(442 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts. The device description focuses on ultrasonic technology and standard electrical and safety testing.
Yes
The device is used for dental applications like scaling, root canal treatment, and periodontal and cavity preparation, which are therapeutic interventions.
No
Explanation: The device description and intended use clearly state that this product generates ultrasonic waves for treatment purposes such as scaling, root canal treatment, periodontal, and cavity preparation. It does not mention any function for identifying, evaluating, or monitoring a disease or condition.
No
The device description clearly states it is a "compact, portable control unit" and comes with "tip inserts" and a "Handpiece transducer," indicating it is a physical hardware device that utilizes software for control. The performance studies also mention testing against electrical safety and biocompatibility standards, which are relevant to hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the product is for "dental applications such as scaling, root canal treatment, periodontal and cavity preparation." These are procedures performed directly on the patient's body, not on samples taken from the body for diagnostic purposes.
- Device Description: The description details a device that generates ultrasonic waves for use in dental procedures. This aligns with a therapeutic or procedural device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or any diagnostic purpose.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ELC
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental clinic /dental office use.
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)
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)
- 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)
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
§ 872.4850 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.
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 Shimohinata
Kanuma-Shi, Tochigi-Ken Japan 322-8666 | MAR 0 5 2013 |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| 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: | 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 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. | |
| Statement of
Intended 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. | |
| Summary of
Technological
Characteristics: | The Varios 370 is a compact, portable control unit, allowing easy installation into
any dental unit, and powered by the iPiezo® engine. During the mode of operation, a
sinusoidal electrical signal, at ultrasonic frequency (f > 20Khz), is generated and
delivered to the 'piezoelectric ceramic' located inside the handpiece transducer. The
electrical signal is converted into mechanical vibrations and propagated to the distal
end of the handpiece. | |
| Summary of
Testing: | 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:
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