(269 days)
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 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.
I am sorry, but the provided text describes a 510(k) premarket notification for a medical device called "Sterilization Package/Reel." This document focuses on the substantial equivalence of the device to existing predicate devices, primarily through non-clinical bench testing and comparisons of technological characteristics.
The information you requested, relating to acceptance criteria and studies proving an AI/Software as a Medical Device (SaMD)'s performance (such as sample size for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), is not present in the provided text.
The document discusses validation of sterilization processes (ISO 11135, ISO 17665-1), material compatibility, package integrity, and biocompatibility, which are standard tests for physical sterilization packaging, not for AI device performance.
Therefore, I cannot fulfill your request for this specific information based on the text provided.
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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"
{1}------------------------------------------------
(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
{3}------------------------------------------------
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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| Specification Size (WXL) | Content/Max Load(lbs) | |||||
|---|---|---|---|---|---|---|
| Product Name | Item | Inch | Dimension | Metal | Plastic | Gauze/Linens |
| 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 | |
| SelfSealingSterilizationPouch | 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 | |
| FlatSterilizationReel | 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 | |
| GussetedSterilizationReel | 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 40V. 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 CaraVill |
|---|
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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 BridgeEconomic Development Zone ,246000 Anqing City, AnhuiProvince,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 Shanghai200120 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 |
{7}------------------------------------------------
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.):
{8}------------------------------------------------
| Product Name | Item | Specification Size (WXL) | Content/Max Load(lbs) | |||
|---|---|---|---|---|---|---|
| Inch | Dimension | Metal | Plastic | Gauze/Linens | ||
| 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 | |
| SelfSealingSterilizationPouch | 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 | |
| FlatSterilizationReel | 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 | |
| GussetedSterilizationReel | 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 |
|---|---|---|---|
| SterilizationProcess Validation | ISO 11135:2014 | Ethylene oxide: 60 minutes at 55 °C; relativehumidity between 50%- 80%;ethylene oxide concentrationis 735 mg/L, 8 hours aerationtime at 60°C (140°F).SAL=10-6 | SAL=10-6Pass |
| ISO 17665-1:2006;ISO TS 17665-2:2009 | Steam; 4 minutes at 132°C;30 minutes dry time.SAL=10-6 | SAL=10-6Pass | |
| EO/ECH Residuals | ISO 10993-7:2008 | EO < 4mg/dECH < 9mg/d | Pass |
| Package Integrity /MaterialCompatibility/SterilityMaintenance | ASTM F 2251-13 | 52μm±10% | Pass |
| ASTMF1140/F1140M-13 | Burst value > 3.2 Kpa or No Burst | Pass | |
| ASTM F1929-15 | The dye solution is no anyleakage across the seal widthof sterile barrier system.(No Infiltration) | No InfiltrationPass | |
| ASTM F88/F88M-21 | Seal strength > 2.5 (N/15mm) | Pass | |
| ISO 1924-2:2008 | Tensile strength:CD $\ge$ 2.2KN/m,MD $\ge$ 4.4KN/m | Pass | |
| ASTM F2096-11 | No Leakage | No LeakagePass | |
| DIN 58953-6 | CFU = 0 | CFU = 0Pass | |
| ISO 5636-3 | 10-50 mL/min·m² | 20-30 mL/min·m²Pass |
Table 2: Performance testing summary – Bench
{10}------------------------------------------------
| Chemical IndicatorEfficacy Testing | ISO 11140-1:2014 | Steam: | The real time aging test |
|---|---|---|---|
| 1. Remain stablebefore use based onits shelf life.2. Maintain theendpoint stability of thecolor change afterbeing in the presenceof the sterilant. | The color of CI changes fromblue to black, when exposedto Steam;EO:The color of CI changes frompink to yellow, when exposedto EO gas. | was carried out thatdemonstrates: the testdevice which exposed toSteam maintain the colorof black, the test groupwhich exposed to EOmaintain the color ofyellow, and the real timeaging test was carried outon the empty SterilizationPackage/Reel thatdemonstrates the testdevice maintain theoriginal color within thestated validity period of 2years. | |
| Shelf-LifeValidation | / | Shelf Life:2 Years;Shelf Life after Sterilized: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
| Biocompatibilitytesting | ISO 10993-5:2009 | Non-cytotoxic | Under conditions of the study, did notshow potential toxicity to L-929 cells.Pass |
|---|---|---|---|
| ISO 10993-23:2021 | Non-irritating | Under the conditions of the study, not anirritant.Pass | |
| ISO 10993-10:2021 | Non-sensitizing | Under conditions of the study, not asensitizer.Pass |
{11}------------------------------------------------
7.0 Technological Characteristic Comparison Table
| Item | Subject DeviceK241565 | Predicate DeviceK212338 | ComparisonAnalysis |
|---|---|---|---|
| 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 880.685021 CFR 880.2800 | Same |
| Class | II | II | Same |
| Indication forUse | 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 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 | Similar |
| The Sterilization Package/Reel isoffered 3 types in the following:Self -Seal Sterilization Pouch;Flat Sterilization Reel;Gusseted Sterilization Reel. | manufacture. The pouch'sexternal chemical ink indicatorsare designed to indicate to theuser that the pouch hasundergone either a steam or EOsterilization process.The SterileRight sterilizationpouch and roll which are madewith Tyvek® is for EO gas | ||
| sterilization only. It also maintainsthe sterility of the encloseddevices for up to 6 monthspost EO gas sterilization, and | |||
| before sterilization hasamaximum shelf life of 3 yearsfrom the date of manufacture. | |||
| MaterialComposition | Composed of medical dialysispaper and transparent coloredPET/CPP composite film , EO andSteam Process Indicator, Print Ink,adhesive | Medical Grade Paper, CPP, PET,adhesive,EO and Steam ProcessIndicator, Print Ink.Tyvek®, PET, PE, adhesive. | Similar |
| SterilizationCycles | • Steam Sterilization at 132°C(270°F) for 4 minutes; Drying timeof 30 minutes.• Ethylene Oxide (EO) with aconcentration 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). | • Gravity steam at 121°C (250°F)for 30 minutes; Drying time of 25minutes.• Pre-vacuum steam at 132°C(270°F) for4 minutes; Drying timeof 20 minutes.• Ethylene Oxide (EO) with aconcentration of 735 mg/L at55°C (131°F) and 50% to 80%relative humidity for 60 minutes.Aeration time of 8hours at 60°C(140°F). | Similar |
| Configuration/Dimension | Various Size, Heat Sealing andSelf Sealing | Various Size, Heat Sealing andSelf Sealing | Same |
| SterilantPenetrationEfficacy | The test meet the requirement ofSAL 10-6 | The test meet the requirement ofSAL 10-6 | Same |
| ChemicalIndicator(CI)Functionalityand Endpoint | The sterilant penetrated throughthe pouch configuration andaffected the CI color change tothe endpoint color | The sterilant penetrated throughthe pouch configuration andaffected the CI color change to theendpoint color | Same |
| Device Designof Steam Cl | The color of Chemical Indicatorchanges from Blue to | The color of Chemical Indicatorchanges 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 | Passed | Same |
| Dye penetration Test ASTM F1929 | Passed | Passed | Same |
| Microbial Barrier Test DIN 58953-6 | Passed | Passed | Same |
| Air permeance testing ISO 5636-3 | Passed | Passed | Same |
| End point stability testing results | The color of chemical indicator for EO sterilization indicator ink is Pink, and the color of chemical indicator for steam sterilization indicator ink is Blue after 2 year shelf life before sterilization.The color of chemical indicator for EO sterilization indicator ink is Yellow, and the color of chemical indicator for steam sterilization | The color of chemical indicator for EO sterilization indicator ink is Blue, and the color of chemical indicator for steam sterilization indicator ink is Pink after 2 year shelf life before sterilization.The color of chemical indicator for EO sterilization indicator ink is Yellow/Brown , and the color of chemical indicator for steam | Similar |
| indicator ink is Blue after EO sterilized and 6 months shelf life. | sterilization indicator ink is Pink after EO sterilized and 6 months shelf life | ||
| The color of chemical indicator for EO sterilization indicator ink is Pink, and the color of chemical indicator for steam sterilization indicator ink is Black after steam sterilized and 6 months shelf life. | The color of chemical indicator for EO sterilization indicator ink is Bue, and the color of chemical indicator for steam sterilization indicator ink is Brown/Black after steam sterilized and 6 months shelf life. | Similar | |
| Maintenance of Sterility | 6 months | 6 months | Same |
| Shelf Life | 2 years from date of manufacture for EO and Steam Indicators | 3 years from date of manufacture for EO and Steam Indicators | Different |
| Biocompatibility | Conform with ISO10993-1 (ISO10993-5, ISO10993-10) | Conform with ANSI/AAMI/ISO 10993-10 | Same |
Table 4- Comparison of Technology Characteristics
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The technological characteristics of the subject device are identical to those of predicate device. The subject device has the same basic design as the predicate device.
The comparison between the subject and predicate devices is based on the following:
- Same intended use
- · Same indications for use
- · Similar material types that meet ISO 10993 biocompatibility requirements
- · Same sterilization methods (EO and Steam sterilization process)
- Same fundamental technology/principal of operation/user interface
The sterilization parameters of the subject device are little different with those of the predicate device, but the EO sterilization validation results demonstrate the subject device fully meet the requirements of ISO 11135 and the steam sterilization validation results fully meet the requirements of ISO 17665-1.
8.0 Summary of Clinical Testing
No clinical study is included in this submission.
9.0 Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the predicate device K212338.
§ 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).