNm | Both devices deliver<br>similar torque / speed<br>profiles, and have<br>very similar motors. |
| Product Comparison - Similarities and Differences | | | |
| Characteristic | Proposed Device | Midwest RDH<br>Freedom Cordless<br>Prophy System | Similarities &<br>Differences |
| Temperature | 10 - 35°C | 10-40°C | Both devices utilize<br>the same low-end<br>temperature, and<br>have high-end<br>temperature ranges<br>consistent with<br>storage,<br>transportation and<br>use conditions in the<br>field today |
| Humidity | 8-80% RH | 45-95% RH | Both devices have<br>humidity ranges<br>consistent with<br>storage,<br>transportation and<br>use conditions in the<br>field today |
| Handpiece | પ્રદર | YES | No difference |
| Foot Pedal | પ્રદર | YES | No difference |
| Handpiece Holding<br>Station | ત્ત્વન્યું પ્રદર્શ | YES | No difference |
| Handpiece Sleeves | ત્ત્વન્યું પ્રદર્શ | પ્રદર | No difference |

This area intentionally left blank

{9}------------------------------------------------

{10}------------------------------------------------

As indicated in Table 1, all relevant comparison items are very similar, and do not exhibit any changes that would impact intended use or the user experience.

{11}------------------------------------------------

## IX. PERFORMANCE DATA DEMONSTRATING SUBSTANTIAL EQUIVALENCE

The Young INIFNITY Cordless Handpiece System has the same intended use and operating principles, with similar features, and functional and performance characteristics as the previously-cleared devices. The device is designed to comply with relevant federal and international safety and performance standards. Conformance to these standards, coupled with no changes in the Indications for Use and no change in the fundamental scientific technology demonstrates substantial equivalence to the predicate devices.

Non-Clinical Performance Data: Testing included verification of component specifications, speed and torque control, connectivity of handpiece / foot controller communication, battery life, noise testing, software validation, chemical compatibility of housing materials, sterilizability, biocompatibility, fluid ingress, and electrical equipment safety. Tests were also performed to compare the speed, torque, weight, and dimensions of the Young INFINITY cordless handpiece system to the Midwest RDH Freedom Cordless Prophy System. The following testing was conducted

- · Sterilization/Cleaning validation activities per ISO 17665-1 and ISO 17665-2. Reprocessing assessment and validation per the FDA Guidance Document for Reprocessing Medical Devices in Heath Care Setting: Validation Methods and Labeling including evaluation of design/mitigation methods to prevent contamination of the internal motor.
- Electrical Safety testing per IEC 60601-1 and Electromagnetic Compatibility . testing per IEC 60601-1-2.
- Biocompatibility validation activities per FDA Guidance Document for Use of . ISO 10993-1. Cytotoxicity testing on the final finished manufactured device per ISO 10993-5.
- Risk Analysis (hardware and software) per ISO 14971 .
- Software documentation for software of moderate level of concern per the . FDA Guidance Document Software Contained in Medical Devices
- · Hardware Performance/Safety Verification/Validation activities including conformance to ISO 14457 Dentistry -- Handpieces and motors

The results of this performance testing, combined with design and intended use comparison with the predicate device, Midwest RDH Freedom Cordless system (K110753), support substantial equivalence to the predicate device.

{12}------------------------------------------------

# X. SUMMARY OF SIMILARITIES AND DIFFERENCES

The intended use and indications for use of the proposed Young INFINITY Cordless Handpiece System are equivalent to the legally marked predicate device, Midwest RDH Freedom Cordless Prophy System. The fundamental scientific technology of the proposed device is unchanged from the legally marketed predicate devices. The predicate device and submitted device share similar design features including battery type, mode of operation, and speed range. The devices share similar methods of control systems and operation. The devices share similar performance specifications including RPM and energy type.

# XI. CONCLUSIONS

The Young INIFNITY Cordless Handpiece System is substantially equivalent to the listed predicate device, Midwest RDH Freedom Cordless Prophy System. The new device has the same intended use and operating principles, with similar features, and functional and performance characteristics.

{13}------------------------------------------------

Young Dental Manufacturing Co. | Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for Young INFINITY Cordless Handpiece System

This page intentionally left blank