(90 days)
The SiroTorque L is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces.
The SiroTorque L is composed of a supply / control unit, supply hoses, connection cables, a transformer and two alternative electric micromotors. The pneumatic outlet from the dental treatment unit, which would be the supply hose for an air-driven instrument (e.g., a high speed handpiece or an air motor), provides the input to the SiroTorque L supply / control unit. The electronic circuitry within the SiroTorque L converts the air pressure input to an electrical signal, which is output to the supply hose for the handpiece electric micromotor. The handpiece electric micromotor is activated using the footswitch of the existing dental operative unit. As the footswitch is pressed farther down, the pressure of the compressed air supply increases, which in turn increases the rotational speed of the micromotor. The permissible speed range is adjustable by the user from 1,000 to 40,000 rpm, although the highest speeds are only attainable if the compressed air supply has a pressure of at least 3 bars. The minimum and maximum speeds are displayed and can be adjusted using the SiroTorque L control panel. The SiroTorque L also provides the user with the following features: Selection of clockwise and counter-clockwise rotation of the dental handpieces, Variable intensity handpiece light, "Satellite" version: The control panel of the SiroTorque L can be separated from the supply / control unit and mounted so as to be more easily accessible for the user.
The provided 510(k) summary for the Sirona Dental Systems SiroTorque L is for a dental handpiece and accessories controller unit, not an AI/ML powered device. Therefore, much of the requested information regarding AI device acceptance criteria and performance evaluation (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and data provenance) is not applicable to this document.
However, I can extract the information that is present and relevant to device performance and substantiation.
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria / Performance Aspect | Reported Device Performance (as stated in the document) |
|---|---|
| Intended Use Equivalence | "substantially equivalent to the Bell International Mark 20 and Mark 25 Hand Engine Controller based on equivalence of the intended uses" |
| Technical Characteristics Equivalence | "substantially equivalent to the Bell International Mark 20 and Mark 25 Hand Engine Controller based on equivalence of...technical characteristics." |
| Safety and Effectiveness Validation | "Performance testing to validate the safety and effectiveness of the SiroTorque L included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions." |
| Pneumatic to Electrical Conversion | Converts pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces. |
| Speed Range | Adjustable by the user from 1,000 to 40,000 rpm. Note: Highest speeds only attainable with compressed air supply of at least 3 bars. |
| Rotation Selection | Provides selection of clockwise and counter-clockwise rotation of the dental handpieces. |
| Handpiece Light | Provides variable intensity handpiece light. |
| Control Panel Flexibility | "Satellite" version allows the control panel to be separated from the supply/control unit and mounted for easier user access. |
Missing/Not Applicable Information (as per AI device context):
Due to the nature of this device (a physical controller for dental handpieces), the following requested information is not relevant or present in the provided 510(k) summary:
- 2. Sample size used for the test set and the data provenance: Not an AI device, so no "test set" of an AI algorithm. Performance testing would have involved physical device testing.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Device functionality is physical, not based on expert-labeled data.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. 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. This is not an AI-assisted diagnostic or interpretative device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of an AI device. "Ground truth" for this device would be its physical specifications and functionality meeting engineering standards.
- 8. The sample size for the training set: Not applicable.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of Device Substantiation:
The Sirona Dental Systems SiroTorque L gains its market clearance based on substantial equivalence to predicate devices (Bell International Mark 20 and Mark 25 Hand Engine Controller). The substantiation largely relies on the equivalence of its intended use and technical characteristics, supported by performance testing covering electrical safety, electromagnetic compatibility, and hardware/software function validation.
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AUG 1 9 2003 510(k) Summary for Sirona Dental Systems SiroTorque L
1. SPONSOR
Sirona Dental Systems GmbH Fabrikstrasse 31 D-64625 Bensheim Germany
Contact Person: Fritz Kolle Telephone: 49 6251 16 32 94
Date Prepared: May 1, 2003
2. Device Name
| Proprietary Name: | SiroTorque L |
|---|---|
| Common/Usual Name: | Energy conversion and controller unit |
| Classification Name: | Dental Handpiece and Accessories |
3. PREDICATE DEVICES
Bell International Mark 20 and Mark 25 Hand Engine Controller (K964860)
INTENDED USE 4.
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 DESCRIPTION ડ.
The SiroTorque L is composed of a supply / control unit, supply hoses, connection cables, a transformer and two alternative electric micromotors. The pneumatic outlet from the dental treatment unit, which would be the supply hose for an air-driven instrument (e.g., a high speed handpiece or an air motor), provides the input to the SiroTorque L supply / control unit. The electronic circuitry within the SiroTorque L
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converts the air pressure input to an electrical signal, which is output to the supply hose for the handpiece electric micromotor.
The handpiece electric micromotor is activated using the footswitch of the existing dental operative unit. As the footswitch is pressed farther down, the pressure of the compressed air supply increases, which in turn increases the rotational speed of the micromotor. The permissible speed range is adjustable by the user from 1,000 to 40,000 rpm, although the highest speeds are only attainable if the compressed air supply has a pressure of at least 3 bars. The minimum and maximum speeds are displayed and can be adjusted using the SiroTorque L control panel.
The SiroTorque L also provides the user with the following features:
- . Selection of clockwise and counter-clockwise rotation of the dental handpieces
- Variable intensity handpiece light .
- "Satellite" version: The control panel of the SiroTorque L can be separated . from the supply / control unit and mounted so as to be more easily accessible for the user
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The SiroTorque L is substantially equivalent to the Bell International Mark 20 and Mark 25 Hand Engine Controller based on equivalence of the intended uses and technical characteristics. Performance testing to validate the safety and effectiveness of the SiroTorque L included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.
Public Health Service
AUG 1 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sirona Dental Systems GmbH C/O Mr. Donald J. Sherratt Responsible Third Party Official Intertek Testing Service 70 Codman Hill Road Boxborough. Massachusetts 01719
Re: K031584
Trade/Device Name: SiroTorque L Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EBW Dated: August 4, 2003 Received: August 6, 2003
Dear Mr. Sherratt:
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.
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 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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Page 2 - Mr. Sherratt
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Susan Runnoe
Susan Runner, DDS, MA Interim 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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510(k) Number (if known):
SiroTorque L__________________________________________________________________________________________________________________________________________________________________ Device Name: ________
Indications for Use:
The SiroTorque L is intended to convert pneumatic output from a dental treatment center to electrical energy for operation of electrically-driven dental handpieces.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ken Maly for MSR
eneral Hospital.
510(k) Number: K031584
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use ______
Sirona Dental Systems 510(k) SiroTorque L
May 1, 2003
§ 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.