(90 days)
FX15 / FX15m / FX25 / FX25m
FX Contra is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations.
FX57 / FX57m
FX Contra is intended for the following application(s): Prophylaxis treatment of the surface of teeth and dental restorations.
The FX Contra includes six models: FX15, FX15m, FX25, FX25m, FX57, and FX57m. The FX Contra handpieces are reusable contra-angle handpieces, driven by an ISO 3964 compliant electronic micromotor or air motor, that are intended for use in a healthcare facility/hospital setting by a trained health care professional in the field of general dentistry. The FX Contra handpieces are designed for general applications to prepare dental cavities for restorations (FX15/FX15m/FX25/FX25m) and for prophylactic teeth cleaning (FX57/FX57m).
The FX Contra handpieces feature ISO 3964 compliant handpiece coupling connecting them to a dental unit through either a micromotor or an air motor. By these means the handpieces receive the energy for the gear for dental treatment. The maximum drive speed is 40,000 min-1 for FX15, FX15m, FX25, and FX25m; and 20,000 min-1 for FX57 and FX57m. The maximum rotation speed is 10,000 min-1 for FX15 and FX15m; 40,000 min-1 for FX25 and FX25m; and 5,000 min-1 for FX57 and FX57m.
The FX Contra handpieces are composed mainly of stainless steel and aluminum and can be sterilized in a steam sterilizer (autoclave).
The provided text describes a 510(k) summary for the Nakanishi Inc. FX Contra dental handpieces. However, it does not include detailed acceptance criteria or a specific study proving the device meets those clinical performance acceptance criteria in the format requested. The document focuses on regulatory compliance, non-clinical performance testing (bench testing, sterilization, cleaning, biocompatibility), and a comparison to a predicate device to establish substantial equivalence.
Therefore, many of the requested fields cannot be filled from the provided text.
Here's a breakdown of what can be extracted and what is explicitly not present:
1. A table of acceptance criteria and the reported device performance
- Not present in the document. The document states that "The product's conformance with applicable international and internal standards was verified in the course of bench testing" and "Tests were performed on the subject device including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent." However, specific numerical acceptance criteria (e.g., minimum torque, maximum vibration) and the corresponding measured performance values are not provided.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not present in the document. The document mentions "bench testing" and "verification/validation testing to internal functional specifications," but it does not specify sample sizes for these tests or the data provenance.
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 present. This type of information is typically relevant for studies involving human interpretation or clinical endpoints. Since this document describes non-clinical performance testing for a dental handpiece, there's no mention of experts establishing a "ground truth" for a test set in the conventional sense of diagnostic or AI-driven medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not present. Similar to point 3, this is relevant for studies involving human readers and interpretations, which are not described here.
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, this was not done. The document explicitly states: "Clinical Testing: Clinical testing was not required as non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the FX Contra handpieces." Therefore, no MRMC study or AI assistance evaluation was performed as per this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a dental handpiece, not an algorithm or AI-driven system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable / Not present in a clinical sense. For the non-clinical tests mentioned (sterilization, performance to ISO standards, cleaning, biocompatibility), the "ground truth" would be the specifications and requirements defined by the respective standards. However, actual data points or methods for confirming these are not detailed.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device that requires a training set.
Summary of available information related to performance testing:
The device is the FX Contra dental handpiece.
The document indicates that the device's substantial equivalence largely relies on non-clinical performance testing and a comparison to a predicate device (SciCan GmbH SANAO Dental Handpieces, K132356).
Performance Testing Mentioned:
- Sterilization Validation: Conformance to AAMI/ANSI/ISO 17665-1:2006 "Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices."
- Performance (General): Conformance to ISO 14457:2017 "Dentistry - Handpieces and Motors." (Specific parameters or acceptance criteria from this standard are not detailed, nor are the measured results).
- Cleaning Validation: Compliance with "Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff."
- Biocompatibility Testing: Selected in accordance with AAMI/ANSI/ISO 10993-1: 2018 and FDA Guidance Use on International Standard ISO 10993. This included:
- Cytotoxicity per ISO10993-5
- Sensitization per ISO10993-10
- Irritation per ISO10993-10
- Acute Systemic Toxicity per ISO 10993-11
- Pyrogenicity per ISO 10993-11
Conclusion from the document:
NAKANISHI INC. considers the FX Contra handpieces to be substantially equivalent to the predicate device based on similarities in primary intended use, principles of operation, functional design, and established medical use, supported by the non-clinical testing. Clinical testing was deemed not required.
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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, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 17, 2022
Nakanishi Inc. % Yulia Nikova Regulatory Affairs Manager Ken Block Consulting LLC 800 E Campbell Road, Suite 202 Richardson. Texas 75081
Re: K222518
Trade/Device Name: FX Contra Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EGS Dated: August 19, 2022 Received: August 19, 2022
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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael E. Adjodha -S
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K222518
Device Name FX Contra
Indications for Use (Describe)
FX15 / FX15m / FX25 / FX25m FX Contra is intended for the following application(s): Caries removal, cavity and crown preparation, removal of dental restorations (fillings and prostheses), finishing and polishing of teeth and dental restorations.
FX57 / FX57m
FX Contra is intended for the following application(s): Prophylaxis treatment of the surface of teeth and dental restorations.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
| Submitter: | NAKANISHI INC.700 ShimohinataKanuma Tochigi 322-8666 Japan |
|---|---|
| Contact Person: | NAKANISHI INC.Mr. Masaaki KikuchiGeneral Manager, Quality/Regulatory Affairs Dept.700 ShimohinataKanuma Tochigi 322-8666 JapanTEL: +81-289-64-7277FAX: +81-289-62-9738m-kikuchi@nsk-nakanishi.co.jp |
| Date Prepared: | November 16, 2022 |
| Submission Type: | Traditional 510(k) |
| Subject Device: | Manufacturer: NAKANISHI INC.Trade/Device Name: FX ContraCommon Name: Handpiece, contra- and right-angle attachment, dentalRegulation Number: 21 CFR 872.4200Regulation Name: Dental Handpiece and AccessoriesRegulatory Class: Class IProduct Code: EGS |
| Predicate Device: | Clearance: K132356 dated January 31, 2014Manufacturer: SciCan GmbHTrade/Device Name: SANAO Dental HandpiecesCommon Name: Handpiece, contra- and right-angle attachment, dentalRegulation Number: 21 CFR 872.4200Regulation Name: Dental Handpiece and AccessoriesRegulatory Class: Class IProduct Code: EGS |
| Device Description: | The FX Contra includes six models: FX15, FX15m, FX25, FX25m, FX57, and FX57m. The FX Contra handpieces are reusable contra-angle handpieces, driven by an ISO 3964 compliant electronic micromotor or air motor, that are intended for use in a healthcare facility/hospital setting by a trained health care professional in the field of general dentistry. The FX Contra handpieces are designed for general applications to prepare dental cavities for restorations (FX15/FX15m/FX25/FX25m) and for prophylactic teeth cleaning (FX57/FX57m).The FX Contra handpieces feature ISO 3964 compliant handpiece coupling connecting them to a dental unit through either a micromotor or an air motor. By these means the handpieces receive the energy for the gear for dental treatment. The maximum drive speed is 40,000 min-1 for FX15, FX15m, FX25, and FX25m; and 20,000 min-1 for FX57 and FX57m. The maximum rotation speed is 10,000 min-1 for FX15 and FX15m; 40,000 min-1 for FX25 and FX25m; and 5,000 min-1 for FX57 and FX57m.The FX Contra handpieces are composed mainly of stainless steel and aluminum and can be sterilized in a steam sterilizer (autoclave). |
NAKANISHI INC.
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Image /page/4/Picture/0 description: The image features the logo of NSK, a company specializing in motion and control technologies. The logo consists of the letters 'NSK' in a bold, sans-serif font, with a stylized line extending from the top of the 'N' over the 'S' and 'K'. The logo is set against a dark blue background, providing a strong contrast that makes the logo easily visible.
| 510(k) Summary | K222518The FX Contra handpieces are intended to be used with ISO 1797-1 compliant burs(FX15, FX15m, FX25 and FX25m) or ISO 13295compliant cups or brush (FX57 andFX 57m). | ||||
|---|---|---|---|---|---|
| Principle ofOperation /Mechanism ofAction: | The principle of operation of the FX Contra handpieces is based on rotatorymovement. The contra-angle FX Contra handpieces are driven by energy ofelectronic micromotor or an air motor, which is converted into mechanical energythrough the motor. This mechanical energy is transferred to the drivetrains in thecontra-angle handpiece in the form of a rotary movement via an ISO 3964 compliantcoupling. The force is transmitted through shafts and gear components to anothercoupling interface located in the head housing, which is designed for safe insertionand removal of ISO 1797 or ISO 13295 compliant tools. The mechanical energy ispassed on to the cutting or polishing part of these tools and thus to the procedure site. | ||||
| Statement ofIntended Use: | FX15 / FX15m / FX25 / FX25mFX Contra is intended for the following application(s):Caries removal, cavity and crown preparation, removal of dental restorations (fillingsand prostheses), finishing and polishing of teeth and dental restorations. | ||||
| FX57 / FX57mFX Contra is intended for the following application(s):Prophylaxis treatment of the surface of teeth and dental restorations. | |||||
| Summary ofTechnologicalCharacteristics: | The intended use, technological characteristics, and functionality are substantiallyequivalent between the subject FX Contra handpieces and the predicate device. Theperformance characteristics are also equivalent to the predicate device. Both devicesare intended to be used by dental health care professionals (e.g., dentists,periodontists). Both devices are intended for multiple patients use and sterilized byautoclave sterilization. Additionally, the FX Contra handpieces and the predicatedevice have the same technological characteristics: | ||||
| Power source● | |||||
| Principle of operation● | |||||
| Push-button auto-chuck● | |||||
| As presented in the brief comparison table below, several differences with respect totechnological characteristics were identified between the subject device and thepredicate, including but not limited to the transmission gear ratios, compatible burs,and material composition. Performance testing was conducted to support substantialequivalence and demonstrate that these differences do not raise different questions ofsafety and effectiveness. | |||||
| A brief summary of the technological characteristics in comparison to those of thepredicate device is as follows: | |||||
| Subject Device: | Predicate Device: | ||||
| Trade/Device Name | FX Contra | SANAO Dental Handpieces | |||
| 510(k) Submitter | NAKANISHI INC. | SciCan GmbH | |||
| [Number] | K222518 | K132356 | |||
| Device Class | Class I | Class I | |||
| Product Code | EGS | EGS |
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510(k) Summary
| Regulation | 21 CFR 872.4200 | K22251821 CFR 872.4200 |
|---|---|---|
| Indications for Use | FX15 / FX15m / FX25 /FX25mFX Contra is intended forthe following application(s):Caries removal, cavity andcrown preparation, removalof dental restorations(fillings and prostheses),finishing and polishing ofteeth and dentalrestorations. | This medical device is onlyintended for dentaltreatment in the area ofdentistry. It is intended to beused for the followingapplications:- SANAO 200 L / 40 ST:The removal of decayedmatter, cavity and crownpreparations, the removal offillings and surfacefinishing of tooth andrestoration surfaces. |
| FX57 / FX57mFX Contra is intended forthe following application(s):Prophylaxis treatment of thesurface of teeth and dentalrestorations. | - SANAO 40 / 40 L / 10 /10 L Cavity preparations,caries excavation,endodontics, surfacefinishing of tooth andrestoration surfaces.- SANAO PSI / PSO:prophylaxis treatment. | |
| Application | General dentistry andprophylaxis | General dentistry andprophylaxis |
| Model Numbers | General ApplicationFX15 / FX15m / FX25 /FX25m | General ApplicationSANAO 10 / SANAO 10 L/ SANAO 40 / SANAO 40L / SANAO 200L / SANAO40 ST |
| ProphylaxisFX57 / FX57m | ProphylaxisSANAO PSI / SANAO PSO | |
| Power Source | Electronic Micromotor orAir Motor | Electronic Micromotor orAir Motor |
| Handpiece ChuckMechanism | Push ButtonFX15 / FX15m / FX25 /FX25m | Push ButtonSANAO 10 / SANAO 10 L/ SANAO 40 / SANAO 40L / SANAO 200 L |
| Not ApplicableFX57 / FX57m | Not ApplicableSANAO PSI / SANAO PSOMechanicalSANAO 40 ST | |
| Burs / Cup or Brush | ISO 1797 Type 1 (2.334 -2.35mm) | ISO 1797 Type 1 (2.35mm) |
| K222518 | ||
| FX15 / FX15m / FX25 /FX25m | SANAO 10 / SANAO 10 L/ SANAO 40 / SANAO 40L | |
| ISO 1797 Type 2 (2.35mm) | ||
| SANAO 40 ST | ||
| ISO 1797 Type 3 (1.60mm) | ||
| SANAO 200 L | ||
| ISO 13295 Type 3SANAO PSI | ||
| ISO 13295 Type 5FX57 / FX57m | ISO 13295 Type 5SANAO PSO | |
| Transmission Ratio | 1:1FX25 / FX25m | 1:1SANAO 40 / SANAO 40 L/ SANAO 40 ST |
| 4:1FX15 / FX15m / FX57 /FX57m | 5:1SANAO 10 / SANAO 10 L/ SANAO PSI / SANAOPSO | |
| 1:5SANAO 200 L | ||
| Materials | Stainless SteelAluminum | Stainless SteelPEEK |
NAKANISHI INC.
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Image /page/6/Picture/0 description: The image features the logo for NSK, a company specializing in motion and control technologies. The logo consists of the letters "NSK" in a bold, sans-serif typeface, rendered in white. The background is a solid, dark blue color, providing a strong contrast that makes the logo stand out.
510(k) Summary
Summary of Non-Clinical Performance Testing:
The FX Contra handpieces are developed and produced under considerations of all applicable technical standards, internal specifications, and FDA guidance documents. The product's conformance with applicable international and internal standards was verified in the course of bench testing.
Tests were performed on the subject device including verification/validation testing to internal functional specifications which demonstrated that the device is substantially equivalent. Specifically,
- -Sterilization has been validated in conformance to the FDA recognized consensus standard AAMI/ANSI/ISO 17665-1:2006 "Sterilization of Health Care Products - Moist Heat - Part 1: Requirements for the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices."
- -Performance has been demonstrated in conformance to ISO 14457:2017 "Dentistry - Handpieces and Motors."
- Cleaning validation was provided demonstrating that the FX Contra handpieces complies with the FDA requirements stated in Guidance for the Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling -Guidance for Industry and Food and Drug Administration Staff.
Biocompatibility Biocompatibility evaluations were selected in accordance with AAMI/ANSI/ISO Testing: 10993-1: 2018 "Biological evaluation of medical devices - Part 1: Evaluation and
NAKANISHI
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Image /page/7/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and is set against a blue background. The letters "NSK" are in a bold, sans-serif font, with a stylized line above the letters.
510(k) Summary K222518 testing" and FDA Guidance Use on International Standard ISO 10993, "Biological evaluation of medical devices – Part 1: Evaluation and Testing " and included: ● Cytotoxicity per ISO10993-5 Sensitization per ISO10993-10 ● Irritation per ISO10993-10 ● Acute Systemic Toxicity per ISO 10993-11 ● Pyrogenicity per ISO 10993-11 ● Clinical Testing: Clinical testing was not required as non-clinical testing is believed to be sufficient for a determination of substantial equivalence of the FX Contra handpieces. Conclusion: NAKANISHI INC. considers the FX Contra handpieces to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, functional design, and established medical use.
NAKANISHI ING
§ 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.