(11 days)
No
The description mentions a microprocessor and programmable memory for controlling velocity and torque, which are standard features for surgical micromotors and do not indicate the use of 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.
No
The device is described as preparing intraoral bone for implantology procedures, which is a preparatory surgical step, not a therapeutic treatment itself.
No
The intended use states that this device is intended to prepare intraoral bone for implantology procedures, indicating a surgical/therapeutic function rather than a diagnostic one.
No
The device description explicitly lists multiple hardware components including a microprocessor controlled unit, foot pedal, electric micromotor, support rods, sterile disposable irrigation tubes, and a peristaltic pump.
No, 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 a patient's body.
- Device Description: The device is a surgical micromotor used in implantology procedures. It involves mechanical action (drilling/preparing bone) and irrigation.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This device does not analyze specimens.
The device is a surgical tool used in vivo (within the living body), not in vitro (in glass/outside the body).
N/A
Intended Use / Indications for Use
The ATR5000, LC5000 and Implant System are intended for the preparation of intra-oral bone for implantology procedures. These ATR Surgical Micromotors are intended to prepare Intraoral bone for implantology procedures.
Product codes
EKX
Device Description
The ATR Surgical Micromotors ATR5000, LC5000 and Implant System, are microprocessor driven surgical micromotors used in implantology procedures. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System consists of a microprocessor controlled unit, foot pedal, electric micromotor, support rods and sterile, disposable irrigation tubes. The units also house the peristaltic pump. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System provide electronic control of velocity and torque. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System can be programmed and retain programs in memory. The ATR Surgical Micromotors ATR5000, LC5000 and Implant System are fully operational from foot pedal.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The ATR 5000, LC 5000 and Implant System were tested in accordance with the technical requirements of UL 2601-1 (IEC 60601-1 with U.S. deviations), IEC 601-1 and IEC 60601-1-2 and successive variants. Whitstanding voltage test and leak current test were performed on devices in conformance with requirements from UL 2601-1. All evaluation of the ATR 5000, LC5000 and Implant System were performed by certified body Laboratory, and all the results comply to standard listed below. Also the predicate device has been evaluated with the same regulation standard. So ATR5000/LC5000 and ATR ImplantSystem and predicate device can be considered substantially equivalent in performance. The conclusions drawn from the performance test are that ATR 5000, LC5000 and Implant System complies with: UL 2601-1 Standard for Medical Electrical Equipment, General requirements . for Safety (IEC 60601-1 with U.S. deviations), UL 601-1 Medical Electrical Equipment, General Requirement for Safety, EMC Conducted RF emissions IEC 55011, Degrees of protection provided by enclosures (IP Code) IEC 60529, IEC 60601-1 Medical Electrical Equipment Part 2, "Genaral Safety Norms", 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, Transformer safety IEC 61558-1, IEC 61558-2-6 Transformer safety-Particular prescriptions, ISO 11498:1997 Dental handpieces Dental low-voltage electrical motors. and are effective and safe to use.
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
NOV 2 5 2003
ATR Surgical Micromotors 510(k): Device Modification
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 SMD 1990 and CFR 807.92.
SUBMITTER INFORMATION 14.1
| a. | Company Name | Advanced Technology Research
(A.T.R.)srl |
|----|------------------------------|----------------------------------------------|
| b. | Company Address | Via del Pescino, 6
51100 PISTOIA
Italy |
| c. | Company phone
Company fax | +39 0573 364 254
+39 0573 364 002 |
| d. | Contact Person | Daniele Poli
President |
| e. | Date Summary Prepared | June 11, 2003 |
DEVICE IDENTIFICATION 14.2
| a. | Trade/Proprietary Names: | ATR5000, LC5000, Implant
System |
|----|--------------------------|------------------------------------------------------|
| b. | Classification Name: | Dental Handpieces and
Accessories 21 CFR 872.4200 |
| c. | Common Names: | Surgical Micromotor for
implantology |
14.3 IDENTIFICATION OF PREDICATE DEVICE
| Company | Device |