U&U Sterilization Pouch and Roll

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure, with three profiles overlapping to suggest community and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 September 9, 2015 U&U Medical Technology Co., Ltd Mr. Garfield Wang General Manager Dongzhou Village, Hengshanqiao RM EE1092 1/F Building 1, No 1755 Hongmei Road Changzhou, Jiangsu China Re: K143637 Trade/Device Name: U&U Sterilization Pouch and Roll Regulation Number: 21 CFR 880.6850 Regulation Name: Sterilization Wrap Regulatory Class: II Product Code: FRG, JOJ Dated: August 2, 2015 Received: August 5, 2015 Dear Mr. 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. 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. {1}------------------------------------------------ Page 2 - Mr. Wang Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, **Tejashri Purohit-Sheth, M.D.** Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K143637 Device Name U&U Sterilization Pouch and Roll #### Indications for Use (Describe) | Form Approved: OMB No. 0910-0120 | |-----------------------------------| | Expiration Date: January 31, 2017 | | See PRA Statement below. | The U&U sterilization pouch and roll are intended to provide with an effective method to enclose devices intended for sterlization in steam and Ethylene Oxide (EtO). The recommended g r a vi t y steam sterilization vole parameters at 121°C. The recommended EiO sterlization cycle is 4 hours at 5°C with a relative humidity between 50%-55% and a sterilant of 600 mgL. Furthernon, the sterlization pouch and roll maintains the enclosed devices up until 90Days post sterial chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. STERILIZATION CYCLE: The recommended g r a v i t y steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes. Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55℃ (130 °F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85% RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C Sterilization 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 181bs. 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. {3}------------------------------------------------ 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." {4}------------------------------------------------ #### Load Types: The following matrix is the types of medical instruments used for steam and EtO sterilization. | Medical Device | Steam | EtO Gas | |------------------------------------------------------------------------------------------------------------|-------|---------| | Reusable surgical instruments such as clamps, scissors, retractors, pliers | X | X | | Endoscopes (thermostable) | X | X | | Endoscopes<br>(thermolabile) | - | X | | Reusable containers | X | - | | Elastic Products such as Rubber or latex (also combined), siliconelastomer, plastics, closed hollow bodies | X | X | | HF-cable and handpieces | X | X | | Powertools | X | X | | Textile Material such as surgical towels | X | X | {5}------------------------------------------------ U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Sterilization Pouch] Rev 1.00 09/09/15 # Sec 005_510(K) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92 Date Prepared: 2015-09-09 Submission Numbers for Pre-Submission: K143637 #### 1. Submitter Name and Address: | Name: | U&U Medical Technology Co., Ltd | |-----------------|---------------------------------------------------------------------------------------------------------------------------| | Address: | Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China<br>RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China | | Contactor Name: | Garfield Wang | | TEL: | +86-13902471751 | | E-mail: | Wangxuebo_11@hotmail.com | #### US Agent: | Name: | CARELIFE (USA) INC. | |------------------|----------------------------------------------| | Address: | 1580 Boggs Rd, Suite 500/600 Duluth GA 30096 | | TEL: | 404 6612228 | | Contact person : | Ms. LI QIAN liqian@shanghaicarelife.com | #### 2. Submission Devices Information: Trade/Proprietary Name: U&U Sterilization Pouch and Roll Common Name: Sterilization Pouch Classification name: 1) Sterilization wrap 2) Indicator, Physical/Chemical Sterilization Process 21 CFR 880.6850 & 21 CFR 880.2800 Class: Il FDA review panel code: General Hospital Product code: 1) FRG 2) JOJ #### 3. Predicate Devices Information: | Trade Name: | SIGMA Sterilization Pouch and Roll | |----------------|------------------------------------| | 510(K) Number: | K102158 | | Manufacturer: | SIGMA Medical Supplies Corp. | ## 4. Devices Description: The U&U Sterilization Pouch and Roll are manufactured from paper and medical plastic film that are heat sealed on three sides. The fourth side has an adhesive tape that is used to seal the pouch or heat-sealed by the heat-seal machine. The paper conforms to recognized material standards and can be sterilized by steam and Eto. The Sterilization Pouch has the same intended use, Essential Component, Raw material, Sterilization method, manufacturing methods and same technological characteristics as the predicate device. Substantial equivalent to the predicate device was established by physical testing of the sterilized finished devices, as well as, performance of these finished devices (seal strength, package burst, and dye migration). {6}------------------------------------------------ U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshangiao,Changzhou,Jiangsu,China U&U (Shanghai) Medical Technology Co., Limited RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China [Sterilization Pouch] Rev 1.00 09/09/15 ### 5. Model numbers of the pouches: | Ref<br>Number | Model<br>Number | Description | Size | |---------------|-----------------|---------------------------------------------|--------------| | UUPP0001 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 3" X 8" | | UUPP0002 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 4" X 10.25" | | UUPP0003 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 6" X 12.5" | | UUPP0004 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 4" X 14" | | UUPP0005 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 8" X 16" | | UUPP0006 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 6" X 16.5" | | UUPP0007 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 10" X 19" | | UUPP0008 | UUPP | STERILIZATION Pouch-Heat-Seal and Self-Seal | 12.5" X 22" | | UUPR0001 | UUPR | STERILIZATION Roll-Heat-seal | 3" X 228' | | UUPR0002 | UUPR | STERILIZATION Roll-Heat-seal | 4" X 228' | | UUPR0003 | UUPR | STERILIZATION Roll-Heat-seal | 6" X 228' | | UUPR0004 | UUPR | STERILIZATION Roll-Heat-seal | 14" X 228' | | UUPR0005 | UUPR | STERILIZATION Roll-Heat-seal | 16.5" X 228' | | UUPR0006 | UUPR | STERILIZATION Roll-Heat-seal | 20" X 228' | #### 5. Intended Use: The U&U sterilization pouch and roll are intended to provide health care workers with an effective method to enclose devices intended for sterilization in steam and Ethylene Oxide (EtO). The recommended gravity steam sterilization cycle parameters are 30 minutes at 121°C. The recommended EtO sterilization cycle is 4 hours at 55°C with a relative humidity between 50%-85% and a sterilant concentration of 600 mg/L. Furthermore, the sterilization pouch and roll maintains the enclosed devices up until 90 Davs post sterilization. Lastly, the pouch's external chemical ink indicators are designed to indicate to the user that the pouch has undergone either a steam or EtO sterilization process. #### STERILIZATION CYCLE: The recommended gravity steam sterilization cycle parameters Steam sterilization temperature: 121°C (250 °F) Steam sterilization time: 30 minutes. Drying time: 25 minutes The recommended EtO sterilization cycle parameters EtO sterilization temperature: 55°C (130 ° F) EtO sterilization time: 4 hour EtO sterilization humidity: 50% to 85%RH EtO sterilization concentration: 600mg/L Aeration time: 8 hours. Aeration Temperature: 60°C #### Sterilization load claim: Two types of sterilization loads were validated Load A: Metal medical instruments and Hand-control pen, the total weight are 24lb. The double pouched devices are placed into the baskets. Load B: Tubing (Silicone) and Surgical Towels. The total weight is 18lbs. ISEC 0051 {7}------------------------------------------------ #### Rev 1.00 09/09/15 #### Load Types: The following matrix is the types of medical instruments used to the sterilization: | Medical Device | Steam | EtO Gas | |------------------------------------------------------------------------------------------------------------------|-------|---------| | Reusable surgical instruments such as<br>clamps, scissors, retractors, pliers | X | X | | Reusable containers | X | - | | Elastic Products such as Rubber or latex<br>(also combined), siliconelastomer,<br>plastics, closed hollow bodies | X | X | | HF-cable and handpieces | X | X | | Powertools | X | X | | Textile Material such as surgical towels | X | X | #### 6. Technological Characteristics: All testing followed the following standards. AAMI/ANSI ST77 Containment devices for reusable medical device sterilization AAMI TIR22 Guidance for ANSI/AAMI/ISO 11607-Packaging for terminally sterilized medical devices-Part 1 and Part 2:2006 AAMI/ANS//ISO 11140-1 Sterilization of health care products - Chemical indicators - Part 1: General requirements ### 7. Performance Testing: Performance testing was conducted to show that the U&U Sterilization Pouch and Roll maintain sterility until the seal of the Pouch/Roll is opened. Performance Tests | Element | Results | |-----------------------------------------|---------| | Sterilant Penetration | PASSED | | Package Integrity | PASSED | | Maintenance of Package Integrity | PASSED | | Material Compatibility | PASSED | | Shelf-Life | PASSED | | Biocompatibility | PASSED | | Labeling | PASSED | | Configurations /Dimensions | PASSED | | Air permeance | PASSED | | Maintenance of Sterility | PASSED | | Endpoint stability of process indicator | PASSED | | Shelf Life of Process Indicator | PASSED | | Chemical Indicator Efficacy | PASSED | | Seal strength | PASSED | | Peel-open characteristic | PASSED | | Seal width | PASSED | | Self seal strength | PASSED | | Visual inspection | PASSED | {8}------------------------------------------------ | U&U ChangZhou Medical Packaging Technology Co., Ltd<br>Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China<br>U&U (Shanghai) Medical Technology Co., Limited<br>RM EE1092 1/F Building 1, No 1755, HONGMEI Road, Shanghai, China | 510(k) Submission | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|----------|--| | [Sterilization Pouch] | Rev 1.00 | 09/09/15 | | | Ethylene oxide residuals | PASSED | | | # 8. SUBSTANTIAL EQUIVALENCE DISCUSSION: Our Sterilization Pouch and the predicate device are same in intended use, components, materials, sterilization, and function. Side by side testing was conducted on the U&U Sterilization Pouch and Roll and SIGMA Sterilization pouch and roll - K102158 to determine substantial equivalence. Sterilant Penetration, Biocompatibility, Package Integrity, Material Compatibility, Sterility Maintenance were the parameters used to determine substantial equivalence and validate the safety and efficacy of the device. | Element of<br>Comparison | Submission Device | Predicate Device<br>K102158 | | | | | | | | | | | |--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--| | Intended Use | The U&U sterilization pouch and roll are<br>intended to provide health care workers<br>with an effective method to enclose<br>devices intended for sterilization in<br>steam and Ethylene Oxide (EtO). The<br>recommended gravity steam sterilization<br>cycle parameters are 30 minutes at<br>121 °C. The recommended Eto<br>sterilization cycle is 4 hours at 55 °C<br>with a relative humidity between 50%-<br>85% and a sterilant concentration of 600<br>mg/L. Furthermore, the sterilization<br>pouch and roll maintains the enclosed<br>devices up until 90Days post sterilization.<br>Lastly, the pouch's external chemical ink<br>indicators are designed to indicate to the<br>user that the pouch has undergone either<br>a steam or Eto sterilization process<br><br>STERILIZATION CYCLE:<br>The recommended gravity steam sterilization cycle<br>parameters<br>Steam sterilization temperature: 121°C (250 °F)<br>Steam sterilization time: 30 minutes.<br>Drying time: 25 minutes<br>The recommended Eto sterilization cycle parameters<br>Eto sterilization temperature: 55°C (130 ° F)<br>Eto sterilization time: 4 hour<br>Eto sterilization humidity: 50% to 85%RH<br>Eto sterilization concentration: 600mg/L<br>Aeration time: 8 hours.<br>Aeration Temperature: 60°C<br><br>Sterilization load claim:<br>Two types of sterilization loads were validated.<br><br>Load A: Metal medical instruments and Hand-control pen,<br>the total weight are 24lb. The double pouched devices are<br>placed into the baskets.<br>Load B: Tubing (Silicone) and Surgical Towels. The total<br>weight is 18lbs. | The SIGMA sterilization pouch and roll<br>are intended to provide health care<br>workers with an effective method to<br>enclose devices intended for sterilization<br>in steam and Ethylene Oxide (EtO). The<br>recommended steam sterilization cycle<br>parameters are 30 minutes at 121 °C.<br>The recommended Eto sterilization cycle<br>is 4 hours at 55 °C with a relative<br>humidity between 50%-85% and a<br>sterilant concentration of 600 mg/L.<br>Furthermore, the sterilization pouch and<br>roll maintains the enclosed devices up<br>until 2 years post sterilization. Lastly, the<br>pouch's external chemical ink indicators<br>are designed to indicate to the user that<br>the pouch has undergone either a steam<br>or EtO sterilization process | | | | | | | | | | | | | | | | | | | | | | | | | | | Medical Device Steam EtO Gas Reusable<br>surgical<br>instruments<br>such as clamps,<br>scissors,<br>retractors, pliers X X Reusable<br>containers X - | | | | | | | | | | | | {9}------------------------------------------------ U&U ChangZhou Medical Packaging Technology Co., Ltd Dongzhou Village,Hengshanqiao,Changzhou,Jiangsu,China (Shanghai) Medical Technology Co., Limited U&U (Shanghai) Medical Technology Co., Limited RM EEE0092 1/F Building 1, No 1755, HONGMEl Road, Shanghai, China [Sterilization Pouch] 510(k) Submission 09/09/15 Rev 1.00 | | Elastic Products<br>such as Rubber<br>or latex (also<br>combined).<br>siliconelastomer<br>, plastics,<br>closed hollow<br>bodies<br>HF-cable and | × | X | | |------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | handpieces | × | X | | | | Powertools | × | X | | | | Textile Material<br>such as surgical<br>towels | × | X | | | Material<br>Composition | Top Web - Medical Porous Paper<br>Bottom Web - Medical Plastic film(CPP)<br>Bottom Web - Medical two-sided adhesive tape<br>EtO gas indicator ink-Process Indicators class 1 | | | Top Web - Medical Porous Paper<br>Bottom Web - Medical Plastic film(CPP)<br>Bottom Web -Medical two-sided adhesive tape<br>EtO gas indicator ink-Process Indicators class 1 | | | Steam indicator ink-Process Indicators class 1 | | | Steam indicator ink-Process Indicators class 1 | | Sterilization<br>Cycles | The recommended gravity steam sterilization cycle<br>parameters are 30 minutes at 121 ℃. The<br>recommended EtO sterilization cycle is 4 hours at<br>55 ℃ with a relative humidity between 50%-85% and<br>a sterilant concentration of 600 mg/L. | | The recommended steam sterilization cycle parameters<br>are 30 minutes at 121 ℃. The recommended EtO<br>sterilization cycle is 4 hours at 55 ℃ with a relative<br>humidity between 50%-85% and a sterilant<br>concentration of 600 mg/L. | | | Confiqurations<br>/Dimensions | For Pouch:<br>Width: ±0.1"" Length ± 0.2""<br>For Roll:<br>Width: ±0.1"" Length ± 3% | | | For Pouch:<br>Width: ±0.1"" Length ± 0.2""<br>For Roll:<br>Width: ±0.1"" Length ± 3% | | Air permeance | The maximum equivalent pore size diameter shall not<br>exceed 50um. | | | The maximum equivalent pore size diameter shall not<br>exceed 50um. | | Sterilant<br>Penetration | Use the EN 868-2:1999 Annex C: Method for the<br>determination of the pore size, the pore size diameter is<br>40 to 44 um<br>The data is a little higher than the predicated device, The<br>difference can be accepted. | | Use the EN 868-2:1999 Annex C: Method for the<br>determination of the pore size, the pore size diameter is<br>38 to 43 um | | | Microbial Barrier<br>Properties<br>(Packaging<br>Integrity) | Use ASTM 1608 method, the LRV is more than 3.5<br>Use ASTM 1929 method, the inspection result is PASS<br>The data is a little higher than the predicated device, The<br>difference can be accepted. | | Use ASTM 1608 method, the LRV is 3.3<br>Use ASTM 1929 method, the inspection result is PASS | | | Material<br>Compatibility | After sterilization, the materials were not degraded | | After sterilization, the materials were not degraded | | | Toxicological<br>Properties(Bioco<br>mpatibility,<br>including<br>Sterilant Residue<br>Limits) | Meet ISO10993-4.Haemolysis Test (Direct-contract<br>Method), ISO10993-10, Test for Irritation (Intractaneous<br>Reactivity Test) and ISO10993-10, Test for Skin<br>sensitization (Maximization test) | | Meet ISO10993-4,Haemolysis Test (Direct-contract<br>Method), ISO10993-10, Test for Irritation (Intractaneous<br>Reactivity Test) and ISO10993-10, Test for Skin<br>sensitization (Maximization test) | | | Maintenance of<br>Sterility | 90 Days | | | 2 years | | Endpoint stability<br>of process<br>indicator | 90 Days | | 2 years | | | Shelf Life of<br>Process Indicator | 18 months | | 2 years | | | Drying time | 25 minutes | | 25 minutes | | | Aeration time | 8 hours at 60°C | | 8 hours at 60°C | | | Chemical<br>Indicator Efficacy | Changed color<br>EtO- YELLOW to COCOA; Steam- GREEN to PURPLE | | Changed color | | | | | | | | # 9. Conclusion: The performance testing data for the U&U Sterilization Pouch and Roll demonstrates substantial equivalence to the SIGMA Sterilization Pouch and Roll (K102158). END