(104 days)
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.
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.
The provided text describes the iProphy mobile, a cordless prophylaxis system, and its FDA 510(k) summary. However, it does not contain the detailed acceptance criteria or a specific study proving the device meets those criteria in the format requested.
The document focuses on demonstrating substantial equivalence to a predicate device (Dentsply Midwest RDH Freedom Cordless System) based on:
- Intended use: Both are cordless prophylaxis handpieces for cleaning and polishing teeth.
- Principles of operation: Both use disposable prophylaxis angles.
- Functional design: Both are handpieces with user controls.
- Established medical use.
Instead of specific quantitative acceptance criteria and a study demonstrating their achievement, it mentions general compliance with standards and internal specifications.
Therefore, many of the requested fields cannot be filled directly from the provided text.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Compliance with ISO 10993-1: Biological evaluation of medical devices | Documentation provided demonstrating compliance. |
| Compliance with FDA Guidance: "Use on International Standard ISO 10993..." | Documentation provided demonstrating compliance. |
| Compliance with FDA requirements for Software Contained in Medical Devices (Guidance for Premarket Submissions) | Documentation provided demonstrating compliance, including verification/validation plus traceability to software requirements and risk hazards. |
| Compliance with IEC 60601-1 (Electrical safety) | Testing confirmed compliance. |
| Compliance with IEC 60601-1-2 (Electromagnetic Compatibility) | Testing confirmed compliance. |
| Compliance with ISO 11498: Dental low-voltage electrical motors | Documentation provided demonstrating compliance. |
| Implicit Criteria (Functional Specifications) | Reported Performance |
| Power on/off functionality | Achieved via user controls on handpiece. |
| Activation of rotation | Achieved via user controls on handpiece. |
| Setting rotation speed | Achieved via user controls on handpiece. |
| Observing speed setting | Achieved via indicators on handpiece. |
| Observing battery charging status | Achieved via indicators on handpiece. |
| Observing battery status | Achieved via indicators on handpiece. |
| Auto power-off function (after approx. 10 mins non-operation) | Device features this function. |
| Last memory function (recalls most recent settings) | Device features this function. |
| Compatibility with commercially available disposable prophylaxis angles (DPA) | Device can utilize any commercially available compatible DPA. |
Missing Information for Acceptance Criteria: The document does not provide specific quantitative acceptance criteria such as speed ranges, battery life, torque, or safety thresholds (e.g., maximum temperature rise, noise levels, vibration). It generally states compliance with standards.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document mentions "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." This refers to internal product development testing rather than a clinical study with a specific patient sample size.
- Data Provenance: Not specified. The testing seems to be internal to the manufacturer (Nakanishi, Inc. in Japan) for engineering verification and validation.
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)
- Not applicable. This device is a dental handpiece, not an AI/diagnostic software that requires expert ground truth for a test set. The validation is based on engineering and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This device is a dental handpiece, and its validation involves engineering and safety testing, not expert adjudication of diagnostic outcomes.
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
- Not applicable. This is a physical dental device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical dental device, not an algorithm. The device itself is "standalone" in that it performs its function when operated, but this is a different context than AI software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth Type: For a physical device like this, "ground truth" refers to compliance with established engineering standards (e.g., IEC 60601-1, ISO 11498) and the device's ability to meet its functional specifications (e.g., maintain set speed, indicate battery life). There isn't an "expert consensus" or "pathology" type of ground truth for a mechanical and electrical device's performance in this context.
8. The sample size for the training set
- Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is a physical device, not a machine learning algorithm that requires a training set.
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5. 510(k) SUMMARY
| Submitter: | Nakanishi, Inc.700 ShimohinataKanuma-Shi, Tochigi-Ken Japan 322-8666 | |||
|---|---|---|---|---|
| Contact Person: | Mr. Toshihiko ShinozakiAssistant Manager, R&D Dept. Pharmaceutical Affairs Gr.TEL: 0289(64)3380FAX: 0289(62)6665t-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 motordriven handpiece and an AC powered battery charger (stand). The handpieceutilizes commercially available disposable, single use Disposable Prophy angles(DPA). The handpiece features on-board user controls for power, on/off, and speedwith indicators for battery charging, battery life, and speed selection. The iProphymobile is to be used with disposable handpiece sleeves. | |||
| Statement ofIntended Use(Indications for Use): | The Nakanishi iProphy mobile is a cordless prophylaxis handpiece for use withdisposable prophylaxis angles in hygiene operatory to perform cleaning andpolishing procedures on teeth. | |||
| Summary ofTechnologicalCharacteristics: | Using commercially available disposable Prophy angles (DPA), the NakanishiiProphy mobile can be used to clean and polish teeth. The iProphy mobile softwaredriven user controls are located on the cordless handpiece allowing the user topower 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 thebattery status. In addition, the iProphy mobile features and auto power-off functionafter approximately 10 minutes of non-operation, and a last memory function thatrecalls 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; thepredicate utilizes a re-sterilizable sheath while the iProphy mobile utilizesdisposable handpiece shields like many other dental devices; and the iProphymobile can utilize any commercially available compatible DPA, while the predicateidentifies specific compatible DPAs. These minor differences do not impactsubstantial 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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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 (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
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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
Page 25 of 328
§ 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.