(90 days)
Not Found
No
The device description focuses on the conversion of pneumatic to electrical energy and basic electronic control of a dental handpiece, with no mention of AI/ML algorithms, data processing for learning, or features typically associated with AI/ML in medical devices.
No
The device converts pneumatic energy to electrical energy for dental handpieces; it does not directly treat a disease or condition.
No
The device is described as converting pneumatic output to electrical energy for dental handpieces and controlling their rotation speed, indicating it is an accessory for operative dental procedures rather than for diagnosis.
No
The device description explicitly states it is composed of hardware components including a supply/control unit, hoses, cables, a transformer, and micromotors, and the performance studies include validation testing of both hardware and software functions.
Based on the provided information, the SiroTorque L is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to convert pneumatic output to electrical energy for operating dental handpieces. This is a mechanical/electrical function related to powering a dental tool, not for examining specimens from the human body.
- Device Description: The description details the components and how it functions to power a dental handpiece. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in specimens
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The SiroTorque L is a device used in a dental setting to facilitate the operation of dental tools. It does not perform any diagnostic testing on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EBW
Device Description
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
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 to validate the safety and effectiveness of the SiroTorque L included electrical safety, electromagnetic compatibility, and validation testing of both hardware and software functions.
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
§ 872.4200 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
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
1
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.
2
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