(128 days)
Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The Implantmed SI-1015 is intended for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue.
The new Implantmed SI-1015 is a redesigned version of the old one.
The submission consists of :
- the control unit,
- a motor with cable with or without light (EM-19 LC/EM-19),
- a wireless or wired foot control (S-NW or S-N2),
- the Osstell Module (SI-SQ)
- and as an attachment the surgical handpieces
- (WS-56 L, WS-75 L, WS-91 L, WS-92 L and S-11 L).
The user can select five different programs. Switching between these programs is performed by foot control or via touch display.
Programs 1-3 are used for adjusting the speed and programs 4-5 are for adjusting the torque.
The control unit is intended to be used with the EM-19 or EM-19 L motor.
The Implantmed SI-1015 will be delivered with software on the control unit.
To run the Implantmed SI-1015 according to its intended use, W&H provides five different surgical handpieces.
This document concerns the 510(k) premarket notification for the "Implantmed SI-1015 incl. Accessories," a dental handpiece and accessories, and not an AI/ML powered device. As such, the concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as accuracy, sensitivity, specificity, and the involvement of ground truth, expert opinions, sample sizes for training/testing, MRMC studies, or standalone algorithm performance) is not applicable here.
Instead, the document focuses on demonstrating substantial equivalence to a previously legally marketed predicate device (Implantmed SI-915/923, cleared under K052741) based on non-clinical performance testing and functional comparison.
Here's a breakdown of the provided information, reinterpreted to align with device performance and comparison for a traditional medical device:
1. Table of Acceptance Criteria and Reported Device Performance (Reinterpreted as comparison to predicate and safety standards)
| Feature/Test | Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance (Implantmed SI-1015) |
|---|---|---|
| Intended Use | Identical to predicate device. | Mechanical drive unit with coolant supply for transmission instruments with ISO 3964 (DIN 13940) compatible coupling system, for use in dental surgery, implantology and maxillofacial surgery (CMF) for treatment of dental hard tissue. (Identical to predicate). |
| Technological Characteristics | Main technological characteristics same or similar to predicate. | Control Unit: Main dimensions: 100x262x291mm (Predicate: 90x252x254mm). Front panel: TFT display with capacitive touch (Predicate: Graphical display without backlighting). Programs: 5 (same as predicate). Irrigation: 100ml/min (same as predicate). Irrigation Tubing can be inserted ergonomically on the unit's side face (Predicate: inserted on front face). |
| Foot Control: Features: 4 buttons for pump on/off, Forward/reverse, Change programs, Motor control (on/off and variable) (all same as predicate). Power supply: wireless via 3xAA batteries (Predicate: wired via cable). | ||
| Motor with cable: Length: 71.65 mm, With LED contacts (Predicate: 75 mm, Without LED contacts). | ||
| W&H SI-SQ (Osstell Module): Connection via USB-cable (Predicate (Osstell ISQ): Stand-alone device). | ||
| Differences noted for Foot Control, Motor, and SI-SQ, but deemed not to raise additional questions regarding substantial equivalence. | ||
| Material Composition | Identical to predicate device. | Control unit housing: plastic material (Same as predicate). |
| Tubing outer sheath: Customer specific (Same as predicate). | ||
| Motor with cable: Stainless steel (Same as predicate). | ||
| Surgical handpieces: Chromium coated steel and chromium coated brass (Same as predicate). | ||
| SI-SQ: Stainless steel (Same as predicate). | ||
| Hygiene/Maintenance | Identical to predicate device. | Lubrication: After max. 30 minutes of use (EM-19 LC/EM-19: No lubrication needed) (Same as predicate). |
| Cleaning: Rinse under demineralized water ( |
§ 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.