(442 days)
This product is intended only for dental clinic /dental office use. This device generates ultrasonic waves intended for use in dental applications such as scaling, root canal treatment, periodontal and cavity preparation.
The Varios 370 is a compact, portable control unit powered by the iPiezo® engine. The product comes with a wide range of tip inserts, which can be attached at the distal end of the Varios 2 Handpiece transducer and vibrates at ultrasonic frequencies of 28 to 32 KHz. The Varios 370 LUX features twin LED lights, assuring generally clearer vision and easier identification of the treatment area.
This report does not contain information about the acceptance criteria and the study proving the device meets those criteria from an AI/ML perspective. The document is a 510(k) summary for an ultrasonic scaler (Varios 370 / Varios 370 Lux) and focuses on regulatory compliance, outlining the device's description, intended use, technological characteristics, and a summary of testing against applicable industry standards (e.g., electrical safety, biocompatibility, sterilization).
Here's a breakdown of what is provided, and why it doesn't align with the requested AI/ML-centric information:
What is provided in the document:
- Device: Varios 370 / Varios 370 Lux (Ultrasonic Scaler)
- Intended Use: Dental clinic/office use for applications like scaling, root canal treatment, periodontal and cavity preparation using ultrasonic waves.
- Summary of Testing: The document states the device underwent "design validation, including software validation" as required by 21 CFR 820.30(g) and was tested in accordance with several standards:
- IEC 60601-1 (Electrical Safety)
- UL 60601-1 (Electrical Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- ISO 10993-1 (Biocompatibility)
- ISO 22374 (Dental handpieces Electrical-powered scalers and scaler tips)
- AAMI/ANSI/ISO 17665-1 (Sterilization)
- Predicate Device: K031421 – Nakanishi Varios 350 / Varios 350 Lux, to which the current device is considered "substantially equivalent."
- Conclusion: Substantial equivalence is based on similarities in primary intended use, principles of operation, design rationale, test results, and performance.
Why this doesn't fit the requested AI/ML acceptance criteria study:
The provided document describes a traditional medical device (an ultrasonic scaler) and its regulatory submission. It does not mention any AI or Machine Learning components. Therefore, there are no AI/ML acceptance criteria, no studies on algorithm performance, no discussions of training or test sets, no data provenance related to AI, no ground truth establishment for AI, and no MRMC studies or standalone algorithm performance metrics.
To answer your specific questions based on the absence of AI/ML in this document:
-
A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (for regulatory submission): The device successfully met the requirements of the standards listed (IEC 60601-1, UL 60601-1, IEC 60601-1-2, ISO 10993-1, ISO 22374, AAMI/ANSI/ISO 17665-1) and successfully underwent design validation, including software validation, as per 21 CFR 820.30(g). Performance was also deemed similar to the predicate device.
- Reported Device Performance (for AI/ML): Not applicable, as there is no AI/ML component.
-
Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for AI/ML. The device's performance was likely evaluated through engineering tests (e.g., electrical safety, EMC, vibration frequency, biocompatibility tests) rather than a clinical "test set" in the context of data analysis for AI.
-
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 for AI/ML. Ground truth, in this context, would relate to the physical and functional specifications of the device meeting its design intent and safety standards, rather than expert interpretation of data.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for AI/ML.
-
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, as there is no AI component.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as there is no AI component.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc): The "ground truth" for this device would be defined by the technical specifications, performance standards, and safety requirements outlined in the referenced IEC/ISO/UL standards. For example, for electrical safety, the ground truth is whether the device adheres to leakage current limits. For biocompatibility, it's whether the materials are non-toxic.
-
The sample size for the training set: Not applicable, as there is no AI/ML component.
-
How the ground truth for the training set was established: Not applicable, as there is no AI/ML component.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and is set against a black background. The letters "NSK" are in a bold, sans-serif font. There is a horizontal line above the letters.
ド || 3717
" 5. 510(k) SUMMARY
| Submitter: | Nakanishi, Inc.700 ShimohinataKanuma-Shi, Tochigi-Ken Japan 322-8666 | MAR 0 5 2013 |
|---|---|---|
| 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: | March 5, 2013 | |
| Trade Name: | Varios 370 / Varios 370 Lux | |
| Common Name: | Ultrasonic Scaler | |
| Classification Name: | ELC 872.4850 Scaler, Ultrasonic | |
| Predicate Device: | K031421 – Nakanishi Varios 350 / Varios 350 Lux | |
| Device Description: | The Varios 370 is a compact, portable control unit powered by the iPiezo® engine.The product comes with a wide range of tip inserts, which can be attached at thedistal end of the Varios 2 Handpiece transducer and vibrates at ultrasonicfrequencies of 28 to 32 KHz.The Varios 370 LUX features twin LED lights, assuring generally clearer visionand easier identification of the treatment area. | |
| Statement ofIntended Use: | This product is intended only for dental clinic /dental office use. This devicegenerates ultrasonic waves intended for use in dental applications such as scaling,root canal treatment, periodontal and cavity preparation. | |
| Summary ofTechnologicalCharacteristics: | The Varios 370 is a compact, portable control unit, allowing easy installation intoany dental unit, and powered by the iPiezo® engine. During the mode of operation, asinusoidal electrical signal, at ultrasonic frequency (f > 20Khz), is generated anddelivered to the 'piezoelectric ceramic' located inside the handpiece transducer. Theelectrical signal is converted into mechanical vibrations and propagated to the distalend of the handpiece. | |
| Summary ofTesting: | As required by 21 CFR 820.30(g), the Varios 370 has been successfully subjected to design validation, including software validation. Software validation documentation was provided in compliance with FDA document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.In addition, the Varios 370 has been successfully tested in accordance with the following applicable standards for medical devices:Electrical Safety: IEC 60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance) Electrical Safety: UL 60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Safety) |
Image /page/0/Picture/4 description: This image shows the header of a document. It indicates that it is "Section 5: Page 1 of 2". It also includes the company name "NAKANISHI INC." along with their headquarters address: 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan. The Tokyo office address is also listed as MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan.
Image /page/0/Picture/5 description: The image shows a black and white drawing of a bird in flight. The bird has long, pointed wings and a long tail. The bird's body is slender and streamlined. The bird is flying against a white background. The words "Powerful Partner" are written in small font below the bird.
{1}------------------------------------------------
Image /page/1/Picture/0 description: The image shows the logo for NSK, a Japanese manufacturer of bearings. The logo is white and features the letters "NSK" in a bold, sans-serif font. A horizontal line is placed above the letters, adding a distinctive element to the design. The logo appears to be slightly distressed, giving it a textured look.
- Electromagnetic Compatibility: IEC 60601-1-2 (General requirements for . basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests}
- Biocompatibility: ISO 10993-1 (Biological evaluation of medical devices -. Part 1: Evaluation and testing)
- Dentistry: ISO 22374 (Dental handpieces Electrical-powered scalers and . scaler tips)
- Sterilization: AAMI/ANSI/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)
Conclusion:
Nakanishi, Inc. considers the Varios 370 Ultrasonic Scaler to be substantially equivalent to the predicate device listed above. This conclusion is based on the similarities in primary intended use, principles of operation, design rationale, test results, and performance.
Image /page/1/Picture/7 description: The image shows a logo with a black silhouette of a person's hand holding a pen or stylus over a tablet or similar device. The hand and device are positioned diagonally across the frame. Below the image is the text "Powerful Partner" in a smaller font size.
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wavy lines extending from its body, representing the department's commitment to health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the eagle symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 5, 2013
Nakanishi, Incorporated C/O Ms. Diane Rutherford Regulatory Engineer Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080
Re: K113717
Trade/Device Name: Varios 370 / Varios 370 Lux Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: February 15, 2013 Received: February 19, 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 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.
{3}------------------------------------------------
INDICATIONS FOR USE
KII3717 510(k) Number:
Device Name: Varios 370 / Varios 370 Lux
Indications for Use:
This product is intended only for dental clinic /dental office use. This device generates ultrasonic waves intended for use in dental applications such as scaling, root canal treatment, periodontal and cavity preparation.
Prescription Use X (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)
Mary S Runner -2013.03.05
15:23:53 -05.00 ANA ನ್ನು ಸ
(Division Sign-Off) Division of Anesthesloicgy, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
Section 4: Page 1 of 1
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.