STATClave G4 Chamber Autoclave

K192910 · Scican , Ltd. · FLE · Jun 19, 2020 · General Hospital

Device Facts

• Record ID: K192910
• Device Name: STATClave G4 Chamber Autoclave
• Applicant: Scican , Ltd.
• Product Code: FLE · General Hospital
• Decision Date: Jun 19, 2020
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6880
• Device Class: Class 2

Intended Use

The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam. It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

Device Story

STATCLAVE G4 is a table-top, dynamic-air-removal (pre-vacuum) steam sterilizer. It uses pressurized steam to sterilize medical and dental instruments. Operated by healthcare providers in clinical settings. Device processes various loads including solid/hollow instruments (wrapped/unwrapped), textiles, and rubber/plastic. User selects cycle based on load type; device executes sterilization at 121°C or 132°C with specific exposure and drying times. Output is sterilized instruments ready for clinical use. Benefits include effective sterilization of reusable medical devices, reducing risk of cross-contamination.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Table-top steam sterilizer; dynamic-air-removal (pre-vacuum) technology. Operates at 121°C or 132°C. Supports various load types (solid, hollow, textile, rubber/plastic) with defined exposure and drying cycles. Connectivity features (G4) for data logging/monitoring.

Indications for Use

Indicated for healthcare providers to sterilize steam-compatible dental and medical instruments, including solid and hollow instruments, textiles, and rubber/plastic items. Not for liquid loads, bio-medical waste, or steam-incompatible materials.

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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June 19, 2020

SciCan Ltd. Teresa Boyce Director of Regulatory Affairs 1440 Don Mills Road Toronto, Ontario, Canada M3B3P9

Re: K192910

Trade/Device Name: STATCLAVE G4 CHAMBER AUTOCLAVE Regulation Number: 21 CFR 880.6880 Regulation Name: Steam Sterilizer Regulatory Class: Class II Product Code: FLE Dated: May 15, 2020 Received: May 20, 2020

Dear Teresa Boyce:

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.

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

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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 (OS) 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.

Christopher K. Dugard, M.S. Assistant Director (acting) 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)

K192910

Device Name STATCLAVE G4 CHAMBER AUTOCLAVE

## Indications for Use (Describe)

The STATCLAVE G4 is a dynamic-air-removal (pre-vacuum) table-top steam sterilizer intended for use by a health care provider to sterilize medical products by means of pressurized steam.

It is suitable for the sterilization of dental and medical instruments that are validated to be steam. The STATCLAVE G4 has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization. The processing of such loads may result in incomplete sterilization and / or damage to the autoclave.

Please refer to the table below for program description, cycle times, temperature and dry times.

| Type of Use (Select one or both, as applicable) | |
|--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|
| <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |

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| PROGRAM | LOAD DESCRIPTION | STERILIZATION<br>TEMPERATURE /<br>EXPOSURE TIME | MINIMUM DRYING<br>TIME** | MAXIMUM<br>LOAD |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------------------------------------------|------------------|
| Solid/Unwrapped | IUSS CYCLE* for unwrapped<br>solid instruments (mirrors,<br>explorers), hinged instruments<br>(hemostats) on trays. | 132°C /270°F for 4<br>minutes | Not applicable | 6.0 Kg /13.2 lbs |
| Solid/Wrapped | Wrapped IMS cassettes with<br>solid instruments, rigid<br>sterilization containers with solid<br>instruments or single pouched<br>solid instruments on a pouch<br>rack. | 132°C /270°F for 4<br>minutes | 35 minutes (up to 6<br>kg / 13.2 lbs of load) | 6.0 Kg /13.2 lbs |
| | | | 25 minutes (up to<br>2.5 kg / 5.5 lbs of<br>load) | |
| | | | 15 minutes (up to<br>1.4 kg / 3 lbs of<br>load**) | |
| Hollow/Unwrapped | IUSS CYCLE* for unwrapped<br>dental handpieces on trays. | 132°C /270°F for 4<br>minutes | Not applicable | 6.0 Kg /13.2 lbs |
| Hollow/Wrapped | Single-pouched dental<br>handpieces on a pouch rack. | 132°C /270°F for 4<br>minutes | 40 minutes (up to<br>3.5 kg / 7.7 lbs of<br>load) | 3.5 kg / 7.7 lbs |
| | | | 25 minutes (up to<br>2.2 kg / 4.8 lbs of<br>load) | |
| | | | 15 minutes (up to<br>1.1 kg / 2.4 lbs of<br>load**) | |
| Textiles/Porous<br>Wrapped | Textiles | 132°C /270°F for 4<br>minutes | 20 minutes | 2.0 Kg /4.4 lbs |
| Rubber & Plastic | IUSS CYCLE* for unwrapped<br>solid or hollow instrument. | 121 °C /250°F for 20<br>minutes | Not applicable | 2.0 Kg /4.4 lbs |

*Immediate Use Steam Sterilization cycle.

**For optimal drying of these loads, use only one pouch rack loaded on the second from top rail.