(248 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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This document describes a 510(k) premarket notification for the "STATCLAVE G4 CHAMBER AUTOCLAVE," a steam sterilizer. The FDA has determined it is substantially equivalent to legally marketed predicate devices.
The document outlines the device's indications for 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." It's explicitly stated that the device "has not been designed to sterilize liquid loads, bio-medical waste or materials not compatible with steam sterilization."
The document includes a table of program descriptions, cycle times, temperature, and dry times for various load types.
Based on the provided text, the following information regarding acceptance criteria and a study to prove device performance can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
The document provides performance parameters for different sterilization programs. While not explicitly labeled as "acceptance criteria" in a formal sense, these are the validated operational parameters for the device's intended use. The "reported device performance" is implicitly that the device operates according to these specifications to achieve sterilization.
| PROGRAM | LOAD DESCRIPTION | STERILIZATION TEMPERATURE / EXPOSURE TIME | MINIMUM DRYING TIME** | MAXIMUM LOAD | Reported Performance (Implicit) |
|---|---|---|---|---|---|
| Solid/Unwrapped (IUSS Cycle) | 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 | Achieves sterilization at specified parameters. |
| 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 | 35 minutes (up to 6 kg / 13.2 lbs) | 6.0 Kg / 13.2 lbs | Achieves sterilization at specified parameters. |
| 25 minutes (up to 2.5 kg / 5.5 lbs) | |||||
| 15 minutes (up to 1.4 kg / 3 lbs)** | |||||
| Hollow/Unwrapped (IUSS Cycle) | unwrapped dental handpieces on trays. | 132°C / 270°F for 4 minutes | Not applicable | 6.0 Kg / 13.2 lbs | Achieves sterilization at specified parameters. |
| Hollow/Wrapped | Single-pouched dental handpieces on a pouch rack. | 132°C / 270°F for 4 minutes | 40 minutes (up to 3.5 kg / 7.7 lbs) | 3.5 kg / 7.7 lbs | Achieves sterilization at specified parameters. |
| 25 minutes (up to 2.2 kg / 4.8 lbs) | |||||
| 15 minutes (up to 1.1 kg / 2.4 lbs)** | |||||
| Textiles/Porous Wrapped | Textiles | 132°C / 270°F for 4 minutes | 20 minutes | 2.0 Kg / 4.4 lbs | Achieves sterilization at specified parameters. |
| Rubber & Plastic (IUSS Cycle) | unwrapped solid or hollow instrument. | 121°C / 250°F for 20 minutes | Not applicable | 2.0 Kg / 4.4 lbs | Achieves sterilization at specified parameters. |
Note: The acceptance criteria for a sterilizer would typically involve demonstrating a Sterility Assurance Level (SAL) of 10^-6 or better for microbial inactivation, along with meeting physical parameters like temperature, pressure, and biological indicator (BI) kill rates. These specific details are not provided in this regulatory letter, which focuses on substantial equivalence to a predicate device. The table above reflects the operational parameters of the device as cleared.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified in the provided text.
- Data provenance: Not specified in the provided text. This document is an FDA 510(k) clearance letter, not the study report itself. It refers to a "premarket notification," which usually includes performance data, but that data is not detailed here. It's highly probable the data would be prospective studies conducted by the manufacturer for validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable and not provided. Sterilizer validation typically involves microbiological testing (e.g., biological indicators, inoculated product) and physical parameter monitoring, rather than expert consensus on images or interpretations.
4. Adjudication method for the test set:
- Not applicable and not provided. (See point 3).
5. 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:
- Not applicable. This is a medical device (sterilizer) and not an AI/imaging diagnostic tool that involves human readers or AI assistance in interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a standalone medical device (sterilizer), and its performance is assessed directly through its physical and microbiological efficacy, not through an algorithm's classification or diagnostic ability.
7. The type of ground truth used:
- While not explicitly stated in this document, the ground truth for sterilizers is typically established through microbiological validation methods, such as:
- Biological Indicators (BIs): Spore strips or suspensions are placed in worst-case locations within the load and chamber. After the cycle, these BIs are incubated, and the absence of growth (i.e., kill of highly resistant spores) serves as the ground truth for sterility.
- Direct Inoculation: Instruments or materials are intentionally inoculated with high concentrations of resistant microorganisms and then processed. Subsequent culturing determines if all microbes were killed.
- Physical Parameters: Monitoring and verification of temperature, pressure, and steam penetration throughout the cycle against validated ranges.
- The "acceptance criteria" implicitly include achieving a validated sterile outcome based on these scientific ground truths.
8. The sample size for the training set:
- Not applicable. This device does not use a "training set" in the context of machine learning or AI. Its development and validation are based on engineering principles, material science, and microbiology.
9. How the ground truth for the training set was established:
- Not applicable. (See point 8).
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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 | STERILIZATIONTEMPERATURE /EXPOSURE TIME | MINIMUM DRYINGTIME** | MAXIMUMLOAD |
|---|---|---|---|---|
| Solid/Unwrapped | IUSS CYCLE* for unwrappedsolid instruments (mirrors,explorers), hinged instruments(hemostats) on trays. | 132°C /270°F for 4minutes | Not applicable | 6.0 Kg /13.2 lbs |
| Solid/Wrapped | Wrapped IMS cassettes withsolid instruments, rigidsterilization containers with solidinstruments or single pouchedsolid instruments on a pouchrack. | 132°C /270°F for 4minutes | 35 minutes (up to 6kg / 13.2 lbs of load) | 6.0 Kg /13.2 lbs |
| 25 minutes (up to2.5 kg / 5.5 lbs ofload) | ||||
| 15 minutes (up to1.4 kg / 3 lbs ofload**) | ||||
| Hollow/Unwrapped | IUSS CYCLE* for unwrappeddental handpieces on trays. | 132°C /270°F for 4minutes | Not applicable | 6.0 Kg /13.2 lbs |
| Hollow/Wrapped | Single-pouched dentalhandpieces on a pouch rack. | 132°C /270°F for 4minutes | 40 minutes (up to3.5 kg / 7.7 lbs ofload) | 3.5 kg / 7.7 lbs |
| 25 minutes (up to2.2 kg / 4.8 lbs ofload) | ||||
| 15 minutes (up to1.1 kg / 2.4 lbs ofload**) | ||||
| Textiles/PorousWrapped | Textiles | 132°C /270°F for 4minutes | 20 minutes | 2.0 Kg /4.4 lbs |
| Rubber & Plastic | IUSS CYCLE* for unwrappedsolid or hollow instrument. | 121 °C /250°F for 20minutes | 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.
§ 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).