(57 days)
Not Found
No
The device description focuses on basic software control for motor speed, torque, and rotation, with no mention of AI/ML terms or capabilities like image analysis, pattern recognition, or adaptive learning. The performance studies are focused on electrical and mechanical safety and functional verification against predicate devices.
Yes
The device is used for dental procedures like drilling and removing carious material, which directly treat a condition.
No
Explanation: The device is described as a dental handpiece and accessories, primarily used for performing dental procedures such as drilling and removing carious material. Its features focus on controlling the mechanical operation of the handpiece (speed, torque, rotation) rather than gathering information about a patient's condition for diagnosis.
No
The device description explicitly lists hardware components such as a console (controller), electric motor, foot pedal, and motor holder bracket, in addition to being software controlled.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device's function in performing dental procedures on the patient (drilling into the tooth canal, removing carious material from dentin). This is a direct intervention on the human body.
- Device Description: The description details a dental handpiece system used for mechanical manipulation within the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze biological samples. This device is used in vivo (within the living body) for surgical and restorative procedures.
N/A
Intended Use / Indications for Use
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
Product codes
EKX
Device Description
Model Number: AEU-26L
Classification Name: 872.4200 Dental handpiece and accessories
Primary accessories exclusive to the AEU-26L system:
- a) AEU-26L Consol (Controller)
- b) AE-250L-30 Low Voltage Electric Motor
- c) On/Off Foot Pedal
- d) Motor holder attaching bracket
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth canal
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 AEU-26L was assessed to IEC 60601-1:1988-Medical electrical equipment-Part 1: General requirements for safety. This included thermal and electrical safety of the AE-250L-30 motor containing the Light Emitting Diode (LED).
The AEU-26L met electromagnetic compatibility requirements of IEC 60601-1-2—Medical electrical equipment-Part 1: General requirements for safety-2. Collateral standard: Electromannetic compatibility.
Specific performance testing relevant to the AE-250L-30 motor is met by application of ISO 11498 Dental handpieces -- Dental low-voltage electrical motors
All of the functional characteristics for the AEU-26L (e.g. directional and reciprocating drive, speed, torque control, ability to attached selected geared handpieces, etc) were established using comparative design verification methods between the predicate devices and the AEU-26L. Records of these design verification activities are maintained in the Design History File.
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
§ 872.4200 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
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SHIPPING: 8333 - 216th Street SE. Woodin
(425) 487-3157 WORLDWIDE
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FAX: (360) 668-8722
www.aseptico.com
Email: info@aseptico.com
DEPT OF QUALITY AND REGULATORY AFFAIRS
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510(k) Summary
Prepared by: Grant Ramaley
March 16, 2011
Device Description
Model Number: AEU-26L
Classification Name: 872.4200 Dental handpiece and accessories
Product Code: EKX handpiece, direct drive, ac-powered
Primary accessories exclusive to the AEU-26L system:
- a) AEU-26L Consol (Controller)
- b) AE-250L-30 Low Voltage Electric Motor
- c) On/Off Foot Pedal
- d) Motor holder attaching bracket
Intended Use
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
Summary of Technological Characteristics
General operation and use
The AEU-26L is software controlled and has the following features:
- a) Allows adjustment of the motor speed from 300 to 30,000 RPM
- b) Allows setting the torque applied to the motor in gram/cm
- c) Allows selection of gear ratios for different geared E-Type handpieces
- d) Allows selection of forward or reverse drive rotation
- e) Allows reciprocating drive (forward/reverse cycling)
- Allows use of a foot pedal control to operate the attached handpiece motor ರಿ)
- Allows the user to define their own presets for speed (RPM) and torque (gram g)
- h) Allows for attaching geared handpieces that include optics for a light.
See Table 1 of comparisons provided at the end of this summary
1
Substantial Equivalence
Feature equivalency to Aseptico Model AEU-925:
All but two of the features listed above "Technological Characteristics" for the AEU-26L are already part of Aseptico's model AEU-925, which was cleared under 510(k) number K030163. Both models can be used for endodontic surgery.
**Allows attachment of lighted handpieces
The AEU-26L allows use of contra angle handpieces that include optics for a light, to provide illumination from the Light Emitting Diode (LED) of the AE-250L motor. This technology is substantially equivalent to the Aseptic AEU-5000 cleared under 510(k) number K103399.
**Reciprocating drive
Reciprocating drive is a forward and reverse cycle that can be selected as an alternate motion to simply driving forward or reverse. Bench testing of the AEU-26L establishes that the AEU-26L provides the same type of reciprocation as the ATR TECNIKA device, cleared under K000547.
** Technological characteristics from predicate devices other than Aseptico's Model AEU-925
Performance data
The AEU-26L was assessed to IEC 60601-1:1988-Medical electrical equipment-Part 1: General requirements for safety. This included thermal and electrical safety of the AE-250L-30 motor containing the Light Emitting Diode (LED).
The AEU-26L met electromagnetic compatibility requirements of IEC 60601-1-2—Medical electrical equipment-Part 1: General requirements for safety-2. Collateral standard: Electromannetic compatibility.
Specific performance testing relevant to the AE-250L-30 motor is met by application of ISO 11498 Dental handpieces -- Dental low-voltage electrical motors
All of the functional characteristics for the AEU-26L (e.g. directional and reciprocating drive, speed, torque control, ability to attached selected geared handpieces, etc) were established using comparative design verification methods between the predicate devices and the AEU-26L. Records of these design verification activities are maintained in the Design History File.
Conclusions
The AEU-26L bears all the features necessary to perform endodontic surgery of its predecessor AEU-925. using all of the same technological developments and feature that are in place for performing endodontic dental surgery. In addition, the AEU-26L includes the ability to utilize legally marketed geared handpieces that have optics to carry the light for illuminating the working area of the tooth. It also includes a reciprocating drive feature that is substantially equivalent to the ATR TECNIKA device, cleared under K000547.
2
TABLE 1
SUMMARY ONLY -- See Substantial Equivalence Discussion for more details
Comparison chart of AEU-26L Essential Performance and Features
| AEU-26L | AEU-925 | ATR TECNIKA | AEU-5000 | |
|---|---|---|---|---|
| a) Allows | ||||
| adjustment of the | ||||
| motor speed from | ||||
| 300 to 30,000 RPM | 300 to 30000 RPM | |||
| Configurable | 300 to 30000 RPM | |||
| Configurable | 1600 to 12800 RPM | |||
| Configurable | 2000 to 40000 RPM | |||
| Configurable | ||||
| b) Allows setting | ||||
| the torque applied | ||||
| to the motor in | ||||
| gram/cm | *Yes | |||
| Better than predicate | ||||
| device AE- 925 | ||||
| Torque accuracy | *Yes | |||
| Torque accuracy | Units not in gram/cm. | |||
| Torque is configurable from | ||||
| 0 to 100 | ||||
| (no units specified) | Units not in gram/cm. | |||
| Torque is configurable from | ||||
| 5% to 100% | ||||
| c) Allows | ||||
| selection of gear | ||||
| ratios for different | ||||
| geared E-Type | ||||
| handpieces | 1:5, 1:1 | |||
| 8:1, 16:1 Reduction | 1:5, 1:4, 1:3, 1:2, 1:1 | |||
| 35:1 to 3:1 Reduction | 1:1 | |||
| 8:1, 16:1, 18:1, 20:1 | ||||
| Reduction | 1:5, 1:2, 1:1 | |||
| 5:1 and 8:1 Reduction | ||||
| d) Allows | ||||
| selection of forward | ||||
| or reverse drive | ||||
| rotation | Yes | Yes | Yes | Yes |
| e) Allows | ||||
| reciprocating drive | ||||
| (forward/reverse | ||||
| cycling) | Yes | No | Yes | No |
| f) Allows use of a | ||||
| foot pedal control to | ||||
| operate the | ||||
| attached handpiece | ||||
| motor | Yes, electronic foot control | Yes, electronic foot control | Yes, electronic foot control | Yes, pneumatic sensor |
| g) Allows the user | ||||
| to define their own | ||||
| presets for speed | ||||
| and torque | Yes | Yes | Yes | Yes |
| h) Allows for | ||||
| attaching geared | ||||
| handpieces that | ||||
| include optics for a | ||||
| light. | Yes | No | No | Yes |
Page 18
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aseptico, Incorporated C/O Mr. Jeff D. Rongero Responsible Third Party Official Underwriters Laboratories, Incorporated 12 Laboratory Drive Research Triangle, North Carolina 27709
JUN 1 4 2011
Re: K111078
Trade/Device Name: AEU-26L Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: II Product Code: EKX Dated: June 7, 2011 Received: June 8, 2011
Dear Mr. Rongero:
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.
4
Page 2 - Mr. Rongero
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.tda.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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Anthony Di Roston
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
5
Indications for Use
510(k) Number (if known):
Device Name: AEU-26L
Indications For Use:
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
Prescription Use × (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 (ODE)
Susan Ruane
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K11078
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