SIGMA Sterilization Pouch and Roll

K202462 · Sigma Medical Supplies Corporation · FRG · Apr 23, 2021 · General Hospital

Device Facts

• Record ID: K202462
• Device Name: SIGMA Sterilization Pouch and Roll
• Applicant: Sigma Medical Supplies Corporation
• Product Code: FRG · General Hospital
• Decision Date: Apr 23, 2021
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.6850
• Device Class: Class 2

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 the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: - Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes. - Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes. - Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes. - Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. - Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes. - EO sterilization cycle is 4 hours at 55°C (131°F) 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 pouch has undergone either a steam or EO sterilization process.

Device Story

Device consists of sterilization pouches and rolls used by healthcare workers to enclose medical instruments for steam or EO sterilization. Pouches/rolls are constructed from medical-grade paper and plastic film (CPP/PET) with PU adhesive. External chemical ink indicators printed on the paper 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 instruments for up to 3 years post-EO and 6 months post-steam. The device is used in clinical settings; instruments are placed inside, sealed (self-sealing or heat-sealed), and processed in a sterilizer. The color-changing indicator provides visual verification of exposure, aiding in workflow management, though it does not replace biological indicators. Benefits include maintaining instrument sterility and providing a clear visual signal of processing status.

Clinical Evidence

No clinical data. Bench testing only. Validation included sterilant penetration (SAL 10^-6), drying time, aeration, biocompatibility (ISO 10993-10), package integrity (ASTM F2251, F1140, F1929, F88, F2096), and chemical indicator efficacy (ISO 11140-1). Accelerated aging studies (ASTM F1980) confirmed 3-year shelf life for EO and 6-month shelf life for steam.

Technological Characteristics

Materials: Medical grade paper, CPP, PET, PU adhesive. Sensing: Chemical indicator ink (color change). Connectivity: None. Sterilization: Steam and EO gas. Form factor: Pouches (self-sealing, flat, gusseted, multi) and rolls (flat, gusseted). Standards: ASTM F2251, D882, D1004, F1140, F1929, F88, F1980, F2096, F1608; ISO 11607-1, 1924-2, 5636-3, 10993-10, 11140-1; DIN 58953-6.

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization via steam or ethylene oxide (EO) gas. Suitable for various instrument types within specified load limits. Not for use as a primary sterilization indicator.

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 (K180661)

Submission Summary (Full Text)

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Sigma Medical Supplies Corporation % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. I5F-2, No.I, Lane 26, Mincyuan 1st Rd., Lingya District, Kaohsiung City, 802 Taiwan

Re: K202462

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: August 21, 2020 Received: August 27, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Clarence W. Murray, III, Ph.D. Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K202462

#### 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 the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

- · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 30 minutes.
- · Gravity steam at 132°C (270°F) for 15 minutes; Drying time of 30 minutes.
- · Gravity steam at 135°C (275°F) for 10 minutes; Drying time of 30 minutes.
- · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.

· EO sterilization cycle is 4 hours at 55°C (131°F) 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 pouch has undergone either a steam or EO sterilization process.

The SIGMA sterilization pouch and roll is offered in the following 6 types:

- · Self-sealing sterilization pouches
- · Self-sealing sterilization multi 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)

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

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| Type | Size | Model |
|------------------------------------------|--------------------------------------------------------------|-------|
| Self-sealing sterilization pouches | L: 133 mm ~ 610 mm<br>W: 57 mm ~ 460 mm | SMSE |
| Self-sealing sterilization multi pouches | L: 283 mm ~ 335 mm<br>W: 90 mm ~ 240 mm | SMSE |
| Sterilization pouches, Flat | L: 150 mm ~ 600 mm<br>W: 75 mm ~ 420 mm | SMFP |
| Sterilization pouches, Gusseted | L: 300 mm ~ 500 mm<br>W: 100 mm ~ 300 mm<br>H: 40 mm ~ 70 mm | SMGP |
| Sterilization rolls, Flat | L: 30.5M~200 M<br>W: 50 mm ~ 400 mm | SMFR |
| Sterilization rolls, Gusseted | L: ~100 M<br>W: 75 mm ~ 400 mm<br>H: 35 mm ~ 80 mm | SMGR |

The maximum validated pouch load is 3.53 pounds (1.6 kg).

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## Submitter's Information

| Name: | SIGMA Medical Supplies Corp. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | No.34, Ding-Ping Road, Rui Fang Industrial Park, Rui Fang Dist., New Taipei City 224, Taiwan (R.O.C.) |
| Establishment Registration Number: | 3004970050 |
| Contact: | Isabel Tsai<br>RA<br>Legal & Regulatory Affairs Dept.<br>886-3-3748880 ext. 3561<br>email: [e-mail]<br>Or<br>Ethan Lin<br>Sr. Specialist<br>Market Planning Sec.<br>886-3-3648880 ext. 3572<br>email: Ethan.Lin @sigma-medical.com.tw |
| Date Prepared: | August 21, 2020 |
| 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 Process |
| Panel: | General Hospital |
| Classification Product Code: | 1) FRG |
| Subsequent Product Code: | 2) JOJ |
| Device Classification: | Class II |
| Regulation Number: | 1) 21 CFR 880.6850<br>2) 21 CFR 880.2800 |

## Predicate Devices

The predicate device [510(k) Notification K180661, cleared June 05, 2018] is the SIGMA Sterilization Pouch and Roll.

Manufacturer: SIGMA Medical Supplies Corp.

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Product Code: 1) FRG 2) JOJ 510(k) number: K180661

# 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 the Steam Sterilizer and via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

- Gravity steam at 121℃ (250°F) for 30 minutes; Drying time of 30 minutes. .
- Gravity steam at 132℃ (270°F) for 15 minutes; Drying time of 30 minutes. .
- · Gravity steam at 135℃ (275°F) for 10 minutes; Drying time of 30 minutes.
- Pre-vacuum steam at 132℃ (270°F) for 4 minutes; Drying time of 20 minutes. .
- · Pre-vacuum steam at 135°C (275°F) for 3 minutes; Drying time of 16 minutes.
- EO sterilization cycle is 4 hours at 55℃ (131 °F) 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 6 types:

- Self-sealing sterilization pouches ●
- Self-sealing sterilization multi pouches
- . Sterilization pouches. Flat
- Sterilization pouches, Gusseted
- Sterilization rolls,
- Flat Sterilization rolls, Gusseted

The defining characteristics of the 6 types are 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.
- · Self-sealing sterilization multi pouches: These pouches have the same components as the Self-sealing sterilization pouches, except that the interior of the pouch is divided into several compartments for packaging multiple instruments separately.

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- · Sterilization pouches, Flat: These pouches have 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.) | | |
|------------------------------------------------|------------|-------------------------|----------------------------|---------|---------------------|
| | | | Metal | Plastic | Linens and<br>Gauze |
| | SMSE057133 | 57 mm x 133 mm | 0.11 | 0.03 | 0.03 |
| | SMSE070257 | 70 mm × 257 mm | 0.39 | 0.11 | 0.10 |
| | SMSE090162 | 90 mm x 162 mm | 0.30 | 0.09 | 0.08 |
| | SMSE090168 | 90 mm × 168 mm | 0.32 | 0.09 | 0.08 |
| | SMSE090257 | 90 mm × 257 mm | 0.57 | 0.16 | 0.14 |
| | SMSE090265 | 90 mm x 265 mm | 0.59 | 0.17 | 0.15 |
| | SMSE090594 | 90 mm x 594 mm | 1.35 | 0.45 | 0.39 |
| | SMSE133289 | 133 mm × 289 mm | 1.00 | 0.33 | 0.28 |
| | SMSE133391 | 133 mm x 391 mm | 1.43 | 0.48 | 0.41 |
| | SMSE135193 | 135 mm x 193 mm | 0.67 | 0.19 | 0.17 |
| | SMSE135283 | 135 mm × 283 mm | 0.99 | 0.33 | 0.28 |
| Self-Sealing<br>Sterilization<br>Pouches | SMSE180335 | 135 mm x 335 mm | 1.20 | 0.40 | 0.34 |
| | SMSE150610 | 150 mm x 610 mm | 2.08 | 0.83 | 0.69 |
| | SMSE190358 | 190 mm x 358 mm | 1.75 | 0.64 | 0.54 |
| | SMSE190365 | 190 mm x 365 mm | 1.79 | 0.65 | 0.55 |
| | SMSE200435 | 200 mm x 435 mm | 2.00 | 0.80 | 0.67 |
| | SMSE300380 | 300 mm x 380 mm | 2.48 | 1.10 | 0.90 |
| | SMSE300474 | 300 mm x 474 mm | 2.63 | 1.50 | 1.17 |
| | SMSE300485 | 300 mm x 485 mm | 2.70 | 1.54 | 1.20 |
| | SMSE303474 | 303 mm x 474 mm | 2.66 | 1.52 | 1.18 |
| | SMSE305416 | 305 mm x 416 mm | 2.56 | 1.28 | 1.02 |
| | SMSE356483 | 356 mm x 483 mm | 2.88 | 1.92 | 1.44 |
| | SMSE380635 | 380 mm x 635 mm | 3.16 | 2.53 | 1.80 |
| | SMSE460610 | 460 mm x 610 mm | 3.40 | 2.83 | 2.00 |
| | SMSE090283 | 90 mm × 283 mm | 0.24 | 0.07 | 0.06 |
| Self-sealing<br>Sterilization<br>Multi Pouches | SMSE097314 | 97 mm x 314 mm | 0.31 | 0.09 | 0.08 |
| | SMSE152314 | 152 mm x 314 mm | 0.41 | 0.12 | 0.10 |
| | SMSE228314 | 228 mm × 314 mm | 0.64 | 0.18 | 0.16 |
| | SMSE240335 | 240 mm x 335mm | 0.78 | 0.22 | 0.20 |
| Type | Model | Dimension in S.I. | *Content / Max Load (lbs.) | | |
| | | | Metal | Plastic | Linens and<br>Gauze |
| | SMFP075150 | 75 mm × 150 mm | 0.25 | 0.07 | 0.06 |
| | SMFP075200 | 75 mm × 200 mm | 0.36 | 0.10 | 0.09 |
| | SMFP075300 | 75 mm × 300 mm | 0.57 | 0.16 | 0.14 |
| | SMFP100200 | 100 mm × 200 mm | 0.55 | 0.16 | 0.14 |
| | SMFP100300 | 100 mm × 300 mm | 0.78 | 0.24 | 0.21 |
| | SMFP100550 | 100 mm × 550 mm | 1.32 | 0.44 | 0.33 |
| | SMFP120250 | 120 mm × 250 mm | 0.81 | 0.25 | 0.22 |
| | SMFP120280 | 120 mm × 280 mm | 0.92 | 0.28 | 0.25 |
| | SMFP150200 | 150 mm × 200 mm | 0.82 | 0.25 | 0.22 |
| | SMFP150250 | 150 mm × 250 mm | 1.07 | 0.33 | 0.29 |
| | SMFP150300 | 150 mm × 300 mm | 1.16 | 0.39 | 0.33 |
| | SMFP150380 | 150 mm × 380 mm | 1.51 | 0.50 | 0.43 |
| Sterilization<br>Pouches, Flat | SMFP150550 | 150 mm × 550 mm | 1.94 | 0.70 | 0.60 |
| | SMFP180300 | 180 mm × 300 mm | 1.44 | 0.48 | 0.41 |
| | SMFP200330 | 200 mm × 330 mm | 1.56 | 0.57 | 0.48 |
| | SMFP200400 | 200 mm × 400 mm | 1.94 | 0.70 | 0.60 |
| | SMFP200600 | 200 mm × 600 mm | 2.75 | 1.10 | 0.92 |
| | SMFP205400 | 205 mm × 400 mm | 2.48 | 1.10 | 0.90 |
| | SMFP250300 | 250 mm × 300 mm | 2.26 | 1.00 | 0.82 |
| | SMFP250450 | 250 mm × 450 mm | 2.61 | 1.04 | 0.87 |
| | SMFP300380 | 300 mm × 380 mm | 2.65 | 1.06 | 0.88 |
| | SMFP300460 | 300 mm × 460 mm | 2.98 | 1.49 | 1.19 |
| | SMFP300500 | 300 mm × 500 mm | 3.26 | 1.63 | 1.30 |
| | SMFP420400 | 420 mm × 400 mm | 3.32 | 2.21 | 1.66 |
| | SMFP420600 | 420 mm × 600 mm | 3.44 | 2.86 | 2.02 |
| Sterilization<br>Pouches,<br>Gusseted | SMGP100300 | 100 mm × 40 mm × 300 mm | 2.26 | 1.88 | 1.33 |
| | SMGP150400 | 150 mm × 50 mm × 400 mm | 2.55 | 2.13 | 1.50 |
| | SMGP200400 | 200 mm × 50 mm × 400 mm | 2.68 | 2.23 | 1.58 |
| | SMGP250480 | 250 mm × 60 mm × 480 mm | 3.06 | 2.55 | 1.80 |
| | SMGP300500 | 300 mm × 70 mm × 500 mm | 3.45 | 2.88 | 2.03 |
| Type | Model | Dimension in S.I. | *Content / Max Load (lbs.) | | |
| | | | Metal | Plastic | Linens and<br>Gauze |
| Sterilization<br>Rolls, Flat | SMFR 022 | 50 mm × 200 M | 0.26 | 0.08 | 0.07 |
| | SMFR902 | 50.8 mm × 200 M | 0.27 | 0.08 | 0.07 |
| | SMFR 032 | 75 mm × 200 M | 0.57 | 0.16 | 0.14 |
| | SMFR912 | 76.2 mm × 200 M | 0.58 | 0.17 | 0.15 |
| | SMFR 042 | 100 mm × 200 M | 0.87 | 0.25 | 0.22 |
| | SMFR922 | 101.6 mm × 200 M | 0.89 | 0.26 | 0.22 |
| | SMFR 062 | 150 mm × 200 M | 1.40 | 0.47 | 0.40 |
| | SMFR932 | 152.4 mm × 200 M | 1.43 | 0.48 | 0.41 |
| | SMFR 082 | 200 mm × 200 M | 1.86 | 0.75 | 0.62 |
| | SMFR942 | 203.2 mm × 200 M | 1.90 | 0.76 | 0.63 |
| | SMFR 102 | 250 mm × 200 M | 2.41 | 0.96 | 0.80 |
| | SMFR952 | 254 mm × 200 M | 2.45 | 0.98 | 0.82 |
| | SMFR 122 | 300 mm × 200 M | 2.77 | 1.38 | 1.11 |
| | SMFR962 | 304.8 mm × 200 M | 2.82 | 1.41 | 1.13 |
| | SMFR 142 | 350 mm × 200 M | 3.28 | 1.64 | 1.31 |
| | SMFR 162 | 400 mm × 200 M | 3.53 | 2.36 | 1.77 |
| | SMFR02-1 | 50.8 mm × 30.5 M | 0.27 | 0.08 | 0.07 |
| | SMFR03-1 | 76.2 mm × 30.5 M | 0.58 | 0.17 | 0.15 |
| | SMFR04-1 | 101.6 mm × 30.5 M | 0.89 | 0.26 | 0.22 |
| | SMFR06-1 | 152.4 mm × 30.5 M | 1.43 | 0.48 | 0.41 |
| | SMFR08-1 | 203.2 mm × 30.5 M | 1.90 | 0.76 | 0.63 |
| | SMFR10-1 | 254 mm × 30.5 M | 2.45 | 0.98 | 0.82 |
| Sterilization<br>Rolls,<br>Gusseted | SMGR 031 | 75 mm × 35 mm × 100 M | 2.21 | 1.84 | 1.30 |
| | SMGR 041 | 100 mm × 40 mm × 100M | 2.26 | 1.88 | 1.33 |
| | SMGR 061 | 150 mm × 50 mm × 100 M | 2.47 | 2.06 | 1.45 |
| | SMGR 081 | 200 mm × 50 mm × 100 M | 2.56 | 2.13 | 1.51 |
| | SMGR 101 | 250 mm × 60 mm × 100 M | 2.73 | 2.27 | 1.61 |
| | SMGR 121 | 300 mm × 70 mm × 100 M | 2.93 | 2.44 | 1.73 |
| | SMGR 141 | 350 mm × 80 mm × 100 M | 3.17 | 2.64 | 1.87 |
| | SMGR 161 | 400 mm × 80 mm × 100 M | 3.32 | 2.76 | 1.95 |

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

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## Device Description

The SIGMA sterilization pouches and rolls 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.

## Description of Comparison and Substantial Equivalence

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 | | |
|-------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Device name | SIGMA sterilization pouch and roll<br>(K202462) | SIGMA sterilization pouch and<br>roll (K180661) | Comparison | |
| Material<br>Composition | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam<br>Process Indicator, Print Ink | Medical Grade Paper, CPP, PET, PU<br>adhesive, EO and Steam Process<br>Indicator, Print Ink | Same | |
| Intended use | The SIGMA sterilization pouch and roll are intended to<br>provide health care workers with an effective method to<br>enclose devices intended for sterilization in the Steam<br>Sterilizer and via Ethylene Oxide (EO). The<br>recommended sterilization cycles are as follows:<br>• Gravity steam at 121 °C for 30 min; Drying time of 30 min.<br>• Gravity steam at 132°C for 15 min; Drying time of 30 min.<br>• Gravity steam at 135°C for 10 min; Drying time of 30 min.<br>• Pre-vacuum steam at 132°C for 4 min; Drying time of 20 min.<br>• Pre-vacuum steam at 135°C for 3 min; Drying time of 16 min.<br>• EO sterilization cycle is 4 hours at 55°C with a relative<br>humidity between 50%-85% and a sterilant concentration of<br>600 mg/L.<br>Furthermore, the sterilization pouch and roll maintains<br>the enclosed devices up until 3 years post EO gas<br>sterilization and maintains the enclosed devices up until<br>6 months post Steam sterilization. Lastly, the pouch's<br>external chemical ink indicators are designed to<br>indicate to the user that the pouch has undergone either<br>a steam or EO sterilization process. | The sterilization pouch and roll are<br>intended to provide health care<br>workers with an effective method to<br>enclose devices intended for<br>sterilization in steam auto claves and<br>via Ethylene Oxide (EO). The<br>recommended steam sterilization<br>cycle parameters are 30 minutes at<br>121°C. The recommended EO<br>sterilization cycle is 4 hours at 55°C<br>with a relative humidity between<br>50%-85% and a sterilant<br>concentration of 600 mg/L.<br>Furthermore, the sterilization pouch<br>and roll maintains the enclosed<br>devices up until 3 years post<br>sterilization. Lastly, the pouch's<br>external chemical ink indicators are<br>designed to indicate to the user that<br>the pouch has undergone either a<br>steam or EO sterilization process. | Only the Steam<br>recommended<br>sterilization cycles<br>are different.<br>The recommended<br>Steam sterilization<br>cycles of proposed<br>device increase 4<br>types of<br>sterilization cycle,<br>which are Gravity<br>132°C/15 min,<br>Gravity 135°C/10<br>min, Pre-vacuum<br>132°C/ 4 min and<br>Pre-vacuum<br>135°C/ 3 min. | |
| Feature | Subject device: SIGMA sterilization pouch and roll | | Predicate devices: SIGMA sterilization pouch and roll (K180661) | Comparison |
| Pouch Types | Self-sealing sterilization pouches Self-sealing sterilization multi 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 | The proposed device increase one type of the sterilization pouch, which is "Self-sealing sterilization multi pouches". |
| Device models (Configurations/Dimensions) | Self-Sealing Sterilization Pouches | | Self-Sealing Sterilization Pouches | |
| | Size<br>L: 133 mm ~ 610 mm<br>W: 57 mm ~ 460 mm | Model<br>SMSE | Size<br>L: 133 mm ~ 610 mm<br>W: 57 mm ~ 460 mm<br>Model<br>SMSE | Same |
| | Self-Sealing Sterilization Multi Pouches | | N/A | The proposed device increase one type and the size is different. |
| | Size<br>L: 283 mm ~ 335 mm<br>W: 90 mm ~ 240 mm | Model<br>SMSE | | |
| | Sterilization Pouches, Flat | | Sterilization Pouches, Flat | Same |
| | Size<br>L: 150 mm ~ 600 mm<br>W: 75 mm ~ 420 mm | Model<br>SMFP | Size<br>L: 150 mm ~ 600 mm<br>W: 75 mm ~ 420 mm<br>Model<br>SMFP | |
| | Sterilization pouches, Gusseted | | Sterilization pouches, Gusseted | Same |
| | Size<br>L: 300 mm ~ 500 mm<br>W: 100 mm ~ 300 mm<br>H: 40 mm ~ 70 mm | Model<br>SMGP | Size<br>L: 300 mm ~ 500 mm<br>W: 100 mm ~ 300 mm<br>H: 40 mm ~ 70 mm<br>Model<br>SMGP | |
| | Sterilization rolls, Flat | | Sterilization rolls, Flat | Same |
| | Size<br>L: 30.5M ~ 200 M<br>W: 50 mm ~ 400 mm | Model<br>SMFR | Size<br>L: 30.5M ~ 200 M<br>W: 50 mm ~ 400 mm<br>Model<br>SMGP | |
| | Sterilization Rolls, Gusseted | | Sterilization Rolls, Gusseted | Same |
| | Size<br>L: ~100 M<br>W: 75 mm ~ 400 mm<br>H: 35 mm ~ 80 mm | Model<br>SMGR | Size<br>L: ~100 M<br>W: 75 mm ~ 400 mm<br>H: 35 mm ~ 80 mm<br>Model<br>SMGR | |

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

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