SIGMA Sterilization Pouch and Roll

K180661 · Sigma Medical Supplies Corp. · FRG · Jun 5, 2018 · General Hospital

Device Facts

• Record ID: K180661
• Device Name: SIGMA Sterilization Pouch and Roll
• Applicant: Sigma Medical Supplies Corp.
• Product Code: FRG · General Hospital
• Decision Date: Jun 5, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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°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 Story

Device consists of medical-grade paper and plastic film pouches/rolls used to enclose medical instruments for sterilization. Healthcare workers insert devices into pouches, seal them (via self-adhesive strip or heat-sealing), and process them in steam or EO sterilization systems. External chemical ink indicators on the paper surface change color (Blue to Greenish Black for steam; Red to Yellow for EO) to confirm exposure to the sterilization process. The device maintains sterility of enclosed items for up to 6 months post-steam or 3 years post-EO sterilization. It serves as a sterile barrier system to protect instruments until use.

Clinical Evidence

Bench testing only. Studies included sterilant penetration, drying time, aeration, biocompatibility (ISO 10993-10), package integrity (ASTM F88, F1929, F1140, F1980, etc.), and chemical indicator efficacy (ISO 11140-1). Results confirmed SAL 10^-6 achievement, negative biocompatibility reactions, and maintenance of package integrity over the claimed shelf life.

Technological Characteristics

Materials: Medical grade paper, CPP, PET, PU adhesive, and EO/Steam process indicator ink. Form factors: Self-sealing pouches, flat pouches, gusseted pouches, flat rolls, and gusseted rolls. Standards: ISO 11607-1, ISO 11140-1, ISO 10993, ASTM D882, ASTM F2251, ASTM F1929, ASTM F1140. Sterilization: Steam (121°C, 30 min) and EO (55°C, 4 hrs, 600 mg/L).

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization via steam autoclave or Ethylene Oxide (EO) gas. Applicable to various medical devices including metal instruments, plastic items, and linens/gauze.

Regulatory Classification

Identification

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

Predicate Devices

• SIGMA Sterilization Pouch and Roll (K102158)

Submission Summary (Full Text)

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

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

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

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

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

#### 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)

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

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.

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

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 3.38<br>Linens and Gauze 1.16 |
| Self-Sealing Sterilization Pouches | 380 mm × 635 mm | Metal 1.48 Plastic 4.42<br>Linens and Gauze 1.51 |
| Self-Sealing Sterilization Pouches | 460 mm × 610 mm | Metal 1.79 Plastic 5.34<br>Linens 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 0.03<br>Linens 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 1.13<br>Linens and Gauze 0.51 |
| Sterilization Pouches, Flat | 200 mm x 600 mm | Metal 1.29 Plastic 1.69<br>Linens 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 4.92<br>Linens 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 3.78<br>Linens and Gauze 1.82 |

Table 1. Recommended Sterilization Load

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

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

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

| 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.

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

# K180661 510(k) Summary

#### 1 Sumitter's Information

| Name: | SIGMA Medical Supplies Corp. |
|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | NO.34, Ding-Ping Road, Rui Fang Industrial Park, Rui Fang<br>Dist., New Taipei City 224, Taiwan (R.O.C.) |
| Establishment<br>Registration Number: | 3004970050 |
| Contact: | Mason Huang<br>Regulatory Affair Specialist<br>886-4-24366111 ext. 127<br>E-mail: [e-mail]<br>Or<br>Jack Wang<br>President /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.<br>2) Indicator, Physical/Chemical Sterilization Pro-<br>cess |
| Panel: | General Hospital |
| Classification Product Code:<br>Subsequent Product Code: | 1) FRG<br>2) JOJ |
| Device Classification: | Class II |
| Regulation Number: | 1) 21 CFR 880.6850<br>2) 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

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

510(k) number:K102158

{9}------------------------------------------------

### 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):

{10}------------------------------------------------

| Type | Model | Dimension in S.I. | *Content/Max Load (lbs) |
|------------------------------------------|-----------------|--------------------------------------------------|--------------------------------------------------|
| Self-Sealing<br>Sterilization<br>Pouches | 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 3.38<br>Linens and Gauze 1.16 | |
| SMSE380635 | 380 mm × 635 mm | Metal 1.48 Plastic 4.42<br>Lines and Gauze 1.51 | |
| SMSE460610 | 460 mm × 610 mm | Metal 1.79 Plastic 5.34<br>Lines and Gauze 1.82 | |
| Type | Model | Dimension in S.I. | *Content/Max Load (lbs) |
| Sterilization Pouches, Flat | SMFP075150 | 75 mm × 150 mm | Metal 0.13<br>Plastic 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 0.03<br>Linens and Gauze 0.03 |
| | SMFP180300 | 180 mm × 300 mm | Metal 0.13 Plastic 0.02<br>Linens and Gauze 0.02 |
| | SMFP200330 | 200 mm × 330 mm | Linens and Gauze 0.02 |
| | SMFP200400 | 200 mm × 400 mm | Metal 0.86 Plastic 1.13<br>Linens and Gauze 0.51 |
| | SMFP200600 | 200 mm × 600 mm | Metal 1.29 Plastic 1.69<br>Linens 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 3.28<br>Linens and Gauze 1.61 |
| | SMFP300500 | 300 mm × 500 mm | |
| | SMFP420400 | 420 mm × 400 mm | |
| | SMFP420600 | 420 mm × 600 mm | Metal 1.12 Plastic 4.92<br>Linens and Gauze 2.41 |
| Sterilization<br>Pouches, Gus-<br>seted | SMGP100300 | 100 mm × 40 mm × 300 mm | Metal 0.21 Plastic 0.05<br>Linens and Gauze 0.08 |
| | SMGP150400 | 150 mm × 50 mm × 400 mm | |
| | SMGP200400 | 200 mm × 50 mm × 400 mm | Metal 0.87 Plastic 1.68<br>Linens and Gauze 0.90 |
| | SMGP250480 | 250 mm × 60 mm × 480 mm | |
| | SMGP300500 | 300 mm × 70 mm × 500 mm | Metal 1.45 Plastic 3.78<br>Linens and Gauze 1.82 |

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

{11}------------------------------------------------

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

{12}------------------------------------------------

| Type | Model | Dimension in S.I. | *Content/Max Load (lbs) |
|----------------------------------|-----------|------------------------|--------------------------------------------------|
| Sterilization<br>Rolls, Flat | SMFR 022 | 50 mm × 200 M | Metal 0.02<br>Plastic 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 1.13<br>Linens 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 2.99<br>Linens and Gauze 2.94 |
| Sterilization<br>Rolls, Gusseted | SMFR 02-1 | 50.8 mm × 30.5 M | Metal 0.02<br>Plastic 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 1.13<br>Linens and Gauze 0.51 |
| | SMFR 10-1 | 254 mm × 30.5 M | |
| | SMGR 031 | 75 mm × 35 mm × 100 M | Metal 0.12<br>Plastic 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 1.68<br>Linens 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 3.00<br>Linens 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.

{13}------------------------------------------------

# 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.

{14}------------------------------------------------

### 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 Indicator<br>Print Ink | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator<br>Print 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.<br>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.<br>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

{15}------------------------------------------------

| Feature | Proposed device: SIGMA sterilization pouch and roll | Predicate devices: SIGMA sterilization pouch and roll (K102158) | Comparison |
|----------------------------------------------|-----------------------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device models<br>(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

{16}------------------------------------------------

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

| Feature | Proposed device: SIGMA sterilization pouch and roll…