(131 days)
No
The description focuses on the mechanical function and sterilization of a dental handpiece, with no mention of AI or ML capabilities.
Yes
The stated "Intended Use" clearly indicates its purpose is for "drilling of teeth in a variety of dental procedures," which is a direct therapeutic action.
No
The device is described as a low-speed handpiece used for drilling teeth, which is a therapeutic or procedural function, not a diagnostic one.
No
The device description clearly states it is a low-speed air motor handpiece, which is a physical hardware device used for drilling teeth. The performance studies also focus on hardware-related aspects like sterilization, cleaning, and material biocompatibility.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "drilling of teeth in a variety of dental procedures." This describes a physical intervention on the patient's body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is described as a "low speed air motor" used as a "handpiece." This is a tool used directly in a dental procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing. The performance studies focus on sterilization, reprocessing, and mechanical standards for dental handpieces.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used in vivo (within the body) for a therapeutic or procedural purpose.
N/A
Intended Use / Indications for Use
Low-speed (vane motor) handpiece is used for drilling of teeth in a variety of dental procedures.
Product codes
EFB
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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
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
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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3
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
Image /page/3/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized, abstract shape on the left, resembling a curved, segmented form. To the right of the shape are the words "Dentsply" on the top line and "Sirona" on the bottom line, with the two words stacked vertically. The text and the shape are in a dark gray color.
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-Powered | ||
| Handpieces and Handpiece | ||
| Attachments (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.
4
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 | ||
|---|---|---|---|---|---|---|
| Midwest | ||||||
| Rhino XE | Air Motor | |||||
| M | LS-100 (K792302) | W&H Air-Powered Handpieces and | ||||
| Handpiece Attachments (Air Motor | ||||||
| AM-25 E RM) (K162926) | ||||||
| Indications | ||||||
| for Use | Low-speed (vane motor) | |||||
| handpiece is used for | ||||||
| drilling of teeth in a variety | ||||||
| of dental procedures. | Low-speed (vane motor) | |||||
| handpiece is used for | ||||||
| drilling of teeth in a | ||||||
| variety of dental | ||||||
| procedures. | The turbine handpiece is intended | |||||
| for the following applications: | ||||||
| removal of decayed materials, | ||||||
| cavities and crown preparation, | ||||||
| removal of fillings, finishing of tooth | ||||||
| and restoration surfaces. | ||||||
| The dental handpiece/contra-angle is | ||||||
| intended for the following applications: | ||||||
| removal of decayed materials, cavities | ||||||
| and crown cement, removal of fillings, | ||||||
| finishing and polishing of tooth and | ||||||
| restorations surfaces. | Identical for the predicate device as | |||||
| used in a variety of dental activities. | ||||||
| Similar to the reference device | ||||||
| indications for use for which are detailed | ||||||
| as to the specific application the device | ||||||
| is used. | ||||||
| Operational | ||||||
| Mode | Air-powered | Air-powered | Air-powered | Identical | ||
| Operating | ||||||
| Pressure (psi) | 42 $ ± $ 2.9 | 40-45 | 42 | There is no significant difference in | ||
| the operating pressure of the | ||||||
| proposed air motors when comparing | ||||||
| them to the predicate air motor. The | ||||||
| proposed devices fall within the | ||||||
| cleared range of the | ||||||
| predicate 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 speed | |||||
| comes through the planetary gearing | ||||||
| of the proposed Midwest Rhino XE | ||||||
| and Air Motor M. Conformity testing to | ||||||
| the requirements of ISO 14457 | ||||||
| requirements are included to support | ||||||
| substantial equivalence. | ||||||
| Table 5.1- Comparison of proposed devices and the predicate device | ||||||
| Element | Proposed Devices | Predicate Device | Reference Device | Differences | ||
| Midwest Rhino | ||||||
| XE | Air Motor M | LS-100 | ||||
| (K792302) | W&H Air-Powered Handpieces and | |||||
| Handpiece Attachments (Air Motor | ||||||
| AM-25 E RM) (K162926) | ||||||
| Torque (N/cm) | ~2.0 | ~2.1 | ~6 | 4 | The difference of the motor torque | |
| comes through the planetary gearing | ||||||
| of the Midwest Rhino XE and Air | ||||||
| Motor M. It changes speed into | ||||||
| torque. Conformity testing to the | ||||||
| requirements of ISO 14457 | ||||||
| requirements are included to support | ||||||
| substantial equivalence. | ||||||
| External | ||||||
| Spray Port | NA | Yes | NA | Yes | The external spray port in the design | |
| of the proposed Air Motor M is an | ||||||
| optional feature to facilitate | ||||||
| connection of dental instruments with | ||||||
| an external spray connection. | ||||||
| Spray Air | ||||||
| Pressure in | ||||||
| bar (psi) | NA | $2.3 \pm 0.2$ | ||||
| $33.4 \pm 2.9$ | NA | 2.2-3* | ||||
| Spray Water | ||||||
| Pressure in | ||||||
| bar (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 T1 | |||||
| Spray | ||||||
| (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 to | |
| the predicate device. | ||||||
| Coupling | Midwest 4-hole | |||||
| coupling | Midwest 4-hole | |||||
| coupling | ||||||
| Borden 2/3- | ||||||
| hole coupling | Midwest 4-hole | |||||
| coupling | Fixed connection standard 4-hole* | The Air Motor M is also available in | ||||
| version with a Borden 2/3-hole | ||||||
| coupling. This coupling is another type | ||||||
| of connection that can be used to | ||||||
| connect the | ||||||
| handpiece to the air motor hose. |
5
6
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.