SIGMA STERILIZATION POUCH & ROLL

K102158 · Sigma Medical Supplies Corp. · FRG · Aug 2, 2011 · General Hospital

Device Facts

• Record ID: K102158
• Device Name: SIGMA STERILIZATION POUCH & ROLL
• Applicant: Sigma Medical Supplies Corp.
• Product Code: FRG · General Hospital
• Decision Date: Aug 2, 2011
• Decision: SESE
• Submission Type: Traditional
• 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 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 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.

Device Story

Sterilization packaging system consisting of pouches and rolls; used by healthcare workers to enclose medical instruments prior to steam or EO sterilization. Composed of medical-grade paper and plastic film (CPP/PET); features external chemical ink indicators that change color upon exposure to sterilization processes. Available in self-sealing, flat, and gusseted configurations. Provides a sterile barrier for up to 3 years post-sterilization. Enables visual confirmation of processing; ensures instrument sterility until point of use.

Clinical Evidence

Bench testing only. Validated per AAMI/ANSI/ISO 11607-1:2006. Testing included sterilant penetration, drying time, aeration, biocompatibility (ISO 10993-10:2010), package integrity, material compatibility, sterility maintenance, and chemical indicator efficacy (ISO 11140-1:2005). Results confirmed effective sterilant penetration, negative biocompatibility reactions, and package integrity.

Technological Characteristics

Materials: Medical grade paper, CPP, PET, PU adhesive, EO/Steam process indicator ink. Configurations: Self-sealing pouches, flat pouches, gusseted pouches, flat rolls, gusseted rolls. Sterilization: Steam (121°C) and EO (55°C). Standards: ANSI/AAMI/ISO 11607-1:2006, ISO 11140-1:2005.

Indications for Use

Indicated for healthcare workers to enclose medical devices for sterilization via steam autoclave (121°C, 30 min) or Ethylene Oxide (55°C, 4 hrs, 50-85% RH, 600 mg/L). Maintains sterility for up to 3 years.

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

• Medicom Self Sealing Sterilization Pouch (K070428)
• Winner® Self Seal Sterilization pouch (K051242)

Submission Summary (Full Text)

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

# AUG - 2 2011

# 510 (K) Summary For SIGMA Sterilization Pouch and Roll

SIGMA Medical Supplies Corp. NO.34, Ding-Ping Road, Ruei Fang Industrial Park Ruei Fang Chen, Taipei Hsien 224,Taiwan, R.O.C. Tel : [phone] Fax: [phone]

Contact :

. .

Jeff Huang Quality Assurance / Regulatory Affairs Manager

Or

· Jack Chu President /C.E.O

Tel: [phone] ext. 281 Fax: [phone] E-mail: [e-mail]

Summary Date:

January 3, 2011

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

K102158

## 1. Device Name

| Trade Name: | SIGMA Sterilization Pouch and Roll |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Common/usual Name: | SIGMA Sterilization Pouch and Roll |
| Device Classification<br>Names: | 1) Sterilization wraps containers, trays, cassettes &<br>accessories.<br>2) Indicator, Physical/Chemical Sterilization Process |
| Classification/Panel: | Class II, 21 CFR 880.6850 & 21 CFR 880.2800 |
| Classification Advisory<br>Committee: | General Hospital |
| Product Code: | 1) FRG 2) JOJ |
| Recognized Performance<br>Standard | 1) ANSI/AAMI/ISO 11607-1:2006 (KCT)<br>2) ISO 11140-1:2005 (JOJ) |

## 2. Predicate Devices

- K070428, Medicom Self Sealing Sterilization Pouch, Product Code [KCT; JO]] .
- K051242, Winner® Self Seal Sterilization pouch, Product Code [KCT] .

## 3. 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 ℃. 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.

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:

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

- Self-seating sterilization powches: 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 2-1) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, dimension and characteristics:

| Type | Model | Dimension in S.I. | Characteristics |
|------------------------------------------|------------|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Self-Sealing<br>Sterilization<br>Pouches | SMSE057133 | 57 mm × 133 mm | These pouches are made from a<br>medical grade plastic film that is<br>heat-sealed on three sides. The forth<br>side has an adhesive strip that is<br>paper and used to seal the pouch. |
| | SMSE090162 | 90 mm × 162 mm | Release paper used in the pouch is a<br>laminated sheet with composing<br>structure of PE/paper/PE. It is a strip<br>to cover the adhesive area and is<br>released before seal the pouch. The |
| | SMSE070257 | 70 mm × 257mm | |
| | SMSE090257 | 90 mm × 257 mm | |
| | SMSE135283 | 135 mm × 283 mm | |
| | SMSE180335 | 135 mm × 335 mm | medical grade paper conforms to<br>recognized material standards and |
| | SMSE190358 | 190 mm × 358 mm | can be sterilized by steam or<br>ethylene oxide gas. The Process |
| | SMSE300380 | 300 mm × 380 mm | Indicators Ink printed on the medical<br>grade paper will exhibit a color |
| | SMSE300474 | 300 mm × 474 mm | change after the pouch is exposed to<br>steam or ethylene oxide gas. |

#### Table 2-1 The model numbers of SIGMA sterilization pouch and roll ne Model Dimension and Characteristics)

K102158

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

K102158

| Sterilization<br>Pouches, Flat | SMFP075200 | 75 mm × 200 mm | These pouches has the same<br>components with the Self-sealing<br>sterilization pouches, except the<br>forth side is left opened instead of a<br>adhesive strip and will be heat-<br>sealed when using. |
|------------------------------------|------------|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SMFP075300 | 75 mm × 300 mm | |
| | SMFP100200 | 100 mm × 200 mm | |
| | SMFP100300 | 100 mm × 300 mm | |
| | SMFP150300 | 150 mm × 300 mm | |
| | SMFP200400 | 200 mm × 400 mm | |
| | SMFP250450 | 250 mm × 450 mm | |
| | SMFP300500 | 300 mm × 500 mm | |
| Sterilization<br>Pouches, Gusseted | SMGP100300 | 100 mm × 40 mm× 300 mm | These rolls are the same with the<br>Sterilization pouches, flat, except<br>that the plastic film is folded on both<br>longest sides instead of flat. This<br>design is convenient to enclose the<br>medical devices with certain height |
| | SMGP150400 | 150 mm × 50 mm× 400 mm | |
| | SMGP200400 | 200 mm × 50 mm× 400 mm | |
| | SMGP250480 | 250 mm × 60 mm× 480 mm | |
| | SMGP300500 | 300 mm × 70 mm× 500 mm | |
| | | | |
| Sterilization Rolls,<br>Flat | SMFR 022 | 50 mm × 200 M | These rolls are made from a medical<br>grade paper and plastic film that are<br>heat sealed on opposite two sides. It<br>will be cut into the suitable length<br>and the opened sides will be heat-<br>sealed. The indicators printed on the<br>medical grade paper are the same<br>with the self-sealing sterilization<br>pouches. |
| | 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 | |
| Sterilization Rolls,<br>Gusseted | SMGR 031 | 75 mm × 35 mm ×100 M | These rolls are the same with the flat<br>sterilization roll, except that the<br>plastic film is folded on both longest<br>sides instead of flat. This design is<br>convenient to enclose the medical<br>devices with certain height. |
| | SMGR 041 | 100 mm × 40 mm ×100M | |
| | SMGR 061 | 150 mm × 50 mm ×100 M | |
| | SMGR 081 | 200 mm × 50 mm ×100 M | |
| | SMGR 101 | 250 mm × 60 mm ×100 M | |
| | SMGR 121 | 300 mm × 70 mm × 100 M | |
| | SMGR 141 | 350 mm × 80 mm ×100 M | |
| | SMGR 161 | 400 mm × 80 mm ×100 M | |

### 4. 510(k) Statement

A 510(k) statement for the new device, as required by 21 CFR 93, is replaced with this 510(k) summary.

## 5. Proposed Labeling

A comparison with the predicate labeling confirms our claim of substantial equivalence with the predicate. A draft copy of the proposed and predicate device labeling may be found in Section 13.

## 6. Device Description

January 3, 2011

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

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 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.

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

- Self-sealing sterilization pouches: These pouches are made from a medical grade plastic film that . 0 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 2-2) lists the model numbers of the SIGMA sterilization pouch and roll by type, model, and dimension:

| Type | Model | Dimension in S.I. |
|------------------------------------|------------|-------------------|
| Self-Sealing Sterilization Pouches | SMSE057133 | 57 mm × 133 mm |
| | SMSE090162 | 90 mm × 162 mm |
| | SMSE070257 | 70 mm × 257mm |
| | SMSE090257 | 90 mm × 257 mm |
| | SMSE135283 | 135 mm × 283 mm |
| | SMSE180335 | 135 mm × 335 mm |
| | SMSE190358 | 190 mm × 358 mm |
| | SMSE300380 | 300 mm × 380 mm |
| | SMSE300474 | 300 mm × 474 mm |

| Table 2-2 The model numbers of SIGMA sterilization pouch and roll |
|-------------------------------------------------------------------|
| (Type, Model and Dimension) |

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

| Sterilization Pouches, Flat | SMFP075200 | 75 mm × 200 mm |
|---------------------------------|------------|-------------------------|
| | SMFP075300 | 75 mm × 300 mm |
| | SMFP100200 | 100 mm × 200 mm |
| | SMFP100300 | 100 mm × 300 mm |
| | SMFP150300 | 150 mm × 300 mm |
| | SMFP200400 | 200 mm × 400 mm |
| | SMFP250450 | 250 mm × 450 mm |
| | SMFP300500 | 300 mm × 500 mm |
| Sterilization Pouches, Gusseted | SMGP100300 | 100 mm × 40 mm × 300 mm |
| | SMGP150400 | 150 mm × 50 mm × 400 mm |
| | SMGP200400 | 200 mm × 50 mm × 400 mm |
| | SMGP250480 | 250 mm × 60 mm × 480 mm |
| | SMGP300500 | 300 mm × 70 mm × 500 mm |
| Sterilization Rolls, Flat | 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 |
| Sterilization Rolls, Gusseted | SMGR 031 | 75 mm × 35 mm ×100 M |
| | SMGR 041 | 100 mm × 40 mm ×100M |
| | SMGR 061 | 150 mm × 50 mm ×100 M |
| | SMGR 081 | 200 mm × 50 mm ×100 M |
| | SMGR 101 | 250 mm × 60 mm ×100 M |
| | SMGR 121 | 300 mm × 70 mm ×100 M |
| | SMGR 141 | 350 mm × 80 mm ×100 M |
| | SMGR 161 | 400 mm × 80 mm ×100 M |

## 7. 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 2-3.

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

| Device | New Device | Predicate devices | | | |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | SIGMA sterilization pouch and roll | Medicom® Self Sealing<br>sterilization pouch | Winner® Self Seal<br>Sterilization pouch | | |
| 510(k) Number | K102158 | K070428 | K051242 | | |
| Material<br>Composition | Medical Grade Paper, CPP, PET, PU<br>adhesive, EO and Steam Process Indicator<br>Print Ink | Medical Grade Paper, CPP,<br>PET, PU adhesive, EO and<br>Steam Process Indicator<br>Print Ink | Medical Grade paper, PP,<br>PE, PU adhesive, EO and<br>Steam Process Indicator<br>Print Ink | | |
| Intended use | The sterilization pouch and roll are<br>intended to provide health care workers<br>with an effective method to enclose devices<br>intended for sterilization in steam auto<br>claves and via Ethylene Oxide (EO). The<br>recommended steam sterilization cycle<br>parameters are 30 minutes at 121 C. The<br>recommended EO sterilization cycle is 4<br>hours at 55C with a relative humidity<br>between 50%-85% and a sterilant<br>concentration of 600 mg/L. Furthermore,<br>the sterilization, pouch and roll maintains<br>the enclosed devices up until 3 years post<br>sterilization. Lastly, the pouch's external<br>chemical ink indicators are designed to<br>indicate to the user that the pouch has<br>undergone either a steam or EO sterilization<br>process | The self-sealing sterilization<br>pouches are intended to provide<br>health care workers with an<br>effective method to enclose<br>devices intended for<br>sterilization in steam auto<br>claves and via Ethylene Oxide<br>(EO). The recommended steam<br>sterilization cycle parameters<br>are 30 minutes at 121°C. The<br>recommended EO sterilization<br>cycle is 100 - 120 minutes at<br>50 0C with a relative humidity<br>between 60 - 85% and a<br>sterilant concentration of 600<br>mg/L. Furthermore, the<br>sterilization pouch maintains<br>the enclosed devices sterile up<br>until one-year post sterilization.<br>Lastly, the pouch's external<br>chemical ink indicators are<br>designed to indicate to the user<br>that the pouch has undergone<br>either a steam or EO<br>sterilization process. | Winner® Self Seal<br>Sterilization Pouches are<br>intended to be used to<br>enclose another medical<br>device that is to be sterilized<br>by a health provider by<br>steam 121°C for 15 minutes<br>or ethylene oxide (EtO). It is<br>intended to allow<br>sterilization of the enclosed<br>medical device and also to<br>maintain sterility of the<br>enclosed device until used. | | |
| Device models<br>(Configurations/Di<br>mensions) | Model | Product<br>Code | Description | Model | Description |
| | SMSE057133 57mm × 133mm<br>SMSE090162 70mm×257mm<br>SMSE070257 90mm × 162mm<br>SMSE090257 90mm×257mm,<br>SMSE135283 135mm×283mm<br>SMSE180335 135mm×335mm<br>SMSE190358 190mm×358mm<br>SMSE300380 300mm × 380mm<br>SMSE300474 300mm x 474mm<br>SMFP075200 75 mm × 200 mm<br>SMFP075300 75 mm x 300 mm<br>SMFP100200 100 mm × 200 mm<br>SMFP100300 100 mm x 300 mm<br>SMFP150300 150 mm x 300 mm<br>SMFP200400 200 mm x 400 mm<br>SMFP250450 250 mm × 450 mm<br>SMFP300500 300 mm x 500 mm | 68015<br>68000<br>88015<br>68005<br>68020<br>68010<br>88000<br>88005<br>88010<br>68025<br>68030<br>88030<br>88035<br>68035<br>88040<br>68040 | 35mm x 73mm<br>49mm x 200mm.<br>57mm x 100 mm<br>62mm x 103mm<br>62mm x 220mm<br>69mm x 200mm<br>70mm x 229 mm<br>89mm x 133 mm<br>89mm x 229 mm<br>116mm x 219mm<br>133 mm. x 254 mm.<br>170mm x 237mm<br>190 mm x 330 mm<br>254mm x 356 mm<br>305 mm x 432 mm<br>230mm x 305mm | N/A | 76mm x 203mm<br>89mm x 203mm<br>89mm x 229mm<br>89mm x 559mm<br>102 mmx 203mm<br>102mm x 279mm<br>102 mmx 559mm<br>127mm x 381mm<br>133mm x 254mm<br>191mm x 330mm<br>203mm x 254mm<br>203mm x 406mm<br>232mm x 648mm<br>254mmx 381mm<br>267 mmx 211mm<br>305mm x 381mm<br>305 mmx 457mm<br>330mm x 381mm<br>330 mmx 457mm<br>406mm x 406mm |
| | | | | | |
| | | SMGP100300 100 mm × 40 mm× 300 mm | N/A | N/A | |
| | | SMGP150400 150 mm × 50 mm× 400 mm | | | |
| | | SMGP200400 200 mm × 50 mm× 400 mm | | | |
| | | SMGP250480 250 mm × 60 mm× 480 mm | | | |
| | | SMGP300500 300 mm × 70 mm× 500 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 |…