The 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

Device Description

Sterilization Pouch/Roll Made with Tyvek® is intended to contain medical devices to be terminally sterilized in the STERRAD® 100S Sterilization System. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the STERRAD® 100S Sterilization System (The recommended cycle parameter is 6 minutes (Injection volume: 2880µL) at 50°C.). After completion of the sterilization process, the Pouch/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 until used up to 3 years post sterilization.

The Pouch/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 STERRAD® 100S Sterilization System.

The pouches are constructed from Tyvek®/plastic films, with H2O2 Chemical Indicator printed onto the Tyvek® film. The Self-seal pouch permits sealing of the pouch without need of heat- sealing equipment, while the heat sealed pouches and rolls are heat sealed prior to processing in the STERRAD® Sterilization Systems.

The H2O2 Chemical Indicator offers an additional way to verify processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. H2O2 Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the hydrogen peroxide. The color of the Chemical Indicator changes from red to blue (or lighter) when exposed to hydrogen peroxide.

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

AI/ML Overview

The provided text describes the regulatory submission for a medical device (Sterilization Pouch/Roll Made with Tyvek®) seeking 510(k) clearance from the FDA. This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the safety and effectiveness of a novel AI/software-as-a-medical-device (SaMD).

Therefore, the information typically requested regarding acceptance criteria and study design for AI/SaMD devices (like sample size for test/training sets, data provenance, expert
qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance) is not applicable to this submission. This device is a physical product, and its performance is evaluated through material science, sterility, and packaging tests.

However, I can extract the acceptance criteria and reported performance for the physical device based on the non-clinical testing summaries.

1. A table of acceptance criteria and the reported device performance:

Test Category	Test Method / Standard (Acceptance Criteria)	Reported Device Performance
Sterilant Penetration	AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices" (Acceptance: Able to penetrate and sustain direct contact with the medical instrument inside)	Confirmed that the sterilant is able to penetrate the device and sustain direct contact with the medical instrument inside.
Sterilant Penetration	Half-Cycle Efficacy (Acceptance: 6 log reduction of Geobacillus stearothermophilus)	Showed a 6 log reduction of Geobacillus stearothermophilus.
Biocompatibility	ISO 10993-10:2010(E), "Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization" (Acceptance: Meets requirements, non-irritating)	Showed "negative reaction" (non-irritating) and met requirements.
Package Integrity	ASTM F2251-03, "Standard Test Method for Thickness Measurement of Flexible Packaging Material" (Acceptance: Passed)	Passed
Package Integrity	ASTM D882, "Standard Test Method for Tensile Properties of Thin Plastic Sheeting" (Acceptance: Passed)	Passed
Package Integrity	ASTM D 5035, "Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method)" (Acceptance: Passed)	Passed
Package Integrity	ASTM D1922, "Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method" (Acceptance: Passed)	Passed
Package Integrity	ASTM F1140-07, "Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages" (Acceptance: Passed)	Passed
Package Integrity	ASTM F88/F88M; ISO 11607-1, "Standard Test Method for Seal Strength of Flexible Barrier Materials" (Acceptance: Passed)	Passed
Package Integrity	ASTM F1929-98 (04); ISO 11607-1, "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration" (Acceptance: Passed)	Passed
Material Compatibility	AAMI / ANSI / ISO 11607-1:2006//A1:2014, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems" (Acceptance: Met criteria)	Met material compatibility acceptance criteria.
Sterility Maintenance	DIN 58953-6:2010-05, "Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized" (Acceptance: Passed)	Passed
Sterility Maintenance	AAMI / ANSI / ISO 11607-1:2006//A1:2014 (Acceptance: Met criteria for sterility maintenance after aging)	Met sterility maintenance acceptance criteria.
Sterility Maintenance	Durability: Accelerated Aging Test (ASTM F 1980-2007; ISO 11607-1) (Acceptance: Passed for 3 years accelerated aging, maintaining seal strength)	Passed (3 years accelerated aging, seal strength maintained).
Chemical Indicator Efficacy	AAMI / ANSI / ISO 11140-1:2014, "Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements" (Acceptance: Sterilant penetrated through pouch, CI color changed to endpoint color, color stability for 3 years, completeness/uniformity of color change)	The sterilant penetrated through the pouch, the CI color changed to the endpoint, indicator dye remained stable for 3 years real-time aging, and the color change was effective.

For the following points, as explained, they are not applicable because this is a 510(k) submission for a physical medical device (sterilization pouches) based on substantial equivalence, not an AI/SaMD (Software as a Medical Device). The evaluation focuses on material properties and performance under sterilization conditions rather than algorithmic performance on complex data (like images or medical records).

2. Sample sizes used for the test set and the data provenance: Not applicable. The tests performed are engineering and material-science based, using samples of the device and specific test setups, not patient-derived data. The document does not specify a "test set" in the context of an AI algorithm, nor "data provenance" (e.g., country of origin) relevant to patient data. The non-clinical tests were likely conducted in a controlled laboratory environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. Ground truth as typically defined for AI/SaMD (e.g., disease diagnosis from medical images) is not relevant here. The "ground truth" for these tests are objective measurements against established engineering and biological standards (e.g., quantitative measures of tensile strength, observable microbial growth, or chemical indicator color change).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are used to resolve disagreements among human annotators/experts for ground truth establishment in AI/SaMD; this is not relevant for materials testing.

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 is not an AI-assisted device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for the performance evaluations are based on established industry standards and scientific principles for material properties (e.g., ASTM standards for mechanical properties), biological efficacy (e.g., 6-log reduction for sterilization), and chemical reactivity (e.g., color change of indicators). No human expert consensus or outcomes data in a clinical context is used as "ground truth" for this device's acceptance.

8. The sample size for the training set: Not applicable. There is no AI training set involved.

9. How the ground truth for the training set was established: Not applicable. There is no AI training set involved.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of 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.

June 6, 2018

Sigma Medical Supplies Corporation % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. 15F .- 2, No.1, Lane 26, Mincyuan 1st Rd., Lingya District Kaohsiung City, 802 Taiwan

Re: K180672

Trade/Device Name: Sterilization Pouch/Roll Made with Tyvek Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: February 27, 2018 Received: March 14, 2018

Dear Uta Shih:

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. 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); good

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manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Geeta K. Pamidimukkala -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K180672

Device Name Sterilization Pouch/Roll Made with Tyvek®

Indications for Use (Describe)

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

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

_ Prescription Use (Part 21 CFR 801 Subpart D)

区 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:

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"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."

FORM FDA 3881 (7/17)

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K180672 510(K) Summary

5.1 Submitter's Information

Name:	SIGMA Medical Supplies Corp.
Address:	NO.34, Ding-Ping Road, Rui Fang Industrial Park, RuiFang Dist., New Taipei City 224, Taiwan (R.O.C.)
EstablishmentRegistration Number:	3004970050
Contact:	Mason HuangRegulatory Affair Specialist886-4-24366111 ext. 127E-mail: mason@sigma-medical.com.twOrJack WangPresident /C.E.O
Date Prepared:	May 23, 2018
5.2 Device Trade Name:
Trade Name:	Sterilization Pouch/Roll Made with Tyvek®
Common/usual Name:	Sterilization Pouch/Roll Made with Tyvek®
Device Classification Names:	1) Wrap, Sterilization.2) Indicator, Physical/Chemical Sterilization Pro-cess
Panel:	General Hospital
Classification Product Code:Subsequent Product Code:	1) FRG2) JOJ
Device Classification:	Class II
Regulation Number:	1) 21 CFR 880.68502) 21 CFR 880.2800

5.3 Predicate Devices:

The predicate device [510(k) Notification K133838, cleared March 11, 2015] is the Sterilization Pouch/Roll Made with Tyvek®

Manufacturer: SIGMA Medical Supplies Corp. Product Code:1) FRG 2) JOJ 510(k) number:K133838

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5.4 Intended Use

The 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 STER-RAD® 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.

5.5 Device Description

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

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The defining characteristics of the 5 types as follows:

· Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that is heat sealed on three sides. The forth side has an adhesive strip that is Tyvek® and used to seal the pouch. Release Tyvek® used in the pouch is a laminated sheet with composing structure of Tyvek®, PET, PE. It is a strip to cover the adhesive area and is released before seal the pouch. The Tyvek® conforms to recognized material standards and can be sterilized by Gas plasma in the STER-RAD® 100S Sterilization System's standard cvcle. The Process Indicators Ink printed on the Tyvek® will exhibit a color change after the pouch is exposed to Gas plasma.
. Sterilization pouches, Flat: These pouches have the same components with the Selfsealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when used.
· Sterilization pouches, Gusseted: These pouches are the same as the Sterilization pouches, flat, except that the plastic film is folded on both long sides instead of flat. This design is convenient to enclose the medical devices with certain height.
· Sterilization rolls. Flat: These rolls are made from a Tyvek® and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the Tyvek® are the same with the self-sealing sterilization pouches.
· Sterilization rolls. Gusseted: These rolls are the flat sterilization roll. except that the plastic film is folded on both long sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The following table (Table 5-1) lists the model numbers of the Sterilization Pouch/Roll Made with Tyvek® by type, model, dimensions, and max load (for pouches):

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Type	Model	Dimensions (mm)	Content / Max Load (lbs)
			Metal	Plastic	Linens and Gauze
Self-sealing SterilizationPouches	TYSE057133	57mm×133mm	0.0354	0.0327	0.0141
	TYSE090162	90mm×162mm	0.0534	0.0495	0.0214
	TYSE090256	90 mm×256 mm	0.1218	0.1129	0.0734
	TYSE070257	70mm×257mm	0.0807	0.0748	0.0323
	TYSE090257	90mm×257mm	0.1218	0.1129	0.0734
	TYSE133282	133 mm×282 mm	0.2424	0.4144	0.1940
	TYSE135283	135mm×283mm	0.2424	0.4144	0.1940
	TYSE135335	135mm×335mm	0.2986	0.5548	0.2502
	TYSE190358	190mm×358mm	0.4809	1.0107	0.4325
	TYSE254408	254 mm ×408 mm	0.7224	1.5303	0.6804
	TYSE300380	300mm×380mm	0.8488	1.9303	0.8004
	TYSE300474	300mm×474mm	1.0744	2.4943	1.0260
	TYSE305485	305 mm × 485 mm	1.0794	2.4995	1.0296
Sterilization Pouches,Flat	TYFP075200	75mm×200mm	0.0826	0.0347	0.017
	TYFP075300	75mm×300mm	0.1576	0.0662	0.032
	TYFP100200	100mm×200mm	0.1326	0.0557	0.027
	TYFP100300	100mm×300mm	0.2326	0.0977	0.0474
	TYFP150255	150 mm × 255 mm	0.2326	0.0977	0.0474
	TYFP150300	150mm×300mm	0.3826	0.3977	0.1974
	TYFP190330	190 mm×330 mm	0.5836	0.9407	0.3654
	TYFP200400	200mm×400mm	0.7326	1.0977	0.5474
	TYFP250450	250mm×450mm	1.0576	1.7477	0.8724
	TYFP300500	300mm×500mm	1.4326	2.4977	1.2474
Sterilization Pouches,Gusseted	TYGP100300	100mm×40mm300mm	0.2592	0.0488	0.0146
	TYGP150400	150mm×50mmx400mm	0.5592	0.9488	0.2842
	TYGP200400	200mm×50mmx400mm	0.7592	1.5488	0.4842
	TYGP250480	250mm×60mmx480mm	1.1592	2.7488	0.8842
	TYGP300500	300mm×70mmx500mm	1.4592	3.6488	1.1842
Type	Model	Dimensions (mm)	Content / Max Load (lbs)
			Metal	Plastic	Linens and Gauze
	TYFR050070	50mm×70M	0.0354	0.0327	0.0141
	TYFR022f	50.8 mm × 61 M	0.0354	0.0327	0.0141
	TYFR075070	75mm×70M	0.0811	0.0342	0.016
	TYFR100070	100mm×70M	0.1326	0.0557	0.027
	TYFR042f	101.6 mm ×61 M	0.1326	0.0557	0.027
	TYFR150070	150mm×70M	0.2326	0.0977	0.0474
	TYFR062f	152.4 mm×61 M	0.2326	0.0977	0.0474
	TYFR200070	200mm×70M	0.7326	1.0977	0.5474
	TYFR082f	203.2 mm× 61 M	0.7326	1.0977	0.5474
	TYFR250070	250mm×70M	1.0576	1.7477	0.8724
	TYFR102f	254 mm ×61 M	1.0576	1.7477	0.8724
	TYFR300070	300mm×70M	1.4326	2.4977	1.2474
	TYFR350070	350mm×70M	1.6326	2.7977	1.4474
	TYFR400070	400mm×70M	1.8306	3.2931	1.6422
	TYFR450070	450mm×70M	2.664	4.3655	2.1795
	TYFR500070	500mm×70M	3.559	6.2162	3.0885
	TYFR050100	50mm×100M	0.0354	0.0327	0.0141
Sterilization Rolls,Flat	TYFR075100	75mm×100M	0.0811	0.0342	0.016
	TYFR100100	100mm×100M	0.1326	0.0557	0.027
	TYFR150100	150mm×100M	0.2326	0.0977	0.0474
	TYFR200100	200mm×100M	0.7326	1.0977	0.5474
	TYFR250100	250mm×100M	1.0576	1.7477	0.8724
	TYFR300100	300mm×100M	1.4326	2.4977	1.2474
	TYFR350100	350mm×100M	1.6326	2.7977	1.4474
	TYFR400100	400mm×100M	1.8306	3.2931	1.6422
	TYFR450100	450mm×100M	2.664	4.3655	2.1795
	TYFR500100	500mm×100M	3.559	6.2162	3.0885
	TYFR050200	50mm×200M	0.0354	0.0327	0.0141
	TYFR075200	75mm×200M	0.0811	0.0342	0.016
	TYFR100200	100mm×200M	0.1326	0.0557	0.027
	TYFR150200	150mm×200M	0.2326	0.0977	0.0474
	TYFR200200	200mm×200M	0.7326	1.0977	0.5474
	TYFR250200	250mm×200M	1.0576	1.7477	0.8724
	TYFR300200	300mm×200M	1.4326	2.4977	1.2474
	TYFR350200	350mm×200M	1.6326	2.7977	1.4474
	TYFR400200	400mm×200M	1.8306	3.2931	1.6422
	TYGR075100	75mm×35mm×100M	0.1966	0.0434	0.012
	TYGR100100	100mm×40mm×100M	0.2592	0.0488	0.0146
Sterilization Rolls,Gusseted	TYGR150100	150mm×50mm×100M	0.5592	0.9488	0.2842
	TYGR200100	200mm×50mm×100M	0.7592	1.5488	0.4842
	TYGR250100	250mm×60mm×100M	1.1592	2.7488	0.8842
	TYGR300100	300mm×70mm×100M	1.4592	3.6488	1.1842
	TYGR350100	350mm×80mm×100M	1.7959	4.1601	1.8547
	TYGR400100	400mm×80mm×100M	2.0685	4.5816	2.5917

Table 5-1. The model numbers of Sterilization Pouch/Roll Made with Tyvek® (Type, Model, Dimension, Max Load)

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K180672 510(K) SUMMARY

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5.6 Comparison of Technological Characteristics

A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 5-2.

Feature	Proposed device	Predicate device	Comparison
Device name	Sterilization Pouch/Roll Madewith Tyvek® (K180672)	Sterilization Pouch/Roll Madewith Tyvek® (K133838)
MaterialComposition	Tyvek®, PET, PE, Water, CH3COOH,Alcohol, n-Heptane adhesive, Hydrogenperoxide vapor Process Indicator Print Ink	Tyvek®, PET, PE, Water, CH3COOH,Alcohol, n-Heptane adhesive, Hydrogenperoxide vapor Process Indicator Print Ink	Same
Intended use	Sterilization Pouch/Roll Made withTyvek® are intended to provide health careworkers with an effective method to en-close devices intended for sterilization inthe STERRAD® 100S Sterilizer. The de-vice is intended to allow sterilization ofenclosed devices and also to maintain ste-rility of the enclosed devices until used upto 3 years post sterilization.The pouches and rolls are printed with achemical indicator bar which is a processindicator (ISO 11140-1:2005) that changesfrom red to blue (or lighter) when exposedto hydrogen peroxide vapor during pro-cessing in the STERRAD® 100S Sterilizer.	Sterilization Pouch/Roll Made withTyvek® are intended to provide health careworkers with an effective method to en-close devices intended for sterilization inthe STERRAD® 100S Sterilizer. The de-vice is intended to allow sterilization ofenclosed devices and also to maintain ste-rility of the enclosed devices until used upto 3 years post sterilization.The pouches and rolls are printed with achemical indicator bar which is a processindicator (ISO 11140-1:2005) that changesfrom red to blue (or lighter) when exposedto hydrogen peroxide vapor during pro-cessing in the STERRAD® SterilizationSystem.	Same
Pouch Types	· Self-sealing sterilization pouches· Sterilization pouches, Flat· Sterilization pouches, Gusseted· Sterilization rolls, Flat· Sterilization rolls, Gusseted	· Self-sealing sterilization pouches· Sterilization pouches, Flat· Sterilization pouches, Gusseted· Sterilization rolls, Flat· Sterilization rolls, Gusseted	Same
Device models(Configura-tions/Dimensions)	Self-sealing Sterilization PouchesModel Dimensions (mm)TYSE057133 57mm×133mmTYSE090162 90mm×162mmTYSE090256 90 mm×256 mmTYSE070257 70mm×257mmTYSE090257 90mm×257mmTYSE133282 133 mm×282 mmTYSE135283 135mm×283mmTYSE135335 135mm×335mmTYSE190358 190mm×358mmTYSE254408 254 mm×408 mmTYSE300380 300mm×380mmTYSE300474 300mm×474mmTYSE305485 305 mm × 485 mm	Self-sealing Sterilization PouchesModel Dimensions (mm)TYSE057133 57mm×133mmTYSE090162 90mm×162mmTYSE070257 70mm×257mmTYSE090257 90mm×257mmTYSE135283 135mm×283mmTYSE135335 135mm×335mmTYSE190358 190mm×358mmTYSE300380 300mm×380mmTYSE300474 300mm×474mm	The models(dimensions)of type "Self-Sealing Steri-lizationPouches" aredifferent.There are 4additionalmodels inProposed de-vice.The additionalmodels (Type,Model andDimension) ofProposed de-vice are shownin Table 5-3.
Feature	Proposed device: SterilizationPouch/Roll Made with Tyvek®(K180672)		Predicate devices: SterilizationPouch/Roll Made with Tyvek®(K133838)	comparison
Device models(Configurations/Dimensions)	Sterilization Pouches, FlatModel	Dimensions (mm)	Sterilization Pouches, FlatModel	Dimensions (mm)
	TYFP075200	75mm × 200mm	TYFP075200	75mm × 200mm
	TYFP075300	75mm × 300mm	TYFP075300	75mm × 300mm
	TYFP100200	100mm × 200mm	TYFP100200	100mm × 200mm
	TYFP100300	100mm × 300mm	TYFP100300	100mm × 300mm
	TYFP150255	150 mm × 255 mm	TYFP150300	150mm × 300mm
	TYFP150300	150mm × 300mm	TYFP200400	200mm × 400mm
	TYFP190330	190 mm × 330 mm	TYFP250450	250mm × 450mm
	TYFP200400	200mm × 400mm	TYFP300500	300mm × 500mm
	TYFP250450	250mm × 450mm
	TYFP300500	300mm × 500mm
	Sterilization Rolls, FlatModel	Dimensions (mm)	Sterilization Rolls, FlatModel	Dimensions (mm)
	TYFR050070	50mm × 70M	TYFR050070	50mm × 70M
	TYFR022f	50.8 mm × 61 M	TYFR075070	75mm × 70M
	TYFR075070	75mm × 70M	TYFR100070	100mm × 70M
	TYFR100070	100mm × 70M	TYFR150070	150mm × 70M
	TYFR042f	101.6 mm × 61 M	TYFR200070	200mm × 70M
	TYFR150070	150mm × 70M	TYFR250070	250mm × 70M
	TYFR062f	152.4 mm × 61 M	TYFR300070	300mm × 70M
	TYFR200070	200mm × 70M	TYFR350070	350mm × 70M
	TYFR082f	203.2 mm × 61 M	TYFR400070	400mm × 70M
	TYFR250070	250mm × 70M	TYFR450070	450mm × 70M
	TYFR102f	254 mm × 61 M	TYFR500070	500mm × 70M
	TYFR300070	300mm × 70M	TYFR050100	50mm × 100M
	TYFR350070	350mm × 70M	TYFR075100	75mm × 100M
	TYFR400070	400mm × 70M	TYFR100100	100mm × 100M
	TYFR450070	450mm × 70M	TYFR150100	150mm × 100M
	TYFR500070	500mm × 70M	TYFR200100	200mm × 100M
	TYFR050100	50mm × 100M	TYFR250100	250mm × 100M
	TYFR075100	75mm × 100M	TYFR300100	300mm × 100M
	TYFR100100	100mm × 100M	TYFR350100	350mm × 100M
	TYFR150100	150mm × 100M	TYFR400100	400mm × 100M
	TYFR200100	200mm × 100M	TYFR450100	450mm × 100M
	TYFR250100	250mm × 100M	TYFR500100	500mm × 100M
	TYFR300100	300mm × 100M	TYFR050200	50mm × 200M
	TYFR350100	350mm × 100M	TYFR075200	75mm × 200M
	TYFR400100	400mm × 100M	TYFR100200	100mm × 200M
	TYFR450100	450mm × 100M	TYFR150200	150mm × 200M
	TYFR500100	500mm × 100M	TYFR200200	200mm × 200M
	TYFR050200	50mm × 200M	TYFR250200	250mm × 200M
	TYFR075200	75mm × 200M	TYFR300200	300mm × 200M
	TYFR100200	100mm × 200M	TYFR350200	350mm × 200M
	TYFR150200	150mm × 200M	TYFR400200	400mm × 200M
	TYFR200200	200mm × 200M
	TYFR250200	250mm × 200M
	TYFR300200	300mm × 200M
	TYFR350200	350mm × 200M
	TYFR400200	400mm × 200M

Table 5-2 Summary of the Proposed and Predicate Devices Technological Characteristics

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Table 5-2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics

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								Table 5-2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
--	--	--	--	--	--	--	--	----------------------------------------------------------------------------------------------------

Feature	Proposed device: SterilizationPouch/Roll Made with Tyvek®(K180672)		Predicate devices: SterilizationPouch/Roll Made with Tyvek®(K133838)		com-parison
Device models(Configura-tions/Dimensions)	Model	Dimensions (mm)	Model	Dimensions (mm)	Same
	TYGR075100	75mm×35mm×100M	TYGR075100	75mm×35mm×100M
	TYGR100100	100mm×40mm×100M	TYGR100100	100mm×40mm×100M
	TYGR150100	150mm×50mm×100M	TYGR150100	150mm×50mm×100M
	TYGR200100	200mm×50mm×100M	TYGR200100	200mm×50mm×100M
	TYGR250100	250mm×60mm×100M	TYGR250100	250mm×60mm×100M
	TYGR300100	300mm×70mm×100M	TYGR300100	300mm×70mm×100M
	TYGR350100	350mm×80mm×100M	TYGR350100	350mm×80mm×100M
	TYGR400100	400mm×80mm×100M	TYGR400100	400mm×80mm×100M
	Sterilization Pouches, Gusseted		Sterilization Pouches, Gusseted
	Model	Dimensions (mm)	Model	Dimensions (mm)
	TYGP100300	100mm×40mm×300mm	TYGP100300	100mm×40mm×300mm
	TYGP150400	150mm×50mm×400mm	TYGP150400	150mm×50mm×400mm
	TYGP200400	200mm×50mm×400mm	TYGP200400	200mm×50mm×400mm
	TYGP250480	250mm×60mm×480mm	TYGP250480	250mm×60mm×480mm
	TYGP300500	300mm×70mm×500mm	TYGP300500	300mm×70mm×500mm
Sterilizationcycle	STERRAD® 100S CycleThe recommended Gas Plasma Sterilization Cycleparameters are exposure time: 6 minutes (Injectionvolume: 2880 µ L), exposure Temperature: 50°C, Plas-ma Stage - Delivered power: 400 Watt.		STERRAD® 100S CycleThe recommended Gas Plasma Sterilization Cycleparameters are exposure time: 6 minutes (Injectionvolume: 2880 µ L), exposure Temperature: 50°C, Plas-ma Stage - Delivered power: 400 Watt.		Same
Design features	Self-sealing sterilization pouches: These pouches aremade from a medical grade plastic film that is heatsealed on three sides. The forth side has an adhesivestrip that is Tyvek® and used to seal the pouch. ReleaseTyvek® used in the pouch is a laminated sheet withcomposing structure of Tyvek®, PET, PE. It is a strip tocover the adhesive area and is released before seal thepouch. The Tyvek® conforms to recognized materialstandards and can be sterilized by Gas plasma. TheProcess Indicators Ink printed on the Tyvek® will ex-hibit a color change after the pouch is exposed to Gasplasma.Sterilization pouches, Flat: These pouches have thesame components with the Self-sealing sterilizationpouches, except the forth side is left opened instead ofan adhesive strip and will be heat-sealed when used.Sterilization rolls, Flat: These rolls are made from aTyvek® and plastic film that are heat sealed on oppo-site two sides. It will be cut into the suitable length andthe opened sides will be heat-sealed. The indicatorsprinted on the Tyvek® are the same with the self-sealing sterilization pouches.Sterilization pouches, Gusseted: These pouches arethe same with the Sterilization pouches, flat, exceptthat the plastic film is folded on both longest sidesinstead of flat. This design is convenient to enclose themedical devices with certain height.Sterilization rolls, Gusseted: These rolls are the samewith the flat sterilization roll, except that the plasticfilm is folded on both longest sides instead of flat. Thisdesign is convenient to enclose the medical deviceswith certain height.		Self-sealing sterilization pouches: These pouches aremade from a medical grade plastic film that is heatsealed on three sides. The forth side has an adhesivestrip that is Tyvek® and used to seal the pouch. ReleaseTyvek® used in the pouch is a laminated sheet withcomposing structure of Tyvek®, PET, PE. It is a strip tocover the adhesive area and is released before seal thepouch. The Tyvek® conforms to recognized materialstandards and can be sterilized by Gas plasma. TheProcess Indicators Ink printed on the Tyvek® will ex-hibit a color change after the pouch is exposed to Gasplasma.Sterilization pouches, Flat: These pouches have thesame components with the Self-sealing sterilizationpouches, except the forth side is left opened instead ofan adhesive strip and will be heat-sealed when used.Sterilization rolls, Flat: These rolls are made from aTyvek® and plastic film that are heat sealed on oppo-site two sides. It will be cut into the suitable length andthe opened sides will be heat-sealed. The indicatorsprinted on the Tyvek® are the same with the self-sealing sterilization pouches.Sterilization pouches, Gusseted: These pouches arethe same with the Sterilization pouches, flat, exceptthat the plastic film is folded on both longest sidesinstead of flat. This design is convenient to enclose themedical devices with certain height.Sterilization rolls, Gusseted: These rolls are the samewith the flat sterilization roll, except that the plasticfilm is folded on both longest sides instead of flat. Thisdesign is convenient to enclose the medical deviceswith certain height.		Same
Chemical Indica-tor Device De-	The color of the Chemical Indicator changes from redto blue (or lighter) when exposed to hydrogen peroxide.		The color of the Chemical Indicator changes from redto blue (or lighter) when exposed to hydrogen peroxide.		Same

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SECTION 5 K180672 510(K) SUMMARY

sign
Feature		Proposed device: Steriliza-tion Pouch/Roll Made withTyvek® (K180672)	Predicate devices: Steriliza-tion Pouch/Roll Made withTyvek® (K133838)	compari-son
Performance Testing
SterilantPenetra-tion	Half-Cycle Efficacy	Showed a 6 log reduction ofGeobacillusstearothermophilus	Showed a 6 log reduction ofGeobacillusstearothermophilus	Same
	Chemical Indicator (CI) Func-tionality and Endpoint	The sterilant penetratedthrough the pouch configura-tion and affected the CI colorchange to the endpoint color	The sterilant penetratedthrough the pouch configura-tion and affected the CI colorchange to the endpoint color	Same
PackageIntegrity(PhysicalProperties)	Thickness VariationsASTM F 2251	Passed	Passed	Same
	Tensile strength of plastic film* ASTM D882	Passed	Passed	Same
Tests con-ducted onunaged andaged (3years accel-erated ag-ing) devic-es, beforeand aftersterilization	Tensile strength of Tyvek®* ASTM D 5035	Passed	Passed	Same
	Tear Resistance* ASTM D1922	Passed	Passed	Same
	Burst StrengthASTM F1140	Passed	Passed	Same
	Seal Peel TestASTM F88/F88M; ISO 11607-1	Passed	Passed	Same
	Dye penetration Test (Seal In-tegrity Test)ASTM F 1929; ISO 11607-1	Passed	Passed	Same
	Microbial Barrier Test*DIN 58953-6	Passed	Passed	Same
Toxicological Properties (BiocompatibilityTests; skin irritation)ANSI/AAMI/ISO 10993-10		Test article with indicatordye was non-irritating	Test article with indicatordye was non-irritating	Same
Durability: Accelerated Aging TestASTM F 1980; ISO 11607-1		Passed	Passed	Same
	End Point / Post Processing Color Stability	Indicator dye remained stablefollowing 3 years real-timeaging	Indicator dye remained stablefollowing 3 years real-timeaging	Same
	Chemical Indicator (CI)Functionality	3 Years	3 Years	Same
	Accelerated aging test(Seal Strength)	3 Years	3 Years	Same

Note: Tyvek® is a registered trademark of Du Pont.

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Table 5-2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics

Note: *the test items were performed on materials of the products; there is no specification requirements.

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Table 5-3. Additional models of Sterilization Pouch/Roll Made with Tyvek® (Type, Model and Dimension)

Type	Model	Dimensions (mm)
Self-Sealing Sterilization Pouches	TYSE090256	90 mm × 256 mm
	TYSE133282	133 mm × 282 mm
	TYSE254408	254 mm × 408 mm
	TYSE305485	305 mm × 485 mm
Sterilization Pouches, Flat	TYFP150255	150 mm × 255 mm
	TYFP190330	190 mm × 330 mm
Sterilization Rolls, Flat	TYFR022f	50.8 mm × 61 M
	TYFR042f	101.6 mm × 61 M
	TYFR062f	152.4 mm × 61 M
	TYFR082f	203.2 mm × 61 M
	TYFR102f	254 mm × 61 M

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5.7 Summary of Non-Clinical Testing

The Sterilization Pouch/Roll Made with Tyvek® has the identical intended use and indication for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.

The results of the Sterilization Pouch/Roll Made with Tyvek® validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:

The Sterilant Penetration testing performed as described in AAMI / ANSI / ISO 14937:2009, "Sterilization of Health Care Products - General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices". The results confirm that the sterilant is able to penetrate the Sterilization Pouch/Roll Made with Tyvek® and sustain direct contact with the medical instrument inside the subject device.
The Biocompatibility testing performed as described in ISO 10993-10 Third Edition 2010-08-01. "Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization". The testing results demonstrate the Sigma Sterilization Pouch/Roll Made with Tyvek® showed "negative reaction". And the Sterilization Pouch/Roll Made with Tyvek® meets the requirements ISO 10993-10:2010(E).
The Package Integrity, Material Compatibility, Sterility Maintenance testing performed as described in AAMI / ANSI / ISO 11607-1:2006//A1:2014, "Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems"; ASTM D882, "Standard Test Method for Tensile Properties of Thin Plastic Sheeting"; ASTM D 5035, "Standard Test Method for Breaking Force and Elongation of Textile Fabrics (Strip Method)"; ASTM F 2251-03. "Standard Test Method for Thickness Measurement of Flexible Packaging Material"; ASTM D 1922, "Standard Test Method for Propagation Tear Resistance of Plastic Film and Thin Sheeting by Pendulum Method"; ASTM F 1140-07, "Standard Test Methods for Internal Pressurization Failure Resistance of Unrestrained Packages"; ASTM F 1929-98 (04), "Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration"; ASTM F88/F88M-09, "Standard Test Method for Seal Strength of Flexible Barrier Materials"; ASTM F 1980-2007, "Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices"; DIN 58953-6:2010-05, "Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized". The testing results demonstrate of the Sterilization Pouch/Roll Made with Tyvek® met the package integrity, material compatibility, and sterility maintenance testing acceptance criteria for each test mentioned above.
The Chemical Indicator Efficacy testing performed as described in AAMI / ANSI / ISO 11140-1:2014. "Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements". The testing demonstrates the ability of the Sterilization Pouch/Roll Made with Tyvek® to effectively stability of the Process Indicators Ink before use, the lasting quality (color stability) of the color change, the completeness and uniformity of the color change and color change is all or none at the conditions measured, unless a color standard is provided on the indicator.

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5.8 Conclusion:

The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K133838.

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).