(431 days)
Not Found
No
The document describes a vaporized hydrogen peroxide sterilizer and associated accessories (cassette, rolls, indicators). There is no mention of AI or ML in the intended use, device description, or performance studies. The device operates based on a pre-programmed cycle and chemical/biological indicators, not data-driven algorithms.
No
This device is a sterilizer for medical instruments and not a therapeutic device used in patient treatment.
No
The device described is a sterilizer and its associated components for sterilizing medical devices. It is not intended for diagnosing medical conditions in patients.
No
The device description clearly outlines hardware components including a sterilizer, pump module, cassette, sterilization rolls, biological indicators, and chemical indicators. While software validation is mentioned in the performance studies, the core device is a physical sterilizer system and associated consumables.
Based on the provided text, none of the described devices are IVDs (In Vitro Diagnostics). Here's why:
- STERLINK mini sterilizer with STERLOAD™ mini cassette: This device is a sterilizer intended for processing medical devices used in healthcare facilities. Its purpose is to inactivate microorganisms on instruments, not to perform tests on biological samples.
- Tyvek® Roll with CI for STERLINK™ Sterilizer: This is a packaging material used to enclose medical devices for sterilization and maintain their sterility. It does not perform any diagnostic testing.
- Terragene Bionova® SCBI (BT96): This is a biological indicator used to monitor the efficacy of the sterilization process. It contains bacterial spores and is used to confirm that the sterilizer is working correctly, not to diagnose a condition in a patient.
- Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio): These are incubators used to process the biological indicators. They are part of the sterilization monitoring system, not a diagnostic device.
- Terragene Chemdye® (CD42) and Terragene Cintape® (CT40): These are chemical indicators used to monitor the sterilization process. They change color to indicate exposure to the sterilizing agent, but they do not perform any diagnostic testing on biological samples.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The devices described here are all related to the sterilization of medical instruments, which is a process performed on the instruments themselves, not on patient samples.
N/A
Intended Use / Indications for Use
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.
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% 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
Product codes (comma separated list FDA assigned to the subject device)
MLR, FRG, JOJ, FRC
Device Description
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 sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method. 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 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 single-use 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 single-use 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 single-use 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A. STERLINK mini Sterilizer with STERLOAD™ mini Cassette Non-Clinical Tests:
- Human factors and usability engineering: Pass (user safety risk and device performance degradation due to user errors should not occur).
- Biocompatibility: Pass (≤ Grade 2).
- Software validation: Pass (the risk of all identified software hazards should be reduced to an acceptable risk level and the device is appropriate for its intended use).
- Electrical safety: Pass (the device conforms to the relevant standards).
- Electromagnetic compatibility (EMC): Pass (the device conforms to the relevant standards).
- Resistance validation for biological indicator test: Pass (the total kill endpoint time should be shorter than the sterilization half cycle).
- Lumen sterilization: Pass (the SAL (Sterility Assurance Level) should be at least 10-6).
- Surface sterilization: Pass (the SAL (Sterility Assurance Level) should be at least 10-6).
- Mated surface sterilization: Pass (the SAL (Sterility Assurance Level) should be at least 10-6).
- Simulated use test: Pass (the microorganisms should not survive after sterilization).
- In-use test: Pass (the microorganisms should not survive after sterilization).
- Sporicidal activity test: Pass (all spores inoculated on the carriers must be sterilized).
- Bacteriostasis test: Pass (sterilized materials should not exhibit the bacteriostatic effects).
- Material compatibility test: Pass (the physical properties of the material after sterilization should be similar to those before sterilization).
- Delivery validation: Pass (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).
- Hydrogen peroxide gas detection test: Pass (= 1kPA - Creep time: > 30 sec in creep pressure (> 80% of burst pressure)).
- Visual inspection test: Pass (There should be no defects in the sealing area).
- Dye penetration test: Pass (There should be no dye leakage).
- Tensile strength of Tyvek®: Pass (The physical properties must meet the criteria specified by the manufacturer).
- Tensile strength of plastic film: Pass (The physical properties must meet the criteria specified by the manufacturer).
- Seal strength: Pass (The physical properties must meet the criteria specified by the manufacturer).
- Tear resistance: Pass (The physical properties must meet the criteria specified by the manufacturer).
- Microbial Barrier Test: Pass (- 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).
- Residual sterilant on Tyvek® validation: Pass (
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 14, 2023
Plasmapp Co., Ltd. % Candace Cederman Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K220345
Trade/Device Name: STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, Sterilization Process Indicator for STERLINK Sterilizer; Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), Terragene Cintape (CT40) Regulation Number: 21 CFR 880.6860 Regulation Name: Ethylene Oxide Gas Sterilizer Regulatory Class: Class II Product Code: MLR, FRG, JOJ, FRC Dated: February 25, 2022 Received: February 28, 2022
Dear Candace Cederman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely. Christopher K. Duqard -2
for Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
STERLINK mini Sterilizer with STERLOAD™ mini Cassette
Indications for Use (Describe)
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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known)
K220345
Device Name Tyvek® Roll with CI for STERLINK™ Sterilizer
Indications for Use (Describe)
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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K220345
Device Name
Sterilization Process Indicator for STERLINK™ Sterilizer
Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), Terragene Cintape® (CT40)
Indications for Use (Describe)
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10% 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
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
Image /page/5/Picture/2 description: The image shows the word "plasmapp" in a teal color. There is a teal asterisk to the left of the word. The font is sans-serif and the letters are lowercase.
510(k) Summary [as required by 21 CFR 807.92(c)]
STERLINK mini Sterilizer with STERLOAD™ mini Cassette Tyvek® Roll with CI for STERLINK™ Sterilizer Sterilization Process Indicator for STERLINK™ Sterilizer
510(k) K220345
General Information
| Applicant/Submitter: | Plasmapp Co., Ltd.
BVC-111, 125, Gwahak-ro,
Yuseong-gu, Daejeon, 34141,
Rep. of Korea (South Korea)
Tel: +82 42 716 2115 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC
1783 Forest Drive, Suite 254
Annapolis, MD 21401
Tel: +1 410 674 2060 |
| Preparation Date: | April 13, 2023 |
Device Name and Code
| Device Trade Name: | A. STERLINK mini Sterilizer with STERLOAD™ mini Cassette
B. Tyvek® Roll with CI for STERLINK™ Sterilizer
C. Sterilization Process Indicator for STERLINK™ Sterilizer;
Terragene Bionova® SCBI (BT96); Terragene Bionova®
Reader Incubators (IC10/20FRLCD, Mini-Bio); Terragene
Chemdye® (CD42); Terragene Cintape® (CT40) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | A. Vapor Phase Hydrogen Peroxide Sterilization System
B. Tyvek® Roll for VH2O2 Sterilizer
C. Self-contained Biological Indicator, Self-Contained Biological
Indicator Incubator, Chemical Indicator. |
6
| Classification Name: | A. Ethylene Oxide Gas Sterilizer
B. Sterilization Wrap
C. Sterilization Process Indicator |
|----------------------|-------------------------------------------------------------------------------------------------|
| Product Code: | A. MLR
B. FRG, JOJ
C. FRC, JOJ |
| Regulation Number: | A. 21 CFR 880.6860
B. 21 CFR 880.6850, 21 CFR 880.2800
C. 21 CFR 880.2800 |
| Classification: | Class II |
| Review Panel: | General Hospital |
STERLINK mini Sterilizer with STERLOAD™ mini Cassette A.
Device Description A.1
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 sterilizer offers an effective, safe, fast, economical, easy to use, reliable, and flexible sterilization method.
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.
A.2 Indications / Intended Use
The subject and predicate device have the same intended use. The specific indications for use differ only in the size and weight of the medical devices that can be sterilized in each chamber.
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
7
sterilization cycle operates at low pressure and low temperature and is thus suitable for processing medical devices sensitive to heat and moisture.
- I 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 for all lumen sizes 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.
A.3 Technical Characteristics in Comparison to Predicate Devices
A summary of the technical characteristics of the subject device and predicate device can be found in the table below.
8
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Same | |
| Device Name | STERLINK mini | FPS-15s Plus | - |
| 510(k) Number | K212200 | - | |
| Device | |||
| Classification | |||
| Name | Ethylene oxide gas sterilizer | Ethylene oxide gas sterilizer | Same |
| Classification | |||
| Product Code | MLR | MLR | Same |
| Regulation | |||
| Number | 21 CFR 880.6860 | 21 CFR 880.6860 | Same |
| Intended Use | The STERLINK mini sterilizer with STERLOADTM | ||
| 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 pressure and 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 for all lumen sizes 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 | The STERLINKTM FPS-15s Plus sterilizer with
STERLOADTM 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 pressure and low temperature and is
thus suitable for processing medical devices sensitive
to heat and moisture.
The STERLINKTM FPS-15s Plus 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 2.4 mm or larger and a
length of 280 mm or shorter
The validation testing for all lumen sizes 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 | Similar;
Intended Use is the
same with the
exception of the
maximum load and
lumen specification |
| | Subject Device | Predicate Device | Comparison |
| | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Same |
| | validation studies were performed using a validation | validation studies were performed using a validation | |
| | load with a total weight of 1.54 lbs. | load with a total weight of 3.97 lbs. | |
| Physical
Characteristic | Self-contained, stand-alone device | Self-contained, stand-alone device | Same |
| Design and
Construction | Welded frame onto which is mounted the
sterilization chamber along with a variety of
instruments and components, and controls, piping, all
of which is housed in covered frame as main
sterilizer.
The vacuum pump is housed in a frame with a cover
and configured separately, and connected to the main
sterilizer through a pumping pipe. | Welded frame onto which is mounted the sterilization
chamber along with a variety of instruments and
components, controls, piping, and vacuum pump, all
of which is housed in covered frame | Same Components as
Predicate with a
different configuration |
| Chamber Volume | 7 L | 14 L | Smaller than Predicate |
| Weight | Main sterilizer: 44.1 lbs (20 kg)
Pump module: 46.3 lbs (21 kg) | 147 lbs (67 kg) | Lighter than Predicate |
| Max Power | 1000 W | 1000 W | Same |
| Control System | Embedded Linux | Embedded Linux | Same |
| Internal process monitor | | | |
| Temperature | Chamber and vaporizer thermocouple | Chamber and vaporizer thermocouple | Same |
| Pressure | Chamber pressure transducers | Chamber pressure transducers | Same |
| Sterilant
Concentration | None | None | Same |
| Operational
Principle | Sterilization of the intended devices by exposure
under controlled conditions of pressure, temperature,
and time | Sterilization of the intended devices by exposure
under controlled conditions of pressure, temperature,
and time | Same |
| Operational
Parameters | Low pressure (vacuum; sub-atmospheric down to 3
Torr) and temperature (60°C) | Low pressure (vacuum; sub-atmospheric down to 3
Torr) and temperature (60°C) | Same |
| Pre-processing
Requirements | Cleaned, rinsed, and dried devices | Cleaned, rinsed, and dried devices | Same |
| | Subject Device | Predicate Device | Comparison |
| | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Same |
| Devices | Reusable metal and non-metal medical devices that
are used in healthcare facilities, including those that
are sensitive to heat and moisture | Reusable metal and non-metal medical devices that
are used in healthcare facilities, including those that
are sensitive to heat and moisture | Same |
| Sterilization Cycles | One (1) pre-programmed; approximately 18 minutes | One (1) pre-programmed; approximately 36 minutes | Similar; Shortened
cycle compared to
Predicate |
| Sterilant | | | |
| Model Name | STERLOAD™ mini | STERLOAD™ | Different |
| Type | Cassette type (unit dose) | Cassette type (unit dose) | Same |
| Sterilant | 58-59.5% aqueous solution of hydrogen peroxide | 58-59.5% aqueous solution of hydrogen peroxide | Same |
| Shelf Life | 12 months | 12 months | Same |
| Monitoring accessories | | | |
| Biological
Indicator | Self-contained biological indicator, Geobacillus
stearothermophilus | Self-contained biological indicator, Geobacillus
stearothermophilus | Same |
| Process Challenge
Device /
Routine Test Pack | Self-contained biological indicator, Geobacillus
stearothermophilus | Self-contained biological indicator, Geobacillus
stearothermophilus | Same |
| Chemical Indicator | Terragene® CI Strips and Tapes | Terragene® CI Strips and Tapes | Same |
| Miscellaneous (Sterilization wrap) * | | | |
| Load Packaging | Tyvek® and PET/LLDPE film | Tyvek® and PET/LLDPE film | Same |
9
10
- Denotes revision made to correct manufacturing material (previously listed as Tyvek®/HDPE)
Technological differences between the STERLINK mini sterilizer and the predicate device are minimal and include:
- · The STERLINK mini sterilizer has a smaller sterilization chamber volume, which is lighter and requires separated pump module.
11
Performance Data A.4
| The non-clinical tests performed are listed in the table below. | |||
|---|---|---|---|
| -- | -- | ----------------------------------------------------------------- | -- |
| Test | Purpose | Acceptable criteria | Result |
|---|---|---|---|
| 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 | ||
| Test | Purpose | Acceptable criteria | Result |
| 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 |
18
| Performance Test | Purpose | Acceptable criteria | Result |
|---|---|---|---|
| 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® | Pass | ||
| Tensile strength of plastic film | To confirm the physical properties of the sterilized | ||
| device at shelf life in accordance with ASTM F1980- | The physical properties must meet the criteria | ||
| specified by the manufacturer. | Pass | ||
| Seal strength | 16, ASTM D5035-11, ASTM D882, ASTM F88, and | ||
| ASTM D1922-20. | Pass | ||
| Tear resistance | 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 |
19
C. Sterilization Process Indicator for STERLINK™ Sterilizer
C.1 Device Description
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.
C.2 Indications for Use / Intended Use
The subject and predicate device have the same intended use. The specific indications for use differ only in the identification of the appropriate sterilization cycles. The revised indications for use are as follows:
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.
20
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 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
C.3 Technical Characteristics in Comparison to Predicate Devices
A summary of the technical characteristics of the subject device and predicate device can be found in the table below.
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Sponsor | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Same |
| Device Name | Sterilization Process Indicator for | ||
| STERLINKTM Sterilizer | |||
| Terragene Bionova® SCBI (BT96); | |||
| Terragene Bionova® Reader | |||
| Incubators (IC10/20FRLCD, Mini-Bio); | |||
| Terragene Chemdye® (CD42); | |||
| Terragene Cintape® (CT40) | Terragene Bionova® SCBI (BT96); | ||
| Terragene Bionova® Reader | |||
| Incubators (IC10/20FRLCD, Mini-Bio); | |||
| Terragene Chemdye® (CD42); | |||
| Terragene Cintape® (CT40) | Same | ||
| 510(k) | |||
| Number | - | K212193 | - |
| Manufacturer | Terragene® S.A. | Terragene® S.A. | Same |
| Device | |||
| Classification | |||
| Name | Sterilization Process Indicator | Sterilization Process Indicator | Same |
| Classification | |||
| Product Code | FRC (biological indicators) | ||
| JOJ (chemical indicators) | FRC (biological indicators) | ||
| JOJ (chemical indicators) | Same | ||
| Regulation | |||
| Number | 21 CFR 880.2800 | 21 CFR 880.2800 | Same |
21
| Subject Device | Predicate Device | Comparison | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications for | |||||||||||
| Use | 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® 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 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 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. | Similar; | ||||||||||
| Expanded to | |||||||||||
| include | |||||||||||
| additional | |||||||||||
| device and its | |||||||||||
| operating | |||||||||||
| mode | |||||||||||
| 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. | 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 self-contained biological indicator | ||||||||||
| and chemical processing indicators are | |||||||||||
| intended for use with the | |||||||||||
| STERLINKTM FPS-15s Plus when | |||||||||||
| operating in chamber mode. | |||||||||||
| Intended Use: | |||||||||||
| Cycles | Vaporized Hydrogen Peroxide Models Cycle BT96, | ||||||||||
| CD42, | |||||||||||
| CT40 STERLINKTM FPS-15s | |||||||||||
| Plus - Chamber mode | |||||||||||
| STERLINK mini - | |||||||||||
| Chamber mode | Vaporized Hydrogen Peroxide Models Cycle BT96, | ||||||||||
| CD42, | |||||||||||
| CT40 STERLINKTM FPS-15s | |||||||||||
| Plus - Chamber mode | Similar; | ||||||||||
| Expanded to | |||||||||||
| include | |||||||||||
| additional | |||||||||||
| device and its | |||||||||||
| operating | |||||||||||
| mode |
22
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Terragene Bionova® SCBI (BT96) | |||
| Type of | |||
| Biological | |||
| Indicator | Self-Contained | Self-Contained | Same |
| Organism | |||
| Spore | |||
| Species | |||
| Strain | Geobacillus stearothermophilus | ||
| ATCC 7953 spores inoculated on a | |||
| strip (spore carrier) | Geobacillus stearothermophilus | ||
| ATCC 7953 spores inoculated on a | |||
| strip (spore carrier) | Same | ||
| Viable Spore | |||
| Population | ≥ 106 | ≥ 106 | Same |
| Resistance | |||
| characteristics | D-value | ||
| Survival time/Kill window | D-value | ||
| Survival time/Kill window | Same | ||
| Intended | |||
| Sterilization | |||
| Cycles | STERLINKTM FPS-15s Plus - | ||
| Chamber mode (overall cycle: 36 | |||
| minutes) | |||
| STERLINK mini - Chamber mode | |||
| (overall cycle: 18 minutes) | STERLINKTM FPS-15s Plus - | ||
| Chamber mode (overall cycle: 36 | |||
| minutes) | Similar; | ||
| Expanded to | |||
| include | |||
| additional | |||
| device and its | |||
| operating | |||
| mode | |||
| Shelf Life | 2 years | 2 years | Same |
| Terragene Chemdye® (CD42), Terragene Chemdye® (CT40) | |||
| Intended | |||
| Sterilization | |||
| Cycles | STERLINKTM FPS-15s Plus - | ||
| Chamber mode (overall cycle: 36 | |||
| minutes) | |||
| STERLINK mini - Chamber mode | |||
| (overall cycle: 18 minutes) | STERLINKTM FPS-15s Plus - | ||
| Chamber mode (overall cycle: 36 | |||
| minutes) | Similar; | ||
| Expanded to | |||
| include | |||
| additional | |||
| device and its | |||
| operating | |||
| mode | |||
| Device design | Strip, Tape | Strip, Tape | Same |
| Color Change | |||
| upon Exposure | |||
| to H2O2 | CD42: red to yellow | ||
| CT40: purple to green | CD42: red to yellow | ||
| CT40: purple to green | Same | ||
| Recommended | |||
| Storage | |||
| Conditions | Dry place, away from sunlight, at | ||
| temperature between 10-30°C, 30- | |||
| 80% relative humidity. Do not wet. | |||
| Do not store close to sterilizing | |||
| agents. | Dry place, away from sunlight, at | ||
| temperature between 10-30°C, 30-80% | |||
| relative humidity. Do not wet. Do not | |||
| store close to sterilizing agents. | Same | ||
| Shelf Life | 5 years | 5 years | Same |
The subject and predicate devices are identical with respect to the organism, accessories, spore population, resistance characteristics, culture conditions, carrier materials, packaging, storage conditions and claimed shelf life. The only difference between the subject and predicate devices
23
are the proposed indications for use, to label the indicators for use with the STERILINK mini when operating in chamber mode.
C.4 Performance Data
The non-clinical tests performed are listed in the table below.
| Item | Test | Purpose | Acceptable criteria | Result |
|---|---|---|---|---|
| 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 |
24
Clinical Data
This submission does not contain any data from clinical testing
Conclusions
The conclusions drawn from the nonclinical tests demonstrate that the subject devices, STERLINK mini Sterilizer with STERLOAD mini Cassette, Tyvek Roll with CI for STERLINK Sterilizer, and Sterilization Process Indicator for STERLINK Sterilizer: Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42) and Terragene Cintape (CT40) are as safe, as effective, and perform as well as or better than the legally marketed predicate devices, STERLINK FPS-15s Plus Sterilizer with STERLOAD™ Cassette, Tyvek® Roll with CI for STERLINK™ Sterilizer, and Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), Terragene Cintape® (CT40).