Sterilization Package/Reel
Device Facts
| Record ID | K241565 |
|---|---|
| Device Name | Sterilization Package/Reel |
| Applicant | Anqing Clean Dental Instrument Technology Co., Ltd. |
| Product Code | FRG · General Hospital |
| Decision Date | Feb 24, 2025 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
Indications for Use
The Sterilization Package/Reel is 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: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 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℃(140°F). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.
Device Story
Sterilization packaging system consisting of self-seal pouches, flat reels, and gusseted reels; used by healthcare workers to enclose medical devices prior to sterilization. Input: medical devices placed inside pouch/reel. Transformation: physical enclosure allows sterilant penetration (Steam or EO) while maintaining post-sterilization barrier. Output: sterile-packaged medical devices with external chemical ink indicators (Type 1 Process Indicator) that change color to verify exposure to sterilization process. Indicators change blue-to-black (Steam) or pink-to-yellow (EO). Device maintains sterility for 6 months post-processing. Healthcare providers use indicators to confirm processing; indicators do not signify sterility, only exposure. Benefits: provides effective method for sterilization and maintenance of sterile barrier for clinical use.
Clinical Evidence
No clinical data. Bench testing only. Performance validated via ISO 11135 (EO) and ISO 17665-1 (Steam) achieving SAL 10^-6. Biocompatibility confirmed per ISO 10993-5, -10, -23. Physical testing included burst strength (ASTM F1140), seal strength (ASTM F88), dye penetration (ASTM F1929), and microbial barrier (DIN 58953-6).
Technological Characteristics
Materials: medical dialysis paper, PET/CPP composite film, adhesive, chemical indicator ink. Sensing: Type 1 chemical process indicators (ISO 11140-1:2014). Form factors: self-seal pouches, flat reels, gusseted reels. Sterilization: Steam (132°C) and EO (735 mg/L). Shelf life: 2 years pre-sterilization; 6 months post-sterilization.
Indications for Use
Indicated for healthcare workers to enclose medical devices for sterilization via Steam or Ethylene Oxide (EO) gas. Maintains sterility of enclosed devices for up to 6 months post-sterilization.
Regulatory Classification
Identification
A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.
Predicate Devices
- SterileRight Sterilization Pouch and Roll (K212338)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format. The logo is simple and professional, and it is easily recognizable.
February 24, 2025
Anqing Clean Dental Instrument Technology Co., Ltd. % Wang Boyle General Manager Shanghai Truthful Information Technology Co., Ltd. Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai. 200120 China
Re: K241565
Trade/Device Name: Sterilization Package/Reel Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: January 20, 2025 Received: January 24, 2025
Dear Wang Boyle:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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Sincerely,
Stephen A. Anisko -S
Digitally signed by Stephen A. Anisko -S Date: 2025.02.24 20:03:28 -05'00'
for: Christopher K. Dugard, M.S. Director DHT4C: Division of Infection Control Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K241565
Device Name Sterilization Package/Reel
#### Indications for Use (Describe)
The Sterilization Package/Reel is 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: · Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 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℃(140°F).
Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process.
The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.
The following table (Table 1) lists the model numbers of the Sterilization Package/Reel by type, model, dimensions, and content/max. load (lbs.):
| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------|--------------|
| <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | |
| <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) | <div> </div> |
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| | | Specification Size (WXL) | | Content/Max Load(lbs) | | |
|-------------------------------------------|-------------|--------------------------|-----------------|-----------------------|---------|------------------|
| Product Name | Item | Inch | Dimension | Metal | Plastic | Gauze/Linen<br>s |
| | KLDT-90165 | 3.5"x6.5" | 90mmx165mm | 0.12 | 0.11 | 0.1 |
| | KLDT-305430 | 12"x17" | 305mmx430mm | 1.10 | 1.09 | 0.66 |
| | KLDT-70230 | 2.75"x9" | 70mm×230mm | 0.09 | 0.08 | 0.07 |
| | KLDT-135280 | 3⅛"x11" | 135mmx280mm | 0.50 | 0.47 | 0.46 |
| | KLDT-90135 | 3.5"x5.25 | 90mmx135mm | 0.10 | 0.09 | 0.08 |
| Self<br>Sealing<br>Sterilization<br>Pouch | KLDT-70260 | 2.75"x10" | 70mm×260mm | 0.10 | 0.09 | 0.08 |
| | KLDT-90260 | 3.5"x10" | 90mmx260mm | 0.15 | 0.14 | 0.12 |
| | KLDT-135260 | 3⅛"x10" | 135mmx260mm | 0.48 | 0.46 | 0.45 |
| | KLDT-250370 | 10"x14.5" | 250mmx370mm | 1.06 | 1.05 | 0.62 |
| | KLDT-190360 | 7.5"x14" | 190mmx360mm | 0.60 | 0.58 | 0.55 |
| | KLDT-57130 | 2.25"x5" | 57mm×130mm | 0.04 | 0.03 | 0.005 |
| | KLDT-57100 | 2.25"x4" | 57mm×100mm | 0.03 | 0.02 | 0.004 |
| | KLDT-135330 | 3⅛"x13" | 135mmx330mm | 0.55 | 0.53 | 0.50 |
| | KLDT-90230 | 3.5"x9" | 90mmx230mm | 0.14 | 0.13 | 0.11 |
| Flat<br>Sterilization<br>Reel | KLDT-200200 | 8" | 200mm×200m | 0.60 | 0.58 | 0.55 |
| | KLDT-300200 | 12" | 300mm×200m | 1.04 | 1.03 | 0.60 |
| | KLDT-75200 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 |
| | KLDT-100200 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 |
| | KLDT-50200 | 2" | 50mm×200m | 0.02 | 0.01 | 0.003 |
| | KLDT-400200 | 16" | 400mm×200m | 1.08 | 1.07 | 0.64 |
| | KLDT-250200 | 10" | 250mm×200m | 0.80 | 0.78 | 0.58 |
| | KLDT-350200 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 |
| | KLDT-55200 | 2.25" | 55mm×200m | 0.03 | 0.02 | 0.003 |
| | KLDT-150200 | 6" | 150mm×200m | 0.55 | 0.53 | 0.50 |
| Gusseted<br>Sterilization<br>Reel | KLDT-75100 | 3" | 75mm×30mm×100m | 0.09 | 0.05 | 0.004 |
| | KLDT-350100 | 14" | 350mm×80mm×100m | 1.06 | 1.05 | 0.62 |
| | KLDT-150100 | 6" | 150mm×50mm×100m | 0.55 | 0.53 | 0.50 |
| | KLDT-400100 | 16" | 400mm×80mm×100m | 1.08 | 1.07 | 0.64 |
| | KLDT-250100 | 10" | 250mm×65mm×100m | 0.80 | 0.78 | 0.58 |
| | KLDT-300100 | 12" | 300mm×75mm×100m | 1.04 | 1.03 | 0.60 |
| | KLDT-200100 | 8" | 200mm×55mm×100m | 0.60 | 0.58 | 0.55 |
Table 1. The model numbers of Sterilization Package/Reel (Type, Model and Dimension and Content/Max. Load)
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| KLDT-100100 | A 11 | 100mm×50mm×100m | CALI | 0 40<br>V. IV | Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara Cara<br>Vill |
|-------------|------|-----------------|------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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# 510(k) Summary K241565
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.
#### 1.0 Submitter's Information
| Name: | Anqing Clean Dental Instrument Technology Co.,LTD. | |
|----------|-------------------------------------------------------------------------------------------------------------------------------------|------------------|
| Address: | Floor 2, D4-A,Jiabao Industrial Park.Yangtze River Bridge<br>Economic Development Zone ,246000 Anqing City, Anhui<br>Province,China | |
| Tel: | | 0086-556-5577869 |
| Contact: | | Wu Yiming |
#### Designated Submission Correspondent
| Contact: | Mr. Boyle Wang |
|----------|-----------------------------------------------------------------------|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai<br>200120 China |
| Tel: | +86-21-50313932 |
| Email: | Info@truthful.com.cn |
Date Submitted: Jan.20,2025
#### 2.0 Device Information
| Trade/Device name: | Sterilization Package/Reel |
|------------------------------|----------------------------|
| Common name: | Sterilization Package/Reel |
| Classification name: | Sterilization Wrap; |
| Classification Product Code: | FRG,JOJ |
| Regulation number: | 21 CFR880.6850 |
| Classification: | Class II |
| Panel: | General Hospital |
# 3.0 Predicate Device Information
# Predicate Device:
| Manufacturer: | Sterileright Packaging Mfg., Inc. |
|--------------------|-------------------------------------------|
| Trade/Device Name: | SterileRight Sterilization Pouch and Roll |
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510(k) number: K212338
# 4.0 Device Description
The medical devices are inserted into the Sterilization Package/Reel,sealed, and then sterilized. After completion of the sterilization process, the Pouch/Roll main- tains 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 Sterilization Package permits the sealing of the pouch without the need of heat-sealing equipment, while the Heat-Seal Sterilization Reel are heat-sealed prior to processing in the steam/or EO Sterilization.
The chemical indicators ink printed on the "medical dialysis paper" will exhibit a color change after the Package/Reel is exposed to steam or ethylene oxide gas. The color of the Chemical Indicator changes from blue to black when exposed to Steam. And the color changes from pink to yellow, when exposed to EO gas.
The Chemical Indicator which is Type 1 Process Indicator as categorized by ISO 11140-1:2014 offers an addition way to verity processing in the sterilization cycle. The Chemical Indicator should be used in addition to, not in place of, the biological indicator. The Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to Steam/or EO gas.
## 5.0 Indication for Use Statement
The Sterilization Package/Reel is 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:
· Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 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).
Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process.
The Sterilization Package/Reel is offered 3 types in the following: Self -Seal Sterilization Pouch; Flat Sterilization Reel; Gusseted Sterilization Reel.
The following table (Table 1) lists the model numbers of the Sterilization Package/Reel by type, model, dimensions, and content/max. load (Ibs.):
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| Product Name | Item | Specification Size (WXL) | | Content/Max Load(lbs) | | |
|-------------------------------------------|-------------|--------------------------|-----------------|-----------------------|---------|------------------|
| | | Inch | Dimension | Metal | Plastic | Gauze/Linen<br>s |
| | KLDT-90165 | 3.5"x6.5" | 90mmx165mm | 0.12 | 0.11 | 0.1 |
| | KLDT-305430 | 12"x17" | 305mmx430mm | 1.10 | 1.09 | 0.66 |
| | KLDT-70230 | 2.75"x9" | 70mm×230mm | 0.09 | 0.08 | 0.07 |
| | KLDT-135280 | 3⅛"x11" | 135mmx280mm | 0.50 | 0.47 | 0.46 |
| | KLDT-90135 | 3.5"x5.25<br>" | 90mmx135mm | 0.10 | 0.09 | 0.08 |
| Self<br>Sealing<br>Sterilization<br>Pouch | KLDT-70260 | 2.75"x10" | 70mm×260mm | 0.10 | 0.09 | 0.08 |
| | KLDT-90260 | 3.5"x10" | 90mmx260mm | 0.15 | 0.14 | 0.12 |
| | KLDT-135260 | 3⅛"×10" | 135mmx260mm | 0.48 | 0.46 | 0.45 |
| | KLDT-250370 | 10"x14.5" | 250mmx370mm | 1.06 | 1.05 | 0.62 |
| | KLDT-190360 | 7.5"x14" | 190mmx360mm | 0.60 | 0.58 | 0.55 |
| | KLDT-57130 | 2.25"x5" | 57mm×130mm | 0.04 | 0.03 | 0.005 |
| | KLDT-57100 | 2.25"x4" | 57mm×100mm | 0.03 | 0.02 | 0.004 |
| | KLDT-135330 | 3⅛"×13" | 135mmx330mm | 0.55 | 0.53 | 0.50 |
| | KLDT-90230 | 3.5"x9" | 90mmx230mm | 0.14 | 0.13 | 0.11 |
| | KLDT-200200 | 8" | 200mm×200m | 0.60 | 0.58 | 0.55 |
| | KLDT-300200 | 12" | 300mm×200m | 1.04 | 1.03 | 0.60 |
| | KLDT-75200 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 |
| | KLDT-100200 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 |
| Flat<br>Sterilization<br>Reel | KLDT-50200 | 2" | 50mm×200m | 0.02 | 0.01 | 0.003 |
| | KLDT-400200 | 16" | 400mm×200m | 1.08 | 1.07 | 0.64 |
| | KLDT-250200 | 10" | 250mm×200m | 0.80 | 0.78 | 0.58 |
| | KLDT-350200 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 |
| | KLDT-55200 | 2.25" | 55mm×200m | 0.03 | 0.02 | 0.003 |
| | KLDT-150200 | 6" | 150mm×200m | 0.55 | 0.53 | 0.50 |
| Gusseted<br>Sterilization<br>Reel | KLDT-75100 | 3" | 75mm×30mm×100m | 0.09 | 0.05 | 0.004 |
| | KLDT-350100 | 14" | 350mm×80mm×100m | 1.06 | 1.05 | 0.62 |
| | KLDT-150100 | 6" | 150mm×50mm×100m | 0.55 | 0.53 | 0.50 |
| | KLDT-400100 | 16" | 400mm×80mm×100m | 1.08 | 1.07 | 0.64 |
| | KLDT-250100 | 10" | 250mm×65mm×100m | 0.80 | 0.78 | 0.58 |
| | KLDT-300100 | 12" | 300mm×75mm×100m | 1.04 | 1.03 | 0.60 |
| | KLDT-200100 | 8" | 200mm×55mm×100m | 0.60 | 0.58 | 0.55 |
| KLDT-100100 | 4" | 100mmx50mmx100m | 0.14 | 0.13 | 0.11 | |
Table 1. The model numbers of Sterilization Package/Reel (Type, Model and Dimension and Content/Max. Load)
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# 6.0 Summary of Non-Clinical Testing
Summary of non-clinical and performance testing bench testing was performed to evaluate the performance and functionality of the subject device against requirement specification. The test results demonstrated the subject device is confirmed to be safe and effective for the intended use.
| Test Item | Test Methodology | Acceptance Criteria or End Point | Test Results |
|-------------------------------------------------------------------------------|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| Sterilization<br>Process Validation | ISO 11135:2014 | Ethylene oxide: 60 minutes at 55 °C; relative<br>humidity between 50%- 80%;<br>ethylene oxide concentration<br>is 735 mg/L, 8 hours aeration<br>time at 60°C (140°F).<br>SAL=10-6 | SAL=10-6<br>Pass |
| | ISO 17665-1:2006;<br>ISO TS 17665-2:2009 | Steam; 4 minutes at 132°C;<br>30 minutes dry time.<br>SAL=10-6 | SAL=10-6<br>Pass |
| EO/ECH Residuals | ISO 10993-7:2008 | EO < 4mg/d<br>ECH < 9mg/d | Pass |
| Package Integrity /<br>Material<br>Compatibility<br>/Sterility<br>Maintenance | ASTM F 2251-13 | 52μm±10% | Pass |
| | ASTM<br>F1140/F1140M-13 | Burst value > 3.2 Kpa or No Burst | Pass |
| | ASTM F1929-15 | The dye solution is no any<br>leakage across the seal width<br>of sterile barrier system.<br>(No Infiltration) | No Infiltration<br>Pass |
| | ASTM F88/F88M-21 | Seal strength > 2.5 (N/15mm) | Pass |
| | ISO 1924-2:2008 | Tensile strength:<br>CD $\ge$ 2.2KN/m,MD $\ge$ 4.4KN/m | Pass |
| | ASTM F2096-11 | No Leakage | No Leakage<br>Pass |
| | DIN 58953-6 | CFU = 0 | CFU = 0<br>Pass |
| | ISO 5636-3 | 10-50 mL/min·m² | 20-30 mL/min·m²<br>Pass |
#### Table 2: Performance testing summary – Bench
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| Chemical Indicator<br>Efficacy Testing | ISO 11140-1:2014 | Steam: | The real time aging test |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 1. Remain stable<br>before use based on<br>its shelf life.<br><br>2. Maintain the<br>endpoint stability of the<br>color change after<br>being in the presence<br>of the sterilant. | The color of CI changes from<br>blue to black, when exposed<br>to Steam;<br><br>EO:<br>The color of CI changes from<br>pink to yellow, when exposed<br>to EO gas. | was carried out that<br>demonstrates: the test<br>device which exposed to<br>Steam maintain the color<br>of black, the test group<br>which exposed to EO<br>maintain the color of<br>yellow, and the real time<br>aging test was carried out<br>on the empty Sterilization<br>Package/Reel that<br>demonstrates the test<br>device maintain the<br>original color within the<br>stated validity period of 2<br>years. |
| Shelf-Life<br>Validation | / | Shelf Life:2 Years;<br>Shelf Life after Sterilized:<br>6 months | Pass |
# Biocompatibility Testing
The biocompatibility evaluation for the Sterilization Package/Reel was conducted in accordance with the FDA's Biocompatibility Guidance "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"
Table 3 Summary test of Biocompatibility Testing
| Biocompatibility<br>testing | ISO 10993-5:2009 | Non-cytotoxic | Under conditions of the study, did not<br>show potential toxicity to L-929 cells.<br>Pass |
|-----------------------------|-------------------|-----------------|-------------------------------------------------------------------------------------------|
| | ISO 10993-23:2021 | Non-irritating | Under the conditions of the study, not an<br>irritant.<br>Pass |
| | ISO 10993-10:2021 | Non-sensitizing | Under conditions of the study, not a<br>sensitizer.<br>Pass |
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# 7.0 Technological Characteristic Comparison Table
| Item | Subject Device<br>K241565 | Predicate Device<br>K212338 | Comparison<br>Analysis |
|----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Product Name | Sterilization Package/Reel | SterileRight sterilization pouch and roll | ---- |
| Product Code | FRG,JOJ | FRG,JOJ | Same |
| Regulation No. | 21 CFR 880.6850 | 21 CFR 880.6850<br>21 CFR 880.2800 | Same |
| Class | II | II | Same |
| Indication for<br>Use | The Sterilization Package/Reel is 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:<br>Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time of 30 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). Furthermore, the Sterilization Package/Reel maintains the enclosed devices up until 6 months post EO gas sterilization and maintains the enclosed devices up until 6 months post Steam sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the Sterilization Package/Reel has undergone either a steam or EO sterilization process. | 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:<br>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 | Similar |
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| | The Sterilization Package/Reel is<br>offered 3 types in the following:<br>Self -Seal Sterilization Pouch;<br>Flat Sterilization Reel;<br>Gusseted Sterilization Reel. | manufacture. The pouch's<br>external chemical ink indicators<br>are designed to indicate to the<br>user that the pouch has<br>undergone either a steam or EO<br>sterilization process.<br>The SterileRight sterilization<br>pouch and roll which are made<br>with Tyvek® is for EO gas | |
| | | sterilization only. It also maintains<br>the sterility of the enclosed<br>devices for up to 6 months<br>post EO gas sterilization, and | |
| | | before sterilization has<br>a<br>maximum shelf life of 3 years<br>from the date of manufacture. | |
| Material<br>Composition | Composed of medical dialysis<br>paper and transparent colored<br>PET/CPP composite film , EO and<br>Steam Process Indicator, Print Ink,<br>adhesive | Medical Grade Paper, CPP, PET,<br>adhesive,EO and Steam Process<br>Indicator, Print Ink.<br>Tyvek®, PET, PE, adhesive. | Similar |
| Sterilization<br>Cycles | • Steam Sterilization at 132°C<br>(270°F) for 4 minutes; Drying time<br>of 30 minutes.<br>• Ethylene Oxide (EO) with a<br>concentration of 735 mg/L at 55°<br>C (131 ° F) and 50% to 80%<br>relative humidity for 60 minutes.<br>Aeration time of 8 hours at 60°C<br>(140°F). | • Gravity steam at 121°C (250°F)<br>for 30 minutes; Drying time of 25<br>minutes.<br>• Pre-vacuum steam at 132°C<br>(270°F) for4 minutes; Drying time<br>of 20 minutes.<br>• Ethylene Oxide (EO) with a<br>concentration of 735 mg/L at<br>55°C (131°F) and 50% to 80%<br>relative humidity for 60 minutes.<br>Aeration time of 8hours at 60°C<br>(140°F). | Similar |
| Configuration/<br>Dimension | Various Size, Heat Sealing and<br>Self Sealing | Various Size, Heat Sealing and<br>Self Sealing | Same |
| Sterilant<br>Penetration<br>Efficacy | The test meet the requirement of<br>SAL 10-6 | The test meet the requirement of<br>SAL 10-6 | Same |
| Chemical<br>Indicator<br>(CI)<br>Functionality<br>and Endpoint | The sterilant penetrated through<br>the pouch configuration and<br>affected the CI color change to<br>the endpoint color | The sterilant penetrated through<br>the pouch configuration and<br>affected the CI color change to the<br>endpoint color | Same |
| Device Design<br>of Steam Cl | The color of Chemical Indicator<br>changes from Blue to | The color of Chemical Indicator<br>changes from Pink to | Similar |
| | Black, when exposed to Steam | Brown/Black, when exposed to Steam | |
| Device Design of EO gas CI | The color of Chemical Indicator changes from Pink to Yellow, when exposed to Steam | The color changes from Blue to Yellow/Brown, when exposed to EO gas | Similar |
| Thickness Variations (mm) ASTM F 2251 | Passed | Passed | Same |
| Tensile strength ISO 1924-2 | Passed | Passed | Same |
| Burst Strength (kPa) ASTM F1140 | Passed | Passed | Same |
| Bubble Leak Test ASTM D 3078 or ASTM-F 2096 | Passed | Passed | Same |
| Seal Peel Test (N/15mm) ASTM F88/F88M ; ISO 11607-1 | Passed…
