(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. Pass | |
| For 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 Years | |
| Shelf Life after Sterilized: 6 Months | ||
| The 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= $10^{-6}$. Pass | |
| For 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.
§ 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).