(27 days)
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.
The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows: Z95L 1:5 Increasing, Z85L 1:5 Increasing, Z25L 1:1 Direct Drive, Z15L 4:1 Reducing, Z10L 16:1 Reducing. The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area. The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019. The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece. The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.
The provided document is a 510(k) premarket notification for a dental handpiece. It describes modifications to an existing device and compares it to predicate devices to demonstrate substantial equivalence. However, it does not contain the detailed information necessary to answer all parts of your request, which primarily focuses on clinical study data, acceptance criteria related to performance metrics, and human-in-the-loop assessments for AI/ML devices.
This document is for a Class I dental handpiece, which is a physical mechanical device, not an AI/ML powered device that would typically involve acceptance criteria like accuracy, sensitivity, specificity, or studies with expert adjudications and MRMC designs.
Here's a breakdown of what can and cannot be answered based on the provided text:
What can be extracted (and interpreted for context):
The document primarily focuses on demonstrating substantial equivalence for a modified physical medical device (a dental handpiece) to a previously cleared predicate device. For such devices, acceptance criteria often revolve around engineering performance, material compatibility, and safety standards rather than clinical performance metrics like those for AI/ML.
1. A table of acceptance criteria and the reported device performance
The document mentions "applicable technical standards, internal specifications, and FDA guidance documents" were used. It also states:
| Performance Aspect | Acceptance Criteria Implied (from testing) | Reported Device Performance (from summary) |
|---|---|---|
| Risk Analysis | Mitigation of identified risks and hazardous conditions. | "The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted." (This implies the device met the acceptance criterion of acceptable risk.) |
| Compliance to Standards | Compliance with applicable technical standards, internal specifications, and FDA guidance documents. | "Testing confirmed that the General Cutting Contra Handpiece device complies with the applicable technical standards, internal specifications, and FDA guidance documents and is safe and effective for its intended use." (This implies the device met relevant performance standards, though the specific metrics are not detailed here). |
| Cleaning & Sterilization | Meets established performance requirements for cleaning and sterilization. | "Cleaning and sterilization validation testing presented in the predicate 510(k) clearance [K182999] is leveraged to demonstrate that the product continues to meet established performance requirements." (This implies the device, with its modifications, met the same cleaning and sterilization performance as the predicate, which itself would have had acceptance criteria for microbial inactivation and material integrity.) |
| Biocompatibility | Safe biocompatibility profile. | "The biocompatibility testing was not repeated as the subject device is made from the same material, same manufacturing processes, and same packaging configuration as those utilized in the fabrication of both the predicate [K182999] and reference devices [K121901]. The biocompatibility testing conducted on the predicate and reference devices ensures that the modified General Cutting Contra Handpiece has a safe biocompatibility profile and is safe to use." (This implies the device met the acceptance criteria for biocompatibility by reference to predicate.) |
| Mechanical Performance | (Implied) Maintain specified rotation speeds, bur compatibility, and coupling type as the predicate. | The comparative table lists identical "Max Rotation Speed (motor)," "Gear Ratio Max rotation speed (handpiece)," and "Burs" specifications to the predicate device, indicating equivalent mechanical performance. |
| Water Spray Functionality | Ability to alternate between water spray (water + air) and water jet (water only), reducing splatter. | The primary modification is "an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device... to reduce the area of irrigation water splattering." (The performance is described as achieving this alternation and reduction, which would be the acceptance criteria for this new feature). |
| Coating Material Durability | (Implied) Equivalent or improved durability/performance compared to previous coating. | "The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019." (This implies the new coating meets acceptance criteria for durability/safety based on prior clearance.) |
What cannot be answered from the provided text:
The following points are typically relevant to AI/ML or diagnostic devices that rely on data for performance metrics (e.g., sensitivity, specificity, AUC). Since this document is for a physical dental handpiece, these concepts don't directly apply in the way you've framed them.
- Sample sizes used for the test set and the data provenance: Not applicable. Performance testing for a mechanical device would involve engineering tests (e.g., torque, speed, durability, material testing) rather than a "test set" of patient data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no "ground truth" in the clinical data sense for a mechanical device's direct performance. Adherence to engineering specifications and safety standards are the benchmarks.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable. This device is not an AI/ML diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI/ML algorithm. For this device, the "ground truth" for performance would be established engineering specifications, material standards, and safety requirements.
- The sample size for the training set: Not applicable. There is no "training set" for a mechanical device.
- How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 27, 2020
Nakanishi Inc. % Yulia Nikova Regulatory Project Manager Ken Block Consulting LLC 800 East Campbell Road, Suite 202 Richardson. Texas 75081
Re: K202960
Trade/Device Name: General Cutting Contra Handpiece Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: September 29, 2020 Received: September 30, 2020
Dear Yulia Nikova:
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
{1}------------------------------------------------
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,
for Srinivas "Nandu" Nandkumar, Ph.D. 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name General Cutting Contra Handpiece
Indications for Use (Describe)
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
5. 510(K) SUMMARY K202960
| Submitter: | NAKANISHI INC.700 ShimohinataKanuma, Tochigi 322-8666 Japan | |
|---|---|---|
| Contact Person: | Mr. Masaaki KikuchiGeneral Manager/Quality & Regulatory Affairs Dept.TEL: +81-289-64-7277FAX: +81-289-62-9738email: m-kikuchi@nsk-nakanishi.co.jp | |
| Date Prepared: | September 29, 2020 | |
| Submission Type: | Special 510(k) | |
| Subject Device: | Manufacturer:Trade Name:Common Name:Regulatory Class:Product Code:Regulation: | NAKANISHI INC.General Cutting Contra HandpieceHandpiece, Contra- And Right-Angle Attachment,DentalClass IEGS21 CFR 872.4200, Dental handpiece and accessories |
| Predicate Device: | Clearance:Manufacturer:Trade Name:Common Name:Regulatory Class:Classification Name:Product Code:Regulation: | K182999 dated April 16, 2019NAKANISHI INC.General Cutting Contra HandpieceHandpiece, Contra- And Right-Angle Attachment,DentalClass IHandpiece, Contra- And Right-Angle Attachment,DentalEGS21 CFR 872.4200, Dental handpiece and accessories |
| Reference device: | Clearance:Manufacturer:Trade Name:Regulatory Class:Classification Name:Product Code:Regulation: | K121901 dated February 28, 2013NAKANISHI INC.Ti-Max Z45Class IHandpiece, Contra- And Right-Angle Attachment,DentalEGS21 CFR 872.4200, Dental handpiece and accessories |
| Reference device: | Clearance:Manufacturer:Trade Name:Regulatory Class:Classification Name:Product Code:Regulation: | K173905 dated June 19, 2018NAKANISHI INC.Surgic Pro, Surgic Pro+Class IController, Foot, Handpiece And CordEBW21 CFR 872.4200, Dental handpiece and accessories |
Section 5: Page 1 of 5
NAKANISHI INC.
{4}------------------------------------------------
Device Description: The subject modified General Cutting Contra Handpiece (modified Ti-Max Z Series: Z10L, Z15L, Z25L, Z85L, Z95L) is a contra-angle dental handpiece powered by either an air-motor or electronic-micromotor for use in general dentistry. The modified General Cutting Contra Handpiece is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials, and removal of crowns and filling materials. The modified General Cutting Contra Handpiece transmits rotational force from the motor to the gears through a clutch. The allowable maximum speed for the motor is 40,000 min-1. Then the rotation force reaches the chuck and the dental bur receives the rotation force. The dental bur cuts and grinds teeth using the rotation force. The rotation speed varies depending on the gear ratios as follows:
| Z95L | 1:5 Increasing |
|---|---|
| Z85L | 1:5 Increasing |
| Z25L | 1:1 Direct Drive |
| Z15L | 4:1 Reducing |
| Z10L | 16:1 Reducing |
The modified General Cutting Contra Handpiece feature fiber optic providing illumination to the cutting area.
The subject of this Special 510(k) submission is an addition of the Switching Valve that allows to alternate between two types of water spray options: water spray (water + air) and water jet (water only) to the cleared device [K182999] to reduce the area of irrigation water splattering. This alternation is enabled using the Wrench accessory that has been previously cleared as a part of K121901. The coating material for the exterior of the handpiece has been changed from DURACOAT (Ti+MRK-T) to DURAGRIP (Ti+CrN). The coating material was previously used in the exterior of the nano Series of the predicate General Cutting Contra Handpiece [K182999] and has been cleared by FDA in 2019.
The original submission [K182999] included four series of contra handpieces: the S-Max M Series, the Ti-Max X Series, the Ti-Max Z Series, and the Ti-Max nano Series. The proposed modification applies solely to the Ti-Max Z series. The following models will be affected by this change: Z10L, Z15L, Z25L, Z85L, Z95L. The modified models are marked with "SW" on the neck on the handpiece.
The models that were cleared under the original General Cutting Contra Handpieces submission are not impacted by the present submission.
{5}------------------------------------------------
Indication for Use: The Indication for Use statement is identical to the predicate device. The intended use of the modified device, as described in the labeling, has not changed as a result of the modification.
The General Cutting Contra Handpiece is powered by either an air-motor or electronic micromotor for use in general dentistry. The device is intended for cutting and grinding teeth, cavity preparations, tooth and crown preparations, finishing and trimming teeth and filling materials.
Summary of Technological Characteristics: Comparison with the predicate device shows the characteristics of the proposed modification (an addition of a switching valve in order to alternate between two types of water spray options: water spray (water + air) and water jet (water only)) to the modified General Cutting Contra Handpiece to be substantially equivalent to the predicate device.
| New Device | Predicate Device | Reference Device | |
|---|---|---|---|
| Trade Name | General CuttingContra Handpiece | General CuttingContra Handpiece | Ti-Max Z45 |
| 510(k) Submitter | NAKANISHI INC. | NAKANISHI INC. | NAKANISHI INC. |
| [Number] | [TBD] | [K182999] | [K121901] |
| Product Code(s) | EGS | EGS | EGS |
| Indications forUse | The General CuttingContra Handpiece ispowered by either anair-motor orelectronicmicromotor for use ingeneral dentistry. Thedevice is intended forcutting and grindingteeth, cavitypreparations, toothand crownpreparations,finishing andtrimming teeth andfilling materials andremoval of crownsand filling materials. | The General CuttingContra Handpiece ispowered by either anair-motor orelectronicmicromotor for use ingeneral dentistry. Thedevice is intended forcutting and grindingteeth, cavitypreparations, toothand crownpreparations,finishing andtrimming teeth andfilling materials andremoval of crownsand filling materials. | Ti-Max Z45 ispowered by either anair-motor or electricmicromotor for use ingeneral dentistry. Thedevice is intended forcutting and grindingteeth, cavitypreparations, toothand crownpreparations,finishing andtrimming teeth andfilling materials, andremoval of crownsand filling materials. |
| Application | General Dentistry | General Dentistry | General Dentistry |
| Model Numbers | Z10L, Z15L,Z25L,Z85L, Z95L | Z10L, Z15L,Z25L,Z85L, Z95L | Z45, Z45L |
| Weight | 57g - 59.5g | 57g - 59.5g | 66.5 g |
{6}------------------------------------------------
| Burs | ISO 1797-1(Type1)ISO 1797-1(Type3) | ISO 1797-1(Type1)ISO 1797-1(Type3) | ISO 1797-1(Type3)φ1.59-1.60mm FGBur |
|---|---|---|---|
| ISO 3964 (EN ISO3964) | ISO 3964 (EN ISO3964) Standard | ISO 3964 | |
| Coupling Type | Standard Coupling | Coupling | |
| Max RotationSpeed (motor) | 40,000min-1 max | 40,000min-1 max | 40,000 min-1 max |
| 16:1 Reduction-2,500min-1 | 16:1 Reduction-2,500min-1 | ||
| 4:1 Reduction-10,000min-1 | 4:1 Reduction-10,000min-1 | ||
| Gear RatioMax rotationspeed(handpiece) | 1:1 Direct Drive-40,000min-1 | 1:1 Direct Drive-40,000min-1 | 168,000 min-1 |
| 1:5 Increasing-200,000min-1 | 1:5 Increasing-200,000min-1 | ||
| Cleaners/Lubricants | Cleaners: N/ALubricants: NSKPANA SPRAY[K052700], NSKPANA SPRAYPlus [K131014], orNSK automatichandpiece cleaningand lubricationsystem [K081811] | ||
| NSK PANASPRAYPlus [K163483] | NSK PANASPRAYPlus [K163483] | ||
| SterilizationMethod | Steam Autoclave(Moist Heat) | Steam Autoclave(Moist Heat) | Steam Autoclave(Moist Heat) |
| SterilizationStandard | ISO17665-1:2006 | ISO17665-1:2006 | ISO17665-1:2006 |
Summary of Performance Testing:
The fundamental scientific technology of the General Cutting Contra Handpiece has not been modified. The risks and hazardous impacts of the device modification were analyzed by FMEA methodology. The specific risk control and protective measures to mitigate the risks from the modification were reviewed and implemented as part of product design. The overall assessment concluded that all identified risks and hazardous conditions were successfully mitigated and accepted.
Testing confirmed that the General Cutting Contra Handpiece device complies with the applicable technical standards, internal specifications, and FDA guidance documents and is safe and effective for its intended use.
Section 5: Page 4 of 5
{7}------------------------------------------------
| Cleaning and sterilization validation testing presented in the predicate 510(k)clearance [K182999] is leveraged to demonstrate that the product continues tomeet established performance requirements. | |
|---|---|
| BiocompatibilityTesting: | The biocompatibility testing was not repeated as the subject device is made fromthe same material, same manufacturing processes, and same packagingconfiguration as those utilized in the fabrication of both the predicate [K182999]and reference devices [K121901]. The biocompatibility testing conducted on thepredicate and reference devices ensures that the modified General CuttingContra Handpiece has a safe biocompatibility profile and is safe to use. |
| Discussion of theClinical Tests: | Clinical testing was not required for a determination of substantial equivalenceof the modified General Cutting Contra Handpiece. |
| Conclusion: | NAKANISHI INC. considers the modified General Cutting Contra Handpieceto be substantially equivalent to the predicate device listed above. Thisconclusion is based on the similarities in primary intended use, principles ofoperation, functional design, materials, and established medical use. |
§ 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.