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.

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

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

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.

AI/ML Overview

This document describes the acceptance criteria and supporting study for the STERLINK™ plus Sterilizer with STERLOAD™ Cassette and associated components (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)).

The document asserts substantial equivalence to a predicate device (STERLINK™ FPS-15s Plus Sterilizer with STERLOAD™ Cassette, K212200), and therefore, the acceptance criteria are generally met by demonstrating compliance with recognized standards and establishing equivalence in performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission demonstrating substantial equivalence to a predicate, specific numerical "acceptance criteria" for novel performance metrics are not explicitly stated in the provided text as they would be for a de novo device. Instead, the acceptance criteria are implicitly that the device performs as well as or better than the predicate device and meets established standards for sterilization, packaging, and indicators. The reported device performance is presented as "Pass" for compliance with these standards.

Acceptance Criteria Category	Specific Criteria / Standard Met	Reported Device Performance
STERLINK™ plus Sterilizer with STERLOAD™ Cassette
Risk management	ISO 14971	Pass
Human factors and usability engineering	Guidance / IEC 62366-1	Pass
Biocompatibility	ISO 10993-5	Pass
Software validation	IEC 62304 / FDA Guidance	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
Tyvek® Roll with CI for STERLINK™ Sterilizer
Sterilization efficacy test (for sterilant penetration)	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 test standard	Pass
Sterilization Process Indicator (BT96, CD42, CT40)
Resistance validation for biological indicator test (BT96)	ISO 11138-1:2017	Pass
BI & Test pack validation test	Manufacturer's internal standard	Pass
Chemical indicator validation (CD42, CT40)	Manufacturer's internal standard	Pass

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes used for each specific test or the country of origin/provenance of the data. It refers to various ISO and ASTM standards, which typically specify test methodologies and sample size requirements. The studies are non-clinical, likely laboratory-based evaluations to demonstrate performance against these standards. The submission originates from Plasmapp Co., Ltd. in South Korea, suggesting studies were likely conducted either internally or by contract research organizations, potentially in South Korea, in accordance with international standards. The studies would be prospective in nature, as they are tests performed on the device to prove its compliance with standards and equivalence.

Sample Size: Not explicitly stated for individual tests.
Data Provenance: Not explicitly stated (e.g., country of origin). The applicant is Plasmapp Co., Ltd., BVC-111, 125, Gwahak-ro, Yuseong-gu, Daejeon, 34141, Rep. of Korea (South Korea).
Retrospective or Prospective: Implied to be prospective as the tests were conducted to demonstrate device performance against defined standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This submission is for a sterilization system and associated components, which are evaluated based on defined physical, chemical, and biological performance standards (e.g., sporicidal activity, material compatibility, chemical indicator color change) rather than interpretation of complex medical images or patient data. Therefore, the concept of "experts establishing ground truth" in the diagnostic AI sense (e.g., radiologists for an imaging device) is not directly applicable here. The "ground truth" is established by the well-defined parameters and pass/fail criteria of the referenced ISO and ASTM standards for sterility, material science, and indicator performance.
The experts involved would be laboratory technicians and engineers performing and verifying the tests, and potentially subject matter experts in sterilization science and engineering within Plasmapp and the regulatory body. Their qualifications are not specified but would be implicit in their roles and adherence to the testing standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. This is a technical performance study against objective standards, not a diagnostic study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a sterilization system and its accessories, not an AI-based diagnostic device intended for use by human readers.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a physical sterilization system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance evaluation of sterilization devices and accessories typically refers to:

Biological inactivation: Complete kill of test microorganisms (e.g., Geobacillus stearothermophilus spores) for sterilizers and biological indicators, confirmed through culture methods.
Physical and chemical parameters: Confirmation that specified physical conditions (temperature, pressure, time) were met and chemical indicators changed appropriately, as defined by industry standards and internal specifications.
Material integrity: No degradation or adverse effects on device materials after sterilization, as per material compatibility tests.
Packaging integrity: Maintenance of sterility barrier, confirmed by physical and microbial barrier tests.

These 'ground truths' are established through validated laboratory tests against international and national standards (ISO, ASTM, AOAC).

8. The sample size for the training set

Not applicable. This is a hardware device (sterilizer, packaging, indicators) and not an AI/machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/machine learning model, there is no training set and therefore no ground truth establishment for a training set.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K231169

Device Name STERLINK Plus Sterilizer with STERLOAD Cassette

Indications for Use (Describe)

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

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."

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Indications for Use

510(k) Number (if known) K231169

Device Name Tyvek® Roll with CI for STERLINK Sterilizer

Indications for Use (Describe)

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 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.

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."

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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® 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.

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."

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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 LLC1783 Forest Drive, Suite 254Annapolis, MD 21401Tel: +1 410 674 2060
Preparation Date:	May 22, 2023

Device Name and Code

Device Trade Name:	A. STERLINK plus Sterilizer with STERLOADTM CassetteB. Tyvek® Roll with CI for STERLINKTM SterilizerC. Terragene Bionova SCBI (BT96), Terragene Bionova ReaderIncubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye(CD42), Terragene Cintape (CT40)
Common Name:	A. Vapor Phase Hydrogen Peroxide Sterilization SystemB. Tyvek® Roll for VH2O2 SterilizerC. Self-contained Biological Indicator, Self-Contained BiologicalIndicator Incubator, Chemical Indicator.

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Classification Name:	A. Ethylene Oxide Gas SterilizerB. Sterilization WrapC. Sterilization Process Indicator
Product Code:	A. MLRB. FRG, JOJC. FRC, JOJ
Regulation Number:	A. 21 CFR 880.6860B. 21 CFR 880.6850, 21 CFR 880.2800C. 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® ReaderIncubators (IC10/20FRLCD, Mini-Bio), Terragene Chemdye® (CD42),Terragene Cintape® (CT40) - (K212193)

STERLINK plus Sterilizer with STERLOAD™ Cassette A.

Device Description A.1

Indications / Intended Use A.2

The Intended use of the subject device is identical to that of the predicate device cleared under K212200.

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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	SubstantiallyEquivalentor Difference
Device Name(Model)	STERLINK plus Sterilizerwith STERLOAD™ Cassette	FPS-15s Plus Sterilizer withSTERLOAD™ Cassette
510(k) Number	-	K212200
Product Code	MLR	MLR	Identical
Intended Use	The STERLINK plus sterilizerwith STERLOAD™ cassette isa vaporized hydrogen peroxidesterilizer intended for use in theterminal sterilization of cleaned,rinsed, and dried reusable metaland nonmetal medical devicesused in healthcare facilities.A pre-programmed sterilizationlumen cycle operates at lowpressure and low temperatureand is thus suitable forprocessing medical devicessensitive to heat and moisture.The STERLINK plus cansterilize*:• Instruments with diffusion-restricted spaces such as thehinged portion of forceps andscissors• Medical devices with a singlestainless-steel lumen with:	The STERLINK™ FPS-15s Plussterilizer with STERLOAD™cassette is a vaporized hydrogenperoxide sterilizer intended for usein the terminal sterilization ofcleaned, rinsed, and dried reusablemetal and nonmetal medicaldevices used in healthcare facilities.A pre-programmed sterilizationlumen cycle operates at lowpressure and low temperature and isthus suitable for processing medicaldevices sensitive to heat andmoisture.The STERLINK™ FPS-15s Pluscan sterilize*:• Instruments with diffusion-restricted spaces such as thehinged portion of forceps andscissors• Medical devices with a singlestainless-steel lumen with:	Identical
	Subject Device	Predicate Device	SubstantiallyEquivalentor Difference
Device Name(Model)	STERLINK plus Sterilizerwith STERLOADTM Cassette	FPS-15s Plus Sterilizer withSTERLOADTM Cassette
	- An inside diameter of 2.4 mm or larger and a length of280 mm or shorter	- An inside diameter of 2.4 mm orlarger and a length of 280 mmor shorter
	*The validation testing for alllumen sizes was conductedusing a maximum of five (5)lumens per load. Hospital loadsshould not exceed the maximumnumber of lumens validated bythis testing. The validationstudies were performed using avalidation load with a totalweight of 3.97 lbs.	*The validation testing for alllumen sizes was conducted using amaximum of five (5) lumens perload. Hospital loads should notexceed the maximum number oflumens validated by this testing.The validation studies wereperformed using a validation loadwith a total weight of 3.97 lbs.
PhysicalCharacteristic	Self-contained, stand-alonedevice	Self-contained, stand-alone device	Identical
Design andConstruction	Welded frame onto which ismounted the sterilizationchamber along with a variety ofinstruments and components,controls, piping, and vacuumpump, all of which is housed incovered frame	Welded frame onto which ismounted the sterilization chamberalong with a variety of instrumentsand components, controls, piping,and vacuum pump, all of which ishoused 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 60601-1IEC 61010-1	IEC 60601-1IEC 61010-1	Identical
ElectromagneticCompatibility(EMC)	IEC 60101-1-2	IEC 60101-1-2	Identical
Labeling	STERLINK plus product label,User manual	FPS-15s Plus product label, Usermanual	Differ only inname
	Internal Process Monitor
Temperature	Chamber and vaporizerthermocouple	Chamber and vaporizerthermocouple	Identical
Pressure	Chamber pressure transducers	Chamber pressure transducers	Identical
OperationalPrinciple	Sterilization of the intendeddevices by exposure undercontrolled conditions ofpressure, temperature, and time	Sterilization of the intended devicesby exposure under controlledconditions ofpressure, 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	SubstantiallyEquivalentor Difference
Device Name(Model)	STERLINK plus Sterilizerwith STERLOAD™ Cassette	FPS-15s Plus Sterilizer withSTERLOAD™ Cassette	Identical
Pre-processingRequirements	Cleaned, rinsed, and drieddevices	Cleaned, rinsed, and dried devices	Identical
Devices	Reusable metal and non-metalmedical devices that are used inhealthcare facilities, includingthose that are sensitive to heatand moisture	Reusable metal and non-metalmedical devices that are used inhealthcare facilities, including thosethat are sensitive to heat andmoisture	Identical
SterilizationCycles	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 ofhydrogen peroxide	59% aqueous solution of hydrogenperoxide	Identical
	Monitoring Accessories
BiologicalIndicator	Self-contained biologicalindicator,Geobacillus stearothermophilus	Self-contained biological indicator,Geobacillus stearothermophilus	Identical
Process ChallengeDevice /Routine Test Pack	Self-contained biologicalindicator,Geobacillus stearothermophilus	Self-contained biological indicator,Geobacillus stearothermophilus	Identical
ChemicalIndicator	Terragene® CI Strips and Tapes	Terragene® CI Strips and Tapes	Identical
	Miscellaneous (Sterilization wrap)
Load Packaging	Tyvek® and PET/LLDPE film	Tyvek®/HDPE pouches	SubstantiallyEquivalent

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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 usabilityengineering	Guidance for Industry and Food and DrugAdministration Staff, “Appling Human Factors andUsability Engineering to Medical Devices”, issued onFebruary 3, 2016	Pass
	IEC 62366-1



Biocompatibility	ISO 10993-5	Pass
Test	Standard/Guidance Document	Result
Software validation	IEC 62304Guidance for Industry and Food and DrugAdministration Staff, “Guidance for the Content ofPremarket Submissions for Software Contained inMedical Device”, issued on May 11, 2005	Pass
Electrical safety	IEC 60601-1IEC 61010-1	Pass
Electromagnetic compatibility(EMC)	IEC 60601-1-2	Pass
Resistance validation forbiological indicator test	ISO 11138-1:2017	Pass
Lumen sterilization	ISO 14937:2009	Pass
Surface sterilization	ISO 11737-1:2018ISO 11737-2:2009	Pass
Mated surface sterilization	ISO 14937:2009ISO 11737-1:2018ISO 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 D638ASTM E8/E8M-16ae1ASTM D790ASTM E290-14ASTM D256ASTM E23-18ASTM E1164ASTM D3985ASTM F1249	Pass
Delivery validation	ASTM D4169-14	Pass
Hydrogen peroxide gas detectiontest	OSHA analytical method 1019	Pass

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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

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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.

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 .

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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 forSTERLINK™ Sterilizer	Tyvek® Roll with CI for STERLINK™Sterilizer	Identical
510(k) Number	-	K212198	-
DeviceClassificationName	1) Sterilization Wrap2) Sterilization Process Indicator	1) Sterilization Wrap2) Sterilization Process Indicator	Identical
ClassificationProduct Code	1) FRG2) JOJ	1) FRG2) JOJ	Identical
RegulationNumber	1) 21 CFR 880.68502) 21 CFR 880.2800	1) 21 CFR 880.68502) 21 CFR 880.2800	Identical
Intended Use	Tyvek® Roll with CI forSTERLINK™ Sterilizer, when usedin CHAMBER mode, is intended toprovide health care workers with aneffective method to enclose devicesintended for sterilization in theSTERLINK™ sterilizer. The deviceis intended to allow sterilization ofenclosed devices and also tomaintain sterility of the encloseddevices until used up to 1 month poststerilization.The materials compatible for use inthe Tyvek® Roll with CI forSTERLINK™ Sterilizer, when usedin Chamber mode, are as follows:Aluminum 5052, Aluminum 6061,Stainless Steel 304, Stainless Steel316L, Titanium, AcrylonitrileButadiene Styrene (ABS), HighDensity Polyethylene (HDPE),Polypropylene (PP),Polytetrafluoroethylene (PTFE) andSilicone (Hardness 50).The maximum load weight that canbe placed in the Tyvek® roll is 3.97pounds (1.8 kg).	Tyvek® Roll with CI for STERLINK™Sterilizer, when used in CHAMBERmode, is intended to provide health careworkers with an effective method toenclose devices intended forsterilization in the STERLINK™sterilizer. The device is intended toallow sterilization of enclosed devicesand also to maintain sterility of theenclosed devices until used up to 1month post sterilization.The materials compatible for use in theTyvek® Roll with CI for STERLINK TMSterilizer, 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) andSilicone (Hardness 50).The maximum load weight that can beplaced in the Tyvek® roll is 3.97 lbs.(1.8 kg).The roll is printed with a chemicalindicator bar which is a process	Identical

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	Subject Device	Predicate Device	Comparison
	The roll is printed with a chemicalindicator bar which is a processindicator (ISO 11140-1:2005) thatchanges from red to blue (or lighter)when exposed to hydrogen peroxidevapor during processing in theSTERLINK™ sterilizer.	indicator (ISO 11140-1:2005) thatchanges from red to blue (or lighter)when exposed to hydrogen peroxidevapor during processing in theSTERLINK™ sterilizer.
	The Tyvek® Roll with CI forSTERLINK™ Sterilizer is offeredin the follow 1 type:• Sterilization roll, Flat	The Tyvek® Roll with CI forSTERLINK™ Sterilizer is offered inthe follow 1 type:• Sterilization roll, Flat
Pouch Types	Sterilization roll, Flat	Sterilization roll, Flat	Identical
Device models(Configurations/Dimensions)	Sterilization Roll, FlatModel Dimensions FR400100 400 mm × 100 M			Sterilization Roll, FlatModel Dimensions FR400100 400 mm × 100 M	Identical
MaterialComposition	Tyvek®, PET, PE, Water,CH3COOH, Alcohol, n-Heptaneadhesive, Hydrogen peroxide vaporProcess Indicator Print Ink	Tyvek®, PET, PE, Water, CH3COOH,Alcohol, n-Heptane adhesive,Hydrogen peroxide vapor ProcessIndicator Print Ink	Identical
SterilizationCycle	STERLINK plus - Chamber mode(overall cycle: 36 minutes)	STERLINK™ FPS-15s Plus - Chambermode (overall cycle: 36 minutes)	Identical
Design Feature	Sterilization roll, Flat: This roll ismade from a Tyvek® and plastic filmthat are heat sealed on opposite twosides. It will be cut into the suitablelength and the opened sides will beheat-sealed. The indicators printedon the Tyvek® are the same with theself-sealing sterilization roll.	Sterilization roll, Flat: This roll ismade from a Tyvek® and plastic filmthat are heat sealed on opposite twosides. It will be cut into the suitablelength and the opened sides will beheat-sealed. The indicators printed onthe Tyvek® are the same with the self-sealing sterilization roll.	Identical
ChemicalIndicatorDevice Design	The color of the Chemical Indicatorchanges from red to blue (or lighter)when exposed to hydrogen peroxide	The color of the Chemical Indicatorchanges 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.

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	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 F1980-16:2016ASTM F1140/F1140M-13:2013
	Visual inspection test	ASTM F1980-16:2016ASTM F1886/F1886M-16:2016
	Dye penetration test	ASTM F1980-16:2016ASTM F1929-15:2015
	Tensile strength of Tyvek®	ASTM F1980-16:2016ASTM D5035-11:2019
	Tensile strength of plastic film	ASTM F1980-16:2016ASTM D882
	Seal strength	ASTM F1980-16:2016ASTM F88
	Tear resistance	ASTM F1980-16:2016ASTM D1922-20
	Microbial Barrier Test	ASTM F1980-16:2016DIN 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

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within loads, ensuring an adequate exposure to the sterilizing agent during the sterilization process and allowing to distinguish between processed and unprocessed items.

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 .

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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® ReaderIncubators (IC10/20FRLCD,Mini-Bio);Terragene Chemdye® (CD42);Terragene Cintape® (CT40)	Terragene Bionova® SCBI (BT96);Terragene Bionova® ReaderIncubators (IC10/20FRLCD, Mini-Bio):Terragene Chemdye® (CD42);Terragene Cintape® (CT40)	Identical
510(k)Number	-	K212193	-
Manufacturer	Terragene® S.A.	Terragene® S.A.	Identical
DeviceClassificationName	Sterilization Process Indicator	Sterilization Process Indicator	Identical
ClassificationProduct Code	FRC (biological indicators)JOJ (chemical indicators)	FRC (biological indicators)JOJ (chemical indicators)	Identical
RegulationNumber	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-containedbiological indicator inoculatedwith viable 106 Geobacillusstearothermophilus bacterialspores and is intended formonitoring the efficacy ofvaporized hydrogen peroxidesterilization processes. BT96 hasSuper Rapid readout at 30minutes at 60°C.	Terragene Bionova® SCBI (BT96)is a self-contained biologicalindicator inoculated with viable 106Geobacillus stearothermophilusbacterial spores and is intended formonitoring the efficacy of vaporizedhydrogen peroxide sterilizationprocesses. BT96 has Super Rapidreadout at 30 minutes at 60°C.	Identical
	Terragene Bionova® ReaderIncubators (IC10/20FRLCD,Mini-Bio) incubate at 60°C and37°C and read the TerrageneBionova® SCBI for fluorescentresults at the times prescribed inthe User Manuals.	Terragene Bionova® ReaderIncubators (IC10/20FRLCD, Mini-Bio) incubate at 60°C and 37°C andread the Terragene Bionova® SCBIfor fluorescent results at the timesprescribed in the User Manuals.
	Terragene Chemdye® (CD42) is achemical process indicatorintended for monitoring theefficacy of vaporized hydrogenperoxide sterilization processes.The chemical indicator changesfrom red to yellow for CD42 toindicate that the conditions of thecycle have been met.	Terragene Chemdye® (CD42) is achemical process indicator intendedfor monitoring the efficacy ofvaporized hydrogen peroxidesterilization processes. Thechemical indicator changes from redto yellow for CD42 to indicate thatthe conditions of the cycle havebeen met.
	Terragene Cintape® (CT40) is achemical process indicator tapeintended for monitoring theefficacy of Vaporized HydrogenPeroxide sterilization processes.The indicating tape changes frompurple to green when exposure tovaporized hydrogen peroxide.The self-contained biologicalindicator and chemical processingindicators are intended for usewith the STERLINK plus whenoperating in chamber mode.	Terragene Cintape® CT40 is achemical process indicator tapeintended for monitoring the efficacyof Vaporized Hydrogen Peroxidesterilization processes. Theindicating tape changes from purpleto green when exposure tovaporized hydrogen peroxide.The self-contained biologicalindicator and chemical processingindicators are intended for use withthe STERLINKTM FPS-15s Pluswhen operating in chamber mode.
	Subject Device	Predicate Device	Comparison
Sponsor	Plasmapp Co., Ltd.	Plasmapp Co., Ltd.	Identical
Intended Use:Cycles	ModelsCycleBT96STERLINK plus-CD42Chamber modeCT40	ModelsCycleBT96STERLINK FPS-CD4215s plus-CT40Chamber mode	Identical cyclesDiffer only in name
	Terragene Bionova® SCBI (BT96)
Type ofBiologicalIndicator	Self-Contained	Self-Contained	Identical
OrganismSporeSpeciesStrain	Geobacillus stearothermophilusATCC 7953 spores inoculated ona strip (spore carrier)	Geobacillus stearothermophilusATCC 7953 spores inoculated on astrip (spore carrier)	Identical
Viable SporePopulation	≥ 106	≥ 106	Identical
Resistancecharacteristics	D -valueSurvival time/Kill window	D -valueSurvival time/Kill window	Identical
IntendedSterilizationCycles	STERLINK plus - Chamber mode(overall cycle: 36 minutes)	STERLINKTM FPS-15s PlusChamber mode (overall cycle: 36minutes)	Identical
Shelf Life	2 years	2 years	Identical
	Terragene Chemdye® (CD42), Terragene Chemdye® (CT40)
IntendedSterilizationCycles	STERLIN plus - Chamber mode(overall cycle: 36 minutes)	STERLINKTM FPS-15s PlusChamber mode (overall cycle: 36 minutes)	Identical
Device design	Strip, Tape	Strip, Tape	Identical
Color Changeupon Exposureto H2O2	CD42: red to yellowCT40: purple to green	CD42: red to yellowCT40: purple to green	Identical
RecommendedStorageConditions	Dry place, away from sunlight, attemperature between 10-30°C, 30-80% relative humidity. Do notwet. Do not store close tosterilizing agents.	Dry place, away from sunlight, attemperature between 10-30°C, 30-80% relative humidity. Do not wet.Do not store close to sterilizingagents.	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 andpredicate devices are the proposed indications for use, to label the indicators for use with theSTERLINK plus when operating in chamber mode.

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C.4 Performance Data

Item	Test	Standard/Guidance Document	Result
Self-ContainedBiologicalIndicator(BT96)	Resistance validation forbiological indicator test	ISO 11138-1:2017	Pass
	BI & Test pack validation test	Manufacturer's internal standard	Pass
ChemicalIndicator(CD42, CT40)	Chemical indicatorvalidation	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)

Regulation Number and Section

§ 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).