(209 days)
Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.
The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.
The provided document is a 510(k) premarket notification for a dental air motor. The core of this document is a comparison of the subject devices (Air Motor FX204 M4 and Air Motor M205) against predicate devices to demonstrate substantial equivalence, rather than a clinical study evaluating the device against acceptance criteria in the typical sense of AI/ML performance.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" for AI/ML devices are not applicable in this context. The document focuses on performance testing to demonstrate safety and effectiveness for a mechanical device.
However, I can extract the information relevant to how the device's technical specifications and performance were evaluated against established standards and predicate devices.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical thresholds in a table format for each specific performance metric in the way you might see for an AI algorithm (e.g., AUC > 0.90). Instead, the acceptance criterion for this 510(k) submission is to demonstrate "substantial equivalence" to legally marketed predicate devices by showing that the subject devices perform similarly and meet relevant safety and performance standards.
The closest we have to "reported device performance" and "acceptance criteria" are the comparison tables (Table 1 for FX204 M4 and Table 2 for M205) and the "Judgement" column, which indicates if the subject device is "Same," "Similar," or "Different" to the predicate. For "Different" or "Similar" aspects, further testing or justification is provided to demonstrate that the difference does not raise new questions of safety or effectiveness.
Below are tables summarizing the key performance and safety aspects evaluated and how the subject device's performance compared to the predicates, along with the implicit "acceptance criteria" through this comparison.
For Air Motor, FX204 M4 (model without spray) - (Based on "DEVICE AND PREDICATE COMPARISON TABLE-1")
| Characteristic / Performance Aspect | Acceptance Criteria (Implicit from Predicate Comparison & Standards) | Reported Device Performance (Subject Device: Air Motor, FX204 M4) | Judgment (vs. Predicate/Reference) |
|---|---|---|---|
| Indications for Use | Same as predicate devices for general dental applications. | Driving handpiece for tooth restoration, prophylaxis, root canal preparation. | Same |
| Device Description/Technology | Pneumatically driven air motor for dental handpieces. | Converts compressed air into rotary motion for dental instruments. | Same |
| Supply air pressure | Within acceptable range for dental applications (compared to predicates). | 0.20 – 0.25 MPa | Different (lower pressure than primary predicate, but considered sufficient) |
| Optic lighting | Similar to some predicate devices or not raising new safety/effectiveness concerns. | No | Same with Reference Device (Air-Powered Handpieces) |
| Speed range | Similar upper speed range to predicate devices. | 19,800 - 24,200 min⁻¹ (0.25 MPa) | Similar |
| Max. air consumption | Similar to predicate devices, not raising safety/effectiveness concerns. | < 66 NL/min | Similar with Reference Device (Air-Powered Handpieces) |
| Weight | Similar to predicate devices, not raising safety/effectiveness concerns. | 61.7g | Similar with Reference Device (Air-Powered Handpieces) |
| Performance Testing | Conformity to ISO 14457 (dental handpieces) and other relevant standards (sterilization, cleaning). | Passed ISO 14457:2017; AAMI/ANSI/ISO 17665-1:2006 (Sterilization); FDA Guidance for Cleaning. | Similar (All devices passed ISO 14457, relevant testing to predicates) |
| Biocompatibility | Conformity to ISO 7405 and AAMI/ANSI/ISO 10993-1. | Conformity to ISO 7405:2018; AAMI/ANSI/ISO 10993-1:2018. | Similar |
| Clinical Testing | Not required for this type of device based on its nature and predicate comparison. | NO | Same (as predicates) |
| Air/water port | No spray design, similar to predicate. | No spray | Same |
| Dimensions | Similar to predicate devices, not raising new safety/effectiveness concerns. | 78.3 x φ20 mm | Similar |
| Patient-contacting portions | Indirect contact limited, conformity to biocompatibility standards. | Direct contact: No; Indirect contact: No | Similar |
| Handpiece Connection | ISO 3964 standard connection. | ISO 3964 | Same with Reference Device (Air-Powered Handpieces) |
| Hose Connection | ISO 9168 standard connection. | ISO 9168 | Same with Reference Device (Air-Powered Handpieces) |
| Lubricant | Predetermined lubricant (PANA SPRAY Plus). | PANA SPRAY Plus (K163483) | Similar with Reference Device (Air-Powered Handpieces) |
For Air Motor, M205 (Internal Spray equipped) - (Based on "DEVICE AND PREDICATE COMPARISON TABLE-2")
| Characteristic / Performance Aspect | Acceptance Criteria (Implicit from Predicate Comparison & Standards) | Reported Device Performance (Subject Device: Air Motor, M205) | Judgment (vs. Predicate/Reference) |
|---|---|---|---|
| Indications for Use | Same as predicate devices for general dental applications. | Driving handpiece for tooth restoration, prophylaxis, root canal preparation. | Similar |
| Device Description/Technology | Pneumatically driven air motor for dental handpieces, with water injection. | Converts compressed air into rotary motion; has water injection mechanism. | Same (pneumatically driven, includes spray feature like reference) |
| Supply air pressure | Within acceptable range for dental applications (compared to predicates). | 0.20 – 0.25 MPa | Different (lower pressure than primary predicate, but considered sufficient) |
| Optic lighting | Similar to some predicate devices or not raising new safety/effectiveness concerns. | No | Same with Reference Device (Air-Powered Handpieces) |
| Speed range | Similar upper speed range to predicate devices. | 19,800 - 24,200 min⁻¹ (0.25 MPa) | Similar |
| Max. air consumption | Similar to predicate devices, not raising safety/effectiveness concerns. | < 66 NL/min | Similar with Reference Device (Air-Powered Handpieces) |
| Weight | Similar to predicate devices, not raising safety/effectiveness concerns. | 78.2g | Similar with Reference Device (Air-Powered Handpieces) |
| Spray water flow acc. to ISO 14457 | > 50 (ml/min) based on predicate. | > 50 (ml/min) | Same |
| Water pressure | Similar range to predicate/reference. | 1 – 2.5 (bar) | Similar range |
| Chip air pressure | Similar range to predicate/reference. | 1.5 – 2.5 (bar) | Similar range |
| Performance Testing | Conformity to ISO 14457 (dental handpieces) and other relevant standards (sterilization, cleaning). | Passed ISO 14457:2017; AAMI/ANSI/ISO 17665-1:2006 (Sterilization); FDA Guidance for Cleaning. Also check valve effect verification. | Similar (All devices passed ISO 14457, relevant testing to predicates) |
| Biocompatibility | Conformity to ISO 7405 and AAMI/ANSI/ISO 10993-1. | Conformity to ISO 7405:2018; AAMI/ANSI/ISO 10993-1:2018. | Similar |
| Clinical Testing | Not required for this type of device based on its nature and predicate comparison. | NO | Same (as predicates) |
| Air/water port | Spray equipped. | Spray | Same with Reference Device (Air-Powered Handpieces) |
| Dimensions | Similar to predicate devices, not raising new safety/effectiveness concerns. | 78.3 x φ20 mm | Similar |
| Patient-contacting portions | Indirect contact (waterlines) defined, conformity to biocompatibility standards. | Direct contact: No; Indirect contact: Waterlines | Similar with Reference Device (Air-Powered Handpieces) |
| Composition of the waterlines | Materials compatible with biocompatibility standards. | Fluor rubber, Stainless steel, Aluminum based alloy | Different (but conformity to ISO 10993-1 supports substantial equivalence) |
| Handpiece Connection | ISO 3964 standard connection. | ISO 3964 | Same with Reference Device (Air-Powered Handpieces) |
| Hose Connection | ISO 9168 standard connection. | ISO 9168 | Same with Reference Device (Air-Powered Handpieces) |
| Lubricant | Predetermined lubricant (PANA SPRAY Plus). | PANA SPRAY Plus (K163483) | Similar with Reference Device (Air-Powered Handpieces) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document mentions "Statistical calculation of sample size" under performance testing, but does not provide specific numbers for units tested for each type of test. The nature of these tests (e.g., drop test, reprocessing resistance, water leakage, vibration, sterilization validation) typically involves testing a representative sample of devices, but the exact number isn't quantified in the provided text.
- Data Provenance: Not explicitly stated, however, the applicant is "NAKANISHI INC." based in "700 Shimohinata Kanuma Tochigi, 322-8666, Japan". It's highly probable the testing was conducted in Japan or through certified testing facilities used by the manufacturer. The data would be prospective in the sense that these tests are performed on the manufactured devices to ensure they meet specifications.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- This concept typically applies to clinical studies or studies involving human interpretation (e.g., radiology expert review for AI algorithms). This submission is for a mechanical dental device.
- The "ground truth" here is compliance with engineering standards (e.g., ISO 14457 for dental handpieces), safety standards (e.g., ISO 10993 for biocompatibility), and the performance characteristics of the predicate devices.
- No "experts" in the sense of clinical reviewers establishing ground truth for individual cases are mentioned. Instead, the evaluations are based on technical testing by qualified personnel in accredited laboratories.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation or subjective assessments, often in AI/ML performance evaluation where ground truth is based on expert consensus.
- This is not applicable here as the evaluation is based on objective measurements against engineering standards and comparison with predicate device specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a submission for a mechanical dental motor, not an AI/ML diagnostic or assistive device that would involve human readers interpreting cases.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Not applicable. This device does not involve a software algorithm in the context of an AI/ML device requiring this type of performance evaluation.
7. Type of Ground Truth Used
- The "ground truth" for this submission is primarily technical specifications/performance derived from engineering standards (e.g., ISO 14457, ISO 10993) and comparison to the known and established safety and effectiveness of legally marketed predicate devices.
- For example, passing ISO 14457 test methods indicates the device performs as expected for a dental handpiece. Biocompatibility is "ground-truthed" by adherence to ISO 10993.
8. Sample Size for the Training Set
- Not applicable. This is a mechanical device, not an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" for this type of device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 25, 2024
NAKANISHI INC. % Takahiro Haruyama President Globizz Corpration 1411 W. 190th St. Suite 200 Gardena, California 90248
Re: K233308
Trade/Device Name: Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: March 7, 2024 Received: March 13, 2024
Dear Takahiro Haruyama:
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 E. 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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
Device Name
Air Motor (Model name: FX204 M4) Air Motor (Model name: M205 )
Indications for Use (Describe)
Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for NSK, a company that specializes in bearings and automotive products. The logo is white text on a blue background. The letters "NSK" are in a bold, sans-serif font. The logo is simple and recognizable.
510(k)#: K233308
510(k) Summary
Contact Details
Applicant Name: NAKANISHI INC. Applicant Address: 700 Shimohinata Kanuma Tochigi, 322-8666, Japan Applicant Contact Telephone: +81-289-64-7277 Applicant Contact: Masaaki Kikuchi Applicant Contact Email: nskra@nsk-nakanishi.co.jp
Device Name
Device Trade Name: Air Motor (Model name: FX204 M4) Air Motor (Model name: M205) Common Name: Dental handpiece and accessories Classification Name: Handpiece, Air-Powered, Dental Regulation Number: 872.4200
Device Class: I Product Codes: EFB
Legally Marketed Predicate Devices
Predicate Device #: K143704 Predicate Trade Name: Advanced Air System Product Code: EFB Reference Device #: K162926 Predicate Trade Name: W&H Air-Powered Handpieces And Handpiece Attachments Product Code: EFB
Device Description Summary
The air motor converts the compressed air supplied from the dental unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces.
Intended Use/ Indications for Use
Air Motor is intended for the following application(s): Driving the handpiece for the tooth restoration, prophylaxis, and root canal preparation.
NAKANISHI INC.
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Comparison of Technological Characteristics with the Predicate Device-1
DEVICE AND PREDICATE COMPARISON TABLE-1
For Air Motor, FX204 M4 (model without spray)
| Descriptive Information | Subject Device | Primary Predicate Device | Reference Device | Judgement |
|---|---|---|---|---|
| Device Name | Air Motor, FX204 M4 | Advanced Air System(RM-25 L RM) | Air-Powered Handpiecesand HandpieceAttachments(AM-25 RM: model w/ospray) | |
| K number | K233308 | K143704 | K162926 | |
| Indication for Use | Air Motor is intended forthe followingapplication(s): Driving thehandpiece for the toothrestoration, prophylaxis,and root canalpreparation. | Pneumatic drive systemfor dental handpieces anddental air motors, which isintended to be used ingeneral dental applicationssuch as: removal ofdecayed materials, cavitiesand crown preparations,removal of filings, finishingof tooth and restorationsurfaces, polishing,prophylaxis andendodontics | The turbine handpiece isintended for the followingapplications: Removal ofdecayed materials, cavitiesand crown preparation,removal of fillings,finishing of tooth andrestoration surfaces.The dentalhandpiece/contra-angle isintended for the followingapplications: Removal ofdecayed materials, cavitiesand crown cement,removal of fillings,finishing and polishing oftooth and restorationsurfaces. | Same: all devices areintended for generaldental applicationsincluding restoration,dental cleaning(prophylaxis), and rootcanal preparation |
| Device Description | The air motor convertsthe compressed airsupplied from the dental | The Advanced Air Systemis intended for dentaltransmission instruments | The Air-poweredHandpieces contain pipesinside which supply air for | Same: all devices use airmotors, arepneumatically driven |
| unit into rotary motion. The rotation is transmitted to instruments for tooth restoration, prophylaxis, and root canal preparation connected to straight and geared angle handpieces. | used in the field of preventive dentistry, restorative dentistry such as cavity preparation and prosthodontics such as crown preparation and endodontics. The system consists of the control unit (AC-1.0), which is designed to be built in a dental chair. As an attachment the air-driven handpiece (RK-97 L, RG- 97 L, and/or RK-94 L) or the air motor (RM-25 L RM) can be used. The air-driven handpiece is equipped with a speed sensor, which is connected to a control module that regulates the applied air pressure to the handpiece through a proportional valve in order to maintain constant speed throughout the dental treatment | driving the turbine's impeller as well as supply air and water for creating spray exhausting through 3, 4 or 5 ports located in the handpiece's head and intended for cooling the working area as well as the rotating bur. Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head sided assembled LED light source. The Handpiece Attachments also contain pipes inside which supply air and water for spray exhausting and for cooling the working area as well as the rotating bur. Depending on the type of handpiece – the handle might contain an integrated circuit board and wire bundles, for supplying current and voltage to a head-sided assembled LED light source. | and used for driving dental handpieces. | |
| Supply air | 0.20 – 0.25 MPa | 0.52 – 0.59 MPa | unknown | DifferentThe subject device has |
| lower pressure | ||||
| Optic lighting | no | yes | no | Same with Air-PoweredHandpieces andHandpiece Attachments |
| Speed range | $19,800 - 24,200 min^{-1}$(0.25MPa) | $2,000 – 20,000 rpm$ | $25,000 +/-10%$ | SimilarAll devices have similarupper speed range |
| Max. air consumption | < 66NL/min | 1.5 l/s (3.2 cfm) | 42-50NI/min | Similar with Air-Powered Handpiecesand HandpieceAttachments. |
| Weight | 61.7g | 39 g | 73g | Similar weight to Air-Powered Handpiecesand HandpieceAttachments |
| Performance Testing | Performance: ISO14457:2017Sterilization:AAMI/ANSI/ISO 17665-1:2006Cleaning: Guidance forthe ReprocessingMedical Devices in HealthCare Settings: ValidationMethods and LabelingGuidance for Industry andFood and DrugAdministration Staff. | Electrical Safety Tests: IEC60601-1:2005ElectromagneticCompatibility: IEC 60601-1-1:2007Product testing ofhandpiece function andlife cycle testing: ISO14457:2012Software validation: IEC62304:2006Usability validation: IEC62366:2007Thermal safety: IEC62471:2006 | Product testing of thehandpieces function andlife cycle testing: ISO14457:2012EMC Testing: IEC 60601-1-2:200Thermal safety: IEC62471:2006 | SimilarAll the devices passedthe ISO 14457Performance testing.Relevant testing topredicate devices.• ISO 14457 2017Conformityconfirmation report• Drop test report• Reprocessingresistance test report• Water leakage andwater ingress testreport• Statistical calculationof sample size |
| • Equivalenceconfirmation forpackage test report• Vibration test report• Sterilizationvalidation report• Conformityassessment to theproduct family group forsterilization• Product family groupconformity confirmationon cleaning validation• Cleaning validation | ||||
| report | ||||
| • Cleaning validation ofaccessories | ||||
| Biocompatibility | ISO 7405: 2018AAMI/ANSI/ISO 10993-1:2018 | ISO 7405:2008ISO 10993-5:2009 | ISO 7405:2008ISO 10993-5:2009Evaluation ofbiocompatibility is basedupon the fact that patientcontacting materials in thesubject handpiece areidentical to those in thepreviously clearedpredicates(K143704 and K070663),which as handpieces andhandpiece attachments,present the same level andduration of contact. In | SimilarBiocompatibility testingconfirms compliancewith ISO 10993-1 andsupports substantialequivalence.Relevant testing topredicate devices.• Biological safetyevaluation report• Confirmation ofeffectiveness andbiological safety ofaccessories |
| addition, CytotoxicityTesting per ENISO 10993-5:2009 wasperformed. This evaluationmeets the requirements ofISO 7405:2008 forpreclinical evaluation ofbiocompatibility of dentaldevices. | • MSDS | |||
| Clinical Testing | NO | NO | NO | Same |
| Air/water port | No spray | No spray | No Spray | Same |
| Dimensions | 78.3 x φ20 mm | 87,87 x φ20 mm | Unknown | Similar dimensions withAdvanced Air System.ISO 14457 performancetesting supportssubstantial equivalence. |
| Patient-contacting portions | Direct contact: NoIndirect contact: No | Direct contact: UnknownIndirect contact: No | Direct contact: UnknownIndirect contact: No | SimilarConformity to ISO10993-1 supportssubstantial equivalence. |
| Handpiece Connection | ISO 3964 | Unknown | ISO 3964 | Same with Air-PoweredHandpieces andHandpieceAttachments. |
| Hose Connection | ISO 9168 | Unknown | ISO 9168 | Same with Air-PoweredHandpieces andHandpieceAttachments. |
| Lubricant | PANA SPRAY Plus(K163483) | Unknown | W&H Service Oil F1, MD-400W&H Assistina | Similar with Air-Powered Handpiecesand HandpieceAttachments.Conformity to ISO10993-1 supportssubstantial equivalence. |
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NSK
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Discussion:
Intended use: same. The intended use for the Air Motor FX204 M4 and its predicate device Advanced Air System RM-25 U RM is for general dental applications.
The principle of the operating technology: same (pneumatically driven).
There are differences in the two devices features, such as "supply air pressure". To verify if the subject device affects its efficiency, we compared the subject device and the reference device under air supply pressures, reflecting the and reference device. The performance gap at the lower air supply pressure limit was relatively small. Despite this, the product's performance as an air motor remains sufficient for power transmission to attachments and grinding teeth (Test Report_Equivalence Check of Similar Devices). In terms of performance, it is equivalent to the reference device.
Therefore, we conclude that the subject device Air Motor FX204 M4 and its predicate devices Advanced Air System RM-25 L RM and Air-Powered Handpieces and Handpiece Attachments AM-25 RM are substantially equivalent.
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DEVICE AND PREDICATE COMPARISON TABLE-2
For Air Motor, M205 (Internal Spray equipped)
| Descriptive Information | Subject Device | Primary Predicate Device | Reference Device | Judgement |
|---|---|---|---|---|
| Device Name | Air Motor, M205 | Advanced Air System(RM-25 L RM) | Air-Powered Handpiecesand HandpieceAttachments(AM-25 A RM, model withspray) | |
| K number | K233308 | K143704 | K162926 | |
| Indication for Use | Air Motor is intended forthe followingapplication(s): Driving thehandpiece for the toothrestoration, prophylaxis,and root canalpreparation. | Pneumatic drive systemfor dental handpieces anddental air motors, which isintended to be used ingeneral dental applicationssuch as: removal ofdecayed materials, cavitiesand crown preparations,removal of filings, finishingof tooth and restorationsurfaces, polishing,prophylaxis andendodontics | The turbine handpiece isintended for the followingapplications: Removal ofdecayed materials, cavitiesand crown preparation,removal of fillings,finishing of tooth andrestoration surfaces.The dentalhandpiece/contra-angle isintended for the followingapplications: Removal ofdecayed materials, cavitiesand crown cement,removal of fillings,finishing and polishing oftooth and restorationsurfaces. | Similar: all devices areintended for generaldental applicationsincluding restoration,dental cleaning(prophylaxis), and rootcanal preparation |
| Device Description | The air motor convertsthe compressed airsupplied from the dentalunit into rotary motion.The rotation is | The Advanced Air Systemis intended for dentaltransmission instrumentsused in the field ofpreventive dentistry. | The Air-poweredHandpieces contain pipesinside which supply air fordriving the turbine'simpeller as well as supply | Same: all devices use airmotors, arepneumatically driven,and used for drivingdental handpieces. |
| transmitted toinstruments for toothrestoration, prophylaxis,and root canalpreparation connected tostraight and geared anglehandpieces.M205 has a waterinjection mechanism. | restorative dentistry suchas cavity preparation andprosthodontics such ascrown preparation andendodontics.The system consists of thecontrol unit (AC-1.0),which is designed to bebuilt in a dental chair.As an attachment the air-driven handpiece (RK-97 L,RG- 97 L, and/or RK-94 L)or the air motor (RM-25 LRM) can be used.The air-driven handpiece isequipped with a speedsensor, which is connectedto a control module thatregulates the applied airpressure to the handpiecethrough a proportionalvalve in order to maintainconstant speedthroughout the dentaltreatment | air and water for creatingspray exhausting through3, 4 or 5 ports located inthe handpiece's head andintended for cooling theworking area as well as therotating bur. Depending onthe type of handpiece –the handle might containan integrated circuit boardand wire bundles, forsupplying current andvoltage to a head sidedassembled LED lightsource.The HandpieceAttachments also containpipes inside which supplyair and water for sprayexhausting and for coolingthe working area as well asthe rotating bur.Depending on the type ofhandpiece – the handlemight contain anintegrated circuit boardand wire bundles, forsupplying current andvoltage to a head-sidedassembled LED lightsource. | The subject device, "AirMotor M205" has thesame technology as"Air-PoweredHandpieces andHandpieceAttachments, modelAM-25 A RM" as bothare equipped with pipesinside that supply airand water. | |
| Supply air | 0.20 – 0.25 MPa | 0.52 – 0.59 MPa(75 – 85 psi) | unknown | DifferentThe subject device haslower pressure |
| Optic lighting | no | yes | no | Same with Air-Powered |
| Speed range | 19,800 - 24,200 min-1(0.25MPa) | 2,000 – 20,000 rpm | 25,000 +/-10% | Handpieces andHandpiece AttachmentsSimilarAll devices have similar |
| Max. air consumption | < 66 NL/min | 1.5 l/s (3.2 cfm) | 42-50NI/min | upper speed rangeSimilar with Air-Powered Handpiecesand HandpieceAttachments |
| Weight | 78.2g | 39 g (1 34 oz) | 73g | Similar weight to Air-Powered Handpiecesand HandpieceAttachments |
| Spray water flow acc.to ISO14457 | > 50(ml/min) | Not relevant | > 50(ml/min) | Same |
| Water pressure | 1 – 2.5 (bar) | Not relevant | 1.5-2.5 (bar) | Similar range |
| Chip air pressure | 1.5 – 2.5 (bar) | Not relevant | 2-3 (bar) | Similar range |
| Performance Testing | Performance: ISO14457:2017Sterilization:AAMI/ANSI/ISO 17665-1:2006Cleaning: Guidance forthe Reprocessing | Electrical Safety Tests: IEC60601-1:2005ElectromagneticCompatibility: IEC 60601-1-1:2007Product testing ofhandpiece function and | Product testing of thehandpieces function andlife cycle testing: ISO14457:2012EMC Testing: IEC 60601-1-2:200Thermal safety: IEC62471:2006 | SimilarAll the devices passedthe ISO 14457Performance testingRelevant testing topredicate devices.• ISO 14457 2017 |
| Medical Devices in HealthCare Settings: ValidationMethods and LabelingGuidance for Industry andFood and DrugAdministration Staff. | life cycle testing: ISO14457:2012Software validation: IEC62304:2006Usability validation: IEC62366:2007Thermal safety: IEC62471:2006 | 62471:2006 | Conformityconfirmation report• Drop test report• Reprocessingresistance test report• Water leakage andwater ingress testreport | |
| • Statistical calculationof sample size | ||||
| • Equivalenceconfirmation forpackage test report | ||||
| • Vibration test report | ||||
| • Check valve effectverification test report | ||||
| • Sterilizationvalidation report | ||||
| • Conformityassessment to theproduct family group forsterilization | ||||
| • Product family groupconformity confirmationon cleaning validation | ||||
| • Cleaning validationreport | ||||
| • Cleaning validation ofaccessories | ||||
| Biocompatibility | ISO 7405: 2018AAMI/ANSI/ISO 10993-1:2018 | ISO 7405:2008ISO 10993-5:2009 | ISO 7405:2008ISO 10993-5:2009Evaluation ofbiocompatibility is basedupon the fact that patientcontacting materials in thesubject handpiece areidentical to those in thepreviously clearedpredicates(K143704 and K070663) | SimilarBiocompatibility testingconfirms compliancewith ISO 10993-1 andsupports substantialequivalence.Relevant testing topredicate devices.• Biological safetyevaluation report |
| which as handpieces andhandpiece attachments,present the same level andduration of contact. Inaddition, CytotoxicityTesting per ENISO 10993-5:2009 wasperformed. This evaluationmeets the requirements ofISO 7405:2008 forpreclinical evaluation ofbiocompatibility of dentaldevices. | • Confirmation ofeffectiveness andbiological safety ofaccessory• MSDS | |||
| Clinical Testing | NO | NO | NO | Same |
| Air/water port | Spray | No spray | Spray | Same with Air-PoweredHandpieces andHandpiece Attachments |
| Dimensions | 78.3 x φ20 mm | 87,87 x φ20 mm | Unknown | Similar dimensions withAdvanced Air System.ISO 14457 conformancetesting is performed tosupport substantialequivalence. |
| Patient-contacting portions | Direct contact: NoIndirect contact:Waterlines | Direct contact: UnknownIndirect contact: No | Direct contact: UnknownIndirect contact:Waterlines | Similar with Air-Powered Handpiecesand HandpieceAttachments.Conformity to ISO10993-1 supportssubstantial equivalence. |
| Composition of thewaterlines | Fluor rubber, Stainlesssteel, Aluminum basedalloy | Not relevant | Unknown | DifferentConformity to ISO10993-1 supportssubstantial equivalence. |
| Handpiece Connection | ISO 3964 | Unknown | ISO 3964 | Same with Air-Powered |
| Handpieces andHandpieceAttachments. | ||||
| Hose Connection | ISO 9168 | Unknown | ISO 9168 | Same with Air-PoweredHandpieces andHandpieceAttachments. |
| Lubricant | PANA SPRAY Plus(K163483) | Unknown | W&H Service Oil F1, MD-400W&H Assistina | Similar with Air-Powered Handpiecesand HandpieceAttachments.Conformity to ISO10993-1 supportssubstantial equivalence. |
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Discussion:
Intended use: same. The intended use for the subject device Air Motor M205 and its predicate device Advanced Air System RM-25 L RM is for general dental applications.
The principle of the operating technology: same (pneumatically driven).
There are differences in the two devices features, such as "supply air pressure". To verify if the subject device affects its efficiency, we compared the subject device and the reference device under air supply pressures, reflecting the range for the subject device and reference device. The performance gap at the lower air supply pressure limit was relatively small. Despite this, the product's performance as an air motor remains sufficient for power transmission to attachments and grinding teeth (Test Report Equivalence Check of Similar Devices). In terms of performance, it is equivalent to the reference device.
Therefore, we conclude that the subject device Air Motor M205 and its predicate Air System RM-25 L RM and Air-Powered Handpieces and Handpiece Attachments AM-25 A RM are substantially equivalent.
§ 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.