(272 days)
Nouvag AG's ("Nouvag") TCM 3000 and TCM Endo is a microprocessorcontrolled dental hand piece with controlled electric motor-torque. The TCM 3000 and TCM Endo is intended to be used for dental drilling and tightening of the various types of screws during dental implantation and microsurgery.
The TCM 3000's and TCM Endo's primary components are (1) a console; (2) a motor; (3) a microprocessor; (4) a foot pedal; and (5) an electric cord and plug. The TCM 3000 and TCM Endo is not supplied with dental drills or contra-angles or contra-angles torque wrenches, which are also called dental hand pieces. The Micromotor has a standard E-Type coupling that will fit any E-Type hand pieces and contra-angles.
The console houses the microprocessor and the motor. The buttons for setting the motor speed, contra-angle reduction ratio, motor torque are located on the front panel of the console. The buttons that may be used to start and stop the motor and change the cut-direction of the drill also are located on the front panel. The port connections for the contra-angles and the foot pedal and the main power switch are located on the back of the console.
A lever is located on the foot pedal for starting and stopping the motor. For the second version of the foot pedal the lever also can adjust the motor speed. The TCM 3000/Endo contains an audible alarm that sounds when the drill is turning in the reverse- cut direction.
The TCM 3000/Endo requires an AC current of 115V or 230V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is attached to the back of the console.
The provided document is a 510(k) summary for the Nouvag AG's TCM 3000/Endo device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new clinical study data with acceptance criteria and performance results in the way a novel device might. Therefore, many of the requested details about acceptance criteria, study design, and ground truth establishment are not typically found in this kind of regulatory filing.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not contain specific quantitative acceptance criteria or a table of reported device performance in the context of a clinical study. The basis for clearance is "substantial equivalence" to a predicate device, meaning it's demonstrated to be as safe and effective as a device already on the market.
2. Sample Size Used for the Test Set and Data Provenance:
No test set (in the context of a clinical trial for performance evaluation) is mentioned. The submission relies on a comparison of technological characteristics and intended use to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
Not applicable. No ground truth for a test set was established as part of this submission.
4. Adjudication Method for the Test Set:
Not applicable. No test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
Not applicable. This device is a mechanical dental instrument, not an AI or imaging diagnostic tool that would involve human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Not applicable. This device is a physical instrument, not an algorithm.
7. The Type of Ground Truth Used:
Not applicable. The submission is based on substantial equivalence, not on establishing a new ground truth for a novel device's performance. The "ground truth" in this context is the safety and effectiveness of the predicate device, which has a "long history of safe use."
8. The Sample Size for the Training Set:
Not applicable. No training set for an algorithm was used.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. No training set for an algorithm was used.
Summary of Device Acceptance Criteria (Implied by Substantial Equivalence):
While not explicitly stated as "acceptance criteria," the submission argues that the TCM 3000/Endo meets the following for substantial equivalence to the NOUVAG's Micro-Dispenser 7000 and 8000 (K954722):
| Criterion Category | Implied Acceptance |
|---|---|
| Intended Use | The device is substantially equivalent if its intended use is for "microprocessor-controlled dental drilling and torque-controlled system," similar to the predicate. |
Reported Performance/Claim: "The TCM 3000/Endo and the Micro-Dispenser 7000/8000 have the same general intended use: microprocessor-controlled dental drilling and torque-controlled system." |
| Indications for Use | The device is substantially equivalent if its indications are similar to the predicate, specifically for "dental implantation and microsurgery."
Reported Performance/Claim: "These devices also have very similar indications: dental implantation and oral or microsurgery." |
| Technological Characteristics | The device is substantially equivalent if its primary components (console, motor, microprocessor, foot pedal, electric cord), standard E-Type coupling, and operational features (buttons for speed/ratio/torque, start/stop, cut-direction, audible alarm for reverse operation, AC current requirement) are similar to the predicate. Minor differences should not raise new safety or effectiveness concerns.
Reported Performance/Claim: "The TCM 3000/Endo and the Micro-Dispenser have very similar technological characteristics. More specifically, these dental drilling systems have the following features: (1) buttons on the console... (2) a foot pedal... (3) motor torques that are preset... (4) safety-overload protection; and (5) they require AC current. Both are microprocessor controlled. Neither device is supplied with drills or contra-angles. Both devices can be used with any E-type contra-angles. Although there are some minor differences in their technological characteristics... These differences do not present any new issues of safety or effectiveness." |
| Principles of Operation | The device is substantially equivalent if its operational principles—setting motor speed, contra-angle reduction ratio, motor torque, AS-Torque-Driver Mode, starting/stopping with foot pedal/buttons, forward/reverse cut direction—are similar to the predicate.
Reported Performance/Claim: "In addition, these devices have the same principles of operation. The operator of the device sets the motor speed, contra-angle reduction ratio, and the torque-levels and operates the drill by pushing buttons on the console or on the foot pedal." |
| Safety and Effectiveness | The device is substantially equivalent if its safety and effectiveness are based on the predicate device's established record, and any differences do not raise new safety or effectiveness concerns.
Reported Performance/Claim: "The safety or effectiveness of the TCM 3000/Endo is based on the safety or efficacy of the predicate device... These differences do not present any new issues of safety or effectiveness. Thus, the TCM 3000/Endo is substantially equivalent to the Micro-Dispenser 7000/8000." Bio-compatibility of non-supplied components (drills, contra-angles) is covered by their "long history of safe use." |
Study Proving Device Meets Acceptance Criteria:
The "study" that proves the device meets the acceptance criteria is a comparison to a predicate device (NOUVAG's Micro-Dispenser 7000 and 8000, K954722) to establish substantial equivalence. This is a regulatory pathway that relies on demonstrating that the new device has the same intended use, similar technological characteristics, and similar principles of operation as a legally marketed predicate device, and does not raise new questions of safety or effectiveness.
Key conclusions from the submission:
- The TCM 3000/Endo is declared substantially equivalent to the predicate device because:
- They share the same general intended use and very similar indications.
- They have very similar technological characteristics (e.g., microprocessor-controlled, buttons for settings, foot pedal, safety features, E-type compatibility, AC current).
- They operate on the same principles.
- Minor differences (e.g., specific contra-angle reduction-ratios, pre-selectable torque levels, irrigation pump, foot control variation) do not introduce new issues of safety or effectiveness.
- The biocompatibility of components (drills and contra-angles) not supplied with the device is addressed by their "long history of safe use."
In essence, the "study" is the 510(k) submission itself, which systematically compares the new device to the predicate across various attributes to demonstrate that it meets the regulatory standard of substantial equivalence. This is not a clinical trial in the traditional sense, but rather a regulatory assessment.
§ 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.