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 maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).

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

Device Description

Tyvek® Roll with CI for STERLINK™ Sterilizer is intended to contain medical devices to be terminally sterilized in the STERLINK™ sterilization system. The medical devices are inserted into the roll, sealed, and then sterilized in the STERLINK™ sterilization system. After completion of the sterilization process, the roll maintains sterility of the enclosed medical devices until the seal is opened. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices for up to 1 month post sterilization.

The roll is printed with a chemical indicator bar that changes from red to blue (or lighter) when exposed to hydrogen peroxide vapor during processing in the STERLINK™ 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).

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the Tyvek® Roll with CI for STERLINK™ Sterilizer, by the FDA. It outlines the device's intended use, its technical characteristics compared to a predicate device, and the non-clinical testing performed to establish its substantial equivalence.

However, the request asks for specific details related to the acceptance criteria and the study that proves the device meets the acceptance criteria for an AI/Machine Learning (ML) device, including information like sample size for test/training sets, data provenance, expert ground truth establishment, MRMC studies, and human reader improvement with AI.

The provided document does not describe an AI/ML device. It describes a physical medical device (sterilization wrap) and its chemical indicator. Therefore, the information requested about AI/ML specific study design elements (e.g., sample size for training/test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, effect size of human reader improvement with AI, ground truth establishment for AI models) is not present in the provided text.

The document focuses on non-clinical performance and safety testing of the physical sterilization wrap and its chemical indicator based on established ISO and ASTM standards.

Below is a summary of the acceptance criteria and performance as presented in the document for the physical medical device, acknowledging that it does not pertain to an AI/ML system.

Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)

The document details performance and safety tests for the "Tyvek® Roll with CI for STERLINK™ Sterilizer" against various standards. The acceptance criteria are implicit in the "Pass" result for each test against the specified standard.

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance

Performance Testing	Standard	Reported Device Performance
Sterilant Penetration	ISO 14937	Pass
CI of sterilization roll validation	ANSI/AAMI/ISO 11140-1	Pass
Shelf-life - Internal pressurization test	ASTM F1980-16, ASTM F1140/F1140M-13	Pass
Shelf-life - Visual inspection test	ASTM F1980-16, ASTM F1886/F1886M-16	Pass
Shelf-life - Dye penetration test	ASTM F1980-16, ASTM F1929-15	Pass
Shelf-life - Tensile strength of Tyvek®	ASTM F1980-16, ASTM D5035-11	Pass
Shelf-life - Tensile strength of plastic film	ASTM F1980-16, ASTM D882	Pass
Shelf-life - Seal strength	ASTM F1980-16, ASTM F88	Pass
Tear resistance	ASTM F1980-16, ASTM D1922-20	Pass
Microbial Barrier Test	ASTM F1980-16, DIN 58953-6	Pass
CI of sterilization roll validation	ANSI/AAMI/ISO 11140-1	Pass
Toxicological Properties (Biocompatibility Tests)	ISO 10993-5	Pass - Test article is non-cytotoxic after the sterilization.
Residual sterilant on Tyvek® validation	Internal test standard	Pass
Material compatibility test	Various ASTM standards and Internal test standard	Pass

2. Sample size used for the test set and the data provenance:

The document does not specify the exact sample sizes (number of units tested) for each of the performance and safety tests listed. It only indicates that testing was "evaluated using the STERLINK™ FPS-15s Plus system, operating in Chamber mode."
Data Provenance: The testing was conducted by Plasmapp Co., Ltd. (Applicant/Submitter based in South Korea) or their designated testing facilities. The specific geographical origin of the data (e.g., country) beyond the company's location is not further specified. The studies described are non-clinical (laboratory-based) performance and safety tests, not clinical studies on human subjects, so the "retrospective or prospective" designation as it applies to patient data is not applicable here.

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

This question is not applicable as the device is a physical sterilization wrap and chemical indicator, not an AI/ML device requiring expert interpretation for ground truth establishment. The "ground truth" for this device's performance is determined by adherence to established, quantitative engineering and biological standards (e.g., presence of sterilant, barrier integrity, physical strength).

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

This question is not applicable as the device is a physical product and the testing involves adherence to quantitative standards, not subjective expert review or adjudication.

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:

This question is not applicable as the device is a physical product (sterilization wrap) and its chemical indicator, not an AI-assisted diagnostic or interpretative tool for human readers.

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

This question is not applicable as the device is a physical product, not an algorithm.

7. The type of ground truth used:

The ground truth for the performance of the sterilization wrap and its chemical indicator is based on established standard specifications and laboratory testing protocols for material properties, sterilization efficacy, barrier integrity, and chemical indicator function (e.g., color change upon exposure to hydrogen peroxide). This is not expert consensus, pathology, or outcomes data in the context of diagnostic AI.

8. The sample size for the training set:

This question is not applicable as there is no mention of a training set for an AI/ML model. The device underwent non-clinical performance and safety testing.

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

This question is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 22, 2021

Consultant CardioMed Device Consultants LLC 1783 Forest Drive, Suite 254 Annapolis, Maryland 21401

Re: K212198

Trade/Device Name: Tyvek® Roll with CI for STERLINK™ Sterilizer Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: September 20, 2021 Received: September 21, 2021

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 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

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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,

Clarence W. Murray, III, PhD 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) K212198

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).

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)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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1. 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 DriveSuite 254Annapolis, MD 21401Tel: +1 410 674 2060
Preparation Date:	October 12, 2021

2. Device Name and Code

Device Trade Name:	Tyvek® Roll with CI for STERLINK™ Sterilizer
Common Name:	Tyvek® Roll for VH2O2 Sterilizer
Classification Name:	1) Sterilization Wrap2) Sterilization Process Indicator
Product Code:	1) FRG2) JOJ
Regulation Number:	1) 21 CFR 880.68502) 21 CFR 880.2800
Classification:	Class II
Review Panel:	General Hospital

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3. Indications / Intended Use

The maximum load weight that can be placed in the Tyvek® roll is 3.97 pounds (1.8kg).

The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type:

. Sterilization roll, Flat

4. Device Description

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 STERLINK™ sterilizer.

5. Technical Characteristics in Comparison to Predicate Devices

The proposed subject device uses identical technology as the cited predicate devices and has the same intended uses. Based upon the overall performance characteristics for Tyvek® Roll with CI for STERLINK™ Sterilizer, Plasmapp Co., Ltd. believes there are no significant differences in

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usage of its underlying technological principles between Tyvek® Roll with CI for STERLINK™ Sterilizer and the predicate device.

A summary of the technical characteristics of the subject device and predicate device can be found in the table below.

	Subject Device	Predicate Device
510(k) Sponsor	Plasmapp Co., Ltd.	Sigma Medical Supplies Corp.
Manufacturer	Sigma Medical Supplies Corp.	Same
Device Name	Tyvek® Roll with CI for STERLINK™ Sterilizer	Sterilization Pouch/Roll Made with Tyvek®
510(k) Number	K212198	K180672
Device Classification Name	1) Sterilization Wrap2) Sterilization Process Indicator	Same
Classification Product Code	1) FRG2) JOJ	Same
Regulation Number	1) 21 CFR 880.68502) 21 CFR 880.2800	Same
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 maximum load weight that can be placed in the Tyvek® roll is 3.97lbs (1.8kg).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	Sterilization Pouch/Roll Made with Tyvek are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the STERRAD® 100S Sterilizer. The device is intended to allow sterilization of enclosed devices and also to maintain sterility of the enclosed devices until used up to 3 years post sterilization.The pouches and rolls are 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 STERRAD® 100S Sterilizer.The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:• Self-sealing sterilization pouches• Sterilization pouches, Flat• Sterilization pouches, Gusseted• Sterilization rolls, Flat• Sterilization rolls, Gusseted
Pouch Types	The subject device includes a subset of the predicate device types:Sterilization roll, Flat	Self-sealing sterilization pouchesSterilization pouches, FlatSterilization pouches, GussetedSterilization rolls, FlatSterilization rolls, Gusseted

Summary of Subject and Predicate Device Technical Characteristics

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Subject Device		Predicate Device
		Sterilization Pouches, Flat
		Model	Dimensions
		TYFP075200	75 mm × 200 mm
		TYFP075300	75 mm × 300 mm
		TYFP100200	100 mm × 200 mm
		TYFP100300	100 mm × 300 mm
		TYFP150255	150 mm × 255 mm
		TYFP150300	150 mm × 300 mm
		TYFP190330	190 mm × 330 mm
		TYFP200400	200 mm × 400 mm
		TYFP250450	250 mm × 450 mm
		TYFP300500	300 mm × 500 mm
			Sterilization Rolls, Flat
		Model	Dimensions
		TYFR050070	50 mm × 70 M
		TYFR022f	50.8 mm × 61 M
		TYFR075070	75 mm × 70 M
		TYFR100070	100 mm × 70 M
		TYFR042f	101.6 mm × 61 M
Device models(Configurations/Dimensions)		TYFR150070	150 mm × 70 M
		Sterilization Roll, Flat	TYFR062f	152.4 mm × 61 M
	Model	Dimensions	TYFR200070	200 mm × 70 M
	FR400100	400 mm × 100 M	TYFR082f	203.2 mm × 61 M
		TYFR250070	250 mm × 70 M
		TYFR102f	254 mm × 61 M
		TYFR300070	300 mm × 70 M
		TYFR350070	350 mm × 70 M
		TYFR400070	400 mm × 70 M
		TYFR450070	450 mm × 70 M
		TYFR500070	500 mm × 70 M
		TYFR050100	50 mm × 100 M
		TYFR075100	75 mm × 100 M
		TYFR100100	100 mm × 100 M
		TYFR150100	150 mm × 100 M
		TYFR200100	200 mm × 100 M
		TYFR250100	250 mm × 100 M
		TYFR300100	300 mm × 100 M
		TYFR350100	350 mm × 100 M
		TYFR400100	400 mm × 100 M
		TYFR450100	450 mm × 100 M
		TYFR500100	500 mm × 100 M
		TYFR050200	50 mm × 200 M
		TYFR075200	75 mm × 200 M
		TYFR100200	100 mm × 200 M
		TYFR150200	150 mm × 200 M
		TYFR200200	200 mm × 200 M
		TYFR250200	250 mm × 200 M
		TYFR300200	300 mm × 200 M
		TYFR350200	350 mm × 200 M
		TYFR400200	400 mm × 200 M

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	Subject Device	Predicate Device
Material Composition	Tyvek®, PET, PE, Water, CH3COOH,Alcohol, n-Heptane adhesive, Hydrogenperoxide vapor Process Indicator Print Ink	Same
Sterilization Cycle	STERLINK™ FPS-15s Plus - Chamber mode(overall cycle: 36 minutes)	STERRAD® 100S sterilization cycles:54-minute Short cycle for most surgical instruments 72-minute Long cycle for flexible endoscopes and instruments withlonger lumen
Design Feature	Sterilization roll, Flat: This roll is madefrom a Tyvek® and plastic film that are heatsealed on opposite two sides. It will be cutinto the suitable length and the opened sideswill be heat-sealed. The indicators printed onthe Tyvek® are the same with the self-sealingsterilization roll.	Same
Chemical IndicatorDevice Design	The color of the Chemical Indicator changesfrom red to blue (or lighter) when exposed tohydrogen peroxide.	Same

6. Summary of Non-Clinical Testing

The Tyvek® Roll with CI for STERLINK™ Sterilizer has the identical intended use and indication for use as the predicate devices. Testing of the roll material was previously conducted on the predicate K180672. The identical materials are used in the Tyvek® Roll with CI for STERLINK™ Sterilizer. The size of the subject device is within the range of sizes available for the predicate device.

The performance and safety test of subject device was evaluated using the STERLINK™ FPS-15s Plus system, operating in Chamber mode, following the standards listed in the table below.

Performance Testing		Standard	Result
SterilantPenetration	Sterilization efficacy test	ISO 14937	Pass
	CI of sterilization roll validation	ANSI/AAMI/ISO 11140-1	Pass
Shelf-life	Internal pressurization test	ASTM F1980-16ASTM F1140/F1140M-13	Pass
	Visual inspection test	ASTM F1980-16ASTM F1886/F1886M-16	Pass
	Dye penetration test	ASTM F1980-16ASTM F1929-15	Pass
	Tensile strength of Tyvek®	ASTM F1980-16ASTM D5035-11	Pass
	Tensile strength of plastic film	ASTM F1980-16ASTM D882	Pass
	Seal strength	ASTM F1980-16ASTM F88	Pass

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Tyvek® Roll with CI for STERLINK™ Sterilize
510(k) Summary - K212198

Performance Testing	Standard	Result
Tear resistance	ASTM F1980-16ASTM D1922-20	Pass
Microbial Barrier Test	ASTM F1980-16DIN 58953-6	Pass
CI of sterilization roll validation	ANSI/AAMI/ISO 11140-1	Pass
Toxicological Properties(Biocompatibility Tests)	ISO 10993-5	Pass - Test article is non-cytotoxic after the sterilization.
Residual sterilant on Tyvek® validation	Internal test standard	Pass
Material compatibility test	ASTM D638ASTM E8/E8M-ae1ASTM D790ASTM E290-14ASTM D256ASTM E23-18ASTM E1164ASTM E313ASTM D3985ASTM F1249Internal test standard	Pass

7. Conclusions

The conclusions drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission K212198, Tyvek® Roll with CI for STERLINK™ Sterilizer, is as safe, as effective, and performs as well or better than the legally marketed predicate device cleared under K180672.

Regulation Number and Section

§ 880.6850 Sterilization wrap.

(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).