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510(k) Data Aggregation
(176 days)
The Revolutionary Science Saniclave 250 is designed to be used in medical and dental clinics, hospitals and other facilities where reusable sterile equipment is used. It is intended to sterilize wrapped heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens greater than 3mm inner diameter and less than 70mm in length, excluding dental handpieces) that are compatible with saturated steam sterilization at 121 degrees Celsius for 30 minutes.
The Saniclave 250 by Revolutionary Science (model number RS-SC-250) is a 120 volt front loading autoclave. The Saniclave works like most other table top steam sterilizers by boiling water in a pressurized vessel (or chamber). As the water boils, the chamber pressurizes and the steam sterilizes the instruments placed inside. The Saniclave technology is based on the scientific concept that prolonged saturated pressurized steam at or over a temperature of 121degrees Celsius kills bacteria.
The provided text describes the Saniclave 250, a steam sterilizer, and its comparison to a predicate device for 510(k) clearance. Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Performance Objective) | Reported Device Performance (Saniclave 250) |
|---|---|
| Sterility Assurance Level (SAL): 10⁻⁶ | Achieved 10⁻⁶ SAL for all tested cycles and loads. |
| Sterilization Temperature for all cycles | 121°C |
| Sterilization Time for all cycles | 30 minutes |
| Dry Time (Gravity, small load, wrapped) | 30 minutes |
| Dry Time (Gravity, small load, unwrapped) | N/A |
| Dry Time (Gravity, large load, unwrapped) | N/A |
| Maximum Load (Gravity, small load, wrapped) | 1 tray, 4.5 lbs |
| Maximum Load (Gravity, small load, unwrapped) | 1 tray, 4.5 lbs |
| Maximum Load (Gravity, large load, unwrapped) | 3 trays, 8.0 lbs |
| Compatibility with Instruments | Heat and moisture stable solid instruments, mated surfaces, knurled, hinged devices, including lumened devices and trocars (lumens > 3mm ID and < 70mm length, excluding dental handpieces). |
| Temperature and Pressure inside chamber | Within operating parameters (121°C for 30 min, 15 psi). |
| Electromagnetic Compatibility (EMC) | Compliance to EN 60601-1-2 |
| Electrical Safety | Compliance to EN 60601-1-1, EN 60601-1, EN 61010-2-040, EN 61010-1 |
| Compliance to Sterilizer Standard | ANSI/AAMI ST55:2016 |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify a numerical sample size for the biological indicators or instruments used in the sterilization efficacy tests. It mentions "a loaded test" and "a separate test" with "the inoculum tested." For physical testing, it indicates "Five precalibrated temperature sensors" and "One precalibrated pressure transducer."
- Data Provenance: The document does not explicitly state the country of origin of the data. The tests were performed in accordance with ANSI/AAMI ST55:2016 and EN standards, suggesting international applicability. The studies appear to be prospective as they were conducted as part of the device's validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of human experts to establish ground truth for the sterilization efficacy tests. The "ground truth" for these tests is based on the biological indicator's (G. Bacillus Stearothermophilus) growth or lack thereof, which is a direct, objective measure of sterility.
4. Adjudication Method for the Test Set:
- Not applicable. The primary method for determining sterilization efficacy relies on biological indicators, which provide an objective "growth/no growth" result. There is no mention of a subjective assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This device is a sterilizer, and its performance is evaluated through physical and biological efficacy tests, not human interpretation of medical images or data. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant here.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- This device is a physical steam sterilizer, not an AI algorithm. Its performance is inherently "standalone" in the sense that its sterilization process operates independently once initiated. The testing described (physical and biological) evaluates the device's inherent capability to sterilize without human intervention affecting the outcome of the sterilization cycle itself.
7. The Type of Ground Truth Used:
- The primary ground truth used for sterilization efficacy was biological indicators (G. Bacillus Stearothermophilus in an artificial soil), which provides objective evidence of microbial kill (or lack thereof).
- For physical parameters (temperature and pressure), the ground truth was established by precalibrated sensors and transducers, providing objective measurements against predefined operating parameters.
8. The Sample Size for the Training Set:
- Not applicable. The Saniclave 250 is a physical device, a steam sterilizer, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set for this device.
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