(30 days)
No
The document describes a vaporized hydrogen peroxide sterilizer and associated accessories (cassette, packaging, biological and chemical indicators). There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The technology described is standard sterilization and indicator technology.
No.
The device is a sterilizer that disinfects medical instruments, making it a reprocessing device, not a therapeutic one.
No
Explanation: The device described, the STERLINK Plus sterilizer, is intended for sterilizing medical devices, not for diagnosing medical conditions in patients. While it ensures devices are safe for use by sterilizing them, this is a maintenance function, not a diagnostic one.
No
The device description clearly outlines physical components such as a sterilizer, pump module, cassette, Tyvek® rolls, biological indicators, and chemical indicators. While there is mention of software standards (IEC 62304) in the performance studies, the core functionality and components are hardware-based.
Based on the provided text, the devices described are not IVDs (In Vitro Diagnostics).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Intended Use: The intended use of the STERLINK Plus sterilizer and its associated components (cassette, Tyvek® roll, biological and chemical indicators) is for the sterilization of reusable medical devices. This process is performed on the devices themselves, not on specimens from a patient.
- Device Description: The descriptions clearly outline the function of each component in the sterilization process, which is to inactivate microorganisms on medical instruments.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, diagnosing conditions, or providing information about a patient's health based on laboratory tests.
Therefore, these devices fall under the category of sterilization equipment and accessories for medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The STERLINK Plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal 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 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:
- 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 validation studies were performed using a validation load with a total weight of 3 .97 lbs.
- An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter
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 compatibility for use in the Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, are as follows: Aluminum 6061, Stainless Steel 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50).
The maximum load weight that can be placed in the Tyvek® roll is:
- 3.97 pounds (1.8kg) for CHAMBER mode of FPS-15s Plus
- 3.97 pounds (1.8kg) for CHAMBER mode of STERLINK plus sterilizer
- 1.54 pounds (0.7kg) 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 10^6 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 sterlization 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 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 plus sterilizer with STERLOAD™ 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 plus and STERLOAD™ cassette, respectively. The STERLOAD™ cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (HzO2) which is utilized as the sterilant.
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used 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 STERLINK™ 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 Mini-Bio 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.
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)
Non-clinical tests were performed on the predicate using the following standards and/or guidance documents:
- Risk management: ISO 14971 (Pass)
- Human factors and usability engineering: Guidance for Industry and Food and Drug Administration Staff, “Appling Human Factors and Usability Engineering to Medical Devices”, issued on February 3, 2016; IEC 62366-1 (Pass)
- Biocompatibility: ISO 10993-5 (Pass)
- Software validation: IEC 62304; Guidance for Industry and Food and Drug Administration Staff, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Device”, issued on May 11, 2005 (Pass)
- Electrical safety: IEC 60601-1; IEC 61010-1 (Pass)
- Electromagnetic compatibility (EMC): IEC 60101-1-2 (Pass)
- Resistance validation for biological indicator test: ISO 11138-1:2017 (Pass)
- Lumen sterilization: ISO 14937:2009 (Pass)
- Surface sterilization: ISO 11737-1:2018; ISO 11737-2:2009 (Pass)
- Mated surface sterilization: ISO 14937:2009; ISO 11737-1:2018; ISO 11737-2:2009 (Pass)
- Simulated use test: ASTM E1837-96(2014); ISO 11737-1:2018 (Pass)
- In-use test: ASTM E1837-96(2014) (Pass)
- Sporicidal activity test: AOAC 966.04 (Pass)
- Bacteriostasis test: ISO 11737-1:2018 (Pass)
- Material compatibility test: ASTM D638; ASTM E8/E8M-16ae1; ASTM D790; ASTM E290-14; ASTM D256; ASTM E23-18; ASTM E1164; ASTM D3985; ASTM F1249 (Pass)
- Delivery validation: ASTM D4169-14 (Pass)
- Hydrogen peroxide gas detection test: OSHA analytical method 1019 (Pass)
For Tyvek® Roll with CI for STERLINK™ Sterilizer:
- Sterilization efficacy test: ISO 14937:2009 (Pass)
- CI of sterilization roll validation: ANSI/AAMI/ISO 11140-1:2014 (Pass)
- Shelf-life (Internal pressurization test): ASTM F1980-16:2016; ASTM F1140/F1140M-13:2013 (Pass)
- Shelf-life (Visual inspection test): ASTM F1980-16:2016; ASTM F1886/F1886M-16:2016 (Pass)
- Shelf-life (Dye penetration test): ASTM F1980-16:2016; ASTM F1929-15:2015 (Pass)
- Shelf-life (Tensile strength of Tyvek®): ASTM F1980-16:2016; ASTM D5035-11:2019 (Pass)
- Shelf-life (Tensile strength of plastic film): ASTM F1980-16:2016; ASTM D882 (Pass)
- Shelf-life (Seal strength): ASTM F1980-16:2016; ASTM F88 (Pass)
- Shelf-life (Tear resistance): ASTM F1980-16:2016; ASTM D1922-20 (Pass)
- Shelf-life (Microbial Barrier Test): ASTM F1980-16:2016; DIN 58953-6:2016 (Pass)
- CI of sterilization roll validation: ANSI/AAMI/ISO 11140-1:2014 (Pass)
- Residual sterilant on Tyvek® validation: Manufacturer's internal standard (Pass)
For Sterilization Process Indicator for STERLINK™ Sterilizer:
- Self-Contained Biological Indicator (BT96) Resistance validation for biological indicator test: ISO 11138-1:2017 (Pass)
- Self-Contained Biological Indicator (BT96) BI & Test pack validation test: Manufacturer's internal standard (Pass)
- Chemical Indicator (CD42, CT40) Chemical indicator validation: Manufacturer's internal standard (Pass)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
STERLINK FPS-15s Plus Sterilizer with STERLOAD™ Cassette (K212200), Tyvek® Roll with CI for STERLINK™ Sterilizer (K212198), Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), Terragene Cintape® (CT40) - (K212193)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 25, 2023
Plasmapp Co., Ltd. % Candace Cederman Principal Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401
Re: K231169
Trade/Device Name: STERLINK™ plus Sterilizer with STERLOAD™ Cassette, Tyvek Roll with CI 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: April 24, 2023 Received: April 25, 2023
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.
-2
Christopher K. Dugard
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) K231169
Device Name STERLINK Plus Sterilizer with STERLOAD Cassette
Indications for Use (Describe)
The STERLINK Plus sterilizer with STERLOAD cassette is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed, and dried reusable metal 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 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 validation studies were performed using a validation load with a total weight of 3 .97 lbs.
| 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."
3
Indications for Use
510(k) Number (if known) K231169
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 compatibility for use in the Tyvek® Roll with CI for STERLINK Sterilizer, when used in CHAMBER mode, are as follows: Aluminum 6061, Stainless Steel 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50).
The maximum load weight that can be placed in the Tyvek® roll is:
- · 3.97 pounds (1.8kg) for CHAMBER mode of FPS-15s Plus
- 3.97 pounds (1.8kg) for CHAMBER mode of STERLINK plus sterilizer
- 1.54 pounds (0.7kg) 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) | X |
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) K231169
Device Name
Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42), and Terragene Cintape® (CT40)
Indications for Use (Describe)
Terragene Bionova® SCBI (BT96) is a self-contained biological indicator inoculated with viable 10^6 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 sterlization 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 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."
5
Image /page/5/Picture/1 description: The image shows the word "plasmapp" in a teal color. To the left of the word is a teal asterisk symbol. The font of the word is sans-serif and the letters are lowercase. The image is simple and clean.
510(k) Summary for K231169 [as required by 21 CFR 807.92(c)]
STERLINK plus Sterilizer with STERLOAD™ Cassette Tyvek® Roll with CI for STERLINK™ Sterilizer Sterilization Process Indicator for STERLINK™ Sterilizer
General Information
| Applicant/Submitter: | Plasmapp Co., Ltd.
BVC-111, 125, Gwahak-ro,
Yuseong-gu, Daejeon, 34141,
Rep. of Korea (South Korea)
Tel: +82 (0)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: | May 22, 2023 |
Device Name and Code
| Device Trade Name: | A. STERLINK plus Sterilizer with STERLOADTM Cassette
B. Tyvek® Roll with CI for STERLINKTM Sterilizer
C. 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 |
| Predicate Device: | STERLINK FPS-15s Plus Sterilizer with STERLOAD™ Cassette
(K212200)
Tyvek® Roll with CI for STERLINK™ Sterilizer (K212198)
Terragene Bionova® SCBI (BT96), Terragene Bionova® Reader
Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42),
Terragene Cintape® (CT40) - (K212193) |
STERLINK plus Sterilizer with STERLOAD™ Cassette A.
Device Description A.1
The STERLINK plus sterilizer with STERLOAD™ 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 plus and STERLOAD™ cassette, respectively. The STERLOAD™ cassette contains 58-59.5% (weight concentration) of hydrogen peroxide (HzO2) which is utilized as the sterilant.
Indications / Intended Use A.2
The Intended use of the subject device is identical to that of the predicate device cleared under K212200.
7
The STERLINK 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: ●
- An inside diameter of 2.4 mm or larger and a length of 280 mm or shorter O
- 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 3.97 lbs.
A.3 Technical Characteristics in Comparison to Predicate Devices
The STERLINK plus sterilizer is substantially equivalent to the following legally marketed predicate device.
| | Subject Device | Predicate Device | Substantially
Equivalent
or Difference |
|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Device Name
(Model) | STERLINK plus Sterilizer
with STERLOAD™ Cassette | FPS-15s Plus Sterilizer with
STERLOAD™ Cassette | |
| 510(k) Number | - | K212200 | |
| Product Code | MLR | MLR | Identical |
| Intended Use | The STERLINK plus sterilizer
with STERLOAD™ 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 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: | The STERLINK™ FPS-15s Plus
sterilizer with STERLOAD™
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™ 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: | Identical |
| | Subject Device | Predicate Device | Substantially
Equivalent
or Difference |
| Device Name
(Model) | STERLINK plus Sterilizer
with STERLOADTM Cassette | FPS-15s Plus Sterilizer with
STERLOADTM Cassette | |
| | - An inside diameter of 2.4 m
m or larger and a length of
280 mm or shorter | - 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 validation
studies were performed using a
validation load with a total
weight of 3.97 lbs. | *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 3.97 lbs. | |
| Physical
Characteristic | Self-contained, stand-alone
device | Self-contained, stand-alone device | Identical |
| Design and
Construction | 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 | 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 | Identical |
| Chamber Volume | 14 L | 14 L | Identical |
| Max Power | 1000 W | 1000 W | Identical |
| Weight | 128 lbs. (58kg) | 128 lbs. (58kg) | Identical |
| Control system | Embedded Linux | Embedded Linux | Identical |
| Software | IEC 62304 | IEC 62304 | Identical |
| Electrical Safety | IEC 60601-1
IEC 61010-1 | IEC 60601-1
IEC 61010-1 | Identical |
| Electromagnetic
Compatibility
(EMC) | IEC 60101-1-2 | IEC 60101-1-2 | Identical |
| Labeling | STERLINK plus product label,
User manual | FPS-15s Plus product label, User
manual | Differ only in
name |
| | Internal Process Monitor | | |
| Temperature | Chamber and vaporizer
thermocouple | Chamber and vaporizer
thermocouple | Identical |
| Pressure | Chamber pressure transducers | Chamber pressure transducers | Identical |
| 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 | Identical |
| | Low pressure (vacuum; sub-
atmospheric down to 3 Torr) | Low pressure (vacuum; sub-
atmospheric down to 3 Torr) | Identical |
| | Subject Device | Predicate Device | Substantially
Equivalent
or Difference |
| Device Name
(Model) | STERLINK plus Sterilizer
with STERLOAD™ Cassette | FPS-15s Plus Sterilizer with
STERLOAD™ Cassette | Identical |
| Pre-processing
Requirements | Cleaned, rinsed, and dried
devices | Cleaned, rinsed, and dried devices | Identical |
| 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 | Identical |
| Sterilization
Cycles | One (1) pre-programmed;
approximately 36 minutes | One (1) pre-programmed;
approximately 36 minutes | Identical |
| | Sterilant | | |
| Model Name | STERLOAD™ | STERLOAD™ | Identical |
| Type | Cassette type (unit dose) | Cassette type (unit dose) | Identical |
| Sterilant | 59% aqueous solution of
hydrogen peroxide | 59% aqueous solution of hydrogen
peroxide | Identical |
| | Monitoring Accessories | | |
| Biological
Indicator | Self-contained biological
indicator,
Geobacillus stearothermophilus | Self-contained biological indicator,
Geobacillus stearothermophilus | Identical |
| Process Challenge
Device /
Routine Test Pack | Self-contained biological
indicator,
Geobacillus stearothermophilus | Self-contained biological indicator,
Geobacillus stearothermophilus | Identical |
| Chemical
Indicator | Terragene® CI Strips and Tapes | Terragene® CI Strips and Tapes | Identical |
| | Miscellaneous (Sterilization wrap) | | |
| Load Packaging | Tyvek® and PET/LLDPE film | Tyvek®/HDPE pouches | Substantially
Equivalent |
8
9
No technological differences exist between the subject and predicate devices. The two devices differ only in name.
Performance Data A.4
Non-clinical tests were performed on the predicate using the following standards and/or guidance documents:
| Test | Standard/Guidance Document | Result |
|---|---|---|
| Risk management | ISO 14971 | |
| Human factors and usability | ||
| engineering | Guidance for Industry and Food and Drug | |
| Administration Staff, “Appling Human Factors and | ||
| Usability Engineering to Medical Devices”, issued on | ||
| February 3, 2016 | Pass | |
| IEC 62366-1 | ||
| Biocompatibility | ISO 10993-5 | Pass |
| Test | Standard/Guidance Document | Result |
| Software validation | IEC 62304 | |
| Guidance for Industry and Food and Drug | ||
| Administration Staff, “Guidance for the Content of | ||
| Premarket Submissions for Software Contained in | ||
| Medical Device”, issued on May 11, 2005 | Pass | |
| Electrical safety | IEC 60601-1 | |
| IEC 61010-1 | Pass | |
| Electromagnetic compatibility | ||
| (EMC) | IEC 60601-1-2 | Pass |
| Resistance validation for | ||
| biological indicator test | ISO 11138-1:2017 | Pass |
| Lumen sterilization | ISO 14937:2009 | Pass |
| Surface sterilization | ISO 11737-1:2018 | |
| ISO 11737-2:2009 | Pass | |
| Mated surface sterilization | ISO 14937:2009 | |
| ISO 11737-1:2018 | ||
| ISO 11737-2:2009 | Pass | |
| Simulated use test | ASTM E1837-96(2014) | |
| ISO 11737-1:2018 | Pass | |
| In-use test | ASTM E1837-96(2014) | Pass |
| Sporicidal activity test | AOAC 966.04 | Pass |
| Bacteriostasis test | ISO 11737-1:2018 | Pass |
| Material compatibility test | ASTM D638 | |
| ASTM E8/E8M-16ae1 | ||
| ASTM D790 | ||
| ASTM E290-14 | ||
| ASTM D256 | ||
| ASTM E23-18 | ||
| ASTM E1164 | ||
| ASTM D3985 | ||
| ASTM F1249 | Pass | |
| Delivery validation | ASTM D4169-14 | Pass |
| Hydrogen peroxide gas detection | ||
| test | OSHA analytical method 1019 | Pass |
10
B. Tyvek® Roll with CI for STERLINK™ Sterilizer
Device Description B.1
Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to be used to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are
11
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 STERLINK™ 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).
B.2 Indications / Intended Use
The Intended use of the subject device is identical to that of the predicate device cleared under K212198.
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 304, Stainless Steel 316L, Titanium, Acrylonitrile Butadiene Styrene (ABS), High Density Polyethylene (HPDE), Polypropylene (PP), Polytetrafluorethylene (PTFE) and Silicone (Hardness 50).
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 .
12
B.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 | |
|---|---|---|---|
| 510(k) Sponsor | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Identical |
| Manufacturer | Sigma Medical Supplies Corp. | Sigma Medical Supplies Corp. | Identical |
| Device Name | Tyvek® Roll with CI for | ||
| STERLINK™ Sterilizer | Tyvek® Roll with CI for STERLINK™ | ||
| Sterilizer | Identical | ||
| 510(k) Number | - | K212198 | - |
| Device | |||
| Classification | |||
| Name | 1) Sterilization Wrap |
- Sterilization Process Indicator | 1) Sterilization Wrap
- Sterilization Process Indicator | Identical |
| Classification
Product Code | 1) FRG - JOJ | 1) FRG
- JOJ | Identical |
| Regulation
Number | 1) 21 CFR 880.6850 - 21 CFR 880.2800 | 1) 21 CFR 880.6850
- 21 CFR 880.2800 | Identical |
| Intended Use | 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 304, 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). | 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 TM
Sterilizer, when used in Chamber mode,
are as follows: Aluminum 5052,
Aluminum 6061, Stainless Steel 304,
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 lbs.
(1.8 kg).
The roll is printed with a chemical
indicator bar which is a process | Identical |
13
| Subject Device | Predicate Device | Comparison | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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 | The Tyvek® Roll with CI for | ||||||||||
| STERLINK™ Sterilizer is offered in | |||||||||||
| the follow 1 type: | |||||||||||
| • Sterilization roll, Flat | |||||||||||
| Pouch Types | Sterilization roll, Flat | Sterilization roll, Flat | Identical | ||||||||
| Device models | |||||||||||
| (Configurations | |||||||||||
| /Dimensions) | Sterilization Roll, Flat | ||||||||||
| Model Dimensions FR400100 400 mm × 100 M | Sterilization Roll, Flat | ||||||||||
| Model Dimensions FR400100 400 mm × 100 M | Identical | ||||||||||
| Material | |||||||||||
| Composition | Tyvek®, PET, PE, Water, | ||||||||||
| CH3COOH, Alcohol, n-Heptane | |||||||||||
| adhesive, Hydrogen peroxide vapor | |||||||||||
| Process Indicator Print Ink | Tyvek®, PET, PE, Water, CH3COOH, | ||||||||||
| Alcohol, n-Heptane adhesive, | |||||||||||
| Hydrogen peroxide vapor Process | |||||||||||
| Indicator Print Ink | Identical | ||||||||||
| Sterilization | |||||||||||
| Cycle | STERLINK plus - Chamber mode | ||||||||||
| (overall cycle: 36 minutes) | STERLINK™ FPS-15s Plus - Chamber | ||||||||||
| mode (overall cycle: 36 minutes) | Identical | ||||||||||
| Design Feature | Sterilization roll, Flat: This roll is | ||||||||||
| made from a Tyvek® and plastic film | |||||||||||
| that are heat sealed on opposite two | |||||||||||
| sides. It will be cut into the suitable | |||||||||||
| length and the opened sides will be | |||||||||||
| heat-sealed. The indicators printed | |||||||||||
| on the Tyvek® are the same with the | |||||||||||
| self-sealing sterilization roll. | Sterilization roll, Flat: This roll is | ||||||||||
| made from a Tyvek® and plastic film | |||||||||||
| that are heat sealed on opposite two | |||||||||||
| sides. It will be cut into the suitable | |||||||||||
| length and the opened sides will be | |||||||||||
| heat-sealed. The indicators printed on | |||||||||||
| the Tyvek® are the same with the self- | |||||||||||
| sealing sterilization roll. | Identical | ||||||||||
| Chemical | |||||||||||
| Indicator | |||||||||||
| Device Design | The color of the Chemical Indicator | ||||||||||
| changes from red to blue (or lighter) | |||||||||||
| when exposed to hydrogen peroxide | The color of the Chemical Indicator | ||||||||||
| changes from red to blue (or lighter) | |||||||||||
| when exposed to hydrogen peroxide | Identical |
B.4 Performance data
The Tyvek® Roll with CI for STERLINK™ Sterilizer has the identical intended use and indication for use as the predicate device. Both the size and material of subject device are same as the predicate device.
There are no changes to the mechanical constructions of the device between FPS-15s Plus and STERLINK plus that would impact previously executed performance and safety test.
14
| Performance Testing | Standard | |
|---|---|---|
| Sterilant | Sterilization efficacy test | ISO 14937:2009 |
| Penetration | CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1:2014 |
| Shelf-life | Internal pressurization test | ASTM F1980-16:2016 |
| ASTM F1140/F1140M-13:2013 | ||
| Visual inspection test | ASTM F1980-16:2016 | |
| ASTM F1886/F1886M-16:2016 | ||
| Dye penetration test | ASTM F1980-16:2016 | |
| ASTM F1929-15:2015 | ||
| Tensile strength of Tyvek® | ASTM F1980-16:2016 | |
| ASTM D5035-11:2019 | ||
| Tensile strength of plastic film | ASTM F1980-16:2016 | |
| ASTM D882 | ||
| Seal strength | ASTM F1980-16:2016 | |
| ASTM F88 | ||
| Tear resistance | ASTM F1980-16:2016 | |
| ASTM D1922-20 | ||
| Microbial Barrier Test | ASTM F1980-16:2016 | |
| DIN 58953-6:2016 | ||
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1:2014 | |
| Residual sterilant on Tyvek® validation | Internal test standard |
Sterilization Process Indicator for STERLINK™ Sterilizer C.
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 Mini-Bio 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
15
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 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 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 plus sterilizer
- CHAMBER mode of STERLINK mini .
16
C.3 Technical Characteristics in Comparison to Predicate Devices
The sterilization process indicators for the STERLINK™ sterilizer are identical to the predicate devices cleared under K212193.
| Subject Device | Predicate Device | Comparison | |
|---|---|---|---|
| Sponsor | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Identical |
| Device Name | 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) | Identical | ||
| 510(k) | |||
| Number | - | K212193 | - |
| Manufacturer | Terragene® S.A. | Terragene® S.A. | Identical |
| Device | |||
| Classification | |||
| Name | Sterilization Process Indicator | Sterilization Process Indicator | Identical |
| Classification | |||
| Product Code | FRC (biological indicators) | ||
| JOJ (chemical indicators) | FRC (biological indicators) | ||
| JOJ (chemical indicators) | Identical | ||
| Regulation | |||
| Number | 21 CFR 880.2800 | 21 CFR 880.2800 | Identical |
| Subject Device | Predicate Device | Comparison | |
| Sponsor | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Identical |
| 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. | Identical | ||
| 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. | |||
| 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 the STERLINK plus when | |||
| operating in chamber 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. | |||
| The self-contained biological | |||
| indicator and chemical processing | |||
| indicators are intended for use with | |||
| the STERLINKTM FPS-15s Plus | |||
| when operating in chamber mode. | |||
| Subject Device | Predicate Device | Comparison | |
| Sponsor | Plasmapp Co., Ltd. | Plasmapp Co., Ltd. | Identical |
| Intended Use: | |||
| Cycles | Models | ||
| Cycle | |||
| BT96 | |||
| STERLINK plus- | |||
| CD42 | |||
| Chamber mode | |||
| CT40 | Models | ||
| Cycle | |||
| BT96 | |||
| STERLINK FPS- | |||
| CD42 | |||
| 15s plus- | |||
| CT40 | |||
| Chamber mode | Identical cycles | ||
| Differ only in name | |||
| Terragene Bionova® SCBI (BT96) | |||
| Type of | |||
| Biological | |||
| Indicator | Self-Contained | Self-Contained | Identical |
| 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) | Identical | ||
| Viable Spore | |||
| Population | ≥ 106 | ≥ 106 | Identical |
| Resistance | |||
| characteristics | D -value | ||
| Survival time/Kill window | D -value | ||
| Survival time/Kill window | Identical | ||
| Intended | |||
| Sterilization | |||
| Cycles | STERLINK plus - Chamber mode | ||
| (overall cycle: 36 minutes) | STERLINKTM FPS-15s Plus | ||
| Chamber mode (overall cycle: 36 | |||
| minutes) | Identical | ||
| Shelf Life | 2 years | 2 years | Identical |
| Terragene Chemdye® (CD42), Terragene Chemdye® (CT40) | |||
| Intended | |||
| Sterilization | |||
| Cycles | STERLIN plus - Chamber mode | ||
| (overall cycle: 36 minutes) | STERLINKTM FPS-15s Plus | ||
| Chamber mode (overall cycle: 36 minutes) | Identical | ||
| Device design | Strip, Tape | Strip, Tape | Identical |
| Color Change | |||
| upon Exposure | |||
| to H2O2 | CD42: red to yellow | ||
| CT40: purple to green | CD42: red to yellow | ||
| CT40: purple to green | Identical | ||
| 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. | Identical | ||
| Shelf Life | 5 years | 5 years | Identical |
| 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 are the proposed indications for use, to label the indicators for use with the | |||
| STERLINK plus when operating in chamber mode. |
17
18
19
C.4 Performance Data
| Item | Test | Standard/Guidance Document | Result |
|---|---|---|---|
| Self-Contained | |||
| Biological | |||
| Indicator | |||
| (BT96) | Resistance validation for | ||
| biological indicator test | ISO 11138-1:2017 | Pass | |
| BI & Test pack validation test | Manufacturer's internal standard | Pass | |
| Chemical | |||
| Indicator | |||
| (CD42, CT40) | Chemical indicator | ||
| validation | Manufacturer's internal standard | Pass |
Non-clinical tests were performed using following standards:
Clinical Data:
This submission does not contain any data from clinical testing.
Conclusions
The conclusions drawn from the nonclinical testing demonstrate that the subject devices, STERLINK plus Sterilizer with STERLOAD 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, Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye (CD42), and Terragene Cintape (CT40)