Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are focused on the physical properties and function of a sterilization pouch and roll, with no mention of AI or ML technology.

Therapeutic

No

The device is a sterilization pouch and roll intended to enclose and maintain sterility of other medical devices, not to provide therapy itself.

Diagnostic

No.
The device is a sterilization pouch and roll intended to enclose devices for sterilization; it does not diagnose a medical condition.

SaMD (Software as a Medical Device)

No

The device is a physical sterilization pouch and roll, not a software application. The description details physical components and their function in sterilization processes.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is clearly stated as providing a method to enclose devices for sterilization in steam and ethylene oxide sterilizers and maintaining their sterility. This is a function related to the processing and storage of medical devices, not the diagnosis of disease or other conditions.
Device Description: The description focuses on the physical characteristics of the pouches and rolls, their sealing mechanisms, and the chemical indicators that show exposure to sterilization processes. There is no mention of analyzing biological samples or providing diagnostic information.
Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing human specimens (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, DNA, antibodies, etc.)
- Providing information for diagnosis, monitoring, or treatment decisions based on biological samples.

The device is a sterilization packaging system, which falls under the category of medical devices used in the sterilization and storage of other medical devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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°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

Product codes

FRG, JOJ

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

health care workers

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The SIGMA sterilization pouch and roll have identical intended use and indication for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.

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

Sterilant Penetration/Drying Time/Aeration:

Standards followed: ANSI/AAMI/ISO 17665-1:2006/(R)2013, "Sterilization Of Health Care Products -Moist Heat - Part 1: Requirements For The Development, Validation, And Routine Control Of A Sterilization Process For Medical Devices"; ANSI/AAMI/ISO TIR 17665-2:2009 (R2016), "Sterilization Of Health Care Products - Moist Heat - Part 2: Guidance On The Application Of ANSI/AAMI/ISO 17665-1"; AAMI / ANSI / ISO 11135:2014, "Sterilization Of Health Care Products - Ethylene Oxide - Requirements For Development, Validation And Routine Control Of A Sterilization Process For Medical Devices".
Acceptance criteria: Meet the requirement of SAL 10-6, the test BI (the Steam processed) : No bacterial growth; The weight difference before sterilization and after drying shall not exceed 0 %. For EO: Meet the requirement of SAL 10-6, the test BI (the EO processed) : No bacterial growth.
Results: Using half-cycle and full-cycle analysis. Test BI: No bacterial growth. Weight difference = 0%. Visual are drying. Using half-cycle analysis. Test BI: No bacterial growth.
Conclusion: Pass.

Biocompatibility testing:

Standards followed: ISO 10993-7:2008 (R) 2012, "Biological Evaluation of Medical Devices - Part 7: Ethylene Oxide Sterilization Residuals"; ISO 10993-10 Third Edition 2010-08-01, "Biological Evaluation of Medical Devices- Part 10: Tests for irritation and skin sensitization".
Acceptance criteria: EO 400 kgf/mm2, MD > 450 kgf/mm2; CD > 300 kgf/mm2, MD > 350 kgf/mm2; ±0.02; It pressurize to the 80% of the burst value and hold for 30s. Burst value > 5.0 (kPa); The dye solution is no any leakage across the seal width of sterile barrier system; The strength > 356 (gf /25.4mm); Incubated for 22.5 days under controlled conditions (Temp: 55°C / RH: 50%) simulating the real time for post-steam sterilization (135°C/15min) storage of 6 months. Incubated for 137 days under controlled conditions (Temp: 55°C / RH: 50%) simulating the real time for post-EO gas sterilization storage of 3 years. Incubated for 137 days under controlled conditions (Temp: 55°C / RH: 50%) simulating the real time storage of 3 years. No Leakage for bubble and gross leaks. CFU 1.7.
Results: CD = 458, MD =462, Note: the data is the min. value of test results after Steam Sterilization. CD = 443, MD =453, Note: the data is the min. value of test results after Steam Sterilization. ±0.003. Average Burst pressure = 5.8 (kPa), Note: the data is after Accelerated Aging. No Channels identified on package. Site 1= 588, Site 2= 598, Site 3= 909, Site 4= 1016, Note: the min. value of test results. Accelerated aged as per criteria. No Leakage. No Leakage. CFU

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).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
W: 57 mm ~ 460 mm	SMSE
Self-sealing sterilization multi pouches	L: 283 mm ~ 335 mm
W: 90 mm ~ 240 mm	SMSE
Sterilization pouches, Flat	L: 150 mm ~ 600 mm
W: 75 mm ~ 420 mm	SMFP
Sterilization pouches, Gusseted	L: 300 mm ~ 500 mm
W: 100 mm ~ 300 mm
H: 40 mm ~ 70 mm	SMGP
Sterilization rolls, Flat	L: 30.5M~200 M
W: 50 mm ~ 400 mm	SMFR
Sterilization rolls, Gusseted	L: ~100 M
W: 75 mm ~ 400 mm
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
RA
Legal & Regulatory Affairs Dept.
886-3-3748880 ext. 3561
email: Isabel.Tsai@Benqmaterials.com
Or
Ethan Lin
Sr. Specialist
Market Planning Sec.
886-3-3648880 ext. 3572
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.

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
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
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
Sterilization
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
Sterilization
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
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
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
Pouches,
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
Gauze
Sterilization
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
Rolls,
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)

10

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

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

11

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

Feature	Subject devices:
SIGMA sterilization pouch and roll
(K202462)	Predicate devices:
SIGMA sterilization pouch and roll
(K180661)	Comparison
Steam
Sterilization
cycle	The recommended steam sterilization cycle parameters are as
follows:
• Gravity steam at 121 °C for 30 min; Drying time of 30 min.
• Gravity steam at 132°C for 15 min; Drying time of 30 min.
• Gravity steam at 135°C for 10 min; Drying time of 30 min.
• Pre-vacuum steam at 132°C for 4 min; Drying time of 20 min.
• Pre-vacuum steam at 135°C for 3 min; Drying time of 16 min.	The recommended steam sterilization cycle parameters
are 30 minutes at 121°C; Drying time of 30 minutes.	The recommended
Steam sterilization
cycles of proposed
device increase 4
types of sterilization
cycle, which are
Gravity 132°C/15
min, Gravity
135°C/10 min, Pre-
vacuum 132°C/ 4
min and Pre-vacuum
135°C/ 3 min.
EO gas
Sterilization
cycle	The recommended EO sterilization cycle is 4 hours at 55°C with
a relative humidity between 50%-85% and a sterilant
concentration of 600 mg/L.	The recommended EO sterilization cycle is 4 hours at
55°C with a relative humidity between 50%-85% and a
sterilant concentration of 600 mg/L.	Same
Design
features	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.
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.	Self-sealing sterilization pouches:
These pouches are made from a medical grade
plastic film that is heat sealed on three sides. The
forth side has an adhesive strip that is used to
seal the pouch. Release paper used in the pouch
is a laminated sheet with composing structure of
PE/paper/PE. It is a strip to cover the adhesive
area and is released before seal the pouch. The
medical grade paper conforms to recognized
material standards and can be sterilized by steam
or ethylene oxide gas. The Process Indicators Ink
printed on the medical grade paper will exhibit a
color change after the pouch is exposed to steam
or ethylene oxide gas.
Sterilization pouches, Flat:
These pouches has the same components with the
Self-sealing sterilization pouches, except the
forth side is left opened instead of an adhesive
strip and will be heat-sealed when using.
Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization
pouches, flat, except that the plastic film is
folded on both longest sides instead of flat. This
design is convenient to enclose the medical
devices with certain height.
Sterilization rolls, Flat:
These rolls are made from a medical grade paper
and plastic film that are heat sealed on opposite
two sides. It will be cut into the suitable length
and the opened sides will be heat-sealed. The
indicators printed on the medical grade paper are
the same with the self-sealing sterilization
pouches.
Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization
roll, except that the plastic film is folded on both
longest sides instead of flat. This design is
convenient to enclose the medical devices with
certain height.	The proposed
device increase
one type of the
sterilization
pouch, which is
"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.
	Steam CI
Device Design	The color of Chemical Indicator changes from Blue to Greenish
Black, when exposed to Steam.	The color of Chemical Indicator changes from Blue to
Greenish Black, when exposed to Steam.	Same
	EO gas CI
Device Design	The color changes from red to yellow, when exposed to EO gas.	The color changes from red to yellow, when exposed to
EO gas.	Same
	Feature	Performance Testing	Proposed Device:
SIGMA sterilization
pouch and roll	Predicate Devices:
SIGMA sterilization
pouch and roll (K180661)	Comparison
	Sterilant
Penetration	Half-Cycle Efficacy	The test meet the
requirement of SAL 10-6	The test meet the
requirement of SAL 10-6	Same
		Full-Cycle Efficacy	The test meet the
requirement of SAL 10-6	NA	The proposed device
performs Sterilant
Penetration of Full-
Cycle Efficacy.
		Chemical Indicator (CI)
Functionality and Endpoint	The sterilant penetrated through
the pouch configuration and
affected the CI color change to
the endpoint color.	The sterilant penetrated
through the pouch
configuration and affected the
CI color change to the
endpoint color.	Same
	Package
Integrity
(Physical
Properties)	Thickness Variations (mm)
ASTM F 2251	Passed	Passed	Same
		Tensile strength of plastic film *
(kgf/mm2)
ASTM D882	Passed	Passed	Same
	Tensile strength of paper*
(N/15mm)
ISO 1924-2	Passed	Passed	Same
	Air permeance of paper* (lb/in)
ISO 5636-3	Passed	Passed	Same
	Thickness Variation (mm)
ASTM F2251	Passed	Passed	Same
	Tear Resistance Test (kgf/cm2)
ASTM D 1004	Passed	Passed	Same
	Burst Strength (kPa)
ASTM F1140 ; ISO 11607-1	Passed	Passed	Same
	Bubble Leak Test
ASTM D 3078 ; ASTM-F 2096	Passed	Passed	Same
	Seal Peel Test (g/15mm)
ASTM F88/F88M ; ISO 11607-1	Passed	Passed	Same
	Dye penetration Test
ASTM F 1929 ;ISO 11607-1	Passed	Passed	Same
	Microbial Barrier Test
DIN 58953-6 ;or ASTM F 1608	Passed	Passed	Same
	Toxicological Properties
(Biocompatibility Test)
ANSI/AAMI/ISO 10993-10	Passed	Passed	Same
	Durability: Accelerated Aging Test
ASTM F 1980 ; ISO 11607-1	Passed	Passed	Same
End Point / Post
Processing	after Steam sterilization	6 months	6 months	Same
Color Stability	after EO sterilization	3 Years	3 Years	Same
	Chemical Indicator (CI)
Functionality	3 Years	3 Years	Same
Shelf Life	Accelerated aging test	3 Years	3 Years	Same
Test
completed	Standards followed	Acceptance
criteria	Results
Sterilant
Penetration/
Drying Time/
Aeration	ANSI/AAMI/ISO 17665-1:2006/(R)2013, "Sterilization Of
Health Care Products -Moist Heat - Part 1: Requirements For
The Development, Validation, And Routine Control Of A
Sterilization Process For Medical Devices"
ANSI/AAMI/ISO TIR 17665-2:2009 (R2016), "Sterilization Of
Health Care Products - Moist Heat - Part 2: Guidance On The
Application Of ANSI/AAMI/ISO 17665-1"	- Meet the requirement
of SAL 10-6, the test BI
(the Steam processed ) :
No bacterial growth
-The weight difference
before sterilization and
after drying shall not
exceed 0 %	Using half-cycle and full-
cycle analysis.
Test BI: No bacterial
growth
Weight difference = 0%
Visual are drying.	Pass
	AAMI / ANSI / ISO 11135:2014, "Sterilization Of Health Care
Products - Ethylene Oxide - Requirements For Development,
Validation And Routine Control Of A Sterilization Process For
Medical Devices".	Meet the requirement of
SAL 10-6, the test BI
(the EO processed ) : No
bacterial growth	Using half-cycle analysis.
Test BI: No bacterial
growth	Pass
	ISO 10993-7:2008 (R) 2012, "Biological Evaluation of Medical
Devices - Part 7: Ethylene Oxide Sterilization Residuals	EO 400
MD > 450
(kgf/mm2)	CD = 458
MD =462
Note: the data is the min.
value of test results after
Steam Sterilization.	Pass
	ASTM D 1004 -13, "Standard Test Method for Tear Resistance
(Graves Tear) of Plastic Film and Sheeting"	CD > 300
MD > 350
(kgf/mm2)	CD = 443
MD =453
Note: the data is the min.
value of test results after
Steam Sterilization.	Pass
	ASTM F 2251-13, "Standard Test Method for Thickness
Measurement of Flexible Packaging Material"	±0.02	±0.003	Pass
	ASTM F1140/F1140M-13, "Standard Test Methods for Internal
Pressurization Failure Resistance of Unrestrained Packages";	It pressurize to the 80%
of the burst value and
hold for 30s.
Burst value > 5.0 (kPa)	Average Burst pressure =
5.8 (kPa)
Note: the data is after
Accelerated Aging.	Pass
	ASTM F1929-15, "Standard Test Method for Detecting Seal
Leaks in Porous Medical Packaging by Dye Penetration"	The dye solution is no
any leakage across the
seal width of sterile
barrier system.	No Channels identified on
package	Pass
	ASTM F88/F88M-15, "Standard Test Method for Seal Strength
of Flexible Barrier Materials"	The strength > 356
(gf /25.4mm)	Site 1= 588
Site 2= 598
Site 3= 909
Site 4= 1016
Note: the
min. value of
test results.	Pass
	ASTM F 1980-07, "Standard Guide for Accelerated Aging of
Sterile Barrier Systems for Medical Devices";	Incubated for 22.5 days
under controlled
conditions (Temp: 55°C
/ RH: 50%) simulating
the real time for post-
steam sterilization
(135°C/15min) storage
of 6 months.	a. Test articles (no product
included and steam sterilized
135°C/15min) were
accelerated aged at 55°C and
50% R.H to simulate the real
time aging of 6 months.
b. Test articles (product
included and steam sterilized
135°C/15min) were
accelerated aged at 55°C and
50% R.H to simulate the real
time aging of 6 months.	Pass
Test
completed	Standards followed	Acceptance
criteria	Results
Package
Integrity/
Material
Compatibility/
Sterility
Maintenance	ASTM F 1980-07, "Standard Guide for Accelerated Aging of
Sterile Barrier Systems for Medical Devices";	Incubated for 137 days
under controlled
conditions (Temp: 55°C
/ RH: 50%) simulating
the real time for post-EO
gas sterilization storage
of 3 years.	a. Test articles (no product
included) were accelerated
aged at 55°C and 50% R.H to
simulate the real time aging of
3 years.
b. Test articles (product
included and EO sterilized)
were accelerated aged at 55°C
and 50% R.H to simulate the
real time aging of 3 years.	Pass
	ASTM F 1980-07, "Standard Guide for Accelerated Aging of
Sterile Barrier Systems for Medical Devices";	Incubated for 137 days
under controlled
conditions (Temp: 55°C
/ RH: 50%) simulating
the real time storage of 3
years.	a. Test articles (no product
included) were accelerated
aged at 55°C, and
75% RH to simulate the real
time aging of 3 years.
b. Test articles (product
included) were accelerated
aged at 55°C, and
75% RH to simulate the real
time aging of 3 years.	Pass
	ASTM D3078-02(R2013), "Standard Test Method For
Determination Of Leaks In Flexible Packaging By Bubble
Emission"	No Leakage	No Leakage	Pass
	ASTM F2096-11, "Standard Test Method For Detecting Gross
Leaks In Packaging By Internal Pressurization (Bubble Test)	No Leakage	No Leakage	Pass
	DIN 58953-6, "Sterilization -Sterile supply-Part 6: Microbial
barrier testing of packaging materials for medical devices which
are to be sterilized"	CFU 1.7	Average LRV =3.31	Pass
Chemical
Indicator
Efficacy testing
(Type 1 Process
Indicators )	AAMI/ANSI/ISO 11140-1:2014 "Sterilization of Health Care
Products-Chemical Indicators-Part 1: General Requirements"
Change color in the presence of the sterilant (After steam	Steam
Change color
121°C / 3.0 min & 134°C/
0.5 min: Unacceptable
result
121°C/10.0 min & 134°C/
2.0 min: Acceptable result
Dry heat 140°C/30 min:
Unacceptable result	121°C / 3.0 min & 134°C/ 0.5
min: the result of color is Blue
121°C/10.0 min & 134°C/ 2.0
min: the result of color is from
Blue to Greenish Black
Dry heat 140°C/30 min: the
result of color is Blue.	Pass
	sterilization cycles. The color of Chemical Indicator changes
from Blue to Greenish Black; After EO sterilization cycles. The
color of Chemical Indicator changes from Red to Yellow.)	EO gas
Change color
Absence of EO gas / 90
min: Unacceptable result
EO gas Teat / 2 min :
Unacceptable result
EO gas Teat /20 min:
Acceptable result	Absence of EO gas / 90 min:
the result of color is Red.
EO gas Teat / 2 min: the result
of color is Red.
EO gas Teat /20 min: the
result of color is Yellow.	Pass
	1. Remain stable before use based on its shelf life.

Maintain the endpoint stability of the color change after being
in the presence of the sterilant. | All performance attributes
should maintain the original
color : 3 years shelf life | The real-time test was carried
out from October 15, 2007 to
December 15, 2010 that
demonstrates: the test group
which exposed to Steam
maintain the color of Dark
Green, the test group which
exposed to EO maintain the
color of Yellow, and the
Control group maintain the
original color from October
15, 2007, to December 15,

                    | Pass                                                                                                                         |                                                                                      |

12

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

13

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

Note: *the test items were performed on materials of the products; there is no specification requirements.

14

Summary of Non-Clinical Testing

The SIGMA sterilization pouch and roll have identical intended use and indication for use as the predicate devices. The subject device was compared to the predicate device by testing the Sterilant Penetration, Drying Time, Aeration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance, and Chemical Indicator Efficacy.

The results of the SIGMA sterilization pouch and roll validation studies demonstrate that the sterilization pouches perform as intended. The results are summarized as following Table 3:

Table 3. Summary of Non-Clinical Testing

15

Table 3. (Continued) Summary of Non-Clinical Testing

16

CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that SIGMA Sterilization Pouch and Roll is as safe, as effective, and performs as well as or better than the predicate K180661.