(237 days)
No
The description mentions a microprocessor and programmable memory, but there is no indication of AI or ML algorithms being used for decision-making, analysis, or adaptation. The control is based on electronic control of velocity and torque, which is standard for such devices.
No
The device is described as a surgical micromotor used to prepare bone for implantology procedures, which is a tool for a surgical procedure, not a therapeutic treatment in itself.
No
The device is described as surgical micromotors used to prepare intraoral bone, providing electronic control of velocity and torque, indicating a therapeutic or procedural function rather than a diagnostic one.
No
The device description explicitly lists multiple hardware components including a microprocessor control unit, foot pedal, electric micromotor, support rods, sterile irrigation tubes, and a peristaltic pump.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "prepare intraoral bone for implantology procedures." This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical micromotor system used in implantology procedures. It involves mechanical action (drilling/preparing bone) and irrigation.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a surgical tool used during a medical procedure, not a diagnostic tool used to analyze biological samples.
N/A
Intended Use / Indications for Use
The ATR Surgical Micromotors are intended to prepare intraoral bone for implantology procedures.
Product codes
EFB
Device Description
The ATR Surgical Micromotors are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors consist of a microprocessor control unit, foot pedal, electric micromotor, support rods and sterile irrigation tubes. The microprocessor unit also houses the peristaltic pump. The ATR Surgical Micromotors provide electronic control of velocity and torque. The ATR Surgical Micromotors can be programmed and retains up to five programs in memory. The ATR Surgical Micromotors are also fully operational from the foot pedal. The foot pedal not only controls the functions of the ATR Surgical Micromotors, but it can also be used for programming.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral bone
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
The ATR Surgical Micromotors were subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the ATR Surgical Micromotors conformed to applicable emission, immunity and electromagnetic compatibility standards in accordance with EN and IEC regulations. Results of the testing showed that the ATR Surgical Micromotors perform as intended.
Key Metrics
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
SECTION 14: SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
14.1 SUBMITTER INFORMATION
| a. Company Name: | Advanced Technology Research |
|---|---|
| b. Company Address: | Via Giovanni Verga, 7 |
| 51100 Pistoia ITALY | |
| c. Company Phone: | |
| Company Facsimile: | 39 (0) 573 364 254 |
| 39 (0) 573 364 002 | |
| d. Contact Person: | Sandra Giusti |
| President | |
| e. Date Summary Prepared: | April 21, 1999 |
DEVICE IDENTIFICATION 14.2.
| a. Trade/Proprietary Names: | ATR 3000, ATR 2000, Implant-Pro |
|---|---|
| b. Classification Name: | Dental Handpiece and Accessories |
| 21 CFR 872.4200 |
14.3 IDENTIFICATION OF PREDICATE DEVICE
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| MicroMotors | Dynasurg Electric Handpiece | ||
| and Irrigation System | K911068 | 05/15/91 |
14.4 DEVICE DESCRIPTION
The ATR Surgical Micromotors are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors consist of a
・
1
microprocessor control unit, foot pedal, electric micromotor, support rods and sterile irrigation tubes. The microprocessor unit also houses the peristaltic pump. The ATR Surgical Micromotors provide electronic control of velocity and torque. The ATR Surgical Micromotors can be programmed and retains up to five programs in memory. The ATR Surgical Micromotors are also fully operational from the foot pedal. The foot pedal not only controls the functions of the ATR Surgical Micromotors, but it can also be used for programming.
14.5 SUBSTANTIAL EQUIVALENCE
The ATR Surgical Micromotors are substantially equivalent to the Dynasurg Electric Handpiece and Irrigation System in commercial distribution by Micro Motors.
The fundamental technical characteristics of the ATR Surgical Micromotors are similar to those of the predicate device and are listed on the comparison charts provided in this 510(k) submission. The ATR Surgical Micromotors and the predicate device consist of a control unit, electric micromotor, footswitch and irrigation system. The ATR Surgical Micromotors and the predicate device have adjustable speeds, torque and reduction rates, and are programmable. The micromotor of the ATR Surgical Micromotors and the predicate device is autoclavable.
14.6 INTENDED USE
The ATR Surgical Micromotors are intended for the preparation of intraoral bone for implantology procedures.
14.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the ATR Surgical Micromotors with the predicate device is provided within this submission. The ATR Surgical Micromotors are programmable and retain the programs in
2
memory. The ATR Surgical Micromotors have adjustable speeds and torque that are related to the reduction rate of the handpiece selected. The device has an automatic shut off safety feature in the event that the dynamic resistance of the bone exceeds the set torque value. The ATR Surgical Micromotors can be fully programmed and operated using the foot pedal.
14.8 PERFORMANCE DATA
The ATR Surgical Micromotors were subjected to performance bench testing in accordance with applicable industry and clinical standards. Physical performance studies were conducted to verify that the ATR Surgical Micromotors conformed to applicable emission, immunity and electromagnetic compatibility standards in accordance with EN and IEC regulations. Results of the testing showed that the ATR Surgical Micromotors perform as intended.
14.9 510(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.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized graphic of three abstract human figures in profile, arranged in a row. The figures are connected by flowing lines that suggest movement or connection. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 5 1999
Advanced Technology Research, S.A.S. Ms. Carol Patterson, Consultant for Advanced Technology Research, S.A.S. Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, CA 92630
Re : K991401 Advanced Technology Research ATR Surgical Trade Name: Micromotors Regulatory Class: I Product Code: EFB Dated: October 28, 1999 Received: October 29, 1999
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Page 2 - Ms. Patterson
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for vour device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATION FOR USE
| 510(k) Number: | To Be Assigned By FDA K991401 |
|---|---|
| Device Name: | ATR Surgical Micromotors |
| Indications for Use: | The ATR Surgical Micromotors are intended to prepare |
| intraoral bone for implantology procedures. |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | ✓ |
|---|---|
| ------------------ | ----------------------------------------------------------------------------------------- |
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
| (Division Sign-Off) | Susan Runser |
|---|---|
| Division of Dental, Infection Control, and General Hospital Devices | CONFIDENTIAL |
| 510(k) Number | K991401 |