(151 days)
Not Found
No
The device is a physical sterilization pouch with chemical indicators, and the description focuses on its material, intended use, sterilization parameters, and performance testing against standards. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No.
The device is a sterilization pouch and reel intended to contain other medical devices for sterilization, not to provide therapy directly to a patient.
No
The device, "Sterilization Pouches and Reels," is intended to contain medical devices for sterilization and maintain their sterility, not to diagnose medical conditions. It includes chemical indicators to show exposure to sterilization processes, but these do not perform diagnosis.
No
The device is a physical product (pouches and reels made of medical compound film) used for containing medical devices during sterilization. It includes physical components like chemical indicators and undergoes physical performance testing. There is no mention of software in the description.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a method to enclose devices for sterilization by steam or ethylene oxide. This is a process for preparing medical devices for use, not for performing diagnostic tests on biological samples.
- Device Description: The description focuses on the physical properties of the pouches and reels (medical compound film, heat sealing, sterility maintenance) and the function of the chemical indicators to show exposure to sterilization processes. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or treatment decisions based on biological sample analysis.
The device is clearly intended for the sterilization and sterile storage of other medical devices.
N/A
Intended Use / Indications for Use
The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20°C (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization process. Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)
Product codes
FRG, JOJ
Device Description
The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:
- Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
- b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition 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 steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards (included but not fully described):
- ASTM F88/F88M-2015, Standard Test Method for Seal Strength of Flexible Barrier Materials.(Sterility)
- ASTM F1929-2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
- ASTM F 2096-2011 (2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- ISO 1924-2:2008 Paper and board -- Determination of tensile properties.
- ASTM F 2251-13 Standard Test Method for Thickness Measurement of Flexible Packaging Material
- ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General requirements
- ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
- ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
- ISO 10993-12: Biological evaluation of medical devices Part 12: Sample preparation and reference materials
- ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
- DIN58953-6-2010 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized.
- ISO17665-1:2006 Sterilization of health care products-Moist heat-Part1: requirements for the development, validation and routine control of a sterilization process for medical devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
0
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 21, 2025
Shanghai Jianzhong Medical Packaging Co., Ltd. Xinhua Wei Medical Device Regulatory Affairs Specialist Bldg 16, 789# Puxing Road, Minhang District Shanghai. 201114 China
Re: K242898
Trade/Device Name: Sterilization Pouches and Reels Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: September 24, 2024 Received: January 24, 2025
Dear Xinhua Wei:
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).
2
Sincerely,
Digitally signed by Stephen A. Stephen A. Anisko -S Date: 2025.02.21 Anisko -S 15:53:10 -05'00'
for: Christopher K. Dugard, M.S. Division 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) K242898
Device Name Sterilization Pouches and Reels
Indications for Use (Describe)
The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)
The following tables (Table 1~5) identifies the size of subject device and its Maximum validated load. Table 1:Sterilization Pouches, self seal
| Size of device | Content/Max Load (Ibs.) | |||
|---|---|---|---|---|
| Inch | Metric | Metal | Plastic | Gauze/Linens |
| 2.25"×4" | 57× (100+30) mm | 0.004 | 0.0088 | 0.005 |
| 2.25"×2.75" | 57× (70+30) mm | 0.004 | 0.0088 | 0.004 |
| 2.75"×9" | 70× (230+30) mm | 0.020 | 0.04 | 0.02 |
| 3.5"×6.5" | 90× (135+30) mm | 0.016 | 0.032 | 0.016 |
| 3.5"×9" | 90× (230+30) mm | 0.024 | 0.12 | 0.024 |
| 3.5"×10.5" | 90× (270+30) mm | 0.032 | 0.15 | 0.032 |
| 3.5"×22" | 90× (560+30) mm | 0.072 | 0.32 | 0.072 |
| 5"×15" | 127× (380+30) mm | 0.062 | 0.30 | 0.062 |
| 5.25"×10" | 135× (254+29) mm | 0.045 | 0.22 | 0.045 |
| 5.25"×10" | 135× (255+30) mm | 0.045 | 0.22 | 0.045 |
| 5.25"×12" | 135× (305+30) mm | 0.052 | 0.26 | 0.05 |
| 5.25"×13" | 140× (330+30) mm | 0.072 | 0.36 | 0.07 |
| 6"×9" | 150× (230+30) mm | 0.055 | 0.27 | 0.05 |
| 7.5"×13" | 190× (330+30) mm | 0.102 | 0.48 | 0.10 |
| 8"×12.5" | 200× (320+30) mm | 0.12 | 0.53 | 0.10 |
| 10"×14.5" | 250× (370+30) mm | 0.21 | 0.65 | 0.19 |
| 10.6"×17" | 270× (400+30) mm | 0.38 | 0.78 | 0.22 |
| 10.5"×17" | 270× (430+30) mm | 0.42 | 0.82 | 0.24 |
| 12"×15" | 300× (380+30) mm | 0.52 | 0.90 | 0.23 |
| 12"×16.5" | 300× (420+30) mm | 0.58 | 1.02 | 0.25 |
| 12"×18" | 300× (460+30) mm | 0.68 | 1.10 | 0.28 |
| 14"×19" | 355× (480+30) mm | 0.92 | 1.10 | 0.34 |
4
| 15"×25" | 380× (635+30) mm | 1.30 | 1.10 | 0.50 |
|---|---|---|---|---|
| 20"×22" | 500× (560+40) mm | 1.87 | 1.10 | 0.60 |
Table 2 Sterilization Pouches, flat, heat seal
| Size of device | |
|---|---|
| Inch | Metric |
| 3.5"×22" | 90×560mm |
| 4"×12" | 100×300mm |
| 5"×15" | 127×380mm |
| 6"×10" | 150×254mm |
| 6"×22" | 150×560mm |
| 7.5"×13" | 190×330mm |
| 8"×20" | 200×500mm |
| 12"×15" | 300×380mm |
| 12"×18" | 300×460mm |
| 16.5"×22.5" | 420×570mm |
Table 3 Sterilization Pouches, gusseted, heat seal
| Size of device | |
|---|---|
| Inch | Metric |
| 4"×12" | 100×50×300mm |
| 4"×14" | 100×50×360mm |
| 6"×16" | 150×50×400mm |
| 6"×18" | 150×50×460mm |
| 8"×20" | 200×55×500mm |
| 8"×16" | 200×55×400mm |
| 8"×19" | 250×65×480mm |
| 12"×22" | 300×80×550mm |
| 16.5"×22.5" | 420×100×570mm |
Table 4 Sterilization Reels, flat, heat seal
| Size of device | |
|---|---|
| -- | ---------------- |
| Inch | Metric |
|---|---|
| 3" | 75mm×30.5m |
| 4" | 100mm×30.5m |
| 6" | 150mm×30.5m |
| 8" | 200mm×30.5m |
| 10" | 250mm×30.5m |
| 2" | 50mm × 200m |
| 2.15" | 55mm × 200m |
| 3" | 75mm × 200m |
| 4" | 100mm × 200m |
| 4.7" | 120mm × 200m |
| 6" | 150mm × 200m |
| 8" | 200mm × 200m |
| 10" | 250mm×200m |
| 12" | 300mm × 200m |
| 14" | 350mm × 200m |
| 16" | 400mm × 200m |
| 18" | 450mm × 200m |
| 20" | 500mm × 200m |
| Table 5 Sterilization Reels, gusseted, heat seal | |||||
|---|---|---|---|---|---|
| -- | -------------------------------------------------- | -- | -- | -- | -- |
| Content/Max Load (Ibs.) | Metal | Plastic | Gauze/Linens |
|---|---|---|---|
| 0.005 | 0.01 | 0.020 | |
| 0.004 | 0.0088 | 0.0176 | |
| 0.07 | 0.20 | 0.055 | |
| 0.06 | 0.19 | 0.05 | |
| 0.12 | 0.32 | 0.10 | |
| 0.10 | 0.25 | 0.09 | |
| 0.12 | 0.53 | 0.10 | |
| 0.44 | 0.54 | 0.38 | |
| 0.58 | 0.74 | 0.52 | |
| 1.87 | 1.10 | 0.60 |
| Content/Max Load (Ibs.) | ||
|---|---|---|
| Metal | Plastic | Gauze/Linens |
| 0.004 | 0.0088 | 0.0176 |
| 0.02 | 0.04 | 0.025 |
| 0.05 | 0.12 | 0.04 |
| 0.06 | 0.18 | 0.06 |
| 0.12 | 0.53 | 0.10 |
| 0.12 | 0.48 | 0.10 |
| 0.30 | 0.74 | 0.26 |
| 1.15 | 0.98 | 0.40 |
| 1.87 | 1.10 | 0.60 |
| Content/Max Load (Ibs.) | ||
|---|---|---|
| Metal | Plastic | Gauze/Linens |
| 0.02 | 0.04 | 0.02 |
| 0.025 | 0.15 | 0.032 |
| 0.06 | 0.27 | 0.07 |
| 0.10 | 0.53 | 0.10 |
| 0.12 | 0.53 | 0.10 |
| 0.004 | 0.0088 | 0.004 |
| 0.004 | 0.0088 | 0.005 |
| 0.02 | 0.04 | 0.002 |
| 0.025 | 0.08 | 0.035 |
| 0.04 | 0.10 | 0.04 |
| 0.06 | 0.20 | 0.06 |
| 0.12 | 0.38 | 0.08 |
| 0.12 | 0.53 | 0.10 |
| 0.52 | 0.53 | 0.25 |
| 0.92 | 1.05 | 0.34 |
| 1.08 | 1.07 | 0.52 |
| 1.30 | 1.10 | 0.58 |
| 1.87 | 1.10 | 0.60 |
5
| Size of device | Content/Max Load (Ibs.) | |||
|---|---|---|---|---|
| Inch | Metric | Metal | Plastic | Gauze/Linens |
| 4.15" | 55mm × 100m | 0.004 | 0.0088 | 0.004 |
| 3" | 75mm × 100m | 0.02 | 0.04 | 0.04 |
| 4" | 100mm × 100m | 0.05 | 0.15 | 0.08 |
| 6" | 150mm × 100m | 0.07 | 0.20 | 0.10 |
| 8" | 200mm x 100m | 0.12 | 0.53 | 0.10 |
| 10" | 250mm x 100m | 0.12 | 0.53 | 0.10 |
| 12" | 300mm × 100m | 1.15 | 0.98 | 0.40 |
| 14" | 350mm x 100m | 1.35 | 1.0 | 0.50 |
| 16" | 400mm × 100m | 1.65 | 1.03 | 0.58 |
| 18" | 450mm x 100m | 1.87 | 1.10 | 0.60 |
| 20" | 500mm x 100m | 1.87 | 1.10 | 0.60 |
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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6
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.The
assigned 510(k) Number: K242898
-
- Date of Preparation: February 20, 2025
-
- Sponsor Identification
Shanghai Jianzhong Medical Packaging Co., Ltd.
Bldg 16, 789# Puxing Road, Minhang District, Shanghai 201114, P.R. China Registration Number: 3005030944. Contact Person: Xinhua Wei Position: Medical Device Regulatory Affairs Specialist Tel: +86-21-54315666-5201 Fax: +86-21-54315801 Email: weixinhua@mpackchina.com
-
- Identification of Proposed Device
Trade Name: Sterilization Pouches and Reels
- Identification of Proposed Device
Common Name: Sterilization Pouches and Reels
Regulatory Information
Classification Name: Wrap, Sterilization
Classification: II;
Product Code: FRG;
Subsequent Product Code: JOJ;
Regulation Number: 21 CFR 880.6850
Review Panel: General Hospital;
-
- Identification of Predicate Device 510(k) Number: K221875 Product Name: Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II
7
Product Code: FRG, Subsequent Product Code: JOJ Dated: January 17, 2023 Received: January 17, 2023
5. Device Description
The Sterilization Pouches and Reels is composed of medical compound film. It is intended to be used to contain medical devices to be terminally sterilized by Steam or EO sterilization process. The recommended sterilization cycle parameters are as follows:
- Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes. a)
- b) Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20℃ (68 °F).
The medical devices are inserted into the Pouches/Reels, and then sterilized for the EO or Steam Sterilization Process. The heat-sealed Pouches/Reels are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouches/Reels maintain sterility of the enclosed medical devices until the seal is opened. The Sterilization Pouches and Reels maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture.
The Sterilization Pouches and Reels is printed with chemical indicator bars that changed from Pink to Cocoa(Steam) or Blue to Golden Brown (EO) when exposed to steam vapor or EO gas during process. The steam and EO chemical indicator offer an addition 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 steam and EO chemical indicators do not signify sterilization; they only indicate that the indicators have been exposed to the Steam or EO.
-
- Indication for Use Statement
The Sterilization Pouches and Reels is intended to provide health care workers with an effective method to enclosed devices in a single or double pouch configuration by steam or ethylene oxide sterilization. The recommended sterilization cycle parameters are as follows:
- Indication for Use Statement
a) Steam sterilization at 132°C (270°F) for 4 minutes; Drying time of 20 minutes.
b) Ethylene Oxide (EQ) with a concentration of 800 mg/L at 55 ℃ (131 °F) and 40%-80% relative humidity for 6 hours. Aeration time of 7 days at 20°C (68 °F).
The Sterilization Pouches and Reels is composed of medical compound film, maintains the sterility of the enclosed devices for up to 12 months post Steam or EO gas sterilization, and before sterilization has a maximum shelf life of 5 years from the date of manufacture. The pouch's external chemical indicators are designed to indicate to the user that the pouch has undergone either a steam or EO Sterilization process. Sterilization indicators will change color according to the sterilization method (Steam, Ethylene oxide). The color of steam sterilization indicator changes from Pink before sterilization to Cocoa after sterilization. The color of
8
Ethylene oxide sterilization indicator changes from Blue before sterilization to Golden Brown after sterilization. The maximum validated pouch load is 1.87 lbs. (850g); The maximum validated reel load is 1.87 lbs. (850 g)
| Item | Size of Device | Content/Max Load(Ibs) | |||
|---|---|---|---|---|---|
| Inch | Metric | Metal | Plastic | Gauze/Linens | |
| Sterilization | |||||
| Pouches, | |||||
| self-seal | 2.25"x4" | 57x(100+30)mm | 0.004 | 0.0088 | 0.005 |
| 2.25"x2.75" | 57x(70+30)mm | 0.004 | 0.0088 | 0.004 | |
| 2.75"x9" | 70x(230+30)mm | 0.020 | 0.04 | 0.02 | |
| 3.5"x6.5" | 90x(135+30)mm | 0.016 | 0.032 | 0.016 | |
| 3.5"x9" | 90x(230+30)mm | 0.024 | 0.12 | 0.024 | |
| 3.5"x10.5" | 90x(270+30)mm | 0.032 | 0.15 | 0.032 | |
| 3.5"x22" | 90x(560+30)mm | 0.072 | 0.32 | 0.072 | |
| 5"x15" | 127x(380+30)mm | 0.062 | 0.30 | 0.062 | |
| 5.25"x10" | 135x(254+29)mm | 0.045 | 0.22 | 0.045 | |
| 5.25"x10" | 135x(255+30)mm | 0.045 | 0.22 | 0.045 | |
| 5.25"x12" | 135x(305+30)mm | 0.052 | 0.26 | 0.05 | |
| 5.25"x13" | 140x(330+30)mm | 0.072 | 0.36 | 0.07 | |
| es, | |||||
| self- | |||||
| seal | 6"x9" | 150x(230+30)mm | 0.055 | 0.27 | 0.05 |
| 7.5"x13" | 190x(330+30)mm | 0.102 | 0.48 | 0.10 | |
| 8"x12.5" | 200x(320+30)mm | 0.12 | 0.53 | 0.10 | |
| 10"x14.5" | 250x(370+30)mm | 0.21 | 0.65 | 0.19 | |
| 10.6"x17" | 270x(400+30)mm | 0.38 | 0.78 | 0.22 | |
| 10.5"x17" | 270x(430+30)mm | 0.42 | 0.82 | 0.24 | |
| 12"x15" | 300x(380+30)mm | 0.52 | 0.90 | 0.23 | |
| 12"x16.5" | 300x(420+30)mm | 0.58 | 1.02 | 0.25 | |
| 12"x18" | 300x(460+30)mm | 0.68 | 1.10 | 0.28 | |
| 14"x19" | 355x(480+30)mm | 0.92 | 1.10 | 0.34 | |
| 15"x25" | 380x(635+30)mm | 1.30 | 1.10 | 0.50 | |
| 20"x22" | 500x(560+40)mm | 1.87 | 1.10 | 0.60 | |
| Sterilization | |||||
| Pouches, | |||||
| flat, | |||||
| heat | |||||
| seal | 3.5"x22" | 90x560mm | 0.005 | 0.01 | 0.020 |
| 4"x12" | 100x300mm | 0.004 | 0.0088 | 0.0176 | |
| 5"x15" | 127x380mm | 0.07 | 0.20 | 0.055 | |
| 6"x10" | 150x254mm | 0.06 | 0.19 | 0.05 | |
| 6"x22" | 150x560mm | 0.12 | 0.32 | 0.10 | |
| 7.5"x13" | 190x330mm | 0.10 | 0.25 | 0.09 | |
| 8"x20" | 200x500mm | 0.12 | 0.53 | 0.10 | |
| 12"x15" | 300x380mm | 0.44 | 0.54 | 0.38 | |
| 12"x18" | 300x460mm | 0.58 | 0.74 | 0.52 | |
| 16.5"x22.5" | 420x570mm | 1.87 | 1.10 | 0.60 | |
| 4"x12" | 100x50x300mm | 0.004 | 0.0088 | 0.0176 | |
| 4"x14" | 100x50x360mm | 0.02 | 0.04 | 0.025 | |
| Sterilization | |||||
| Pouch | |||||
| es, | |||||
| gusset | |||||
| ed, | |||||
| heat | |||||
| seal | 6"x16" | 150x50x400mm | 0.05 | 0.12 | 0.04 |
| 6"x18" | 150x50x460mm | 0.06 | 0.18 | 0.06 | |
| 8"x20" | 200x55x500mm | 0.12 | 0.53 | 0.10 | |
| 8"x16" | 200x55x400mm | 0.12 | 0.48 | 0.10 | |
| 8"x19" | 250x65x480mm | 0.30 | 0.74 | 0.26 | |
| 12"x22" | 300x80x550mm | 1.15 | 0.98 | 0.40 | |
| 16.5"x22.5" | 420x100x570mm | 1.87 | 1.10 | 0.60 | |
| 3" | 75mmx30.5m | 0.02 | 0.04 | 0.02 | |
| 4" | 100mmx30.5m | 0.025 | 0.15 | 0.032 | |
| 6" | 150mmx30.5m | 0.06 | 0.27 | 0.07 | |
| 8" | 200mmx30.5m | 0.10 | 0.53 | 0.10 | |
| 10" | 250mmx30.5m | 0.12 | 0.53 | 0.10 | |
| 2" | 50mm x 200m | 0.004 | 0.0088 | 0.004 | |
| 2.15" | 55mm x 200m | 0.004 | 0.0088 | 0.005 | |
| Sterilization | |||||
| Reels, | |||||
| flat, | |||||
| heat | |||||
| seal | 3" | 75mm x 200m | 0.02 | 0.04 | 0.002 |
| 4" | 100mm x 200m | 0.025 | 0.08 | 0.035 | |
| 4.7" | 120mm x 200m | 0.04 | 0.10 | 0.04 | |
| 6" | 150mm x 200m | 0.06 | 0.20 | 0.06 | |
| 8" | 200mm x 200m | 0.12 | 0.38 | 0.08 | |
| 10" | 250mmx200m | 0.12 | 0.53 | 0.10 | |
| 12" | 300mm x 200m | 0.52 | 0.53 | 0.25 | |
| 14" | 350mm x 200m | 0.92 | 1.05 | 0.34 | |
| 16" | 400mm x 200m | 1.08 | 1.07 | 0.52 | |
| 18" | 450mm x 200m | 1.30 | 1.10 | 0.58 | |
| 20" | 500mm x 200m | 1.87 | 1.10 | 0.60 | |
| 4.15" | 55mm x 100m | 0.004 | 0.0088 | 0.004 | |
| Sterilization | |||||
| Reels, | |||||
| gusset | |||||
| ed, | 3" | 75mm x 100m | 0.02 | 0.04 | 0.04 |
| 4" | 100mm x 100m | 0.05 | 0.15 | 0.08 | |
| 6" | 150mm x 100m | 0.07 | 0.20 | 0.10 | |
| 8" | 200mm x 100m | 0.12 | 0.53 | 0.10 | |
| heat | |||||
| seal | 10" | 250mm x 100m | 0.12 | 0.53 | 0.10 |
| 12" | 300mm x 100m | 1.15 | 0.98 | 0.40 | |
| 14" | 350mm x 100m | 1.35 | 1.0 | 0.50 | |
| 16" | 400mm x 100m | 1.65 | 1.03 | 0.58 | |
| 18" | 450mm x 100m | 1.87 | 1.10 | 0.60 | |
| 20" | 500mm x 100m | 1.87 | 1.10 | 0.60 |
(Model and Dimension and Content/Max. Load)
9
10
7. Non-Clinical Test Conclusion
Performance testing and Biocompatibility assessment were conducted to verify that the subject device met all design specifications. The test results demonstrated that the subject device meet the following standards (included but not fully described):
-
ASTM F88/F88M-2015, Standard Test Method for Seal Strength of Flexible Barrier Materials.(Sterility)
-
ASTM F1929-2015 Standard Test Method for Detecting Seal Leaks in Porous Medical Package by Dye Penetration
-
ASTM F 2096-2011 (2019) Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)
- A ISO 1924-2:2008 Paper and board -- Determination of tensile properties.
- A ASTM F 2251-13 Standard Test Method for Thickness Measurement of Flexible Packaging Material
-
ISO 11140-1:2014 Sterilization of health care products. Chemical indicators. General requirements
-
ISO 10993-1: Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization
-
ISO 10993-12: Biological evaluation of medical devices Part 12: Sample preparation and reference materials
-
ISO 11135: 2014 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
-
DIN58953-6-2010 Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized.
-
ISO17665-1:2006 Sterilization of health care products-Moist heat-Part1: requirements for the development, validation and routine control of a sterilization process for medical devices.
11
8. Technological Characteristic Comparison Table
| ITEM | Subject Device | Predicate Device K221875 | Comparison
analysis |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FRG, JOJ | FRG, JOJ | same |
| Regulation No. | 21 CFR 880.6850 | 21 CFR 880.6850 | same |
| Class | II | II | same |
| Indication for Use | The Sterilization Pouches and Reels is intended to provide
health care workers with an effective method to enclosed
devices in a single or double pouch configuration by steam or
ethylene oxide sterilization. The recommended sterilization
cycle parameters are as follows:
a) Steam sterilization at 132°C (270°F) for 4 minutes;
Drying time of 20 minutes.
b) Ethylene Oxide (EO) with a concentration of 800 mg/L
at 55 °C (131 °F) and 40%-80% relative humidity for 6
hours. Aeration time of 7 days at 20℃ (68 °F).
The Sterilization Pouches and Reels is composed of medical
grade paper and medical compound film, maintains the sterility
of the enclosed devices for up to 12 months post Steam or EO
gas sterilization, and before sterilization has a maximum shelf
life of 5 years from the date of manufacture.
The pouch's external chemical indicators are designed to
indicate to the user that the pouch has undergone either a steam
or EO Sterilization process. Sterilization indicators will change
color according to the sterilization method (Steam, Ethylene
oxide). The color of steam sterilization indicator changes from
Pink before sterilization to Cocoa after sterilization. The color
of Ethylene oxide sterilization indicator changes from Blue
before sterilization to Golden Brown after sterilization.
The maximum validated pouch load is 1.87 lbs. (850g); The
maximum validated reel load is 1.87 lbs. (850 g) | The 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:
• Steam Sterilization at 132°C
(270°F) for 4 minutes; Drying time of 20 minutes.
• Ethylene Oxide (EO) with a concentration of 800 mg/L at
55°C (131 °F) and 40% to 90% relative humidity for 6 hours.
Aeration time of 7 days at 20℃).
The sterilization pouch and roll are made with medical grade
paper and medical compound film. The sterilization pouch and
roll maintains the sterility of the enclosed devices for up to 24
months post Steam or EO gas sterilization, and before
sterilization has a maximum shelf life of 5 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.
Sterilization indicator will change color according to the
sterilization method (ethylene oxide, steam). Ethylene oxide
sterilization indicator color change from Pink before
sterilization to Yellow after sterilization. The steam
sterilization indicator color change from Blue before
sterilization to Dark Grey after sterilization. | Same |
| | | | K242898 |
| Material Composition | Composed of medical grade paper and medical compound film
and printed with a chemical indicator bar that changed from
Pink to Cocoa (Steam) or Blue to Golden Brown (EO) when
exposed to Steam vapor or EO gas during process.
"Sterilization Pouches, flat, self seal" type contains tape. | Composed of medical grade paper, medical compound film,
EO and Steam Process Indicator. | Similar. The
Pouches with tape
were validated for
their effectiveness
and safety. The test
results show that
the pouches are as
effective and safe
as predicate device. |
| Sterilization
Cycles | Steam sterilization at 132°C (270°F) for 4 minutes; Drying time
of 20 minutes.
Ethylene Oxide (EO) with a concentration of 800 mg/L at 55 °C
(131 °F) and 40%-80% relative humidity for 6 hours. Aeration
time of 7 days at 20°C (68 °F). | Steam Sterilization at 132°C (270°F) for 4 minutes; Drying time
of 20 minutes.
Ethylene Oxide (EO) with a concentration of 800 mg/L at 55°C
(131 °F) and 40% to 90% relative humidity for 6 hours. Aeration
time of 7 days at 20°C. | same |
| Dimensions | Length of Pouches ranges from 2.75" to 25";
Width of Pouches ranges from 2.25" to 20";
Length of Reels ranges from 30.5m (=1200.78") to 200m
(=7874.01");
Width of Reels ranges from 2" to 20";
There are 72 sizes in total.
Please refer to table of Comparison of Dimension for detailed
information. | Length of Pouches ranges from 3.5" to 17";
Width of Pouches ranges from 2.25" to 12";
Length of Reels (or Rolls) ranges from 100m (=3937") to
200m (=7874.01");
Width of Reels ranges from 2" to 17.7"
There are 32 sizes in total.
Please refer to table of Comparison of Dimension for detailed
information. | Similar |
| Sterilant Penetration Efficiency | It meets the requirement of SAL10-6 | It meets the requirement of SAL10-6 | same |
| EO、ECH residue | Referring to ISO 10993-7:2008, EO 3.0 Kpa
Pass | same |
| Bubble Leak Test
ASTM F 2096-2011 (2019) | No Leakage
Pass | No Leakage
Pass | same |
| Seal Peel Test (N/15mm)
ASTM F88/F88M-2023 | Min value= 1.89
Pass | Min value= 2.10
Pass | same |
| Dye penetration Test ASTM
F1929-15 | No Infiltration
Pass | No Infiltration
Pass | same |
| Microbial
Barrier Test
DIN 58953-6-2016 | CFU = 0
Pass | CFU = 0
Pass | same |
| EO、ECH residue | Referring to ISO 10993-7:2008, EO