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K Number
K212338
Device Name
SterileRight sterilization pouch and roll
Manufacturer
SterileRight Packaging Mfg., Inc.
Date Cleared
2021-11-01

(97 days)

Product Code
FRGJOJ
Regulation Number
880.6850
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows: - · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes. - · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. - · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F). The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film. The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. 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 SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.
Device Description
The medical devices are inserted into the Sterilization Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains the 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 6 months post Steam or EO gas sterilization. The Self-seal pouch permits the sealing of the pouch without the need of heat-sealing equipment, while the heat-sealed pouches and rolls are heat-sealed prior to processing in the steam/or EO Sterilization. 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 the Chemical Indicator changes from Pink to Brown/Black when exposed to Steam. And the color changes from Blue to Yellow/Brown, when exposed to EO gas. The Chemical Indicator offers an additional way to verify 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. The SterileRight sterilization pouch and roll made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization.
More Information

K102158

Not Found

No
The device description focuses on the physical properties and chemical indicators of sterilization pouches and rolls, with no mention of AI or ML technology.

No.
This device is a sterilization pouch and roll intended to enclose and maintain the sterility of medical devices, not to directly treat or diagnose a medical condition.

No

The device is a sterilization pouch and roll intended to enclose devices for sterilization and maintain their sterility. It includes chemical indicators to show exposure to sterilization processes, but these indicators do not signify sterilization itself and are not for diagnosis.

No

The device described is a physical sterilization pouch and roll with integrated chemical indicators, not a software-only medical device.

Based on the provided text, the SterileRight Sterilization Pouch and Roll is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is to enclose devices for sterilization and maintain their sterility. This is a function related to the processing and storage of medical devices, not the examination of specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
  • Device Description: The description focuses on the physical properties of the pouch/roll, its ability to allow sterilant penetration, maintain sterility, and the function of the chemical indicators to show exposure to sterilization agents. None of these functions involve analyzing biological samples.
  • Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
    • Analyzing biological specimens (blood, urine, tissue, etc.)
    • Detecting or measuring analytes
    • Providing diagnostic information
    • Using reagents or calibrators

The SterileRight Sterilization Pouch and Roll is a device used in the sterilization process of other medical devices. It is a packaging and sterility maintenance product, not a diagnostic tool.

N/A

Intended Use / Indications for Use

The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

  • Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
  • Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
  • Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film.

The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. 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 SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

Product codes (comma separated list FDA assigned to the subject device)

FRG, JOJ

Device Description

The medical devices are inserted into the Sterilization Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains the 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 6 months post Steam or EO gas sterilization.

The Self-seal pouch permits the sealing of the pouch without the need of heat-sealing equipment, while the heat-sealed pouches and rolls are heat-sealed prior to processing in the steam/or EO Sterilization.

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 the Chemical Indicator changes from Pink to Brown/Black when exposed to Steam. And the color changes from Blue to Yellow/Brown, when exposed to EO gas.

The Chemical Indicator offers an additional way to verify 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.

The SterileRight sterilization pouch and roll made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization.

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

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 %; 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. Pass. Using half-cycle analysis. Test BI: No bacterial growth. 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 3.2 Kpa or No Burst • Creep Test: Pass (Set Pressure > 40% of burst value.); The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration); Seal strength > 2.5 (N/15mm); • 3 years accelerated aging Incubation: Range of Actual Value: Temp: 60°C± 2°C, Incubated for 13.9 weeks under controlled conditions simulating the real time for storage of 3 years. • 6 months accelerated aging Incubation: Range of Actual Value: Temp: 60°C± 2°C, Incubated for 17 days under controlled conditions simulating the real time for post-steam/EO sterilization storage of 6 months; No Leakage; CFU = 0.
  • Results: STD DEV. 0.8. Pass. Minimum of Burst pressure = 6.4 (kPa). Pass. No Infiltration. Pass. Minimum of Seal strength = 2.9. Pass. • 3 years accelerated aging Incubation: Range of Actual Value: Temp: 60°C± 2°C, Incubated for 13.9 weeks under controlled conditions simulating the real time for storage of 3 years. • 6 months accelerated aging Incubation: Range of Actual Value: Temp: 60°C± 2°C, Incubated for 17 days under controlled conditions simulating the real time for post-steam/EO sterilization storage of 6 months. Pass. No Leakage. Pass. CFU = 0. Pass.

Chemical Indicator Efficacy testing (Type 1 Indicators)

  • Standards followed: AAMI/ANSI/ISO 11140-1:2014 "Sterilization of Health Care Products-Chemical Indicators-Part 1: General Requirements" Steam; The color of CI changes from Pink to Brown/Black, when exposed to Steam. EO gas; The color of CI changes from Blue to Yellow/Brown, when exposed to EO gas. 1. Remain stable before use based on its shelf life. 2. Maintain the endpoint stability of the color change after being in the presence of the sterilant.
  • Acceptance criteria: Steam Change the color: • 121°C / 2.0 min & 134°C/ 0.3 min: Unacceptable result • 121°C/10.0 min & 134°C/ 2.0 min: Acceptable result • Dry heat 140°C/30 min: Unacceptable result; EO gas Change the color: • EO gas Teat / 2 min: Unacceptable result • EO gas Teat /20 min: Acceptable result • Absence of EO gas / 90 min: Unacceptable result; All performance attributes should maintain the original color: 3 years shelf life.
  • Results: • 121°C / 2.0 min & 134°C/ 0.3 min: the result of color is Pink • 121°C/10.0 min & 134°C/ 2.0 min: the result of color is from Pink to Black • Dry heat 140°C/30 min: the result of color is Pink. Pass. • EO gas Teat / 2 min: the result of color is Blue. • EO gas Teat /20 min: the result of color is Yellow. • Absence of EO gas / 90 min: the result of color is Blue. Pass. The real-time test was carried out from March 15, 2018 to April 15, 2021 that demonstrates: the test group which exposed to Steam maintain the color of Black, the test group which exposed to EO maintain the color of Yellow, and the Control group maintain the original color from March 15, 2018 to April 15, 2021. Pass.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K102158

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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).

0

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November 1, 2021

SterileRight Packaging Mfg., Inc. % Uta Shih Regulatory Affairs Manager Sen Mu Technology Co., LTD. 15F-2, No.1, Lane 26, Mincyuan 1st Rd., Lingya District Kaohsiung City, 802 Taiwan

Re: K212338

Trade/Device Name: SterileRight sterilization pouch and roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: July 28, 2021 Received: August 3, 2021

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) 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 (QS) 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 medical devices and radiation-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.

Clarence W. Murray, III, PhD 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

2

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212338

Device Name

SterileRight Sterilization Pouch and Roll

Indications for Use (Describe)

The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

  • · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
  • · Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
  • · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

The SterileRight provides the sterilization pouch and roll made with Paper/Film or Tyvek®/Film.

The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. 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 SterileRight sterilization pouch and roll which are made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

TypeSizeModel
Paper/Film Sterilization Flat RollW: 50mm ~ 400mm
L: ~ 200MP01
Paper/Film Sterilization Gusseted RollW: 75mm ~ 400mm
L: ~ 100MP02
Paper/Film Self-seal Sterilization PouchW: 57mm ~ 300mm
L: 133mm ~ 474mmP03
Paper/Film Sterilization PouchW: 50mm ~ 400mm
L: 100mm ~ 600mmP04
Tyvek®/Film Sterilization Flat RollW: 50mm ~ 400mm
L: ~ 200MT01
Tyvek®/Film Sterilization Gusseted RollW: 75mm ~ 400mm
L: ~ 100MT02
Tyvek®/Film Self-seal Sterilization PouchW: 57mm ~ 300mm
L: 133mm ~ 474mmT03
Tyvek®/Film Sterilization PouchW: 50mm ~ 400mm
L: 100mm ~ 600mmT04

The maximum validated pouch load is 3.3 pounds (1.49 kg).

4

510 (k) Summary for K212338

Submitter's Information

Name:Sterileright Packaging Mfg., Inc.
Address:1F, No.33-7, Dahua 2nd Rd., Qidu Dist., Keelung
City 206,Taiwan
Establishment
Registration Number:1st submission
Contact:Laney Huang
Sales Director
Factory: +886-2-2455-5498
Office: +886-2-2697-5499
email: laney@sterileright.com.tw
Or
Thomas Chou
RD Director
Factory: +886-2-2455-5498
Office: +886-2-2697-5499
email: thomas@sterileright.com.tw
Date Prepared:July 22, 2021
Device Name
Trade Name:
Common/usual Name:SterileRight Sterilization Pouch and Roll
SterileRight Sterilization Pouch and Roll
Device Classification Names:1) Wrap, Sterilization.
  1. Indicator, Physical/Chemical Sterilization Pro-
    cess |
    | Panel: | General Hospital |
    | Classification Product Code:
    Subsequent Product Code: | 1) FRG
  2. JOJ |

Device Classification: Class II Regulation Number: 1) 21 CFR 880.6850 2) 21 CFR 880.2800

Predicate Devices

The predicate device [510(k) Notification K102158, cleared August 02, 2011] is the SIGMA Sterilization Pouch and Roll.

5

Indications for Use

The SterileRight Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in the Steam or via Ethylene Oxide (EO). The recommended sterilization cycles are as follows:

  • · Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25 minutes.
  • Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
  • · Ethylene Oxide (EO) with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80% relative humidity for 60 minutes. Aeration time of 8 hours at 60°C (140°F).

The SterileRight provide sterilization pouch and roll made with Paper/Film or Tyvek® /Film.

The SterileRight sterilization pouch and roll which are made with Paper maintains the sterility of the enclosed devices for up to 6 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture. 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 SterileRight sterilization pouch and roll which are made with Tvyek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization, and before sterilization has a maximum shelf life of 3 years from the date of manufacture.

The SterileRight sterilization pouch and roll is offered 8 types in the following:

  • · Paper/Film Sterilization Flat Roll
  • · Paper/Film Sterilization Gusseted Roll
  • · Paper/Film Self-seal Sterilization Pouch
  • · Paper/Film Sterilization Pouch
  • · Tyvek® /Film Sterilization Flat Roll
  • · Tyvek® /Film Sterilization Gusseted Roll
  • · Tyvek® /Film Self-seal Sterilization Pouch
  • · Tyvek® /Film Sterilization Pouch

The following table (Table 1) lists the model numbers of the SterileRight sterilization pouch and roll by type, model, dimensions, and content/max. load (lbs.):

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TypeDescriptionModelDimensionContent / Max Load (lbs.)
MetalPlasticGauze / Linens
P01Paper/Film Sterilization Flat Roll
(with EO, Steam Indicators)P01-05003050mm x 30m0.040.030.01
P01-07503075mm x 30m0.060.050.02
P01-100030100mm x 30m0.220.190.09
P01-150030150mm x 30m0.400.350.18
P01-200030200mm x 30m0.630.570.28
P01-250030250mm x 30m2.222.081.04
P01-300030300mm x 30m2.642.641.32
P01-350030350mm x 30m2.642.641.32
P01-400030400mm x 30m2.642.641.32
P01-05020050mm x 200m0.040.030.01
P01-07520075mm x 200m0.060.050.02
P01-100200100mm x 200m0.220.190.09
P01-150200150mm x 200m0.400.350.18
P01-200200200mm x 200m0.630.570.28
P01-250200250mm x 200m2.222.081.04
P01-300200300mm x 200m2.642.641.32
P01-350200350mm x 200m2.642.641.32
P01-400200400mm x 200m2.642.641.32
P02Paper/Film Sterilization Gusseted Roll
(with EO, Steam Indicators)P02-07503075mm x 30m0.080.060.03
P02-100030100mm x 30m0.130.090.05
P02-150030150mm x 30m0.670.430.22
P02-200030200mm x 30m1.130.710.36
P02-250030250mm x 30m1.781.090.55
P02-300030300mm x 30m3.303.301.65
P02-350030350mm x 30m3.303.301.65
P02-400030400mm x 30m3.303.301.65
P02-07510075mm x 100m0.080.060.03
P02-100100100mm x 100m0.130.090.05
P02-150100150mm x 100m0.670.430.22
P02-200100200mm x 100m1.130.710.36
P02-250100250mm x 100m1.781.090.55
P02-300100300mm x 100m3.303.301.65
P02-350100350mm x 100m3.303.301.65
P02-400100400mm x 100m3.303.301.65
TypeDescriptionModelDimensionContent / Max Load (lbs.)
MetalPlasticGauze /
Linens
P03Paper/Film
Self-seal Steri-
lization Pouch
(with EO,
Steam Indica-
tors)P03-05713357mm x 133mm0.040.030.01
P03-07025770mm x 257mm0.110.090.04
P03-09016290mm x 162mm0.080.070.03
P03-09025790mm x 257mm0.150.130.06
P03-09059490mm x 594mm0.530.470.23
P03-133391133mmX391mm0.500.450.22
P03-135283135mm x 283mm0.310.270.14
P03-180335180mm x 335mm0.640.570.29
P03-190358190mm x 358mm0.780.700.35
P03-200435200mm x 435mm1.181.080.54
P03-300380300mm x 380mm1.881.760.88
P03-300474300mm x 474mm2.642.631.32
P04Paper/Film
Sterilization
Pouch (with
EO, Steam In-
dicators)P04-05010050mm x 100mm0.020.020.01
P04-07515075mm x 150mm0.060.050.02
P04-07520075mm x 200mm0.080.070.03
P04-100200100mm x 200mm0.120.100.05
P04-100550100mm x 550mm0.550.490.25
P04-120250120mm x 250mm0.220.190.09
P04-120280120mm x 280mm0.260.220.11
P04-150200150mm x 200mm0.220.190.09
P04-150250150mm x 250mm0.300.260.13
P04-150380150mm x 380mm0.580.520.26
P04-150550150mm x 550mm1.080.990.49
P04-180300180mm x 300mm0.540.480.24
P04-200330200mm x 330mm0.740.670.33
P04-200600200mm x 600mm2.061.930.96
P04-205400205mm x 400mm1.070.980.49
P04-250300250mm x 300mm0.920.830.42
P04-300380300mm x 380mm1.881.760.88
P04-300460300mm x 460mm2.642.491.25
P04-400600400mm x 600mm2.642.641.32
DimensionContent / Max Load (lbs.)
TypeDescriptionModelMetalPlasticGauze /
Linens
T01Tyvek®/Film
Sterilization Flat
RollT01-05006050mm x 60m0.040.030.01
T01-07506075mm x 60m0.060.050.02
T01-100060100mm x 60m0.220.190.09
T01-150060150mm x 60m0.400.350.18
T01-200060200mm x 60m0.630.570.28
T01-250060250mm x 60m2.222.081.04
T01-300060300mm x 60m2.642.641.32
T01-350060350mm x 60m2.642.641.32
T01-400060400mm x 60m2.642.641.32
T01-05020050mm x 200m0.040.030.01
T01-07520075mm x 200m0.060.050.02
T01-100200100mm x 200m0.220.190.09
T01-150200150mm x 200m0.400.350.18
T01-200200200mm x 200m0.630.570.28
T01-250200250mm x 200m2.222.081.04
T01-300200300mm x 200m2.642.641.32
T01-350200350mm x 200m2.642.641.32
T01-400200400mm x 200m2.642.641.32
T02Tyvek®/Film
Sterilization
Gusseted RollT02-07503075mm x 30m0.080.060.03
T02-100030100mm x 30m0.130.090.05
T02-150030150mm x 30m0.670.430.22
T02-200030200mm x 30m1.130.710.36
T02-250030250mm x 30m1.781.090.55
T02-300030300mm x 30m3.303.301.65
T02-350030350mm x 30m3.303.301.65
T02-400030400mm x 30m3.303.301.65
T02-07510075mm x 100m0.080.060.03
T02-100100100mm x 100m0.130.090.05
T02-150100150mm x 100m0.670.430.22
T02-200100200mm x 100m1.130.710.36
T02-250100250mm x 100m1.781.090.55
T02-300100300mm x 100m3.303.301.65
T02-350100350mm x 100m3.303.301.65
T02-400100400mm x 100m3.303.301.65
TypeDescriptionModelDimensionContent / Max Load (lbs.)
MetalPlasticGauze /
Linens
T03Tyvek®/Film
Self-seal Sterilization PouchT03-05713357mm x 133mm0.040.030.01
T03-07025770mm x 257mm0.110.090.04
T03-09016290mm x 162mm0.080.070.03
T03-09025790mm x 257mm0.150.130.06
T03-135283135mm x 283mm0.310.270.14
T03-180335180mm x 335mm0.640.570.29
T03-190358190mm x 358mm0.780.700.35
T03-254408254mm x 408mm1.591.480.74
T03-300380300mm x 380mm1.881.760.88
T03-300474300mm x 474mm2.642.631.32
T04Tyvek®/Film
Sterilization PouchT04-05010050mm x 100mm0.020.020.01
T04-100200100mm x 200mm0.120.100.05
T04-150255150mm x 255mm0.310.270.14
T04-150380150mm x 380mm0.580.520.26
T04-190330190mm x 330mm0.680.610.31
T04-200330200mm x 330mm0.740.670.33
T04-250300250mm x 300mm0.920.830.42
T04-300380300mm x 380mm1.881.760.88
T04-300460300mm x 460mm2.642.491.25
T04-400600400mm x 600mm2.642.641.32

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

7

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

8

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

9

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

Device Descrintion

The medical devices are inserted into the Sterilization Pouch/Roll, sealed, and then sterilized in the Sterilization System. After completion of the sterilization process, the Pouch/Roll maintains the 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 6 months post Steam or EO gas sterilization.

The Self-seal pouch permits the sealing of the pouch without the need of heat-sealing equipment, while the heat-sealed pouches and rolls are heat-sealed prior to processing in the steam/or EO Sterilization.

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 the Chemical Indicator changes from Pink to Brown/Black when exposed to Steam. And the color changes from Blue to Yellow/Brown, when exposed to EO gas.

10

The Chemical Indicator offers an additional way to verify 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.

The SterileRight sterilization pouch and roll made with Tyvek® is for EO gas sterilization only. It also maintains the sterility of the enclosed devices for up to 6 months post EO gas sterilization.

Description of Technological Characteristics Comparison

A summary of the technological characteristics of the device subject of this premarket notification in comparison to those of the predicate devices is included in Table 2.

FeatureProposed devicePredicate deviceComparison
Device
nameSterileRight sterilization pouch and rollSIGMA sterilization pouch and roll
(K102158)
Material
Composi-
tionMedical Grade Paper, CPP, PET, adhesive, EO and Steam Process Indicator, Print Ink. Tyvek®, PET, PE, adhesive.Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator, Print Ink.SimilarThe Pro-
posed de-
vice pro-
vides extra
Tyvek®
material.
Intended
useThe SterileRight Sterilization Pouch and Roll are
intended to provide health care workers with an ef-
fective method to enclose devices intended for ster-
ilization in the Steam or via Ethylene Oxide (EO).
The recommended sterilization cycles are as fol-
lows:
•Gravity steam at 121°C (250°F) for 30 minutes;
Drying time of 25 minutes.
•Pre-vacuum steam at 132°C (270°F) for 4
minutes; Drying time of 20 minutes.
•Ethylene Oxide (EO) with a concentration of 735
mg/L at 55°C (131°F) and 50% to 80% relative
humidity for 60 minutes. Aeration time of 8 hours
at 60°C (140°F).
The SterileRight provides the sterilization pouch
and roll made with Paper/Film or Tyvek® /Film.
The SterileRight sterilization pouch and roll which
are made with Paper maintains the sterility of the
enclosed devices for up to 6 months post Steam or
EO gas sterilization, and before sterilization has a
maximum shelf life of 3 years from the date of
manufacture. The pouch's external chemical ink in-
dicators are designed to indicate to the user that the
pouch has undergone either a steam or EO steriliza-
tion process.
The SterileRight sterilization pouch and roll which
are made with Tyvek® is for EO gas sterilization
only. It also maintains the sterility of the enclosed
devices for up to 6 months post EO gas sterilization,
and before sterilization has a maximum shelf life of
3 years from the date of manufacture.The sterilization pouch and roll are intended
to provide health care workers with an effec-
tive method to enclose devices intended for
sterilization in steam auto claves and via Eth-
ylene 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 hu-
midity between 50%-85% and a sterilant con-
centration of 600 mg/L. Furthermore, the ster-
ilization pouch and roll maintains the en-
closed devices up until 3 years post steriliza-
tion. 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.SimilarThe Steam
sterilization
of the pro-
posed de-
vice in-
crease by
one cycle
(Pre-vac-
uum 132°C/
4 min).
The param-
eters of EO
gas sterili-
zation are
similar.

11

FeatureProposed device: SterileRight sterilization pouch and rollPredicate device: SIGMA sterilization pouch and roll (K102158)ComparisonNote
Pouch
TypesPaper/Film Sterilization Flat Roll Paper/Film Sterilization Gusseted Roll Paper/Film Self-seal Sterilization Pouch Paper/Film Sterilization Pouch Tyvek® /Film Sterilization Flat Roll Tyvek® /Film Sterilization Gusseted Roll Tyvek® /Film Self-seal Sterilization Pouch Tyvek® /Film Sterilization PouchSelf-sealing sterilization pouches Sterilization pouches, Flat Sterilization pouches, Gusseted Sterilization rolls, Flat Sterilization rolls, GussetedSimilarThe Proposed device provides extra types Tyvek® /Film Sterilization pouch and roll.
Device
models
(Configu-
ra-
tions/Di-
mensions)Paper/Film Sterilization Flat Roll Size Model W: 50mm ~ 400mm
L: ~ 200M P01 Paper/Film Sterilization Gusseted Roll Size Model W: 75mm ~ 400mm
L: ~ 100M P02 Paper/Film Self-seal Sterilization Pouch Size Model W: 57mm ~ 300mm
L: 133mm ~ 474mm P03 Paper/Film Sterilization Pouch Size Model W: 50mm ~ 400mm
L: 100mm ~ 600mm P04Sterilization rolls, Flat Size Model W: 50 mm ~ 400 mm
L: ~ 200 M SMFR Sterilization rolls, Gusseted Size Model W: 75 mm ~ 400 mm
L: ~ 100M
H: 35 mm ~ 80 mm SMGR Self-Sealing Sterilization Pouches Size Model W: 57 mm ~ 300 mm
L: 133 mm ~ 474 mm SMSE Sterilization Pouches, Flat Size Model W: 75 mm ~ 300 mm
L: 200 mm ~ 500 mm SMFP Sterilization Pouches Gusseted Size Model W: 100 mm ~ 300 mm
L: 30 mm ~ 500 mm
H:40 mm ~ 70 mm SMGPSame Similar Same Similar Different
N/AThe Predicate device provides one extra type.
Tyvek® /Film Sterilization Flat Roll Size Model W: 50mm ~ 400mm
L: ~ 200M T01N/ADifferentThe Proposed device provides one extra type.
Tyvek® /Film Sterilization Gusseted Roll Size Model W: 75mm ~ 400mm
L: ~ 100M T02N/ADifferentThe Proposed device provides one extra type.
Tyvek® /Film Self-seal Sterilization Pouch Size Model W: 57mm ~ 300mm
L: 133mm ~ 474mm T03N/ADifferentThe Proposed device provides one extra type.
Tyvek® /Film Sterilization Pouch Size Model W: 50mm ~ 400mm
L: 100mm ~ 600mm T04N/ADifferentThe Proposed device provides one extra type.

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

12

FeatureProposed Device:Predicate device:ComparisonNote
SterileRight sterilization pouch and rollSIGMA sterilization pouch and roll
(K102158)
Steam
Steriliza-
tion
cycleThe recommended steam sterilization parameters are as follows:
• Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25
minutes.
• Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20
minutes.The recommended steam sterilization parameters
are 30 minutes at 121°C; Drying time of 30
minutes.Similar
EO gas
Steriliza-
tion
cycleThe recommended EO sterilization parameters is as follows:
• EO with a concentration of 735 mg/L at 55°C (131°F) and 50% to 80%
relative humidity for 60 minutes. Aeration time of 8 hours at 60°C
(140°F).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.Similar
Design
featuresPaper/Film Sterilization Flat Roll:
These rolls are made from medical-grade paper and plastic film that are
heat-sealed on opposite two sides. It will be cut into a suitable length and
the opened sides will be heat-sealed. The medical-grade paper conforms
to recognized material standards and can be sterilized by steam or eth-
ylene 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.
Paper/Film Sterilization Gusseted Roll:
These rolls are the same as the flat sterilization roll, except that the plas-
tic film is folded on both longest sides instead of flat. This design is con-
venient to enclose the medical devices at a certain height.
Paper/Film Self-seal Sterilization Pouch:
These pouches are made from medical-grade paper and plastic film that
is heat-sealed on three sides. The fourth side has an adhesive strip that is
used to seal the pouch. Release paper used in the pouch is a laminated
sheet composing the structure of PE/paper/PE. It is a strip to cover the
adhesive area and is released before sealing the pouch. The medical-
grade paper conforms to recognized material standards and can be steri-
lized 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.
Paper/Film Sterilization Pouch:
These pouches have the same components as the Self-sealing steriliza-
tion pouches, except the fourth side is left open instead of an adhesive
strip and will be heat-sealed when using.
Tyvek® /Film Sterilization Flat Roll:
These rolls are made from Tyvek® and plastic film that are heat-sealed
on opposite two sides. It will be cut into a suitable length and the opened
sides will be heat-sealed. The Tyvek-Film Sterilization Flat Roll can be
sterilized by ethylene oxide gas.
Tyvek® /Film Sterilization Gusseted Roll:
These rolls are the same as the Tyvek® 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 at a certain height. The
Tyvek-Film Sterilization Gusseted Roll can be sterilized by ethylene ox-
ide gas.
Tyvek® /Film Self-seal Sterilization Pouch:
These pouches are made from a Tyvek® and plastic film that is heat-
sealed on three sides. The fourth side has an adhesive strip that is used to
seal the pouch. Release paper used in the pouch is a laminated sheet
composing the structure of PE/paper /PE. It is a strip to cover the adhe-
sive area and is released before sealing the pouch. The Tyvek-Film Self-
seal Sterilization Pouch can be sterilized by ethylene oxide gas.
Tyvek® /Film Sterilization Pouch:
These pouches have the same components as the Self-sealing steriliza-
tion pouches, except the fourth side is left open instead of an adhesive
strip and will be heat-sealed when using. The Tyvek-Film Sterilization
Pouch can be sterilized by ethylene oxide gas.Self-sealing sterilization pouches:
These pouches are made from a medical grade
plastic film that is heat sealed on three sides. The
fourth 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 ma-
terial 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 have the same components with
the Self-sealing sterilization pouches, except the
fourth side is left open instead of an adhesive
strip and will be heat-sealed when using.
Sterilization pouches, Gusseted:
These pouches are the same with the Steriliza-
tion pouches, flat, except that the plastic film is
folded on both longest sides instead of flat. This
design is convenient to enclose the medical de-
vices 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 in-
dicators 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 steriliza-
tion 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.SimilarThe Pro-
posed de-
vice pro-
vides ex-
tra types
Tyvek®
/Film
Steriliza-
tion pouch
and roll.

13

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

| Feature | | Proposed Device:
SterileRight sterilization
pouch and roll | Predicate Devices:
SIGMA sterilization pouch
and roll (K102158) | Comparison |
|-------------------------------------------------------------|-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------|
| Performance Testing | | | | |
| Sterilant
Penetration | Half-Cycle Efficacy | The test meet the requirement
of SAL 10-6 | The test meet the require-
ment of SAL 10-6 | Same |
| | Chemical Indicator (CI) Func-
tionality and Endpoint | The sterilant penetrated through
the pouch configuration and af-
fected the CI color change to the
endpoint color | The sterilant penetrated through
the pouch configuration and af-
fected the CI color change to the
endpoint color | Same |
| | Device Design of Steam CI | The color of Chemical Indicator
changes from Pink to
Brown/Black, when exposed to
Steam. | The color of Chemical Indicator
changes from Blue to Greenish
Black, when exposed to Steam. | Similar |
| | Device Design of EO gas CI | The color changes from Blue to
Yellow/Brown, when exposed to
EO gas. | The color changes from red to
yellow, when exposed to EO
gas. | Similar |
| Package In-
tegrity
(Physical
Properties) | Thickness Variations (mm)
ASTM F 2251 | Passed | Passed | Same |
| | Tensile strength of paper* (kN/m;
N/15mm) ISO 1924-2 | Passed | Passed | Same |
| | Air permeance of paper* (µm
/(Pa.s)) ISO 5636-3 | Passed | Passed | Same |
| | Thickness Variation (µm;mm)
ASTM F2251 | 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 (N/15mm)
ASTM F88/F88M ; ISO 11607-1 | Passed | Passed | Same |
| | Visual Inspection (Seal Integrity)
ASTM F1886/F1886M; | 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 |
| | Accelerated Aging Test (Durability)
ASTM F 1980 ; ISO 11607-1 | Passed | Passed | Same |
| End Point /
Post Pro-
cessing
Color Stabil-
ity | after Steam sterilization | 6 months | 6 months | Same |
| | after EO sterilization | 6 months | 3 Years | Similar |
| Shelf Life | Chemical Indicator (CI)
Functionality | 3 Years | 3 Years | Same |
| | Accelerated aging test | 3 Years | 3 Years | Same |

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

14

Summary of Non-Clinical Testing

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

| Test com-
pleted | Standards followed | Acceptance
criteria | Results | |
|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Sterilant Pene-
tration/ Drying
Time/ Aeration | ANSI/AAMI/ISO 17665-1:2006/(R)2013, "Sterilization
Of Health Care Products -Moist Heat - Part 1: Require-
ments For The Development, Validation, And Routine
Control Of A Sterilization Process For Medical Devices" | - Meet the requirement of SAL
10-6, the test BI (the Steam pro-
cessed ) : 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 |
| | ANSI/AAMI/ISO TIR 17665-2:2009 (R2016), "Steriliza-
tion Of Health Care Products - Moist Heat - Part 2: Guid-
ance 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". | Meet the requirement of SAL
10-6, the test BI (the EO pro-
cessed ) : 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 3.2 Kpa or No
Burst
• Creep Test: Pass (Set Pressure

40% of burst value.) | Minimum of Burst pres-
sure = 6.4 (kPa) | Pass |
| | ASTM F1929-15, "Standard Test Method for Detecting
Seal Leaks in Porous Medical Packaging by Dye Penetra-
tion" | The dye solution is no any leak-
age across the seal width of ster-
ile barrier system.
(No Infiltration) | No Infiltration | Pass |
| | ASTM F88/F88M-15, "Standard Test Method for Seal
Strength of Flexible Barrier Materials" | Seal strength > 2.5 (N/15mm) | Minimum of Seal strength
= 2.9 | Pass |
| | ASTM F 1980-07, "Standard Guide for Accelerated Ag-
ing of Sterile Barrier Systems for Medical Devices"; | • 3 years accelerated aging Incu-
bation:
Range of Actual Value: Temp:
60°C± 2°C, Incubated for 13.9
weeks under controlled condi-
tions simulating the real time for
storage of 3 years.
• 6 months accelerated aging In-
cubation:
Range of Actual Value: Temp:
60°C± 2°C, Incubated for 17
days under controlled conditions
simulating the real time for post-
steam/EO sterilization storage of
6 months. | • 3 years accelerated aging
Incubation:
Range of Actual Value:
Temp: 60°C± 2°C, Incu-
bated for 13.9 weeks under
controlled conditions simu-
lating the real time for stor-
age of 3 years.
• 6 months accelerated ag-
ing Incubation:
Range of Actual Value:
Temp: 60°C± 2°C, Incu-
bated for 17 days under
controlled conditions simu-
lating the real time for
post-steam/EO sterilization
storage of 6 months. | Pass |
| Test
completed | Standards followed | Acceptance
criteria | Results | |
| Package Integri-
ty/ Material
Compatibility/
Sterility Mainte-
nance | 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 = 0 | CFU = 0 | Pass |
| Chemical Indi-
cator Efficacy
testing
(Type 1 Indica-
tors) | AAMI/ANSI/ISO 11140-1:2014 "Sterilization of Health Care
Products-Chemical Indicators-Part 1: General Requirements"
Steam | Steam
Change the color:
• 121°C / 2.0 min &
134°C/ 0.3 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 / 2.0 min &
134°C/ 0.3 min: the re-
sult of color is Pink
• 121°C/10.0 min &
134°C/ 2.0 min: the re-
sult of color is from
Pink to Black
• Dry heat 140°C/30 min:
the result of color is
Pink. | Pass |
| | The color of CI changes from Pink to Brown/Black, when
exposed to Steam.
EO gas | | | |
| | The color of CI changes from Blue to Yellow/Brown,
when exposed to EO gas. | EO gas
Change the color:
• EO gas Teat / 2 min :
Unacceptable result
• EO gas Teat /20 min:
Acceptable result
• Absence of EO gas / 90
min: Unacceptable re-
sult | • EO gas Teat / 2 min:
the result of color is
Blue.
• EO gas Teat /20 min:
the result of color is
Yellow.
• Absence of EO gas / 90
min: the result of color
is Blue. | Pass |
| | 1. Remain stable before use based on its shelf life.

  1. Maintain the endpoint stability of the color change afterbeing
    in the presence of the sterilant. | All performance attributes
    should maintain the origi-
    nal color : 3 years shelf
    life | The real-time test was
    carried out from March
    15, 2018 to April 15,
    2021 that demonstrates:
    the test group which ex-
    posed to Steam maintain
    the color of Black, the
    test group which exposed
    to EO maintain the color
    of Yellow, and the Con-
    trol group maintain the
    original color from
    March 15, 2018 to April
    15,2021. | Pass |

Table 3. Summary of Non-Clinical Testing

15

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

CONCLUSION

The conclusions drawn from the nonclinical tests demonstrate that SterileRight Sterilization Pouch and Roll is as safe, as effective, and performs as well as or better than the predicate K102158