(205 days)
The Cassette Autoclave (ACA5) is suitable for the sterilization of dental and medical instruments designed to withstand steam sterilization. The Cassette Autoclave (ACA5) has not been designed to sterilize liquids, 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 below sterilization cycles for Program Name / Load Description/Sterilization Temperature/Sterilization Time/Drying Time and Load Weight.:
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Program Name: 134 ℃
Load Description: Solid objects, small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped.
Sterilization Temperature: 134 ℃ (273℉)
Sterilization Time: 4 minutes
Drying Time: 60 minutes
Load Weight: 0.9 kg -
Program Name: 121℃
Load Description: Solid objects, small porous objects, narrow-clearance items, dental handpieces and textile, wrapped or unwrapped.
Sterilization Temperature: 121 ℃ (250℉)
Sterilization Time: 30 minutes
Drying Time: 60 minutes
Load Weight: 0.9 kg
The Cassette Autoclave (ACA5) 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. The Cassette Autoclave (ACA5) consists of five modules: water supply, disinfection, air dry, exhaust steam processing and control system.
The main working principle is as follows: The water supply module supplies clean distilled water to the disinfection module. Inside the steam generator, the electric heating element generates high- temperature saturated steam at 121℃ for a period of 4 minutes and 134℃ for a period of 30 minutes. This steam is then utilized within a sealed disinfection box to sterilize instruments. During sterilization, excess high- temperature steam is condensed in the exhaust steam processing module. After the sterilization, high- temperature steam and coolant water remain inside the disinfection box. Air dry cycle works for ventilation and drying. Ultimately, you can get the dry and sterile instruments.
Basic parameters/use conditions/power supply specifications are as follows:
Name: Cassette Autoclave （ACA5）
Machine Dimensions (ABC): 650mm416mm200mm
Cassette Sizes (DEF): 495mm196mm78.5mm
Maximum Load for a Single Sterilization: 1.5kg
Sterilization Chamber Volume: 5.1L
Weight (Without water): 43KG
Rated Operating Temperature: 134℃
Rated Working Pressure: 212kPa（Gauge Pressure）
Relief Valve Pressure Setting: Pressure set: 300kpa (relative pressure), pressure release when exceeded
Operating Temperature Range: 121℃～134℃
Reservoir Volume: 4L
Input Voltage: a.c.110v，60Hz
Rated Power: 1300VA
Fuse(250VH15AT): 10A
Working Medium: Steam
Illumination level: (215±15) lx to (1500±15) lx
Operating Mode: Non--continuous operation, with a maximum of 6 cycles per hour.
Water Supply: Purified water
Noise: Less than 70dB
Service life: 10 years
The provided FDA 510(k) clearance letter is for a Cassette Autoclave (ACA5), which is a steam sterilizer. This type of device is an electromechanical product, not an AI/ML-driven diagnostic device. Therefore, the information typically requested about acceptance criteria and studies for AI/ML performance (such as sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this document.
The document discusses the device's performance in terms of its ability to sterilize medical instruments, adhering to established standards for steam sterilizers.
Here's an analysis based on the information provided, focusing on the relevant acceptance criteria and performance metrics for a sterilizer:
Acceptance Criteria and Device Performance for Cassette Autoclave (ACA5)
This device is a medical instrument sterilizer. The performance criteria provided are related to the physical efficacy of sterilization, electrical safety, and electromagnetic compatibility, not diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance / Result |
|---|---|---|---|
| ANSI AAMI ST55:2016 Vacuum Test | Verify air removal performance | Average leak rate of 1 milliliter of mercury (mmHg) (0.13 kPa) (0.019 psia) per min or less | Pass |
| Bowie Dick Test | Verify air removal performance | The Bowie-Dick-test indicator sheet shall show a uniform color change, i.e., the color in the center should be the same as that at the outer edges. | Pass |
| Temperature Control Performance | |||
| (Hollow unwrapped (S) 134˚C/4min, | |||
| Solid unwrapped(N) 134˚C/4min, | |||
| Hollow wrapped(S) 134˚C/4min, | |||
| Rubber/plastic(S) 121˚C/30min) | Verify temperature control performance | The chamber temperature during the exposure time remains within +3 ºC and –0 ºC of the selected sterilization exposure temperature. | Pass |
| Pressure Control Performance | |||
| (Hollow unwrapped (S) 134˚C/4min, | |||
| Solid unwrapped(N) 134˚C/4min, | |||
| Hollow wrapped(S) 134˚C/4min, | |||
| Rubber/plastic(S) 121˚C/30min) | Verify pressure control performance | The chamber pressure is within ±0.3 bar within the chamber. | Pass |
| Moisture Retention Performance | |||
| (Hollow unwrapped (S) 134˚C/4min/dry 60min, | |||
| Solid unwrapped(N) 134˚C/4min/dry 60min, | |||
| Hollow wrapped(S) 134˚C/4min/dry 60min, | |||
| Rubber/plastic(S) 121˚C/30min/dry 60min) | Verify Moisture retention performance | No visible moisture on outside of loads or instruments. | |
| Less than 2% moisture gain in PCD (textile test pack) and less than 0.5% moisture gain in PCD (wrapped instrument test tray). | Pass | ||
| Biological Performance | |||
| (Hollow unwrapped (S) 134˚C/4min/dry 60min, | |||
| Solid unwrapped(N) 134˚C/4min/dry 60min, | |||
| Hollow wrapped(S) 134˚C/4min/dry 60min, | |||
| Rubber/plastic(S) 121˚C/30min/dry 60min) | Verify Biological performance | Biological indicators (BIs) and spore suspensions shall show no growth of test spores. Sufficient lethality to reduce microbial population with D121°C value of at least 1.0 min to a 10^-6 probability of surviving organism (overkill method). | Pass |
| **IEC 61010-1:2010/AMD1:2016 | |||
| IEC 61010-2-040:2020** | Verify electrical safety | Meets specifications of standard | Pass |
| IEC 61326-1:2020 | Verify electromagnetic compatibility | Meets specifications of standards | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact number of cycles or units tested for each performance metric. It states "The device had been validated to comply with the following bench testing." These are laboratory bench tests performed on the physical device itself, not studies on patient data. The provenance of this data is from the manufacturer's non-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth for sterilizer performance is established by metrological standards (temperature, pressure, moisture measurements) and microbiological testing (biological indicators), not by human expert consensus on diagnostic images.
4. Adjudication Method for the Test Set
Not applicable. Performance is measured against physical and biological thresholds, not requiring expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
Not applicable. This is not an AI/ML diagnostic or image interpretation device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is an electromechanical sterilizer. Its "performance" is its ability to meet the physical and biological parameters of sterilization, which is inherently a "standalone" function of the machine.
7. The Type of Ground Truth Used
The ground truth used for this type of device is based on accepted international standards for sterilization and electrical/electromagnetic safety. This includes:
- Precise physical measurements (temperature, pressure, vacuum, moisture content).
- Microbiological challenge tests using biological indicators to confirm the inactivation of spores to a specified sterility assurance level (SAL).
8. The Sample Size for the Training Set
Not applicable. This is a manufactured electromechanical device, not a machine learning algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable for the reason stated in 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).