(351 days)
The Heat Sealing Sterilization Pouch Flat are intended 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 Heat Sealing 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:
Prevacuum steam: 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
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 Heat Sealing Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is 300x, 90 x 559 mm size pouch is 250g, and 102 x 203 size pouch is 110g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Device Size (mm): 90x559, 102x203, 127x381, 150x300, 150x300, 152x254, 152x559, 191x330, 200x300, 203x406, 300x400, 305x381, 305x457, 400x500, 457x559, 500x600.
Heat Sealing Sterilization Pouch Gusseted
The Heat Sealing Sterilization Pouch Gusseted are intended 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is 400g, and 65 x 40 x 254 mm size pouch is 200g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 65x40x254.70 x 35 x 145.90 x 50 x 155.128 x 50 X 190.137x40x305, 150x50x380, 165x75x295. 200x33x340, 200x98x440,250x60x340,250x60x480,300x65x560.
Heat Sealing Sterilization Pouch Roll Flat
The Heat Sealing 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50 x 200 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 50 x 200,100 x 200,120 x 200,150 x 200,200 x 200,250 x 200,300 x 200,350 x 200, 400 x 200, 500 x 200,600 x 200.
Heat Sealing Sterilization Pouch Roll Gusseted
The Heat Sealing Sterilization Roll Gusseted are intended 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 100 mm size pouch is 750g, 250 x 100 mm size pouch is 375g and 75 x 100 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 75 x 100,100 x 100,200 x 100,200 x 100,300 x 100,350 x 100,400 x 100,500 x 100,
The Heat Sealing Sterilization Pouch/Roll is intended to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Prevacuum steam: 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day 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 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark Green (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 Sterilization Pouch/Roll is offered in the follow 4 types:
- Heat Sealing Sterilization Pouch Flat;
- Heat Sealing Sterilization Pouch Gusseted;
- Heat Sealing Sterilization Pouch Roll Flat;
- Heat Sealing Sterilization Pouch Roll Gusseted.
The defining characteristics of the 4 types as follows:
Heat Sealing 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.
Heat Sealing Sterilization Pouch Gusseted: These rolls are the same with the Heat Sealing Sterilization Pouch Flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
Heat Sealing Sterilization Pouch 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 with the sterilization pouches.
Heat Sealing Sterilization Pouch 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 provided text is a 510(k) Summary for a medical device (Heat Sealing Sterilization Pouch/Roll). It details the device's technical characteristics and non-clinical testing performed to establish substantial equivalence to a predicate device. However, it does not describe a study involving human readers or AI assistance. Therefore, information regarding effect size of human readers with AI assistance (MRMC study) and standalone algorithm performance, as well as several aspects related to AI/ML device studies, cannot be extracted directly from this document.
Here's the breakdown of the information that can be extracted or inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Microorganism Penetration testing as ASTM F1608 | Retention rate > 99.9% | Meet the acceptance criteria |
| Ethylene oxide residues testing as ISO 10993-7 | < 4 mg | Meet the acceptance criteria |
| Internal pressure testing as ASTM F1140/F1140M | > 30 kPa for bursting | Meet the acceptance criteria |
| Chemical Indicators performance testing as ISO 11140-1 | EO indicator: Initial Color: Pink -> Signal Color: Yellow; Steam indicator: Initial Color: Blue -> Signal Color: Dark Green | Meet the acceptance criteria |
| Tensile strength Testing as ASTM D882 | > 7.0 KN/m | Meet the acceptance criteria |
| Thickness testing as ASTM F2251 | (138 ± 3) µm | Meet the acceptance criteria |
| Air Permeability Coefficient Testing as ISO 5636-3 | > 8 µm/Pa.s | Meet the acceptance criteria |
| Tear Strength testing as ASTM D1922 | > 500 mN/15mm | Meet the acceptance criteria |
| Seal strength testing as ASTM F88 / F88M | > 4 N/15mm | Meet the acceptance criteria |
| Dye Penetration Testing as ASTM F1929 | No Dye Leakage | Meet the acceptance criteria |
| Dry Validation | 10 minutes (for prevacuum steam cycle) | Meet the acceptance criteria |
2. Sample size used for the test set and the data provenance
The document does not specify exact sample sizes for each test listed. It mentions "Non-clinical tests were conducted with the subject device," implying samples of the device were tested according to the specified ASTM and ISO standards.
- Provenance: These are non-clinical (laboratory) tests performed on samples of the manufactured device. The manufacturing company is Tianchang Jiarui Packaging Material Co., Ltd. in Anhui Province, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a non-clinical device that does not involve expert interpretation or AI/ML ground truth establishment in this context. The acceptance criteria are based on standardized physical, chemical, and biological performance tests.
4. Adjudication method for the test set
Not applicable, as this involves objective laboratory tests with predefined pass/fail criteria, not subjective interpretation requiring adjudication.
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
No MRMC study was done. This document is for a physical medical device (sterilization pouches/rolls) and does not describe an AI/ML component or human reader interaction.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No standalone algorithm performance study was done. This device does not involve an algorithm.
7. The type of ground truth used
The "ground truth" for this device's performance is established by the specified international (ISO) and national (ASTM) standards for physical, chemical, and biological properties of sterilization barrier systems and chemical indicators. For instance, the ground truth for "Microorganism Penetration" is a retention rate >99.9% as measured by ASTM F1608.
8. The sample size for the training set
Not applicable. This device does not involve a training set as it's a physical product, not an AI/ML model.
9. How the ground truth for the training set was established
Not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 9, 2019
Tianchang Jiarui Packaging Material Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 Cn
Re: K181957
Trade/Device Name: Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: Class II Product Code: FRG, JOJ Dated: June 10, 2019 Received: June 13, 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
{1}------------------------------------------------
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 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-reportinemdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/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
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K181957
Device Name
Heat Sealing Sterilization Pouch Flat, Heat Sealing Sterilization Pouch Gusseted, Heat Sealing Sterilization Pouch Roll Flat, Heat Sealing Sterilization Pouch Roll Gusseted
Indications for Use (Describe)
The Heat Sealing Sterilization Pouch Flat are intended 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 Heat Sealing 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:
Prevacuum steam: 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
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 Heat Sealing Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is 300x, 90 x 559 mm size pouch is 250g, and 102 x 203 size pouch is 110g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Device Size (mm): 90x559, 102x203, 127x381, 150x300, 150x300, 152x254, 152x559, 191x330, 200x300, 203x406, 300x400, 305x381, 305x457, 400x500, 457x559, 500x600.
Heat Sealing Sterilization Pouch Gusseted
The Heat Sealing Sterilization Pouch Gusseted are intended 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time. Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is 400g, and 65 x 40 x 254 mm size pouch is 200g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 65x40x254.70 x 35 x 145.90 x 50 x 155.128 x 50 X 190.137x40x305, 150x50x380, 165x75x295. 200x33x340, 200x98x440,250x60x340,250x60x480,300x65x560.
{3}------------------------------------------------
Heat Sealing Sterilization Pouch Roll Flat
The Heat Sealing 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Roll Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50 x 200 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 50 x 200,100 x 200,120 x 200,150 x 200,200 x 200,250 x 200,300 x 200,350 x 200, 400 x 200, 500 x 200,600 x 200.
Heat Sealing Sterilization Pouch Roll Gusseted
The Heat Sealing Sterilization Roll Gusseted are intended 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 100 mm size pouch is 750g, 250 x 100 mm size pouch is 375g and 75 x 100 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization. Device Size (mm): 75 x 100,100 x 100,200 x 100,200 x 100,300 x 100,350 x 100,400 x 100,500 x 100,
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
{4}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{5}------------------------------------------------
510(k) Summary
This 510(k) Summary of 510(k) is being submitted in accordance withTitle 21, CFR Section 807.92.
The assigned 510(k) Number: K181957
-
- Date of Preparation: 07/08/2019
-
- Sponsor Identification
Tianchang Jiarui Packaging Material Co., Ltd. Yeshan Industria Zone, Tianchang City, 239300, Anhui Province of China
Contact Person: Zhang Ruiqing Position: General Manager Tel: +86 550 7981778 Fax: +86 550 7323988 Email: sales@cncarate.com
-
- Designated Submission Correspondent
Mr. Ray Wang
- Designated Submission Correspondent
Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401
Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com
{6}------------------------------------------------
4. Identification of Proposed Device
Trade Name: Heat Sealing Sterilization Pouch Flat/Heat Sealing Sterilization Pouch Gusseted/Heat Sealing Sterilization Pouch Roll Flat/Heat Sealing Sterilization Pouch Roll Gusseted Common Name: Sterilization Pouches & Roll
Model(s):
Heat Sealing Sterilization Pouch Flat
90 x 559mm, 102 x 203 mm, 127 x 381 mm, 130 x 360 mm, 150 x 300 mm, 150 x 300 mm, 152 x 254 mm, 152 x 559 mm, 191 x 330 mm, 200 x 300 mm, 203 x 400 mm, 300 x 400 mm, 305 x 381 mm, 305 x 457 mm, 400 x 500 mm, 300 x 400 mm, 457 x 559 mm, 500 x 600 mm;
Heat Sealing Sterilization Pouch Gusseted
65 x 40 x 254 mm, 70 x 35 x 145 mm, 90 x 50 x 155 mm, 128 x 50 x 190 mm, 137 x 40 x 305 mm, 150 x 50 x 380 mm, 165 x 75 x 295 mm, 200 x 33 x 340 mm, 200 x 98 x 440 mm, 250 x 60 x 340 mm, 250 x 60 x 480 mm, 300 x 65 x 560 mm;
Heat Sealing Sterilization Pouch Roll Flat
75 x 200 mm, 100 x 200 mm, 120 x 200 mm, 150 x 200 mm, 200 x 200 mm, 300 x 200 mm, 350 x 200 mm, 400 x 200 mm, 500 x 200 mm, 600 x 200 mm;
Heat Sealing Sterilization Pouch Roll Gusseted
75 x 100 mm, 100 x 100 mm, 150 x 100 mm, 200 x 100 mm, 300 x 100 mm, 300 x 100 mm, 350 x 100 mm, 400 x 100 mm, 500 x 100 mm;
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
Intended Use Statement:
Heat Sealing Sterilization Pouch Flat
The Heat Sealing Sterilization Pouch Flat are intended 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
{7}------------------------------------------------
The pouch's external chemical ink indicators are designed to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Pouch Flat are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is 300g, 90 x 559 mm size pouch is 250g, and 102 x 203 size pouch is 110g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Heat Sealing Sterilization Pouch Gusseted
The Heat Sealing Sterilization Pouch Gusseted are intended 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 Heat Sealing 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:
Prevacuum steam: 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
The pouch's external chemical ink indicators are designed to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with
lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is 400g, and 65 x 40 x 254 mm size pouch is 200g.
The sterilization pouch maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Heat Sealing Sterilization Pouch Roll Flat
The Heat Sealing Sterilization Roll Flat are intended 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
The pouch's external chemical ink indicators are designed to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Roll Flat are not intended use for any load with lumen/channels and
{8}------------------------------------------------
complex device. The maximum wrapped package weight for 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50 x 200 mm size pouch is 100g..
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Heat Sealing Sterilization Pouch Roll Gusseted
The Heat Sealing 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 Heat Sealing 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:
Prevacuum steam; 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20℃.
The pouch's external chemical ink indicators are designed to the user that the pouch has undergone either a steam or EtO sterilization process.
The Heat Sealing Sterilization Roll Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 500 x 100 mm size pouch is 750g, 250 x 100 mm size pouch is 375g and 75 x 100 mm size pouch is 100g.
The sterilization roll maintains the sterility of the enclosed devices for up to 6 months post sterilization.
Device Description
The Heat Sealing Sterilization Pouch/Roll is intended to contain medical devices to be terminally sterilized by the EtO or Steam sterilization process. The recommended sterilization cycle parameter is:
Prevacuum steam: 4 minutes at 132 ℃; 10 minute dry time.
Ethylene oxide: 1 hours at 55 ℃; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day 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 6 months post sterilization.
The Pouch/Roll is printed with a chemical indicator bar that changes from Pink to Yellow (EtO) or Blue to Dark Green (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
{9}------------------------------------------------
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 Sterilization Pouch/Roll is offered in the follow 4 types:
-
- Heat Sealing Sterilization Pouch Flat;
-
- Heat Sealing Sterilization Pouch Gusseted;
-
- Heat Sealing Sterilization Pouch Roll Flat;
-
- Heat Sealing Sterilization Pouch Roll Gusseted.
The defining characteristics of the 4 types as follows:
Heat Sealing 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.
Heat Sealing Sterilization Pouch Gusseted: These rolls are the same with the Heat Sealing Sterilization Pouch Flat, except that the plastic film is folded on both longest sides instead of flat. This design is convenient to enclose the medical devices with certain height.
Heat Sealing Sterilization Pouch 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 with the sterilization pouches.
Heat Sealing Sterilization Pouch 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.
-
- 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.
- Identification of Predicate Device(s)
{10}------------------------------------------------
6. Technological Characteristics
| ITEM | Subject Device K181957 | Predicate Device K143637 | Comparison | |
|---|---|---|---|---|
| IndicationForUse | The Heat Sealing Sterilization Pouch Flat are intended to be used to encloseanother medical devices that is to be sterilized by a health care provider. It isintended to allow sterilization of the enclosed medical device and also tomaintain sterility of the enclosed device until used.The Heat Sealing Sterilization Pouch Flat are intended for sterilization ofdental instruments, excluding complex devices (endoscopes and instrumentswith lumen/channels).The intended sterilization cycles are listed below:Prevacuum steam; 4 minutes at 132 °C; 10 minute dry time.Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100%ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Pouch Flat are not intended use for any loadwith lumen/channels and complex device. The maximum wrapped packageweight for 500 x 600 mm size pouch is 1470 g, 200 x 300 mm size pouch is300g,90x 559mmsize pouch is 250g, and102x203 size pouch is110g. Thesterilization pouch maintains the enclosed devices for up to 6 months poststerilization. | The U&U sterilization pouch and roll are intended to provide health careworkers with an effective method to enclose devices intended for sterilization insteam and Ethylene Oxide (EtO).The recommended gravity steam sterilization cycle parameters are 30 minutes at121 °C.The recommended EtO sterilization cycle is 4 hours at 55 °C with a relativehumidity between 50%- 85% and a sterilant concentration of 600 mg/L.Furthermore, the sterilization pouch and roll maintains the enclosed devices upuntil 90Days post sterilization. Lastly, the pouch's external chemical inkindicators are designed to indicate to the user that the pouch has undergoneeither a steam or EtO sterilization process.The recommended gravity steam sterilization cycle parametersSteam sterilization temperature: 121°C (250°F)Steam sterilization time: 30 minutes.Drying time: 25 minutesThe recommended EtO sterilization cycle parametersEtO sterilization temperature: 55°C (130 °F)Eto sterilization time: 4 hourEto sterilization humidity: 50% to 85% RHEtO sterilization concentration:600mg/LAeration time: 8 hours. | Different | |
| Heat Sealing Sterilization Pouch GussetedThe Heat Sealing Sterilization Pouch Gusseted are intended to be used toenclose another medical devices that is to be sterilized by a health care provider. |
Table 1 General Comparison
{11}------------------------------------------------
| It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.The Heat Sealing 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:Prevacuum steam; 4 minutes at 132 °C; 10 minute dry time.Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%- 80%; 100% ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Pouch Gusseted are not intended use for any load with lumen/channels and complex device. The maximum wrapped package weight for 300 x 65 x 560 mm size pouch is 1050g, 200 x 33 x 340 mm size pouch is400g, and65x40x254 mmsizepouch is200g.The sterilization pouch maintains the enclosed devices for up to 6 months post sterilization.Heat Sealing Sterilization PouchRoll FlatThe Heat Sealing Sterilization RollFlat areintended tobeused toenclose another medical devices that is to be sterilized by ahealth care provider. It is intended to allowsterilization ofthe enclosed medicaldeviceand also to maintain sterility of theencloseddevice until used.The Heat Sealing Sterilization RollFlat areintendedforsterilizationofdental instruments, excludingcomplex devices (endoscopes andinstruments with lumen/channels).The intended sterilizationcycles are listed below: | 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 is 24lbs.Load B: Tubing (Silicone) and Surgical Towels. The total weight is 18lbs. |
|---|---|
| Prevacuum steam; 4 minutes at 132 °C; 10 minute dry time.Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%-80%; 100%ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°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 Heat Sealing Sterilization Roll Flat are not intended use for any load withlumen/channels and complex device. The maximum wrapped package weightfor 600 x 200 mm size pouch is 910g, 300 x 200 mm size pouch is 450g and 50x200mmsize pouch is 100g.The sterilization pouch maintains the enclosed devices for up to 6 months poststerilization. | Heat Sealing Sterilization PouchRoll GussetedThe Heat Sealing Sterilization RollGusseted are intended to be used to enclosanother medical devices that is to be sterilized by ahealth care provider. It isintended to allowsterilization ofthe enclosed medicaldeviceand also to maintainsterility of theencloseddevice until used.The Heat Sealing Sterilization RollGusseted areintended for sterilization ofdental instruments, excluding complex devices (endoscopes and instruments witlumen/channels).The intended sterilizationcycles are listed below:Prevacuum steam; 4minutes at 132 °C; 10 minutedry time.Ethylene oxide: 1 hoursat55°C;relative humidity between 40%-80%;100%ethylene oxide at aconcentrationof 740 mg/L, 7 day aeration time at20°C. Thepouch's external chemical ink indicatorsare designed toindicate tothe user thatthe pouch has undergone either asteam or EtO sterilization process.The Heat Sealing Sterilization RollGusseted are not intended use for any load |
{12}------------------------------------------------
{13}------------------------------------------------
| with lumen/channels and complex device. The maximum wrapped packageweight for 500 x100mm size pouchis750g, 250x 100 mmsize pouch is 375gand 75x100 mm size pouch is 100g.The sterilization pouch maintains the enclosed devices for up to 6 months poststerilization. | |||
|---|---|---|---|
| Material | TopWeb -Medical Porous Paper | Top Web - Medical Porous Paper | Similar |
| Compostion | Bottom Web-MedicalPlastic film(CPP) | Bottom 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 | ||
| SterilizationCycles | Prevacuum steam; 4 minutes at 132 °C; 10 minute dry time.Ethylene oxide: 1 hours at 55 °C; relative humidity between 40%-80%; 100%ethylene oxide at a concentration of 740 mg/L, 7 day aeration time at 20°C. | The recommended gravity steam sterilization cycle parameters are 30 minutes at121 °C. Therecommended EtO sterilization cycle is 4 hours at 55 °C with a relative humiditybetween 50%-85% and a sterilant concentration of 600 mg/L. | Different |
| 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,the inspection 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; | ISO10993-10,Test forIrritation ;ISO10993-10,Testfor Skin sensitization; | Similar |
| MaintenanceofSterility | 6 months | 90 Days | Different |
| orchemicalindicator endpointstability | |||
| Shelf Life | 2 years | 18 months | Different |
| Drying Time | 10 minutes | 25 minutes | Different |
| Aeration Time | 7 days at 20°C | 8 hours at 60°C | Different |
| ChemicalIndicator Efficacy | Changed color EtO- Pink to Yellow;Steam- Blue to Dark Green | Changed color EtO- YELLOW to COCOA;Steam- GREEN to PURPLE | Different |
{14}------------------------------------------------
{15}------------------------------------------------
7. Non-Clinical Test Conclusion
Non-clinical tests were conducted with the subject device. The test results demonstrated that the subject device met the acceptance criteria. A list on the non-clincial test are provided below:
-
ISO 14937:2009 Sterilization of health care products - General requirements or characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical device
-
ASTM D638-14 Standard Test Method For Tensile Properties of Plastics;
- ASTM F2251-03 Standard Test Method for thickness measurement of flexible packaging A material;
-
ASTM D1922-03 Standard Test Method for Propagation tear resistance of plastic film and thin sheeting by pendulum method;
-
ISO 5636-3:2013 Paper and board - Determination of air permeance (medium range) - Part 3: Bendtsen method;
-
ASTM F1140/f1140M-13 Standard Test Methods for internal pressurization failure resistance of unrestrained package;
- ASTM F1608-00 Standard test methods for Microbial Ranking of Porous packaging materials; A
-
ISO 10993-7:2009 Biological Evaluation of Medical Device - Part 7: Ethylene Oxide Sterilization residuals;
-
ISO 11140-1:2009 Sterilization of Health Care Products - Chemical Indicators - Part 1: General Requirements;
-
ASTM F1929-12 Standard test methods for detecting seal leaks in porous medical packaging by dye penetration.
- A ISO 10993-5:2009 Biological Evaluation of Medical Devices - Part 5: Tests for In Vitro Cytotoxicity;
- ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation A and skin sensitization;
-
Shelf Life Validation Test, validate the shelf life performance to the proposed device as real time aging method.
-
Sterilization Process Validation Test of Self Sealing Sterilization Pouch for EO and Steam sterilization process
-
Verification Test of Self Sealing Sterilization Pouch for EO and Steam Sterilization Process
| Name of Test | Purpose of the test | Acceptance criteria | Test Results |
|---|---|---|---|
| Microorganism Penetrationtesting as ASTM F1608 | MicroorganismPenetration Test | Retentionrate >99.9% | Meet the acceptance criteria |
| Ethylene oxide residues testing asISO 10993-7 | Ethylene oxideresidues | < 4 mg | Meet the acceptance criteria |
| Internal pressure testing as ASTM | Internal pressure | > 30 kPa | Meet the acceptance criteria |
{16}------------------------------------------------
| F1140/F1140M | for bursting | ||
|---|---|---|---|
| Chemical Indicators performancetesting as ISO 11140-1 | ChemicalIndicatorsperformance | EO indicator,Initial Color: Pink-> Signal Color:Yellow;Steam indicator,Initial Color: Blue-> Signal Color:Dark Green | Meet the acceptance criteria |
| Tensile strengthTesting as ASTM D882 | Tensile strength | >7.0 KN/m | Meet the acceptance criteria |
| Thickness testing as ASTMF2251 | Variation inthickness | $(138±3)$ µm | Meet the acceptance criteria |
| Air Permeability CoefficientTesting as ISO 5636-3 | Air PermeabilityCoefficient | > 8μm/Pa.s | Meet the acceptance criteria |
| Tear Strength testing as ASTMD1922 | Tear Strength | > 500 mN/15mm | Meet the acceptance criteria |
| Seal strength testing as ASTMF88 / F88M | Seal strength test | >4 N/15mm | Meet the acceptance criteria |
| Dye Penetration Testing asASTM F1929 | Dye PenetrationTest | No Dye Leakage | Meet the acceptance criteria |
| Dry Validation | Dry time | 10 mins | Meet the acceptance criteria |
{17}------------------------------------------------
- Clinical Test Conclusion 8.
No clinical study is included in this submission.
9. Conclusion
The conclusions drawn from the non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device(K143637)
§ 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).