(57 days)
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.
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
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
- 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.
The AEU-26L device is a software-controlled dental handpiece system. The acceptance criteria and the study proving the device meets these criteria are detailed below, primarily through a comparison with predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the functional characteristics of the predicate devices. The reported device performance for the AEU-26L demonstrates its equivalence or superior performance to these predicates.
| Acceptance Criteria (from Predicate Devices) | Reported Device Performance (AEU-26L) |
|---|---|
| Motor Speed Adjustment: 300 to 30,000 RPM (from AEU-925) | 300 to 30,000 RPM Configurable |
| Torque Control: Yes, with torque accuracy (from AEU-925) | Yes, with Better than predicate device AEU-925 Torque accuracy |
| Gear Ratio Selection: 1:5, 1:4, 1:3, 1:2, 1:1, 35:1 to 3:1 Reduction (from AEU-925) | 1:5, 1:1, 8:1, 16:1 Reduction |
| Forward or Reverse Drive Rotation: Yes (from AEU-925) | Yes |
| Reciprocating Drive: Yes (from ATR TECNIKA) | Yes |
| Foot Pedal Control: Yes, electronic foot control (from AEU-925) | Yes, electronic foot control |
| User-Defined Presets (Speed & Torque): Yes (from AEU-925) | Yes |
| Attachment of Lighted Handpieces: Yes (from AEU-5000) | Yes |
| Safety Standards: Compliance with IEC 60601-1:1988 (thermal/electrical) | Met IEC 60601-1:1988 (thermal and electrical safety of AE-250L-30 motor) |
| EMC Requirements: Compliance with IEC 60601-1-2 | Met IEC 60601-1-2 (electromagnetic compatibility) |
| Motor-Specific Performance: Compliance with ISO 11498 | Met by application of ISO 11498 (Dental handpieces -- Dental low-voltage electrical motors) |
Notes on Performance Comparison:
- Torque Control: The AEU-26L claims improved torque accuracy compared to the AEU-925.
- Gear Ratios: The AEU-26L offers a different set of reduction ratios compared to the AEU-925, but still provides a range for various handpieces.
- Reciprocating Drive & Lighted Handpieces: These are new features to the AEU-26L compared to the AEU-925, and their performance is shown to be equivalent to the respective predicate devices (ATR TECNIKA and AEU-5000).
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a separate "test set" in the context of a clinical trial or a dataset for AI evaluation. Instead, the performance evaluation relies on "bench testing" and "comparative design verification methods" against predicate devices. This implies that the 'test set' consists of the AEU-26L device itself being tested against established industry standards and specifications of its predicate devices.
- Sample Size: Not explicitly stated as a numerical sample size of patients or images. The testing was performed on the AEU-26L device itself.
- Data Provenance: Not applicable in the traditional sense of patient data. The provenance is the performance characteristics of the device and its comparison to known predicate devices from Aseptico (AEU-925, AEU-5000) and ATR TECNIKA. The testing was likely conducted in a controlled laboratory or engineering environment. The study is retrospective in the sense that it compares features and performance to already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in a way that aligns with establishing ground truth for a test set, as this is a device performance study rather than an AI diagnostic study. The "ground truth" for the device's technical specifications and functionality would be the design requirements and the specifications of the predicate devices, established through engineering and regulatory processes.
4. Adjudication Method for the Test Set
Not applicable. There was no expert adjudication process described for a test set in the context of diagnostic interpretation. The evaluation involved verifying the device's functional characteristics and compliance with technical standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
No MRMC comparative effectiveness study was done, as this is a medical device (dental handpiece) and not an AI-assisted diagnostic tool. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not applicable. The AEU-26L is a hardware and software controlled dental handpiece system, not an algorithm being evaluated for standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for the AEU-26L's performance is established by:
- Technical Specifications and Design Requirements: The device's own design specifications setting out its intended functionality (e.g., speed range, torque control, drive types).
- Predicate Device Specifications: The established and cleared performance characteristics of the Aseptico AEU-925, AEU-5000, and ATR TECNIKA devices with which the AEU-26L claims substantial equivalence for specific features.
- Industry Standards: Compliance with recognized international standards for medical electrical equipment (IEC 60601-1, IEC 60601-1-2) and dental handpieces (ISO 11498).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so there is no training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
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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
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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.
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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) Allowsadjustment of themotor speed from300 to 30,000 RPM | 300 to 30000 RPMConfigurable | 300 to 30000 RPMConfigurable | 1600 to 12800 RPMConfigurable | 2000 to 40000 RPMConfigurable |
| b) Allows settingthe torque appliedto the motor ingram/cm | *YesBetter than predicatedevice AE- 925Torque accuracy | *YesTorque accuracy | Units not in gram/cm.Torque is configurable from0 to 100(no units specified) | Units not in gram/cm.Torque is configurable from5% to 100% |
| c) Allowsselection of gearratios for differentgeared E-Typehandpieces | 1:5, 1:18:1, 16:1 Reduction | 1:5, 1:4, 1:3, 1:2, 1:135:1 to 3:1 Reduction | 1:18:1, 16:1, 18:1, 20:1Reduction | 1:5, 1:2, 1:15:1 and 8:1 Reduction |
| d) Allowsselection of forwardor reverse driverotation | Yes | Yes | Yes | Yes |
| e) Allowsreciprocating drive(forward/reversecycling) | Yes | No | Yes | No |
| f) Allows use of afoot pedal control tooperate theattached handpiecemotor | Yes, electronic foot control | Yes, electronic foot control | Yes, electronic foot control | Yes, pneumatic sensor |
| g) Allows the userto define their ownpresets for speedand torque | Yes | Yes | Yes | Yes |
| h) Allows forattaching gearedhandpieces thatinclude optics for alight. | Yes | No | No | Yes |
Page 18
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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.
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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
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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
Page 15
§ 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.