(97 days)
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.
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.
This document is a 510(k) premarket notification for the SterileRight Sterilization Pouch and Roll. It details the device's characteristics, intended use, and comparative performance against a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The primary table summarizing acceptance criteria and results is Table 3. Summary of Non-Clinical Testing (pages 14-15).
| Test Completed | Standards Followed | Acceptance Criteria | Results | Performance |
|---|---|---|---|---|
| Sterilant Penetration/Drying Time/Aeration | ANSI/AAMI/ISO 17665-1:2006/(R)2013, ANSI/AAMI/ISO TIR 17665-2:2009 (R2016) (Steam) | - 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% | Test BI: No bacterial growthWeight difference = 0%Visual are drying. | Pass |
| AAMI / ANSI / ISO 11135:2014 (EO) | Meet the requirement of SAL 10-6, the test BI (the EO processed): No bacterial growth | Test BI: No bacterial growth | Pass | |
| ISO 10993-7:2008 (R) 2012 (EO Residuals) | EO < 4mgECH < 9mg | EO < 0.03mgECH < 0.10 mg | Pass | |
| Biocompatibility Testing | ISO 10993-10 Third Edition 2010-08-01 | Irritation index: 0Sensitization index: 0 | Primary irritation index: 0Sensitization index (Patch test reaction): 0 (No visible change). | Pass |
| Package Integrity/Material Compatibility/Sterility Maintenance | ANSI/AAMI/ISO 11607-1:2019 (General) | |||
| Thickness Variations (mm) | ASTM F 2251-13 | STD DEV. < 1 | STD DEV. 0.8 | Pass |
| Burst Strength (kPa) | ASTM F1140/F1140M-13 | • Burst value > 3.2 Kpa or No Burst• Creep Test: Pass (Set Pressure > 40% of burst value.) | Minimum of Burst pressure = 6.4 (kPa) | Pass |
| Dye Penetration Test | ASTM F1929-15 | The dye solution is no any leakage across the seal width of sterile barrier system.(No Infiltration) | No Infiltration | Pass |
| Seal Peel Test (N/15mm) | ASTM F88/F88M-15 | Seal strength > 2.5 (N/15mm) | Minimum of Seal strength = 2.9 | Pass |
| Accelerated Aging Test (Durability) | ASTM F 1980-07 | • 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. | Both 3-year and 6-month accelerated aging incubations for the specified temperatures and durations were performed and met the criteria. | Pass |
| Gross Leakage (Bubble Test) | ASTM F2096-11 | No Leakage | No Leakage | Pass |
| Microbial Barrier Test | DIN 58953-6; or ASTM F 1608 | CFU = 0 | CFU = 0 | Pass |
| Chemical Indicator Efficacy Testing (Type 1 Indicators) | AAMI/ANSI/ISO 11140-1:2014 (Steam) | Steam:Change the color for acceptable results at 121°C/10.0 min & 134°C/2.0 min.No color change for unacceptable results at 121°C/2.0 min & 134°C/0.3 min or Dry heat 140°C/30 min. | Color changed from Pink to Black for acceptable conditions.Color remained Pink for unacceptable conditions. | Pass |
| AAMI/ANSI/ISO 11140-1:2014 (EO gas) | EO gas:Change the color for acceptable results at EO gas Teat /20 min.No color change for unacceptable results at EO gas Teat / 2 min or Absence of EO gas / 90 min. | Color changed to Yellow for acceptable conditions.Color remained Blue for unacceptable conditions. | Pass | |
| CI Shelf Life & Post-Processing Color Stability | (Implicit: Based on general performance and durability standards for CIs) | 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.All performance attributes should maintain the original color: 3 years shelf life | Real-time test shows the test group exposed to Steam maintained Black color, EO maintained Yellow color, and Control group maintained original color from March 15, 2018 to April 15, 2021 (3 years). | Pass |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document describes non-clinical performance testing. It does not explicitly state the exact sample sizes for each test within the "Summary of Non-Clinical Testing" section. However, it indicates these are validation studies and the results are presented as having "Passed." No specific number of units/pouches per test is given.
- Data Provenance: The studies were conducted by the manufacturer, SterileRight Packaging Mfg., Inc., based in Taiwan (address 1F, No.33-7, Dahua 2nd Rd., Qidu Dist., Keelung City 206, Taiwan, on page 4). The data is prospective as it's part of the premarket submission for a new device.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This document is for a sterilization pouch and roll, which is a physical device, and the testing is primarily non-clinical performance testing (physical, chemical, and biological barrier tests).
- No human expert interpretation of images or other medical data (like radiology reads) is involved. Therefore, the concept of "experts establishing ground truth for a test set" in the context of interpretation of medical data is not applicable here.
- The ground truth is established by objective laboratory measurements against defined engineering and biological standards (e.g., SAL 10-6 for sterility, specific ranges for physical properties, specific color changes for chemical indicators).
4. Adjudication Method for the Test Set:
Not applicable. As noted above, the testing involves objective measurements against established standards, not human interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, an MRMC study was not done. This type of study is relevant for diagnostic devices where multiple human readers interpret medical cases, and the AI's impact on their performance is evaluated. This device is a sterilization wrap, subjected to engineering and biological performance testing, not interpretation by human readers.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
This question implies an AI/algorithm. This device is a physical product (sterilization pouch and roll), not an AI algorithm. Its "standalone" performance is assessed by the non-clinical tests summarized in Table 3, demonstrating its ability to meet acceptance criteria for sterility, barrier integrity, and indicator function independently.
7. The Type of Ground Truth Used:
The ground truth for this device's performance is established by:
- Objective laboratory measurements and validated test methods according to recognized consensus standards (e.g., ISO, ASTM, AAMI).
- Biological indicators (BIs): For sterility, the "ground truth" is the absence of bacterial growth after sterilization, indicating a sterility assurance level (SAL) of $10^{-6}$.
- Physical property measurements: For package integrity, measurements like tensile strength, burst strength, seal peel strength, and thickness variations are compared against defined numerical acceptance criteria.
- Chemical indicator color changes: The "ground truth" for the chemical indicators is a specific, visually identifiable color change after exposure to the sterilant under defined conditions, and the absence of a change under non-sterilant or harsh conditions.
- Biocompatibility testing: Ground truth for biocompatibility is the absence of irritation or sensitization (index of 0).
8. The Sample Size for the Training Set:
This question is typically relevant for machine learning models that require a training set. As this is a physical medical device (sterilization pouch and roll) undergoing non-clinical performance testing, there is no concept of a "training set" in the context of AI/ML. The device's design and manufacturing processes are developed through traditional engineering methods, not trained on data.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
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.
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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
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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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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| Type | Size | Model |
|---|---|---|
| Paper/Film Sterilization Flat Roll | W: 50mm ~ 400mmL: ~ 200M | P01 |
| Paper/Film Sterilization Gusseted Roll | W: 75mm ~ 400mmL: ~ 100M | P02 |
| Paper/Film Self-seal Sterilization Pouch | W: 57mm ~ 300mmL: 133mm ~ 474mm | P03 |
| Paper/Film Sterilization Pouch | W: 50mm ~ 400mmL: 100mm ~ 600mm | P04 |
| Tyvek®/Film Sterilization Flat Roll | W: 50mm ~ 400mmL: ~ 200M | T01 |
| Tyvek®/Film Sterilization Gusseted Roll | W: 75mm ~ 400mmL: ~ 100M | T02 |
| Tyvek®/Film Self-seal Sterilization Pouch | W: 57mm ~ 300mmL: 133mm ~ 474mm | T03 |
| Tyvek®/Film Sterilization Pouch | W: 50mm ~ 400mmL: 100mm ~ 600mm | T04 |
The maximum validated pouch load is 3.3 pounds (1.49 kg).
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510 (k) Summary for K212338
Submitter's Information
| Name: | Sterileright Packaging Mfg., Inc. |
|---|---|
| Address: | 1F, No.33-7, Dahua 2nd Rd., Qidu Dist., KeelungCity 206,Taiwan |
| EstablishmentRegistration Number: | 1st submission |
| Contact: | Laney HuangSales DirectorFactory: +886-2-2455-5498Office: +886-2-2697-5499email: laney@sterileright.com.tw |
| OrThomas ChouRD DirectorFactory: +886-2-2455-5498Office: +886-2-2697-5499email: thomas@sterileright.com.tw | |
| Date Prepared: | July 22, 2021 |
| Device Name | |
| Trade Name:Common/usual Name: | SterileRight Sterilization Pouch and RollSterileRight Sterilization Pouch and Roll |
| Device Classification Names: | 1) Wrap, Sterilization.2) Indicator, Physical/Chemical Sterilization Pro-cess |
| Panel: | General Hospital |
| Classification Product Code:Subsequent Product Code: | 1) FRG2) 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.
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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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| Type | Description | Model | Dimension | Content / Max Load (lbs.) | ||
|---|---|---|---|---|---|---|
| Metal | Plastic | Gauze / Linens | ||||
| P01 | Paper/Film Sterilization Flat Roll(with EO, Steam Indicators) | P01-050030 | 50mm x 30m | 0.04 | 0.03 | 0.01 |
| P01-075030 | 75mm x 30m | 0.06 | 0.05 | 0.02 | ||
| P01-100030 | 100mm x 30m | 0.22 | 0.19 | 0.09 | ||
| P01-150030 | 150mm x 30m | 0.40 | 0.35 | 0.18 | ||
| P01-200030 | 200mm x 30m | 0.63 | 0.57 | 0.28 | ||
| P01-250030 | 250mm x 30m | 2.22 | 2.08 | 1.04 | ||
| P01-300030 | 300mm x 30m | 2.64 | 2.64 | 1.32 | ||
| P01-350030 | 350mm x 30m | 2.64 | 2.64 | 1.32 | ||
| P01-400030 | 400mm x 30m | 2.64 | 2.64 | 1.32 | ||
| P01-050200 | 50mm x 200m | 0.04 | 0.03 | 0.01 | ||
| P01-075200 | 75mm x 200m | 0.06 | 0.05 | 0.02 | ||
| P01-100200 | 100mm x 200m | 0.22 | 0.19 | 0.09 | ||
| P01-150200 | 150mm x 200m | 0.40 | 0.35 | 0.18 | ||
| P01-200200 | 200mm x 200m | 0.63 | 0.57 | 0.28 | ||
| P01-250200 | 250mm x 200m | 2.22 | 2.08 | 1.04 | ||
| P01-300200 | 300mm x 200m | 2.64 | 2.64 | 1.32 | ||
| P01-350200 | 350mm x 200m | 2.64 | 2.64 | 1.32 | ||
| P01-400200 | 400mm x 200m | 2.64 | 2.64 | 1.32 | ||
| P02 | Paper/Film Sterilization Gusseted Roll(with EO, Steam Indicators) | P02-075030 | 75mm x 30m | 0.08 | 0.06 | 0.03 |
| P02-100030 | 100mm x 30m | 0.13 | 0.09 | 0.05 | ||
| P02-150030 | 150mm x 30m | 0.67 | 0.43 | 0.22 | ||
| P02-200030 | 200mm x 30m | 1.13 | 0.71 | 0.36 | ||
| P02-250030 | 250mm x 30m | 1.78 | 1.09 | 0.55 | ||
| P02-300030 | 300mm x 30m | 3.30 | 3.30 | 1.65 | ||
| P02-350030 | 350mm x 30m | 3.30 | 3.30 | 1.65 | ||
| P02-400030 | 400mm x 30m | 3.30 | 3.30 | 1.65 | ||
| P02-075100 | 75mm x 100m | 0.08 | 0.06 | 0.03 | ||
| P02-100100 | 100mm x 100m | 0.13 | 0.09 | 0.05 | ||
| P02-150100 | 150mm x 100m | 0.67 | 0.43 | 0.22 | ||
| P02-200100 | 200mm x 100m | 1.13 | 0.71 | 0.36 | ||
| P02-250100 | 250mm x 100m | 1.78 | 1.09 | 0.55 | ||
| P02-300100 | 300mm x 100m | 3.30 | 3.30 | 1.65 | ||
| P02-350100 | 350mm x 100m | 3.30 | 3.30 | 1.65 | ||
| P02-400100 | 400mm x 100m | 3.30 | 3.30 | 1.65 | ||
| Type | Description | Model | Dimension | Content / Max Load (lbs.) | ||
| Metal | Plastic | Gauze /Linens | ||||
| P03 | Paper/FilmSelf-seal Steri-lization Pouch(with EO,Steam Indica-tors) | P03-057133 | 57mm x 133mm | 0.04 | 0.03 | 0.01 |
| P03-070257 | 70mm x 257mm | 0.11 | 0.09 | 0.04 | ||
| P03-090162 | 90mm x 162mm | 0.08 | 0.07 | 0.03 | ||
| P03-090257 | 90mm x 257mm | 0.15 | 0.13 | 0.06 | ||
| P03-090594 | 90mm x 594mm | 0.53 | 0.47 | 0.23 | ||
| P03-133391 | 133mmX391mm | 0.50 | 0.45 | 0.22 | ||
| P03-135283 | 135mm x 283mm | 0.31 | 0.27 | 0.14 | ||
| P03-180335 | 180mm x 335mm | 0.64 | 0.57 | 0.29 | ||
| P03-190358 | 190mm x 358mm | 0.78 | 0.70 | 0.35 | ||
| P03-200435 | 200mm x 435mm | 1.18 | 1.08 | 0.54 | ||
| P03-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 | ||
| P03-300474 | 300mm x 474mm | 2.64 | 2.63 | 1.32 | ||
| P04 | Paper/FilmSterilizationPouch (withEO, Steam In-dicators) | P04-050100 | 50mm x 100mm | 0.02 | 0.02 | 0.01 |
| P04-075150 | 75mm x 150mm | 0.06 | 0.05 | 0.02 | ||
| P04-075200 | 75mm x 200mm | 0.08 | 0.07 | 0.03 | ||
| P04-100200 | 100mm x 200mm | 0.12 | 0.10 | 0.05 | ||
| P04-100550 | 100mm x 550mm | 0.55 | 0.49 | 0.25 | ||
| P04-120250 | 120mm x 250mm | 0.22 | 0.19 | 0.09 | ||
| P04-120280 | 120mm x 280mm | 0.26 | 0.22 | 0.11 | ||
| P04-150200 | 150mm x 200mm | 0.22 | 0.19 | 0.09 | ||
| P04-150250 | 150mm x 250mm | 0.30 | 0.26 | 0.13 | ||
| P04-150380 | 150mm x 380mm | 0.58 | 0.52 | 0.26 | ||
| P04-150550 | 150mm x 550mm | 1.08 | 0.99 | 0.49 | ||
| P04-180300 | 180mm x 300mm | 0.54 | 0.48 | 0.24 | ||
| P04-200330 | 200mm x 330mm | 0.74 | 0.67 | 0.33 | ||
| P04-200600 | 200mm x 600mm | 2.06 | 1.93 | 0.96 | ||
| P04-205400 | 205mm x 400mm | 1.07 | 0.98 | 0.49 | ||
| P04-250300 | 250mm x 300mm | 0.92 | 0.83 | 0.42 | ||
| P04-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 | ||
| P04-300460 | 300mm x 460mm | 2.64 | 2.49 | 1.25 | ||
| P04-400600 | 400mm x 600mm | 2.64 | 2.64 | 1.32 | ||
| Dimension | Content / Max Load (lbs.) | |||||
| Type | Description | Model | Metal | Plastic | Gauze /Linens | |
| T01 | Tyvek®/FilmSterilization FlatRoll | T01-050060 | 50mm x 60m | 0.04 | 0.03 | 0.01 |
| T01-075060 | 75mm x 60m | 0.06 | 0.05 | 0.02 | ||
| T01-100060 | 100mm x 60m | 0.22 | 0.19 | 0.09 | ||
| T01-150060 | 150mm x 60m | 0.40 | 0.35 | 0.18 | ||
| T01-200060 | 200mm x 60m | 0.63 | 0.57 | 0.28 | ||
| T01-250060 | 250mm x 60m | 2.22 | 2.08 | 1.04 | ||
| T01-300060 | 300mm x 60m | 2.64 | 2.64 | 1.32 | ||
| T01-350060 | 350mm x 60m | 2.64 | 2.64 | 1.32 | ||
| T01-400060 | 400mm x 60m | 2.64 | 2.64 | 1.32 | ||
| T01-050200 | 50mm x 200m | 0.04 | 0.03 | 0.01 | ||
| T01-075200 | 75mm x 200m | 0.06 | 0.05 | 0.02 | ||
| T01-100200 | 100mm x 200m | 0.22 | 0.19 | 0.09 | ||
| T01-150200 | 150mm x 200m | 0.40 | 0.35 | 0.18 | ||
| T01-200200 | 200mm x 200m | 0.63 | 0.57 | 0.28 | ||
| T01-250200 | 250mm x 200m | 2.22 | 2.08 | 1.04 | ||
| T01-300200 | 300mm x 200m | 2.64 | 2.64 | 1.32 | ||
| T01-350200 | 350mm x 200m | 2.64 | 2.64 | 1.32 | ||
| T01-400200 | 400mm x 200m | 2.64 | 2.64 | 1.32 | ||
| T02 | Tyvek®/FilmSterilizationGusseted Roll | T02-075030 | 75mm x 30m | 0.08 | 0.06 | 0.03 |
| T02-100030 | 100mm x 30m | 0.13 | 0.09 | 0.05 | ||
| T02-150030 | 150mm x 30m | 0.67 | 0.43 | 0.22 | ||
| T02-200030 | 200mm x 30m | 1.13 | 0.71 | 0.36 | ||
| T02-250030 | 250mm x 30m | 1.78 | 1.09 | 0.55 | ||
| T02-300030 | 300mm x 30m | 3.30 | 3.30 | 1.65 | ||
| T02-350030 | 350mm x 30m | 3.30 | 3.30 | 1.65 | ||
| T02-400030 | 400mm x 30m | 3.30 | 3.30 | 1.65 | ||
| T02-075100 | 75mm x 100m | 0.08 | 0.06 | 0.03 | ||
| T02-100100 | 100mm x 100m | 0.13 | 0.09 | 0.05 | ||
| T02-150100 | 150mm x 100m | 0.67 | 0.43 | 0.22 | ||
| T02-200100 | 200mm x 100m | 1.13 | 0.71 | 0.36 | ||
| T02-250100 | 250mm x 100m | 1.78 | 1.09 | 0.55 | ||
| T02-300100 | 300mm x 100m | 3.30 | 3.30 | 1.65 | ||
| T02-350100 | 350mm x 100m | 3.30 | 3.30 | 1.65 | ||
| T02-400100 | 400mm x 100m | 3.30 | 3.30 | 1.65 | ||
| Type | Description | Model | Dimension | Content / Max Load (lbs.) | ||
| Metal | Plastic | Gauze /Linens | ||||
| T03 | Tyvek®/FilmSelf-seal Sterilization Pouch | T03-057133 | 57mm x 133mm | 0.04 | 0.03 | 0.01 |
| T03-070257 | 70mm x 257mm | 0.11 | 0.09 | 0.04 | ||
| T03-090162 | 90mm x 162mm | 0.08 | 0.07 | 0.03 | ||
| T03-090257 | 90mm x 257mm | 0.15 | 0.13 | 0.06 | ||
| T03-135283 | 135mm x 283mm | 0.31 | 0.27 | 0.14 | ||
| T03-180335 | 180mm x 335mm | 0.64 | 0.57 | 0.29 | ||
| T03-190358 | 190mm x 358mm | 0.78 | 0.70 | 0.35 | ||
| T03-254408 | 254mm x 408mm | 1.59 | 1.48 | 0.74 | ||
| T03-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 | ||
| T03-300474 | 300mm x 474mm | 2.64 | 2.63 | 1.32 | ||
| T04 | Tyvek®/FilmSterilization Pouch | T04-050100 | 50mm x 100mm | 0.02 | 0.02 | 0.01 |
| T04-100200 | 100mm x 200mm | 0.12 | 0.10 | 0.05 | ||
| T04-150255 | 150mm x 255mm | 0.31 | 0.27 | 0.14 | ||
| T04-150380 | 150mm x 380mm | 0.58 | 0.52 | 0.26 | ||
| T04-190330 | 190mm x 330mm | 0.68 | 0.61 | 0.31 | ||
| T04-200330 | 200mm x 330mm | 0.74 | 0.67 | 0.33 | ||
| T04-250300 | 250mm x 300mm | 0.92 | 0.83 | 0.42 | ||
| T04-300380 | 300mm x 380mm | 1.88 | 1.76 | 0.88 | ||
| T04-300460 | 300mm x 460mm | 2.64 | 2.49 | 1.25 | ||
| T04-400600 | 400mm x 600mm | 2.64 | 2.64 | 1.32 |
Table 1. The model numbers of SterileRight sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)
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Table 1. (Continued) The model numbers of SterileRight sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)
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Table 1. (Continued) The model numbers of SterileRight sterilization pouch and roll (Type, Model and Dimension and Content/Max. Load)
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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.
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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.
| Feature | Proposed device | Predicate device | Comparison | ||
|---|---|---|---|---|---|
| Devicename | SterileRight sterilization pouch and roll | SIGMA sterilization pouch and roll(K102158) | |||
| MaterialComposi-tion | Medical 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. | Similar | The Pro-posed de-vice pro-vides extraTyvek®material. | |
| Intendeduse | The SterileRight Sterilization Pouch and Roll areintended 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 4minutes; Drying time of 20 minutes.•Ethylene Oxide (EO) with a concentration of 735mg/L at 55°C (131°F) and 50% to 80% relativehumidity for 60 minutes. Aeration time of 8 hoursat 60°C (140°F).The SterileRight provides the sterilization pouchand roll made with Paper/Film or Tyvek® /Film.The SterileRight sterilization pouch and roll whichare made with Paper maintains the sterility of theenclosed devices for up to 6 months post Steam orEO gas sterilization, and before sterilization has amaximum shelf life of 3 years from the date ofmanufacture. The pouch's external chemical ink in-dicators are designed to indicate to the user that thepouch has undergone either a steam or EO steriliza-tion process.The SterileRight sterilization pouch and roll whichare made with Tyvek® is for EO gas sterilizationonly. It also maintains the sterility of the encloseddevices for up to 6 months post EO gas sterilization,and before sterilization has a maximum shelf life of3 years from the date of manufacture. | The sterilization pouch and roll are intendedto provide health care workers with an effec-tive method to enclose devices intended forsterilization in steam auto claves and via Eth-ylene Oxide (EO). The recommended steamsterilization cycle parameters are 30 minutesat 121°C. The recommended EO sterilizationcycle 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 chemicalink indicators are designed to indicate to theuser that the pouch has undergone either asteam or EO sterilization process. | Similar | The Steamsterilizationof the pro-posed de-vice in-crease byone cycle(Pre-vac-uum 132°C/4 min).The param-eters of EOgas sterili-zation aresimilar. |
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| Feature | Proposed device: SterileRight sterilization pouch and roll | Predicate device: SIGMA sterilization pouch and roll (K102158) | Comparison | Note | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| PouchTypes | 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 | Self-sealing sterilization pouches Sterilization pouches, Flat Sterilization pouches, Gusseted Sterilization rolls, Flat Sterilization rolls, Gusseted | Similar | The Proposed device provides extra types Tyvek® /Film Sterilization pouch and roll. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Devicemodels(Configu-ra-tions/Di-mensions) | Paper/Film Sterilization Flat Roll Size Model W: 50mm ~ 400mmL: ~ 200M P01 Paper/Film Sterilization Gusseted Roll Size Model W: 75mm ~ 400mmL: ~ 100M P02 Paper/Film Self-seal Sterilization Pouch Size Model W: 57mm ~ 300mmL: 133mm ~ 474mm P03 Paper/Film Sterilization Pouch Size Model W: 50mm ~ 400mmL: 100mm ~ 600mm P04 | Sterilization rolls, Flat Size Model W: 50 mm ~ 400 mmL: ~ 200 M SMFR Sterilization rolls, Gusseted Size Model W: 75 mm ~ 400 mmL: ~ 100MH: 35 mm ~ 80 mm SMGR Self-Sealing Sterilization Pouches Size Model W: 57 mm ~ 300 mmL: 133 mm ~ 474 mm SMSE Sterilization Pouches, Flat Size Model W: 75 mm ~ 300 mmL: 200 mm ~ 500 mm SMFP Sterilization Pouches Gusseted Size Model W: 100 mm ~ 300 mmL: 30 mm ~ 500 mmH:40 mm ~ 70 mm SMGP | Same Similar Same Similar Different | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| N/A | The Predicate device provides one extra type. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Tyvek® /Film Sterilization Flat Roll Size Model W: 50mm ~ 400mmL: ~ 200M T01 | N/A | Different | The Proposed device provides one extra type. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Tyvek® /Film Sterilization Gusseted Roll Size Model W: 75mm ~ 400mmL: ~ 100M T02 | N/A | Different | The Proposed device provides one extra type. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Tyvek® /Film Self-seal Sterilization Pouch Size Model W: 57mm ~ 300mmL: 133mm ~ 474mm T03 | N/A | Different | The Proposed device provides one extra type. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Tyvek® /Film Sterilization Pouch Size Model W: 50mm ~ 400mmL: 100mm ~ 600mm T04 | N/A | Different | The Proposed device provides one extra type. |
Table 2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics
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| Feature | Proposed Device: | Predicate device: | Comparison | Note |
|---|---|---|---|---|
| SterileRight sterilization pouch and roll | SIGMA sterilization pouch and roll(K102158) | |||
| SteamSteriliza-tioncycle | The recommended steam sterilization parameters are as follows:• Gravity steam at 121°C (250°F) for 30 minutes; Drying time of 25minutes.• Pre-vacuum steam at 132°C (270°F) for 4 minutes; Drying time of 20minutes. | The recommended steam sterilization parametersare 30 minutes at 121°C; Drying time of 30minutes. | Similar | |
| EO gasSteriliza-tioncycle | The 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 4hours at 55°C with a relative humidity between50%-85% and a sterilant concentration of 600mg/L. | Similar | |
| Designfeatures | Paper/Film Sterilization Flat Roll:These rolls are made from medical-grade paper and plastic film that areheat-sealed on opposite two sides. It will be cut into a suitable length andthe opened sides will be heat-sealed. The medical-grade paper conformsto recognized material standards and can be sterilized by steam or eth-ylene oxide gas. The Process Indicators Ink printed on the medical gradepaper will exhibit a color change after the pouch is exposed to steam orethylene 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 thatis heat-sealed on three sides. The fourth side has an adhesive strip that isused to seal the pouch. Release paper used in the pouch is a laminatedsheet composing the structure of PE/paper/PE. It is a strip to cover theadhesive 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 printedon the medical grade paper will exhibit a color change after the pouch isexposed 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 adhesivestrip and will be heat-sealed when using.Tyvek® /Film Sterilization Flat Roll:These rolls are made from Tyvek® and plastic film that are heat-sealedon opposite two sides. It will be cut into a suitable length and the openedsides will be heat-sealed. The Tyvek-Film Sterilization Flat Roll can besterilized by ethylene oxide gas.Tyvek® /Film Sterilization Gusseted Roll:These rolls are the same as the Tyvek® flat sterilization roll, except thatthe plastic film is folded on both longest sides instead of flat. This designis convenient to enclose the medical devices at a certain height. TheTyvek-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 toseal the pouch. Release paper used in the pouch is a laminated sheetcomposing 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 adhesivestrip and will be heat-sealed when using. The Tyvek-Film SterilizationPouch can be sterilized by ethylene oxide gas. | Self-sealing sterilization pouches:These pouches are made from a medical gradeplastic film that is heat sealed on three sides. Thefourth side has an adhesive strip that is used toseal the pouch. Release paper used in the pouchis a laminated sheet with composing structure ofPE/paper/PE. It is a strip to cover the adhesivearea and is released before seal the pouch. Themedical grade paper conforms to recognized ma-terial standards and can be sterilized by steam orethylene oxide gas. The Process Indicators Inkprinted on the medical grade paper will exhibit acolor change after the pouch is exposed to steamor ethylene oxide gas.Sterilization pouches, Flat:These pouches have the same components withthe Self-sealing sterilization pouches, except thefourth side is left open instead of an adhesivestrip 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 isfolded on both longest sides instead of flat. Thisdesign is convenient to enclose the medical de-vices with certain height.Sterilization rolls, Flat:These rolls are made from a medical grade paperand plastic film that are heat sealed on oppositetwo sides. It will be cut into the suitable lengthand the opened sides will be heat-sealed. The in-dicators printed on the medical grade paper arethe same with the self-sealing sterilizationpouches.Sterilization rolls, Gusseted:These rolls are the same with the flat steriliza-tion roll, except that the plastic film is folded onboth longest sides instead of flat. This design isconvenient to enclose the medical devices withcertain height. | Similar | The Pro-posed de-vice pro-vides ex-tra typesTyvek®/FilmSteriliza-tion pouchand roll. |
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| Table 2. (Continued) Summary of the Proposed and Predicate Devices Technological Characteristics | ||||
|---|---|---|---|---|
| Feature | Proposed Device:SterileRight sterilizationpouch and roll | Predicate Devices:SIGMA sterilization pouchand roll (K102158) | Comparison | |
|---|---|---|---|---|
| Performance Testing | ||||
| SterilantPenetration | Half-Cycle Efficacy | The test meet the requirementof SAL 10-6 | The test meet the require-ment of SAL 10-6 | Same |
| Chemical Indicator (CI) Func-tionality and Endpoint | The sterilant penetrated throughthe pouch configuration and af-fected the CI color change to theendpoint color | The sterilant penetrated throughthe pouch configuration and af-fected the CI color change to theendpoint color | Same | |
| Device Design of Steam CI | The color of Chemical Indicatorchanges from Pink toBrown/Black, when exposed toSteam. | The color of Chemical Indicatorchanges from Blue to GreenishBlack, when exposed to Steam. | Similar | |
| Device Design of EO gas CI | The color changes from Blue toYellow/Brown, when exposed toEO gas. | The color changes from red toyellow, when exposed to EOgas. | Similar | |
| Package In-tegrity(PhysicalProperties) | 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 TestASTM 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 TestASTM F 1929 ;ISO 11607-1 | Passed | Passed | Same | |
| Microbial Barrier TestDIN 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-cessingColor 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.
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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 | Acceptancecriteria | Results | |
|---|---|---|---|---|
| Sterilant Pene-tration/ DryingTime/ Aeration | ANSI/AAMI/ISO 17665-1:2006/(R)2013, "SterilizationOf Health Care Products -Moist Heat - Part 1: Require-ments For The Development, Validation, And RoutineControl Of A Sterilization Process For Medical Devices" | - Meet the requirement of SAL10-6, the test BI (the Steam pro-cessed ) : No bacterial growth-The weight difference beforesterilization and after dryingshall not exceed 0 % | Using half-cycle and full-cycle analysis.Test BI: No bacterialgrowthWeight 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 OfHealth Care Products - Ethylene Oxide - RequirementsFor Development, Validation And Routine Control Of ASterilization Process For Medical Devices". | Meet the requirement of SAL10-6, the test BI (the EO pro-cessed ) : No bacterial growth | Using half-cycle analysis.Test BI: No bacterialgrowth | Pass | |
| ISO 10993-7:2008 (R) 2012, "Biological Evaluation ofMedical Devices - Part 7: Ethylene Oxide SterilizationResiduals | EO < 4mgECH < 9mg | EO < 0.03mgECH < 0.10 mg | Pass | |
| Biocompatibilitytesting | ISO 10993-10 Third Edition 2010-08-01, "BiologicalEvaluation of Medical Devices- Part 10: Tests for irrita-tion and skin sensitization". | Irritation index : 0Sensitization index : 0 | Primary irritation index : 0Sensitization index (Patchtest reaction): 0 (No visi-ble change). | Pass |
| Package Integ- | ANSI/AAMI/ISO 11607-1:2019 "Packaging for terminally sterilized medical devices- Part 1: Requirements for materials, sterile bar-rier systems and packaging systems" | |||
| rity/ MaterialCompatibility/Sterility Mainte-nance | ASTM F 2251-13, "Standard Test Method for ThicknessMeasurement of Flexible Packaging Material" | STD DEV. < 1 | STD DEV. 0.8 | Pass |
| ASTM F1140/F1140M-13, "Standard Test Methods forInternal Pressurization Failure Resistance of UnrestrainedPackages"; | • Burst value > 3.2 Kpa or NoBurst• 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 DetectingSeal 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 SealStrength 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 13.9weeks under controlled condi-tions simulating the real time forstorage of 3 years.• 6 months accelerated aging In-cubation:Range of Actual Value: Temp:60°C± 2°C, Incubated for 17days under controlled conditionssimulating the real time for post-steam/EO sterilization storage of6 months. | • 3 years accelerated agingIncubation:Range of Actual Value:Temp: 60°C± 2°C, Incu-bated for 13.9 weeks undercontrolled 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 undercontrolled conditions simu-lating the real time forpost-steam/EO sterilizationstorage of 6 months. | Pass | |
| Testcompleted | Standards followed | Acceptancecriteria | Results | |
| Package Integri-ty/ MaterialCompatibility/Sterility Mainte-nance | ASTM F2096-11, "Standard Test Method For Detecting GrossLeaks In Packaging By Internal Pressurization (Bubble Test) | No Leakage | No Leakage | Pass |
| DIN 58953-6, "Sterilization -Sterile supply-Part 6: Microbialbarrier testing of packaging materials for medical devices whichare to be sterilized" | CFU = 0 | CFU = 0 | Pass | |
| Chemical Indi-cator Efficacytesting(Type 1 Indica-tors) | AAMI/ANSI/ISO 11140-1:2014 "Sterilization of Health CareProducts-Chemical Indicators-Part 1: General Requirements"Steam | SteamChange 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 fromPink to Black• Dry heat 140°C/30 min:the result of color isPink. | Pass |
| The color of CI changes from Pink to Brown/Black, whenexposed to Steam.EO gas | ||||
| The color of CI changes from Blue to Yellow/Brown,when exposed to EO gas. | EO gasChange the color:• EO gas Teat / 2 min :Unacceptable result• EO gas Teat /20 min:Acceptable result• Absence of EO gas / 90min: Unacceptable re-sult | • EO gas Teat / 2 min:the result of color isBlue.• EO gas Teat /20 min:the result of color isYellow.• Absence of EO gas / 90min: the result of coloris Blue. | Pass | |
| 1. Remain stable before use based on its shelf life.2. Maintain the endpoint stability of the color change afterbeingin the presence of the sterilant. | All performance attributesshould maintain the origi-nal color : 3 years shelflife | The real-time test wascarried out from March15, 2018 to April 15,2021 that demonstrates:the test group which ex-posed to Steam maintainthe color of Black, thetest group which exposedto EO maintain the colorof Yellow, and the Con-trol group maintain theoriginal color fromMarch 15, 2018 to April15,2021. | Pass |
Table 3. Summary of Non-Clinical Testing
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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
§ 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).