The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

Device Description

The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.

AI/ML Overview

The provided text describes an FDA 510(k) premarket notification for an "Endo Motor" device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a full clinical efficacy study with specific performance acceptance criteria against a defined ground truth.

Therefore, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way you've outlined for diagnostic AI/ML devices. Instead, it focuses on non-clinical tests to show conformity to standards and comparability to a predicate device.

However, I can extract the relevant information regarding performance claims and testing as best as possible from the provided text, especially concerning the "apex locator" function.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a device of this type:

Acceptance Criteria and Device Performance Study (Based on 510(k) Submission)

The Endo Motor (Model: ZR-Rap) is a cordless endodontic treatment motorized handpiece with root canal measuring capability. The 510(k) submission aims to demonstrate substantial equivalence to a predicate device (Changzhou Sifary Medical Technology Co., Ltd. E-Connect S Endo Motor, K201993). The primary "acceptance criteria" in this context are conformity to relevant standards and comparable performance to the predicate, especially regarding the apex locator function.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance (Proposed Device)	Remarks
Canal Enlargement Performance (Rotation Speed)	150rpm-650rpm	This range is different from the predicate (120-1000 rpm) but the submission states: "The rotation speed of Endo Motor is within the speed range of the predicate device, and it has passed performance test, no affect on safety or efficacy." This implies the performance range is deemed acceptable and safe.
Canal Enlargement Performance (Torque)	0.6N.cm-4N.cm	This range is different from the predicate (0.5N.cm-4N.cm) but is implied to meet performance expectations and safety, similarly to rotation speed.
Apex Locator Function Accuracy	-0.5mm to +0.5mm for Apex position.	This is explicitly stated as "Same" as the predicate device. This is the closest to a quantitative performance acceptance criterion mentioned for a functional aspect.
Biocompatibility	Materials conform to ISO10993.	Verified through non-clinical testing against a recognized standard.
Electromagnetic Compatibility (EMC)	Conform to IEC60601-1-2:2014 & IEC60601-1-2	Verified through non-clinical testing against recognized standards.
Electrical, Mechanical, Thermal Safety	Conform to IEC60601-1	Verified through non-clinical testing against a recognized standard.
General Dental Equipment Safety & Performance	Conform to IEC 80601-2-60:2019	Verified through non-clinical testing against a recognized standard.
Handpieces and Motors Standards	Conform to ISO 14457:2017	Verified through non-clinical testing against a recognized standard.
Software Documentation (for medical devices)	Moderate level of software documentation per FDA Guidance.	Software documentation was provided and assessed.
Reprocessing Validation (cleaning, disinfection, sterilization)	Reprocessing validation performed per FDA Guidance Document.	Validated to ensure the device components (Contra Angle, Lip Hook, File clip, Protective silicon cove) can be safely reprocessed, similar to the predicate's autoclavable components.
Comparative Root Canal Measurement Performance (for apex locator function)	Performed to evaluate the root canal length; results demonstrated substantial equivalence (implicitly met the predicate's -0.5mm to +0.5mm accuracy).	This is a specific test for the critical apex locator function. While the exact methodology and pass/fail criteria beyond matching the predicate are not detailed, the conclusion is that it supports substantial equivalence.

2. Sample Size Used for the Test Set and Data Provenance

The document states "A Comparative Root Canal Measurement Performance Test to evaluate the root canal length" was performed. However, it does not specify the sample size (e.g., number of teeth, number of root canals, number of measurements) used for this test set nor the data provenance (e.g., country of origin, retrospective or prospective nature). Given the nature of a 510(k) for an existing technology, such tests are often conducted in-house on extracted teeth or phantoms.

3. Number of Experts Used to Establish the Ground Truth and Qualifications

The document does not specify the number of experts used, their qualifications, or if external experts were involved in establishing ground truth for the "Comparative Root Canal Measurement Performance Test." It implies that the test was conducted to compare its performance with existing methods or the predicate, but details on ground truth establishment are absent.

4. Adjudication Method

The document does not specify an adjudication method (e.g., 2+1, 3+1, none) for any test sets.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with AI/ML diagnostic aids that assist human readers. The Endo Motor is a handpiece with an integrated apex locator, not a diagnostic AI/ML device that interacts with human readers for interpretation.

6. Standalone Performance Study

Yes, a standalone performance study was done for the apex locator function, as indicated by "A Comparative Root Canal Measurement Performance Test to evaluate the root canal length." The stated performance for this function is an accuracy of "-0.5mm to +0.5mm for Apex position." The study directly assessed the device's ability to measure root canal length.
The other "standalone" performance studies were non-clinical tests demonstrating conformity to various safety and performance standards (e.g., ISO, IEC).

7. Type of Ground Truth Used

For the "Comparative Root Canal Measurement Performance Test," the document does not explicitly state the type of ground truth used. For an apex locator, common ground truths involve physical measurements taken after canal preparation (e.g., direct measurement with a caliper after sectioning a tooth or using a known reference point). It's likely an objective, physical measurement rather than expert consensus, pathology, or outcomes data, but this is an inference.

8. Sample Size for the Training Set

The concept of a "training set" is typically applicable to AI/ML models. Since this device is a traditional electromechanical medical instrument with integrated measurement capabilities rather than an AI/ML diagnostic tool, there is no mention or indication of a "training set" in the provided document.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set," this question is not applicable to the information provided in the document.

In summary: The submission relies on demonstrating conformity to international standards, comparing specifications and indications for use with a legally marketed predicate, and conducting specific non-clinical performance tests (like the root canal measurement performance test) to show substantial equivalence. It does not provide the detailed study design, sample sizes, expert qualifications, or ground truth establishment methods typically found in clinical trials for novel diagnostic devices, especially those incorporating AI/ML.

Summary

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April 26, 2023

Shenzhen Perfect Medical Instruments Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th floor, 1500# Century Ave., Shanghai, Shanghai 200122 CHINA

Re: K222548

Trade/Device Name: Endo Motor Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX, LOY Dated: January 30, 2023 Received: January 30, 2023

Dear Jarvis Wu:

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.

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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 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 mediation-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 -S

Michael Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K222548

Device Name Endo Motor

Indications for Use (Describe)

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

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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510(k) Summary K222548

Document Date Prepared:2022/8/12

A. Applicant:

Name: Shenzhen Perfect Medical Instruments Co., Ltd.

Address: Room 102, Building A, Ruiji Factory, No. 3 Zaohekeng, Jixia Community, Nanwan Street,

Longgang District.Shenzhen, P.R. China. 518100

Contact Person: Kristy Mo

Tel: +86- 13929326975

Mail: kristy@medtung.com

Submission Correspondent:

Primary contact: Mr. Jarvis Wu

Shanghai SUNGO Management Consulting Co., Ltd.

14th floor, 1500# Century Ave., Shanghai 200122, China

Tel: +86-21-58817802

Email: haiyu.wang@sungoglobal.com

Secondary contact: Mr. Raymond Luo

14th floor, 1500# Century Ave., Shanghai 200122, China

Tel: +86-21-68828050

Email: fda.sungo@gmail.com

B. Device:

Proprietary Name: Endo Motor Common Name: Endodontic treatment motorized handpiece with built-in apex locator Model(s): ZR-Rap

Regulatory Information

Classification Name: Dental handpiece and accessories Classification: Class I Primary Product code: EKX Secondary Product Code: LQY Regulation Number: 878. 4200

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C. Predicate device:

Manufacturer: Changzhou Sifary Medical Technology Co., Ltd. Device name: E-Connect S Endo Motor With Built-In Apex Locator 510(K) Number: K201993

(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)

D. Indications use of the device:

The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.

E. Device Description:

F. Comparison with predicate device

Table 1 General Comparison

Device	Proposed Device	Predicate device	Comparison
Manufacturer	Shenzhen Perfect MedicalInstruments Co., Ltd.	Changzhou SifaryMedical Technology Co., Ltd.	-
510K number	K222548	K201993	-
Device name	Endo Motor	E-connect S Endo Motor	-
ClassificationRegulation	21CRF 872.4200	21CRF 872.4200	Same
Classification	Class I	Class I	Same
Product Code	EKX, LQY	EKX, LQY	Same
Common name	Endodontic treatment motorizedhandpiece with built-in apexlocator	Endodontic treatment motorizedhandpiece with built-in apexlocator	Same
Indications for use	The Endo Motor, model: ZR-Rap,is a cordless endodontic treatmentmotorized handpiece with rootcanal measuring capability. It canbe used to enlarge canals whilemonitoring the position of the filetip inside the canal. It can be usedas a low-speed motorizedhandpiece and device formeasuring canal length. Thisdevice must only be used inhospital environments, clinics ordental offices by qualified dentalpersonnel.	E-connect S is a cordlessendodontic treatment motorizedhandpiece with root canalmeasuring capability. It can beused to enlarge canals whilemonitoring the position of the filetip inside the canal. It can be usedas a low-speed motorizedhandpiece and device formeasuring canal length. Thisdevice must only be used inhospital environments, clinics ordental offices by qualified dentalpersonnel.	Same
Patient populations	Adult	Adult	Same
Anatomical sites	Root canal, softeneddentin	Root canal, softeneddentin	Same
Where used	Dental clinic, Universityhospital and the otherclinical settings	Dental clinic, Universityhospital and the otherclinical settings	Same
Energy used and/ordelivered	Li-ion battery (DC 3.7V)	Li-ion battery (DC 3.7V)	Same
Exterior Design	28.2cm × 19.0cm × 6.2cm	21.5cm × 17.5cm × 9cm	Similar
Performance 1 -canal enlargement	150rpm-650rpm0.6N.cm-4N.cm	120-1000 rpm0.5N.cm-4N.cm	Different
Performance 2 -apex locator	Accuracy of the root apexlocator function: -0.5mm	Accuracy of the root apexlocator function: -0.5mm	Same
	to +0.5mm for Apex position.	to +0.5mm for Apex position.
Materials	Used materials conform	Used materials conform	Same
Biocompatibility	to ISO10993.	to ISO10993.	Same
Spray Nozzle	Spray nozzle (Oil injector)	Spray nozzle	Same
Compatibilitywith environmentand other devices	Conform to IEC60601-1-2	Conform to IEC60601-1-2	Same
Sterility	Contra Angle, Lip Hook,File clip, Protective silicon cove	Contra Angle, Lip Hook,File clip, InsulatingSleeve autoclavable.	Same
Electrical safety	Conform to IEC60601-1	Conform to IEC60601-1	Same
Mechanical safety	Conform to IEC60601-1	Conform to IEC60601-1	Same
Thermal safety	Conform to IEC60601-1	Conform to IEC60601-1	Same
Radiation safety	Conform to IEC60601-1-2	Conform to IEC60601-1-2	Same

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Shenzhen Perfect Medical Instruments Co., Ltd. Room 102, Building A, Ruiji Factory, No. 3 Zaohekeng, Jixia Community, Nanwan Street, Longgang District,Shenzhen, P.R. China. 518100

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Different Analysis:

The rotation speed of Endo Motor is within the speed range of the predicate device, and it has passed performance test, no affect on safety or efficacy.

G. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and FDA Guidance:

A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
A IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
A IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests
A IEC 80601-2-60: 2019 Medical Electrical Equipment - Part 2-60: Particular Requirements for Basic

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Safety and Essential Performance of Dental Equipment.

ISO 14457: 2017 Dentistry - Handpieces and motors
Moderate level of software documentation per the FDA Guidance for Software Contained in Medical Devices.
A Reprocessing validation (i.e., cleaning, disinfection, and sterilization) per the FDA Guidance Document for Reprocessing Medical Devices in Healthcare Setting.
A Comparative Root Canal Measurement Performance Test to evaluate the root canal length

H. Clinical Test Conclusion

No clinical study is included in this submission.

I. Conclusion

The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Endo Motor (Model: ZR-Rap) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201993.

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.