(179 days)
Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.
The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.
The provided document, K203320, is a 510(k) premarket notification for an "Endo Motor" device. This device is a dental handpiece with root canal measurement capability. The 510(k) summary focuses on demonstrating "substantial equivalence" to a predicate device through non-clinical testing and comparison of technical specifications. It does not present a study proving the device meets specific acceptance criteria based on clinical performance metrics (e.g., accuracy, sensitivity, specificity) of an AI/algorithm-driven device.
The document states that "Performance Comparison Testing of Root Canal Measurement Passed," but it does not provide details on the acceptance criteria or how this testing was conducted (e.g., sample size, ground truth, expert involvement).
Therefore, I cannot fully answer your request for information regarding acceptance criteria and the study proving the device meets them, as the provided document lacks the empirical data and methodology typically found in studies for AI/algorithm-driven devices concerning clinical performance.
However, I can extract the information provided about the non-clinical testing performed to support substantial equivalence:
Acceptance Criteria & Device Performance (Based on Non-Clinical Testing for Substantial Equivalence)
The document primarily relies on non-clinical testing and comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical performance study with explicit acceptance criteria for an AI/algorithm.
| Acceptance Criterion (Non-Clinical) | Reported Device Performance | Comments |
|---|---|---|
| Cytotoxicity testing per ISO 10993-5 | Passed | |
| Sensitization testing per ISO 10993-10 | Passed | |
| Electrical safety testing per IEC 60601-1 | Passed | |
| Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 | Passed | |
| Software verification and validation per IEC 62304/FDA Guidance | Met Requirements | No specific details on software performance are provided beyond meeting general requirements. |
| Usability per IEC 62366-1 | Met specifications | |
| Shipping Containers and Systems Performance, per ASTM D4169 | Demonstrates package integrity maintained | |
| Dental Performance Requirements, per IEC 80601-2-60 | Passed | General statement, no specific metric given. |
| Processing of Medical Device, per ISO 17664 | Passed | |
| Development, Validation and Routine Control of Sterilization Process, per ISO 17665-1 | Passed | |
| Moist Heat Sterilization, per ISO TS 17665-2 | Passed | |
| Dentistry - Handpieces and Motors, per ISO 14457 | Passed | General statement, no specific metric given. |
| Performance Comparison Testing of Root Canal Measurement | Passed | Crucially, no specific acceptance criteria (e.g., accuracy range in mm, error rate) for the root canal measurement capability are explicitly stated, nor are the details of this "Performance Comparison Testing" provided (e.g., sample size, methodology, ground truth establishment). This is the closest the document comes to a performance metric relevant to its "measurement capability." |
Detailed Answers to Specific Questions:
1. A table of acceptance criteria and the reported device performance
See table above. Note that for "Performance Comparison Testing of Root Canal Measurement," while it states "Passed," no quantitative acceptance criteria or specific performance metrics are provided in the document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable / Not provided. The document primarily reports non-clinical engineering and biological tests, and a comparison of technical specifications to a predicate device. There is no mention of a clinical "test set" with a specified sample size or data provenance in the context of root canal measurement performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable / Not provided. There is no mention of expert involvement for establishing ground truth for any performance study in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable / Not provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The device is an "Endo Motor," a physical dental handpiece. It is not an AI/software device that would involve "human readers" or AI assistance in the way described for an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The description implies that the device's "root canal measurement capability" is integral to the motor's function. While there's a "Performance Comparison Testing of Root Canal Measurement Passed," the document does not provide details on whether this was a true "standalone" algorithm performance evaluation with explicit metrics, or simply a functional test. Given the regulatory class (Class I, reserved) and the nature of the device (a physical handpiece), it is highly unlikely that a rigorous clinical standalone performance study, as typically seen for AI/ML devices, was conducted or required.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not provided. For the "Performance Comparison Testing of Root Canal Measurement," the document does not specify how the "ground truth" for root canal length was established.
8. The sample size for the training set
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable / Not provided. This device is not described as an AI/ML device that requires a training set.
In summary, the provided FDA 510(k) document (K203320) focuses on demonstrating "substantial equivalence" of a physical dental device (Endo Motor) through a comparison of design, intended use, and non-clinical testing results against a predicate device. It does not contain the kind of clinical performance study details (e.g., acceptance criteria for diagnostic accuracy, sample sizes of test/training sets, ground truth establishment by experts, MRMC studies) typically associated with AI/algorithm-driven medical devices. The "Performance Comparison Testing of Root Canal Measurement" is mentioned as "Passed," but without any specifics provided in this document regarding its methodology or quantitative results.
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May 10, 2021
Guilin Woodpecker Medical Instrument Co., Ltd. % Giselle Zhang Regulatory Consultant Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746
Re: K203320
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 Dated: April 13, 2021 Received: May 10, 2021
Dear Giselle Zhang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 (OS) 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,
For Michael Adjodha Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203320
Device Name
Endo Motor
Indications for Use (Describe)
Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the file tip inside the canal.
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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5. 510(k) Summary
The following information is provided in accordance with 21 CFR 807.92 for the Premarket 510(k) Summary:
5.1 Submitter Information
| Company: | Alex Wang |
|---|---|
| Registration & Certification | |
| GUILIN WOODPECKER MEDICAL | |
| INSTRUMENT CO., LTD | |
| Information Industrial Park, Guilin National High | |
| Tech Zone | |
| Guilin, Guangxi 541004 P.R. China | |
| Telephone: 0086-773-2350532 | |
| Fax: 0086-773-5822450 | |
| zmnbg03@glwoodpecker.com | |
| Contact: | Giselle Zhang |
| Regulatory Consultant | |
| Emergo Global Consulting, LLC | |
| 2500 Bee Cave Road, Building 1, Suite 300 | |
| Austin, Texas 78746 USA | |
| Telephone: (512) 327-9997 | |
| Fax: (512) 327-9998 | |
| LST.AUS.ProjectManagement@ul.com | |
| Date Summary Prepared: | March 29, 2021 |
5.2 Device Name and Regulatory Information
| Trade Name: | Endo Motor |
|---|---|
| Common Name: | Dental handpiece and accessories |
| Classification Name: | Dental |
| Review Panel: | Dental (DE) |
| Regulation: | 872.4200 |
| Class: | Class I |
| Product Code: | EKX |
5.3 Equivalence Claimed to PredicateDevice
The Endo Motor is equivalent to the Tri Auto ZX2 (K170275), manufactured by J. MORITA USA, INC.. XSmart iQ (K161213) is provided as a reference device.
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5.4 Device Description
The Endo Motor Series includes a cordless hand-piece with charging adapter. The device has a chuck for holding rotary instruments such as dental files, and is mainly used in Endodontic surgeries. The device can enlarge the root canal by filing the dentin and measuring the root canal length, and may also be used for cutting and grinding for the preparation of root canal surgery. The rotary speed and the torque range can also be adjusted.
5.5 Intended Use Statement
Endo Motor, Ai-Motor and Endo Radar Plus are cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the tip inside the canal.
5.6 Non-Clinical Testing
To demonstrate substantial equivalence in safety and effectiveness of Endo Motor Series to the predicate device, Woodpecker completed the following non-clinical tests. Results confirm that the design inputs and performance specifications for the device are met. The Endo Motor Series passed the testing in accordance with internal requirements, and international standards shown below, supporting its safety and its substantial equivalence to the predicate device :
- Cytotoxicity testing per ISO 10993-5 Passed .
- Sensitization testing per ISO 10993-10 Passed ●
- Electrical safety testing per IEC 60601-1 Passed ●
- Electromagnetic Disturbance (EMD) testing per IEC 60601-1-2 Passed ●
- Software verification and validation per IEC 62304/FDA Guidance - Met Requirements
- . Usability per IEC 62366-1 - Met specifications
- Shipping Containers and Systems Performance, per ASTM D4169 Demonstrates package integrity ● maintained
- Dental Performance Requirements, per IEC 80601-2-60 Passed Processing of Medical Device, per ISO ● 17664 - Passed
- Development, Validation and Routine Control of Sterilization Process, per ISO 17665-1 Passed Moist . Heat Sterilization, per ISO TS 17665-2 - Passed
- Dentistry - Handpieces and Motors, per ISO 14457 - Passed
- Performance Comparison Testing of Root Canal Measurement Passed ●
5.7 Substantial Equivalence Discussion
Both Tri Auto ZX2 and Endo Motor Series are battery-driven handpieces with a motor, equipped with a chuck for holding rotary instruments such as a dental file. Both devices can be used for cutting and grinding teeth by transferring rotary movement to a rotary instrument attached to the head. Cutting and grinding of teeth can be done depending on switching/reversing the rotation direction. Rotation speed is acceleratedaccording to the user's preference, rotation control is based on torque detection, or pre-set time. These controls enable the cutting, grinding, enlargement, and preparation of root canals. Both devices can be used as an apex locator, and the measured value can be used for rotation control. Also both devices are intended to be sterilized prior touse.
The Tri Auto ZX2 can be used for the removal of extraneous materials such as gutta-percha points, and for professional mechanical tooth cleaning.
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The XSmart iQ is used as a reference device. As for the XSmart iQ, the Endo Motor series includes cordless motor hand-pieces, and both devices have a console. The Endo Radar Plus has integrated the display on the base but XSmart iQ is based on an Apple iPad Mini®. The motor parameters can be transferred, stored and displayed via the base on the Endo Radar Plus, but XSmart iQ uses iPad Mini® application (Endo iQ app).
| Table 5.1: Substantial Equivalence Discussion | |||
|---|---|---|---|
| Attribute | Endo Motor, Ai- Motor | Endo Motor, Endo Radar Plus | Tri-Auto ZX2 K170275 (Primary) |
| Manufacturer | GUILIN WOODPECKERMEDICAL INSTRUMENTCO., LTD | GUILIN WOODPECKERMEDICAL INSTRUMENTCO., LTD | J. MORITA USA, INC. |
| Intended Use | Canal Enlargement RootCanal Length Measurement | Canal Enlargement RootCanal Length Measurement | Canal Enlargement RootCanal Length Measurement |
| Indication for Use | Endo Motor, Ai- Motor is acordless endo motor withroot canal measurementcapability. It can be used asa endo motor forpreparation andenlargement of root canals,or device for measuringcanal length. It can be usedto enlarge the canals whilemonitoring the position ofthe file tip inside the canal. | Endo Motor, Ai- Motor andEndo Radar Plus arecordless endodontic motorwith root canalmeasurement capability. Itcan be used as a endo motorfor preparation andenlargement of root canals,or device for measuringcanal length. It can be usedto enlarge the canals whilemonitoring the position ofthe file tip inside the canal. | The Tri Auto ZX2 device isa cordless endodontictreatment motorizedhandpiece with root canalmeasurement capability. Itcan be used to enlargecanals while monitoring theposition of the file tipinside the canal. It can beused as a low-speedmotorized handpiece anddevice for measuring canallength. |
| Target Population | Patients in need of rootcanal surgery | Patients in need of rootcanal surgery | Patients in need of rootcanal surgery |
| Anatomical Sites | Root canal Softened dentin | Root canal Softened dentin | Root canal Softened dentin |
| Where Used | Dental ClinicUniversityHospitalThe other clinical settings | Dental ClinicUniversityHospitalThe other clinical settings | Dental ClinicUniversityHospitalThe other clinical settings |
| Dimension | Motor Handpiece: 28 mm x33.7 mmx 199.2 mm | Motor Handpiece:27.8 mm x 29 mmx 212 mm | Motor Handpiece: 30 mm x30 mm x200 mm |
| Weight | 150g | 151g | 140g |
| User Interface | Four push buttons:ON/OFFSetting buttonAdjusting button "+"Adjusting button "-" | Push Button of Handpiece:ON/OFFTouch Button of Base:"Power" button: Controlthe power on or off."Auto Rev" button"REV" button"En-Ap" button"SET" button"SYSTEM" adjustingbutton"FILE" button"TORQUE" button"SPEED" button"ANGLE" button | Four push buttons:ON/OFFSetting buttonAdjusting button “+”Adjusting button "-" |
| Materials of MotorHandpiece | PC/PBT blend (PC-Polycarbonate, PBT-polybutylene terephthalate) | PC/PBT blend (PC-Polycarbonate, PBT-polybutylene terephthalate) | PC/PBT blend (PC-Polycarbonate, PBT-polybutylene terephthalate) |
| lithium battery (3.7V) | 3.7 V) | ||
| Charger Power Supply | AC100V-240V | AC100V-240V | AC100V-240V |
| Frequency of SupplyVoltage | 50Hz ~ 60Hz | 50Hz ~ 60Hz | 50Hz ~ 60Hz |
| Components | Measuring wireFile clip Lip hookTouch probeSilicon CoverTesterSpray Nozzle | Measuring wireFile clip Lip hookTouch probeSilicon CoverTesterSpray Nozzle | TesterSpray Nozzle |
| Safety Mechanism | Automatically stops orreversely rotates as soon asthe file reaches the apicalstop, so as to preventperforation. | Automatically stops orreversely rotates as soon asthefile reaches the apicalstop, so as to preventperforation. | Auto Torque Reverse:The OTR (OptimumTorque Reverse) functionenables the file to reverseits rotational direction uponreaching a certain torque.After rotating in reverse by90 degrees, the file returnsto the cutting direction. |
| Battery Indicator | When the blue indicator onthe charging base flashes, itis charging.When the motor handpieceis fully charged, the blueindicator on the chargingbase would be always on. | Motor hand-piece batterylevel is displayed on base.The battery sign on the basescreen is full toindicate the fully chargedstate.The battery sign on thebase screen is only 2/3 toindicatethe remainingbattery power is about 70%.The battery sign on the basescreen is only 1/3 toindicatethe remainingbattery power is about 30%.The battery sign on the basescreen is blank to indicatethe battery is very low,please charge in time.When charging, the screendisplay panel green powericon will scroll display,when the battery powersign no longer scrolldisplay, indicating that thebattery was fully charged. | The orange light indicatescharging.The green light indicatesfull charge. |
| Torque Range | 0.4 Ncm ~ 5 Ncm | 0.4 Ncm ~ 5 Ncm | 0.4 Ncm ~ 4 Ncm |
| Rotate Speed | 100 rpm~1200 rpm(File in rotary mode) | 100 rpm~1200 rpm(File in rotary mode) | 100 rpm~1000 rpm(File in rotary mode) |
| Adjustability of Speedand Torque | 0.5 Torque setting(Ncm)50 speed steps | 0.5 Torque setting (Ncm)50 speed steps | 0.2 Torque setting(Ncm)75 speed steps |
| Micro Motor | Brushless | Brushless | Brush |
| USB Ports | Yes | Yes | Yes |
| Contra AngleAttachments | 6:1 Contra Angle (Model:CA161) | 6:1 Contra Angle (Model:CA161) | Morita Contra AngleSpecific (Exclusive) toTriAuto ZX2 |
| Primary Contra AngleGear Ratio | 6:1 | 6:1 | 6:1 |
| Operation Mode | Continuous operation | Continuous operation | Continuous operation |
| Biocompatibility | Conforms to 10993 | Conforms to 10993 | Conforms to 10993 |
| Standards | Standards | Standards | |
| Sterilization | End User (Moist Heat) | End User (Moist Heat) | End User (Moist Heat) |
| Electrical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Conform to IEC 60601-1 |
| Mechanical Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Conform to IEC 60601-1 |
| Thermal Safety | Conform to IEC 60601-1 | Conform to IEC 60601-1 | Conform to IEC 60601-1 |
| EMC Safety | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 | Conform to IEC 60601-1-2 |
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5.8 Conclusion
The Endo Motor Series has the same intended use and the same or similar technological characteristics and functionality as the predicate, and therefore is substantially equivalent to the predicate device. The differences are minor and supported by the reference device to demonstrate they do not raise new questions of safety and effectiveness as compared to the predicate device.
§ 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.