Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on mechanical and software control of speed and torque, not AI/ML capabilities.

Therapeutic

Yes

The device is intended for "treatment of dental hard tissue," which implies a therapeutic purpose.

Diagnostic

No

The device is described as a mechanical drive unit for dental surgery, implantology, and maxillofacial surgery (CMF) used for treating dental hard tissue, which points to a treatment function rather than a diagnostic one. While it includes an "Osstell Module (SI-SQ)", which might be associated with diagnostic functions (as suggested by the reference to "Osstell ISQ Implant Stability Meter"), the overall description and stated intended use of the device itself is focused on mechanical operations for treatment.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a control unit, motor, foot control, Osstell Module, and surgical handpieces. While it mentions software on the control unit, it is clearly part of a larger hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for "treatment of dental hard tissue" in dental surgery, implantology, and maxillofacial surgery. This describes a surgical procedure performed directly on the patient's body.
Device Description: The description details a mechanical drive unit, motor, foot control, and surgical handpieces. These are all components used in a surgical procedure. While it includes an "Osstell Module (SI-SQ)", which is related to implant stability measurement (often involving resonance frequency analysis), the primary function of the overall device is the mechanical drive for surgical instruments.
Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body in vitro (outside the body) to provide information for diagnosis, monitoring, or compatibility testing.

IVD devices are specifically designed to test samples like blood, urine, tissue, etc., to provide diagnostic information. This device is a surgical tool used for treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes

EBW

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

dental hard tissue

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dental practice, dental clinic

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

Performance Testing:
Electrical Safety Tests according to IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
Electromagnetic Compatibility Test according to IEC 60601-1-2:2007: General requirement for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
Product testing of handpiece function and lifecycle testing were performed per ISO 14457:2012: Dentistry – Handpieces and Motors. The results demonstrate substantial equivalence in this regard.
Software validation according to IEC 62304:2006: Medical device software – Part 1: Guidance on the application of ISO 14972 to medical device software
Thermal safety according to the standard IEC 62471:2006: Photobiological safety of lamps and lamp systems
Evaluation of biocompatibility is based upon the fact that patient contacting materials in the subject handpiece are identical to those in the previously W&H surgical handpieces K011061 and K080939, which, as handpieces, present the same level and duration of contact. In addition, Cytotoxicity Testing per EN ISO 10993-5:2009-06 was performed. This evaluation meets the requirements of ISO 7405:2008 for preclinical evaluation of biocompatibility of dental devices.
For the new wireless foot control (S-NW) software verification/validation of the functions of the foot control was conducted according to IEC 62304:2006. Additionally, EMC testing was performed to evaluate the risk of communication loss according to IEC 60601-1-2:2007 and Electrical Safety Tests have been done according to IEC 60601-1-1:2005.

Clinical Testing: Not Found

Key results: Not Found

Key Metrics

Not Found

Predicate Device(s)

K052741

Reference Device(s)

K082523, K011061, K080939

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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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

1

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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
Ignaz-Glaser-Strasse 53
A - 5111 Bürmoos
Austria
Tel.: 0043 -6274 / 6236 -397
Fax: 0043 -6274 / 6236 -55 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration
Number | 9681479 |
| Contact
Person | Mag. Anja LINDNER |
| Date Summary
was Prepared | 21st of November, 2016 |
| Device Name | Implantmed SI-1015 incl. Accessories |
| Classification
Name | Dental Handpiece and Accessories |
| Common/Usual
Name | Controller, Foot, Handpiece and Cord |
| Regulation
Number | 21 CFR 872.4200 |
| Regulatory
class | I |
| Product Code | EBW |
| Predicate
Devices | Primary Predicate:
"Implantmed SI-915/923", W&H Dentalwerk Bürmoos GmbH; cleared
under K052741 |
| | Reference devices for the accessories:
"Osstell ISQ Implant Stability Meter", Osstell®; cleared via K082523 |
| | „Surgical contra-angle handpieces”, W&H Dentalwerk, Bürmoos; cleared
under K011061 and K080939 |
| | The predicate has not been subject to a design-related recall. |

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Image /page/4/Picture/0 description: The image shows a logo with the letters "W&H" inside a gray, rounded hexagon. Above the logo is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The logo is simple and modern, with a focus on the company's initials and a statement about its values.

| Device
Description | 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. | | |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|----------------|
| 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
Use: | Implantmed SI-1015 (incl. EM-19/EM-19 L):
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. | | |

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Image /page/5/Picture/0 description: The image shows a logo with the text "W&H" inside a hexagon. Above the logo, there is a green banner with the text "PEOPLE HAVE PRIORITY" in white letters. The logo and banner are set against a light gray background.

	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
Bürmoos GmbH	W&H Dentalwerk
Bürmoos GmbH	-
Where used	Dental practice, dental
clinic	Dental practice, dental
clinic	none
Technological
Characteristics	Indications
for use	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.	Mechanical drive unit
with coolant supply for
transmission
instruments with
coupling system
according to ISO 3964
(Din 13.940) The
equipment is a drive
unit for use in dental
surgery, implantology
and maxilla-facial
surgery for treatment of
dental hard tissue.	none
	Control Unit	Main dimensions:
100x262x291mm
Front panel:
TFT display with
capacitive touch
Programs:
5 programs for various
stages of implantology
Irrigation:
100ml/min.	Main dimensions:
90x252x254mm
Front panel:
Graphical display
without backlighting
Programs:
5 programs for various
stages of implantology
Irrigation:
100ml/min.	none

	Irrigation Tubing can
be inserted
ergonomically on the
unit's side face	inserted on the unit's
front face
	Main dimension:
154x202x210	Main dimension:
215x190x40 (without
cable)
Foot Control	Features:
4 buttons for pump
on/off
Forward/reverse
Change programs	Features:
4 buttons for pump
on/off
Forward/reverse
Change programs	Yes,
the power supply of
the new Implantmed is
performed via wireless
foot control not via
cable.

                                                                                                                                                                                                                                                                                                            |              |  |

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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
housing	plastic material	plastic material	None
Tubing outer
sheath	Customer specific	Customer specific	None
Motor with cable	Stainless steel	Stainless steel	None
Surgical
handpieces	Chromium coated steel and
chromium coated brass	Chromium coated steel and
chromium coated brass	None
	SI-SQ	Stainless steel	Stainless steel	None
	Hygiene / Maintenance
Surgical Handpieces (WS-56 L, WS-75 L, S-11 L, WS-91 L, WS-92 L), EM-19, EM-19 LC
and SI-SQ
	Item	New device	Predicate device	Difference
	Lubrication	after max. 30 minutes of use
EM-19 LC/ EM-19:
No lubrication is needed	after max. 30 minutes of use
Motor with cable:
No lubrication is needed	None
	Cleaning	rinse under demineralized
water (