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

Device Description

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.

AI/ML Overview

The SIGMA Sterilization Pouch and Roll underwent numerous validation studies to demonstrate its effectiveness and safety, confirming its substantial equivalence to predicate devices. These studies adhered to recommended practices, standards, and guidelines from organizations such as AAMI, ISO, and ASTM.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Category	Acceptance Criteria (Standard)	Reported Device Performance
Sterilant Penetration	AAMI / ANSI / ISO 17665-1:2006, ISO TS 17665-2:2009, AAMI / ANSI / ISO 11135-1:2007	Effectively adequate sterilant penetration to most difficult areas. Confirmed sterilant able to penetrate and sustain direct contact with instruments.
Drying Time	AAMI / ANSI / ISO 17665-1:2006, ISO TS 17665-2:2009, AAMI / ANSI / ISO 11135-1:2007	Testing performed as described. Results confirm effective performance (specific quantitative result not detailed, but implied by meeting standard).
Aeration	AAMI / ANSI / ISO 10993-7:2008	Aeration time validation test meets requiremeAAMI / ANSI / ISO 10993-7:2008.
Biocompatibility	ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2007(E), ISO/IEC 17025:2005	Showed "negative reaction." Meets requirements of ISO 10993-10:2010(E).
Package Integrity	AAMI / ANSI / ISO 11607-1:2006, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTM D 1004, ASTM E 1140-07, ASTM E 1929-98 (04), ASTM E 88-2007, ASTM F 1980-2007, ASTM F 1608-00	Effectively adequate Package Integrity.
Material Compatibility	AAMI / ANSI / ISO 11607-1:2006, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTM D 1004, ASTM E 1140-07, ASTM E 1929-98 (04), ASTM E 88-2007, ASTM F 1980-2007, ASTM F 1608-00	Testing performed as described. Results confirm effective performance (specific quantitative result not detailed, but implied by meeting standard).
Sterility Maintenance	AAMI / ANSI / ISO 11607-1:2006, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTM D 1004, ASTM E 1140-07, ASTM E 1929-98 (04), ASTM E 88-2007, ASTM F 1980-2007, ASTM F 1608-00	Testing performed as described. Results confirm effective performance (specific quantitative result not detailed, but implied by meeting standard).
Chemical Indicator Efficacy	AAMI / ANSI / ISO 11140-1:2005	Demonstrates effective stability of ink before use, lasting quality (color stability), completeness and uniformity of color change, and all-or-none change (unless color standard provided). Meets requirements of ISO 11140-1:2005.

2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes used for each specific test within the validation studies. The studies reference adherence to international standards (AAMI, ISO, ASTM), which typically define appropriate sample sizes for such tests.
The data provenance can be inferred as originating from testing laboratories in connection with Sigma Medical Supplies Corp., which is based in Taiwan. The studies appear to be prospective, as they were conducted specifically for the validation of the SIGMA Sterilization Pouch and Roll.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The studies rely on established international standards and laboratory testing rather than expert-based ground truth for the performance criteria of sterilization pouches and chemical indicators.

4. Adjudication Method for the Test Set:
This information is not provided in the document. The validation methods described are primarily objective physical and chemical tests, rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices involving human interpretation of images or clinical data. The SIGMA Sterilization Pouch and Roll is a Class II device for sterilization wraps and indicators, and its performance is evaluated through laboratory testing against established physical and chemical standards.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, the studies described are standalone performance evaluations of the device itself (the pouches and their integrated chemical indicators). This is inherent to the nature of testing sterilization packaging and chemical indicators, which are designed to function independently based on physical and chemical principles, without human interpretation of "algorithm-only" performance in the context of AI.

7. The Type of Ground Truth Used:
The ground truth used for these studies is based on established scientific and engineering principles codified in international consensus standards (AAMI, ISO, ASTM). These standards define the acceptable performance parameters for sterilant penetration, drying time, aeration, biocompatibility, package integrity, material compatibility, sterility maintenance, and chemical indicator efficacy. The "ground truth" is therefore the successful compliance with these predefined objective criteria.

8. The Sample Size for the Training Set:
This is not applicable. The device is a physical product (sterilization pouch and roll) and does not involve AI or machine learning algorithms that require a training set. The validation studies focused on testing the manufactured product's compliance with performance standards.

9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no training set for this device.

Summary

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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 : 886-2-24974121 Fax: 886-2-24974122

Contact :

. .

Jeff Huang Quality Assurance / Regulatory Affairs Manager

· Jack Chu President /C.E.O

Tel: 886-2-24974121 ext. 281 Fax: 886-2-24974122 E-mail: jeff@sigma-medical.com.tw

Summary Date:

January 3, 2011

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K102158

1. Device Name

Trade Name:	SIGMA Sterilization Pouch and Roll
Common/usual Name:	SIGMA Sterilization Pouch and Roll
Device ClassificationNames:	1) Sterilization wraps containers, trays, cassettes &accessories.2) Indicator, Physical/Chemical Sterilization Process
Classification/Panel:	Class II, 21 CFR 880.6850 & 21 CFR 880.2800
Classification AdvisoryCommittee:	General Hospital
Product Code:	1) FRG 2) JOJ
Recognized PerformanceStandard	1) ANSI/AAMI/ISO 11607-1:2006 (KCT)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 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:

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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-SealingSterilizationPouches	SMSE057133	57 mm × 133 mm	These pouches are made from amedical grade plastic film that isheat-sealed on three sides. The forthside has an adhesive strip that ispaper and used to seal the pouch.
	SMSE090162	90 mm × 162 mm	Release paper used in the pouch is alaminated sheet with composingstructure of PE/paper/PE. It is a stripto cover the adhesive area and isreleased 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 torecognized material standards and
	SMSE190358	190 mm × 358 mm	can be sterilized by steam orethylene oxide gas. The Process
	SMSE300380	300 mm × 380 mm	Indicators Ink printed on the medicalgrade paper will exhibit a color
	SMSE300474	300 mm × 474 mm	change after the pouch is exposed tosteam or ethylene oxide gas.

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

K102158

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K102158

SterilizationPouches, Flat	SMFP075200	75 mm × 200 mm	These pouches has the samecomponents with the Self-sealingsterilization pouches, except theforth side is left opened instead of aadhesive strip and will be heat-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
SterilizationPouches, Gusseted	SMGP100300	100 mm × 40 mm× 300 mm	These rolls are the same with theSterilization pouches, flat, exceptthat the plastic film is folded on bothlongest sides instead of flat. Thisdesign is convenient to enclose themedical 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,Flat	SMFR 022	50 mm × 200 M	These rolls are made from a medicalgrade paper and plastic film that areheat sealed on opposite two sides. Itwill be cut into the suitable lengthand the opened sides will be heat-sealed. The indicators printed on themedical grade paper are the samewith the self-sealing sterilizationpouches.
	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	These rolls are the same with the flatsterilization roll, except that theplastic film is folded on both longestsides instead of flat. This design isconvenient to enclose the medicaldevices 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 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 Sealingsterilization pouch	Winner® Self SealSterilization pouch
510(k) Number	K102158	K070428	K051242
MaterialComposition	Medical Grade Paper, CPP, PET, PUadhesive, EO and Steam Process IndicatorPrint Ink	Medical Grade Paper, CPP,PET, PU adhesive, EO andSteam Process IndicatorPrint Ink	Medical Grade paper, PP,PE, PU adhesive, EO andSteam Process IndicatorPrint Ink
Intended use	The sterilization pouch and roll areintended to provide health care workerswith an effective method to enclose devicesintended for sterilization in steam autoclaves and via Ethylene Oxide (EO). Therecommended steam sterilization cycleparameters are 30 minutes at 121 C. Therecommended EO sterilization cycle is 4hours at 55C with a relative humiditybetween 50%-85% and a sterilantconcentration of 600 mg/L. Furthermore,the sterilization, pouch and roll maintainsthe enclosed devices up until 3 years poststerilization. Lastly, the pouch's externalchemical ink indicators are designed toindicate to the user that the pouch hasundergone either a steam or EO sterilizationprocess	The self-sealing sterilizationpouches are intended to providehealth care workers with aneffective method to enclosedevices intended forsterilization in steam autoclaves and via Ethylene Oxide(EO). The recommended steamsterilization cycle parametersare 30 minutes at 121°C. Therecommended EO sterilizationcycle is 100 - 120 minutes at50 0C with a relative humiditybetween 60 - 85% and asterilant concentration of 600mg/L. Furthermore, thesterilization pouch maintainsthe enclosed devices sterile upuntil one-year post sterilization.Lastly, the pouch's externalchemical ink indicators aredesigned to indicate to the userthat the pouch has undergoneeither a steam or EOsterilization process.	Winner® Self SealSterilization Pouches areintended to be used toenclose another medicaldevice that is to be sterilizedby a health provider bysteam 121°C for 15 minutesor ethylene oxide (EtO). It isintended to allowsterilization of the enclosedmedical device and also tomaintain sterility of theenclosed device until used.
Device models(Configurations/Dimensions)	Model	ProductCode	Description	Model	Description
	SMSE057133 57mm × 133mmSMSE090162 70mm×257mmSMSE070257 90mm × 162mmSMSE090257 90mm×257mm,SMSE135283 135mm×283mmSMSE180335 135mm×335mmSMSE190358 190mm×358mmSMSE300380 300mm × 380mmSMSE300474 300mm x 474mmSMFP075200 75 mm × 200 mmSMFP075300 75 mm x 300 mmSMFP100200 100 mm × 200 mmSMFP100300 100 mm x 300 mmSMFP150300 150 mm x 300 mmSMFP200400 200 mm x 400 mmSMFP250450 250 mm × 450 mmSMFP300500 300 mm x 500 mm	68015680008801568005680206801088000880058801068025680308803088035680358804068040	35mm x 73mm49mm x 200mm.57mm x 100 mm62mm x 103mm62mm x 220mm69mm x 200mm70mm x 229 mm89mm x 133 mm89mm x 229 mm116mm x 219mm133 mm. x 254 mm.170mm x 237mm190 mm x 330 mm254mm x 356 mm305 mm x 432 mm230mm x 305mm	N/A	76mm x 203mm89mm x 203mm89mm x 229mm89mm x 559mm102 mmx 203mm102mm x 279mm102 mmx 559mm127mm x 381mm133mm x 254mm191mm x 330mm203mm x 254mm203mm x 406mm232mm x 648mm254mmx 381mm267 mmx 211mm305mm x 381mm305 mmx 457mm330mm x 381mm330 mmx 457mm406mm 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
	SMFR 162	400 mm × 200 M
	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
Sterilization cycles	The recommended steam sterilization cycleparameters are 30 minutes at 121 °C. Therecommended EO sterilization cycle is 4hours at 55 °C with a relative humiditybetween 50%-85% and a sterilantconcentration of 600 mg/L.		The recommended steamsterilization cycle parametersare 30 minutes at 121°C. Therecommended EO sterilizationcycle is 100 - 120 minutes at50 °C with a relative humiditybetween 60 - 85% and asterilant concentration of 600mg/L.	It is to be sterilized by ahealth provider by steam121°C for 15 minutes orethylene oxide (EtO).
Design features	Self-sealing sterilization pouches: Thesepouches are made from a medical grade		The pouches are manufacturedfrom a medical grade paper that	These pouches aremanufactured from a
		plastic film that is heat sealed on threesides. The forth side has an adhesive strip	is thermally sealed to alaminated film on the left,	medical grade paper andplastic film that are heat
		that is used to seal the pouch. Release	right, and bottom of pouch. The	sealed on three sides. The
		paper used in the pouch is a laminatedsheet with composing structure of	forth side has an adhesive stripthat is used to seal the paper to	forth side has an adhesive
		PE/paper/PE. It is a strip to cover the	the film prior to sterilization of	strip that is used to sealpouch. The medical grade
		adhesive area and is released before seal	the enclosed medical device.	paper conform to
	the pouch. The medical grade paper		The pouches contain external	recognized material
	conforms to recognized material standardsand can be sterilized by steam or ethylene		indicators used to indicate thepouches were processed via	standards and can besterilized by team or
		oxide gas. The Process Indicators Ink	steam or EO sterilization.	ethylene oxide gas.
		printed on the medical grade paper will
		exhibit a color change after the pouch isexposed to steam or ethylene oxide gas.

-Table 2-3 Summary of the Proposed and Predicate Devices Technological Characteristics

K102158

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K102158

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SIGMA Response to Request for Additional Information K102158 / SIGMA Sterilization Pouch and Roll

January 3, 2011

B- 8 -

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K102158

SIGMA Response to Request for Additional Information K102158 / SIGMA Sterilization Pouch and Roll

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-seating 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.	N/A	N/A
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----	-----

CONCLUSION:

The SIGMA sterilization pouch and roll, Medicom Self Sealing sterilization pouch and Winner® Self Seal Sterilization pouch are all intended for provide health care workers with an effective method to enclose devices intended for sterilization in steam auto claves and via Ethylene Oxide (EO).

The SIGMA sterilization pouch and roll has many similar technological characteristics when compared to the predicate devices. The material composition of SIGMA sterilization pouch and roll is similar to the predicate devices. Besides parameters of sterilization, the intended use of SIGMA sterilization pouch and roll is similar to the predicate devices. The first type of SIGMA sterilization pouch and roll is Self-sealing sterilization pouches. The device models and design features of Self-sealing sterilization pouches are similar to the predicate devices. The design features that SIGMA sterilization pouch and roll's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EO sterilization process is also similar to the predicate devices.

The SIGMA sterilization pouch and roll has some different design features from the predicate device. The SIGMA sterilization pouch and roll is offered 5 types pouches. The first type of SIGMA sterlization pouch and roll is Self-sealing sterilization pouches. And the design features of Self-sealing sterilization pouches are similar to the predicate devices. The second type of SIGMA sterilization pouch and roll is Sterilization pouches, Flat. "The Sterilization pouches, Flat" 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. The third type of SIGMA sterilization pouch and roll is Sterilization pouches, Gusseted. "The Sterilization pouches, Gusseted" 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. The fourth type of SIGMA sterilization pouch and roll is Sterilization rolls, Flat. "The Sterilization rolls, Flat" 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 seff-sealing sterlization pouches. The fifth type of SIGMA sterilization pouch and roll is Sterilization rolls, Gusseted. "The Sterilization rolls, Gusseted" 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.

Effectiveness and Safety

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

The SIGMA sterilization pouch and roll has the identical intended use and indication for use as the predicate devices. Substantial equivalence to prodicate devices was established by testing the Sterilant Penetration: Drying Time: Aeration-Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.

The SIGMA sterilization pouch and roll validates its effectiveness and safety using recommended practice, standards and guidelines developed by independent organizations such as the Association for the advancement of Medical Instrumentation (AAMI), International Organization for Standardization (ISO), and American Society for Testing and Materials (ASTM). The SIGMA sterilization pouch and roll was validated to meet the requirements of ANSVAAMI/ISO 11607-1:2006, Version three, September 2008.

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

. The Sterilant Penetration, Drying Time, Aeration, testing performed as described in AAMI / ANSI / ISO 17665-1:2006, ISO TS 17665-2:2009, AAMI / ANSI / ISO 11135-1:2007, and AAMI / ANSI / ISO 10993-7:2008. The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll to effectively adequate sterilant penetration to the most difficult areas to reach inside the packaging. The results confirm that the sterilant is able to penetrate the Sigma Sterilization Pouch and Roll and sustain direct contact with the medical instrument inside the package. And the result of aeration time validation test meets the requirements AAMI / ANSI / ISO 10993-7:2008.
� The Biocompatibility testing performed as described in ISO 10993-10:2010(E), ISO 10993-1:2009/Cor. 1:2010(E), ISO 10993-12:2007(E), and ISO/IEC 17025:2005. The testing results demonstrate the Sigma Sterilization Pouch and Roll showed "negative reaction". And the SIGMA sterilization pouch and roll meets the requirements ISO 10993-10:2010(E).
The Package Integrity, Material Compatibility, Sterility Maintenance testing performed as described in AAMI / ANSI / ISO 11607-1:2006, ISO 1924-2, ISO 5636-3, ASTM D 3078-02, ASTM D882, ASTM F 2251-03, ASTMD 1004, ASTME 1140-07, ASTME 1929-98 (04), ASTME 88-2007, ASTM F 1980-2007, ASTMF 1980-2007, and ASTM F 1608-00. The testing results demonstrate the ability of the Sigma Sterilization Pouch and Roll to effectively adequate Package Integrity.

● The Chemical Indicator Efficacy testing performed as described in AAMI / ANSI / ISO 11140-1:2005. The testing demonstrates the ability of the Sigma Sterilization Pouch and Roll to effectively stability of the Process Indicators Ink before use, the lasting quality (color stability) of the color change, the completeness and uniformity of the color change and color change is all or none at the conditions measured, unless a color standard is provided on the indicator. And the SIGMA sterilization pouch and roll meets the requirements ISO 11140-1:2005.

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Sigma Medical Supplies Corporation C/O Ms. Uta Shih Regulatory Affairs Manager Sen Mu Technology Company, Limited # 15-2, LN 26, Mineyuan 1st Road Lingya District Kaohsiung China (Taiwan) 802

AUG - 2 2011

Re: K102158

Trade/Device Name: SIGMA Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG Dated: July 20, 2011 Received: July 27, 2011

Dear Ms. 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 ffor 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.

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Page 2 - Ms. Shih

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRH Offices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
O Swan Ruoier

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

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-Indications-for-use --

510(k) Number: K102158

Device Name: SIGMA sterilization pouch and roll

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 sterlilization 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.

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dairee S. Mayhall In EFC

Division of Anesthesio!og; General Hospital Infection Control, Dental Devices

510(k) Number: K102158

Page 1 of 3

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K102 158

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-seated 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:

Page 2 of 3

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Table 2-1 The model numbers of SIGMA sterilization pouch and roll
(Type, Model, Dimension and Characteristics)

Type	Model	Dimension in S.I.	Characteristics
	SMSE057133	57 mm × 133 mm
Self-SealingSterilizationPouches	SMSE090162	90 mm × 162 mm	These pouches are made from a medical gradeplastic film that is heat-sealed on three sides.The forth side has an adhesive strip that is paperand used to seal the pouch. Release paper used in the pouch is a laminated sheet withcomposing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released beforeseal the pouch. The medical grade paperconforms to recognized material standards andcan be sterilized by steam or ethylene oxide gas.The Process Indicators Ink printed on themedical grade paper will exhibit a color change after the pouch is exposed to steam or ethylene oxide gas.
	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
	SMFP075200	75 mm × 200 mm
	SMFP075300	75 mm × 300 mm
	SMFP100200	100 mm × 200 mm	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.
SterilizationPouches, Flat	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
SterilizationPouches, Gusseted	SMGP100300	100 mm × 40 mm× 300 mm
	SMGP150400	150 mm × 50 mm× 400 mm	These rolls are the same with the Sterilizationpouches, 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.
	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	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.
	SMFR 042	100 mm × 200 M
Sterilization Rolls,Flat	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	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.
	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

K102158

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Regulation Number and Section

§ 880.6850 Sterilization wrap.

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