(269 days)
Not Found
No.
The device description indicates that it is a physical product (sterilization pouches and rolls) used for packaging medical devices for sterilization. There is no mention of any computational or intelligent features that would suggest the presence of an AI model.
No.
Explanation: The device is a sterilization pouch/roll intended to enclose other medical devices for sterilization and maintain their sterility, not to provide therapy itself.
No
The device, a sterilization pouch and roll, is used to enclose medical devices for steam sterilization and maintain their sterility. While it includes a chemical indicator to show exposure to steam, this only verifies a physical process has occurred (steam exposure) and does not diagnose disease or medical conditions.
No
The device is a physical product (sterilization pouches and rolls) made of medical-grade paper and film, used for packaging medical devices for steam sterilization. It is not a software application.
No.
The device is a sterilization pouch/roll, a packaging intended to maintain the sterility of medical devices after sterilization. It is not used for in vitro examination of specimens. Its external chemical ink indicators are designed to indicate exposure to the sterilization process, not to provide diagnostic information about a disease or condition based on in vitro examination.
N/A
Intended Use / Indications for Use
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.
Product codes (comma separated list FDA assigned to the subject device)
FRG, JOJ
Device Description
The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.
(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.
The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.
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)
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.
Performance testing summary – Bench
Test Item: Sterilant penetration/drying time
Test Methodology: ISO 17665-1: 2006; ISO 17665-2: 2009
Acceptance Criteria or End Point: - Meets the requirement of SAL 10-6 - The weight difference before sterilization and after drying shall not exceed 3 %
Results: Pass
Biocompatibility testing
Test Item: Not specified
Test Methodology: ISO 10993-5:2009
Acceptance Criteria or End Point: Non-cytotoxic
Results: Under conditions of the study, did not show potential toxicity to L-929 cells. Pass
Test Item: Not specified
Test Methodology; ISO 10993-23:2021
Acceptance Criteria or End Point: Non-irritating
Results: Under the conditions of the study, not an irritant. Pass
Test Item: Not specified
Test Methodology: ISO 10993-10:2021
Acceptance Criteria or End Point: Non-sensitizing
Results: Under conditions of the study, not a sensitizer. Pass
Package Integrity / Material Compatibility /Sterility Maintenance
Test Item: Package appearance
Test Methodology: ASTM F 1886-16
Acceptance Criteria or End Point: The appearance of the sterilization pouch is clean, intact and sealed on all four sides.
Results: Pass
Test Item: Thickness
Test Methodology: ASTM F2251-13
Acceptance Criteria or End Point: 52±12%μm
Results: Pass
Test Item: Tensile strength of paper
Test Methodology: ISO 1924-2:2008
Acceptance Criteria or End Point: MD≥4.4 KN/m CD≥2.2 KN/m
Results: Pass
Test Item: Bursting test
Test Methodology: ASTM F1140/F1140M-13
Acceptance Criteria or End Point: Burst value > 3 Kpa or No Burst
Results: Pass
Test Item: Dye penetration test
Test Methodology: ASTM F1929-2023
Acceptance Criteria or End Point: The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration)
Results: Pass
Test Item: Seal strength test
Test Methodology: ASTM F88-2023
Acceptance Criteria or End Point: ≧2.5N/15mm
Results: Pass
Test Item: Vacuum leakage test
Test Methodology: ASTM D3078-02
Acceptance Criteria or End Point: No water can penetrate the sterilization pouch.
Results: Pass
Test Item: Microbial barrier
Test Methodology: DIN 58953-6
Acceptance Criteria or End Point: 0 CFU No growth
Results: Pass
Test Item: Chemical Indicator Testing
Test Methodology: ISO 11140-1:2014
Acceptance Criteria or End Point: Color of indicator changes from blue to dark grey after Steam sterilization
Results: Pass
Test Item: Chemical Indicator Testing
Test Methodology: ISO 11140-1:2014
Acceptance Criteria or End Point: Shelf life: 3 months Endpoint stability: 3 months
Results: Pass
Test Item: Shelf life
Test Methodology: ASTM F1980-21
Acceptance Criteria or End Point: Shelf life: 3 months
Results: Pass
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.6850 Sterilization wrap.
(a)
Identification. A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - Sterilization Pouch and Roll
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 26, 2025
Yichang Xinxin Paper Products Co., Ltd.
℅ Boyle Wang
Manager
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong
Shanghai, 200120
China
Re: K243179
Trade/Device Name: Sterilization Pouch and Roll
Regulation Number: 21 CFR 880.6850
Regulation Name: Sterilization wrap
Regulatory Class: Class II
Product Code: FRG, JOJ
Dated: May 20, 2025
Received: May 20, 2025
Dear Boyle Wang:
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.
Page 2
K243179 - Boyle Wang Page 2
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" (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 QS 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243179 - Boyle Wang Page 3
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Christopher K. Dugard -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243179
Device Name: Sterilization Pouch and Roll
Indications for Use (Describe)
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.
Table of Maximum Load
| Item | Size (W) | Size (L) | Content / Max Load (lbs) |
|---|---|---|---|
| PZF-001, PZF-002, PZF-003, PZF-004, PZF-005, PZF-006, PZF-007, PZF-008, PRF-002, PRF-003 | Minimum: 55mm | Minimum: 70mm | Metal: 0.02 |
| Maximum: 90mm | Maximum: 280mm | Plastic: 0.01 | |
| PZF-009, PZF-010, PZF-011, PZF-012, PZF-013, PZF-014, PZF-015, PZF-016, PZF-017, PZF-018, PZF-019, PRF-001, PRF-004, PRF-005, PRF-006, PRF-007, PRF-008, PRF-009 | Minimum: 57mm | Minimum: 183mm | Metal: 0.27 |
| Maximum: 300mm | Maximum: 610mm | Plastic: 0.23 | |
| PZF-020, PZF-021, PZF-022, PZF-023, PZF-024, PRF-010 | Minimum: 300mm | Minimum: 483mm | Metal: 2.92 |
| Maximum: 460mm | Maximum: 635mm | Plastic: 1.13 | |
| PRF-011 | 400mm | 580mm | Metal: 3.38 |
| PRF-012 | 420mm | 600mm | Plastic: 1.13 |
| PRFJ-001, PRFJ-002, PRFJ-003, PRFJ-004, PRFJ-005, PRFJ-006 | Minimum: 55mm | 30M | Metal: 0.02 |
| Maximum: 180mm | Plastic: 0.01 | ||
| PRFJ-007, PRFJ-008, PRFJ-009, PRFJ-010 | Minimum: 200mm | 30M | Metal: 1.13 |
| Maximum: 350mm | Plastic: 0.86 | ||
| PRFJ-011 | 400mm | 30M | Metal: 6.24 |
| Plastic: 2.99 |
Page 5
| Item | Size (W) | Size (H) | Size (L) | Content / Max Load (lbs) |
|---|---|---|---|---|
| LRF-001 | 100mm | 40mm | 300mm | Metal: 0.21 |
| LRF-002 | 150mm | 50mm | 400mm | Plastic: 0.05 |
| LRF-003 | 150mm | 50mm | 400mm | Metal: 1.18 |
| LRF-004 | 200mm | 50mm | 480mm | Plastic: 0.87 |
| LRF-005 | 300mm | 70mm | 500mm | Metal: 3.78 |
| Plastic: 1.82 | ||||
| LRFJ-001, LRFJ-002 | Minimum: 75mm | Minimum: 35mm | 100M | Metal: 0.12 |
| LRFJ-003 | Maximum: 150mm | Maximum: 50mm | 100M | Plastic: 0.02 |
| LRFJ-004, LRFJ-005, LRFJ-006, LRFJ-007 | Minimum: 200mm | Minimum: 50mm | 100M | Metal: 1.68 |
| LRFJ-008 | Maximum: 350mm | Maximum: 80mm | 100M | Plastic: 0.87 |
| 400mm | 80mm | 100M | Metal: 3.67 | |
| Plastic: 3.00 |
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 6
510(k) Summary
K243179
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: Yichang Xinxin Paper Products Co., Ltd.
Address: No. 308, Jianghan Avenue, Majiadian Street, Zhijiang City, Yichang City, Hubei Province, 443200, China.
Tel: +86 18086241888
Contact: Peng Xiao
Designated Submission Correspondent
Contact: Mr. Boyle Wang
Name: Shanghai Truthful Information Technology Co., Ltd.
Address: Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai, 200120, China.
Tel: +86-21-50313932
Email: Info@truthful.com.cn
Date Submitted: June 23, 2025
2.0 Device Information
Trade/Device name: Sterilization Pouch and Roll
Common name: Sterilization Pouch and Roll
Classification name: 1) Wrap, Sterilization
2) Indicator, Physical/Chemical Sterilization Process
Classification Product Code: 1) FRG
Subsequent Product Code: 2) JOJ
Regulation number: 1) 21 CFR880.6850
2) 21 CFR880.2800
Classification: Class II
Panel: General Hospital
3.0 Predicate Device Information
Predicate Device:
Manufacturer: Sigma Medical Supplies Corp.
Trade/Device Name: SIGMA Sterilization Pouch and Roll
Page 7
510(k) number: K180661
4.0 Device Description
The subject Sterilization Pouch and Roll device has five types:
(1) Self-sealing sterilization pouches:
These pouches are made from a medical grade plastic film that is heat sealed on three sides. The fourth side has an adhesive strip that is used to seal the pouch. Release paper used in the pouch is a laminated sheet with composing structure of PE/paper/PE. It is a strip to cover the adhesive area and is released before seal the pouch. The medical grade paper conforms to recognized material standards and can be sterilized by steam. The Process Indicators Ink printed on the medical grade paper will exhibit a color change after the pouch is exposed to steam.
(2) Sterilization pouches, Flat:
These pouches have the same components with the Self-sealing sterilization pouches, except the fourth side is left opened instead of an adhesive strip and will be heat-sealed when using.
(3) Sterilization pouches, Gusseted:
These pouches are the same with the Sterilization pouches, flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
(4) Sterilization rolls, Flat:
These rolls are made from a medical grade paper and plastic film that are heat sealed on opposite two sides. It will be cut into the suitable length and the opened sides will be heat-sealed. The indicators printed on the medical grade paper are the same with the self-sealing sterilization pouches.
(5) Sterilization rolls, Gusseted:
These rolls are the same with the flat sterilization roll, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
The Sterilization pouch and roll is composed of medical grade paper (60g/m2) and medical compound film (52μm), it is intended to be used to contain medical devices to be terminally sterilized by the Steam sterilization process. The recommended sterilization cycle parameters are:
Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the Steam Sterilization Process. The heat-sealed pouch/roll are heat sealed prior to sterilization processing. After completion of the sterilization process, the
Page 8
Pouch/Roll maintain sterility of the enclosed medical devices until the seal is opened.
The device is intended to allow sterilization of enclosed devices and to maintain sterility of the enclosed devices until used up to 6 months post sterilization. The shelf life of the device is 3 months.
The Pouch/Roll is printed with a chemical indicator bar that changes from Blue to Dark grey when exposed to steam during the sterilization process. The steam chemical Indicator offers an addition way to verity processing in the sterilization cycle. The endpoint stability of the chemical indicator color change to dark grey is 3 months. The chemical Indicator should be used in addition to, not in place of, the biological indicator. The steam chemical indicator does not signify sterilization; it only indicates that the indicator has been exposed to steam.
The following table (Table 1~5) lists the model numbers of the sterilization pouch and roll by model, dimensions, and content/max. load (lbs.):
Table 1-The Model of Self-sealing sterilization pouches
| Item | Specification Size (W x L) | Primary Package Dimension | Content / Max Load (lbs) |
|---|---|---|---|
| No. | Inch | mm | mm |
| PZF-001 | 2.24"X2.76" | 57mmX70mm | 62X55X75 |
| PZF-002 | 2.17"X3.94" | 55mmX100mm | 60X55X105 |
| PZF-003 | 2.26"X5.12" | 57.5mmX130mm | 62X55X135 |
| PZF-004 | 2.26"X5.31" | 57.5mmX135mm | 62X55X140 |
| PZF-005 | 2.76"X10.24" | 70mmX260mm | 75X50X265 |
| PZF-006 | 3.54"X5.31" | 90mmX135mm | 95X50X140 |
| PZF-007 | 3.54"X6.5" | 90mmX165mm | 95X50X170 |
| PZF-008 | 3.54"X10.24" | 90mmX260mm | 95X50X265 |
| PZF-008 | 3.54"X12.36" | 90mmX314mm | 95X50X314 |
| PZF-010 | 5.31"X10.04" | 135mmX255mm | 140X50X260 |
| PZF-011 | 5.31"X7.2" | 135mmX183mm | 140X50X188 |
| PZF-012 | 5.31"X11.02" | 135mmX280mm | 140X50X285 |
Page 9
| Plastic: 0.23 | ||||
|---|---|---|---|---|
| PZF-013 | 5.31"X11.61" | 135mmX295mm | 140X50X300 | Metal: 0.27, Plastic: 0.23 |
| PZF-014 | 5.31"X13.19" | 135mmX335mm | 140X50X340 | Metal: 0.27, Plastic: 0.23 |
| PZF-015 | 5.91"X24.02" | 150mmX610mm | 155X50X615 | Metal: 0.27, Plastic: 0.23 |
| PZF-016 | 5.91"X14.17" | 150mmX360mm | 155X50X365 | Metal: 0.27, Plastic: 0.23 |
| PZF-017 | 7.87"X17.13" | 200mmX435mm | 205X50X440 | Metal: 0.27, Plastic: 0.23 |
| PZF-018 | 9.84"X15.55" | 250mmX395mm | 255X50X400 | Metal: 0.27, Plastic: 0.23 |
| PZF-019 | 11.81"X14.96" | 300mmX380mm | 305X50X385 | Metal: 0.27, Plastic: 0.23 |
| PZF-020 | 11.81"X19.49" | 300mmX495mm | 305X50X500 | Metal: 2.92, Plastic: 1.13 |
| PZF-021 | 14.02"X19.02" | 356mmX483mm | 360X50X488 | Metal: 2.92, Plastic: 1.13 |
| PZF-022 | 14.96"X25.0" | 380mmX635mm | 385X50X640 | Metal: 2.92, Plastic: 1.13 |
| PZF-023 | 15.35"X19.69" | 390mmX500mm | 395X50X505 | Metal: 2.92, Plastic: 1.13 |
| PZF-024 | 18.11"X24.02" | 460mmX610mm | 465X50X610 | Metal: 2.92, Plastic: 1.13 |
Table 2-The Model of Sterilization pouches, Flat
| Item | Specification Size (W x L) | Primary Package Dimension | Content / Max Load (lbs) |
|---|---|---|---|
| No. | Inch | mm | mm |
| PRF-001 | 2.24"X22.83" | 57mmX580mm | 62X55X585 |
| PRF-002 | 1.95"X7.87" | 75mmX200mm | 80X55X205 |
| PRF-003 | 1.95"X11.02" | 75mmX280mm | 80X55X285 |
| PRF-004 | 3.94"X16.54" | 100mmX420mm | 105X50X425 |
| PRF-005 | 5.91"X7.87" | 150mmX200mm | 155X50X205 |
| PRF-006 | 5.94"X11.81" | 150mmX300mm | 155X50X305 |
| PRF-007 | 5.94"X21.65" | 150mmX550mm | 155X50X555 |
Page 10
| Plastic: 0.23 | ||||
|---|---|---|---|---|
| PRF-008 | 7.87"X16.54" | 200mmX420mm | 205X50X425 | Metal: 0.27, Plastic: 0.23 |
| PRF-009 | 9.84"X14.17" | 250mmX360mm | 255X50X360 | Metal: 0.27, Plastic: 0.23 |
| PRF-010 | 11.81"X20.08" | 300mmX510mm | 305X50X515 | Metal: 2.92, Plastic: 1.13 |
| PRF-011 | 15.75"X22.83" | 400mmX580mm | 405X50X585 | Metal: 3.38, Plastic: 1.13 |
| PRF-012 | 16.54"X23.62" | 420mmX600mm | 425X50X605 | Metal: 3.38, Plastic: 1.13 |
Table 3-The Model of Sterilization pouches, Gusseted
| Item | Specification Size (W x L) | Primary Package Dimension | Content / Max Load (lbs) |
|---|---|---|---|
| No. | Inch | mm | mm |
| LRF-001 | 3.94"X1.57"X11.81" | 100mmX40mmX300mm | 105X90X305 |
| LRF-002 | 5.91"X1.97"X15.75" | 150mmX50mmX400mm | 155X100X405 |
| LRF-003 | 7.87"X1.97"X15.75" | 200mmX50mmX400mm | 205X100X405 |
| LRF-004 | 9.84"X2.36"X18.9" | 250mmX60mmX480mm | 255X110X485 |
| LRF-005 | 11.81"X2.76"X19.69" | 300mmX70mmX500mm | 305X120X505 |
Table 4-The Model of Sterilization rolls, Flat
| Item | Specification Size (W x L) | Primary Package Dimension | Content / Max Load (lbs) |
|---|---|---|---|
| No. | Inch | mm & M | mm |
| PRFJ-001 | 2.17"X118.11" | 55mmX30M | 110X11.5X11.5 |
| PRFJ-002 | 2.95"X118.11" | 75mmX30M | 150X11.5X11.5 |
| PRFJ-003 | 3.94"X118.11" | 100mmX30M | 200X11.5X11.5 |
| PRFJ-004 | 5.0"X118.11" | 127mmX30M | 250X11.5X11.5 |
| PRFJ-005 | 5.9"X118.11" | 150mmX30M | 200X11.5X11.5 |
| PRFJ-006 | 7.09"X118.11" | 180mmX30M | 250X11.5X11.5 |
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| PRFJ-007 | 7.87"X118.11" | 200mmX30M | 200X11.5X11.5 | Metal: 1.13, Plastic: 0.86 |
|---|---|---|---|---|
| PRFJ-008 | 9.84"X118.11" | 250mmX30M | 250X11.5X11.5 | Metal: 1.13, Plastic: 0.86 |
| PRFJ-009 | 11.81"X118.11" | 300mmX30M | 300X11.5X11.5 | Metal: 1.13, Plastic: 0.86 |
| PRFJ-010 | 13.78"X118.11" | 350mmX30M | 350X11.5X11.5 | Metal: 1.13, Plastic: 0.86 |
| PRFJ-011 | 15.75"X118.11" | 400mmX30M | 400X11.5X11.5 | Metal: 6.24, Plastic: 2.99 |
Table 5-The Model of Sterilization rolls, Gusseted
| Item | Specification Size (W x L) | Primary Package Dimension | Content / Max Load (lbs) |
|---|---|---|---|
| No. | Inch | mm & M | mm |
| LRFJ-001 | 2.95"X1.38"X393.7" | 75mmX35mmX100M | 383X383X77.5 |
| LRFJ-002 | 3.94"X1.57"X393.7" | 100mmX40mmX100M | 383X383X102.5 |
| LRFJ-003 | 5.91"X1.97"X393.7" | 150mmX50mmX100M | 383X383X152.5 |
| LRFJ-004 | 7.87"X1.97"X393.7" | 200mmX50mmX100M | 383X383X202.5 |
| LRFJ-005 | 9.84"X2.36"X393.7" | 250mmX60mmX100M | 383X383X127.5 |
| LRFJ-006 | 11.81"X2.76"X393.7" | 300mmX70mmX100M | 383X383X152.5 |
| LRFJ-007 | 13.78"X3.15"X393.7" | 350mmX80mmX100M | 383X383X177.5 |
| LRFJ-008 | 15.75"X3.15"X393.7" | 400mmX80mmX100M | 383X383X202.5 |
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5.0 Indication for Use Statement
The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows:
• Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time.
The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization.
Table of Maximum Load:
| Item | Size (W) | Size (L) | Content / Max Load (lbs) |
|---|---|---|---|
| PZF-001, PZF-002, PZF-003, PZF-004, PZF-005, PZF-006, PZF-007, PZF-008, PRF-002, PRF-003 | Minimum: 55mm | Minimum: 70mm | Metal: 0.02 |
| Maximum: 90mm | Maximum: 280mm | Plastic: 0.01 | |
| PZF-009, PZF-010, PZF-011, PZF-012, PZF-013, PZF-014, PZF-015, PZF-016, PZF-017, PZF-018, PZF-019, PRF-001, PRF-004, PRF-005, PRF-006, PRF-007, PRF-008, PRF-009 | Minimum: 57mm | Minimum: 183mm | Metal: 0.27 |
| Maximum: 300mm | Maximum: 610mm | Plastic: 0.23 | |
| PZF-020, PZF-021, PZF-022, PZF-023, PZF-024, PRF-010 | Minimum: 300mm | Minimum: 483mm | Metal: 2.92 |
| Maximum: 460mm | Maximum: 635mm | Plastic: 1.13 | |
| PRF-011 | 400mm | 580mm | Metal: 3.38 |
| PRF-012 | 420mm | 600mm | Plastic: 1.13 |
| PRFJ-001, PRFJ-002, PRFJ-003, PRFJ-004, PRFJ-005, PRFJ-006 | Minimum: 55mm | 30M | Metal: 0.02 |
| Maximum: 180mm | Plastic: 0.01 | ||
| PRFJ-007, PRFJ-008, PRFJ-009, PRFJ-010 | Minimum: 200mm | 30M | Metal: 1.13 |
| Maximum: 350mm | Plastic: 0.86 | ||
| PRFJ-011 | 400mm | 30M | Metal: 6.24 |
| Plastic: 2.99 |
Page 13
6.0 Technological Characteristic Comparison Table
Table 2- Comparison of Technology Characteristics
| Item | Subject Device | Predicate Device | Comparison Analysis |
|---|---|---|---|
| Product Name | Sterilization Pouch and Roll | SIGMA Sterilization Pouch and Roll | ---- |
| 510(k) No. | K243179 | K180661 | ---- |
| Product Code | FRG, JOJ | FRG, JOJ | Same |
| Regulation No. | 21 CFR 880.6850, 21 CFR 880.2800 | 21 CFR 880.6850, 21 CFR 880.2800 | Same |
| Class | II | II | Same |
| Intended Use | The Sterilization Pouch and Roll are intended to provide health care workers with an effective method to enclose devices intended for steam sterilization. The recommended sterilization cycle is as follows: • Pre-vacuum Steam: 4 minutes at 132°C (270°F); 30 minutes dry time. The sterilization pouch and roll are made with medical grade paper and medical compound film. The sterilization pouch and roll maintain the sterility of the enclosed devices for up to 6 months post steam sterilization. The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone a steam sterilization process. The steam sterilization indicator color will change from blue before sterilization to dark grey after sterilization. | The SIGMA sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam autoclaves and via Ethylene Oxide (EO). The recommended steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintain the enclosed devices up until 3 years 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 pouch has undergone either a steam or EO sterilization process. | Similar |
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| Item | Subject Device (K243179) | Predicate Device (K180661) | Comparison Analysis |
|---|---|---|---|
| Material Composition | Medical Grade Paper, CPP, PET, PU adhesive, Steam Process Indicator Print Ink | Medical Grade Paper, CPP, PET, PU adhesive, EO and Steam Process Indicator Print Ink | Same |
| Sterilization Cycles | • Pre-vacuum steam: 4 minutes at 132°C (270°F); 30 minutes dry time. | • Steam sterilization cycle parameters are 30 minutes at 121℃. • EO sterilization cycle is 4 hours at 55 ℃ with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. | Similar |
| Types | Self-sealing sterilization pouches, Sterilization pouches, Flat Sterilization pouches, Gusseted, Sterilization rolls, Flat Sterilization rolls, Gusseted | Self-sealing sterilization pouches Sterilization pouches, Flat Sterilization pouches, Gusseted Sterilization rolls, Flat Sterilization rolls, Gusseted | Same |
| Configuration/Dimensions | Various Sizes, Heat Sealing | Various Sizes, Heat Sealing | Similar |
| Sterilant Penetration Efficacy | The test meets the requirement of SAL 10-6 | The tests meet the requirement of SAL 10-6 | Same |
| Chemical Indicator (CI) Functionality and Endpoint | The sterilant penetrated through the pouch configuration and affected the CI color change to the endpoint color. | The sterilant penetrated through the pouch configuration and affected the CI color change to the endpoint color. | Same |
| Device Design of CI | The color of Chemical Indicator changes from Blue to dark grey, when exposed to Steam. | The color of Chemical Indicator changes from Blue to Greenish Black, when exposed to Steam. | Similar |
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| Item | Subject Device (K243179) | Predicate Device (K180661) | Comparison Analysis |
|---|---|---|---|
| Thickness Variations (mm) ASTM F2251 | Passed | Passed | Same |
| Tensile strength ISO 1924-2 | Passed | Passed | Same |
| Burst Strength (kPa) ASTM F1140; ISO 11607-1 | > 3.0 Kpa Passed | Passed | Same |
| Bubble Leak Test ASTM D3078-02(2013) | No Leakage Passed | Passed | Same |
| Seal Peel Test (N/15mm) ASTM F88/F88M; ISO 11607-1 | Min value= 2.08 Passed | Passed | Same |
| Dye penetration Test ASTM F1929; ISO 11607-1 | No Infiltration Passed | Passed | Same |
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| Item | Subject Device (K243179) | Predicate Device (K180661) | Comparison Analysis |
|---|---|---|---|
| Microbial Barrier Test DIN 58953-6 | Passed | Passed | Same |
| End point stability testing results | The color of chemical indicator is blue after 3 months before sterilization. | The color of chemical indicator for EO sterilization indicator ink is Red, and the color of chemical indicator for steam sterilization indicator ink is Blue after 2-year shelf life before sterilization. | Similar |
| The color of the chemical indicator is dark grey after 3 months post sterilization. | The color of chemical indicator for EO sterilization indicator ink is yellow, and the color of chemical indicator for steam sterilization indicator ink is Blue after EO sterilized and 3 years shelf life | Similar | |
| Maintenance of Sterility | 6 months | 3 years post EO gas sterilization 6 months post Steam sterilization | Different |
| Shelf Life | 3 months from date of manufacture | 3 years from date of manufacture for EO and Steam Indicators | Different |
| Biocompatibility | Conform with ISO 10993-1, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-11. | Conform with ISO 10993 standards | Same |
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
• Similar steam sterilization method
• Same fundamental technology/principal of operation/user interface
• The sterilization parameters of the subject device are different than those of the predicate device, but the steam sterilization validation results fully meet the requirements of ISO 17665-1.
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7.0 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.
Table 3: Performance testing summary – Bench
| Test Item | Test Methodology | Acceptance Criteria or End Point | Results |
|---|---|---|---|
| Sterilant penetration/drying time | ISO 17665-1: 2006; ISO 17665-2: 2009 | - Meets the requirement of SAL 10-6 - The weight difference before sterilization and after drying shall not exceed 3 % | Pass |
| Biocompatibility testing | |||
| ISO 10993-5:2009 | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. Pass | |
| ISO 10993-23:2021 | Non-irritating | Under the conditions of the study, not an irritant. Pass | |
| ISO 10993-10:2021 | Non-sensitizing | Under conditions of the study, not a sensitizer. Pass |
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| Test Item | Test Methodology | Acceptance Criteria or End Point | Results |
|---|---|---|---|
| Package Integrity / Material Compatibility /Sterility Maintenance | |||
| Package appearance | ASTM F 1886-16 | The appearance of the sterilization pouch is clean, intact and sealed on all four sides. | Pass |
| Thickness | ASTM F2251-13 | 52±12%μm | Pass |
| Tensile strength of paper | ISO 1924-2:2008 | MD≥4.4 KN/m CD≥2.2 KN/m | Pass |
| Bursting test | ASTM F1140/F1140M-13 | Burst value > 3 Kpa or No Burst | Pass |
| Dye penetration test | ASTM F1929-2023 | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | Pass |
| Seal strength test | ASTM F88-2023 | ≧2.5N/15mm | Pass |
| Vacuum leakage test | ASTM D3078-02 | No water can penetrate the sterilization pouch. | Pass |
| Microbial barrier | DIN 58953-6 | 0 CFU No growth | Pass |
| Chemical Indicator Testing | ISO 11140-1:2014 | Color of indicator changes from blue to dark grey after Steam sterilization | Pass |
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| Test Item | Test Methodology | Acceptance Criteria or End Point | Results |
|---|---|---|---|
| Chemical Indicator Testing | ISO 11140-1:2014 | Shelf life: 3 months Endpoint stability: 3 months | Pass |
| Shelf life | ASTM F1980-21 | Shelf life: 3 months | Pass |
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 subject device is as safe, as effective, and performs as well as the legally marketed predicated device, K180661.
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