(192 days)
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.
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The provided text describes a steam sterilizer (STATCLAVE G4 Chamber Autoclave), not an AI-powered medical device that requires a study to prove its performance based on AI/human interaction, ground truth, or statistical metrics like sensitivity/specificity.
Therefore, many of the requested categories are not applicable. I will extract the relevant information regarding the device's performance based on the provided text.
Here's the information as applicable:
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A table of acceptance criteria and the reported device performance
The device's performance is described by its sterilization programs, temperatures, exposure times, and minimum drying times for various load types. This constitutes the operational criteria and expected performance.
Program Load Description Sterilization Temperature / Exposure Time Minimum Drying Time** Maximum Load Reported Device Performance (Operational Parameters) Solid/Unwrapped IUSS CYCLE* for unwrapped solid instruments (mirrors, explorers), hinged instruments (hemostats) on trays. 132°C / 270°F for 4 minutes Not Applicable 6.0 Kg / 13.2 lbs Meets the specified temperature and time for sterilization. Solid/Wrapped Wrapped IMS cassettes with solid instruments, rigid sterilization containers with solid instruments or single-pouched solid instruments on a pouch rack. 132°C / 270°F for 4 minutes 25 minutes (up to 6 kg / 13.2 lbs)15 minutes (up to 1.4 kg / 3 lbs**) 6.0 Kg / 13.2 lbs Meets the specified temperature, time, and drying for sterilization. Hollow/Unwrapped IUSS CYCLE* for unwrapped dental handpieces on trays. 132°C / 270°F for 4 minutes Not Applicable 6.0 Kg / 13.2 lbs Meets the specified temperature and time for sterilization. Hollow/Wrapped Single-pouched dental handpieces on a pouch rack. 132°C / 270°F for 4 minutes 25 minutes (up to 6 kg / 13.2 lbs)15 minutes (up to 1.4 kg / 3 lbs) 6.0 Kg / 13.2 lbs Meets the specified temperature, time, and drying for sterilization. Textiles/Porous Wrapped Textiles 132°C / 270°F for 4 minutes 20 minutes 2.0 Kg / 4.4 lbs Meets the specified temperature, time, and drying for sterilization. Rubber & Plastic IUSS CYCLE* for unwrapped solid or hollow instrument 121 °C / 250°F for 20 minutes Not Applicable 2.0 Kg / 4.4 lbs Meets the specified temperature and time for sterilization. *IUSS: Immediate Use Steam Sterilization cycle.
**For optimal drying of these loads, SciCan recommends using only one pouch rack loaded on the second from top rail. -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the document describes a steam sterilizer, not an AI/diagnostic device that relies on a test set of data. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable. Sterilizers are validated through engineering and microbiological testing, not expert interpretation of outputs. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. -
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device operates as a standalone sterilizer, but the concept of "standalone performance" as it applies to an AI algorithm is not relevant here. Its performance is inherent to its mechanical and thermodynamic operation. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a steam sterilizer would be the achievement of sterility according to validated microbiological standards (e.g., sterilization of biological indicators), and the physical parameters (temperature, pressure, time) being met. This document does not detail the specific validation studies but rather presents the approved operational parameters once those validations are complete. -
The sample size for the training set
This information is not applicable. -
How the ground truth for the training set was established
This information is not applicable.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 26, 2019
SciCan Ltd. Teresa Boyce Director of Regulatory Affairs 1440 Don Mills Road Toronto, M3B 3P9 Ca
Re: K190062
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: July 3, 2019 Received: July 5, 2019
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
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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 mediation-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,
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 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) K190062
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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| PROGRAM | LOAD DESCRIPTION | STERILIZATION TEMPERATURE / EXPOSURE TIME | MINIMUM DRYING TIME** | MAXIMUM LOAD |
|---|---|---|---|---|
| Solid/Unwrapped | IUSS CYCLE* forunwrapped solidinstruments (mirrors,explorers), hingedinstruments (hemostats) ontrays. | 132°C /270°F for 4minutes | Not Applicable | 6.0 Kg /13.2lbs |
| Solid/Wrapped | Wrapped IMS cassetteswith solid instruments, rigidsterilization containers withsolid instruments or single-pouched solid instrumentson a pouch rack. | 132°C /270°F for 4minutes | 25 minutes (up to 6kg /13.2 lbs of load)15 minutes (up to 1.4kg / 3 lbs of load**) | 6.0 Kg /13.2lbs |
| Hollow/Unwrapped | IUSS CYCLE* forunwrapped dentalhandpieces on trays. | 132°C /270°F for 4minutes | Not Applicable | 6.0 Kg /13.2lbs |
| Hollow/Wrapped | Single-pouched dentalhandpieces on a pouchrack. | 132°C /270°F for 4minutes | 25 minutes (up to 6kg /13.2 lbs of load)15 minutes (up to 1.4kg / 3 lbs of load) | 6.0 Kg /13.2lbs |
| Textiles/PorousWrapped | Textiles | 132°C /270°F for 4minutes | 20 minutes | 2.0 Kg /4.4 lbs |
| Rubber & Plastic | IUSS CYCLE* forunwrapped solid or hollowinstrument | 121 °C /250°F for 20minutes | Not Applicable | 2.0 Kg /4.4 lbs |
*Immediate Use Steam Sterilization cycle.
- Immediate Use Steam Sterlization cycle.
** For optimal drying of these loads, SciCan recommends using only one pouch rack loaded on the second from top rail.
§ 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).