(431 days)
The STERLINK mini sterilizer with STERLOAD™ mini cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal and nonmetal medical devices used in healthcare facilities. A pre-programmed sterilization lumen cycle operates at low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.
The STERLINK mini can sterilize *:
- · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors
- · Medical devices with a single stainless-steel lumen with:
- o An inside diameter of 1.6 mm or larger and a length of 200 mm or shorter
*The validation testing was conducted using a maximum of five (5) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load with a total weight of 1.54 lbs.
Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in CHAMBER mode, is intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERLINK™ sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 1 month post sterilization.
The materials compatible for use in the Tyvek® Roll with CI for STERLINK™ Sterilizer, when used in Chamber mode, are as follows: Aluminum 5052, Aluminum 6061, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HDPE), Polypropylene (PP), Polytetrafluoroethylene (PTFE) and Silicone (Hardness 50).
The maximum load weight that can be placed in the Tyvek® roll is:
- · 3.97 pounds (1.8 kg) for CHAMBER mode of FPS-15s Plus sterilizer
- · 1.54 pounds (0.7 kg) for CHAMBER mode of STERLINK mini sterilizer
The roll is printed with a chemical indicator bar which is a process indicator (ISO 11140 1:2005) that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ sterilizer.
The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type: · Sterilization roll, Flat
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 106 Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. BT96 has Super Rapid readout at 30 minutes at 60°C.
Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C and read the Terragene Bionova® SCBI for fluorescent results at the times prescribed in the User Manuals.
Terragene Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes. The chemical indicator changes from red to yellow for CD42 to indicate that the conditions of the cycle have been met.
Terragene Cintape® (CT40) is a chemical process indicator tape intended for monitoring the efficacy of Vaporized Hydrogen Peroxide sterilization processes. The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
The self-contained biological indicator and chemical processing indicators are intended for use with:
- · CHAMBER mode of FPS-15s Plus sterilizer
- · CHAMBER mode of STERLINK mini sterilizer
The STERLINK mini sterilizer with STERLOAD™ mini cassette is a low temperature sterilizer which uses the STERLINK™ process to inactivate microorganisms on a broad range of medical devices and instruments. This system consists of a main device connected pump module and cassette which are called the STERLINK mini and STERLOAD™ mini cassette, respectively. The STERLOAD™ mini cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (H2O2) which is utilized as the sterilant.
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed medical devices for up to 1 month post sterilization. The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINKTM sterilizer. The Tyvek® Roll with CI for STERLINKIM Sterilizer is offered in one type as a Flat Sterilization roll. The sterilization roll is made from a Tyvek® sheet and a clear plastic film that are heat sealed together on opposite two sides. After being cut into a suitable length, the product to be sterilized is placed inside and the two open ends are heat sealed. The process indicator printed on the Tyvek® will exhibit a color change after the roll is exposed to hydrogen peroxide (H2O2).
Terragene® Bionova® BT96 Fluorescence Super Rapid Readout Biological Indicators are singleuse Self-Contained Biological Indicators (SCBIs) that consist of a polypropylene tube, a spore carrier, and a glass ampoule with a culture medium, enclosed with a colored cap. Each tube contains a population of Geobacillus stearothermophilus ATCC 7953 spores inoculated on a spore carrier, a plastic cap with holes and a barrier permeable to Plasma or Vaporized Hydrogen Peroxide. Each BT96 has a Process Indicator on label that changes from purple to green when exposed to hydrogen peroxide. The Bionova® BT96 Biological Indicators have been designed for monitoring of Vaporized Hydrogen Peroxide sterilization processes when used in conjunction with Bionova® IC10/20FRLCD or MiniBio Auto-Readers Incubators.
Chemdye® CD42 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of plastic strips printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.
Cintape® CT40 Process Indicators (Type 1 according to ISO 11140-1:2014 standard) are singleuse chemical indicators that consist of a roll of self-adhesive plastic tape printed with indicator ink. These indicators have been designed to monitor Plasma or Vaporized Hydrogen Peroxide sterilization processes, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items. The adhesive component of the tape allows the adhesion to different types of packaging and wraps, such as cloth, paper and plastic.
The provided text describes acceptance criteria and study results for medical sterilization devices (STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, and Sterilization Process Indicator for STERLINK Sterilizer).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Device: STERLINK mini Sterilizer with STERLOAD™ mini Cassette
| Test | Purpose | Acceptable Criteria | Reported Device Performance |
|---|---|---|---|
| Human factors and usability engineering | To confirm whether the user error affects the risk to user safety and performance of the device when the device is used according to the intended use in accordance with IEC 62366-1. | User safety risk and device performance degradation due to user errors should not occur. | Pass |
| Biocompatibility | To confirm the biological safety of the sterilized load in accordance with ISO 10993-5. | ≤ Grade 2 | Pass |
| Software validation | To verify that the software is compatible for the intended use of the device in accordance with IEC 62304. | The risk of all identified software hazards should be reduced to an acceptable risk level and the device is appropriate for its intended use. | Pass |
| Electrical safety | To confirm the electrical safety of the device in accordance with IEC 60601-1, IEC 61010-1, and IEC 61010-2-040. | The device conforms to the relevant standards. | Pass |
| Electromagnetic compatibility (EMC) | To confirm the electromagnetic wave safety of the device in accordance with IEC 60601-1-2 and EN 55011. | The device conforms to the relevant standards. | Pass |
| Resistance validation for biological indicator test | To validate the D-value and total kill endpoint of the biological indicators in accordance with ISO 11138-1. | The total kill endpoint time should be shorter than the sterilization half cycle. | Pass |
| Lumen sterilization | To confirm the lumen sterilization performance in accordance with ISO 14937. | The SAL (Sterility Assurance Level) should be at least 10^-6^. | Pass |
| Surface sterilization | To confirm the surface sterilization performance of various materials in accordance with ISO 14937, ISO 11737-1, and ISO11737-2. | The SAL (Sterility Assurance Level) should be at least 10^-6^. | Pass |
| Mated surface sterilization | To confirm the mated surface sterilization performance of various materials in accordance with ISO 14937, ISO 11737-1, and ISO11737-2. | The SAL (Sterility Assurance Level) should be at least 10^-6^. | Pass |
| Simulated use test | To demonstrate the efficacy of the sterilization validation on medical devices contaminated by organic and inorganic matters with bacterial spores in accordance with ASTM E1837-96 and ISO 11737-1. | The microorganisms should not survive after sterilization. | Pass |
| In-use test | To demonstrate the sterilization validation of the used and clinically pretreated medical devices in accordance with ASTM E1837-96. | The microorganisms should not survive after sterilization. | Pass |
| Sporicidal activity test | To confirm the sporicidal activity of the device in accordance with AOAC Official Method 966.04. | All spores inoculated on the carriers must be sterilized. | Pass |
| Bacteriostasis test | To confirm the bacteriostasis action of sterilized various materials after sterilization process in accordance with ISO 11737-1. | Sterilized materials should not exhibit the bacteriostatic effects. | Pass |
| Material compatibility test | To demonstrate the compatibility of various materials in the sterilization cycle in accordance with ASTM D638, ASTM E8/E8M, ASTM D790, ASTM E290-14, ASTM D256, ASTM E23-18, ASTM E1164, ASTM D3985, and ASTM E1240. | The physical properties of the material after sterilization should be similar to those before sterilization. | Pass |
| Delivery validation | To validate the packaging and performance of the device after exposure to simulated shipping conditions in accordance with ASTM D4169-14. | After the distribution cycle of the drop test, significant deformations and defects in the electrical and mechanical performance of the device should not be observed. | Pass |
| Hydrogen peroxide gas detection test | To measure the concentration of the hydrogen peroxide emitted from the device in accordance with Occupational Safety and Health Administration (OSHA, TWA). | 30 sec in creep pressure (> 80% of burst pressure) | Pass |
| Visual inspection test | To confirm the sterilized device integrity was maintained at shelf life in accordance with ASTM F1980-16 and ASTM F1886/F1886M-16. | There should be no defects in the sealing area. | Pass |
| Dye penetration test | To confirm the packaging of the sterilized device was maintained at shelf life in accordance with ASTM F1980-16 and ASTM F1929-15. | There should be no dye leakage. | Pass |
| Tensile strength of Tyvek® | To confirm the physical properties of the sterilized device at shelf life in accordance with ASTM F1980-16, ASTM D5035-11, ASTM D882, ASTM F88, and ASTM D1922-20. | The physical properties must meet the criteria specified by the manufacturer. | Pass |
| Tensile strength of plastic film | (Same purpose as above) | (Same criteria as above) | Pass |
| Seal strength | (Same purpose as above) | (Same criteria as above) | Pass |
| Tear resistance | (Same purpose as above) | (Same criteria as above) | Pass |
| Microbial Barrier Test | To confirm the microbial barrier performance of sterilized devices at shelf life in accordance with ASTM F1980-16 and DIN 58953-6. | - Test with liquid inoculum: No microbial growth should appear. |
- Test with gas inoculum: Only a maximum 15 colonies should grow out of a total of 10 bacterial permeability testers. The number of colonies in each bacterial permeability tester should not be greater than five. | Pass |
| Residual sterilant on Tyvek® validation | To confirm the time required for the residual sterilant to be reduced to a safe amount after sterilization in accordance with the internal test standard. | ≤ 0.05 ppm | Pass |
| Biocompatibility test | To confirm the biological safety after sterilization in accordance with ISO 10993-5. | ≤ Grade 2 | Pass |
Device: Sterilization Process Indicator for STERLINK™ Sterilizer (BT96, CD42, CT40)
| Item | Test | Purpose | Acceptable Criteria | Reported Device Performance |
|---|---|---|---|---|
| Self-Contained Biological Indicator (BT96) | Resistance validation for biological indicator test | To validate the D-value and total kill endpoint of biological indicators in accordance with ISO 11138-1. | The total kill endpoint time should be shorter than the half cycle sterilant exposure time. | Pass |
| BI & Test pack validation test | To verify the suitability of the test pack to be used as monitoring of the sterilization process in accordance with the internal test standard. | The test pack with SCBI should fail to sterilize in half cycle and succeed in full cycle. | Pass | |
| Chemical Indicator (CD42, CT40) | Performance characteristics obtained from resistometer | To evaluate the correct performance of chemical indicators, by testing them at different exposure conditions in accordance with ANSI/AAMI/ISO 11140-1. | The CI should change color correctly only when exposed to the temperature and sterilant concentration conditions specified by the manufacturer. | Pass |
| Biocompatibility | To demonstrate that the CI does not offset or transfer during and after the sterilization process in accordance with ANSI/AAMI/ISO 11140-1. | The CI does not release any substance or bleed when the sterilization process. | Pass | |
| Endpoint stability | To demonstrate the stability of the endpoint reaction of CI at the end of their shelf life and specified period after sterilization in accordance with ANSI/AAMI/ISO 11140-1. | The endpoint reaction of CI should be maintained until the shelf life and specified period after sterilization. | Pass | |
| Shelf life study | To verify the shelf life of the CI in accordance with ANSI/AAMI/ISO 11140-1. | The endpoint reaction of the real time aged CI should be maintained until shelf life. | Pass | |
| Chemical indicator validation | To confirm the compatibility of the CI for the sterilization process in accordance with the internal test standard. | The minimum time required for color change of CI within the sterilization process time should be confirmed. | Pass |
Additional Study Information:
The provided text describes non-clinical tests performed to demonstrate substantial equivalence to predicate devices, not clinical studies involving human patients or complex AI algorithms requiring ground truth from experts. The devices are sterilizers and sterilization indicators, which are typically evaluated through microbiological and engineering performance testing.
Therefore, many of the specific questions about "test set," "ground truth," "experts," "adjudication," and "AI assistance" are not directly applicable to the type of device and testing described in this document.
For completeness, here's what can be extracted or inferred:
-
Sample size used for the test set and the data provenance:
- Sample size: Not explicitly stated as a single "test set" size. The text mentions "maximum of five (5) lumens per load" for lumen sterilization validation and "a validation load with a total weight of 1.54 lbs." for the sterilizer. For the Tyvek roll microbial barrier test, it mentions "a total of 10 bacterial permeability testers." Specific quantities for other tests are not provided.
- Data provenance: Not specified. These are non-clinical engineering and microbiological tests, likely conducted in a laboratory setting by the manufacturer (Plasmapp Co., Ltd. and Terragene S.A.). The country of origin of the manufacturer is South Korea for Plasmapp and presumably Argentina for Terragene (as it's a known Argentinian company). The studies are "non-clinical tests," implying they were conducted in a controlled environment, not on human subjects.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. The tests are laboratory-based and use established microbiological and engineering standards (e.g., ISO, ASTM, AOAC). "Ground truth" is determined by scientific measurements and observation of bacterial kill, physical properties, or chemical indicator changes, not by expert consensus on subjective interpretations.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for subjective assessments (e.g., radiological reads) where multiple experts might disagree. These tests are objective measurements against defined standards.
-
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. These devices do not involve "human readers" interpreting "cases" with or without "AI assistance."
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no AI algorithm component to these devices described in the document.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for these sterilization and chemical indicator tests is based on:
- Microbiological kill: Demonstrating the inactivation of a specified population of resistant spores (e.g., Geobacillus stearothermophilus) to a defined Sterility Assurance Level (SAL), typically 10^-6^. This is confirmed through laboratory culture methods.
- Physical and chemical property measurements: Adherence to established engineering standards (e.g., tensile strength, burst pressure, color change properties of chemical indicators).
- Safety standards: Compliance with international safety and electromagnetic compatibility standards.
-
The sample size for the training set: Not applicable. These devices do not involve machine learning or AI models that require a "training set."
-
How the ground truth for the training set was established: Not applicable, as there is no training set mentioned.
§ 880.6860 Ethylene oxide gas sterilizer.
(a)
Identification. An ethylene gas sterilizer is a nonportable device intended for use by a health care provider that uses ethylene oxide (ETO) to sterilize medical products.(b)
Classification. Class II (performance standards).