MN-111

K172825 · W&H Sterilization S.R.L. · FLE · May 30, 2018 · General Hospital

Device Facts

• Record ID: K172825
• Device Name: MN-111
• Applicant: W&H Sterilization S.R.L.
• Product Code: FLE · General Hospital
• Decision Date: May 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The W&H Steam Sterilizer MN-111 is designed for pressurized steam sterilization of medical and pouched dental instruments, including dental handpiece, porous and hollow loads.

Device Story

The W&H Steam Sterilizer MN-111 is a tabletop steam sterilizer used in dental and clinical settings to reprocess medical and dental instruments. It accepts various load types, including pouched instruments, dental handpieces, porous materials, and hollow loads. The device operates by applying pressurized steam at specific temperatures (121°C or 132°C) and durations based on the selected program (e.g., Pouches Heavy Load, Wrapped Cassettes, Low Temperature). The operator selects the appropriate cycle based on load type and weight; the device then executes the sterilization and drying phases. The output is a sterilized instrument set ready for clinical use. This process ensures the elimination of microorganisms, supporting infection control and patient safety during subsequent medical or dental procedures.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Steam sterilizer; utilizes pressurized steam for sterilization. Operates at 250°F (121°C) or 270°F (132°C). Supports various load configurations including pouches, cassettes, and hollow instruments. Dimensions and materials are consistent with standard tabletop steam sterilizer designs for dental/medical instrument reprocessing.

Indications for Use

Indicated for pressurized steam sterilization of medical and pouched dental instruments, including dental handpieces, porous, and hollow loads. Suitable for use in clinical or dental settings for instrument reprocessing.

Regulatory Classification

Identification

A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains 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.

May 30, 2018

W&H Sterilization s.r.l. Marco Parolini QA and RA Manager Via Bolgara, 2 Brusaporto, Italy

Re: K172825

Trade/Device Name: MN-111 Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: April 27, 2018 Received: April 30, 2018

Dear Marco Parolini:

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 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);

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Geeta K. Pamidimukkala -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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## Indications for Use

510(k) Number (if known)

### K172825

Device Name

W&H Steam Sterilizer MN-111

Indications for Use (Describe)

The W&H Steam Sterilizer MN-111 is designed for pressurized steam sterilization of medical and pouched dental instruments, including dental handpiece, porous and hollow loads. Key program features, including sterilization time, temperature and recommended load type are listed in the following table:

| Program | Type of<br>Load and<br>Load weight | Sterilization<br>Temperature | Sterilization<br>Time | Drying Time<br>(recommended) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------|------------------------------|
| Pouches Heavy<br>Load | Instruments<br>and Dental<br>Handpieces<br>up to 18 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches<br>Medium Load | Instruments<br>and Dental<br>Handpieces<br>up to 3 lbs | 270° F (132°C) | 4 minutes | 25 minutes |
| Pouches<br>Large Load | Instruments<br>and Dental<br>Handpieces<br>up to 6 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches<br>&Wrapped<br>Cassettes | Instruments<br>and Dental<br>Handpieces<br>up to 11 lbs | 270° F (132°C) | 4 minutes | 35 minutes |
| Wrapped<br>Cassettes | Instruments<br>and Dental<br>Handpieces<br>up to 14 lbs | 270° F (132°C) | 4 minutes | 40 minutes |
| Low<br>Temperature | Textiles, Up<br>4.4 lbs, or<br>Instruments<br>and Dental<br>Handpieces<br>Requiring<br>Low<br>Temperature<br>up to 5 lbs. | 250° F (121°C) | 30 minutes | 30 minutes |

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

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

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