W&H Implantmed SI-1015 incl. Accessories

K161957 · W&H Dentalwerk Burmoos GmbH · EBW · Nov 23, 2016 · Dental

Device Facts

• Record ID: K161957
• Device Name: W&H Implantmed SI-1015 incl. Accessories
• Applicant: W&H Dentalwerk Burmoos GmbH
• Product Code: EBW · Dental
• Decision Date: Nov 23, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Implantmed SI-1015 is a mechanical drive unit for dental surgery, implantology, and CMF procedures. System components include a control unit with a TFT capacitive touch display, an electric motor (EM-19/EM-19 LC), a wireless or wired foot control, an Osstell module (SI-SQ) for implant stability measurement, and various surgical handpieces. The device is operated by dental professionals in clinics. Users select from five programs to adjust speed and torque; switching is performed via foot control or touch display. The control unit provides irrigation (100ml/min) and drives the handpiece. The device facilitates precise control of surgical instruments, aiding in dental hard tissue treatment and implant placement. The wireless foot control improves ergonomics. The integrated Osstell module allows for implant stability assessment. The device benefits patients by providing a controlled, efficient, and stable surgical environment for dental and maxillofacial interventions.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), handpiece function and lifecycle testing (ISO 14457), software validation (IEC 62304), thermal safety (IEC 62471), and biocompatibility testing (EN ISO 10993-5, ISO 7405).

Technological Characteristics

Control unit with TFT capacitive touch display; electric motor with LED contacts; wireless/wired foot control; irrigation system (100ml/min). Materials: plastic housing, stainless steel motor, chromium-coated steel/brass handpieces. Standards: IEC 60601-1, IEC 60601-1-2, ISO 14457, IEC 62304, IEC 62471, EN ISO 10993-5. Sterilization: steam (dynamic-air-removal or gravity displacement).

Indications for Use

Indicated for use in dental surgery, implantology, and maxillofacial surgery (CMF) for the treatment of dental hard tissue in patients requiring such procedures.

Regulatory Classification

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.

Predicate Devices

• Implantmed SI-915/923 (K052741)

Reference Devices

• Osstell ISQ Implant Stability Meter (K082523)
• Surgical contra-angle handpieces (K011061)
• Surgical contra-angle handpieces (K080939)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 23, 2016

W&H Dentalwerk Bürmoos GmbH Anja Lindner Mag., Regulatory Affairs Ignaz-Glaser-Straße 53 Buermoos, Salzburg 5111 Austria

Re: K161957

Trade/Device Name: Implantmed SI-1015 incl. Accessories Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EBW

Dated: October 24, 2016 Received: October 27, 2016

Dear Anja Lindner:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Indications for Use Statement

### Indications for Use

510(k) number:

K161957

Device Name:

Implantmed SI-1015 incl. Accessories

Indication for Use:

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.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over The Counter Use (Part 21 CFR 807 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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## 510(k) SUMMARY

| Submitter | W & H DENTALWERK BÜRMOOS GMBH<br>Ignaz-Glaser-Strasse 53<br>A - 5111 Bürmoos<br>Austria<br>Tel.: [phone]<br>Fax: [phone] / 6236 -55 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration<br>Number | 9681479 |
| Contact<br>Person | Mag. Anja LINDNER |
| Date Summary<br>was Prepared | 21st of November, 2016 |
| Device Name | Implantmed SI-1015 incl. Accessories |
| Classification<br>Name | Dental Handpiece and Accessories |
| Common/Usual<br>Name | Controller, Foot, Handpiece and Cord |
| Regulation<br>Number | 21 CFR 872.4200 |
| Regulatory<br>class | I |
| Product Code | EBW |
| Predicate<br>Devices | Primary Predicate:<br>"Implantmed SI-915/923", W&H Dentalwerk Bürmoos GmbH; cleared<br>under K052741 |
| | Reference devices for the accessories:<br>"Osstell ISQ Implant Stability Meter", Osstell®; cleared via K082523 |
| | „Surgical contra-angle handpieces”, W&H Dentalwerk, Bürmoos; cleared<br>under K011061 and K080939 |
| | The predicate has not been subject to a design-related recall. |

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| Device<br>Description | The Implantmed SI-1015 is intended for use in dental surgery, implantology and<br>maxillofacial surgery (CMF) for treatment of dental hard tissue.<br>The new Implantmed SI-1015 is a redesigned version of the old one.<br>The submission consists of :<br>- the control unit,<br>- a motor with cable with or without light (EM-19 LC/EM-19),<br>- a wireless or wired foot control (S-NW or S-N2),<br>- the Osstell Module (SI-SQ)<br>- and as an attachment the surgical handpieces<br>- (WS-56 L, WS-75 L, WS-91 L, WS-92 L and S-11 L).<br>The user can select five different programs. Switching between<br>these programs is performed by foot control or via touch display.<br>Programs 1-3 are used for adjusting the speed and programs<br>4-5 are for adjusting the torque.<br>The control unit is intended to be used with the EM-19 or EM-19 L motor.<br>The Implantmed SI-1015 will be delivered with software on the control unit.<br>To run the Implantmed SI-1015 according to its intended use, W&H provides<br>five different surgical handpieces. | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------|
| Type | Transmission ratio | Max. speed | Max. torque |
| WS-56 L | 1:1 | 50,000 | not applicable |
| WS-75 L | 20:1 | 50,000 | 70 Ncm |
| WS-91 L | 1:2.7 | 50,000 | not applicable |
| WS-92 L | 1:2.7 | 50,000 | not applicable |
| S-11 L | 1:1 | 50,000 | not applicable |
| Indications for<br>Use: | Implantmed SI-1015 (incl. EM-19/EM-19 L):<br>Mechanical drive unit with coolant supply for transmission instruments with ISO<br>3964<br>(DIN 13940) compatible coupling system, for use in dental surgery, implantology<br>and maxillofacial surgery (CMF) for treatment of dental hard tissue. | | |

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| | General specification SI-1015 incl. Accessories | | | | |
|---------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|--|
| Item | New device | predicate device | Difference | | |
| Picture | Image: Implantmed SI-1015 | Image: Implantmed SI-915/923 | - | | |
| Name | Implantmed SI-1015 | Implantmed SI-915/923 | - | | |
| Manufacturer | W&H Dentalwerk<br>Bürmoos GmbH | W&H Dentalwerk<br>Bürmoos GmbH | - | | |
| Where used | Dental practice, dental<br>clinic | Dental practice, dental<br>clinic | none | | |
| Technological<br>Characteristics | Indications<br>for use | Mechanical drive unit<br>with coolant supply for<br>transmission<br>instruments with ISO<br>3964 (DIN 13940)<br>compatible coupling<br>system, for use in<br>dental surgery,<br>implantology and<br>maxillofacial surgery<br>(CMF) for treatment of<br>dental hard tissue. | Mechanical drive unit<br>with coolant supply for<br>transmission<br>instruments with<br>coupling system<br>according to ISO 3964<br>(Din 13.940) The<br>equipment is a drive<br>unit for use in dental<br>surgery, implantology<br>and maxilla-facial<br>surgery for treatment of<br>dental hard tissue. | none | |
| | Control Unit | Main dimensions:<br>100x262x291mm<br>Front panel:<br>TFT display with<br>capacitive touch<br>Programs:<br>5 programs for various<br>stages of implantology<br>Irrigation:<br>100ml/min. | Main dimensions:<br>90x252x254mm<br>Front panel:<br>Graphical display<br>without backlighting<br>Programs:<br>5 programs for various<br>stages of implantology<br>Irrigation:<br>100ml/min. | none | |
| | | | | | |
| | Irrigation Tubing can<br>be inserted<br>ergonomically on the<br>unit's side face | inserted on the unit's<br>front face | | | |
| | Main dimension:<br>154x202x210 | Main dimension:<br>215x190x40 (without<br>cable) | | | |
| Foot Control | Features:<br>4 buttons for pump<br>on/off<br>Forward/reverse<br>Change programs | Features:<br>4 buttons for pump<br>on/off<br>Forward/reverse<br>Change programs | Yes,<br>the power supply of<br>the new Implantmed is<br>performed via wireless<br>foot control not via<br>cable.<br> | | |
| | Motor control (on/off<br>and variable) | Motor control (on/off<br>and variable) | | | |
| | Power supply:<br>wireless<br>via 3xAA batteries | Power supply:<br>wired<br>via cable | | | |
| Motor<br>with<br>cable | Length:<br>71,65 mm<br>With LED contacts | Length:<br>75 mm<br>Without LED contacts | Yes,<br>the new motor with<br>LED contacts (EM-19<br>LC) disposes of better<br>lightning at a lower<br>temperature as the<br>energy transfer is<br>provided via direct<br>voltage supply and not<br>via generator any<br>more. However, this<br>does not raise any<br>additional questions<br>regarding substantial<br>equivalence.<br> | | |
| SI-SQ | W&H SI-SQ:<br>Connection via USB-<br>cable | Osstell ISQ:<br>Stand-alone device | Yes, the Osstell ISQ is<br>already cleared for<br>market (K082523). The<br>W&H SI-SQ has the<br>same intended use,<br>consists of the same<br>materials and is<br>sterilized the same<br>way as the Osstell<br>ISQ. The only<br>differences are the<br>labeling (W&H) and<br>the connection - as the<br>SI-SQ is no stand-<br>alone device.<br>However, this does not<br>raise any additional<br>questions regarding<br>substantial | | |
| | | | | equivalence. | |
| | | Technical data/Functions<br>Implantmed SI-1015 | | | |
| New Device | | | Predicate Device | Difference | |
| Max.<br>mechanical<br>output<br>power | 80 W | | 70 W | Yes5 | |
| Torque at<br>the motor | 6.2 Ncm | | 5.5 Ncm | Yes5 | |
| Speed range<br>of motor | 200 – 40,000 rpm | | 200 – 40,000 rpm | None | |
| Supply<br>voltage | 100-130 VAC | | 100-130 VAC | None | |
| Rated<br>current | 0.3 - 1.6 A | | 0.2 - 1.6 A | None | |
| Frequency | 50-60 Hz | | 50-60 Hz | None | |

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lt allows in its program 4 to adjust torque values up to 80 Ncm (which are needed for implant systems) - instead of previous maximum of 50 Ncm.

This does not lead to any negative effect regarding substantial equivalence because of the constructive power reserves of the motor (no big difference between 5.5 Ncm – 6.2 Ncm for the motor).

| Materials | | | | |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-------------------------------------------------------------------------------|------------|
| Item | New device | Predicate device | Difference | |
| Control unit<br>housing | plastic material | plastic material | None | |
| Tubing outer<br>sheath | Customer specific | Customer specific | None | |
| Motor with cable | Stainless steel | Stainless steel | None | |
| Surgical<br>handpieces | Chromium coated steel and<br>chromium coated brass | Chromium coated steel and<br>chromium coated brass | None | |
| | SI-SQ | Stainless steel | Stainless steel | None |
| | Hygiene / Maintenance<br>Surgical Handpieces (WS-56 L, WS-75 L, S-11 L, WS-91 L, WS-92 L), EM-19, EM-19 LC<br>and SI-SQ | | | |
| | Item | New device | Predicate device | Difference |
| | Lubrication | after max. 30 minutes of use<br>EM-19 LC/ EM-19:<br>No lubrication is needed | after max. 30 minutes of use<br>Motor with cable:<br>No lubrication is needed | None |
| | Cleaning | rinse under demineralized<br>water (< 38°C/100°F) with<br>aid of brush | rinse under demineralized<br>water<br>(< 38°C/100°F) with aid of<br>brush | None |
| | Disinfection | wiping disinfection using<br>disinfectant cloths | wiping disinfection using<br>disinfectant cloths | None |
| | Sterilization | Dynamic-air-removal<br>sterilizers: 270°F (132°C)<br>for 4 minutes or | Dynamic-air-removal<br>sterilizers: 270°F (132°C) for<br>4 minutes or | None |
| | | Gravity displacement<br>sterilizers:<br>270°F (132°C) for 15<br>minutes | Gravity displacement<br>sterilizers:<br>270°F (132°C) for 15 minutes | |
| | W&H's Implantmed SI-1015 represents a redesigned and improved<br>version of the predicate device.<br>The technical principle is the same as within the predicate device.<br>The main technological characteristics are the same or, at least, quite similar to<br>those of the comparable product.<br>The Indications for Use statement for the Implantmed SI-1015 is<br>identical to the predicate device. | | | |
| Comparison of<br>the device to<br>the predicate<br>device | The target field of application, the intended use, functions and<br>technological features, performance parameter and material are the same or,<br>at least, quite similar to those of the predicate device.<br>The new device is substantially equivalent to the predicate device. | | | |

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# Implantmed SI-1015 incl. Accessories

Section 5 Page 6 of 7

510(k) Summary

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| Performance<br>Testing | Electrical Safety Tests according to IEC 60601-1:2005, Medical electrical<br>equipment<br>– Part 1: General requirements for basic safety and essential performance. |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Electromagnetic Compatibility Test according to IEC 60601-1-2:2007:<br>General requirement for basic safety and essential performance –<br>Collateral standard: Electromagnetic compatibility – Requirements and tests |
| | Product testing of handpiece function and lifecycle testing were performed<br>per ISO 14457:2012: Dentistry – Handpieces and Motors.<br>The results demonstrate substantial equivalence in this regard. |
| | Software validation according to IEC 62304:2006: Medical device software –<br>Part 1:<br>Guidance on the application of ISO 14972 to medical device software |
| | Thermal safety according to the standard IEC 62471:2006:<br>Photobiological safety of lamps and lamp systems |
| | Evaluation of biocompatibility is based upon the fact that patient<br>contacting materials in the subject handpiece are identical to those in the<br>previously W&H surgical handpieces K011061 and K080939, which, as<br>handpieces,<br>present the same level and duration of contact.<br>In addition, Cytotoxicity Testing per EN ISO 10993-5:2009-06 was performed.<br>This evaluation meets the requirements of ISO 7405:2008 for preclinical<br>evaluation of biocompatibility of dental devices. |
| | For the new wireless foot control (S-NW) software verification/validation of the<br>functions of the foot control was conducted according to IEC 62304:2006.<br>Additionally, EMC testing was performed to evaluate the risk of communication<br>loss according to IEC 60601-1-2:2007 and Electrical Safety Tests have been<br>done according to IEC 60601-1-1:2005. |
| | Clinical<br>Testing |
| Conclusion | W&H considers the “Implantmed SI-1015 incl. Accessories” to be<br>substantially equivalent to the predicate devices listed above. This conclusion is<br>based on the similarities in intended use, principles of operation, functional<br>design, and establishment medical use. Differences between the devices shown<br>in the side-by-side comparison table above are minor and do not have any<br>negative effect on equivalence. |