(104 days)
Not Found
No
The summary describes a standard cordless prophylaxis handpiece with basic controls and indicators. There is no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on electrical safety, biocompatibility, and functional specifications, not on algorithmic performance metrics typically associated with AI/ML.
No
The device is used for cleaning and polishing teeth, which is a prophylactic procedure, not a therapeutic one. It's designed for maintenance and prevention, not for treating a disease or condition.
No
Explanation: The device is described as a prophylaxis handpiece for cleaning and polishing teeth, which is a treatment procedure, not a diagnostic one.
No
The device description explicitly states it is a "cordless prophylaxis system consisting of an electric motor driven handpiece and an AC powered battery charger (stand)." This indicates the device includes significant hardware components beyond just software. While software is mentioned as being verified and validated, it is part of a larger hardware system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cleaning and polishing procedures on teeth." This is a mechanical procedure performed directly on the patient's teeth.
- Device Description: The device is a "cordless prophylaxis handpiece" that uses disposable angles to perform the cleaning and polishing. This describes a tool used for a physical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze any such specimens.
The device is a dental handpiece used for a direct dental procedure, not for in vitro diagnostic testing.
N/A
Intended Use / 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 teeth.
Product codes (comma separated list FDA assigned to the subject device)
EKX
Device Description
The iProphy mobile is a cordless prophylaxis system consisting of an electric motor driven handpiece and an AC powered battery charger (stand). The handpiece utilizes commercially available disposable, single use Disposable Prophy angles (DPA). The handpiece features on-board user controls for power, on/off, and speed with indicators for battery charging, battery life, and speed selection. The iProphy mobile is to be used with disposable handpiece sleeves.
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
hygiene operatory
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
:
, "
5. 510(k) SUMMARY
| Submitter: | Nakanishi, Inc.
700 Shimohinata
Kanuma-Shi, Tochigi-Ken Japan 322-8666 | | | |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------|-------------------------------------|--|
| Contact Person: | Mr. Toshihiko Shinozaki
Assistant Manager, R&D Dept. Pharmaceutical Affairs Gr.
TEL: 0289(64)3380
FAX: 0289(62)6665
t-shinozaki@nsk-nakanishi.co.jp | | | |
| 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
driven handpiece and an AC powered battery charger (stand). The handpiece
utilizes commercially available disposable, single use Disposable Prophy angles
(DPA). The handpiece features on-board user controls for power, on/off, and speed
with indicators for battery charging, battery life, and speed selection. The iProphy
mobile is to be used with disposable handpiece sleeves. | | | |
| Statement of
Intended Use
(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 teeth. | | | |
| Summary of
Technological
Characteristics: | Using commercially available disposable Prophy angles (DPA), the Nakanishi
iProphy mobile can be used to clean and polish teeth. The iProphy mobile software
driven user controls are located on the cordless handpiece allowing the user to
power the device on and off, activate rotation of the device, set the rotation speed,
observe the speed setting, observe the battery charging status, and observe the
battery status. In addition, the iProphy mobile features and auto power-off function
after approximately 10 minutes of non-operation, and a last memory function that
recalls the most recent settings from when the device was last powered off.
Minor differences exist between the Nakanishi iProphy mobile and the predicate.
The predicate requires the use of a foot pedal while the iProphy mobile does not;
the predicate requires a higher water exposure rating than the iProphy mobile; the
predicate utilizes a re-sterilizable sheath while the iProphy mobile utilizes
disposable handpiece shields like many other dental devices; and the iProphy
mobile can utilize any commercially available compatible DPA, while the predicate
identifies specific compatible DPAs. These minor differences do not impact
substantial equivalence of the Nakanishi iProphy mobile. | | | |
Section 5: Page 1 of 2
ﮨﮯ ﭘﺎ
NAKANISHI INC. Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan
www.nsk-inc.com www.nsk-inc.com
1
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.
Image /page/1/Picture/9 description: The image shows a black and white drawing of a bird. The bird has a long neck and a pointed beak. The bird's wings are spread out, and its tail is long and thin. The bird is flying over a body of water.
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
2
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.
3
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
4
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:
Page 1 of 1
Section 4: Page 1 of 1
Traditional 510(k)
iProphy mobile
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