(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).
§ 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).