(428 days)
No
The description focuses on the ultrasonic scaling mechanism and the iPiezo® engine, with no mention of AI or ML capabilities.
Yes
The device is described as an "electronic scaler" with various intended uses including scaling, perio, implant maintenance, endodontic, and restorative procedures, which are all therapeutic interventions for dental conditions.
No
The device is described as an electronic scaler intended for various dental procedures such as scaling, perio, implant maintenance, and restorative work. Its function is to perform interventions rather than to diagnose conditions.
No
The device description clearly outlines hardware components including a control unit, irrigation bottles, handpiece, and tip inserts. It is a physical ultrasonic scaler, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes procedures performed directly on a patient (scaling, perio, implant maintenance, etc.). IVDs are used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health.
- Device Description: The description details an ultrasonic scaler used for dental procedures, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing specimens, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is clearly intended for therapeutic and procedural use within the oral cavity.
N/A
Intended Use / Indications for Use
This device, Varios 970 / Varios 970 Lux, an electronic scaler, is intended for use with an appropriate tip for following use:
- Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for ・ Minimal Intervention/ Finishing/Trimming/ Polishing/Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
Product codes
ELC
Device Description
Varios 970 is a stand-alone ultrasonic scaler device powered by the iPiezo® engine. The Varios 970 consists of the Varios 970 Control Unit, two independent 400 mL irrigation bottles, handpiece, and a wide range of tip inserts. The tip inserts, when attached at the distal end of the handpiece transducer, resonate at ultrasonic frequencies of 28 -32 kHz. The 400 mL bottles each can carry different solutions with independent pumps. The Varios 970 LUX features twin LED lights that last longer, are more durable, and generate less heat than halogen bulbs.
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
Not Found
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 Varios 970 has been tested in accordance with applicable standards for medical device electrical safety, electromagnetic compatibility, and the particular requirements for sterilization.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 consists of the letters "NSK" in a bold, sans-serif font. The letters are slightly slanted to the right, giving the logo a sense of movement. The logo is simple and modern, and it is easily recognizable.
- 510(k) SUMMARY
Submitter:
KII 3530
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 Application Ms. Diane Rutherford Correspondent: Ken Block Consulting TEL: 972-480-9554 FAX: 972-767-4325 rutherford@kenblockconsulting.com Date Prepared: November 23, 2011 Trade Name: Varios 970 / Varios 970 Lux Common Name: Ultrasonic Scaler Classification Name: ELC 872.4850 Scaler, Ultrasonic Predicate Device: K071447 - Nakanishi Varios 75 Varios 970 is a stand-alone ultrasonic scaler device powered by the iPiezo® engine. The Device Description: Varios 970 consists of the Varios 970 Control Unit, two independent 400 mL irrigation bottles, handpiece, and a wide range of tip inserts. The tip inserts, when attached at the distal end of the handpiece transducer, resonate at ultrasonic frequencies of 28 -32 kHz. The 400 mL bottles each can carry different solutions with independent pumps. The Varios 970 LUX features twin LED lights that last longer, are more durable, and generate less heat than halogen bulbs. Statement of This device, Varios 970, an electronic ultrasonic scaler, is intended for use with an Intended Use: appropriate tip for following use: Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for ----Minimal Intervention/ Finishing/Trimming/ Polishing/Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
Both the Varios 970 and the predicate Varios75 utilize the iPiezo engine to generate ultrasonic frequencies of 28 -32 kHz. Both have the same operating modes, irrigation Characteristics: modes, and operating time. 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 The Varios 970 has been tested in accordance with applicable standards for medical device Test Data: electrical safety, electromagnetic compatibility, and the particular requirements for sterilization.
Conclusion: Nakanishi, Inc. considers the Varios 970 Ultrasonic Scaler to be substantially equivalent to the predicate device (Varios 75) listed above. This conclusion is based on the similarities in primary intended use, principles of operation, design rationale, and performance.
Section 5: Page 1 of 1
JAN 3 1 2013
NAKANISHI INC. www.nsk-inc.com
Summary of Technological
Headquarters : 700 Shimohihata Kanuma-shi Tochigi 322-8666, Japan Tokyo Office : MY Building 1-13-3 Ueno Taito-ku Tokyo 110-0005, Japan
Image /page/0/Picture/9 description: The image shows a hand holding a pen or pencil, presumably for writing or drawing. The hand is depicted in a stylized, possibly cartoonish manner, with bold lines defining its shape and the pen. Below the hand, the words "Powerful Penmanship" are written in a simple font, suggesting a theme related to writing skills or the impact of written communication.
1
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 31, 2013
Nakanishi. Incorporated C/O Ms. Diane Rutherford Submissions Manager Ken Block Consulting 1201 Richardson Drive, Suite 280 RICHARDSON TX 75080
Re: K113530
Trade/Device Name: Varios 970 / Varios 970 Lux Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: January 28, 2013 Received: January 29, 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.
2
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 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1.15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
hor
E. Reth
Harshidio.
Anthony D. Watson, B.S., M.S., M.B.A. 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: K113530
Device Name: Varios 970 / Varios 970 Lux
Indications for Use:
This device, Varios 970 / Varios 970 Lux, an electronic scaler, is intended for use with an appropriate tip for following use:
- Scaling, Perio, Implant Maintenance, Endodontic, Retrograde Endo, Restorative (for ・ Minimal Intervention/ Finishing/Trimming/ Polishing/Caries of Dentin), Prosthetics (Condensation / Loosening / Plugging)
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)
Andrew I. Steen
2013.01.31 13:29:47 -05'00'
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K113530
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