SIGMA Sterilization Pouch and Roll

• K Number: K180661
• Device Name: SIGMA Sterilization Pouch and Roll
• Manufacturer: Sigma Medical Supplies Corp.
• Date Cleared: 2018-06-05 ( 83 days)
• Product Code: FRG
• Regulation Number: 880.6850
• Type: Abbreviated
• Panel: General Hospital
• Reference & Predicate Devices: K102158
• Predicate For: K202462 , K243179

Intended Use

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

Device Description

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain 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 EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.

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 steam/or EO Sterilization cycles.

The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.

The Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

AI/ML Overview

This document is a 510(k) Premarket Notification from Sigma Medical Supplies Corp. to the FDA regarding their SIGMA Sterilization Pouch and Roll. It seeks to prove substantial equivalence to a previously cleared device (K102158).

Here's an analysis of the acceptance criteria and the study proving the device meets them, based solely on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the comparison of the proposed device to the predicate device and the requirement to meet various ISO and ASTM standards. The study's "performance" is reported as "Passed" or "Meets requirements."

Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Expected Outcome)	Reported Device Performance
Material Composition	Same as predicate (Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator Print Ink)	Same as predicate (Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator Print Ink)
Steam Sterilization Cycle Parameters	30 minutes at 121°C	Same (30 minutes at 121°C)
EO Gas Sterilization Cycle Parameters	4 hours at 55°C, 50%-85% RH, 600 mg/L sterilant concentration	Same (4 hours at 55°C, 50%-85% RH, 600 mg/L sterilant concentration)
Pouch Types	Same as predicate (Self-sealing, Flat, Gusseted pouches; Flat, Gusseted rolls)	Same as predicate
Sterilant Penetration (Half-Cycle Efficacy)	Meet requirement of SAL 10^-6^	The test meets the requirement of SAL 10^-6^
Chemical Indicator (CI) Functionality & Endpoint	Sterilant penetrates and causes CI color change to endpoint color	The sterilant penetrated and affected the CI color change to the endpoint color
Package Integrity (Physical Properties)	Passed (based on various ASTM/ISO standards)	Passed for all listed tests (Thickness Variations, Tensile Strength of plastic film, Tensile Strength of paper, Air Permeance of paper, Tear Resistance Test, Burst Strength, Bubble Leak Test, Seal Peel Test, Dye Penetration Test, Microbial Barrier Test)
Toxicological Properties (Biocompatibility Test)	Passed (based on ANSI/AAMI/ISO 10993-10)	Passed. Showed "negative reaction". Meets ISO 10993-10:2010(E). EO sterilization residuals meet AAMI/ANSI/ISO 10993-7:2008 (R) 2012.
Durability: Accelerated Aging Test	Passed (based on ASTM F 1980; ISO 11607-1)	Passed
End Point / Post Processing Color Stability (Steam)	6 months	6 months
End Point / Post Processing Color Stability (EO)	3 Years	3 Years
Shelf Life (Chemical Indicator Functionality)	3 Years	3 Years
Shelf Life (Accelerated aging test - Seal Strength)	3 Years	3 Years
Class 1 Process Indicators for STEAM (Pouch & CI)	Remain stable before use, change color in presence of sterilant, maintain endpoint stability, meet ISO 11140-1:2014 requirements	Demonstrates ability to remain stable, change color, maintain endpoint stability. Meets ISO 11140-1:2014.
Class 1 Process Indicators for EO Gas (Pouch & CI)	Remain stable before use, change color in presence of sterilant, maintain endpoint stability, meet ISO 11140-1:2014 requirements	Demonstrates ability to remain stable, change color, maintain endpoint stability. Meets ISO 11140-1:2014.
Maintenance of Sterility (Steam)	Up to 6 months post Steam sterilization	Maintains up until 6 months post Steam sterilization
Maintenance of Sterility (EO)	Up to 3 years post EO gas sterilization	Maintains up until 3 years post EO gas sterilization

Study Details:

1. Sample Size Used for the Test Set and Data Provenance:

   • The document does not specify the exact sample sizes used for each test. It states that "The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll" and "The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll."
   • Data Provenance: The manufacturer is Sigma Medical Supplies Corp. located in Taiwan (R.O.C.). The testing (non-clinical) would likely have been conducted by or for this company. The document does not specify if the data is retrospective or prospective, but given it's a premarket notification for a new device (albeit similar to a predicate), it would be prospective data generated specifically for this submission.

2. Number of Experts Used to Establish Ground Truth and Qualifications:

   • This document describes performance testing of a medical device (sterilization pouches and rolls) against established standards (ISO, ASTM). It does not involve human interpretation of images or other data for which "ground truth" would be established by experts in a clinical sense (e.g., radiologists for diagnostic AI).
   • The "ground truth" in this context is defined by the technical specifications and performance requirements of the relevant industry standards (e.g., attainment of SAL 10^-6^ for sterilization, specified physical properties, color change of chemical indicators).
   • Therefore, the concept of "ground truth" established by a panel of human experts in the way it's used for AI/clinical diagnostic studies is not directly applicable here. The validity of the tests themselves is based on adherence to the referenced standards.

3. Adjudication Method for the Test Set:

   • Not applicable in this context. Adjudication is typically used for reconciling disagreements among human readers or evaluators in clinical studies. Here, the tests are objective measurements against defined standards.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

   • No, an MRMC study was not done. This type of study is relevant for assessing the impact of AI on human reader performance in diagnostic tasks, which is not the purpose of this device or its reported testing.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Yes, implicitly. All the described tests (Sterilant Penetration, Package Integrity, Biocompatibility, Chemical Indicator Efficacy, etc.) are evaluating the physical and functional properties of the device itself, independent of human interaction during its use (beyond following instructions). These are "algorithm only" in the sense that the device's performance is measured against objective criteria, not as part of a human-AI system.

6. The Type of Ground Truth Used:

   • The ground truth is based on industry-recognized technical standards (e.g., ISO, ASTM) for sterilant efficacy, package integrity, biocompatibility, and chemical indicator performance. For example, "SAL 10^-6^" or physical property thresholds defined by the standards.

7. The Sample Size for the Training Set:

   • This document describes premarket notification for a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The device is manufactured based on design specifications and then tested.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device. The design and manufacturing processes are likely informed by prior engineering knowledge and adherence to quality systems for medical device production.

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 5, 2018

Sigma Medical Supplies Corp. % 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: K180661

Trade/Device Name: SIGMA Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG 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 ([e-mail]) or phone [phone] 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 Drug Administration

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

Indications for Use

510(k) Number (if known) K180661

Device Name SIGMA sterilization pouch and roll

Indications for Use (Describe)

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll is offered in the following 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)

| 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."

FORM FDA 3881 (7/17)

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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 used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
• · Sterilization pouches, Flat: These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
• · Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest 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 medical grade paper 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 heatsealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
• · Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

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The following table (Table 1) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, dimensions, and content/max load (1bs):

Type	Dimension in S.I.	*Content / Max Load (lbs)
Self-Sealing Sterilization Pouches	57 mm × 133 mm	Metal 0.02
Self-Sealing Sterilization Pouches	70 mm × 257 mm	Plastic 0.01
Self-Sealing Sterilization Pouches	90 mm × 162 mm	Linens and Gauze 0.01
Self-Sealing Sterilization Pouches	90 mm × 168 mm
Self-Sealing Sterilization Pouches	70 mm × 257mm
Self-Sealing Sterilization Pouches	90 mm × 257 mm
Self-Sealing Sterilization Pouches	90 mm × 265 mm
Self-Sealing Sterilization Pouches	90 mm × 594 mm
Self-Sealing Sterilization Pouches	133 mm × 289 mm	Metal 0.23
Self-Sealing Sterilization Pouches	133 mm × 391 mm	Plastic 0.27
Self-Sealing Sterilization Pouches	135 mm × 193 mm	Linens and Gauze 0.10
Self-Sealing Sterilization Pouches	135mm × 283 mm
Self-Sealing Sterilization Pouches	135 mm × 335 mm
Self-Sealing Sterilization Pouches	150mm × 610 mm
Self-Sealing Sterilization Pouches	190 mm × 358 mm
Self-Sealing Sterilization Pouches	190 mm × 365 mm
Self-Sealing Sterilization Pouches	200 mm x 435 mm
Self-Sealing Sterilization Pouches	300 mm × 380 mm
Self-Sealing Sterilization Pouches	300 mm × 474 mm	Metal 1.13
Self-Sealing Sterilization Pouches	300 mm × 485 mm	Plastic 2.92
Self-Sealing Sterilization Pouches	303 mm × 474 mm	Linens and Gauze 1.00
Self-Sealing Sterilization Pouches	305 mm × 416 mm
Self-Sealing Sterilization Pouches	356 mm × 483 mm	Metal 1.31 Plastic 3.38Linens and Gauze 1.16
Self-Sealing Sterilization Pouches	380 mm × 635 mm	Metal 1.48 Plastic 4.42Linens and Gauze 1.51
Self-Sealing Sterilization Pouches	460 mm × 610 mm	Metal 1.79 Plastic 5.34Linens and Gauze 1.82
Type	Dimension in S.I.	*Content / Max Load (lbs)
Sterilization Pouches, Flat	75 mm x 150 mm	Metal 0.13
Sterilization Pouches, Flat	75 mm × 200 mm	Plastic 0.02
Sterilization Pouches, Flat	75 mm x 300 mm	Linens and Gauze 0.02
Sterilization Pouches, Flat	100 mm × 200 mm
Sterilization Pouches, Flat	100 mm × 300 mm
Sterilization Pouches, Flat	100 mm ×550 mm
Sterilization Pouches, Flat	120 mm x 250 mm
Sterilization Pouches, Flat	120 mm × 280 mm
Sterilization Pouches, Flat	150 mm × 200 mm
Sterilization Pouches, Flat	150 mm x 250 mm
Sterilization Pouches, Flat	150 mm x 300 mm
Sterilization Pouches, Flat	150 mm x 380 mm
Sterilization Pouches, Flat	150 mm x 550 mm	Metal 0.23 Plastic 0.03Linens and Gauze 0.03
Sterilization Pouches, Flat	180 mm x 300 mm	Metal 0.13 Plastic 0.02
Sterilization Pouches, Flat	200 mm x 330 mm	Linens and Gauze 0.02
Sterilization Pouches, Flat	200 mm x 400 mm	Metal 0.86 Plastic 1.13Linens and Gauze 0.51
Sterilization Pouches, Flat	200 mm x 600 mm	Metal 1.29 Plastic 1.69Linens and Gauze 0.76
Sterilization Pouches, Flat	205 mm x 400 mm	Metal 0.86
Sterilization Pouches, Flat	250 mm x 300 mm	Plastic 1.13
Sterilization Pouches, Flat	250 mm x 450 mm	Linens and Gauze 0.51
Sterilization Pouches, Flat	300 mm × 380 mm	Metal 0.75
Sterilization Pouches, Flat	300 mm × 460 mm	Plastic 3.28
Sterilization Pouches, Flat	300 mm x 500 mm	Linens and Gauze 1.61
Sterilization Pouches, Flat	420 mm x 400 mm
Sterilization Pouches, Flat	420 mm × 600 mm	Metal 1.12 Plastic 4.92Linens and Gauze 2.41
Sterilization Pouches, Gusseted	100 mm × 40 mm ×300 mm	Metal 0.21 Plastic 0.05
Sterilization Pouches, Gusseted	150 mm × 50 mm × 400 mm	Linens and Gauze 0.08
Sterilization Pouches, Gusseted	200 mm × 50 mm × 400 mm	Metal 0.87 Plastic 1.68
Sterilization Pouches, Gusseted	250 mm × 60 mm × 480 mm	Linens and Gauze 0.90
Sterilization Pouches, Gusseted	300 mm × 70 mm × 500 mm	Metal 1.45 Plastic 3.78Linens and Gauze 1.82

Table 1. Recommended Sterilization Load

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			Table 1. (Continued) Recommended Sterilization Load
--	--	--	-----------------------------------------------------	--	--

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Type	Dimension in S.I.	*Content / Max Load (lbs)
Sterilization Rolls, Flat	50 mm × 200 M	Metal 0.02
Sterilization Rolls, Flat	50.8 mm × 200 M	Plastic 0.01
Sterilization Rolls, Flat	75 mm × 200 M	Linens and Gauze 0.01
Sterilization Rolls, Flat	76.2 mm × 200 M
Sterilization Rolls, Flat	100 mm × 200 M
Sterilization Rolls, Flat	101.6 mm × 200 M
Sterilization Rolls, Flat	150 mm × 200 M
Sterilization Rolls, Flat	152.4 mm × 200 M
Sterilization Rolls, Flat	200 mm × 200 M	Metal 0.86
Sterilization Rolls, Flat	203.2 mm × 200 M	Plastic 1.13
Sterilization Rolls, Flat	250 mm × 200 M	Linens and Gauze 0.51
Sterilization Rolls, Flat	254 mm × 200 M
Sterilization Rolls, Flat	300 mm × 200 M
Sterilization Rolls, Flat	304.8 mm × 200 M
Sterilization Rolls, Flat	350 mm × 200 M
Sterilization Rolls, Flat	400 mm × 200 M	Metal 6.24 Plastic 2.99 Linens and Gauze 2.94
Sterilization Rolls, Flat	50.8 mm × 30.5 M	Metal 0.02
Sterilization Rolls, Flat	76.2 mm × 30.5 M	Plastic 0.01
Sterilization Rolls, Flat	101.6 mm × 30.5 M	Linens and Gauze 0.01
Sterilization Rolls, Flat	152.4 mm × 30.5 M
Sterilization Rolls, Flat	203.2 mm × 30.5 M	Metal 0.86 Plastic 1.13
Sterilization Rolls, Flat	254 mm × 30.5 M	Linens and Gauze 0.51
Sterilization Rolls, Gusseted	75 mm × 35 mm × 100 M	Metal 0.12
Sterilization Rolls, Gusseted	100 mm × 40 mm × 100 M	Plastic 0.02
Sterilization Rolls, Gusseted	150 mm × 50 mm × 100 M	Linens and Gauze 0.03
Sterilization Rolls, Gusseted	200 mm × 50 mm × 100 M	Metal 0.87
Sterilization Rolls, Gusseted	250 mm × 60 mm × 100 M	Plastic 1.68
Sterilization Rolls, Gusseted	300 mm × 70 mm × 100 M	Linens and Gauze 0.90
Sterilization Rolls, Gusseted	350 mm × 80 mm × 100 M
Sterilization Rolls, Gusseted	400 mm × 80 mm × 100 M	Metal 3.67 Plastic 3.00 Linens and Gauze 3.44

Table 1. (Continued) Recommended Sterilization Load

*Content:

1. Metal: For example, scalpels, clips, forceps and trays. 2. Plastic: For example, infusion tubes, syringes, foley tubes and gloves, etc. 3. Linens and Cotton: For example, linens, drapes, and cotton wool, etc.

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K180661 510(k) Summary

1 Sumitter's Information

Name:	SIGMA Medical Supplies Corp.
Address:	NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui FangDist., New Taipei City 224, Taiwan (R.O.C.)
EstablishmentRegistration Number:	3004970050
Contact:	Mason HuangRegulatory Affair Specialist886-4-24366111 ext. 127E-mail: [e-mail] WangPresident /C.E.O
Date Prepared:	May 30, 2018
2 Device Name
Trade Name:	SIGMA Sterilization Pouch and Roll
Common/usual Name:	SIGMA Sterilization Pouch and Roll
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

3 Predicate Devices

The predicate device [510(k) Notification K102158, cleared August 02, 2011] is the SIGMA Sterilization Pouch and Roll.

Manufacturer: SIGMA Medical Supplies Corp.

Product Code:1) FRG 2) JOJ

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510(k) number:K102158

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4 Indications for Use

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121℃. The recommended EO sterilization cycle is 4 hours at 55℃ with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll is offered in the following 5 types:

• · Self-sealing sterilization pouches
• · Sterilization pouches, Flat
• Sterilization pouches, Gusseted
• Sterilization rolls, Flat
• Sterilization rolls, Gusseted

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 used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
• · Sterilization pouches, Flat: These pouches has the same components with the Self-sealing sterilization pouches, except the forth side is left opened instead of an adhesive strip and will be heat-sealed when using.
• · Sterilization pouches, Gusseted: These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest 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 medical grade paper 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 medical grade paper are the same with the self-sealing sterilization pouches.
• · Sterilization rolls, Gusseted: These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.

The following table (Table 1) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, dimensions, and content/max load(lbs):

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Type	Model	Dimension in S.I.	*Content/Max Load (lbs)
Self-SealingSterilizationPouches	SMSE057133	57 mm × 133 mm	Metal 0.02
	SMSE070257	70 mm × 257 mm	Plastic 0.01
	SMSE090162	90 mm × 162 mm	Lines and Gauze 0.01
	SMSE090168	90 mm × 168 mm
	SMSE070257	70 mm × 257mm
	SMSE090257	90 mm × 257 mm
	SMSE090265	90 mm × 265 mm
	SMSE090594	90 mm × 594 mm	Metal 0.23
	SMSE133289	133 mm × 289 mm	Plastic 0.27
	SMSE133391	133 mm × 391 mm	Lines and Gauze 0.10
	SMSE135193	135 mm × 193 mm
	SMSE135283	135 mm × 283 mm
	SMSE180335	135 mm × 335 mm
	SMSE150610	150 mm × 610 mm
	SMSE190358	190 mm × 358 mm
	SMSE190365	190 mm × 365 mm
	SMSE200435	200 mm × 435 mm
	SMSE300380	300 mm × 380 mm
SMSE300474	300 mm × 474 mm	Metal 1.13
SMSE300485	300 mm × 485 mm	Plastic 2.92
SMSE303474	303 mm × 474 mm	Lines and Gauze 1.00
SMSE305416	305 mm × 416 mm
SMSE356483	356 mm × 483 mm	Metal 1.31 Plastic 3.38Linens and Gauze 1.16
SMSE380635	380 mm × 635 mm	Metal 1.48 Plastic 4.42Lines and Gauze 1.51
SMSE460610	460 mm × 610 mm	Metal 1.79 Plastic 5.34Lines and Gauze 1.82
Type	Model	Dimension in S.I.	*Content/Max Load (lbs)
Sterilization Pouches, Flat	SMFP075150	75 mm × 150 mm	Metal 0.13Plastic 0.02
	SMFP075200	75 mm × 200 mm	Linens and Gauze 0.02
	SMFP075300	75 mm × 300 mm
	SMFP100200	100 mm × 200 mm
	SMFP100300	100 mm × 300 mm
	SMFP100550	100 mm × 550 mm
	SMFP120250	120 mm × 250 mm
	SMFP120280	120 mm × 280 mm
	SMFP150200	150 mm × 200 mm
	SMFP150250	150 mm × 250 mm
	SMFP150300	150 mm × 300 mm
	SMFP150380	150 mm × 380 mm
Sterilization Pouches, Flat	SMFP150550	150 mm × 550 mm	Metal 0.23 Plastic 0.03Linens and Gauze 0.03
	SMFP180300	180 mm × 300 mm	Metal 0.13 Plastic 0.02Linens and Gauze 0.02
	SMFP200330	200 mm × 330 mm	Linens and Gauze 0.02
	SMFP200400	200 mm × 400 mm	Metal 0.86 Plastic 1.13Linens and Gauze 0.51
	SMFP200600	200 mm × 600 mm	Metal 1.29 Plastic 1.69Linens and Gauze 0.76
	SMFP205400	205 mm × 400 mm	Metal 0.86
	SMFP250300	250 mm × 300 mm	Plastic 1.13
	SMFP250450	250 mm × 450 mm	Linens and Gauze 0.51
	SMFP300380	300 mm × 380 mm	Metal 0.75
	SMFP300460	300 mm × 460 mm	Plastic 3.28Linens and Gauze 1.61
	SMFP300500	300 mm × 500 mm
	SMFP420400	420 mm × 400 mm
	SMFP420600	420 mm × 600 mm	Metal 1.12 Plastic 4.92Linens and Gauze 2.41
SterilizationPouches, Gus-seted	SMGP100300	100 mm × 40 mm × 300 mm	Metal 0.21 Plastic 0.05Linens and Gauze 0.08
	SMGP150400	150 mm × 50 mm × 400 mm
	SMGP200400	200 mm × 50 mm × 400 mm	Metal 0.87 Plastic 1.68Linens and Gauze 0.90
	SMGP250480	250 mm × 60 mm × 480 mm
	SMGP300500	300 mm × 70 mm × 500 mm	Metal 1.45 Plastic 3.78Linens and Gauze 1.82

Table 1. The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)

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Table 1. (Continued) The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)

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Type	Model	Dimension in S.I.	*Content/Max Load (lbs)
SterilizationRolls, Flat	SMFR 022	50 mm × 200 M	Metal 0.02Plastic 0.01
	SMFR 902	50.8 mm × 200 M	Linens and Gauze 0.01
	SMFR 032	75 mm × 200 M
	SMFR 912	76.2 mm × 200 M
	SMFR 042	100 mm × 200 M
	SMFR 922	101.6 mm × 200 M
	SMFR 062	150 mm × 200 M
	SMFR 932	152.4 mm × 200 M
	SMFR 082	200 mm × 200 M	Metal 0.86
	SMFR 942	203.2 mm × 200 M	Plastic 1.13Linens and Gauze 0.51
	SMFR 102	250 mm × 200 M
	SMFR 952	254 mm × 200 M
	SMFR 122	300 mm × 200 M
	SMFR 962	304.8 mm × 200 M
	SMFR 142	350 mm × 200 M
	SMFR 162	400 mm × 200 M	Metal 6.24 Plastic 2.99Linens and Gauze 2.94
SterilizationRolls, Gusseted	SMFR 02-1	50.8 mm × 30.5 M	Metal 0.02Plastic 0.01
	SMFR 03-1	76.2 mm × 30.5 M	Linens and Gauze 0.01
	SMFR 04-1	101.6 mm × 30.5 M
	SMFR 06-1	152.4 mm × 30.5 M
	SMFR 08-1	203.2 mm × 30.5 M	Metal 0.86 Plastic 1.13Linens and Gauze 0.51
	SMFR 10-1	254 mm × 30.5 M
	SMGR 031	75 mm × 35 mm × 100 M	Metal 0.12Plastic 0.02
	SMGR 041	100 mm × 40 mm × 100M	Linens and Gauze 0.03
	SMGR 061	150 mm × 50 mm × 100 M
	SMGR 081	200 mm × 50 mm × 100 M	Metal 0.87
	SMGR 101	250 mm × 60 mm × 100 M	Plastic 1.68Linens and Gauze 0.90
	SMGR 121	300 mm × 70 mm × 100 M
	SMGR 141	350 mm × 80 mm × 100 M
	SMGR 161	400 mm × 80 mm × 100 M	Metal 3.67 Plastic 3.00Linens and Gauze 3.44

Table 1. (Continued) The model numbers of SIGMA sterilization pouch and roll (Type, Model and Dimension and Content/Max Load)

*Content:

1.Metal: For example, scalpels, clips, pins, forceps and trays. 2. Plastic: For example, infusion tubes, syringes, foley tubes and gloves, etc. 3. Linens and Cotton: For example, linens, drapes, and cotton wool, etc.

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5 Device Description

The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintain 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 EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.

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 steam/or EO Sterilization cycles.

The chemical indicators ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas. The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. And the color changes from red to yellow, when exposed to EO gas.

The Chemical Indicator offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.

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6 Technological Characteristic Comparison

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 2.

Feature	Proposed device	Predicate device	Comparison
Device name	SIGMA sterilization pouch and roll	SIGMA sterilization pouch and roll (K102158)
Material Composition	Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process IndicatorPrint Ink	Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process IndicatorPrint Ink	Same
Intended use	The sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.	The sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 3 years post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process.	Only the maintenance of sterility is different.The proposed device maintains the enclosed devices up until 3 years post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization.
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 (Configurations/Dimensions)	Self-Sealing Sterilization Pouches Model Dimension (mm) SMSE057133 $57 \text{ mm } \times 133 \text{ mm}$ SMSE070257 $70 \text{ mm } \times 257 \text{ mm}$ SMSE090162 $90 \text{ mm } \times 162 \text{ mm}$ SMSE090168 $90 \text{ mm } \times 168 \text{ mm}$ SMSE070257 $70 \text{ mm } \times 257 \text{ mm}$ SMSE090257 $90 \text{ mm } \times 257 \text{ mm}$ SMSE090265 $90 \text{ mm } \times 265 \text{ mm}$ SMSE090594 $90 \text{ mm } \times 594 \text{ mm}$ SMSE133289 $133 \text{ mm } \times 289 \text{ mm}$ SMSE133391 $133 \text{ mm } \times 391 \text{ mm}$ SMSE135193 $135 \text{ mm } \times 193 \text{ mm}$ SMSE135283 $135 \text{ mm } \times 283 \text{ mm}$ SMSE180335 $135 \text{ mm } \times 335 \text{ mm}$ SMSE150610 $150 \text{ mm } \times 610 \text{ mm}$ SMSE190358 $190 \text{ mm } \times 358 \text{ mm}$ SMSE190365 $190 \text{ mm } \times 365 \text{ mm}$ SMSE200435 $200 \text{ mm } \times 435 \text{ mm}$ SMSE300380 $300 \text{ mm } \times 380 \text{ mm}$ SMSE300474 $300 \text{ mm } \times 474 \text{ mm}$ SMSE300485 $300 \text{ mm } \times 485 \text{ mm}$ SMSE303474 $303 \text{ mm } \times 474 \text{ mm}$ SMSE305416 $305 \text{ mm } \times 416 \text{ mm}$ SMSE356483 $356 \text{ mm } \times 483 \text{ mm}$ SMSE380635 $380 \text{ mm } \times 635 \text{ mm}$ SMSE460610 $460 \text{ mm } \times 610 \text{ mm}$																																																					Self-Sealing Sterilization Pouches Model Dimension (mm) SMSE057133 $57 \text{ mm } \times 133 \text{ mm}$ SMSE090162 $90 \text{ mm } \times 162 \text{ mm}$ SMSE070257 $70 \text{ mm } \times 257 \text{ mm}$ SMSE090257 $90 \text{ mm } \times 257 \text{ mm}$ SMSE135283 $135 \text{ mm } \times 283 \text{ mm}$ SMSE180335 $135 \text{ mm } \times 335 \text{ mm}$ SMSE190358 $190 \text{ mm } \times 358 \text{ mm}$ SMSE300380 $300 \text{ mm } \times 380 \text{ mm}$ SMSE300474 $300 \text{ mm } \times 474 \text{ mm}$																					The models (dimensions) of type "Self-Sealing Sterilization Pouches" are different. There are 16 additional models in Proposed device.The additional models (Type, Model and Dimension) of Proposed device are shown in Table 3.

Table 2. Summary of the Proposed and Predicate Devices Technological Characteristics

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Feature	Proposed device: SIGMA sterilization pouch and roll	Predicate devices: SIGMA sterilization pouch and roll (K102158)	Comparison
Device models(Configurations/Dimensions)	Sterilization Pouches, Flat		The models (dimensions) of type "Sterilization Pouches, Flat" are different. There are 17 additional models in Proposed device. The additional models (Type, Model and Dimension) of Proposed device are shown in Table 3.
	Model	Dimension (mm)
	SMFP075150	75 mm × 150 mm
	SMFP075200	75 mm × 200 mm
	SMFP075300	75 mm × 300 mm
	SMFP100200	100 mm × 200 mm
	SMFP100300	100 mm × 300 mm
	SMFP100550	100 mm ×550 mm
	SMFP120250	120 mm × 250 mm
	SMFP120280	120 mm × 280 mm
	SMFP150200	150 mm × 200 mm
	SMFP150250	150 mm × 250 mm
	SMFP150300	150 mm × 300 mm
	SMFP150380	150 mm × 380 mm
	SMFP150550	150 mm × 550 mm
	SMFP180300	180 mm × 300 mm
	SMFP200330	200 mm × 330 mm
	SMFP200400	200 mm × 400 mm
	SMFP200600	200 mm × 600 mm
	SMFP205400	205 mm × 400 mm
	SMFP250300	250 mm × 300 mm
	SMFP250450	250 mm × 450 mm
	SMFP300380	300 mm × 380 mm
	SMFP300460	300 mm × 460 mm
	SMFP300500	300 mm × 500 mm
	SMFP420400	420 mm × 400 mm
	SMFP420600	420 mm × 600 mm
	Sterilization Pouches, Gusseted
	Model	Dimension (mm)	Same
	SMGP100300	100mm×40mm×300mm
	SMGP150400	150mm×50mm×400mm
	SMGP200400	200mm×50mm×400mm
	SMGP250480	250mm×60mm×480mm
	SMGP300500	300mm×70mm×500mm

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

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

Feature	Proposed device: SIGMA sterilization pouch and roll	Predicate devices: SIGMA sterilization pouch and roll (K102158)	Comparison
Device models (Configurations/Dimensions)	Sterilization Rolls, Flat Model Dimension (mm) SMFR 022 50 mm × 200 M SMFR902 50.8 mm × 200 M SMFR 032 75 mm × 200 M SMFR912 76.2 mm × 200 M SMFR 042 100 mm × 200 M SMFR922 101.6 mm × 200 M SMFR 062 150 mm × 200 M SMFR932 152.4 mm × 200 M SMFR 082 200 mm × 200 M SMFR942 203.2 mm × 200 M SMFR 102 250 mm × 200 M SMFR952 254 mm × 200 M SMFR 122 300 mm × 200 M SMFR962 304.8 mm × 200 M SMFR 142 350 mm × 200 M SMFR 162 400 mm × 200 M SMFR02-1 50.8 mm x 30.5 M SMFR03-1 76.2 mm x 30.5 M SMFR04-1 101.6 mm x 30.5 M SMFR06-1 152.4 mm x 30.5 M SMFR08-1 203.2 mm × 30.5 M SMFR10-1 254 mm x 30.5 M																																															Sterilization Rolls, Flat Model Dimension (mm) SMFR 022 50 mm × 200 M SMFR 032 75 mm × 200 M SMFR 042 100 mm × 200 M SMFR 062 150 mm × 200 M SMFR 082 200 mm × 200 M SMFR 102 250 mm × 200 M SMFR 122 300 mm × 200 M SMFR 142 350 mm × 200 M SMFR 162 400 mm × 200 M																					The models (dimensions) of type "Sterilization Rolls, Flat" are different. There are 13 additional models in Proposed device. The additional models (Type, Model and Dimension) of Proposed device are shown in Table 3.
	Sterilization Rolls, Gusseted Model Dimension (mm) SMGR 031 75mm×35mm×100 M SMGR 041 100mm×40mm×100M SMGR 061 150mm×50mm×100M SMGR 081 200mm×50mm×100M SMGR 101 250mm×60mm×100M SMGR 121 300mm×70mm×100M SMGR 141 350mm×80mm×100M SMGR 161 400mm×80mm×100M																			Sterilization Rolls, Gusseted Model Dimension (mm) SMGR 031 75mm×35mm×100 M SMGR 041 100mm×40mm×100M SMGR 061 150mm×50mm×100M SMGR 081 200mm×50mm×100M SMGR 101 250mm×60mm×100M SMGR 121 300mm×70mm×100M SMGR 141 350mm×80mm×100M SMGR 161 400mm×80mm×100M																			Same

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Feature	Proposed Device:SIGMA sterilization pouch and roll	Predicate devices:SIGMA sterilization pouch and roll (K102158)	Comparison
SteamSterilizationcycle	The recommended steam sterilization cycle parameters are 30 minutes at 121°C.	The recommended steam sterilization cycle parameters are 30 minutes at 121°C.	Same
EO gasSterilizationcycle	The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L.	The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L.	Same
Designfeatures	Self-sealing sterilization pouches:These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.Sterilization pouches, Flat:These pouches has the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.Sterilization pouches, Gusseted:These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest 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 medical grade paper 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 medical grade paper are the same with the self-sealing sterilization pouches.Sterilization rolls, Gusseted:These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.	Self-sealing sterilization pouches:These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam or ethylene oxide gas. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.Sterilization pouches, Flat:These pouches has the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.Sterilization pouches, Gusseted:These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest 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 medical grade paper 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 medical grade paper are the same with the self-sealing sterilization pouches.Sterilization rolls, Gusseted:These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.	Same
SteamChemicalIndicator Device Design	The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam.	The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam.	Same
EO gasChemicalIndicator Device Design	The color changes from red to yellow, when exposed to EO gas.	The color changes from red to yellow, when exposed to EO gas.	Same
Feature		Proposed Device:SIGMA sterilization	Predicate Devices:SIGMA sterilization pouch	Compar-
Performance Testing		pouch and roll	and roll (K102158)	ison
SterilantPenetration	Half-Cycle Efficacy	The test meet the require-ment of SAL 10-6	The test meet the require-ment of SAL 10-6	Same
	Chemical Indicator (CI) Func-tionality and Endpoint	The sterilant penetratedthrough the pouch configu-ration and affected the CIcolor change to the end-point color	The sterilant penetratedthrough the pouch configu-ration and affected the CIcolor change to the end-point color	Same
PackageIntegrity(PhysicalProperties)	Thickness Variations (mm)ASTM F 2251	Passed	Passed	Same
	Tensile strength of plastic film *(kgf/mm2)ASTM D882	Passed	Passed	Same
	Tensile strength of paper*(N/15mm)ISO 1924-2	Passed	Passed	Same
	Air permeance of paper* (lb/in)ISO 5636-3	Passed	Passed	Same
	Thickness Variation (mm)ASTM F2251	Passed	Passed	Same
	Tear Resistance Test (kgf/cm2)ASTM D 1004	Passed	Passed	Same
	Burst Strength (kPa)ASTM F1140 ; ISO 11607-1	Passed	Passed	Same
	Bubble Leak TestASTM D 3078 ; ASTM-F 2096	Passed	Passed	Same
	Seal Peel Test (g/15mm)ASTM F88/F88M ; ISO 11607-1	Passed	Passed	Same
	Dye penetration TestASTM F 1929 ;ISO 11607-1	Passed	Passed	Same
	Microbial Barrier TestDIN 58953-6 ;or ASTM F 1608	Passed	Passed	Same
	Toxicological Properties(Biocompatibility Test)ANSI/AAMI/ISO 10993-10	Passed	Passed	Same
	Durability: Accelerated AgingTestASTM F 1980 ; ISO 11607-1	Passed	Passed	Same
End Point /Post Pro-cessing Col-or Stability	after steam sterilization	6 months	6 months	Same
	after EO sterilization	3 Years	3 Years	Same
Shelf Life	Chemical Indicator (CI)Functionality	3 Years	3 Years	Same
	Accelerated aging test(Seal Strength)	3 Years	3 Years	Same

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

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Table 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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Type	Model	Dimension in S.I.
Self-Sealing Sterilization Pouches	SMSE070257	70 mm × 257 mm
	SMSE090168	90 mm × 168 mm
	SMSE090265	90 mm × 265 mm
	SMSE090594	90 mm × 594 mm
	SMSE133289	133 mm × 289 mm
	SMSE133391	133 mm × 391 mm
	SMSE135193	135 mm × 193 mm
	SMSE150610	150 mm × 610 mm
	SMSE190365	190 mm × 365 mm
Self-Sealing Sterilization Pouches	SMSE200435	200 mm × 435 mm
Self-Sealing Sterilization Pouches	SMSE300485	300 mm × 485 mm
Self-Sealing Sterilization Pouches	SMSE303474	303 mm × 474 mm
Self-Sealing Sterilization Pouches	SMSE305416	305 mm × 416 mm
Self-Sealing Sterilization Pouches	SMSE356483	356 mm × 483 mm
Self-Sealing Sterilization Pouches	SMSE380635	380 mm × 635 mm
Self-Sealing Sterilization Pouches	SMSE460610	460 mm × 610 mm
Sterilization Pouches, Flat	SMFP075150	75 mm × 150 mm
	SMFP100550	100 mm ×550 mm
	SMFP120250	120 mm × 250 mm
	SMFP120280	120 mm × 280 mm
	SMFP150200	150 mm × 200 mm
	SMFP150250	150 mm × 250 mm
	SMFP150380	150 mm × 380 mm
	SMFP150550	150 mm × 550 mm
	SMFP180300	180 mm × 300 mm
	SMFP200330	200 mm × 330 mm
	SMFP200600	200 mm × 600 mm
	SMFP205400	205 mm × 400 mm
	SMFP250300	250 mm × 300 mm
	SMFP300380	300 mm × 380 mm
	SMFP300460	300 mm × 460 mm
	SMFP420400	420 mm × 400 mm
Sterilization Pouches, Flat	SMFP420600	420 mm × 600 mm
Sterilization Rolls, Flat	SMFR 902	50.8 mm × 200 M
	SMFR 912	76.2 mm × 200 M
	SMFR 922	101.6 mm × 200 M
	SMFR 932	152.4 mm × 200 M
	SMFR 942	203.2 mm × 200 M
	SMFR 952	254 mm × 200 M
	SMFR 962	304.8 mm × 200 M
	SMFR 02-1	50.8 mm × 30.5 M
	SMFR 03-1	76.2 mm × 30.5 M
	SMFR 04-1	101.6 mm × 30.5 M
	SMFR 06-1	152.4 mm × 30.5 M
	SMFR 08-1	203.2 mm × 30.5 M
	Sterilization Rolls, Flat	SMFR 10-1

Table 3 Additional models of SIGMA sterilization pouch and roll (Type, Model and Dimension)

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7 Summary of Non-Clinical Testing

The SIGMA sterilization pouch and roll 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, Drying Time, Aeration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.

The results of the SIGMA sterilization pouch and roll validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as follows:

• · The Sterilant Penetration, Drying Time, Aeration, testing performed as described in AAMI / ANSI / ISO 17665-1:2006/(R)2013 and ISO TS 17665-2:2009 for steam sterilization as well as AAMI / ANSI / ISO 11135:2014 for EO. The testing results demonstrate the ability of the sterilant to penetrate the Sigma Sterilization Pouch and Roll.
• · The Biocompatibility testing performed as described in ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2012(E), and ISO/IEC 17025:2005. The testing results demonstrate the Sigma Sterilization Pouch and Roll showed "hegative reaction". And the SIGMA sterilization pouch and roll meets the requirements ISO 10993-10:2010(E). The EO sterilization residuals meets the requirements AAMI / AN-SI / ISO 10993-7:2008 (R) 2012.
• · 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 the ability of the Sigma Sterilization Pouch and Roll to maintain the package integrity over the claimed shelf life.

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". There are two types of the Process Indicator ink printed on the SIGMA sterilization pouch and roll. The description of the two types ink as follows: - Class 1 Process Indicators for STEAM

The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll and its Class 1 Process Indicators for STEAM to remain stable before use based on its shelf life data, change color in the presence of the sterilant, and to maintain the endpoint stability of the color change after being in the presence of the sterilant. The STEAM Pro

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cess Indicators ink printed on the SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2014.

• Class 1 Process Indicators for EO gas

The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll and its Class 1 Process Indicators for STEAM to remain stable before use based on its shelf life data, change color in the presence of the sterilant, and to maintain the endpoint stability of the color change after being in the presence of the sterilant. The EO gas Process Indicators ink printed on the SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2014.

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8 CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that SIGMA Sterilization Pouch and Roll is as safe, as effective, and performs as well as or better than the predicate K102158.

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).