(279 days)
No
The document describes a standard ultrasonic scaler with modifications to the handpiece, pump tubing, and overall design for improved performance and ease of use. There is no mention of AI, ML, image processing, or any data-driven algorithms.
Yes
The device is described as an ultrasonic scaler intended for various dental procedures such as removing calculus deposits, scaling and root planning, and preparing root canals, all of which are considered therapeutic interventions for dental health.
No
Explanation: The "Intended Use / Indications for Use" section lists procedures for treatment and maintenance (e.g., removing calculus, scaling, root planing, preparing cavities, cementing), but it does not mention any function related to diagnosing a condition or disease.
No
The device description clearly outlines multiple hardware components including a main chassis, power supply, controls, displays, ultrasonic generator, irrigation system, footswitch, handpiece, and instruments.
Based on the provided information, the miniMaster LED is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses listed are all related to direct treatment and manipulation of the teeth and surrounding structures within the patient's mouth (e.g., removing calculus, scaling, root planning, preparing cavities, cementing). IVD devices are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device used for physical procedures within the oral cavity, not for analyzing biological samples.
- Anatomical Site: The anatomical sites listed are all within the patient's body.
- Performance Studies: The performance studies mentioned are related to electrical safety, electromagnetic compatibility, and sterilization, which are typical for medical devices used in a clinical setting, but not specifically for IVD performance characteristics like sensitivity or specificity.
- Key Metrics: There are no mentions of metrics like sensitivity, specificity, PPV, or NPV, which are crucial for evaluating the performance of IVD devices.
In summary, the miniMaster LED is a therapeutic dental device used for procedures performed directly on the patient, not for analyzing samples in a laboratory setting.
N/A
Intended Use / Indications for Use
The miniMaster LED 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 planning
- 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 LED 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.
The miniMaster LED is a modification of the miniMaster Ultrasonic Scaler that was the subject of K050710. The overall design of the miniMaster LED is identical to the design of the miniMaster. The introduction of Piezon handpiece LED, materials changes to the peristaltic pump tubing, and design modifications implemented for the miniMaster LED were made to improve the functional performance and ease of use of the ultrasonic scaler. These design changes are listed in Table 1.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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 appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. Testing conducted on the proposed miniMaster LED included the following:
- UL 60601-1, "Medical Electrical Equipment—Part 1: General Requirements for Safety" (2nd edition including amendments 1&2)
- IEC 60601-1-2, "Medical electrical equipment. Part 1 General requirements for safety - Part 2 Collateral standard: Electromagnetic compatibility: Requirements and Tests" (1993)
- ISTA 2A, ''Packaged-Products 150 lb (68 kg) or Less''
The reprocessing instructions for the reusable handpiece, instruments, and accessories were validated in accordance with ANSI/AAMI ST79:2006, "Comprehensive guide to steam sterilization and sterility assurance in health care facilities". The steam sterilization process was validated to an SAL of 10^6 using a half cycle method in accordance with ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".
No clinical testing was submitted to support the claim of substantial equivalence.
The miniMaster LED met all defined acceptance criteria for the non-clinical testing listed in Section 7. The information provided confirms that the miniMaster LED is safe and effective for its intended use and performs as well or better than the miniMaster.
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
510(k) Summary For miniMaster LED Ultrasonic Scaler
1. SPONSOR
SEP 0 8 2010
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 September 3, 2010
2. DEVICE NAME
Proprietary Name: miniMaster LED Common/Usual Name: Ultrasonic Scaler Ultrasonic Scaler (21 CFR 872.4850, Product Code Classification Name: ELC)
3. PREDICATE DEVICES
4. INTENDED USE
- Removing supra and subgingival calculus deposits and stains from the teeth .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement �
- Scaling and root planning .
- 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
1
5. DEVICE DESCRIPTION
The miniMaster LED 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.
The miniMaster LED is a modification of the miniMaster Ultrasonic Scaler that was the subject of K050710. The overall design of the miniMaster LED is identical to the design of the miniMaster. The introduction of Piezon handpiece LED, materials changes to the peristaltic pump tubing, and design modifications implemented for the miniMaster LED were made to improve the functional performance and ease of use of the ultrasonic scaler. These design changes are listed in Table 1.
| Ultrasonic Scaler
. Component/Accessory
| (Part Reference) | Design Modification |
|---|---|
| Piezon handpiece LED (EN-060/A) | Compatibility with Piezon handpiece LED which includes a light |
| guide and 6 LEDs placed under the nozzle to improve illumination of | |
| the treatment area. | |
| Handpiece LED cord (EM-113A/A) | Handpiece cords adapted to integrate LEDs |
| Cord connector (EK-300) | Cord connectors adapted to support LED |
| Water adjustment ring | Water adjustment ring relocated to handpiece side of handpiece cord |
| Electronics | Electronic PCB upgraded to drive the LED |
| Peristaltic Pump tubing* | Internal irrigation tubing replaced with fluorocarbon rubber material |
Table 1. Design Modifications Incorporated in the miniMaster LED
PCB = printed circuit board
LED = light emitting diode
- Peristaltic Pump identical to Piezon Master 700, K093000
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the proposed and predicate devices is provided in Table 2.
11,
2
| Item for
| Comparison | miniMaster | miniMaster LED |
|---|---|---|
| Intended Use | Ultrasonic scaler intended for use in dental and periodontal cleaning, preparatory, endo and | |
| restorative procedures. | ||
| Operational | ||
| environment | Stand alone | Stand alone |
| Power supply | • External transformer 24 V | |
| • 100-240V/50-60 Hz | • External transformer 24 V | |
| • 100-240V/50-60 Hz | ||
| Water supply | • Irrigating liquid bottle | |
| • Peristaltic pump | • Irrigating liquid bottle | |
| • Peristaltic pump | ||
| Ultrasonic | ||
| power | ||
| adjustment | Ten discrete power settings | Same |
| Water | ||
| adjustment | • Flow regulator on handpiece cord | |
| • Flow rate: 0-50 ml/min. minimum | • Flow regulator on handpiece cord | |
| • Flow rate: 0-50 ml/min. minimum | ||
| Dry/Wet work | ||
| capability | • miniMaster: Both Wet and Dry Work | |
| • ULTRAPIEZON: Wet Work only | • miniMaster: Both Wet and Dry Work | |
| Output | ||
| performance | ||
| specifications | 0-8 W Standard Mode | |
| 0-4.5 W Soft (Endo) Mode | ||
| 24-32 kHz (nominal) | Same | |
| (Soft mode identified as "ENDO mode") | ||
| Footswitch | Electrical command, two positions for independent | |
| control of water flow and ultrasonic tip movement | Same | |
| Materials: | ||
| Handpiece | • Autoclavable plastic | • Autoclavable plastic |
| Instruments | • Stainless steel | • Stainless steel |
| Main Chassis | ||
| Weight and | ||
| Dimensions | Weight: 1.3 kg | |
| Height: 96 mm | ||
| Width: 213 mm | ||
| Length: 80 mm | Weight: 1.3 kg: | |
| Height: 96 mm | ||
| Width: 213 mm | ||
| Length: 80 mm |
Table 2. Comparison of Technological Characteristics of Proposed and Predicate Devices
7. NON-CLINICAL TESTING
The appropriate design verification and design validation activities were conducted to address the potential risks identified in the Hazard Analysis. Testing conducted on the proposed miniMaster LED included the following:
- · UL 60601-1, "Medical Electrical Equipment—Part 1: General Requirements for Safety" (2nd edition including amendments 1&2)
- · IEC 60601-1-2, "Medical electrical equipment. Part 1 General requirements for safety - Part 2 Collateral standard: Electromagnetic compatibility: Requirements and Tests" (1993)
- ISTA 2A, ''Packaged-Products 150 lb (68 kg) or Less''
The reprocessing instructions for the reusable handpiece, instruments, and accessories were validated in accordance with ANSI/AAMI ST79:2006, "Comprehensive guide
3
to steam sterilization and sterility assurance in health care facilities". The steam sterilization process was validated to an SAL of 106 using a half cycle method in accordance with ANSI/AAMI/ISO 17665-1:2006 "Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices".
8. CLINICAL TESTING
No clinical testing was submitted to support the claim of substantial equivalence.
9. CONCLUSIONS
The proposed and predicate devices have the same general intended use and principles of operation. The overall design of the proposed and predicate devices is similar. The differences between these devices are limited to design modifications implemented to replace the ultrasonic module and improve the product's ease of use. These design modifications are minor and raise no new issues of safety or effectiveness.
The miniMaster LED met all defined acceptance criteria for the non-clinical testing listed in Section 7. The information provided confirms that the miniMaster LED is safe and effective for its intended use and performs as well or better than the miniMaster.
CONFIDENTIAL Page 4
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
EMS Electro Medical Systems SA C/O Ms. Cynthia J.M. Nolte Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K093723
Trade/Device Name: miniMaster LED Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: August 30, 2010 Received: August 31, 2010
Dear Ms. 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. 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
SEP 0 8 2010
5
Page 2- Mr. Nolte
lease 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/ucm115809.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/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Jus. J. S
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
6
Indications for Use
510(k) Number (if known):
miniMaster LED Device Name:
K193723 SEP 0 8 2010 .
Indications for Use:
The miniMaster LED 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 planning .
- 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 | X | |
|---|---|---|
| (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)
Susan Russo
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K092363