(42 days)
No
The description focuses on the mechanical and electrical aspects of the device (ultrasonic vibrations, frequency, power controls, switching mechanism) and performance testing against existing standards and predicate devices. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes.
The device's intended uses, "General Supra and Subgingival scaling applications" and "Periodontal debridement for non-surgical treatment of Periodontal diseases," directly involve treating medical conditions related to dental health, which falls under the definition of a therapeutic device.
No
The device is described as an ultrasonic scaler for dental procedures, specifically "General Supra and Subgingival scaling applications" and "Periodontal debridement," which are therapeutic rather than diagnostic actions.
No
The device description clearly outlines hardware components such as a control unit, handpiece, foot control, and the mechanism for converting electrical current into vibrations, indicating it is a physical device, not software-only.
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 device is for "General Supra and Subgingival scaling applications" and "Periodontal debridement". These are procedures performed directly on a patient's teeth and gums.
- Device Description: The description details a physical device that generates ultrasonic vibrations for use in dental procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to diagnose, monitor, or screen for diseases or conditions. This device's function is entirely focused on a physical intervention within the oral cavity.
N/A
Intended Use / Indications for Use
This device generates ultrasonic vibrations intended for ultrasonic procedures: 1.) General Supra and Subgingival scaling applications; 2.) Periodontal debridement for non-surgical treatment of Periodontal diseases.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Swerv Magnetostrictive Ultrasonic Scaler is a portable stand alone scaler, handpiece and foot control. The Swerv Magnetostrictive Ultrasonic Scaler operates at 25 kHz and accepts voltage inputs between 100-240V.
The available power output is segmented into two over zones to assist the user in selecting the recommended power setting for a selected ultrasonic insert. The power and water controls of the Swerv' Scaler are located in the control unit.
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)
Results of in-house testing with Hu-Friedy ultrasonic inserts (ref. K953919 and K912473) in the Swerv' Scaler demonstrated that they performed within recommended specifications. Moreover, analysis of frequency and stroke data demonstrated equivalency to predicated devices in the market and that the Swerv scaling system meets ISO 22374 requirements. EMC and Safety testing conducted by Underwriters Laboratories on the Swerv System have demonstrated compliance with the international requirements for this device. The performance testing performed on the Swerv Magnetostrictive Ultrasonic Scaler demonstrates the safety and efficacy for its intended use.
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.
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.
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Image /page/0/Picture/0 description: The image is a logo for Hu-Friedy, a company that manufactures dental instruments. The logo is black and white and features the company name in a bold, sans-serif font. The name is written in white on a black oval background. The registered trademark symbol is located in the bottom right corner of the oval.
Chicago Illinois IISA 60618-5935 773-975-3975 ext.3495
K100401 1581
510(k) SUMMARY
NAME & ADDRESS: HU-FRIEDY MFG. CO., INC. 3232 N. ROCKWELL STREET CHICAGO, IL 60618 (773) 975-3975 EXT. 3495 FAX (773) 868-3558
MAR 3 0 2010
510(k) NOTIFICATION (21 CFR 807.90(e) SUBMISSION TYPE: TRADITIONAL 510K SUBMITTER: HU-FRIEDY MFG. CO. INC. DATE PREPARED: 12/16/2009 CONTACT: MARIA VRABIE- MANAGER OF REGULATORY AFFAIRS TRADE NAME: HU-FRIEDY® SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER CLASSIFICATION NAME: ULTRASONIC SCALER REGULATION NUMBER: 21.CFR, 872.4850 REGULATORY DEVICE CLASS- II PRODUCT PANEL &CODE: 76 ELC PREDICATE DEVICES: K970123 & K033705
DESCRIPTION: The Swerv Magnetostrictive Ultrasonic Scaler is a portable stand alone scaler, handpiece and foot control. The Swerv Magnetostrictive Ultrasonic Scaler operates at 25 kHz and accepts voltage inputs between 100-240V.
The available power output is segmented into two over zones to assist the user in selecting the recommended power setting for a selected ultrasonic insert. The power and water controls of the Swerv' Scaler are located in the control unit.
INTENDED USE: This device generates ultrations intended for ultrasonic procedures: 1.) General Supra and Subgingival scaling applications; 2.) Periodontal debridement for non-surgical treatment of Periodontal diseases.
TECHNOLOGICAL CHARACTERISTICS: The Swerv2 Magnetostrictive Ultrasonic Scaler plugs into an ordinary electrical outlet and converts the AC current into high frequency electro-mechanical vibrations. The Swerv3 Scaler features a patented switching mechanism to support the use of either 25 kHz or 30 kHz inserts. Therefore, the scaling system accepts both Hu-Friedy 25 kHz and 30 kHz Ultrasonic Inserts. Hu-Friedy has 510(k) market clearance for our 25 kHz and 30 kHz Ultrasonic Inserts/Tips (K953919 and K912473). The addition of the Swerv Scaler will complete our Magnetostrictive ultrasonic scaling product line and offer customers a complete package for their scaling needs.
Results of in-house testing with Hu-Friedy ultrasonic inserts (ref. K953919 and K912473) in the Swerv' Scaler demonstrated that they performed within recommended specifications. Moreover, analysis of frequency and stroke data demonstrated equivalency to predicated devices in the market and that the Swerv scaling system meets ISO 22374 requirements. EMC and Safety testing conducted by Underwriters Laboratories on the Swerv System have demonstrated compliance with the international requirements for this device. The performance testing performed on the Swerv Magnetostrictive Ultrasonic Scaler demonstrates the safety and efficacy for its intended use.
All the materials used in the device have been used in legally marketed Hu-Friedy devices or found to be safe for dental use. Hu-Friedy believes the unit to be substantially equivalent to the Dentsply® Cavitron SPS PLUS (30 kHz) and Dentsply Cavitron Bobcat (25 kHz) Ultrasonic Scalers.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
HU-Friday MFG. Company, Incorporated C/O Ms. Casey Conry Responsible Third Party Official Underwriters Laboratories, Incorporated 1285 Walt Whitman Road Melville, New York 11747
MAR 3 0 2010
Re: K100401
Trade/Device Name: Swerv3 Magnetostrictive Ultrasonic Scaler System Regulation Number: 21CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 12, 2010 Received: March 16, 2010
Dear Ms. Conry:
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
Page 2 - Ms. Conry
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/ucm 115809.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,
h for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Image /page/3/Picture/0 description: The image shows the logo for Hu-Friedy. The logo is in black and white, with the words "Hu-Friedy" in a bold, sans-serif font. The background of the logo is a textured pattern. The logo is likely for a company that manufactures dental instruments.
Chicago, Illinois USA 60618-5935 Phone: 773-975-3975 ext.3495 www.hu-friedy.com
K100401 167,
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Indications for Use
510 (k) Number (if known: __K100401
Device Name: Swerv3 Magnetostrictive Ultrasonic Scaler System
INTENDED USE:
This device generates ultrasonic vibrations intended for ultrasonic procedures: 1.) General Supra and Subgingival scaling applications; 2.) Periodontal debridement for non-surgical treatment of Periodontal diseases.
Prescription Use . X (Part 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 CDRH, Office of Device Evaluation
Qheenabner for. Dr. K.P. Muly
RSBetaPos for Dr. K.P. Muly
(Division Sign-Off)
Division of Anesthesiology, General Hospital
Infection Control, Dental Devices
510(k) Number: K100401
An ISO 13485 International Company