MOST-T Autoclave

K220102 · Shinva Medical Instrument Co., Ltd. · FLE · Oct 12, 2022 · General Hospital

Device Facts

• Record ID: K220102
• Device Name: MOST-T Autoclave
• Applicant: Shinva Medical Instrument Co., Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Oct 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended 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.

Device Story

MOST-T Autoclave is a table-top steam sterilizer for medical/surgical instruments. Device utilizes vacuum pulses and controlled temperature/time cycles to sterilize solid, hollow, and porous loads. Operated by clinical staff in medical, dental, or ophthalmic clinics. Device provides automated cycles (e.g., B134UNIV, B121UNIV, N-Quick, B-Quick) with specific exposure temperatures, vacuum pulses, and drying times. Output is a sterilized instrument load, verified by cycle completion. Benefits include effective decontamination of complex hollow instruments and textiles, supporting infection control protocols in point-of-care settings.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Table-top steam sterilizer. Operates via vacuum-assisted steam sterilization cycles. Features multiple pre-programmed cycles (B-type and N-type) with varying vacuum pulses, exposure temperatures (121°C/134°C), and drying times. Available in 24L and 45L capacities. Connectivity and software details not specified.

Indications for Use

Indicated for sterilization of medical and surgical goods (wrapped/unwrapped, solid, hollow, porous, hollow A) in clinical settings including ophthalmic, dental, medical clinics, and first aid rooms.

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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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.

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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 ([e-mail]) or phone [phone] 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<br>temperature<br>°C/°F | Numbers of<br>vacuum<br>pulses | Exposure<br>time<br>(minutes) | Dry time<br>(minutes) | Applicable load type |
|------------|----------------------------------|--------------------------------|-------------------------------|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| B134UNIV. | 134/273 | 3 | 4 | 20 | Packaged or unpackaged instrument or textile.<br>Maximum weight of instrument:<br>24L:5.5kg ,45L:10.5kg.<br>Maximum weight of textile:<br>24L:0.8kg ,45L:1.3kg. |
| B121UNIV. | 121/250 | 3 | 20 | 20 | Packaged or unpackaged instrument or textile.<br>Maximum weight of instrument:<br>24L:5.5kg ,45L:10.5kg.<br>Maximum weight of textile:<br>24L:0.8kg ,45L:1.3kg. |
| USER | 134/273 | 3 | 4 | 20 | Packaged or unpackaged instrument or textile.<br>Maximum weight of instrument:<br>24L:5.5kg ,45L:10.5kg.<br>Maximum weight of textile:<br>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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