(58 days)
The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
Based on the provided FDA 510(k) summary, the device in question is a Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a clinical study of AI performance. Therefore, many of the typical acceptance criteria and study details for AI/ML-driven medical devices (e.g., Sensitivity, Specificity, MRMC studies, ground truth establishment for images) are not applicable here.
This device is not an AI/ML-driven diagnostic or therapeutic device. It is a traditional medical device (a dental handpiece). The "acceptance criteria" and "study" described in the document relate to engineering and performance testing to ensure the device meets established safety and performance standards for dental handpieces, and demonstrates substantial equivalence to predicate devices.
Here's an attempt to answer your questions based on the provided text, while noting where AI/ML-specific criteria are not relevant:
Acceptance Criteria and Device Performance for the Dental Handpiece, Wireless Endodontic Handpiece, endoit (Model EH-C500)
This device is a dental handpiece, and its acceptance criteria are primarily related to its mechanical, electrical, and material safety and performance, rather than diagnostic accuracy as would be the case for an AI/ML algorithm. The "study" described is a series of engineering design verification and validation tests, along with biocompatibility testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a non-AI device, the acceptance criteria are not typically expressed as traditional metrics like sensitivity, specificity, or AUC. Instead, they are related to compliance with recognized standards and successful completion of pre-defined engineering tests. The document states that "The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate that the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate (K220577) Dental Handpiece model CA160L and predicated (K123582) Endo A Class."
Here's a summary of the types of criteria and the general performance statement:
| Acceptance Criterion Type | Specific Standard/Test (where mentioned) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | Intended Use/Indications for Use (same as predicate K220577) | The device is intended for "removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth." This is stated as "the same" as predicate K220577, and the functional principle, while having a different power method, achieves the same intended use. |
| Electrical Safety & Performance | IEC 60601-1 (2005) "Medical electrical equipment – Part 1: General requirements for basic safety and essential performance" | "The aforementioned IEC testing... is provided as eCopy 007 and eCopy 008." "Favorable test results... confirmed to meet the FDA recognized standards..." |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 (2014) "Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests" | "The aforementioned IEC testing... is provided as eCopy 007 and eCopy 008." "Favorable test results... confirmed to meet the FDA recognized standards..." |
| Mechanical Performance (Handpiece) | ISO 14457 (2017) "Dentistry Handpieces and motors" | "Favorable test results... confirmed to meet the FDA recognized standards as well as ISO standard." |
| Mechanical Performance (Shanks) | ISO 1797 (2017) "Dentistry - Shanks for rotary and oscillating instruments" | "Favorable test results... confirmed to meet the FDA recognized standards as well as ISO standard." |
| Sterilization | ISO 17665-1 (Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices on the final finished device) | "Sterilizable according to ISO 17665-1." "Conform to the same standards for user sterilization." |
| Biocompatibility | ISO 10993-1:2009 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management system) - Specific tests mentioned: ISO MEM Elution, ISO Guinea Pig Maximization Sensitization, ISO Intracutaneous Irritation, ISO Materials Mediated Rabbit Pyrogen, ISO Acute Systemic Injection Test. | "The biocompatibility testing conducted for the predicate device... is applicable to the proposed Dental Handpiece... All of the patient-contacting raw materials... are the same as the predicate device... with no new introduction." "The proposed device... is categorized under 'Externally Communicating Device-Tissue/bone/dentin (Limited contact duration)'... This is the same category of the biocompatibility evaluation as the predicate." |
| General Design Verification & Validation | ISO 14971:2019/A1:2021 Medical devices - applications of risk management to medical devices. Specific test types mentioned: Appearance Test, Operation Test, Rotational Speed Test, Noise Test, Serviceable Year/Shelf-Life Test. | "The favorable results of the design verification testing demonstrate the design output... conforms to the applicable, pre-determined design requirements of the Dental Handpiece." "The testing results also further demonstrate the proposed Dental Handpiece... is substantially equivalent to the predicate..." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated as a number of "cases" or "patients" as would be for an AI study. The testing for this device involves:
- Biocompatibility: Likely conducted on samples of device materials, not a "test set" of patients. The document references testing done on a previous predicate device (K192809) which results were applied.
- Design Verification and Validation: This typically involves testing a certain number of manufactured units of the device (e.g., several units tested for rotational speed, noise, durability, etc.). The exact number is not specified in the summary but would be detailed in the full test reports.
- Electrical/EMC Testing: This would be conducted on device units in specialized labs.
- Data Provenance: Not applicable in the sense of patient data origin. The testing is laboratory and bench testing of the physical device and its materials. This is effectively "prospective" testing of the new device's engineering performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. For this type of device, "ground truth" is established by engineering specifications, recognized industry standards (e.g., ISO, IEC), and scientific principles, not by expert interpretation of clinical data or images. The "ground truth" is that the device must meet the specified performance parameters (e.g., a certain rotational speed, torque, noise level) and safety requirements (e.g., electrical safety, material biocompatibility). These are verified through objective measurements and accepted testing methodologies.
4. Adjudication Method for the Test Set
- Not applicable. As there are no human interpretations of data (e.g., images) that require consensus, there is no need for an adjudication method. Test results are objective measurements against established engineering and safety thresholds.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
- No. This is not an AI/ML diagnostic device, so an MRMC study comparing human reader performance with and without AI assistance is not relevant or performed for this type of 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware medical device with an electromechanical function, not a software algorithm. Therefore, "standalone algorithm-only performance" is not a relevant concept for this product. The device's "standalone performance" is its ability to meet its engineering and safety specifications on its own, which is what the various design verification tests confirm.
7. The Type of Ground Truth Used
- Engineering Specifications and Recognized Standards: The "ground truth" is defined by the requirements outlined in the relevant ISO and IEC standards (e.g., ISO 14457 for handpieces and motors, IEC 60601-1 for electrical safety, ISO 10993-1 for biocompatibility) and the manufacturer's own pre-defined design requirements for functional performance (e.g., rotational speed range, noise limits). Successful completion of tests against these standards constitutes meeting the "ground truth."
8. The Sample Size for the Training Set
- Not applicable. This device does not use an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no AI/ML algorithm or training set, this question is not relevant.
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November 9, 2023
Micro-NX Co., Ltd. % Brandon Green RA Associate K-Bio Solutions 201 South 4th Street, Suite 727 San Jose, California 95112
Re: K232810
Trade/Device Name: Dental Handpiece, Wireless Endodontic Handpiece, endoit Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX Dated: September 4, 2023 Received: September 12, 2023
Dear Brandon Green:
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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
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Sincerely,
Michael E. Adjodha -S
Michael Adjodha, MChE, RAC, CQIA 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) K232810
Device Name
Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no.(EH-C500)
Indications for Use (Describe)
The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
| 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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K232810 510(k) SUMMARY
Pursuant to Section 510(k) of Chapter V of the Federal Food, Drug, and Cosmetic Act and in accordance with subpart E of Part 807, Title 21 of the Code of Federal Regulations, MICRO-NX Co., Ltd. submits the following information as premarket notification for the proposed device, Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500)
I. SUBMITTER
510(k) Correspondent: Brandon Green RA Associate, K-Bio Solutions (brandon.green@kbiotechsolutions.com) Tel: 82-2-597-2700
Sponsor: MICRO-NX Co., Ltd. 22, Maeyeo-ro 1 gil, Dong-gu, Daegu Postal code: 41059, Republic of Korea Tel: 82-053-650-1000 Fax: 82-053-650-1005
Manufacturer Contact: Haim Yoon (haimyoon1@micronx.co.kr) Date Prepared: September 4th, 2023
II. SUBMISSION DEVICE
- Trade Name(s) of Device: Dental Handpiece, Wireless Endodontic Handpiece, ● endoit (model number: EH-C500)
- Regulation Number: 21 CFR 872.4200 ●
- Regulation Name: Dental handpiece and accessories ●
- Product Code: EKX (Handpiece, Direct Drive, Ac-Powered) ●
- Review Panel: Dental
- Regulatory Class: Class I ●
- Traditional 510(k) Registration .
Prior formal correspondence with the FDA resulted in the 510(k) clearance of the Micro-NX Dental Handpiece (K220577) Model CA160, CA160L, and CA500L
III. PREDICATE DEVICES
- Dental Handpiece model CA160L (K220577), Manufacturer: Micro-NX Co., Ltd. ●
- Endo A Class (K123582), Manufacturer: Saeyang Microtech Co., Ltd. ●
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IV. DEVICE DESCRIPTION
The intended use of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is the same as the intended use of the predicate (K220577) Dental Handpiece model CA160L and similar to the predicate (K123582) Endo A Class.
- Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) . is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
- Predicate Dental Handpiece (K220577) model CA160L is intended for the removal of . carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, restorations, and for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
- . Predicate Endo A Class (K123582) has the following intended use: This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
Compared to the predicate device Dental Handpiece model CA160L (K220577), the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) contains additional components of a Charging Cradle and AC/DC Adapter. Therefore, the primary distinction between the predicate device (K220577) and the EH-C500 is their power/charging method. The EH-C500 relies on the AC/DC Adapter and Charging Cradle to recharge its Main Body, whereas the predicate (K220577) receives electrical input from an external electric motor that is typically attached to the distal end of the dental handpiece's Main Body. Thus, the main technological characteristics in terms of achieving the intended use for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and for polishing teeth are identical between the predicate (K220577) and Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500)
Compared to the predicate device Endo A Class (K123582), the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has the same components and similar
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technological characteristics including a connectable Contra Angle, charging method, and wireless functionality.
The identified difference between the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and predicate Dental Handpiece model CA160L (K220577) lies primarily within their power/charging methods. However, this difference has been assessed and it has been determined not to raise different questions regarding the safety or effectiveness of either the predicate devices CA160L and Endo A Class or the proposed device EH-C500, which have been tested according to the FDA's recognized IEC standards listed below:
- . IEC 60601-1 (2005) "Medical electrical equipment - Part 1: General requirements for basic safety and essential performance"
- IEC60601-1-2 (2014) "Edition 4.0 2014-02 Medical electrical equipment Part 1-2: . General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
The aforementioned IEC testing of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is provided as eCopy 007 and eCopy 008. Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is provided with a connectable Contra Angle component, that is connected to the Main Body, The Contra Angle and Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) together make up the main body system of the device. Essentially, the Contra Angle and Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) together serve the similar technological characteristics as the main body system of the predicate (K220577) Dental Handpiece model CA160L. Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is a wireless, electric, and chargeable device utilized in root canal treatment. The battery inside the Main Body of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) generates power to transmit rotational force for the general dental treatments. The speed of the rotation and torque value can be controlled using the buttons on the main body of the device. The rotational force is transmitted under the permitted rotation mechanism.
Components associated with the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the Main Body, Contra Angle (EH-A01), Charging Cradle, and AC/DC Adapter. The Charging Cradle and AC/DC Adapter are accessory components of the device.
Components associated with the predicate Dental Handpiece model CA160L are the Main Body handle which includes Contra Angle. The accessory component associated with the CA160L model is the Spray Adapter.
Components associated with the predicate Endo A Class are the Main Body, Contra Angle, Charging Cradle, and AC/DC Adapter. The Charging Cradle and AC/DC Adapter are accessory components of the device.
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The components of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) in comparison of those of the predicate devices Dental Handpiece model CA160L and Endo A Class are provided in Table IV-1 below.
| Model | Proposed Device:EH-C500 | Predicate Device:CA160L | Predicate Device:Endo A Class |
|---|---|---|---|
| Main Body | X | X | X |
| Contra Angle | X | X | X |
| Charging Cradle(accessory) | X | X | X |
| AC/DC Adapter(accessory) | X | X | X |
| Spray Adapter(accessory) | X | X | X |
Table IV-1 Proposed Device Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) Component Specification
The component names and function of the proposed Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500) and predicate Dental Handpiece model CA160L are provided in Table IV-2 and Table IV-3 below.
Table IV-2 Component Names and Functional Descriptions for Critical Components of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500)
| No. | Component Name | Function |
|---|---|---|
| A. Components of Main Body of the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) | ||
| A1 | Handpiece Top Case | Top part of the Handpiece case |
| A2 | Handpiece Bottom Case | Bottom part of the Handpiece case |
| A3 | Name plate | Sticker for button identification and exterior design |
| A4 | Button | Button to activate functions of the Dental Handpiece |
| A5 | LCD Plate | Protects LCD |
| A6 | PCB Assembly | Internal PCB |
| A7 | Handle Cap | For connecting internal parts |
| A8 | Index Ring | For connecting internal parts |
| A9 | Motor Assembly | Motor that transmits rotational power |
| A10 | Battery | Power the motor |
| B. Contra Angle (EH-A01) | ||
| B1 | Head Assembly | Transmits rotational power from the handpiece to the bur |
| B2 | Shank Assembly | Connects Handpiece and the Head part |
| No. | ComponentName | Function |
| A. Components of Main Body of the Dental Handpiece Model CA160L | ||
| A1 | Spindle Assembly | Receives torque from Middle Gear Assembly and transmits torque to final dental bur |
| A2 | Middle GearAssembly | Transmitting the rotational force from the Inner Handle Assembly and delivers the rotational force to the Spindle Assembly |
| A3 | Button Assembly | Button for removal and attachment of the hand piece head |
| A4 | Head Cap | Case that wraps the Spindle Assembly. Head Cap is assembled with Button Assembly and Middle Gear Assembly |
| A5 | Head Assembly | The component that is assembled Spindle Assembly, Middle Gear Assembly, Button Assembly, Head Assembly |
| A6 | Gear BoxAssembly | It consists of several gears and decelerates. |
| A7 | Joint GearAssembly | Transmits the torque received from the motor to the Head Assembly |
| A8 | Inner Handle | Case to fix Joint Assembly |
| A9 | Locking Handle | Head assembly's attachment and detachment. |
| A10 | Angle HandleAssembly | The case of Joint Gear Assembly, Optic, Head |
| B. Components only available for CA160L | ||
| B1 | Optic | Optical fiber that allows light to pass from the motor's LED light source to the handpiece head |
| B2 | Angle Body | The case is installed in Handle Assembly and protect the optics. |
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Table IV-3 Component Names and Functional Descriptions for Critical Components of Dental Handpiece model CA160L
V. INDICATIONS FOR USE/INTENDED USE
Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth
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preparations, and restorations for polishing teeth. The Dental Handpiece is designed for use by a trained professional in the field of general dentistry.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Fundamental technological characteristics of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) are substantially equivalent to the predicate devices, MICRO-NX Dental Handpiece model CA160L (K220577) and Saeyang Microtech Co., Ltd. Endo A Class (K123582) as demonstrated in Table VI-1 below.
| Proposed Device:Dental Handpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) | Predicate Device:Dental Handpiecemodel CA160L(MICRO-NX,K220577) | Predicate Device:Endo A Class(SaeyangMicrotech Co.,Ltd., K123582) | SubstantialEquivalenceAssessments | |
|---|---|---|---|---|
| Intended Use/ Indicationsfor Use | Dental Handpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) isintended for theremoval of cariousmaterial, reducingof hard toothstructure, cavityand crownpreparations, rootcanal preparations,removal of fillings,processing andfinishing toothpreparations, andrestorations forpolishing teeth.Dental Handpieceis designed for useby a trainedprofessional in thefield of generaldentistry. | Dental Handpiecemodel CA160L isintended for theremoval of cariousmaterial, reducingof hard toothstructure, cavityand crownpreparations, rootcanal preparations,removal of fillings,processing andfinishing toothpreparations, andrestorations forpolishing teeth.Dental Handpieceis designed for useby a trainedprofessional in thefield of generaldentistry. | This applicationarea extends toendodonticprocedures using aroot canalinstrument which isintended by themanufacturer foruse in themechanical androtary preparationof root canals. | Intended use andindications for useare the samebetween DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) and thepredicate deviceDental Handpiecemodel CA160L forthe removal ofcarious material,reducing of hardtooth structure,cavity and crownpreparations, rootcanal preparations,removal of fillings,processing andfinishing toothpreparations, andrestorations forpolishing teeth.Dental Handpieceis designed for useby a trained |
| field of generaldentistry. | ||||
| FunctionalPrinciple | Compared to thepredicate(K220577) DentalHandpiece modelCA160L that iscoupled tohandpiececonnectors toreceive energy, theproposed DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) has abuilt-in battery inthe main body thatgenerates torqueforce to transmitrotational force tothe contra angle forthe general dentaltreatments. | Through the micromotor connected tothe dental treatmentunit, the DentalHandpiece modelCA160L contraangle handpiece isequipped with ahandpiececonnection thatreceives the energy,the cooling waterand air fortreatment and thelight forillumination theoperating area. | The motor turnedby the powerconverted intoDC2.4V bycontroller deliversits turning power tothe file throughspin to performpunching, cuttingandremovingfunctions. Thehand-piece can beoperated, stoppedandset/adjusted on/inits speed, torqueand turningdirection byhandling of thecontroller. | Similar FunctionalPrincipleIn order to addressthe wirelessfunction of theproposed device, anadditional predicatedevice, Endo AClass, is beingsubmitted. Thewireless functiondoes not raisequestions about thesafety oreffectiveness of theproposed devicecompared to thepredicate device. |
| Dimensions | Main BodyWidth: 23mmLength: 27mmHeight: 155mmContra Angle(EH-A01)Diameter: 17mmLength: 71mmHeight: 30mmHead Length:8.1mm | ConnectionDiameter: 20mmLength: 95mmHead Length:14mmHead Diameter:9mm | Main BodyWidth: 27mmLength: 28mmHeight: 192mm | The head size,height, anddiameter of DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) arebroadly inalignment with thedimensions of thepredicate |
| Head Diameter:10.7mm | (K220577) DentalHandpiece modelCA160L. Theminor differencesin the identifieddimensions do notraise differentquestions in termsof the safety oreffectiveness of theproposed DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500). | |||
| Directpatient-contactingportions ofthe device | All materials forthe DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) arelisted in the rawmaterial tableincluding chemicalcomposition of thewaterlines and thepatient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementsystem - ISO10993-1:2009) | All materials forDental Handpiecemodels are listed inthe raw materialtable includingchemicalcomposition of thewaterlines and thepatient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementsystem - ISO10993-1:2009) | Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementsystem - ISO10993-1:2009) | The proposedDental Handpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) is anadditional model tothe predicate(K220577) DentalHandpiece modelCA160L and hasidentical in-directpatient contactingmaterials.Therefore, thepredicate devicebiocompatibilitytest results per thestandard of ISO10993-1 areapplicable to theproposed DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500). |
| Indirectpatient-contactingportions ofthe device | All materials forthe DentalHandpiece,WirelessEndodontic | All materials forDental Handpiecemodel CA160L arelisted in the tablesabove including | Biocompatibleaccording to ISO10993-1(Biologicalevaluation of | The proposedDental Handpiece,WirelessEndodonticHandpiece, endoit |
| (water / air lines) | ||||
| Handpiece, endoit(model number:EH-C500) arelisted includingchemicalcomposition of thewaterlines and thepatient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementsystem - ISO10993-1:2009) | chemicalcomposition of thewaterlines and thepatient-contactingportions of thedevice.Biocompatibleaccording to ISO10993-1(Biologicalevaluation ofmedical devices -Part 1: Evaluationand testing within arisk managementsystem - ISO10993-1:2009) | medical devices -Part 1: Evaluationand testing within arisk managementsystem - ISO10993-1:2009) | (model number:EH-C500) is anadditional model tothe predicate(K220577) DentalHandpiece modelCA160L and hasidentical in-directpatient contactingmaterials.Therefore, thepredicate devicebiocompatibilitytest results per thestandard of ISO10993-1 areapplicable to theproposed DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500). | |
| ChargingMethod | Charging Cradle | External electricmotor | Charging CradleThe chargingmethod of theproposed DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) is acharging cradle,identical to thepredicate device(K123582). | |
| ChuckDesign | Push Button Chuck | Push Button Chuck | Push Button ChuckThe chuck designof the proposedDental Handpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) is pushbutton chuck,identical to thepredicate device | |
| Motor SpeedRange(RPM's) | 120 ~ 500 rpm | Up to 20,000 rpm | 140-500rpm | The motor speed range of the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is within a lower range compared to the predicate (K220577) CA160L Dental Handpiece model. Since the maximum speed range of the predicate device encompasses the speed range of the proposed model, it does not have any significant impact on establishing substantial equivalence. |
| ConformanceStandards(Handpiecesand Motors) | ISO 14457(Dentistry -Handpieces andmotors - ISO14457:2012) | ISO 14457(Dentistry -Handpieces andmotors - ISO14457:2012) | ISO 14457(Dentistry -Handpieces andmotors - ISO14457:2012) | Compliant with the same standards for dentistry handpiece and motors. |
| ConformanceStandards(Shanks) | ISO 1797 (2017)"Dentistry - Shanksfor rotary andoscillatinginstruments" | ISO 1797 (2017)"Dentistry - Shanksfor rotary andoscillatinginstruments" | ISO 1797 (2017)"Dentistry - Shanksfor rotary andoscillatinginstruments" | Compliant with the same standards of dentistry shanks. |
| Sterilization | Sterilizableaccording to ISO17665-1(Sterilization ofhealth careproducts - Moistheat - Part 1:Requirements forthe development,validation androutine control of asterilization processfor medical deviceson the final | Sterilizableaccording to ISO17665-1(Sterilization ofhealth careproducts - Moistheat - Part 1:Requirements forthe development,validation androutine control of asterilization processfor medical deviceson the final | Sterilizableaccording to ISO17665-1(Sterilization ofhealth careproducts - Moistheat - Part 1:Requirements forthe development,validation androutine control of asterilization processfor medical deviceson the final | Conform to the same standards for user sterilization. |
| finished device -ISO 176651:2006) | finished device -ISO 176651:2006) | finished device -ISO 176651:2006) | ||
| Gear Ratio | 1:1 | 16:1 | 4:1, 10:1, 16:1,20:1 | Compared to thepredicate(K220577) ofDental Handpiecemodel CA160Lgear ratio of 16:1,the proposedDental Handpiece,WirelessEndodonticHandpiece, endoit(model number:EH-C500) lowergear ratio of 1:1does not raisedifferent questionsin terms of thesafety oreffectiveness of theproposed DentalHandpiece,WirelessEndodonticHandpiece, endoit(model number:EH C500) |
Table VI-1. Substantial Equivalence Assessment between Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and Predicate Devices (K220577) and K(123582)
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Overall, design verification testing were performed to assess the following critical elements of medical devices used in dentistry applications. The favorable test results of the proposed device which confirmed to meet the FDA recognized standards as well as ISO standard demonstrate that the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) retains the substantially equivalent profile in safety and essential performance of medical electrical equipment as the predicate (K220577) Dental Handpiece model CA160L and predicated (K123582) Endo A Class.
- ISO 14457 (2017) "Dentistry Handpieces and motors" (Recognition List Number: 031 . Effective Date: 09/15/2012)
- ISO 1797 (2017) "Dentistry - Shanks for rotary and oscillating instrument
The following IEC standard tests have been completed to evaluate electrical safety and performance of the Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500):
- IEC 60601-1 (2005) "Medical electrical equipment Part 1: General requirements for basic ● safety and essential performance"
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- IEC60601-1-2 (2014) "Edition 4.0 2014-02 Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests"
VII. DESIGN VERIFICATION & PERFORMANCE DATA
The following design verification and performance data are provided in support of the conclusive determination that the proposed dental handpiece is substantially equivalent to the predicate device Dental Handpiece model CA160L (MICRO-NX, K220577).
Biocompatibility Testing
The biocompatibility testing conducted for the predicate device Dental Handpiece model CA 160L(MICRO-NX, K220577) is applicable to the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500). The proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is an additional model to the predicate device Dental Handpiece model CA160L (MICRO-NX, K220577). All of the patientcontacting raw materials of the proposed Dental Handpiece. Wireless Endodontic Handpiece, endoit (model number: EH-C500) are the same as the predicate device Dental Handpiece (MICRO-NX, K220577) with no new introduction of patient contacting raw materials for the proposed Dental Handpiece model.
In accordance with ISO 10993-1: 2009. Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process, the Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is categorized under "Externally Communicating Device-Tissue/bone/dentin (Limited contact duration). This is the same category of the biocompatibility evaluation as the predicate (K220577) Dental Handpiece model CA160L.
The biocompatibility testing has been conducted with the FDA-approved Dental Handpiece model SG200L (K192809) in 2019 in order to ensure FDA's latest consensus standards with respect to biological safety evaluations are met for the proposed device. The predicate (K220577) Dental Handpiece model CA160L was approved by the FDA on July 29th, 2022 and in this submission the Dental Handpiece including model SG200L was used as the predicate device (K192809) for substantial equivalence. The Dental Handpiece model CA160L (K220577) and Dental Handpiece including model SG200L (K192809) were assessed as substantially equivalent and the biocompatibility test results of the Dental Handpiece model SG200L was used as evidence for the Dental Handpiece CA160L (K220577).
- ISO MEM Elution Using L-929 Mouse Fibroblast Cells (GLP)
- ISO Guinea Pig Maximization Sensitization Test (GLP 2 Extracts) ●
- ISO Intracutaneous Irritation Test (GLP 2 Extracts) ●
- ISO Materials Mediated Rabbit Pyrogen (GLP) ●
- . ISO Acute Systemic Injection Test (GLP - 2 Extracts)
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Design Verification and Validation Testing
The proposed, Micro-NX Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) has been evaluated and risk management practices have been implemented in accordance with ISO 14971:2019/A1:2021 Medical devices - applications of risk management to medical devices.
- Appearance Test ●
- Operation Test
- Rotational Speed Test ●
- . Noise Test
- Serviceable Year/ Shelf-Life Test ●
- IEC 60601-1
- IEC 60601-1-2 ●
The favorable results of the design verification testing demonstrate the design output of Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) conforms to the applicable, pre-determined design requirements of the Dental Handpiece. The testing results also further demonstrate the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) is substantially equivalent to the predicate (K220577) Dental Handpiece model CA160L, as the proposed and predicate device are subject to the same applicable test standards of design requirements for dental handpieces.
Therefore, the identified differences in terms of the dimensions and outer appearance between the proposed Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) and the predicate (K220577) Dental Handpiece model CA160L do not raise different questions regarding the safety or effectiveness of the proposed device.
VIII. CONCLUSIONS
Overall, the proposed device is assessed substantially equivalent to the predicate devices given the fact that its indications for use are the same, and fundamental technological characteristics are equivalent to those of the predicate device Dental Handpiece (MICRO-NX, K220577). The positive outcomes from the design verification and performance testing mentioned above confirm alignment with the relevant standards related to dental handpieces. Furthermore, they highlight that there are no additional concerns regarding safety and effectiveness assessment when compared to the predicate devices of Dental Handpiece model CA160L (MICRO-NX, K220577) or the Endo A Class (K123582).
§ 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.