(254 days)
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Not Found
No
The summary describes a steam sterilizer with pre-defined sterilization programs based on load type and weight. There is no mention of adaptive learning, data analysis for decision making, or any other characteristics typically associated with AI/ML.
No
The device is described as a steam sterilizer for medical and dental instruments, indicating it is used for disinfection and not for directly treating a medical condition or disease.
No
This device is a steam sterilizer designed to sterilize medical instruments, not to diagnose medical conditions.
No
The device description is not available, but the intended use clearly describes a physical steam sterilizer (W&H Steam Sterilizer MN-111) designed for sterilizing medical and dental instruments. This indicates a hardware device, not software only.
Based on the provided information, the W&H Steam Sterilizer MN-111 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed for the "pressurized steam sterilization of medical and pouched dental instruments, including dental handpiece, porous and hollow loads." This is a process for making medical devices safe for reuse, not for performing tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, 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's function is to sterilize instruments, which is a crucial step in infection control within a healthcare setting, but it does not perform diagnostic testing.
N/A
Intended Use / Indications for 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. Key program features, including sterilization time, temperature and recommended load type are listed in the following table:
| Program | Type of Load and Load weight | Sterilization Temperature | Sterilization Time | Drying Time (recommended) |
|---|---|---|---|---|
| Pouches Heavy Load | Instruments and Dental Handpieces up to 18 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches Medium Load | Instruments and Dental Handpieces up to 3 lbs | 270° F (132°C) | 4 minutes | 25 minutes |
| Pouches Large Load | Instruments and Dental Handpieces up to 6 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches & Wrapped Cassettes | Instruments and Dental Handpieces up to 11 lbs | 270° F (132°C) | 4 minutes | 35 minutes |
| Wrapped Cassettes | Instruments and Dental Handpieces up to 14 lbs | 270° F (132°C) | 4 minutes | 40 minutes |
| Low Temperature | Textiles, Up 4.4 lbs, or Instruments and Dental Handpieces Requiring Low Temperature up to 5 lbs. | 250° F (121°C) | 30 minutes | 30 minutes |
Product codes
FLE
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6880 Steam sterilizer.
(a)
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.(b)
Classification. Class II (performance standards).
0
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);
1
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,
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
2
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
Load and
Load weight | Sterilization
Temperature | Sterilization
Time | Drying Time
(recommended) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------|-----------------------|------------------------------|
| Pouches Heavy
Load | Instruments
and Dental
Handpieces
up to 18 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches
Medium Load | Instruments
and Dental
Handpieces
up to 3 lbs | 270° F (132°C) | 4 minutes | 25 minutes |
| Pouches
Large Load | Instruments
and Dental
Handpieces
up to 6 lbs | 270° F (132°C) | 4 minutes | 30 minutes |
| Pouches
&Wrapped
Cassettes | Instruments
and Dental
Handpieces
up to 11 lbs | 270° F (132°C) | 4 minutes | 35 minutes |
| Wrapped
Cassettes | Instruments
and Dental
Handpieces
up to 14 lbs | 270° F (132°C) | 4 minutes | 40 minutes |
| Low
Temperature | Textiles, Up
4.4 lbs, or
Instruments
and Dental
Handpieces
Requiring
Low
Temperature
up to 5 lbs. | 250° F (121°C) | 30 minutes | 30 minutes |
3
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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