Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a mechanical device for cleaning and lubricating dental instruments, with no mention of AI or ML capabilities. The performance studies focus on electrical safety, EMC, software validation (standard for medical devices), biological assessment, risk analysis, and bench testing of mechanical functions. There is no indication of data processing or algorithmic decision-making related to AI/ML.

Therapeutic

No.
This device is described as a maintenance unit for dental and surgical handpieces, turbines, air motors, and air-driven dental scalers, designed to clean and lubricate these instruments. It does not directly treat or diagnose a medical condition in a patient.

Diagnostic

No

This device is for cleaning and lubricating dental and surgical handpieces, not for diagnosing medical conditions or diseases. Its function is maintenance of equipment, not patient assessment.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a physical, electrically and pneumatically driven maintenance device with mechanical functions (rinsing, drying, lubricating). The performance studies include electrical safety, EMC, and bench tests, indicating hardware components. While software validation is mentioned, it's in the context of controlling a physical device, not as the primary or sole component.

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 is for cleaning and lubricating dental and surgical handpieces, turbines, air motors, and air-driven dental scalers. This is a maintenance function for medical devices, not a diagnostic test performed on biological samples.
Device Description: The device description details the mechanical and pneumatic functions of cleaning and lubricating the internal parts of dental instruments. It does not mention any analysis of biological samples.
Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions

The device is clearly intended for the maintenance of dental instruments, which falls under the category of medical device support equipment, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers.

Product codes (comma separated list FDA assigned to the subject device)

EFB

Device Description

The W&H Assistina TWIN MB-302 is an electrically and pneumatically driven maintenance device with the following functions:

Rinsing the spray channels with cleaning solution (water basis) and drying with compressed air.
Lubricating the rotational internal gear parts. The oil is spread and a constant lubrication film is set up.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Electrical Safety Tests according to IEC 61010-1, Safety requirements for electrical equipment for measurement, control and laboratory use – Part 1: General requirements for safety
Electromagnetic Compatibility Test according to IEC 61326-1: Electrical equipment for measurement, control and laboratory use, EMC requirements – Part 1: General requirements for safety
Software validation according to IEC 62304:2006: Medical device software - Part 1: Guidance on the application of ISO 14972 to medical device software
Biological Assessment and Cytotoxicity Testing of the liquids according to EN ISO 10993 was performed. The evaluation meets the requirements.
Risk Analysis according to ISO 14971.
Testing of cleaning performance according to ISO 15883.
Validation of wipe disinfection according to the IFU.
Different Bench Tests like Lifetime tests - Activation of start button, moving/removing of sliding door, Lifecycle test according to internal requirements. The results demonstrate substantial equivalence in this regards.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K081811

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K010127

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 8, 2017

W & H Dentalwerk Buermoos GmbH Mag. Anja Lindner Manager Regulatory Affairs Ignaz-Glaser-StraBe 53 5111 Buermoos AUSTRIA

Re: K171553

Trade/Device Name: W&H Assistina Twin Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: November 7, 2017 Received: November 9, 2017

Dear Mag. 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

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, Mary S. Runner -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

2

Indications for Use

510(k) Number (if known) K171553

Device Name Assistina Twin MB-302

Indications for Use (Describe)

Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers.

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

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 of
Submission | 7th of November, 2017 |
| Device Name | Assistina TWIN MB-302 |
| Classification
Name | Dental Handpieces and Accessories |
| 510(k) number | K171553 |
| Regulation
Number | 21 CFR 872.4200 |
| Regulatory
class | I |
| Product Code | EFB |
| Predicate
Devices | Primary Predicate: "Care3 Plus", NSK.; cleared under K081811
Reference Predicate: Assistina 301+, W&H Dentalwerk Bürmoos, cleared
under K010127.
The predicate has not been subject to a design-related recall. |
| Device
Description | The W&H Assistina TWIN MB-302 is an electrically and pneumatically
driven maintenance device with the following functions:

Rinsing the spray channels with cleaning solution (water basis)
and drying with compressed air.
Lubricating the rotational internal gear parts. The oil is spread
and a constant lubrication film is set up. |

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Image /page/4/Picture/0 description: The image shows a partial view of a graphic with the words "PEOPLE HAVE PRIORITY" in a green box at the top. Below this, there is a gray graphic element that appears to be part of a larger design, possibly a logo or a visual representation of a concept. The text "IORITY" is visible at the bottom, suggesting that it is part of the word "PRIORITY" from the phrase above.

510(k) Summary

		Technical data:
		Assistina TWIN MB-302
		Cycle duration	10 sec.
		Air consumption	Approx. 40 NI/min.
		Operating pressure	5 – 10 bar (controlled via an integrated, automatic pressure controller)
		Supply voltage	100 – 240 VAC
		Max. power consumption	18 VA
		Weight	3,8 kg
		Dimensions	297 x 435 x 190 mm
Indications for Use:	Unit for cleaning the spray channels and lubricating the moving parts of dental and surgical handpieces, turbines, air motors and air-driven dental scalers.
	Item	New device	Predicate device	Judgment
	Name	W&H Assistina TWIN MB-302	NSK Care3 Plus	---
Technological Characteristics	Photo	Image: W&H Assistina TWIN MB-302	Image: NSK Care3 Plus	---
	Where used	Dental practice, dental clinic.	Dental practice, dental clinic.	same
	Manufacturer	W&H Dentalwerk Bürmoos GmbH
www.wh.com	Nakanishi Inc.
www.nsk-inc.com	---
	510(k)	------	K081811	---

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510(k) Summary

| Indication for
Use | Unit for cleaning the spray channels
and lubricating the moving parts of
dental and surgical handpieces,
turbines, air motors and air- driven
scalers. | Care3 Plus is intended for
internal cleaning e.g. purging
of old lubricant, for the
maintenance of rotating
dental and surgical
instruments. | Similar |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Scope of
submission | - Assistina TWIN MB-302
device

```
        Adapter HPI
```
```
        Air supply hose
```
```
        TWIN Care Set (including
```
```
        lubricant, detergent and
```

HEPA filter)

        Power supply unit | -             Care3 unit

```
        AC power cord
```
```
        Maintenance oil
```
```
        Oil supply funnel
```
```
        with filter
```
```
        Mist filter set
```
```
        Air tube
```
```
        Oil absorber sheet
```
```
        O- ring set
```
```
        Test bur
```
```
        Magnet | Similar |
```

Technical Da

Technical Data:
Item	New device
MB-302	Predicate device
Care3 Plus	Judgment
Power
supply	100 – 240 V AC ± 10%	120 – 230 V AC ± 10%	Similar
Power
consumption	18 VA	19.5 VA	Similar
Air pressure	5 – 10 bar	3.5 – 6 bar	Similar*
Cleaning	Clean the process chambers with a dry cloth and wipe- disinfect the exterior and the process chambers.	Not known	Similar

Process liquids:

| | Lubricant | W&H Service Oil F1 MD-
302 (cartridge containing
200ml lubricant)* | NSK maintenance oil
(1 liter bottle) | Similar |
|--|-----------|--------------------------------------------------------------------------|-----------------------------------------|---------|
| | Detergent | W&H Activefluid MC-302
(cartridge containing 200ml
detergent)** | not applicable | --- |

6

510(k) Summary

	301+ only without alcohol and is therefore no dangerous good any more.
	The technical principle is the same as within the predicate device.
The main technological characteristics are the same or, at least, quite
similar to those of the comparable product.
The intended use is identical to the predicate device
Comparison of
the device to
the predicate
device	The target field of application, the intended use, performance parameter
and material are the same or, at least, quite similar to those of the
predicate device.
The only differences are some technological features: different modes,
different number of buttons, different number of chambers.
The predicate device has no cleaning function. However, these
differences do not have any negative effect on the safety and/or
effectiveness of the subject device.
The new device is substantially equivalent to the predicate device.
Performance
Testing	Electrical Safety Tests according to IEC 61010-1, Safety requirements for
electrical equipment for measurement, control and laboratory use – Part
1: General requirements for safety
	Electromagnetic Compatibility Test according to IEC 61326-1: Electrical
equipment for measurement, control and laboratory use, EMC
requirements – Part 1: General requirements for safety
	Software validation according to IEC 62304:2006: Medical device
software - Part 1: Guidance on the application of ISO 14972 to medical
device software
	Biological Assessment and Cytotoxicity Testing of the liquids according
to EN ISO 10993 was performed. The evaluation meets the
requirements.
	Risk Analysis according to ISO 14971.
	Testing of cleaning performance according to ISO 15883.
Validation of wipe disinfection according to the IFU.
	Different Bench Tests like Lifetime tests - Activation of start button,
moving/removing of sliding door, Lifecycle test according to internal
requirements. The results demonstrate substantial equivalence in this
regards.
	Clinical
Testing
Conclusion	W&H considers the Assistina Twin MB-302 to be substantially equivalent
to the predicate device listed above. This conclusion is based on the
similarities in intended use, principles of operation, functional design, and

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510(k) Summary

establishment medical use. Differences between the devices shown in the side-by-side comparison table above are minor and do not have any negative effect on equivalence.