Tyvek(R) Roll with CI for STERLINKTM Sterilizer

K212198 · Plasmapp Co,., Ltd. · FRG · Oct 22, 2021 · General Hospital

Device Facts

• Record ID: K212198
• Device Name: Tyvek(R) Roll with CI for STERLINKTM Sterilizer
• Applicant: Plasmapp Co,., Ltd.
• Product Code: FRG · General Hospital
• Decision Date: Oct 22, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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 3.97 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 Story

Sterilization packaging system for medical devices; consists of Tyvek® sheet and clear plastic film heat-sealed into flat rolls. Used by healthcare workers in clinical settings to enclose instruments before processing in STERLINK™ sterilizer. Features integrated chemical indicator bar (ISO 11140-1:2005) printed on Tyvek®; changes color from red to blue/lighter upon exposure to hydrogen peroxide vapor. Provides visual confirmation of exposure to sterilization process. Maintains sterility of enclosed items for up to 1 month post-sterilization. Protects patient by ensuring instrument sterility at point of use.

Clinical Evidence

No clinical data. Bench testing only. Performance validated per ISO 14937, ANSI/AAMI/ISO 11140-1, ASTM F1980-16, ASTM F1140/F1140M-13, ASTM F1886/F1886M-16, ASTM F1929-15, ASTM D5035-11, ASTM D882, ASTM F88, ASTM D1922-20, DIN 58953-6, ISO 10993-5, and various material compatibility standards (ASTM D638, D790, D256, etc.). All tests passed.

Technological Characteristics

Materials: Tyvek®, PET, PE, adhesive, and hydrogen peroxide-sensitive ink. Form factor: Flat sterilization roll. Principle: Passive barrier packaging with integrated chemical process indicator (ISO 11140-1:2005). Sterilization compatibility: Hydrogen peroxide vapor (STERLINK™ system). Standards: ASTM F1980-16 (shelf-life), ASTM F1929-15 (dye penetration), ASTM F88 (seal strength), ISO 10993-5 (biocompatibility).

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization in the STERLINK™ sterilizer (CHAMBER mode) and maintain sterility for up to 1 month post-sterilization. Maximum load weight: 1.8kg.

Regulatory Classification

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.

Predicate Devices

• Sterilization Pouch/Roll Made with Tyvek® (K180672)

Submission Summary (Full Text)

{0}------------------------------------------------

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K212198

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 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

| Type of Use (Select one or both, as applicable) | | |
|-------------------------------------------------|--|--|
| | | |

| | Prescription Use (Part 21 CFR 801 Subpart D)

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

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 1. General Information

| Applicant/Submitter: | Plasmapp Co., Ltd.<br>BVC-111, 125, Gwahak-ro,<br>Yuseong-gu, Daejeon, 34141,<br>Rep. of Korea (South Korea)<br>Tel: [phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Candace Cederman |
| Address: | CardioMed Device Consultants LLC<br>1783 Forest Drive<br>Suite 254<br>Annapolis, MD 21401<br>Tel: [phone] |
| 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 Wrap<br>2) Sterilization Process Indicator |
| Product Code: | 1) FRG<br>2) JOJ |
| Regulation Number: | 1) 21 CFR 880.6850<br>2) 21 CFR 880.2800 |
| Classification: | Class II |
| Review Panel: | General Hospital |

{4}------------------------------------------------

# 3. Indications / 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 3.97 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
## 4. 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).

## 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

{5}------------------------------------------------

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 Wrap<br>2) Sterilization Process Indicator | Same |
| Classification Product Code | 1) FRG<br>2) JOJ | Same |
| Regulation Number | 1) 21 CFR 880.6850<br>2) 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.<br><br>The maximum load weight that can be placed in the Tyvek® roll is 3.97lbs (1.8kg).<br><br>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.<br><br>The Tyvek® Roll with CI for STERLINK™ Sterilizer is offered in the follow 1 type:<br>• 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.<br><br>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.<br><br>The Sterilization Pouch/Roll Made with Tyvek® is offered in the follow 5 types:<br>• Self-sealing sterilization pouches<br>• Sterilization pouches, Flat<br>• Sterilization pouches, Gusseted<br>• Sterilization rolls, Flat<br>• Sterilization rolls, Gusseted |
| Pouch Types | The subject device includes a subset of the predicate device types:<br>Sterilization roll, Flat | Self-sealing sterilization pouches<br>Sterilization pouches, Flat<br>Sterilization pouches, Gusseted<br>Sterilization rolls, Flat<br>Sterilization rolls, Gusseted |

## Summary of Subject and Predicate Device Technical Characteristics

{6}------------------------------------------------

| 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<br>(Configurations<br>/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 | |

{7}------------------------------------------------

| | Subject Device | Predicate Device |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Material Composition | Tyvek®, PET, PE, Water, CH3COOH,<br>Alcohol, n-Heptane adhesive, Hydrogen<br>peroxide vapor Process Indicator Print Ink | Same |
| Sterilization Cycle | STERLINK™ FPS-15s Plus - Chamber mode<br>(overall cycle: 36 minutes) | STERRAD® 100S sterilization cycles:<br>54-minute Short cycle for most surgical instruments 72-minute Long cycle for flexible endoscopes and instruments with<br>longer lumen |
| Design Feature | Sterilization roll, Flat: This roll is made<br>from a Tyvek® and plastic film that are heat<br>sealed on opposite two sides. It will be cut<br>into the suitable length and the opened sides<br>will be heat-sealed. The indicators printed on<br>the Tyvek® are the same with the self-sealing<br>sterilization roll. | Same |
| Chemical Indicator<br>Device Design | The color of the Chemical Indicator changes<br>from red to blue (or lighter) when exposed to<br>hydrogen 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 |
|--------------------------|-------------------------------------|---------------------------------------|--------|
| Sterilant<br>Penetration | Sterilization efficacy test | ISO 14937 | Pass |
| | CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass |
| Shelf-life | Internal pressurization test | ASTM F1980-16<br>ASTM F1140/F1140M-13 | Pass |
| | Visual inspection test | ASTM F1980-16<br>ASTM F1886/F1886M-16 | Pass |
| | Dye penetration test | ASTM F1980-16<br>ASTM F1929-15 | Pass |
| | Tensile strength of Tyvek® | ASTM F1980-16<br>ASTM D5035-11 | Pass |
| | Tensile strength of plastic film | ASTM F1980-16<br>ASTM D882 | Pass |
| | Seal strength | ASTM F1980-16<br>ASTM F88 | Pass |

{8}------------------------------------------------

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

| Performance Testing | Standard | Result |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Tear resistance | ASTM F1980-16<br>ASTM D1922-20 | Pass |
| Microbial Barrier Test | ASTM F1980-16<br>DIN 58953-6 | Pass |
| CI of sterilization roll validation | ANSI/AAMI/ISO 11140-1 | Pass |
| Toxicological Properties<br>(Biocompatibility Tests) | ISO 10993-5 | Pass - Test article is non-<br>cytotoxic after the sterilization. |
| Residual sterilant on Tyvek® validation | Internal test standard | Pass |
| Material compatibility test | ASTM D638<br>ASTM E8/E8M-ae1<br>ASTM D790<br>ASTM E290-14<br>ASTM D256<br>ASTM E23-18<br>ASTM E1164<br>ASTM E313<br>ASTM D3985<br>ASTM F1249<br>Internal 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.