(12 days)
Not Found
No
The document does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the physical components and intended uses of a standard ultrasonic scaler.
Yes
The device performs procedures such as removing calculus deposits, scaling, root planing, and preparing root canals, all of which are therapeutic interventions.
No
The provided text describes the miniMaster as an ultrasonic scaler used for various dental treatment procedures (removing calculus, scaling, root planing, preparing cavities, etc.), not for diagnosing conditions.
No
The device description explicitly details hardware components such as a main chassis, power supply, controls, displays, ultrasonic generator, irrigation system, footswitch, handpiece, and instruments. This indicates it is a physical medical device with integrated hardware, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This includes reagents, calibrators, control materials, specimen receptacles, software, and related instruments or apparatus.
- Device Function: The miniMaster is an ultrasonic scaler used for various dental procedures performed directly on the patient's teeth and surrounding tissues. It physically removes calculus, performs scaling, prepares cavities, etc.
- Lack of Specimen Analysis: The device does not analyze any specimens (like blood, urine, tissue samples) taken from the body. Its function is entirely external and procedural.
The intended uses and device description clearly indicate that the miniMaster is a therapeutic and procedural device used in a dental setting, not a diagnostic device that analyzes samples.
N/A
Intended Use / Indications for Use
The miniMaster is an ultrasonic scaler that is intended for the following:
- . Removing supra and subgingival calculus deposits and stains from the teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
- . Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- . Plugging for amalgam condensation
- Amalgam burnishing ●
- . Preparing, cleaning, and irrigating root canals
- . Preparing approximal cavities
- Cementing inlays and onlays .
- . Retrograde preparation of root canals
Product codes
ELC
Device Description
The miniMaster is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece.
Two versions of the miniMaster will be commercially distributed in the US, one with and the other without the capability for dry work.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
teeth, periodontal pocket, root canals, approximal cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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MAR 3 0 2005
Special 510(k) Summary For miniMaster Ultrasonic Scaler
1. SPONSOR
E.M.S. Electro Medical Systems SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
Contact Person: Suzanne Fassio-Hardy Telephone: 022 994 47 00
Date Prepared March 17, 2005
2. DEVICE NAME
| Proprietary Name: | miniMaster |
|---|---|
| Common/Usual Name: | Ultrasonic Scaler |
| Classification Name: | Ultrasonic Scaler |
3. PREDICATE DEVICES
EMS Kermit (K992504)
ব' INTENDED USE
- Removing supra and subgingival calculus deposits and stains from the teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- . Scaling and root planing
- Releasing crowns, bridges, inlays and posts as well as condensing gutta percha .
- Plugging for amalgam condensation
- . Amalgam burnishing
- Preparing, cleaning, and irrigating root canals .
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- . Preparing approximal cavities
- Cementing inlays and onlays .
- Retrograde preparation of root canals .
ನ್ DEVICE DESCRIPTION
The miniMaster is an ultrasonic scaler consisting of a main chassis containing an external electric power supply, controls and displays, ultrasonic generator, and a bottle-fed irrigation system. A 2-step footswitch is connected to the main chassis by a footswitch cord. A handpiece is connected to the main chassis by a handpiece cord, with irrigant flow control located on the cord itself. Instruments designed for specific dental procedures are attached to the distal end of the handpiece.
Two versions of the miniMaster will be commercially distributed in the US, one with and the other without the capability for dry work.
6. BASIS FOR SUBSTANTIAL EQUIVALENCE
The modifications made to the parent EMS Kermit to produce the proposed miniMaster were implemented to improve the functional performance and ease of use of the ultrasonic scaler. These modifications do not alter the intended use or fundamental scientific technology of the device.
The intended uses of the proposed miniMaster and predicate EMS Kermit are identical. Both the proposed and parent devices are ultrasonic scalers intended for use in dental and periodontal cleaning, preparatory, and restorative procedures. All of the procedures for which the miniMaster is indicated were cleared for use with the EMS Kermit.
The modifications made to the parent EMS Kermit to produce the proposed miniMaster include the following:
- Conversion of internal to external electrical power supply .
- . Cosmetic changes to the C-51 ultrasonic generator
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- Change from external water supply to bottle irrigation with a peristaltic . pump
- Compatibility with Universal Piezon Handpiece .
- . Addition of newly designed instruments
- . Movement of irrigant flow control to handpiece cord
- Minor design changes including reorientation of pump in housing and . addition of a handpiece cord disconnect on the housing
The appropriate design verification and design validation activities were conducted to address the potential risks associated with the modified device that were identified in the Risk Analysis. The results confirm that the modified miniMaster is safe and effective for the dental and periodontal cleaning, preparatory, and restorative procedures listed in Section 8.
The similarities in intended use, technical specifications, and functional performance between the miniMaster and the parent EMS Kermit lead to a conclusion of substantial equivalence between the proposed and parent devices.
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Image /page/3/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an abstract image of a human face.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 3 0 2005
E.M.S. Electro Medical Systems SA C/O Cynthia J. M. Nolte, PhD., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760
Re: K050710
Trade/Device Name: MiniMaster Ultrasonic Scaler Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 17, 2005 Received: March 21, 2005
Dear Dr. Nolte:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 -- Cynthia J. M. Nolte, PhD., RAC
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours,
Chiu S. Lin, Ph.D.
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: miniMaster Ultrasonic Scaler
Indications for Use:
The miniMaster is an ultrasonic scaler that is intended for the following:
- . Removing supra and subgingival calculus deposits and stains from the teeth
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
- . Releasing crowns, bridges, inlays and posts as well as condensing gutta percha
- . Plugging for amalgam condensation
- Amalgam burnishing ●
- . Preparing, cleaning, and irrigating root canals
- . Preparing approximal cavities
- Cementing inlays and onlays .
- . Retrograde preparation of root canals
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Mulvey for MSP
sion Sign-Off) ision of Anesthesiology, General Hospital. Sation Control, Dental Devices
Number: K 05671C