IPROPHY MOBILE

K131578 · Nakanishi, Inc. · EKX · Sep 12, 2013 · Dental

Device Facts

• Record ID: K131578
• Device Name: IPROPHY MOBILE
• Applicant: Nakanishi, Inc.
• Product Code: EKX · Dental
• Decision Date: Sep 12, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Nakanishi iProphy mobile is a cordless prophylaxis handpiece for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth.

Device Story

iProphy mobile is a cordless, electric motor-driven dental prophylaxis handpiece; used in hygiene operatory by dental professionals for tooth cleaning and polishing. Device utilizes disposable, single-use prophylaxis angles (DPA) and disposable handpiece sleeves. Handpiece features on-board user controls for power, on/off, and speed selection; includes indicators for battery life, charging status, and speed. Device incorporates software-driven functions: auto power-off after 10 minutes of inactivity; last memory function to recall previous settings. Powered by an AC-connected battery charger stand. Output is mechanical rotation of the DPA; healthcare provider uses device manually to perform dental hygiene. Benefits include cordless operation, eliminating foot pedal requirements, and improved ergonomics for the clinician.

Clinical Evidence

No clinical data. Bench testing only. Verification and validation testing confirmed compliance with functional specifications, software requirements, electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and dental handpiece standards (ISO 11498). Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Cordless electric motor-driven handpiece. Materials: disposable handpiece shields. Connectivity: standalone with AC-powered charging base. Software: embedded, controls speed, power, and memory functions. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), ISO 11498 (dental handpieces).

Indications for Use

Indicated for use by dental professionals in a hygiene operatory to perform cleaning and polishing procedures on teeth using disposable prophylaxis angles.

Regulatory Classification

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.

Predicate Devices

• Midwest RDH Freedom Cordless System (K110753)

Submission Summary (Full Text)

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## 5. 510(k) SUMMARY

| Submitter: | Nakanishi, Inc.<br>700 Shimohinata<br>Kanuma-Shi, Tochigi-Ken Japan 322-8666 | | | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------------------------------------|--|
| Contact Person: | Mr. Toshihiko Shinozaki<br>Assistant Manager, R&D Dept. Pharmaceutical Affairs Gr.<br>TEL: [phone]<br>FAX: [phone]<br>[e-mail] | | | |
| Date Prepared: | May 28, 2013 revised August 23, 2013 | | | |
| Trade Name: | iProphy mobile | | | |
| Common Name: | Cordless Prophy System | | | |
| Classification Name: | EKX | 872.4200 | Handpiece, Direct Drive, AC Powered | |
| Predicate Device: | K110753 | Dentsply | Midwest RDH Freedom Cordless System | |
| Device Description: | The iProphy mobile is a cordless prophylaxis system consisting of an electric motor<br>driven handpiece and an AC powered battery charger (stand). The handpiece<br>utilizes commercially available disposable, single use Disposable Prophy angles<br>(DPA). The handpiece features on-board user controls for power, on/off, and speed<br>with indicators for battery charging, battery life, and speed selection. The iProphy<br>mobile is to be used with disposable handpiece sleeves. | | | |
| Statement of<br>Intended Use<br>(Indications for Use): | The Nakanishi iProphy mobile is a cordless prophylaxis handpiece for use with<br>disposable prophylaxis angles in hygiene operatory to perform cleaning and<br>polishing procedures on teeth. | | | |
| Summary of<br>Technological<br>Characteristics: | Using commercially available disposable Prophy angles (DPA), the Nakanishi<br>iProphy mobile can be used to clean and polish teeth. The iProphy mobile software<br>driven user controls are located on the cordless handpiece allowing the user to<br>power the device on and off, activate rotation of the device, set the rotation speed,<br>observe the speed setting, observe the battery charging status, and observe the<br>battery status. In addition, the iProphy mobile features and auto power-off function<br>after approximately 10 minutes of non-operation, and a last memory function that<br>recalls the most recent settings from when the device was last powered off.<br><br>Minor differences exist between the Nakanishi iProphy mobile and the predicate.<br>The predicate requires the use of a foot pedal while the iProphy mobile does not;<br>the predicate requires a higher water exposure rating than the iProphy mobile; the<br>predicate utilizes a re-sterilizable sheath while the iProphy mobile utilizes<br>disposable handpiece shields like many other dental devices; and the iProphy<br>mobile can utilize any commercially available compatible DPA, while the predicate<br>identifies specific compatible DPAs. These minor differences do not impact<br>substantial equivalence of the Nakanishi iProphy mobile. | | | |

Section 5: Page 1 of 2

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NAKANISHI INC. Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan
www.nsk-inc.com www.nsk-inc.com

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Performance Testing:

The iProphy mobile was developed and is produced under consideration of all applicable technical standards, and internal specifications. Tests were performed which demonstrated that the device is substantially equivalent to the predicate device. Tests included verification/validation testing to internal functional specifications, including software.

Documentation was provided demonstrating compliance of the iProphy mobile with ISO 10993-1: "Biological evaluation of medical devices -- Part 1: Evaluation and testing" and FDA Guidance "Use on International Standard ISO 10993, "Biological evaluation of medical devices -- Part 1: Evaluation and testing"

Documentation was provided demonstrating compliance of the iProphy mobile to all FDA requirements stated in Guidance for the Content of Premarket Submissions Software Contained in Medical Devices, including results of for for verification/validation plus traceability of verification/validation tests to software requirements and software risk hazards.

Testing confirmed that the iProphy mobile complies with relevant voluntary safety standards for Electrical safety and Electromagnetic Compatibility testing, specifically 1EC standards 60601-1 and 60601-1-2.

Documentation was provided to demonstrate that the iProphy mobile is compliant to ISO 11498: "Dental handpieces: Dental low-voltage electrical motors".

Together, these verification/validation activities successfully demonstrated that the iProphy mobile correctly performs as designed, has been validated for its intended use, and raises no new questions regarding either safety or effectiveness when compared to the predicate device. Therefore, the verification/validation testing conducted supports a determination of substantial equivalence for the iProphy mobile device.

Conclusion:

The iProphy mobile does not introduce new concerns regarding safety and effectiveness. Therefore, Nakanishi considers the iProphy mobile to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in: intended use; principles of operation; functional design; and established medical use.

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Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan AKANISHI INC. Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan www.nsk-inc.com

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a caduceus, a symbol often associated with medicine and healthcare.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 12, 2013

Nakanishi, Incorporated C/O Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080

Re: K131578

Trade/Device Name: iProphy mobile Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: June 14, 2013 Received: June 17, 2013

Dear Ms. Rutherford:

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. 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 warrenties. 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 If your device 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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Page 2 - Ms. Rutherford

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 80}), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21

CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Mary S. Runner -S

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

510(k) Number: K131578

Device Name: iProphy mobile

Indications for Use:

The Nakanishi iProphy mobile is a cordless prophylaxis handpiece for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on leeth.

Prescription Use × (21 CFR 801 Subpart D)

AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDHR, Office of Device Evaluation (ODE)

Andrew I. Steen 2013.09.12 09:48:56

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

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Section 4: Page 1 of 1

Traditional 510(k)

iProphy mobile

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