(467 days)
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.
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. 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.
The provided text is a 510(k) summary for the Young INFINITY Cordless Handpiece System, which is a dental handpiece. It aims to demonstrate substantial equivalence to a predicate device.
The document describes performance data for the device, but it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria related to artificial intelligence, machine learning, or complex algorithmic performance involving human-in-the-loop interaction, ground truth establishment by experts, or large-scale data sets for training/testing.
The performance data mentioned relates to standard medical device testing for safety, functionality, and biocompatibility, such as:
- Sterilization/Cleaning validation: Per ISO 17665-1 and ISO 17665-2, and FDA Guidance Document.
- Electrical Safety and Electromagnetic Compatibility: Per IEC 60601-1 and IEC 60601-1-2.
- Biocompatibility validation: Per FDA Guidance Document for Use of ISO 10993-1, and ISO 10993-5 cytotoxicity testing.
- Risk Analysis: Per ISO 14971 (hardware and software).
- Software documentation: For software of moderate level of concern per FDA Guidance Document Software Contained in Medical Devices.
- Hardware Performance/Safety Verification/Validation: Including conformance to ISO 14457 Dentistry -- Handpieces and motors.
- Verification of component specifications, speed and torque control, connectivity, battery life, noise testing, chemical compatibility, fluid ingress, weight, and dimensions.
Given the nature of the device (a cordless dental handpiece) and the type of performance data presented, the questions about AI/ML specific study design elements (human readers, effect size, standalone algorithm performance, expert adjudication, training/test set sample sizes for algorithms, ground truth for AI) are not applicable to this 510(k) submission.
Therefore, I cannot populate the table or answer the specific questions related to AI/ML acceptance criteria and studies based on the provided document. The document describes a traditional medical device premarket notification demonstrating substantial equivalence based on engineering, safety, and performance characteristics, not AI/ML performance.
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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
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
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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)
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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: 314-344-0010 Email: bprange@youngdental.com
II. OFFICIAL CORRESPONDENCE/CONTACT PERSON
Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045
Tel: 314-344-0010 Email: bprange@youngdental.com
III. 510(K) PREPARER
Scott Edwards 8888 Keystone Crossing Suite 1550 Indianapolis, IN 46240
Tel: 317-968-9531 Email: sedwards@maetrics.com
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
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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.
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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.
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SUBSTANTIAL EQUIVALENCE VIII.
K110753: Midwest RDH Freedom Cordless Prophy System
| Product Comparison - Similarities and Differences | |||
|---|---|---|---|
| Characteristic | Proposed Device | Midwest RDHFreedom CordlessProphy System | Similarities &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 /Indications for Use | Battery drivenelectrical drive unitwith wireless footcontroller for use withdisposableprophylaxis angles inhygiene operatory toperform cleaning andpolishing of toothsurfaces and fillings. | The MIDWEST® RDHFREEDOM™ CordlessProphy System is ahigh-performancecordless prophylaxishandpiece with awireless foot pedalfor use with Freedomdisposableprophylaxis angles ina hygiene operatoryto perform cleaningand polishingprocedures on teeth. | No significantdifferences. Bothdevices have thesame components,and are intended toclean and polishteeth. The proposeddevice has smalldifferences in userpopulation, but aremore syntax thanpractical differences. |
| Product Code | EKX | EKX | No difference |
| Use | Rx Only | Rx Only | No difference |
| Handpiece geometry | Cylindrical shape withreverse radiusgeometry to aid indevice handling.Tapered, swivelednosecone area. | Cylindrical shape withtapered nosecone. | Both shapes aredesigned to fit in theuser's hand |
| Handpiece Power | Lithium-Ion Batterycapable of being re-charged multipletimes by inclusion ofan AC/DC powersupply. | Lithium-Ion Batterycapable of being re-charged multipletimes by inclusion ofan AC/DC powersupply. | No difference |
| Handpiece Chargetime | Approximately 2hours | At least 90 minutes | Both products canbe charged over night |
| Table 1. Device Comparison (Similarities and Differences) |
|---|
| ------------------------------------------------------------ |
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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 RDHFreedom CordlessProphy System | Similarities &Differences |
| HandpieceDimensions | 25mm Dia x 156mm | 30mm Dia X 190mmlength | Both products allowfor similar interactionwith the user. |
| Foot Pedal Power | Foot pedal contains alithium ion batterycapable of being re-charged multipletimes by inclusion ofAC/DC power supply. | Foot pedal contains alithium ion batterycapable of being re-charged multipletimes by inclusion ofAC/DC power supply. | No difference |
| Prophy Angle Fit | Similar to mostcorded handpieces onthe market today, ourdevice will have aDoriot style nosewhich allows mostprophy angles to beused on the device. | ProprietaryDisposable ProphyAngles that workexclusively with thesystem. | The prophy angle fitdoes not impact theuser experienceduring cleaning andpolishing procedures. |
| Nose Cone | Nose cone willswivel. The noseconewill also beremovable andautoclavable forinfection control. | Contains aremovable,autoclavable outersheath for infectioncontrol. | Both products aidusers reprocessing |
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| Characteristic | Proposed Device | Midwest RDHFreedom CordlessProphy System | Similarities &Differences |
|---|---|---|---|
| Infection Control /Sterilization Method | Remove noseconeand sterilize viaautoclave.The nosecone is to becleaned and sterilizedprior to first use andafter each patientDo not sterilize thehandpiece cradle,handpiece, or footcontrol. Thesedevices may only bedisinfected. Thehandpiece is to becovered with an FDAcleared disposablebarrier sleeve. | Outer sheath is to beto cleaned andsterilized prior to firstuse and after eachpatient.Do not sterilize theinner module orcharging station.These may be wipedwith intermediatelevel disinfectants.The handpiece is tobe covered with anFDA cleareddisposable barriersleeve. | Both products utilizea steam sterilizationprocedure for theremoveablenosecone, anddisinfectionprocedure for thehandpiece. |
| Lubrication Method | Lubricant Free motor.Do not uselubrication. | Lubricant Free motor.Do not uselubrication. | No difference |
| Product Comparison - Similarities and Differences | |||
| Characteristic | Proposed Device | Midwest RDHFreedom CordlessProphy System | Similarities &Differences |
| User Interface onHandpiece | That handpiece willhave a POWERbutton, which willenable connection tothe foot pedal foractivation. | Handpiece does nothave any userinterface, and thehandpiece iscontrolled exclusivelyby the cordless footpedal. | Both devices haveclear methods forturning the device ON |
| Auto-Off | Handpiece will entera standby mode if idlefor more than 4minutes. The userwould then have topress the POWERbutton to activate thehandpiece again. | Handpiece will enterstandby mode if idlefor more than 1minuteProduct goes intoenhanced battery-saving mode after 1week of non-use. | Both devices haveclear methods forautomatically turningthe device OFF tosave battery power.The timing of auto-offsequences does notimpact use. |
| Mode of Operation | Rotary | Rotary | No difference |
| Speed Control | Speed is controlledand adjusted throughvarying pressure onthe foot pedal. Themotor itself has alimit of 3000RPM(±10%). | Speed is controlledand adjusted throughvarying pressure onthe foot pedal. | No difference |
| Speed Range | 500 - 3000 RPM(±10%) | 3000 RPM MAX | The top speed is thesame on both devices.The low end speedlimit does not impactuse. |
| Torque Range | 1Ncm torque | 10 mNm | Both devices deliversimilar torque / speedprofiles, and havevery similar motors. |
| Product Comparison - Similarities and Differences | |||
| Characteristic | Proposed Device | Midwest RDHFreedom CordlessProphy System | Similarities &Differences |
| Temperature | 10 - 35°C | 10-40°C | Both devices utilizethe same low-endtemperature, andhave high-endtemperature rangesconsistent withstorage,transportation anduse conditions in thefield today |
| Humidity | 8-80% RH | 45-95% RH | Both devices havehumidity rangesconsistent withstorage,transportation anduse conditions in thefield today |
| Handpiece | પ્રદર | YES | No difference |
| Foot Pedal | પ્રદર | YES | No difference |
| Handpiece HoldingStation | ત્ત્વન્યું પ્રદર્શ | YES | No difference |
| Handpiece Sleeves | ત્ત્વન્યું પ્રદર્શ | પ્રદર | No difference |
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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.
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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.
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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.
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Young Dental Manufacturing Co. | Premarket Notification 510(k) Submission Under 21 CFR § 807.87 for Young INFINITY Cordless Handpiece System
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§ 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.