(15 days)
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.
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.
The Bien Air OPTIMA MX is an operative dental unit intended for use in dental restoration, prophylaxis, and endodontic procedures. It provides control for motorized dental handpieces by converting pneumatic output from a dental treatment center.
Here's an analysis of its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The submission doesn't explicitly state "acceptance criteria" but rather presents a comparison to a predicate device (SiroTorque L) to demonstrate substantial equivalence. The implication is that meeting or performing comparably to the predicate device in key performance aspects constitutes acceptance.
| Feature / Performance Metric | Acceptance Criteria (Implied - Comparable to Predicate Device) | Reported Device Performance (OPTIMA MX) |
|---|---|---|
| Intended Use | For dentistry for restoration, prophylaxis, and endodontic procedures, converting pneumatic output to electrical energy for electrically-driven dental handpieces. | 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. (Identical in essence, slightly different wording for conversion mechanism - motorized vs. electrical energy for handpieces). |
| Speed Range | 2,000 - 40,000 rpm | 100 - 40,000 rpm |
| Torque | 2.4 Ncm maximum | 3 Ncm maximum |
| Rotation | Clockwise, counterclockwise | Clockwise, counterclockwise |
| Light | Variable intensity | Variable intensity |
| Cooling Air Requirements | 30 NI/min | 25 NI/min |
| Spray Air Pressure | 39 psi (2.7 bar) | 36 psi (2.5 bar) |
| Spray Water Pressure | 29 psi (2 bar) | 29 psi (2 bar) |
| Motor Length | 60 mm | 69 mm |
| Motor Diameter | 21 mm | 21.2 mm |
| Rotational Speed Control | Good control of speed across the range. | Good control of speed, "slightly better at lower speeds" than the predicate. |
| Torque Curve Trend | Similar torque curve trend to predicate and theoretical. | Torque curves developed for both devices shared a "similar trend." Compared to theoretical, both showed slightly lower torque in the upper range and slightly more in the lower range. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "Performance testing of the OPTIMA MX was conducted to evaluate the rotational speed and torque measurements of the device." This implies a series of measurements, but the number of individual units tested, or the number of measurements taken, is not specified.
- Data Provenance: The testing was conducted internally by Bien Air, Switzerland ("Bien Air SA Switzerland"). The testing appears to be prospective as it was conducted specifically to evaluate the OPTIMA MX against the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a mechanical/electrical unit, and its performance is evaluated against engineering specifications and comparison to a predicate device, not against expert human interpretation or "ground truth" derived from clinical experts in the same way an AI diagnostic tool would be.
4. Adjudication Method for the Test Set
Not applicable. As described above, the performance was measured objectively based on rotational speed and torque, not on subjective assessment requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic imaging device or an AI assistant for human readers. Therefore, an MRMC study is not relevant to its evaluation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in a sense. The performance testing described (rotational speed and torque measurements) represents the standalone performance of the device itself. There isn't a "human-in-the-loop" component in the direct performance evaluation of the motor's speed and torque.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance evaluation is based on:
- Physical Measurements: Objective measurements of rotational speed and torque.
- Engineering Specifications: Comparison against theoretical curves and the specifications of the predicate device.
- Substantial Equivalence: The ultimate "ground truth" for regulatory clearance is demonstrating substantial equivalence to a legally marketed predicate device.
8. The Sample Size for the Training Set
Not applicable. This device does not use machine learning or AI algorithms that require a "training set" in the conventional sense. Its functionality is based on direct engineering design and control systems.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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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 60Case postale 60082500 Bienne 6. Switzerland |
| c. Company Phone:Company Facsimile: | (011) 41 32 344 64 64(011) 41 32 344 64 91 |
| d. Contact Person: | Alain LeonettiRegulatory 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 Unit21 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
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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 SYSTEMSK031584 | |
|---|---|---|
| Device | OPTIMA MX | SIROTORQUE L |
| Indications for Use | The Optima MX is intended for use indentistry for restoration, prophylaxis andendodontic procedures. It provides controlfor motorized dental handpieces byconverting pneumatic output from a dentaltreatment center. | The SiroTorque L is intended to convertpneumatic output from a dental treatmentcenter to electrical energy for operation ofelectrically-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 AirRequirements | 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 |
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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.
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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 & 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.
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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
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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
§ 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.