(111 days)
Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09E / Skytron Integrity 215 SG Steam Sterilizer are designed and optimized for use in health care facilities. Sakura Steam Sterilizer ASSV-AB-09 / Skytron Integrity 215 Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09E / Skytron Integrity 215 SG Steam Sterilizer incorporate high-pressure steam to sterilize non-porous and porous, heat and moisture-stable items and materials used in the health care facilities.
The SKYTRON Integrity 215 Steam Sterilizer. SKYTRON Integrity 215 SG Steam Sterilizer, Sakura Steam Stenlizer ASSV-AB09, Sakura Steam Sterilizer ASSV-AB09E Steam Sterilizers are Class II, Product Code FLE Medical Devices as defined by CFR§880.6880 and defined for use in healthcare facilities. The SKYTRON Integrity 215 Steam Sterilizer, SKYTRON Integrity 215 SG Steam Sterilizer, Sakura Steam Sterilizer ASSV-AB09, Sakura Steam Sterilizer ASSV-AB09E Steam Sterilizers provide efficient steam sterilization of non-porous and porous, heat and moisture stable materials. The sterilizers also dry items that have been sterilized with wet steam.
This document is a 510(k) Summary for the SKYTRON Integrity 215 Steam Sterilizer and its variations. It focuses on the device's capabilities to sterilize instruments and materials in healthcare facilities. It does not describe an AI/ML device, therefore, the following requested information points are not applicable as they pertain to AI/ML device studies.
Therefore, I will provide the available information from the document regarding the device's acceptance criteria and the study conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the steam sterilizers are defined by the factory-programmed sterilization cycle values, which indicate the maximum validated loads, sterilize temperature, sterilize time, and dry time for various cycles. The reported device performance is that these cycles were "validated according to ANSI/AAMI ST8: 2008" and that the device "passed all of the tests based on pre-determined Pass/Fail criteria."
| Cycle | Acceptance Criteria: Maximum Validated Loads | Acceptance Criteria: Sterilize Temp | Acceptance Criteria: Sterilize Time | Acceptance Criteria: Dry Time | Reported Device Performance |
|---|---|---|---|---|---|
| Flash 1 (IU 1) | One unwrapped, nonporous instrument no heavier than 0.22 lbs. (100 gram) | 270 F (132 C) | 3 minutes | 1 minute | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Flash 2 (IU 2) | Maximum of six (6) unwrapped instrument trays, maximum weight 25 pound (11.3 kg) each. Max three (3) 2 mm ID (min) and 400 mm long (max) lumen instruments per cycle load. | 270 F (132 C) | 4 minutes | 1 minute | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Prevacuum 270 | Maximum of six (6) double-wrapped instrument trays, maximum weight 25 pound (11.3kg) each. Max three (3) 2 mm ID (min) and 400 mm long (max) lumen instruments per cycle load. (Also 12 fabric packs with 15 min dry time) | 270 F (132 C) | 4 minutes | 30 minutes (or 15 min for fabric) | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Prevacuum 275 | Maximum of six (6) double-wrapped instrument trays, maximum weight 25 pound (11.3 kg) each. Max three (3) 2 mm ID (min) and 400 mm long (max) lumen instruments per cycle load. | 275 F (135 C) | 3 minutes | 30 minutes | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Express Prevacuum (IU 3) | Maximum of six (6) single wrapped instrument trays, maximum weight 25 pound (11.3 kg) each. Max three (3) 2 mm ID (min) and 400 mm long (max) lumen instruments per cycle load. (Immediate-use, not sterile barrier) | 270 F (132 C) | 4 minutes | 3 minutes | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Gravity 1 | Maximum of twelve (12) - fabric packs. | 250 F (121 C) | 30 minutes | 15 minutes | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Gravity 2 | Maximum of six (6) double-wrapped instrument trays, maximum weight 25 pound (11.3 kg) each. (Also 12 fabric packs with adjusted times) | 270 F (132 C) | 15 minutes (or 25 min for fabric) | 30 minutes (or 15 min for fabric) | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Liquid | Maximum of three (3) 1,000 mill-liter containers with vented closures. (Non-patient contact only) | 250 F (121 C) | 45 minutes | 0 Minute | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Leak Test | Empty Chamber, test time of 15 minutes. | N/A | N/A | N/A | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Warm Up | Empty Chamber | 270 F (132C) | 4 minutes | 3 minutes | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
| Bowie-Dick Test | Bowie-Dick Test Pack | 273 F (134 C) | 3.5 minutes | 2 Minute | Validated according to ANSI/AAMI ST8: 2008; Passed all pre-determined Pass/Fail criteria. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the "sample size" in terms of number of sterilization cycles or tests performed during validation. However, it mentions that "Efficacy of sterilizer function and exposure time recommendations are ultimately shown by complete kill of biological indicators and verifying an appropriate safety factor or sterility assurance level (SAL) of at least 10^-6 reduction."
The data provenance is not specified beyond "Sakura Seiki Co., Ltd. validates its sterilization cycles by recommended practices, standards and guidelines developed by various independent organizations such as the Association for Advancement of Medical Instrumentation (AAMI)." The document also states the testing was "Non-clinical: Verification, validation and testing activities were conducted to establish the performance, functionality and reliability characteristics" of the sterilizers. This suggests the data was collected specifically for validation purposes of this device, likely in a controlled, prospective manner, but the geographic origin of the testing is not detailed. The manufacturer is based in Japan.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided. The efficacy is demonstrated by the "complete kill of biological indicators" to achieve a sterility assurance level (SAL) of at least 10^-6, which is a quantified scientific outcome, not dependent on expert consensus for ground truth.
4. Adjudication Method for the Test Set
This is not applicable as the validation focuses on objective performance measures (sterility assurance) rather than subjective assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
This is not applicable, as this is not an AI/ML diagnostic device with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable, as this is not an AI/ML device. The device's "standalone" performance in a sense refers to its ability to sterilize independently, which was validated.
7. The Type of Ground Truth Used
The ground truth used for establishing the effectiveness of the sterilizer is based on biological indicators (BIs) and achieving a sterility assurance level (SAL) of at least 10^-6 reduction. This signifies that the probability of a viable microorganism remaining after sterilization is 1 in 1,000,000. This is an objective, scientifically established outcome. The validation also adheres to ANSI/AAMI ST8: 2008.
8. The Sample Size for the Training Set
This is not applicable, as this is not an AI/ML device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable, as this is not an AI/ML device.
§ 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).