(84 days)
The Siemens T1 LINE dental handpieces are intended for use in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.
The Siemens T1 LINE Dental Handpieces are intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings, and for dental cleanings. The devices can be either AC-powered or air-powered. They are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Water delivery has optional one, two, and three spray outlets, and includes a one-way retraction valve to prevent the ingress of external air or liquid when the spray system is not in use. The device can be sterilized by the steam autoclave method.
The provided 510(k) summary for the Siemens T1 LINE Dental Handpieces describes performance testing rather than acceptance criteria and study results in the typical sense of a clinical trial for a diagnostic device. Dental handpieces are Class I devices, which generally have lower regulatory hurdles and typically rely on adherence to established consensus standards and mechanical performance testing rather than clinical effectiveness studies with human subjects.
Here's a breakdown of the information based on the provided text, addressing your questions where applicable and noting when information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a Class I mechanical device, the "acceptance criteria" are compliance with relevant ISO standards and demonstrated durability/sterilization effectiveness.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with ISO Standard 1797-1: Dental Rotary Instruments - Shanks made of metal | "The Siemens T1 LINE Dental Handpieces comply with ISO Standard 1797-1" |
| Compliance with ISO Standard 3964: Dental Handpieces - Coupling dimensions | "The Siemens T1 LINE Dental Handpieces comply with ... ISO Standard 3964" |
| Compliance with ISO 7785-2: Straight and geared angle handpieces | "The Siemens T1 LINE Dental Handpieces comply with ... ISO 7785-2" |
| Sterilization Process Efficacy: Device effectiveness and integrity after repeated sterilization cycles | "Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness following 2000 sterilization cycles." (No specific quantitative results provided in this summary, just that it was validated). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of clinical testing with patients or data. The testing mentioned refers to mechanical and sterilization validation.
- Test set sample size: Not applicable/not specified for clinical data. For the mechanical and sterilization testing, the sample size of handpieces tested is not listed.
- Data provenance: Not applicable for clinical data. The performance testing was conducted by Siemens AG, a German company (Bensheim, Germany).
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The device is a mechanical tool, and its performance is assessed against engineering standards and functional tests, not by expert interpretation of clinical data.
4. Adjudication Method
Not applicable. There is no expert adjudication process described for the mechanical performance testing of the handpiece.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study is relevant for diagnostic devices where human readers interpret medical images or data. This is a mechanical dental tool, and as such, an MRMC study was not performed.
6. Standalone (Algorithm Only) Performance
No. The concept of "standalone performance" typically applies to AI algorithms or diagnostic tools operating without human intervention. This is a physical dental handpiece, so this concept is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Adherence to international engineering standards (ISO 1797-1, 3964, 7785-2).
- Demonstrated functionality and safety (sterilization effectiveness) through laboratory performance testing.
8. Sample Size for the Training Set
Not applicable. There is no mention of a "training set" as this device does not involve machine learning or AI algorithms that require training data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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510(k) SUMMARY SIEMENS AG T1 LINE DENTAL HANDPIEC
DATE PREPARED 1.
June 26, 1997
SUBMITTER 2.
Siemens AG Medical Technology/Dental Systems Fabrikstrasse 31 64625 Bensheim Germany
3. CONTACT
Mr. Hermann Landgraf 011-49-62-5116-2359
DEVICE NAME 4.
Proprietary Name: Common/Usual Name: Classification Name:
T1 LINE Dental Handpieces Dental Handpiece Dental Handpiece
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
DEVICE CLASSIFICATION 5.
Dental handpieces and accessories have been classified under Section 513 of the Act as Class I devices by the Dental Devices Panel.
Classification Regulation: 21 CFR 872.4200 Product Code: 76 EFB
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DEVICE DESCRIPTION AND COMPARISON TO PREDICATE PRODUCTS 6.
The Siemens T1 LINE Dental Handpieces are intended for use in the dental operatory to prepare dental cavities for restorations, such as fillings, and for dental cleanings. The devices can be either AC-powered or air-powered. They are reusable, ergonomically shaped, and are provided both with and without a fiber optic light system. Water delivery has optional one, two, and three spray outlets, and includes a one-way retraction valve to prevent the ingress of external air or liquid when the spray system is not in use. The device can be sterilized by the steam autoclave method.
The Siemens T1 LINE Dental handpieces are similar in design, function, and intended use to other dental handpieces currently in U.S. commercial distribution. Examples of substantially equivalent devices include the A-DEC/W&H Low Speed Handpieces.
PERFORMANCE TESTING 7.
The Siemens T1 LINE Dental Handpieces comply with ISO Standard 1797-1 for Dental Rotary Instruments - Shanks made of metal, ISO Standard 3964 for Dental Handpieces - Coupling dimensions, and ISO 7785-2 for Straight and geared angle handpieces. Additional performance testing was conducted on the device to validate the sterilization process and device effectiveness following 2000 sterilization cycles.
6/27/97
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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 features a stylized depiction of an eagle or bird-like figure, composed of three curved lines that suggest the head, body, and tail feathers. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 2 1997
Diane E. Minear, RAC Senior Staff Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re : K972436 T1 Line Dental Consultants Incorporated Trade Name: Regulatory Class: I Product Code: EFB Dated: June 27, 1997 Received: June 30, 1997
Dear Ms. Minear:
We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may . be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Minear
This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Cluz. L/on
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and -------Radiological Health
Enclosure -----
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510(k) Number (if known): _ K972 Y36
Device Name: T1 LINE DENTAL HANDPIECES
Indications For Use:
The Siemens T1 LINE dental handpieces are intended for use in the dental operatory to prepare dental cavities for restorations such as fillings, and for cleaning teeth.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number .
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Siemens AG--510(k) for T1 Line Dental Handpieces
Page v
§ 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.