(131 days)
Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures.
The Midwest Rhino XE and Air Motor M are low speed air motors. The motors are reusable and can be sterilized in an autoclave. Air Motor M includes an external spray port whereas the Midwest Rhino XE does not have the external sprayport.
This document is a 510(k) premarket notification for the Dentsply Sirona Midwest Rhino XE and Air Motor M dental handpieces. As such, it focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove them.
The information provided confirms that no clinical performance data from human studies was included to support substantial equivalence. The substantial equivalence is based on:
- Identical Indications for Use with the predicate device (LS-100, K792302).
- Same fundamental technology and intended uses as the predicate and a reference device (W&H Air-Powered Handpieces and Handpiece Attachments (Air Motor AM-25 E RM), K162926).
- Non-clinical performance testing to verify conformity with various ISO standards and FDA guidance documents.
Therefore, many of the requested sections related to acceptance criteria and a primary study are not applicable to this 510(k) submission. However, I can extract the relevant information regarding the performance comparison and the non-clinical testing conducted to support substantial equivalence.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, "acceptance criteria" in the context of a primary study proving efficacy are not explicitly stated as they would be for a novel device. Instead, the "acceptance criteria" can be inferred as demonstration of meeting relevant standards and having comparable technical specifications to predicates. The "reported device performance" are the specifications of the proposed devices.
| Element | Acceptance Criteria (Implied: Comparable to Predicate/Reference & Conforming to Standards) | Midwest Rhino XE (Proposed) Performance | Air Motor M (Proposed) Performance | LS-100 (Predicate) Performance | W&H Air-Powered (Reference) Performance |
|---|---|---|---|---|---|
| Indications for Use | Identical to predicate device | Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures. | N/A (same as XE) | Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures. | Broader, specific applications (e.g., removal of decayed materials, cavities and crown preparation, removal of fillings, finishing of tooth and restoration surfaces). |
| Operational Mode | Air-powered | Air-powered | Air-powered | Air-powered | Air-powered |
| Operating Pressure (psi) | Within range of predicate (40-45 psi) | 42 ± 2.9 | N/A (same as XE) | 40-45 | 42 |
| Motor Speed (rpm) | Conformity to ISO 14457 requirements (due to planetary gearing difference) | 0 - 24,000 | ≥ 18,000 | 0-8,000 | 2.2 bar: 5,000-20,000*; 3 bar: 5,000-25,000* |
| Torque (N/cm) | Conformity to ISO 14457 requirements (due to planetary gearing difference) | ~2.0 | ~2.1 | ~6 | 4 |
| External Spray Port | Compared to predicate/reference | NA | Yes | NA | Yes |
| Spray Air Pressure | Compared to reference if applicable (for Air Motor M) | NA | 2.3 ± 0.2 bar (33.4 ± 2.9 psi) | NA | 2.2-3 bar* |
| Spray Water Pressure | Compared to reference if applicable (for Air Motor M) | NA | 2.0 ± 0.2 bar (29.0 ± 2.9 psi) | NA | 1.5-2.5 bar* |
| Sterilization | Steam Autoclave | Steam Autoclave | Steam Autoclave | Steam Autoclave | Steam Autoclave |
| Lubricant | Sirona T1 Spray (K150750) or equivalent | Sirona T1 Spray (K150750) | Sirona T1 Spray (K150750) | Sirona T1 Spray (K150750) | W&H Service Oil F1, MD-400 |
| Type of Chuck | ISO-Coupler or equivalent | ISO-Coupler | ISO-Coupler | Midwest-Coupler | ISO 3964 connection |
| Coupling | Midwest 4-hole coupling, Borden 2/3-hole coupling, or equivalent | Midwest 4-hole coupling | Midwest 4-hole coupling, Borden 2/3-hole coupling | Midwest 4-hole coupling | Fixed connection standard 4-hole* |
| Biocompatibility | Equivalency with reference device materials (K150750) | Demonstrated equivalency | Demonstrated equivalency | N/A | N/A |
| Reprocessing Validation | Conformity to FDA Guidance Document "Reprocessing Medical Devices..." & AAMI TIR 30, ISO 15883-5 | Verified | Verified | N/A | N/A |
| Risk Analysis | Mitigation of known potential failures | Performed per ISO 14971 | Performed per ISO 14971 | N/A | N/A |
Note: The document primarily highlights differences and how they are addressed (e.g., conformity testing to ISO 14457). The "Acceptance Criteria" for proposed devices are framed as demonstrating substantial equivalence to the predicate, often meaning being within a cleared range or addressing differences through standard conformity.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document as it pertains to non-clinical performance testing. The document states "Testing to verify the performance requirements of the proposed devices... was conducted." It specifies the standards to which this testing conformed but not the sample size, data provenance, or whether it was retrospective/prospective.
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)
This is not applicable as no human clinical studies were performed, and thus no expert-established ground truth for a test set was necessary for this type of 510(k) submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as no human clinical studies were performed.
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
This is not applicable. This device is a dental handpiece, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as the device is a physical dental handpiece and not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance data, the "ground truth" can be considered the established requirements and parameters defined by the various ISO standards and FDA guidance documents listed (e.g., ISO 14457 for dentistry handpieces and motors, ISO 17665-1 for moist heat sterilization, ANSI/AAMI ST79 for steam sterilization, AAMI TIR 30 and ISO 15883-5 for cleaning validation, ISO 10993-1 and ISO 7405 for biocompatibility). The devices' performance was "verified" against these technical and safety standards.
8. The sample size for the training set
This is not applicable as no algorithm or AI component is involved requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as no algorithm or AI component is involved.
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January 13, 2020
Dentsply Sirona Karl Nittinger Vice President, Corporate Regulatory Affairs 221 W Philadelphia Street. Suite 60W York, Pennsylvania 17401
Re: K192409
Trade/Device Name: Midwest Rhino XE and Air Motor M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: October 14, 2019 Received: October 15, 2019
Dear Karl Nittinger:
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
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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
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Indications for Use
510(k) Number (if known)
Device Name
Midwest Rhino XE and Air Motor M
Indications for Use (Describe)
Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures.
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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Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
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SECTION 5. 510(k) SUMMARY for
Midwest Rhino XE and Air Motor M (K192409)
Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Contact Person: Karl Nittinger Telephone Number: 717-849-4424 Fax Number: 717-849-4343 Email: karl.nittinger@dentsplysirona.com
872.4200
EFB
Date Prepared:
January 13, 2020
Midwest Rhino XE and Air Motor M
Dental Handpiece and Accessories
Handpiece, Air-Powered, Dental
Device Name:
- Proprietary Name: ●
- Common Name: .
- Classification Name: ●
- CFR Number: .
- Device Class:
- Product Code: .
Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| LS-100 | K792302 | Dentsply Sirona |
| Reference Device Name | 510(k) | Company Name |
| W&H Air-PoweredHandpieces and HandpieceAttachments (Air Motor AM-25-E RM) | K162926 | W&H Dentalwerk GmbH |
Description of Device:
The Midwest Rhino XE and Air Motor M are low speed air motors. The motors are reusable and can be sterilized in an autoclave. Air Motor M includes an external spray port whereas the Midwest Rhino XE does not have the external sprayport.
Indications for Use:
Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures.
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Substantial Equivalence:
The subject devices have identical indications for use as the predicate device, LS-100 (K792302). Table 5.1 show a comparison of the indications for use and technological features of the proposed devices and the predicate device.
| Element | Proposed Devices | Predicate Device | Reference Device | Differences | ||
|---|---|---|---|---|---|---|
| MidwestRhino XE | Air MotorM | LS-100 (K792302) | W&H Air-Powered Handpieces andHandpiece Attachments (Air MotorAM-25 E RM) (K162926) | |||
| Indicationsfor Use | Low-speed (vane motor)handpiece is used fordrilling of teeth in a varietyof dental procedures. | Low-speed (vane motor)handpiece is used fordrilling of teeth in avariety of dentalprocedures. | The turbine handpiece is intendedfor the following applications:removal of decayed materials,cavities and crown preparation,removal of fillings, finishing of toothand restoration surfaces.The dental handpiece/contra-angle isintended for the following applications:removal of decayed materials, cavitiesand crown cement, removal of fillings,finishing and polishing of tooth andrestorations surfaces. | Identical for the predicate device asused in a variety of dental activities.Similar to the reference deviceindications for use for which are detailedas to the specific application the deviceis used. | ||
| OperationalMode | Air-powered | Air-powered | Air-powered | Identical | ||
| OperatingPressure (psi) | 42 $ ± $ 2.9 | 40-45 | 42 | There is no significant difference inthe operating pressure of theproposed air motors when comparingthem to the predicate air motor. Theproposed devices fall within thecleared range of thepredicate device. | ||
| Motor Speed(rpm) | 0 - 24,000 | $ ≥ $ 18,000 | 0-8,000 | 2.2 bar: 5,000-20,000*3 bar: 5,000-25,000* | The difference of the motor speedcomes through the planetary gearingof the proposed Midwest Rhino XEand Air Motor M. Conformity testing tothe requirements of ISO 14457requirements are included to supportsubstantial equivalence. | |
| Table 5.1- Comparison of proposed devices and the predicate device | ||||||
| Element | Proposed Devices | Predicate Device | Reference Device | Differences | ||
| Midwest RhinoXE | Air Motor M | LS-100(K792302) | W&H Air-Powered Handpieces andHandpiece Attachments (Air MotorAM-25 E RM) (K162926) | |||
| Torque (N/cm) | ~2.0 | ~2.1 | ~6 | 4 | The difference of the motor torquecomes through the planetary gearingof the Midwest Rhino XE and AirMotor M. It changes speed intotorque. Conformity testing to therequirements of ISO 14457requirements are included to supportsubstantial equivalence. | |
| ExternalSpray Port | NA | Yes | NA | Yes | The external spray port in the designof the proposed Air Motor M is anoptional feature to facilitateconnection of dental instruments withan external spray connection. | |
| Spray AirPressure inbar (psi) | NA | $2.3 \pm 0.2$$33.4 \pm 2.9$ | NA | 2.2-3* | ||
| Spray WaterPressure inbar (psi) | NA | $2.0 \pm 0.2$$29.0 \pm 2.9$ | NA | 1.5-2.5* | ||
| Sterilization | Steam Autoclave | Steam Autoclave | Steam Autoclave | Identical | ||
| Lubricant | Sirona T1 Spray(K150750) | Sirona T1Spray(K150750) | Sirona T1 Spray(K150750) | W&H Service Oil F1, MD-400 | Identical | |
| Type of Chuck | ISO-Coupler | ISO-Coupler | Midwest-Coupler | ISO 3964 connection | The proposed devices are identical tothe predicate device. | |
| Coupling | Midwest 4-holecoupling | Midwest 4-holecouplingBorden 2/3-hole coupling | Midwest 4-holecoupling | Fixed connection standard 4-hole* | The Air Motor M is also available inversion with a Borden 2/3-holecoupling. This coupling is another typeof connection that can be used toconnect thehandpiece to the air motor hose. |
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Non-Clinical Performance Data.
Testing to verify the performance requirements of the proposed devices, Midwest Rhino XE and Air Motor M, was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence.
Tests included in this premarket notification verify the conformity of the proposed devices, Midwest Rhino XE and Air Motor M, with the requirements of:
- EN 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.
- ANSI/AAMI ST79:2010 and A1:2010 and A2:2011 and A3:2012 and A4:2013-.
Comprehensive guide to steam sterilization and sterility assurance in health care facilities.
- Reprocessing validation per the FDA Guidance Document entitled, ● "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" dated March 17, 2015
- Cleaning Process Validation per AAMI TIR 30 and ISO 15883-5 ●
- ISO 14457:2-17-10- Dentistry-Handpiece and motors ●
- ISO 9168-Dental Handpieces-Hose Connections .
- ISO 3964-Dental Handpiece-Coupling dimensions .
- Biocompatibility equivalency with the reference device (K150750) as far as . material composition is included in support of substantial equivalence. The equivalency statement is made in reference to the requirements of ISO 10993-1:2010-Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process and ISO 7405:2013-Dentistry-Evaluation of biocompatibility ofmedical devices used in dentistry.
- ISO 13504:2012-Dentistry-General requirements for instruments and related ● accessories used in dental implant placement and treatment
- Guidance for Industry and FDA Staff-Dental Handpieces-Premarket . Notification [510(k)] Submissions
Risk Analvsis
Risk analysis was performed on the proposed devices based on ISO 14971. The results of the risk analysis performed concluded that all device design controls and process controls will be able to mitigate known potential failures andeffect.
Clinical Performance Data.
No data from human clinical studies has been included to support the substantial equivalence of the proposed Midwest Rhino XE and Air Motor M handpieces.
Conclusion Regarding Substantial Equivalence
The proposed Midwest Rhino XE and Air Motor M handpieces are air-powered dental handpieces which are used for drilling of teeth in a variety of dental procedures. The proposed Midwest Rhino XE and Air Motor M handpieces have identical indications for use as those cleared for the predicate device, LS-100 (K792302). The proposed devices incorporate the same fundamental technology and have same intended uses as the predicate device, LS-100 (K792302) and the reference device, W&H Air-Powered Handpieces and Handpiece Attachments (Air Motor AM-25 E RM) (K162926). Test data according to ISO 14457:2017-10 to verify the performance of the Midwest Rhino XE and Air Motor M handpieces has been provided and the results of this testing, combined with the design and intended use comparison with the predicate device, support substantial equivalence.
§ 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.