(423 days)
The Sterilization Pouch Flat are intended to be used to enclose another medical devices 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. The Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470 g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Pouch Gusseted
The Sterilization Pouch Gusseted are intended to be used to enclose another medical devices 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 sterlity of the enclosed device until used. The Sterilization Pouch Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Flat
The Sterilization Roll Flat are intended to be used to enclose another medical devices 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.
The Sterilization Roll Flat are intended for sterilization of dental instruments, excluding complex devices and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Gusseted
The Sterilization Roll Gusseted are intended to be used to enclose another medical devices 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 sterlity of the enclosed device until used. The Sterilization Roll Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
The Paper Sterilization Pouch and Roll is intended to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Steam; 30 minutes at 121°C; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.
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 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Red/Pink to Yellow/Brown (EtO) or Blue to Brown/Black (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.
The Paper Sterilization Pouch and Roll is offered in the follow 4 types:
- Sterilization Pouch Flat;
- Sterilization Pouch Gusseted;
- Sterilization Pouch Roll Flat;
- Sterilization Pouch Roll Gusseted.
The defining characteristics of the 4 types as follows:
Sterilization Pouch Flat: These pouches are made from a medical grade paper and plastic (CPP/PET) film that is heat sealed on three sides, the forth side is left opened and will be heat-sealed when using. The Process Indicators Ink printed on the Pouch will exhibit a color change after the pouch is exposed to EtO gas or Steam.
Sterilization Pouch Gusseted: These rolls are the same as the Sterilization Pouch Flat, with the Heat Sealing 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.
Sterilization Roll Flat: These rolls are made from a medical grade paper and plastic (CPP/PET) 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 it are the same as the sterilization pouches.
Sterilization Roll 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 medical device in question is a Paper Sterilization Pouch and Roll. The K182184 submission includes non-clinical testing to demonstrate that the device meets its acceptance criteria. No clinical studies were included in this submission.
1. Table of Acceptance Criteria and Reported Device Performance:
| Testing Name | Acceptance Criteria OR End Point | Test Results |
|---|---|---|
| Tensile strength | ≥4.4 KN/m | The test results of all samples are ≥4.4 KN/m. Pass |
| Thickness | 138±13 µm | The test results of all samples are in the range of 138±13 µm. Pass |
| Tear Strength | ≥ 550 mN/15mm | The test results of all samples are ≥ 550 mN/15mm. Pass |
| Air permeability coefficient | ≥3.4µm/Pa.s | The test results of all samples are ≥3.4µm/Pa.s. Pass |
| Burst Strength | ≥2.0 kPa | The test results of all samples are ≥2.0 kPa. Pass |
| Microorganism Penetration | Microbial Barrier LRV ≥ 2.0 Retention Rate (spore%) ≥ 99.0% | The Microbial Barrier LRV test results of all samples are ≥2.0. The Retention Rate test results of all samples are ≥99.0%. Pass |
| Chemical Indicator Performance | For EtO sterilization indicator ink: Color changed from Red/Pink to Golden Yellow/Brown at the condition of 4 hours at 55 °C; relative humidity between 50%-85%; ethylene oxide concentration is 600 mg/L.For Steam sterilization indicator ink: Color changed from Blue to Brown/Black at the condition of Gravity Steam, 121°C, 30 mins. | For EtO sterilization indicator ink: Color changed from Red/Pink to Golden Yellow/Brown under indicated condition and no changed under other condition. PassFor Steam sterilization indicator ink: Color changed from Blue to Brown/Black under indicated condition and no changed under other condition. Pass |
| Dye penetration | No dye leakage | No dye leakage/Pass |
| Seal strength | ≥1.5 N/15 mm | The test results of all samples are ≥1.5 N/15 mm. Pass |
| EO residue | No more than 4 mg per set | The test results of all samples are no more than 4 mg per set. Pass |
| ECH residue | No more than 9 mg per set | The test results of all samples are no more than 9 mg per set. Pass |
| In Vitro Cytotoxicity | In Vitro Cytotoxicity | Under the conditions of the study, the test article (pouches and chemical indicator) extract did not show potential toxicity to L-929 cells before and after sterilized. |
| Skin Irritation AND Skin Sensitization | Skin sensitization | Under the conditions of the study, the test article (pouches and chemical indicator) extract did not show no significant evidence of causing skin sensitization in the guinea pig before and after sterilized. |
| Skin Irritation | Under the conditions of the study, the test article (pouches and chemical indicator) extract did not induce intracutaneous reactivity in rabbit before and after sterilized. | |
| Shelf Life Validation | Shelf Life: 2 YearsShelf Life after Sterilized: 6 MonthsThe performance shall meet the requirements of: Tensile strength: ≥4.4 KN/m; Thickness: 138±13 µm; Tear Strength: ≥ 550 mN/15mm; Air permeability coefficient: ≥3.4µm/Pa.s; Burst Strength: ≥2.0 kPa; Microbial Barrier LRV ≥ 2.0; Retention Rate (spore%) ≥ 99.0%; Dye penetration: No dye leakage; Seal strength: ≥1.5 N/15 mm; Color of indicator shall be meet the specification. | The test results of all samples meet the requirements. Pass |
| Sterilization Process Validation | Ethylene oxide: 4 hours at 55 °C; relative humidity between 50%-85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°C. SAL= $10^{-6}$.Steam: 30 minutes at 121 °C; 25 minutes dry time. SAL= $10^{-6}$. | For EO: SAL= $10^{-6}$. PassFor Steam: SAL= $10^{-6}$. Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state generalized "sample sizes" for the test sets. Instead, it refers to "all samples" for each specific test, indicating that a sufficient number of units were tested to demonstrate compliance with the acceptance criteria for each non-clinical test. The data provenance is described as "Non-clinical tests were conducted to subject device." This implies tests were performed on the actual device components or finished products. The country of origin of the data is not explicitly specified as part of the test report, but the manufacturer is MDK (ShangHai) Medical Packing Co., Ltd., which is located in China. The studies are retrospective as they were conducted (and results obtained) prior to the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This submission involves non-clinical performance testing of a physical device (sterilization pouches and rolls) rather than studies requiring expert interpretation or ground truth establishment by clinical experts. The ground truth for these tests is based on established performance standards and laboratory measurements.
4. Adjudication method for the test set:
Not applicable. As noted above, this submission involves non-clinical performance testing against pre-defined engineering and biological standards, not clinical studies requiring expert adjudication methods like 2+1 or 3+1.
5. 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 device is a physical product (sterilization pouches and rolls) and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not involve an algorithm or AI.
7. The type of ground truth used:
The ground truth for the non-clinical tests is based on established standard specifications and methodologies (e.g., ASTM, ISO standards) for material properties (tensile strength, thickness, tear strength, air permeability, burst strength, seal strength), microbial barrier properties, chemical indicator performance, residual levels of sterilants (EO and ECH), biocompatibility (cytotoxicity, skin irritation, skin sensitization), shelf-life validation, and sterilization process validation (Sterility Assurance Level - SAL).
8. The sample size for the training set:
Not applicable. This device is a physical product and does not involve a training set for an algorithm.
9. How the ground truth for the training set was established:
Not applicable. This device is a physical product and does not involve a training set for an algorithm.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 10, 2019
MDK (ShangHai) Medical Packing Co., Ltd. Ray Wang Official Correspondent No. 233 Fengijan Rd, FengCheng Town, FengXian District ShangHai, 201409 Cn
Re: K182184 Trade/Device Name: Paper Sterilization Pouch and Roll (Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted) Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: September 5, 2019 Received: September 9, 2019
Dear Ray 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.
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Page 2
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 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 (QS) 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.
For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K182184
Device Name
Paper Sterilization Pouch and Roll (Sterilization Pouch Gat, Sterlization Roll Flat and Sterilization Roll Gusseted)
Indications for Use (Describe)
Sterilization Pouch Flat
The Sterilization Pouch Flat are intended to be used to enclose another medical devices 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.
The Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470 g.
The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Pouch Gusseted
The Sterilization Pouch Gusseted are intended to be used to enclose another medical devices 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 sterlity of the enclosed device until used.
The Sterilization Pouch Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470g.
The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Flat
The Sterilization Roll Flat are intended to be used to enclose another medical devices 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.
The Sterilization Roll Flat are intended for sterilization of dental instruments, excluding complex devices and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60℃.
{3}------------------------------------------------
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g.
The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Gusseted
The Sterilization Roll Gusseted are intended to be used to enclose another medical devices 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 sterlity of the enclosed device until used.
The Sterilization Roll Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).
The intended sterilization cycles are listed below:
Gravity Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°C.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.
The Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g.
The sterilization roll maintains the enclosed devices up until 6 months post 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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510(k) Summary
This 510(k) Summary of 510(k) is being submitted in accordance with Title 21, CFR Section 807.92.
The assigned 510(k) Number: K182184
-
- Date of Preparation: 10/7/2018
-
- Sponsor Identification
MDK (ShangHai) Medical Packing Co., Ltd.
No .: 233 Fengjian Rd, FengCheng Town, FengXian District, Shanghai, 201409, China
Establishment Registration Number: Not yet registered or the Number not issued yet.
Contact Person: Gong Yaoren Position: Quality Manager Tel: +86 18601673483 Fax: +86 21 64868852 Email: gongyr@126.com
-
- Designated Submission Correspondent
Mr. Ray Wang Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com
- Designated Submission Correspondent
-
- Identification of Proposed Device
Trade Name: Paper Sterilization Pouch and Roll(Sterilization Pouch Flat, Sterilization Pouch Gusseted, Sterilization Roll Flat and Sterilization Roll Gusseted)
- Identification of Proposed Device
Common Name: Sterilization Pouches
Type(s): Sterilization Pouch Flat/ Sterilization Pouch Gusseted/ Sterilization Roll Flat/ Sterilization Roll Gusseted
Regulatory Information Classification Name: Wrap, Sterilization/Indicator, Physical/Chemical Sterilization Process Classification: 2
Product Code: FRG/JOJ Regulation Number: 21 CFR 880.6850/ 21 CFR 880.2800 Review Panel: General Hospital
Page 1 of 16
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-
న. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K143637 Product Name: U & U Sterilization Pouch and Roll Model Name: U&U Medical Technology Co., Ltd. -
- Device Description
The Paper Sterilization Pouch and Roll is intended to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
- Device Description
Steam; 30 minutes at 121°C; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.
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 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Red/Pink to Yellow/Brown (EtO) or Blue to Brown/Black (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.
The Paper Sterilization Pouch and Roll is offered in the follow 4 types:
-
- Sterilization Pouch Flat;
-
- Sterilization Pouch Gusseted;
-
- Sterilization Pouch Roll Flat;
-
- Sterilization Pouch Roll Gusseted.
The defining characteristics of the 4 types as follows:
Sterilization Pouch Flat: These pouches are made from a medical grade paper and plastic (CPP/PET) film that is heat sealed on three sides, the forth side is left opened and will be heat-sealed when using. The Process Indicators Ink printed on the Pouch will exhibit a color change after the pouch is exposed to EtO gas or Steam.
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Sterilization Pouch Gusseted: These rolls are the same as the Sterilization Pouch Flat, with the Heat Sealing 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.
Sterilization Roll Flat: These rolls are made from a medical grade paper and plastic (CPP/PET) 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 it are the same as the sterilization pouches.
Sterilization Roll 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.
| Type | Model | Dimension in S.I |
|---|---|---|
| Sterilization Pouch Flat | PFP001 | 55mm*150mm |
| PFP002 | 55mm*200mm | |
| PFP003 | 55mm*250mm | |
| PFP004 | 55mm*300mm | |
| PFP005 | 75mm*150mm | |
| PFP006 | 75mm*200mm | |
| PFP007 | 75mm*250mm | |
| PFP008 | 75mm*300mm | |
| PFP009 | 100mm*150mm | |
| PFP010 | 100mm*200mm | |
| PFP011 | 100mm*250mm | |
| PFP012 | 100mm*300mm | |
| PFP013 | 100mm*350mm | |
| PFP014 | 100mm*400mm | |
| PFP015 | 125mm*150mm | |
| PFP016 | 125mm*200mm | |
| PFP017 | 125mm*250mm | |
| PFP018 | 125mm*300mm | |
| PFP019 | 125mm*350mm | |
| PFP020 | 125mm*400mm | |
| PFP021 | 150mm*200mm | |
| PFP022 | 150mm*250mm | |
| PFP023 | 150mm*300mm | |
| PFP024 | 150mm*350mm | |
| PFP025 | 150mm*400mm | |
| PFP026 | 200mm*250mm | |
| PFP027 | 200mm*300mm | |
| PFP028 | 200mm*350mm | |
| PFP029 | 200mm*400mm | |
| PFP030 | 200mm*450mm |
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| PFP031 | 250mm*300mm |
|---|---|
| PFP032 | 250mm*350mm |
| PFP033 | 250mm*400mm |
| PFP034 | 250mm*450mm |
| PFP035 | 300mm*300mm |
| Type | Model | Dimension in S.I |
|---|---|---|
| Sterilization Pouch Gusseted | PFP036 | 300mm*350mm |
| PFP037 | 300mm*400mm | |
| PFP038 | 300mm*450mm | |
| PFP039 | 350mm*450mm | |
| PFP040 | 450mm*550mm | |
| PGP001 | 75mm25mm150mm | |
| PGP002 | 100mm50mm300mm | |
| PGP003 | 150mm*50mm *350mm | |
| PGP004 | 150mm *50mm *450mm | |
| PGP005 | 200mm*50mm *350mm | |
| PGP006 | 200mm*50mm *450mm | |
| Sterilization Roll Flat | PGP007 | 250mm55mm400mm |
| PGP008 | 300mm*60mm *400mm | |
| PGP009 | 350mm65mm450mm | |
| PGP010 | 400mm75mm500mm | |
| PFR001 | 55mm *200m | |
| PFR002 | 75mm *200m | |
| PFR003 | 100mm *200m | |
| PFR004 | 125mm *200m | |
| PFR005 | 150mm *200m | |
| PFR006 | 175mm *200m | |
| PFR007 | 200mm *200m | |
| Sterilization Roll Flat | PFR008 | 250mm*200m |
| PFR009 | 300mm *200m | |
| PFR010 | 350mm *200m | |
| PFR011 | 400mm*200m | |
| PFR012 | 450mm *200m | |
| PGR001 | 75mm25mm100m | |
| PGR002 | 100mm50mm100m | |
| PGR003 | 150mm50mm100m | |
| PGR004 | 200mm50mm100m | |
| PGR005 | 250mm55mm100m | |
| Sterilization Roll Gusseted | PGR006 | 300mm60mm100m |
| PGR007 | 350mm65mm100m | |
| PGR008 | 400mm75mm100m |
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7. Indication Use Statement:
Sterilization Pouch Flat
The Sterilization Pouch Flat are intended to be used to enclose another medical devices 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. The Sterilization Pouch Flat are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470 g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Pouch Gusseted
The Sterilization Pouch Gusseted are intended to be used to enclose another medical devices 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. The Sterilization Pouch Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 1470g. The sterilization pouch maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Flat
The Sterilization Roll Flat are intended to be used to enclose another medical devices 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.
The Sterilization Roll Flat are intended for sterilization of dental instruments, excluding complexdevices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%-85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone Page 5 of 16
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either a steam or EtO sterilization process. The Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
Sterilization Roll Gusseted
The Sterilization Roll Gusseted are intended to be used to enclose another medical devices 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. The Sterilization Roll Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels). The intended sterilization cycles are listed below:
Steam; 30 minutes at 121 ℃; 25 minutes dry time.
Ethylene oxide: 4 hours at 55 ℃; relative humidity between 50%- 85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60 ℃.
The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. The Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g. The sterilization roll maintains the enclosed devices up until 6 months post sterilization.
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8. Technological Characteristics Comparison Table
Table 1 General Comparison
| ITEM | Proposed Device | Predicate Device K143637 | Remark |
|---|---|---|---|
| Indication For Use | Sterilization Pouch Flat | The U&U sterilization pouch and roll are intended to provide health care | Similar |
| The Sterilization Pouch Flat are intended to be used to enclose another medical | workers with an effective method to enclose devices intended for sterilization | ||
| devices that is to be sterilized by a health care provider. It is intended to allow | in steam and Ethylene Oxide (EtO). | ||
| sterilization of the enclosed medical device and also to maintain sterility of the | The recommended gravity steam sterilization cycle parameters are 30 minutes | ||
| enclosed device until used. | at 121 °C. | ||
| The Sterilization Pouch Flat are intended for sterilization of dental instruments, | The recommended EtO sterilization cycle is 4 hours at 55 °C with a relative | ||
| excluding complex devices (endoscopes and instruments with lumen/channels). | humidity between 50%- 85% and a sterilant concentration of 600 mg/L. | ||
| The intended sterilization cycles are listed below: | Furthermore, the sterilization pouch and roll maintain the enclosed devices up | ||
| Steam; 30 minutes at 121 °C; 25 minutes dry time. | until 90Days post sterilization. Lastly, the pouch's external chemical ink | ||
| Ethylene oxide: 4 hours at 55 °C; relative humidity between 50%- 85%; ethylene | indicators are designed to indicate to the user that the pouch has undergone | ||
| oxide concentration is 600 mg/L, 8 hours aeration time at 60°C. | either a steam or EtO sterilization process. | ||
| The pouch's external chemical ink indicators are designed to indicate to the user | |||
| that the pouch has undergone either a steam or EtO sterilization process. | The recommended gravity steam sterilization cycle parameters | ||
| The Sterilization Pouch Flat are not intended use for any load with | Steam sterilization temperature: 121°C (250°F) | ||
| lumen/channels and complex device. The maximum wrapped package weight for | Steam sterilization time: 30 minutes. | ||
| each pouch is 1470 g. | Drying time: 25 minutes | ||
| The sterilization pouch maintains the enclosed devices up until 6 months post | The recommended EtO sterilization cycle parameters | ||
| sterilization. | EtO sterilization temperature: 55°C (130 °F) | ||
| Sterilization Pouch Gusseted | EtO sterilization time: 4 hours | ||
| The Sterilization Pouch Gusseted are intended to be used to enclose another | EtO sterilization humidity: 50% to 85% RH | ||
| medical devices that is to be sterilized by a health care provider. It is intended to | EtO sterilization concentration:600mg/L |
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| allow sterilization of the enclosed medical device and also to maintain sterility ofthe enclosed device until used.The Sterilization Pouch Gusseted are intended for sterilization of dentalinstruments, excluding complex devices (endoscopes and instruments withlumen/channels).The intended sterilization cycles are listed below:Steam; 30 minutes at 121 °C; 25 minutes dry time.Ethylene oxide: 4 hours at 55 °C; relative humidity between 50%-85%; ethyleneoxide concentration is 600 mg/L, 8 hours aeration time at 60°C.The pouch's external chemical ink indicators are designed to indicate to the userthat the pouch has undergone either a steam or EtO sterilization process.The Sterilization Pouch Gusseted are not intended use for any load withlumen/channels and complex device. The maximum wrapped package weight foreach pouch is 1470g.The sterilization pouch maintains the enclosed devices up until 6 months poststerilization.Sterilization Roll FlatThe Sterilization Roll Flat are intended to be used to enclose another medicaldevices that is to be sterilized by a health care provider. It is intended to allowsterilization of the enclosed medical device and also to maintain sterility of theenclosed device until used.The Sterilization Roll Flat are intended for sterilization of dental instruments,excluding complex devices (endoscopes and instruments with lumen/channels).The intended sterilization cycles are listed below:Steam; 30 minutes at 121 °C; 25 minutes dry time.Ethylene oxide: 4 hours at 55 °C; relative humidity between 50%-85%; ethylene | Aeration time: 8 hours.Aeration Temperature: 60°CSterilization load claim:Two types of sterilization loads were validated.Load A: Metal medical instruments and Hand-control pen, the total weight is24lbs.Load B: Tubing (Silicone) and Surgical Towels. The total weight is 18lbs. |
|---|---|
| oxide concentration is 600 mg/L, 8 hours aeration time at 60°C.The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.The Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g.The sterilization roll maintains the enclosed devices up until 6 months post sterilization. | |
| Sterilization Roll GussetedThe Sterilization Roll Gusseted are intended to be used to enclose another medical devices 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.The Sterilization Roll Gusseted are intended for sterilization of dental instruments, excluding complex devices (endoscopes and instruments with lumen/channels).The intended sterilization cycles are listed below:Steam; 30 minutes at 121 °C; 25 minutes dry time.Ethylene oxide: 4 hours at 55 °C; relative humidity between 50%-85%; ethylene oxide concentration is 600 mg/L, 8 hours aeration time at 60°C.The pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process.The Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for each pouch is 910g.The sterilization roll maintains the enclosed devices up until 6 months post sterilization. |
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| Material | Top Web - Medical Porous Paper Bottom | Top Web - Medical Porous Paper Bottom | Similar |
|---|---|---|---|
| Composition | Web - Medical Plastic film(CPP) | Web - Medical Plastic film(CPP) | |
| EtO gas indicator ink-Process IndicatorsSteam indicator ink-Process Indicators | EtO gas indicator ink-Process Indicators class 1Steam indicator ink-Process Indicators class 1 | ||
| Sterilization | Prevacuum steam; 30 minutes at 121 °C; 25 minutes dry time. | The recommended gravity steam sterilization cycle parameters are 30 minutesat 121 °C. | Similar |
| Cycles | Ethylene oxide: 4 hours at 55 °C; relative humidity between 50%- 85% and a | The recommended EtO sterilization cycle is 4 hours at 55 °C with a | |
| sterilant concentration of 600 mg/L. | relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. | ||
| Configuration/Dimension | Various Size, Heat Sealing | Various Size, Heat Sealing and Self Sealing | Similar |
| Air Permeance | The maximum equivalent pore size diameter shall not exceed 50um. | The maximum equivalent pore size diameter shall not exceed 50um. | Similar |
| Microbial BarrierProperties(PackagingIntegrity) | Use ASTM 1608 method, the LRV is more than 4.0 Use ASTM 1929 method, theinspection result is PASS | Use ASTM 1608 method, the LRV is more than 3.5 Use ASTM 1929 method,the inspection result is PASS | Similar |
| MaterialCompatibility | After sterilization, the materials were not degraded | After sterilization, the materials were not degraded | Similar |
| Biocompatibility | ISO10993-10, Test for Irritation; ISO10993-10, Test for Skin sensitization; Bothwere non-cytotoxic post sterilization. | ISO10993-10, Test for Irritation; ISO10993-10, Test for Skin sensitization; Bothwere non-cytotoxic post sterilization. | Similar |
| Maintenance ofSterility | 6 months | 90 Days | Similar |
| Shelf Life | 2 years from date of manufacture for EO and Steam Indicators | 18 months from date of manufacture for EO and steam Indicators | Similar |
| Drying Time | 25 minutes | 25 minutes | Similar |
| Aeration Time | 8 hours at 60°C | 8 hours at 60°C | Similar |
| Chemical | Changed color EtO- Red/Pink to Yellow/Brown; | Changed color EtO- YELLOW to COCOA; | Similar |
| Indicator Efficacy | Steam- Blue to Brown/Black | Steam- GREEN to PURPLE | Similar |
| End point stabilitytesting results | The color of chemical indicator for EO sterilization indicator ink is Red/Pink, andthe color of chemical indicator for steam sterilization indicator ink is Blue after 2year shelf life before sterilization. | The color of chemical indicator could maintain stability as claimed shelf life (18months from date of manufacture for EO and steam indicators, 90 daysmaintenance of sterility after sterilization process) | Similar |
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| The color of chemical indicator for EO sterilization indicator ink is GoldenYellow/Brown, and the color of chemical indicator for steam sterilization indicatorink is Blue after EO sterilized and 6 months shelf life. |
|---|
| The color of chemical indicator for EO sterilization indicator ink is Red/Pink , andthe color of chemical indicator for steam sterilization indicator ink is Brown/Black |
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9. Summary of Non-Clinical Testing
The proposed device Non-clinical tests were conducted to subject device. The test results demonstrated that the subject device met the acceptance criteria, and the conducted tests listed as below:
| Testing Name | Brief Description of Test | Acceptance criteria OR End Point | Test Results |
|---|---|---|---|
| Tensilestrength | ASTM D882-12 Standard Test Methods for TensileProperties of Thin Plastic Sheeting; | ≥4.4 KN/m | The test results of all samples are ≥4.4 KN/m.Pass |
| Thickness | ASTM F2251-03 Standard Test Method for thicknessmeasurement of flexible packaging material; | 138±13 µm | The test results of all samples are in the rangeof 138±13 µm.Pass |
| Tear Strength | ASTM D1922-03 Standard Test Method for Propagationtear resistance of plastic film and thin sheeting by pendulummethod; | ≥ 550 mN/15mm | The test results of all samples are ≥ 550mN/15mm.Pass |
| Airpermeabilitycoefficient | ISO 5636-3:2013 Paper and board - Determination of airpermeance (medium range) – Part 3: Bendtsen method; | ≥3.4µm/Pa.s | The test results of all samples are ≥3.4µm/Pa.s.Pass |
| Burst Strength | ASTM F1140/f1140M-13 Standard Test Methods forinternal pressurization failure resistance of unrestrainedpackage; | ≥2.0 kPa | The test results of all samples are ≥2.0 kPa.Pass |
| MicroorganismPenetration | ASTM F1608-00 Standard test methods for MicrobialRanking of Porous packaging materials; | Microbial Barrier LRV ≥ 2.0Retention Rate (spore%) ≥ 99.0% | The Microbial Barrier LRV test results of allsamples are ≥2.0. |
| The Retention Rate test results of all samples are ≥99.0%. | |||
| Pass | |||
| ChemicalIndicatorPerformance | ISO 11140-1:2009 Sterilization of Health Care Products -Chemical Indicators - Part 1: General Requirements; | Color changed from Red/Pink to GoldenYellow/Brown for EO sterilization indicator ink at the condition of 4 hours at 55 °C; relativehumidity between 50%- 85%; ethylene oxide concentration is 600 mg/L;Color changed from Blue to Brown/Black at the condition of Gravity Steam, 121°C, 30 mins; | Color changed from Red/Pink to GoldenYellow/Brown under indicated condition and no changed under other condition.PassColor changed from Blue to Brown/Black under indicated condition and no changed under other condition.Pass |
| Dyepenetration | ASTM F1929-12 Standard test methods for detecting seal leaks in porous medical packaging by dye penetration. | No dye leakage | No dye leakage/Pass |
| Seal strength | ASTM F88-15 Standard Test Method for Seal Strength of Flexible Barrier Materials | ≥1.5 N/15 mm | The test results of all samples are ≥1.5 N/15 mm.Pass |
| EO residue | ISO 10993-7:2008 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | No more than 4 mg per set | The test results of all samples are no more than 4 mg per set.Pass |
| ECH residue | No more than 9 mg per set | The test results of all samples are no more than 9 mg per set.Pass | |
| In VitroCytotoxicity | ISO 10993-5:2009 Biological Evaluation of MedicalDevices – Part 5: Tests for In Vitro Cytotoxicity; | In Vitro Cytotoxicity | Under the conditions of the study, the testarticle (pouches and chemical indicator)extract did not show potential toxicity to L-929 cells before and after sterilized. |
| Skin IrritationAND SkinSensitization | ISO 10993-10:2010 Biological Evaluation of MedicalDevices - Part 10: Tests for irritation and skin sensitization; | Skin sensitization; | Under the conditions of the study, the testarticle (pouches and chemical indicator)extract did not show no significant evidence ofcausing skin sensitization in the guinea pigbefore and after sterilized. |
| Skin Irritation | Under the conditions of the study, the testarticle (pouches and chemical indicator)extract did not induce intracutaneousreactivity in rabbit before and after sterilized. | ||
| Shelf LifeValidation | Shelf Life Validation Test;Conducted the shelf life testing as real time aging method. | After the shelf life indicated as following,Shelf Life: 2 Years;Shelf Life after Sterilized: 6 Months;The performance shall be meet the requirementsof :Tensile strength: ≥4.4 KN/m;Thickness: 138±13 µm;Tear Strength: ≥ 550 mN/15mm;Air permeability coefficient: ≥3.4µm/Pa.s;Burst Strength: ≥2.0 kPa; | The test results of all samples are meet therequirements.Pass |
| Microbial Barrier LRV ≥ 2.0;Retention Rate (spore%) ≥ 99.0%;Dye penetration: No dye leakage;Seal strength: ≥1.5 N/15 mm;Color of indicator shall be meet the specification. | |||
| SterilizationProcessValidation | EO Sterilization Process Validation Test.Conducted the EO sterilization process validation as themethod/principle of ISO 14937:2009.Use the half cycle method to validate the EO sterilizationcycle claimed in indication for use is effective. | Ethylene oxide: 4 hours at 55 °C; relativehumidity between 50%- 85%; ethylene oxideconcentration is 600 mg/L, 8 hours aeration timeat 60°C.SAL= $10^{-6}$ . | SAL= $10^{-6}$ .Pass |
| Steam Sterilization Process Validation Test.Conducted the Steam sterilization process validation as themethod/principle of ISO 14937:2009.Use the half cycle method to validate the EO sterilizationcycle claimed in indication for use is effective. | Steam; 30 minutes at 121 °C; 25 minutes drytime.SAL= $10^{-6}$ . | SAL= $10^{-6}$ .Pass |
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10. Clinical Test Conclusion
No clinical study is included in this submission.
11. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the subject device is as safe, as effective and performs as well as or better than the legally marketed predicate device.
§ 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).