AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) by Aseptico, Inc.

The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification from the FDA for a dental handpiece and accessories, the AEU-7000L-70V Implant/Endodontic Dental System. It primarily addresses the substantial equivalence of this device to previously marketed predicate devices under the 510(k) pathway.

The 510(k) pathway focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. This typically involves performance testing to show that the new device meets the same or similar specifications as the predicate. It does not generally involve clinical trials or extensive studies to establish acceptance criteria for novel clinical endpoints in the same way a PMA (Pre-Market Approval) would for high-risk devices.

Therefore, many of the specific questions about acceptance criteria for AI/ML devices, such as sample sizes for test sets, expert adjudication methods, MRMC studies, and detailed ground truth establishment, are not applicable to this type of device and submission.

Here's a breakdown based on the provided document:

A table of acceptance criteria and the reported device performance:
- The document does not explicitly state specific quantifiable acceptance criteria (e.g., accuracy, sensitivity, specificity) in the way one would see for an AI/ML diagnostic device.
- For a device like a dental handpiece, acceptance criteria would typically revolve around engineering specifications, safety standards (e.g., electrical safety, biocompatibility, sterilization efficacy), and performance characteristics (e.g., motor speed, torque, irrigation flow, noise levels, vibration) that are compared to the predicate device.
- The document states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This implies that Aseptico, Inc. provided data (likely bench testing, engineering reports, and comparisons to predicate device specifications) to demonstrate this substantial equivalence, and the FDA found that data acceptable. However, the details of these tests and their specific acceptance criteria are not included in this FDA letter.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided in this document. As this is a 510(k) for a dental handpiece, testing would primarily involve bench testing of the device's mechanical and electrical components, not a "test set" of patients or data in the AI/ML context.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided in this document. There is no "ground truth" in the clinical imaging interpretation sense for this device. Ground truth for mechanical devices would be established by validated measurement techniques and engineering standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided in this document. This applies to clinical interpretation studies, not mechanical device performance.
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:
- Not applicable / Not provided in this document. This is a mechanical device, not an AI/ML diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not provided in this document. This device does not have an "algorithm only" component. It is a physical dental system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided in this document. For a dental handpiece, "ground truth" for performance would be based on engineering specifications, validated measurement methods, and compliance with recognized standards (e.g., ISO standards for dental equipment).
The sample size for the training set:
- Not applicable. This device does not use machine learning or require a "training set."
How the ground truth for the training set was established:
- Not applicable. This device does not use machine learning or require a "training set."

In summary: The provided FDA 510(k) letter confirms substantial equivalence for a dental handpiece. It does not contain the detailed performance data, acceptance criteria, or study methodologies that would be typical for an AI/ML device submission because the device itself is a mechanical-electrical system, not a software algorithm. The FDA's determination means they were satisfied with the comparisons made to predicate devices and the data supporting those comparisons, which would primarily be engineering and bench testing data.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2015

Aseptico, Inc. Ms. Cherie Tregoning Regulatory Affairs Specialist 8333 216th Street South East Woodinville Washington, 98072

Re: K150129

Trade/Device Name: AEU-7000L-70V Implant/Endodontic Dental System Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX Dated: April 24, 2015 Received: April 29, 2015

Dear Ms. Tregoning:

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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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Tina
Kiang -S

for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the logo for Aseptico, a company that specializes in advancing dental technology. The logo features the company name in a stylized font, with a blue swirl design to the left. Contact information is listed to the right of the logo, including the phone number 800.426.5913, fax number 360.668.8722, and website www.aseptico.com.

Indications for Use

Device Name: AEU-7000L-70V Implant / Endodontic Dental System

Indications for Use:

Prescription Use _ X

And/Or

Over-The-Counter Use (21CFR 801 Subpart C)

Regulation Number and Section

§ 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.