The “PROXEO Twist Cordless Polishing System PL-40 H” is an electrical drive unit for cleaning and polishing tooth surfaces and fillings by use of Disposable Prophy Angles, so-called "DPAs". The system consists of - the cordless drive handpiece PL-40 H, - the wireless foot controller C-NW, - a handpiece holder, and - a charger inclusive adaptor. Its basic function is the conversion of electrical energy into a mechanical rotary motion. Power is supplied by a Li-ion battery, which is assembled in the drive handpiece and can be recharged by means of the provided charging cable. The battery is not changeable by the user. The device's application is intended in dentistry.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for a dental device, the "PROXEO Twist Cordless Polishing System PL-40 H." This document aims to demonstrate substantial equivalence to a legally marketed predicate device, not to prove the device meets specific performance acceptance criteria for an AI/ML medical device.

Therefore, the information required to answer your request (acceptance criteria, study details for AI/ML performance, sample sizes, expert qualifications, ground truth, etc.) is not present in the provided text. The document focuses on regulatory compliance for a traditional medical device, specifically dental handpieces, through comparison of technological characteristics and non-clinical testing for safety and electrical performance.

The document explicitly states:

Clinical Testing: "Clinical performance testing was not conducted." (Page 6)
The comparison is based on "similarities in intended use, principles of operation, functional design and structure." (Page 6)

In summary, the provided text does not contain the information requested about acceptance criteria and studies demonstrating performance for an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 24, 2021

W&H Dentalwerk Buermoos GmbH Johann Scharl Manager Regulatory Affairs Ignaz Glaser Strasse 53 Buermoos, Salzburg AT - 5111 Austria

Re: K201703

Trade/Device Name: PROXEO Twist Cordless Polishing System PL-40 H Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: November 20, 2020 Received: November 27, 2020

Dear Johann Scharl:

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/cdrh/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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201703

Device Name

PROXEO Twist Cordless Polishing System PL-40 H

Indications for Use (Describe)

Battery driven electrical drive unit with wireless foot controller to perform cleaning and polishing of tooth surfaces and fillings.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K201703

Submitter	W & H DENTALWERK BÜRMOOS GMBHIgnaz-Glaser-Strasse 53A - 5111 BürmoosAustriaTel.: 0043 -6274 / 6236 -297Fax: 0043 -6274 / 6236 -55
Registration Number	9681479
Contact Person	Ing. Johann Georg SCHARL
Date of Preparation	Feb. 22, 2021
Device Name	PROXEO Twist Cordless Polishing System PL-40 H
Classification Name	Dental Handpiece and Accessories
Regulation Number	872.4200
Regulatory class	I
Product Code	EKX
Predicate Devices	Device Name: Young INFINITY Cordless Handpiece System510(k) Number: K171377 (Decision Date: August 20th, 2018)Manufacturer: Young Dental Manufacturing Co.
Device Description	The “PROXEO Twist Cordless Polishing System PL-40 H” isan electrical drive unit for cleaning and polishing toothsurfaces and fillings by use of Disposable Prophy Angles, so-called "DPAs".The system consists of- the cordless drive handpiece PL-40 H,- the wireless foot controller C-NW,- a handpiece holder, and- a charger inclusive adaptor.Its basic function is the conversion of electrical energy into amechanical rotary motion. Power is supplied by a Li-ionbattery, which is assembled in the drive handpiece and canbe recharged by means of the provided charging cable. Thebattery is not changeable by the user.The device's application is intended in dentistry.
Indications for Use:	Battery driven electrical drive unit withwireless foot controller to performcleaning and polishing of tooth surfaces and fillings.

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		New device	Predicatedevice	Judg-ment
	Product Designation	PROXEO TwistCordless PolishingSystem PL-40 H	Young INFINITYCordless HandpieceSystem	different
	510k number	K201703	K171377	different
	Manufacturer	W&H DentalwerkBuermoos GmbHReg. No.: 9681479	Young DentalManufacturing Co.Reg. No. 1941138	different
	Regulation Number	21 CFR 872.4200	21 CFR 872.4200	same
	Product Code	EKX	EKX	same
	Regulatory Class	Class I	Class I	same
	Use	RX only	RX only	same
Comparison:TechnologicalCharacteristics	Indications for Use	Battery drivenelectrical drive unit withwireless foot controllerto perform cleaningand polishing of toothsurfaces and fillings.	Battery driven electricaldrive unit with wirelessfoot controller for usewith disposableprophylaxis angles inhygiene operatory toperform cleaning andpolishing of toothsurfaces and fillings.	equivalent
	appearance	Image: PROXEO Twist Cordless Polishing System PL-40 H	Image: Young INFINITY Cordless Handpiece System	equivalent(differentmarking)
	Handpiece drive	PL-40 H	(PL-40 H)	(same)
	Battery type:	Li-Ion	Li-Ion	same
	Runtime:	8 treatments with apolishing duration of 6min.	8 treatments with apolishing duration of 6min.	same
	Standby:	automatically after 4min.	automatically after 4min.	same
	Charging time:	approx. 2 h	approx. 2 h	same
	Rated voltage:	3,7 V	3,7 V	same
	Rated capacity:	680 mAh	680 mAh	same
	Max. speed:	3.000 rpm	3.000 rpm	same
	Maximum torque:	2 Ncm	2 Ncm	same
	Dimensions(W x D x H):	160 x 25 x 28 mm	160 x 25 x 28 mm	same
	Weight:	118 g	118 g	same
		New device	Predicatedevice	Judg-ment
	Foot control	C-NW	(C-NW)	(same)
	Battery type:	Li-ion	Li-ion	same
	Runtime:	approx. 2 months	approx. 2 months	same
	Standby:	automatically if notactuated	automatically if notactuated	same
Comparison:	Charging time:	approx. 3 h	approx. 3 h	same
	Rated voltage:	3.7 V	3.7 V	same
TechnologicalCharacteristics	Rated capacity:	680 mAh	680 mAh	same
	Dimensions (WxDxH):	117 x 117 x 38 mm	117 x 117 x 38 mm	same
	Weight:	190 g	190 g	same
	Charger:Rated voltage:	100 - 240 V	100 - 240 V	same
	Permissible voltagefluctuation:	$\pm$ 10 %	$\pm$ 10 %	same
	Frequency:	50 - 60 Hz	50 - 60 Hz	same
	Power:	7 VA	7 VA	same
Comparison:New deviceversusPredicate device	The target field of application, the intended use, performance parameter andmaterial are the same or, at least, quite similar to those of the predicate device.The differences are restricted to the devices' labelling: the type designations andthe devices' as well as their manufacturers' names are differently indicated on theproducts themselves, on their packaging, Instructions for Use, etc.Seen from the technological point of view, the products are identical.The above-mentioned differences do not have any negative effect on thesubstantial equivalence.Therefore, the new device is substantially equivalent to the predicate device.

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Non-clinical testing	Type testing according toISO 14457:2017 “Dentistry – Handpieces and motors"Electrical Safety Tests according toIEC 80601-2-60:2012-02 “Medical electrical equipment – Part2-60: Particular requirements for the basic safety andessential performance of dental equipment"andIEC 60601- 1:2005, 3rd Ed. + Corr.1:2006 + Corr2:2007as well asIEC 60601-1: 2012, 3.1 Ed."Medical electrical equipment – Part: General requirementsfor safety"
	Electromagnetic Compatibility Test according toIEC 60601-1-2:2014 “Medical electrical equipment - Part 1-2:General requirements for basic safety and essentialperformance - Collateral standard: Electromagneticcompatibility - Requirements"andFCC 47CFR Part 15 C § 15.247 "Operation within the bands902-928 MHz, 2400-2483.5 MHz, and 5725-5850 MHz"
	Safety Tests according toIEC 62133:2012 + Corr1:2013 "Secondary cells and batteriescontaining alkaline or other non-acid electrolytes - Safetyrequirements for portable sealed secondary cells, and forbatteries made from them, for use in portable applications"
	Software validation according toIEC 62304:2006 + A1:2015 "Medical device software –Software life-cycle processes".
	Usability validation according toIEC 60601-1-6:2010 + A1:2015 “Medical electrical equipment– Part 1-6: General requirements for basic safety andessential performance - Collateral standard: Usability"
	Biological Assessment / Cytotoxicity Testing according toISO 10993-1:2009 + Cor 1:2010 "Biological evaluation ofmedical devices - Part 1: Evaluation and testing"andISO 7405:2008 + A1:2013 "Dentistry – Evaluation ofbiocompatibility of medical devices used in dentistry"
Non-clinical testing	Reprocessing Tests under consideration ofISO 17664:2017 “Reprocessing of Health Care Products -Information to be provided by the manufacturer for theprocessing of medical devices”andANSI/AAMI ST79:2010 + A1:2010 + A2:2011 + A3:2012 +A4:2013 “Comprehensive guide to steam sterilization andsterility assurance in health care facilities”as well asISO 17665-1:2006 “Sterilization of health care products –Moist heat - Part 1: Requirements for the development,validation and routine control of a sterilization process formedical devices”Risk Assessment according toISO 14971:2007. “Medical devices - Application of riskmanagement to medical devices”Additionally, different further bench tests, such as materialtests (reg. chemical resistance), life time tests, torque andfunctionality test and tests for ensuring the stability ofpackaging were performed house-internally and confirmedthe product's suitability for the use in practice.
Clinical Testing	Clinical performance testing was not conducted.W&H considers the PROXEO Twist Cordless PolishingSystem PL-40 H to be substantially equivalent to thepredicate device listed above.
Conclusion	This conclusion is based on the similarities in intended use,principles of operation, functional design and structure.Differences between the devices shown in the comparisonsection above are minor and do not have any negative effecton equivalence.

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Regulation Number and Section

§ 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.