(214 days)
Not Found
No
The description focuses on programmable settings for speed and torque/angles, which are standard features of electric motors and do not indicate AI/ML. There is no mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML algorithms.
Yes
The device is used to prepare root canals, which is a therapeutic procedure involving the treatment and removal of infected pulp from the tooth.
No
The device description states it is an "electric motor-driven handpiece intended for root canal preparation procedures." Its function is to prepare the root canal using files and drills, not to diagnose a condition.
No
The device description clearly outlines hardware components including an electric motor-driven handpiece, a control unit with an LCD screen, and a foot pedal. The performance studies also reference testing against hardware-specific standards (IEC 60601-1, IEC 60601-1-2, etc.).
Based on the provided information, the I-Endo Dual is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "standard endodontic procedures using endodontic files and endodontic drills" and "root canal preparation procedures." This describes a procedure performed directly on a patient's tooth, not on a sample taken from the body.
- Device Description: The device is an "electric motor-driven handpiece" used for "root canal preparation." This is a mechanical tool used within the body.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, health, or disease. The I-Endo Dual does not perform this function.
The device is clearly intended for use in vivo (within the living body) during dental procedures, which is not the definition of an IVD.
N/A
Intended Use / Indications for Use
The I ENDO DUAL is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
The I ENDO DUAL is an electric motor-driven handpiece intended for root canal preparation procedures in the endodontic industry. It works in both reciprocating mode and continuous rotation.
The motor allows the dentist to program 10 settings of their choice for speed and torque control in rotating mode and to program 10 setting of their choice for speed and angles in reciprocating mode.
The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate and deactivate the motor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental root canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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)
I-ENDO DUAL was tested in accordance with the technical requirements of IEC 60601-1 and IEC 60601-1-2.
All evaluation of the I-ENDO DUAL were performed by Notified Laboratory, and all the results comply to standard listed below.
The conclusions drawn from the performance test are that I-ENDO DUAL comply with:
- EMC Conducted RF emissions IEC 55011 .
- Degrees of protection provided by enclosures (IP Code) IEC 60529 .
- Medical Electrical Equipment Part 2,"Genaral Safety Norms" IEC 60601-1 .
- IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC .
- IEC 61000-4-2 EMC Electrostatic Discharge Immunity ●
- IEC 61000-4-3 Radiated RF immunity .
- IEC 61000-4-4 Fast Transient Immunity .
- IEC 61000-4-5 Pulse immunity ●
- IEC 61000-4-6 Conducted RF immunity ●
- IEC 61000-4-11 Supply Voltage Hole Immunity .
- ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors .
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
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Summary of Safety and Effectiveness – "510 (k) Summary"
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMD 1990 and CFR 807.92.
SUBMITTER INFORMATION
| a. | Company Name | SATELEC |
|---|---|---|
| b. | Company Address | 17 Avenue Gustave Eiffel |
| BP 30216 | ||
| 33708 Merignac Cedex | ||
| France | ||
| c. | Company phone | +01133556340607 |
| Company fax | 01133556349292 | |
| d. | Contact Person | Rick Rosati |
| Satelec | ||
| c/o ACTEON, Inc. | ||
| 124 Gaither Drive, Suite 140 | ||
| MT Laurel, NJ 08054 | ||
| Tel : 800 289-6367 ext 39 | ||
| Fax : 856 222-4726 | ||
| Email : | ||
| Rick.Rosati@us.acteongroup.com | ||
| e. | Date Summary Prepared | November, 11, 2011 |
1
DEVICE IDENTIFICATION
| a. | Trade/Proprietary Names: | I-ENDO DUAL |
|---|---|---|
| b. | Common name | Dental Motor |
| c. | Classification Name | Dental Handpiece and |
| Accessories | ||
| d. | CFR Number | 872.4200 |
| e. | Device Class | I |
| f. | Product Code | EBW |
IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Dentsply Int. | E3 Torque Control | ||
| Motor | K103653 | 26 May. 2011 |
DEVICE DESCRIPTION
The I ENDO DUAL is an electric motor-driven handpiece intended for root canal preparation procedures in the endodontic industry. It works in both reciprocating mode and continuous rotation.
The motor allows the dentist to program 10 settings of their choice for speed and torque control in rotating mode and to program 10 setting of their choice for speed and angles in reciprocating mode.
The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate and deactivate the motor.
2
INDICATIONS FOR USE
The I ENDO DUAL is a medical device designed for use by dentists for use with dental root canal instruments in continuous rotation with torque control or in reciprocating movement.
SUBSTANTIAL EQUIVALENCE
The I-ENDO DUAL is substantially equivalent to the E3 Torque Control Motor in commercial distribution by Dentsply International.
The fundamental technical characteristics of the I-ENDO DUAL are similar to those of the predicate device and are listed on the comparison chart provided in this 510(k) submission.
TECHNICAL CHARACTERISTICS
I-ENDO DUAL was designed and developed to provide a microprocessor controlled endodontic system with similar performances compared to predicate device. I-ENDO DUAL :
- is equivalent in functions to the predicate device, ●
- has adjustable speeds and torque values (related to the reduction rate of the handpiece . selected) that are fully customisable by the end user,
- . has automatic motor shutdown/autoreverse system which provides to switch off/reverse the motor whenever set torque is reached,
- has reciprocating movements fully customizable. .
PERFORMANCE DATA
I-ENDO DUAL was tested in accordance with the technical requirements of IEC 60601-1 and IEC 60601-1-2.
All evaluation of the I-ENDO DUAL were performed by Notified Laboratory, and all the results comply to standard listed below.
The conclusions drawn from the performance test are that I-ENDO DUAL comply with:
- EMC Conducted RF emissions IEC 55011 .
- Degrees of protection provided by enclosures (IP Code) IEC 60529 .
- Medical Electrical Equipment Part 2,"Genaral Safety Norms" IEC 60601-1 .
- IEC 60601-1-2 Medical Electrical Equipment Part 1 EMC .
- IEC 61000-4-2 EMC Electrostatic Discharge Immunity ●
- IEC 61000-4-3 Radiated RF immunity .
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K111623 4
- IEC 61000-4-4 Fast Transient Immunity .
- IEC 61000-4-5 Pulse immunity ●
- IEC 61000-4-6 Conducted RF immunity ●
- IEC 61000-4-11 Supply Voltage Hole Immunity .
- ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors .
510(k) CHECKLIST
This notification contains all information required by 21 CFR 807.87.
A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
CONCLUSION AS TO SUBSTANTIAL EQUIVALENCE
I-ENDO DUAL is substantially equivalent to the E3 Torque Control Motor (K103653) based on equivalence of the intended use, the non-clinical performance data and technological characteristics. Performance testing data of the I-ENDO DUAL was compared to the substantially equivalent of the E3 Torque Control Motor (K103653). This included electrical safety, electromagnetic compatibility, and non-clinical performance testing of both hardware and software functions. The I-ENDO DUAL does not raise any new issues of substantially equivalent or performance of the product when compared to the E3 Torque Control Motor (K103653. These test results support a determination of substantial equivalence.
4
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SATELEC-ACTEON Group C/O Mr. Rick Rosati Quality Manager ACETON, Incorporated 124 Gaither Drive, Suite 140 Mt Laurel, New Jersey 08054
JAN 1 0 2012
Re: K111623
Trade/Device Name: I-ENDO DUAL Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: January 2, 2012 Received: January 4, 2012
Dear Mr. Rosati:
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.
5
Page 2 - Mr. Rosati
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 ( vopering on 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 yours,
Nh 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
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Indication for use Statement
510(k) Number:
111623 To be assigned by FDA
Device Name:
Endodontic Micromotor
Model:
I-ENDO DUAL
Indications for Use:
I-Endo Dual is indicated for use by dentists in standard endodontic procedures using endodontic files and endodontic drills.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use______________________________________________________________________________________________________________________________________________________________
OR
Over-The -Counter Use
(Per 21 CFR 801.109)
Susan Ranne
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111623
SATELEC / By Dental - Acteon Group I-ENDO DUAL