(15 days)
Not Found
No
The description focuses on programmable control of motor speed and torque, which is standard functionality for dental handpiece control units and does not indicate the use of AI/ML. There are no mentions of AI, ML, image processing, or data sets for training/testing.
No
The device is a dental unit that controls motorized dental handpieces for restorative, prophylactic, and endodontic procedures, but it does not directly treat or diagnose a disease or condition.
No
The device is intended for dental procedures involving restoration, prophylaxis, and endodontics by controlling motorized dental handpieces. It focuses on functional control like speed and torque, not on detecting, diagnosing, or monitoring medical conditions.
No
The device description explicitly lists hardware components such as a power supply, control unit, hose, and brushless micromotor.
Based on the provided information, the Optima MX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is clearly stated as "for use in dentistry for restoration, phophylaxis and endodontic procedures." These are clinical procedures performed directly on a patient's teeth and surrounding structures.
- Device Description: The device description details components like a power supply, control unit, hose, and brushless micromotor, all designed to control a dental handpiece for mechanical procedures.
- 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, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are specifically designed to perform tests on biological samples outside of the body. The Optima MX is a tool used for direct intervention and manipulation within the oral cavity.
N/A
Intended Use / Indications for Use
The Optima MX is intended for use in dentistry for restoration, phophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
Product codes (comma separated list FDA assigned to the subject device)
EIA
Device Description
The Optima MX dental unit for use in dental restoration, phophylaxis and endodontic procedures. The Optima MX is composed of a power supply, control unit, hose and a brushless micromotor. The control unit is a programmable unit that controls the torque, speed and clockwise or counterclockwise rotation of the motor. The inputs to the control unit are supplied by a color touchscreen on the Optima MX. Inputs can also be made by the foot pedal of the treatment center through the pneumatic outlet. The micromotor is a brushless motor with 4 quadrant speed control. The micromotor has a rotation speed of 100 - 40,000 rpm and can be rotated in a clockwise or counterclockwise direction.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance testing of the OPTIMA MX was conducted to evaluate the rotational speed and torque measurements of the device. This testing was done in comparison to the predicate device, the SiroTorque. Results of the testing showed that the both devices had good control of speed with the OPTIMA MX being slightly better at lower speeds. Torque curves were developed for the tow devices and they were found to share a similar trend. Compared to the theoretical curve, both devices showed a slightly lower torque in the upper range and slightly more torque in the lower range.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.
0
OCT 2 0 2004
Bien Air OPTIMA MX Abbreviated Premarket 510(k) Notification
SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 15:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
SUBMITTER INFORMATION 11:1
| a. Company Name: | Bien Air |
|---|---|
| b. Company Address: | Langasse 60 |
| Case postale 6008 | |
| 2500 Bienne 6. Switzerland | |
| c. Company Phone: | |
| Company Facsimile: | (011) 41 32 344 64 64 |
| (011) 41 32 344 64 91 | |
| d. Contact Person: | Alain Leonetti |
| Regulatory Affairs & Quality Manager | |
| e. Date Summary Prepared: | October 19, 2004 |
DEVICE IDENTIFICATION 15.2.
| a. | Trade/Proprietary Name: | OPTIMA MX |
|---|---|---|
| b. | Classification Name: | Operative Dental Unit |
| 21 CFR 872.6640 | ||
| c. | Common Name: | Operative Dental Unit |
IDENTIFICATION OF PREDICATE DEVICES । ਦੇ ਤੋ
| Company | Device | 510(k) No. | Date Cleared |
|---|---|---|---|
| Sirona Dental Systems | SiroTorque L | K031584 | 08/19/2003 |
DEVICE DESCRIPTION 15.4
The Optima MX dental unit for use in dental restoration, phophylaxis and endodontic procedures. The Optima MX is composed of a power supply, control unit, hose and a brushless micromotor. The control unit is a programmable unit that controls the torque, speed and clockwise or counterclockwise rotation of the motor. The inputs to the control unit are supplied by a color touchscreen on the
1
Bien Air OPTIMA MX
Abbreviated Premarket S10(k) Notification
Optima MX. Inputs can also be made by the foot pedal of the treatment center through the pneumatic outlet. The micromotor is a brushless motor with 4 quadrant speed control. The micromotor has a rotation speed of 100 - 40,000 rpm and can be rotated in a clockwise or counterclockwise direction.
INTENDED USE । ਦੇ ਦ
The OPTIMA MX is intended for use in dentistry for restoration, phophylaxis and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
TECHNOLOGICAL CHARACTERISTICS 15.6
The OPTIMA MX is composed of a control unit, power supply, hose and micromotor. Performance testing was conducted to validate the safety and effectiveness of the OPTIMA MX and included electrical safety, electromagnetic compatibility and validation and verification testing of the software functions. Testing was conducted in accordance with recognized consensus standards.
| | BIEN AIR (Proposed) | SIRONA DENTAL SYSTEMS
K031584 |
|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device | OPTIMA MX | SIROTORQUE L |
| Indications for Use | The Optima MX is intended for use in
dentistry for restoration, prophylaxis and
endodontic procedures. It provides control
for motorized dental handpieces by
converting pneumatic output from a dental
treatment center. | The SiroTorque L is intended to convert
pneumatic output from a dental treatment
center to electrical energy for operation of
electrically-driven dental handpieces |
| Device Components | Control unit with hose and electrical motor | Control unit with hose and electrical motor |
| Speed Range | 100 - 40,000 rpm | 2,000 - 40,000 rpm |
| Torque | 3 Ncm maximum | 2.4 Ncm maximum |
| Rotation | Clockwise, counterclockwise | Clockwise, counterclockwise |
| Light | Variable intensity | Variable intensity |
| Cooling Air
Requirements | 25 NI/min | 30 NI/min |
| Spray Air Pressure | 36 psi (2.5 bar) | 39 psi (2.7 bar) |
| Spray Water Pressure | 29 psi (2 bar) | 29 psi (2 bar) |
| Motor Length | 69 mm | 60 mm |
| Motor Diameter | 21.2 mm | 21 mm |
2
Bien Air OPTIMA MX Abbreviated Premarket 510(k) Notification
PERFORMANCE TESTING 15.7
Performance testing of the OPTIMA MX was conducted to evaluate the rotational speed and torque measurements of the device. This testing was done in comparison to the predicate device, the SiroTorque. Results of the testing showed that the both devices had good control of speed with the OPTIMA MX being slightly better at lower speeds. Torque curves were developed for the tow devices and they were found to share a similar trend. Compared to the theoretical curve, both devices showed a slightly lower torque in the upper range and slightly more torque in the lower range.
15.8 CONCLUSIONS
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. Performance and software evaluations of the OPTIMA MX show that the device performs as intended. Comparison of the OPTIMA MX to the predicate device show that the device is substantially equivalent.
The OPTIMA MX is substantially equivalent to the SiroTorque L based on equivalence of the intended uses, comparison testing and technical characteristics. The OPTIMA MX and the SiroTorque were comparison tested for rotational speed and torque measurement. Both devices were shown to be comparable in speed and torque values.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines representing its wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2004
Bien-Air SA Switzerland C/O Ms. Erin Sparnon Responsible Third Party Official CITECH 5200 Butler Pike Plymouth Meeting, Pennsylvania 19462-1298
Re: K042759
Trade/Device Name: Optima MX Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: October 4, 2004 Received: October 5, 2004
Dear Ms. Sparnon:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becarermined 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 merslate conmisered prior to the have been reclassified in accordance with the provisions of Ameliuments, or to do research Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the stration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting (1 Mrs), it may of bund in the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device can be round there announcements concerning your device in the Federal Register.
4
Page 2 - Ms. Sparnon
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s issualice of a substantes with other requirements
mean that FDA has made a determination that your device Federal agencies mean that FDA has made a decemination that your as ininistered by other Federal agencies.
of the Act or any Federal statutes and regulations administered by segments of the Act of ally rederal statutes and regaratents, including, but not limited to: registration You music comply with an the Fee broq 21 CFR Part 801); good manufacturing practice and listing (21 CFR Fall 807), laboling (21 CFR Pat 820), and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your device to a I his letter will anow you to begin maileding your device of your device to a premarket notification. The PDA miding of oussification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific advice for your do records on the Also, please note the regulation
Please contact the Office of Compliance at (240) 276-0115. Also, please note the V please contact the Other or Ochiphanton (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may outain of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Binary 2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Abbreviated Premarket 510(k) Notification
INDICATION FOR USE
K 04 2759
510(k) Number:
Device Name:
Optima MX
Indications for Use:
The Optima MX is intended for use in dentistry for restoration, phophylaxis and The Optima MX is intended for use in dentify for motorcessed dental handpieces by
endodontic procedures. It provides control for motorcesses by
on and ontic procedures. It pr endodontic procedures. It provides comment center.
converting pneumatic output from a dental treatment center.
Prescription Use _ X OR
Over-The-Counter Use _
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Suvarna
(Division Sign-Off) (Division Sign-Off)
Division of Anesthesiology, General Hospital, Division of Anestheolorology.
Infection Control, Dental Devices
510(k) Number:۔
CONFIDENTIAL