(273 days)
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No
The document describes a standard autoclave for sterilization and contains no mention of AI, ML, or related concepts.
No
The device is an autoclave, which is used for sterilizing medical and surgical goods. Sterilization is a process that renders items free of microorganisms, which is a necessary step for preventing infection during medical procedures, but the autoclave itself does not directly treat a disease or condition in a patient.
No
This device is an autoclave, used for sterilizing medical and surgical goods. It does not perform any diagnostic functions like detecting, monitoring, or diagnosing diseases or conditions.
No
The device is described as a "table-top autoclave," which is a physical piece of equipment used for sterilization. This indicates it is a hardware device, not software-only.
Based on the provided information, the MOST-T Autoclave is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is designed for sterilizing medical and surgical goods. This is a process performed on instruments and materials, not on biological samples taken from the human body for diagnostic purposes.
- 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.)
- Providing information about a patient's health status, disease, or condition
- Using reagents or assays to detect or measure substances in biological samples
IVDs are devices used to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The MOST-T Autoclave's function is to sterilize equipment, which is a crucial step in preventing the spread of infection in healthcare settings, but it does not perform diagnostic tests.
N/A
Intended Use / Indications for Use
The MOST-T Autoclave is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, medical clinics; and in first aid rooms.
Product codes
FLE
Device Description
The MOST-T Autoclave is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, medical clinics; and in first aid rooms.
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
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Indicated Patient Age Range
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Intended User / Care Setting
ophthalmic, dental, medical clinics; and in first aid rooms.
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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
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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.
October 12, 2022
Shinva Medical Instrument Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technology, Inc. 9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K220102
Trade/Device Name: MOST-T Autoclave Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: September 19, 2022 Received: September 19, 2022
Dear Olivia Meng:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220102
Device Name MOST-T Autoclave
Indications for Use (Describe)
The MOST-T Autoclave is a table-top autoclave designed for sterilizing medical and surgical goods, including both wrapped and unwrapped, solid, hollow, and porous products and goods defined as hollow A (e.g., dental hand pieces; suction pipes) in ophthalmic, dental, medical clinics; and in first aid rooms.
| Cycle name | Exposure
temperature
°C/°F | Numbers of
vacuum
pulses | Exposure
time
(minutes) | Dry time
(minutes) | Applicable load type |
|------------|----------------------------------|--------------------------------|-------------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B134UNIV. | 134/273 | 3 | 4 | 20 | Packaged or unpackaged instrument or textile.
Maximum weight of instrument:
24L:5.5kg ,45L:10.5kg.
Maximum weight of textile:
24L:0.8kg ,45L:1.3kg. |
| B121UNIV. | 121/250 | 3 | 20 | 20 | Packaged or unpackaged instrument or textile.
Maximum weight of instrument:
24L:5.5kg ,45L:10.5kg.
Maximum weight of textile:
24L:0.8kg ,45L:1.3kg. |
| USER | 134/273 | 3 | 4 | 20 | Packaged or unpackaged instrument or textile.
Maximum weight of instrument:
24L:5.5kg ,45L:10.5kg.
Maximum weight of textile:
24L:0.8kg ,45L:1.3kg. |
| N-Quick | 134/273 | 0 | 4 | 1 | Single unwrapped solid instrument |
| B-Quick | 134/273 | 2 | 4 | 1 | Single unwrapped hollow instrument |
| BD Test | 134/273 | 3 | 3.5 | 15 | Bowie Dick Test Pack |
| Leak Test | -- | -- | -- | -- | Empty Chamber |
| Preheat | 134/273 | 0 | 4 | 0.5 | Empty Chamber |
| Drying | -- | -- | -- | -- | Packaged or unpackaged instrument or textile. |
| Cleaning | -- | -- | -- | -- | Empty Chamber |
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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