(230 days)
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 hour. 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 prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.
The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).
The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Steam: 4 minutes at 132°C (270°F); 20 minutes dry time.
Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or 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 also to maintain sterility of the enclosed devices until used up to 24 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator 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 EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
Based on the provided text, the device in question is a "Sterilization Pouch and Roll" and the document describes non-clinical performance testing rather than a study involving human subjects or AI algorithms. Therefore, many of the typical acceptance criteria and study design elements for AI/ML-based medical devices (like MRMC studies, expert adjudication for ground truth for training/test sets, effect sizes of human performance improvement with AI, etc.) are not applicable to this document.
The document discusses the physical and chemical performance of a sterilization packaging product. The studies described are bench testing and laboratory validation against established ISO and ASTM standards.
Here's the breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Methodology | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Sterilization Process Validation (EO) | ISO 11135:2014 | Ethylene oxide: 6 hours at 55 °C; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20°C. SAL=10-6 | SAL=10-6 (Pass) |
| Sterilization Process Validation (Steam) | ISO 17665-1:2006; ISO TS 17665-2:2009 | Steam: 8 minutes at 134°C; 8 minutes dry time. SAL=10-6 | SAL=10-6 (Pass) |
| EO/ECH Residuals | ISO 10993-7:2008 | EO < 4mg; ECH < 9mg | Pass |
| Biocompatibility Testing (Cytotoxicity) | ISO 10993-5:2009 | Non-cytotoxic | Under conditions of the study, did not show potential toxicity to L-929 cells. (Pass) |
| Biocompatibility Testing (Irritation) | ISO 10993-10:2010 | Non-irritating | Under the conditions of the study, not an irritant. (Pass) |
| Biocompatibility Testing (Sensitization) | ISO 10993-10:2010 | Non-sensitizing | Under conditions of the study, not a sensitizer. (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Film Thickness) | ASTM F 2251-13 | 52μm±12% | Pass (Specific value not given, but stated as meeting requirements and passing) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Burst Value) | ASTM F1140/F1140M-13 | Burst value > 3 Kpa or No Burst | Minimum of Burst pressure = 6.4 (kPa) (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Dye Penetration) | ASTM F1929-15 | The dye solution is no any leakage across the seal width of sterile barrier system. (No Infiltration) | No Infiltration (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Seal Strength) | ASTM F88/F88M-15 | Seal strength > 2.5 (N/15mm) | Minimum of Seal strength = 2.9 (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Tensile Strength) | ISO 1924-2:2008 | Tensile strength: CD ≥ 2.2KN/m, MD ≥ 4.4KN/m | Pass |
| Package Integrity / Material Compatibility / Sterility Maintenance (Aging - Shelf Life) | Real time aging | 5 years real time aging (Incubation for empty pouch); 24 months real time aging Incubation for post steam/EO sterilization storage | The test results of all samples meet the requirements. (Pass) (Real-time test for empty pouch: Jan. 08, 2017 to Jan. 28, 2022. Real-time test for exposed pouch: Jan. 08, 2020 to Jan. 20, 2022). |
| Package Integrity / Material Compatibility / Sterility Maintenance (Leakage) | ASTM F2096-11 | No Leakage | No Leakage (Pass) |
| Package Integrity / Material Compatibility / Sterility Maintenance (Microbial Barrier) | DIN 58953-6 | CFU = 0 | CFU = 0 (Pass) |
| Chemical Indicator Efficacy Testing (Steam) | ISO 11140-1:2014 | The color of CI changes from Blue to Dark Grey, when exposed to Steam; Change the color: Color of indicator changes from blue to dark grey after Steam sterilization. Should remain stable before use (5 years shelf life) and maintain endpoint stability (24 months post-sterilization). | Color of indicator changes from blue to dark grey under indicated condition and no changed under other condition. (Pass). (Empty pouch: Original color maintained Jan. 08, 2017 to Jan. 28, 2022. Exposed pouch: Dark Grey color maintained Jan. 08, 2020 to Jan. 20, 2022). |
| Chemical Indicator Efficacy Testing (EO) | ISO 11140-1:2014 | The color of CI changes from Pink to Yellow, when exposed to EO gas. Color of indicator changes from pink to yellow after EO sterilization. Should remain stable before use (5 years shelf life) and maintain endpoint stability (24 months post-sterilization). | Color of indicator changes from pink to yellow under indicated condition and no changed under other condition. (Pass). (Empty pouch: Original color maintained Jan. 08, 2017 to Jan. 28, 2022. Exposed pouch: Yellow color maintained Jan. 08, 2020 to Jan. 20, 2022). |
Since this is a non-clinical device (sterilization pouch), the following points are not applicable as they relate to clinical studies, AI/ML models, and human expert evaluations of diagnostic imaging.
- Sample size used for the test set and the data provenance: Not applicable. This refers to physical samples of the sterilization pouches and rolls tested in a laboratory setting, not a "test set" in the context of an AI/ML model. The provenance would be the manufacturing site (China) and the tests are prospective lab tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is established by physical measurements and compliance with international standards (ISO, ASTM), not by human expert opinion.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Ground truth is determined by standardized test methods.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI/ML diagnostic device for human interpretation.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth is based on the specified performance criteria defined by international standards (ISO, ASTM) and physical/chemical properties.
- The sample size for the training set: Not applicable. This device does not involve a training set for an algorithm.
- How the ground truth for the training set was established: Not applicable.
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Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China
Re: K221875
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: January 17, 2023 Received: January 17, 2023
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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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).
Sincerely,
Anne D. Talley -S for
Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K221875
Device Name Sterilization Pouch and Roll
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 hour. Aeration time of 7 days at 20℃).
The sterilization pouch and roll are made with 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.
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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The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).
| Model | Item | Specification Size (WXL) | Content/Max Load(lbs) | |||
|---|---|---|---|---|---|---|
| NO. | Inch | mm*mm | Metal | Plastic | Gauze/Linens | |
| P-001 | 2.25"x3.5" | 57x90 | 0.02 | 0.01 | 0.003 | |
| P-002 | 2.25"x4" | 57x100 | 0.03 | 0.02 | 0.004 | |
| P-003 | 2.25"x5" | 57x130 | 0.04 | 0.03 | 0.005 | |
| P-004 | 2.75"x10" | 70x260 | 0.09 | 0.08 | 0.07 | |
| P-005 | 3.5"x5.25" | 90x135 | 0.10 | 0.09 | 0.08 | |
| P-006 | 3.5"x6.5" | 90x165 | 0.12 | 0.11 | 0.1 | |
| P-007 | 3.5"x10" | 90x260 | 0.14 | 0.13 | 0.11 | |
| PLANE-01SterilizationPouch | P-008 | 51/3"x10" | 135x260 | 0.48 | 0.46 | 0.45 |
| P-009 | 51/3"x11 | 135x280 | 0.50 | 0.47 | 0.46 | |
| P-010 | 51/3"x13" | 135x330 | 0.55 | 0.53 | 0.50 | |
| P-011 | 7.5"x14" | 190x360 | 0.60 | 0.58 | 0.55 | |
| P-012 | 10"x14.5" | 250x370 | 1.06 | 1.05 | 0.62 | |
| P-013 | 10.25"x16" | 260x410 | 1.08 | 1.07 | 0.64 | |
| P-014 | 12"x17.7" | 300x450 | 1.10 | 1.09 | 0.66 | |
| ROLL-01SterilizationRoll | R-101 | 2" | 50mm×200m | 0.02 | 0.01 | 0.003 |
| R-102 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 | |
| R-103 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 | |
| R-104 | 6" | 150mm×200m | 0.55 | 0.53 | 0.50 | |
| R-105 | 8" | 200mm×200m | 0.60 | 0.58 | 0.55 | |
| R-106 | 10' | 250mm×200m | 1.06 | 1.05 | 0.62 | |
| R-107 | 12" | 300mm×200m | 0.60 | 0.58 | 0.55 | |
| R-108 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 | |
| R-109 | 16" | 400mm×200m | 1.08 | 1.07 | 0.64 | |
| R-110 | 17.7" | 450mm×200m | 1.10 | 1.09 | 0.66 | |
| R-111 | 20" | 500mm×200m | 1.10 | 1.09 | 0.66 | |
| GR-201 | 3" | 75mm×100m | 0.09 | 0.05 | 0.004 | |
| GR-202 | 4" | 100mm×100m | 0.14 | 0.13 | 0.11 | |
| GR-203 | 6" | 150mm×100m | 0.55 | 0.53 | 0.50 | |
| GR-204 | 8" | 200mm×100m | 0.60 | 0.58 | 0.55 | |
| GR-205 | 10" | 250mm×100m | 1.06 | 1.05 | 0.62 | |
| GR-206 | 12" | 300mm×100m | 0.60 | 0.58 | 0.55 | |
| GR-207 | 14" | 350mm×100m | 1.06 | 1.05 | 0.62 | |
| GR-208 | 16" | 400mm×100m | 1.08 | 1.07 | 0.64 |
(Model and Dimension and Content/Max. Load)
{4}------------------------------------------------
510(k) Summary K221875
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: | Qianjiang Kingphar Medical Packaging & Printing Co., Ltd. |
|---|---|
| Address: | Dongjing Road 23, Yuanlin Office, 433100 Qianjiang,PEOPLE'S REPUBLIC OF CHINA |
| Tel: | +86-13349816939 |
| Contact: | Zhao Fusong |
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: Feb.11,2023
2.0 Device Information
| Trade/Device name: | Sterilization Pouch and Roll |
|---|---|
| Common name: | Sterilization Pouch and Roll |
| Regulation Name: | 1) Sterilization Wrap;2) Sterilization process indicator |
| Classification Product Code: | 1) FRG; |
| Subsequent Product Code: | 2) JOJ |
| Regulation number: | 1) 21 CFR880.68502) 21 CFR880.2800 |
| Classification: | Class II |
| Panel: | General Hospital |
3.0 Predicate Device Information
Predicate Device:
{5}------------------------------------------------
| Manufacturer: | Sterileright Packaging Mfg., Inc |
|---|---|
| Trade/Device Name: | SterileRight Sterilization Pouch and Roll |
| 510(k) number: | K212338 |
Reference Device:
| Manufacturer: | Sigma Medical Supplies Corp. |
|---|---|
| Trade/Device Name: | SIGMA Sterilization Pouch and Roll |
| 510(k) number: | K180661 |
4.0 Device Description
The Sterilization pouch and roll is composed of medical grade paper(60g/m²) and medical compound film(52um), it is intended to be used to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Steam: 4 minutes at 132°C (270°F); 20 minutes dry time.
Ethylene oxide: 6 hours at 55 ℃; relative humidity between 40%- 90%; ethylene oxide concentration is 800 mg/L, 7 days aeration time at 20 ℃.
The medical devices are inserted into the Pouch/Roll, sealed, and then sterilized for the EtO or 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 also to maintain sterility of the enclosed devices until used up to 24 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark grey (Steam) when exposed to EtO gas or Steam vapor during process. The EtO and Steam Chemical Indicator 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 EtO and Steam Chemical Indicators do not signify sterilization; they only indicate that the indicator has been exposed to the EtO or Steam.
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 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 hour. Aeration time of 7 days at 20℃).
{6}------------------------------------------------
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 prink before sterilization to yellow after sterilization. The steam sterilization indicator color change from blue before sterilization to dark grey after sterilization.
The maximum validated pouch load is 1.1 lbs (0.5kg); The maximum validated roll load is 1.1 lbs (0.5kg).
| Model | ItemNo. | Specification Size (WXL) | Content/Max Load(lbs) | |||
|---|---|---|---|---|---|---|
| Inch | mm*mm | Metal | Plastic | Gauze/Linens | ||
| P-001 | 2.25"x3.5" | 57x90 | 0.02 | 0.01 | 0.003 | |
| P-002 | 2.25"x4" | 57x100 | 0.03 | 0.02 | 0.004 | |
| P-003 | 2.25"x5" | 57x130 | 0.04 | 0.03 | 0.005 | |
| P-004 | 2.75"x10" | 70x260 | 0.09 | 0.08 | 0.07 | |
| P-005 | 3.5"x5.25" | 90x135 | 0.10 | 0.09 | 0.08 | |
| P-006 | 3.5"x6.5" | 90x165 | 0.12 | 0.11 | 0.1 | |
| P-007 | 3.5"x10" | 90x260 | 0.14 | 0.13 | 0.11 | |
| PLANE-01SterilizationPouch | P-008 | 51/3"x10" | 135x260 | 0.48 | 0.46 | 0.45 |
| P-009 | 51/3"x11 | 135x280 | 0.50 | 0.47 | 0.46 | |
| P-010 | 51/3"x13" | 135x330 | 0.55 | 0.53 | 0.50 | |
| P-011 | 7.5"x14" | 190x360 | 0.60 | 0.58 | 0.55 | |
| P-012 | 10"x14.5" | 250x370 | 1.06 | 1.05 | 0.62 | |
| P-013 | 10.25"x16" | 260x410 | 1.08 | 1.07 | 0.64 | |
| P-014 | 12"x17.7" | 300x450 | 1.10 | 1.09 | 0.66 | |
| R-101 | 2" | 50mm×200m | 0.02 | 0.01 | 0.003 | |
| R-102 | 3" | 75mm×200m | 0.09 | 0.05 | 0.004 | |
| R-103 | 4" | 100mm×200m | 0.14 | 0.13 | 0.11 | |
| R-104 | 6" | 150mm×200m | 0.55 | 0.53 | 0.50 | |
| ROLL-01SterilizationRoll | R-105 | 8" | 200mm×200m | 0.60 | 0.58 | 0.55 |
| R-106 | 10' | 250mm×200m | 1.06 | 1.05 | 0.62 | |
| R-107 | 12" | 300mm×200m | 0.60 | 0.58 | 0.55 | |
| R-108 | 14" | 350mm×200m | 1.06 | 1.05 | 0.62 | |
| R-109 | 16" | 400mm×200m | 1.08 | 1.07 | 0.64 | |
| R-110 | 17.7" | 450mm×200m | 1.10 | 1.09 | 0.66 |
(Model and Dimension and Content/Max. Load)
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| R-111 | 20" | 500mm×200m | 1.10 | 1.09 | 0.66 |
|---|---|---|---|---|---|
| GR-201 | 3" | 75mm×100m | 0.09 | 0.05 | 0.004 |
| GR-202 | 4" | 100mm×100m | 0.14 | 0.13 | 0.11 |
| GR-203 | 6" | 150mm×100m | 0.55 | 0.53 | 0.50 |
| GR-204 | 8" | 200mm×100m | 0.60 | 0.58 | 0.55 |
| GR-205 | 10" | 250mm×100m | 1.06 | 1.05 | 0.62 |
| GR-206 | 12" | 300mm×100m | 0.60 | 0.58 | 0.55 |
| GR-207 | 14" | 350mm×100m | 1.06 | 1.05 | 0.62 |
| GR-208 | 16" | 400mm×100m | 1.08 | 1.07 | 0.64 |
6.0 Summary of Non-Clinical Testing
Summary of non-clinical and performance 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 | Results |
|---|---|---|---|
| SterilizationProcess Validation | ISO 11135:2014 | Ethylene oxide: 6 hours at 55 °C; relativehumidity between 40%- 90%;ethylene oxide concentrationis 800 mg/L, 7days aerationtime at 20°C.SAL=10-6 | SAL=10-6Pass |
| ISO 17665-1:2006;ISO TS 17665-2:2009 | Steam; 8 minutes at 134°C; 8minutes dry time.SAL=10-6 | SAL=10-6Pass | |
| EO/ECH Residuals | ISO 10993-7:2008 | EO < 4mgECH < 9mg | Pass |
| Biocompatibilitytesting | ISO 10993-5:2009 | Non-cytotoxic | Under conditions of thestudy, did not showpotential toxicity to L-929cells.Pass |
| ISO 10993-10:2010 | Non-irritating | Under the conditions ofthe study, not an irritant.Pass | |
| ISO 10993-10:2010 | Non-sensitizing | Under conditions of thestudy, not a sensitizer.Pass | |
| Package Integrity /MaterialCompatibility/SterilityMaintenance | ASTM F 2251-13ASTM F1140/F1140M-13 | 52μm±12%Burst value > 3 Kpa or No Burst | PassMinimum of Burst pressure = 6.4 (kPa)Pass |
| ASTM F1929-15 | The dye solution is no any leakage across the seal width of sterile barrier system.(No Infiltration) | No InfiltrationPass | |
| ASTM F88/F88M-15 | Seal strength > 2.5 (N/15mm) | Minimum of Seal strength = 2.9Pass | |
| ISO 1924-2:2008 | Tensile strength:CD $≧$ 2.2KN/m,MD $≧$ 4.4KN/m | Pass | |
| Real time aging | 5 years real time agingIncubation 24 months real time aging Incubation for post steam/EO sterilization storage | The test results of all samples are meet the requirements.Pass | |
| ASTM F2096-11 | No Leakage | No LeakagePass | |
| DIN 58953-6 | CFU = 0 | CFU = 0Pass | |
| Chemical IndicatorEfficacy Testing | ISO 11140-1:2014 Steam:The color of CI changes from Blue to Dark Grey, when exposed to Steam; | SteamChange the color:Color of indicator changes from blue to dark grey after Steam sterilization | Color of indicator changes from blue to dark grey under indicated condition and no changed under other condition.Pass |
| EO:The color of CI changes from Pink to Yellow, when exposed to EO gas. | EO gasColor of indicator changes from pink to yellow after EO sterilization | Color of indicator changes from pink to yellow under indicated condition and no changed under other condition.Pass | |
| 1. Remain stablebefore use based onits shelf life.2. Maintain theendpoint stability of thecolor change afterbeing in the presenceof the sterilant. | All performance attributesshould maintain the originalcolor : 5 years shelf life | The real-time test wascarried out from Jan. 08,2020 to Jan.20, 2022 thatdemonstrates: the testdevice which exposed toSteam maintain the colorof Dark Grey, the testgroup which exposed toEO maintain the color ofYellow, and the real-timetest was carried out onthe empty pouch thatdemonstrates the testdevice maintain theoriginal color from Jan.08, 2017 to Jan.28, 2022. |
Table 1: Performance testing summary – Bench
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7.0 Technological Characteristic Comparison Table
| Item | Subject Device | Predicate Device | Reference Device | ComparisonAnalysis |
|---|---|---|---|---|
| Product Name | Sterilization Pouch and Roll | SterileRight sterilization pouchand roll | SIGMA Sterilization Pouch andRoll | ---- |
| 510(k) No. | K221875 | K 212338 | K180661 | ---- |
| Product Code | FRG,JOJ | FRG,JOJ | FRG | Same |
| Regulation No. | 21 CFR 880.685021 CFR 880.2800 | 21 CFR 880.6850 | 21 CFR 880.6850 | Same |
| Class | II | II | II | Same |
| Intended Use | The Sterilization Pouch and Rollare intended to provide health careworkers with an effective methodto enclose devices intended forsterilization in the Steam or viaEthylene Oxide (EO). Therecommended sterilization cyclesare as follows:- Steam Sterilization at 132°C(270°F) for 4 minutes; Drying timeof 30 minutes.- Ethylene Oxide (EO) with a | The SterileRight SterilizationPouch and Roll are intended toprovide health care workerswith an effective method toenclose devices intended forsterilization in the Steam or viaEthylene Oxide (EO). Therecommended sterilization cyclesare as follows:- Gravity steam at 121°C (250°F)for 30 minutes; Drying time of 25minutes. | The SIGMA sterilization pouchand roll are intended to providehealth care workers with aneffective method to enclosedevices intended for sterilizationin steam auto claves and viaEthylene Oxide (EO). Therecommended steam sterilizationcycle parameters are 30 minutesat 121°C. The recommended EOsterilization cycle is 4 hours at55°C with a relative humidity | Similar |
Table 2- Comparison of Technology Characteristics
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| concentration of 800 mg/L at 55°C (131 ° F) and 40% to 90%relative humidity for 6 hour.Aeration time of 7 days at 20°C).The sterilization pouch and roll aremade with medical grade paperand medical compound film.Thesterilization pouch and rollmaintains the sterility of theenclosed devices for up to 24months post Steam or EO gassterilization, and beforesterilization has a maximum shelflife of 5 years from the date ofmanufacture.The pouch's external chemical inkindicators are designed to indicateto the user that the pouch hasundergone either a steam or EOsterilization process. Sterilizationindicator will change coloraccording to the sterilizationmethod (ethylene oxide, steam).Ethylene oxide sterilizationindicator color change from Prink | • Pre-vacuum steam at 132°C(270°F) for 4 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 8 hours at 60°C(140°F).The SterileRight providesterilization pouch and roll madewith Paper/Film or Tyvek® /Film.The SterileRight sterilizationpouch and roll which are madewith Paper maintains the sterilityof the enclosed devices for up to6 months post Steam or EO gassterilization, and beforesterilization has a maximum shelflife of 3 years from the date ofmanufacture. The pouch'sexternal chemical ink indicatorsare designed to indicate to theuser that the pouch hasundergone either a steam or EOsterilization process. | between 50%-85% and a sterilantconcentration of 600 mg/L.Furthermore, the sterilizationpouch and roll maintains theenclosed devices up until 3 yearspost EO gas sterilizationand maintains the encloseddevices up until 6 months postSteam sterilization. Lastly, thepouch's external chemical inkindicators are designed toindicate to the user that the pouchhas undergone either a steam orEO sterilization process.The SIGMA sterilization pouchand roll is offered in the following5 types:• Self-sealing sterilizationpouches• Sterilization pouches, Flat• Sterilization pouches,Gusseted•Sterilization rolls, Flat•Sterilization rolls, Gusseted |
|---|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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| before sterilization to Yellow after sterilization. The steamsterilization indicator color change from Blue before sterilization toDark Grey after sterilization. | The SterileRight sterilizationpouch and roll which are made with Tyvek® is for EO gassterilization only. It also maintains the sterility of the encloseddevices for up to 6 months post EO gas sterilization, andbefore sterilization has a maximum shelf life of 3 yearsfrom the date of manufacture. | |||
|---|---|---|---|---|
| MaterialComposition | Composed of medical grade paperand medical compound film, EOand Steam Process Indicator | Medical Grade Paper, CPP, PET,adhesive,EO and Steam ProcessIndicator, Print Ink.Tyvek®, PET, PE, adhesive. | Medical Grade Paper, CPP, PET,PU adhesive, EO and SteamProcess IndicatorPrint Ink | Same |
| SterilizationCycles | • Steam Sterilization at 132°C(270°F) for 4 minutes; Drying timeof 20 minutes.• Ethylene Oxide (EO) with aconcentration of 800 mg/L at 55°C (131 ° F) and 40% to 90%relative humidity for 6 hour.Aeration time of 7 days at 20°C). | • 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). | • Steam sterilization cycleparameters are 30 minutes at121°C.• EO sterilization cycle is 4hours at 55 °C with a relativehumidity between 50%-85%and a sterilant concentration of600 mg/L | Different |
| Configuration/Dimension | Various Size, Heat Sealing | Various Size, Heat Sealing andSelf Sealing | Various Size, Heat Sealing | Same |
| Performance Testing | ||||
| SterilantPenetrationEfficacy | The test meet the requirement ofSAL 10-6 | 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 Cl color change tothe endpoint color | The sterilant penetrated throughthe pouch configuration andaffected the CI color change to theendpoint color | The sterilant penetrated throughthe pouch configuration andaffected the Cl color change to theendpoint color | Same |
| Device Designof Steam CI | The color of Chemical Indicatorchanges from Blue todark grey, when exposed toSteam | The color of Chemical Indicatorchanges from Pink toBrown/Black, when exposed toSteam | The color of Chemical Indicatorchanges from Blue toGreenish Black, when exposed toSteam | Similar |
| Device Designof EO gas CI | The color of Chemical Indicatorchanges from Pink to Yellow,when exposed to Steam | The color changes from Blue toYellow/Brown, when exposed toEO gas | The color changes from - Red toYellow, when exposed to EO gas | Similar |
| ThicknessVariations (mm)ASTM F 2251 | Passed | Passed | Passed | Same |
| Tensile strengthISO 1924-2 | Passed | Passed | Passed | Same |
| Burst Strength(kPa)ASTM F1140 : | > 3.0 KpaPassed | Passed | Passed | Same |
| ISO 11607-1 | ||||
| Bubble LeakTestASTM D 3078or ASTM-F2096 | No LeakagePassed | Passed | Passed | Same |
| Seal Peel Test(N/15mm)ASTMF88/F88M ;ISO 11607-1 | Min value= 2.08Passed | Passed | Passed | Same |
| Dye penetrationTest ASTMF1929 ;ISO11607-1 | No InfiltrationPassed | Passed | Passed | Same |
| MicrobialBarrier TestDIN 58953-6 | CFU = 0Passed | Passed | Passed | Same |
| End pointstabilitytesting results | The color of chemical indicator forEO sterilization indicator ink isPink, and the color of chemicalindicator for steam sterilizationindicator ink is Blue after 5 yearshelf life before sterilization. | The color of chemical indicator forEO sterilization indicator ink isBlue, and the color of chemicalindicator for steam sterilizationindicator ink is Pink after 2year shelf life before sterilization. | The color of chemical indicator forEO sterilization indicator ink isRed, and the color of chemicalindicator for steam sterilizationindicator ink is Blue after 2 yearshelf life before sterilization. | Similar |
| The color of chemical indicator for | The color of chemical indicator for | The color of chemical indicator for | Similar | |
| EO sterilization indicator ink isYellow, and the color of chemicalindicator for steam sterilizationindicator ink is Blue after EOsterilized and 24 months shelf life. | EO sterilization indicator ink isYellow/Brown , and the color ofchemical indicator for steamsterilization indicator ink is Pinkafter EO sterilized and 6 monthsshelf life | EO sterilization indicator ink isyellow, and the color of chemicalindicator for steam sterilizationindicator ink is Blue after EOsterilized and 3 years shelf life | ||
| The color of chemical indicator forEO sterilization indicator ink isPink, and the color of chemicalindicator for steam sterilizationindicator ink is Dark Grey aftersteam sterilized and 24 monthsshelf life. | The color of chemical indicator forEO sterilization indicator ink isBlue, and the color of chemicalindicator for steam sterilizationindicator ink is Brown/Black aftersteam sterilized and 6 monthsshelf life. | The color of chemical indicator forEO sterilization indicator ink isRed, and the color of chemicalindicator for steam sterilizationindicator ink is Greenish Blackafter steam sterilized and 6months shelf life. | Similar | |
| Maintenance ofSterility | 24 months | 6 months | 3 years post EO gas sterilization6 months post Steam sterilization | Different |
| Shelf Life | 5 years from date of manufacturefor EO and Steam Indicators | 3 years from date of manufacturefor EO and Steam Indicators | 3 years from date of manufacturefor EO and Steam Indicators | Different |
| Biocompatibility | Conform with ISO10993-1(ISO10993-4, ISO10993-5,ISO10993-10, ISO10993-11) | Conform with ANSI/AAMI/ISO10993-10 | Conform with ISO 10993standards | Same |
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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 is different with those of the predicate device, but the EO sterilization 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. The subject device is confirmed to be substantial equivalence as the predicate device.
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).